Upload
others
View
7
Download
0
Embed Size (px)
Citation preview
CMA Submission to TGA on Consultation Draft TGO 92
Standards for the Labels of non-prescription medicines
Submission to
TGA Medicine Labelling Consultation
Management and Coordination Section
Office of Scientific Evaluation
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
labellingreviewtgagovau
From
Complementary Medicines Australia
PO Box 450
MAWSON ACT 2607
23 December 2015
Contents
PART 1 - CMA RESPONSE ON THE DRAFT TGO 92 5
Standard for the Labels of Non-Prescription Medicines 5
EXECUTIVE SUMMARY 6
General overview of comments on TGO 92 7
Section 7 General requirements including label presentation 7
Section 8 Info1mation to be included on the label 8
Section 9 Info1mation to be included on the main label 9
Section 10 Qualifications and special requirements 11
International hannonisation considerations - homeopathic naming conventions 13
Section 11 - How Info1mation is to be expressed 15
Use of appropriate rnetric units 15
Expression of quantity or propo1tion of active ingredients 15
Regulatory Impact Statement (RIS)- general requirements for labels of medicines version 10
August 2014 16
Transition a1Tange1nents 17
Schedule 1 - Substances or groups of substances present in medicines that are required to be declared on the label of medicines18
Schedule 2 - Specified Units for Enzymes 20
CMA comment on the Guideline for medicine labels draft version 10 October 2015 20
CMA resomces in reference to the labelling of complementa1y medicines 21
CMA detailed table of refo1m recommendations and impact of TGO 92 22
Appendix 1 - mock up labels to TGO 92 requirements 23
Page 3 of 23
PART 1- CMA RESPONSE ON THE DRAFT TGO 92
Standard for the Labels of Non-Prescription Medicines
Page 5 of 23
EXECUTIVE SUMMARY
Complementary Medicines Australia (CMA) welcomes the opportunity to provide a response
to the Therapeutic Goods Administration on its targeted consultation draft TGO 92 -
Standard for the labels of non-prescription medicines and related guidance document dated
October 2015 This submission follows from CMAs response to the Therapeutic Goods
Order for medicine labels (TGO 79) 2014 and the Medicine Labelling and Packaging Review
2012
In general complementary medicines (CMs) are lower-risk medicines As such the majority
of complementary medicines are self-selected by consumers necessitating the medicine
label as a vital information source allowing consumers to make informed purchasing
decisions and to use the medicine safely It is therefore in the interest of the community
that complementary medicine labelling be well designed and effective for its intended
purpose
Overall CMA supports the revision of the labelling Order into two separate Orders for
prescription medicines and non-prescription medicines including complementary
medicines This approach was supported in recognition that different types of medicines
present different levels of risk Following from this CMA also supports that these different
levels of risk are relevant within the registered non prescription type for example lower
risk registered complementary medicines
We support that the guidance document details a tiered approach in the recognition of
levels of risk within the registered medicine category and we have provided additional
comment around how this could be further clarified in the Order itself
CMA supports the aims of the review to the Labelling Order as outlined in the 2014
Regulatory Impact Statement1 are to address and prevent confusion and accidents such as
overdosing under medicating or medicating with the incorrect medicines that are
associated with unclear labelling on medicines It is important that label requirements aim
to ensure medicines supplied in Australia provide healthcare professionals and consumers
with access to information on the medicine including the active ingredient name and in the
case of over-the-counter medicines proper and safe usage
However our sector continues to outline that the increased regulatory requirements
required to implement TGO 92 outweigh the perceived benefit to the community in the
absence of any usage testing or extensive RIS calculations
CMA believes the cost to the complementary sector is disproportionate to the risk arising
from the sector particularly when weighing the likely benefit arising from the proposed
changes One of CMAs members estimates these changes will cost their business alone in
excess of $2 million for their complementary medicine range over the granted transition
period Overall CMA supports further improvements to processes be made within the
context of the existing framework
1 Regulation Impact Statement (RIS) - General requirements for labels for medicines 2014
httpswwwtgagovau sites defaultfilesconsult-labelling-medicines-140822-rispdf
Page 6 of 23
General overview of comments on TGO 92
We reiterate that the labelling of complementary medicines should be well designed and
effective for its intended purpose This has been explored during a number of labelling
consultations undertaken over the years however no evidence of consumer misuse due to
labelling of complementary medicines has been presented to CMA to indicate a change
required to the way in which these lower risk medicines (including homeopathic medicines)
should be labelled
Sponsors of listed medicines are already required to certify that the medicines meet a range
of requirements In particular they must certify that bull the medicine is eligible for Listing bull the presentation is not unacceptable bull the medicine is safe for the purposes for which it is to be used and bull evidence is held to support any claim made in relation to the medicine
As such there remains a number of requirements proposed in the redrafted Order that
appear unjustified and result in an unnecessary increase to the regulatory burden for this
sector
The Labelling Order as a legislative instrument will be legally enforceable by the TGA under
powers provided by the Therapeutic Goods Act 1989 The labelling Order will be supported
by best practice principles outlined in the Australian Regulatory Guidelines for
Complementary Medicines (ARGCM)
Aspects of the proposed Order could arguably be seen to be open to a level of
interpretation For example that the name of the medicine on the main label must be
presented in a continuous uninterrupted manner and not be broken up by additional
information or background text CMA considers any requirements that could be open to
interpretation should not be included in a legislative instrument as this is legally
enforceable rather it should be articulated clearly in best practice guidelines
CMA supports that the current mechanisms in place for the labelling of complementary
medicines are sufficient to promote the quality use of these medicines by consumers CMA
supports where not further indicated in this submission that the current labelling
requirements of TGO 69 be maintained for listed low risk medicines including homeopathic
medicines
Section 7 General requirements including label presentation
bull Labels must be in a colour or colours contrasting strongly with the background
As stated in the CMA 2014 submission ambiguous and subjective requirements should on
principle not be included in a legislative instrument
Page 7 of 23
Considering the guidance document elaborates on the proposed requirement CMA
reiterates that we are not aware of there being consumer safety issues of this nature
reported for CM products which are of a lower risk and hence consider the mandatory
requirement unjustified for this sector of goods
TGO 92 should be amended to include this as a best practice principle only in the guideline
for registered non prescriptions medicines excluding listed medicines and registered
complementary medicines
Section 8 Information to be included on the label
bull Section 8(2) Labels of registered medicines must provide information in a consistent -
order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important
information access to other information is also necessary for consumers to make an
informed purchasing decision
CMA is of the position that for lower risk registered medicines such as registered
complementary medicines there should be flexibility to present mandatory information in a
clear and concise manner without the constraint of a medicine information panel (MIP)
This will minimise unnecessary costs to the CM industry associated with resizing labels or
providing goods in larger container sizes with increased headspace
Section 155 of the Guidance document outlines that a medicine information panel is not
required for certain lower risk registered medicines - these are detailed in subsection 8(2)
of TGO 92 Subsection 8(2) however does not appear to detail specifically what types of
lower risk registered medicines would not require a MIP CMA suggests that this part of the
Order and guidance is expanded to include specifically that registered complementary
medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the
amendment impact registered complementary medicines mock up labels have been
provided to demonstrate that the requirement would necessitate a change to label sizes for
complementary medicines which is considered unjustified
CMA provides at the appendix example 1 a mock up of a registered complementary
medicine to demonstrate how the inclusion of a MIP would not work and necessitate
labelling complications and medicine container size considerations
Page 8 of 23
Section 9 Information to be included on the main label
bull Section 9(2) The name of medicine on the main label must be presented in a continuous uninterrupted manner and not be broken up by additional information or background text
bull Section 9(S) All text required by this Order to appear on the main label must be orientated in the same direction
CMA submits that the proposed requirements to orientate all text in the same direction on
the main label and for medicine names to be presented in a continuous and uninterrupted
manner would not for lower risk medicines have any meaningful impact upon consumer
safety and as such the change is considered unjustified for lower risk medicines
Feedback from our members indicates that medicine labels are often developed as a result
of consumer testing In addition CMA has not been presented with information that
consumers have any usability difficulties with the presentation of information on
complementary medicine labels
It is well documented that consumers generally select complementary medicines and nonshy
prescription medicines by brand and category and seek out brands that they know
Branding is important for complementary medicines and consumers are familiar with many
well-known brands of medicines for general well being cough and cold joint health bone
health and many other categories Limited label space is therefore an important issue
particularly for certain products and label types
Such a change would impact upon brand recognition for many companies As such CMA
considers this an unjustified change to requirements adding to unnecessary regulatory
burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact
on branding and does not require consequential changes to dimensions of packs or labels or
changes to the packaging details of a medicine
bull Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
bull Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 3 0millimeters on the front panel directly under the trade name
Given consumers use complementary medicines as part of self-care the label of these
medicines is the primary source of information for consumers This requirement would
mean that a large portion of the main label would be used to display the active ingredients
which are detailed on the label elsewhere
Page 9 of 23
Information on active ingredients is not always the most meaningful aspect in consumer self
selection of these goods rather information sought by consumers tends to be focused
around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space
and there will be reduced space to indicate the intended purpose of the product on the
front of pack If the container and label size are increased as a result of this without
increasing the number of tablets or capsules in the bottle this could give the consumer a
negative perception due to the increased head space of the container Ultimately this would
also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at the appendix example 1 a mock up of a registered complementary
medicine to demonstrate how the inclusion of 9 7)(a) would not work and necessitate
labelling complications and medicine container size considerations
bull Sec 9 (6) If the medicine is intended to be or is listed goods
(b) if there are four or more active ingredients in the medicine - the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on
As outlined in our 2014 submission subsection 9(6)(b) is not supported for inclusion in the
labelling Order The requirement for change to listed and registered complementary
medicines was not adequately justified from a risk perspective rather the requirements
appear to be a hangover from the risks perceived from the prescription and registered nonshy
prescription medicine sector
CMAs position on the number of active ingredients that may appear on the front of a label
for listed goods is that TGO 69 requirements be maintained
By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active
ingredients to four or more active ingredients that may be declared on a side panellabel or
rear panellabel This would increase the regulatory cost for these lower risk listed
medicines without any evidence of consumer benefit being presented
CMA suggests the following amendment to TGO 92
If the medicine is intended to be or is listed goods
6 b) if the medicine is a listed complementary medicine - the name of every active
ingredient together with the quantity or proportion of every active ingredient may appear
on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO
69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014
Page 10 of 23
CMA includes specific examples at appendix 1 example 2 impact on label size for listed
complementary medicines containing three active ingredients to be displayed on the front
of the label (currently they may be detailed at the side or rear)
bull Sec 9 (7) If the medicine is intended to be or is registered goods then
(a) where the medicine contains three or four active ingredients the name of the active
ingredient(s) and the quantity or proportion of active ingredient(s) must be displayed on
the main label in a text size of not less than 3 millimetres
(b) where the medicine contains four or more active ingredients and the requirements of
subsection 8(2) do not apply then the names and the quantities or proportion of the
active ingredients may be included on a side panellabel or rear panellabel when
displayed in a text size of not less than 2Smm
CMAs position on this section is that TGO 69 requirements be maintained
By imposing subsection 9(7)(b) would mean a requirement to go from two or more active
ingredients to four or more active ingredients that may be declared on a side panellabel or
rear panellabel This would increase the regulatory costs for registered complementary
medicines without any specific evidence of consumer benefit relating to this lower risk class
of good being presented
Within the complementary medicine category listed and registered complementary
medicines will be presented (depending on the number of active ingredients present) in a
different manner That is some will detail active ingredients at the front of the pack while
others (with 4 or more active ingredients) will detail the ingredients at the side or rear of
the pack CMA submits that for the purposes of standardisation and consistency on where
to find information for lower risk goods consumers should be encouraged to refer to the
backside of the pack for ingredient information
CMA provides a mock up of a registered CM provided to demonstrate how the inclusion of
9 (7)(a) would not work and necessitate labelling complications and medicine container size
considerations
Section 10 Qualifications and special requirements
Sec 10(3) amp Sec 10 (4)(a) where all the active ingredients in a medicine are homoeopathic
preparations the main label on the container and the main label on the primary pack (if
any) must in addition to the requirements referred to in sections 8 and 9 above include a
statement to the effect that the medicine is a homoeopathic medicine in text size that is
not less than 50 of the text size of the name of the medicine and (in any event) not less
than 2millimeters
Page 11of23
CMA does not support any additional change to this lower risk category of medicine
No explanation or justification has been provided during the course of labelling
consultations as to why there is a new mandatory requirement to include a statement on
the main label that the medicine is a homeopathic medicine or contains homeopathic
preparations in an increased font size to that of a general listed complementary medicine
No real explanation has been provided as to why an increase to the font size for the
statement homeopathic medicine was considered a requirement based on a consumer
safety perspective
Previous explanations for this addition has centred on factors that the statement is intended
to assist consumers with an appropriate selection for a medicine and minimise confusion
that may arise with self-selection However the current labelling Order requires there to
be a declaration that clearly states the product is homeopathic and contains homeopathic
ingredients on the front of the pack and the additional detail of this information on the back
of the pack in the ingredients and indications section would clearly justify the medicine as
being based in the homoeopathic paradigm As such CMA proposes that this section be
removed from the Order
bull Section 6 Interpretation in the Order Homeopathic medicines - naming conventions
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic
preparation (i) either the name of the active ingredient or the substance from which the
dilution was prepared that is accepted for inclusion in the Australian Approved Names
(AAN) List together with a statement of the homeopathic potency or (ii) until such time
as a name is accepted for inclusion in the Australian Approved Names List a traditional
homoeopathic name in full or as traditionally abbreviated with a statement of
homeopathic potency
Given the recent redraft of the labelling Order it is an opportune time to explore potential
amendments that aim to increase the clarity for requirements around homeopathic
medicines for both industry and the regulator
CMA submitted in May 2013 via the International Harmonisation of Ingredient Names
consultation that there appeared to be no mention of the naming of homoeopathic
ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS) traditional naming or
the application of new AAN homoeopathic names As such we resubmit information for
consideration here
It is suggested that an amendment be made to allow for homeopathic medicines
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
Page 12 of 23
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
That is the traditional homeopathic name is to be used as the primary name including the
AAN unless on small containers Both the traditional names and AANs could be included
on full website information which would allow additional space to elaborate on the naming
of traditional homeopathic ingredients (where required)
To implement this CMA proposes the following amendment to the definition of the name
of the active ingredient
(b) where the ingredient is a homoeopathic preparation
(i) the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency and the name that is also accepted for inclusion in the Australian Approved Names List (if available) in brackets
(ii) for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
It is in the consumers interest that traditional pharmacopeial names be amended so as to
be the primary name The concern here is that by enforcing the current definition and taking
the AAN name alone outside of the traditional context the consumer may only get the
name in its full chemicalnon homeopathic form causing potential confusion and or safety
concerns Additionally the AAN name alone (due to small label space requirements) may
appear as a different active ingredient all together causing consumer alarm
For example False Unicorn Root
Traditional homeopathic name AAN name
Helonias dioica Chamaelirium luteum
If a consumer wishes to know more about a homeopathic medicine ingredient many
sources of information (pharmacopoeias texts materia medica) refer to the traditional
name as the primary point of reference To elaborate further examples have been provided
(Appendix 1 example 5) with this submission
International harmonisation considerations - homeopathic naming
conventions
ACSS Consortium
Page 13 of 23
website
(httpwebprodhc-scgccanhpidshy
bdipsnatRegdoatid=homeopathy)
(httpljwwwhc-scgccadhp-mpsprodnaturlegislationdocsehmg-nprhshy
engphpaS)
The TGA is part of the ACSS Consortium along with Health Canada Health Sciences Authority of Singapore and Swissmedic According to the TGA the ACSS Consortium
was formed in 2007 by like-minded regulatory authorities to promote greater regulatory
collaboration and alignment of regulatory requirements with the goal of maximising
international cooperation reduce duplication and increase each agencys capacity to
ensure consumers have timely access to high quality safe and effective therapeutic
products
Heath Canada
The Health Canada website
provides guidance to industry for the preparation of
Product Licence Applications (PLAs) and labels for natural health product market
authorization for homeopathic products (updated July 2015) It states
bull The proper name(s) common name(s) and source material(s) must be as per the homeopathic
monograph referenced as the Standard or Grade (please refer to the specifications)
bull The medicinal ingredient(s) must be a permitted substance with a homeopathic monograph in one
of the Natural and Non-Prescription Health Products Directorate (NNHPD) accepted homeopathic
pharmacopoeia
The Standards or Grades refers to a list of homeopathic pharmacopoeias containing the
traditional homeopathic names
Health Canada also includes guidance for the labelling of homeopathic medicines on its
website
It includes the following guidance for labelling for small packages
53 Labels for Small Packages
The NNHPD recognizes that small packages such as those used by some homeopathic medicine manufacturers
may not have an area large enough for the inner labelling requirements Therefore separate small package
labelling requirements have been developed Please see the Labelling guidance document for infonnation
specific to small package labelling
SwissMedic
In Switzerland homeopathy has been fully integrated into the Swiss medical system
SwissMedics HAS (Homeopathic and Anthroposophical medicines) list includes both Latin
chemical names and their homeopathic synonyms It appears that homeopathic products in
Switzerland also allow for the use of homeopathic names on products labels (noting the
strong tradition of use of homeopathy in the region)
FDA
The FDA also recognises the traditional homeopathic names with HPUS as the standard The HPUS has labelling guidelines for homeopathic medicines2 that links in with the labelling
2 httpwwwhpuscomRevised-Labeling-Guidelines-04-14pdf
Page 14 of 23
provisions of Sections 502 and 503 of the Federal Food Drug and Cosmetic Act Part 201
Title 21 of the Code of Federal Regulations (CFR) and the FDAs Compliance Policy Guide
400400
Section 11 How Information is to be expressed -
Use of appropriate metric units
bull Sec 11 (l)(b) The abbreviations to mg and g can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation microg may be used
Where several ingredients are presented on a label statement in microgram microliter
quantities the repetition of expressing the unit in full greatly expands the length of the text
and hence label space becomes an important issue
Further CMA questions if the requirement is mandatory given it is expressed as should in
the standard compared to must in the guideline
This proposed requirement if mandatory does not allow for consistency on the label and
increased label space is required CMA submits that an abbreviated form of microgram
should be permitted in the standard
Expression of quantity or proportion of active ingredients
Sec 11 (2) Expression of quantity or propo1iion of active ingredients
11(2)(i) states that in addition to the requirements of paragraphs 1 1(2)(a)-1 1(2)(h) and
therefore includes 1 1 (2)( a) the quantity of the active ingredient
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the
herbal material from which the preparation was derived except
This amendment appears to propose that herbal ingredients include the actual amount of
herbal extract in addition to the equivalent amount of starting herbal material from which
the preparation was derived
As detailed in our 2014 submission we do not support the increased information
requirements for the expression of herbal medicines to be expanded on the medicine label
(section 11(2))
The 2014 consultation suggested the reasoning for the additional requirement to include
the input amount of the herbal material on the label was that it enables the consumer to
Page lS of 23
version
gain meaningful information in relation to the strength concentration or quantified levels
in general of the herbal ingredients in the medicine
To implement this requirement however it would require the addition of an extra line of
information for each herbal material ingredient to express both quantities on the medicine
label The majority of complementary medicines are multi ingredient formulations
sometimes with as many as 25 ingredients in a product The addition of at least two lines to
express each herbal ingredient would for the average consumer most likely only create
confusion as to which line of expression to draw a meaningful conclusion from
The main concern is that this would lead to two quantification values for the same inputted
ingredient which would be open to misunderstanding and if other than the native extract
amount potentially no more helpful to the consumer Additionally this requirement does
not appear to impact upon the safe or proper usage of the medicine if used within the
context outlined on the label
CMA considers that this requirement would significantly increase the regulatory burden of
lower risk medicines by increasing the amount of information required on a label and hence
label size Label space will become an issue and an impracticality pushed to some degree
and with an obscure label this could lead to other potentially misleading packaging issues
We again provide mock up labels at the appendix to demonstrate this significant increase in
requirement
Clear concise labelling of ingredients with one quantity the extract equivalent of the herb
provides consumers with satisfactory information that allows comparison with other
products
CMA requests that TGA provides a detailed reasoning behind the proposed amendment
including evidence that the current requirement is impacting on the safe and proper usage
of listed medicines if that is the case In the absence of this information CMA does not
support implementing this section of the labelling Order and that it be drafted without this
specific requirement
CMA provides a mock up label at the appendix 1 example 3 to demonstrate the increased
requirements to listed low risk medicines
Regulatory Impact Statement (RIS)- general requirements for labels of medicines version 10 August 2014
The TGA provided a regulatory impact statement and other supporting documents3 as
evidence in support of a change to the labelling of medicines the proposed changes were
however largely based on the risk profile associated with prescription and registered over
the counter medicines with no direct reference to misuse of complementary medicines in
3 Labelling and packaging practices 10 January 2013 fileCUserstechnicalDownloadsconsultshy
labelling-packaging-review-1205 24-an alysis-evidencepdf
Page 16 of 23
the context of self-selection being outlined The extra regulatory requirements for labelling
and packaging of complementary medicines are considered to be out of proportion to the
risk classifications of these medicines
The 2014 consultation highlighted that due to lower risk medicines being available for self selection this factor alone poses a risk as the consumer receives no additional information
except the instructions on the label Indeed while this highlights the importance of the
information on the medicine label no evidence has been provided that the proposed
changes would contribute to the provision of better consumer information or safety A
change to the amount of active ingredients that can be included on the front of the
medicine label and additional information around the expression of herbal ingredients for
example are proposals for change that are not supported by CMA as they have not been
evidenced to be a safety issue nor undergone consumer use testing to demonstrate any
improvement on the status quo would be gained In summary they will have little affect on
consumers self-selection
The 2014 labelling consultation included a regulatory impact statement which from an
industry point of view grossly underestimated the cost of changes
Copy from the RIS
The labour burden for businesses who need to change a label would be
approximately 20 hours (includes reading the current guidance and applying it to
their design work and the small amount of labour involved in providing new label
information as part of the application to vary the entry) at a labour rate of $42 per
hour
The additional requirements proposed in the Order and schedule 1 will result in all
companies conducting a review of each medicine formulation checking for compliance to
these revised requirements It is estimated that the $42 per hour labour rate above would
increase to approximately $60 per hour for the time required to carry out the review One
member estimates that the labour hours would increase from 20 to 30 hours and takes into
account that different sections within an organisation and external organisations are
involved in obtaining documentation for example suppliers distributors manufacturers
Testing may also be required to confirm if any allergen residue remains in the raw material
Transition arrangements
CMA notes that the proposed transition arrangement includes a four year period where by
compliance with the current labelling Order (TGO 69) or the revised TGO 92 would be
permitted By 2020 full compliance with TGO 92 would be required While this is an
improvement from the 2014 proposal CMA highlights that further refinements to TGO 92 is
required to reduce the regulatory burden for complementary medicines
Page 17 of 23
Should the Order be implemented as currently drafted there will be many complementary
medicine businesses that would be negatively impacted Not in the lest many small ownershy
operator complementary medicine businesses would not generally be in the practice of
changing their medicine labels every few years as indicated in the TGA RIS document
The transition period will also be particularly problematic where the labelled information
will differ despite no change in formulation eg change in apparent quantification
ingredient name or ingredient placement
The RIS document also detailed that the new labelling Order would be a one-off cost for
those businesses that would not be changing their labels during the transition period
The 2014 participants in the TGA industry survey included larger CM company
representatives and therefore is only indicative of that sector of the industry
Specifically the RIS did not look at the fact that smaller companies would employ the skills
of professional consultants to carry out the work required to ensure compliance with the
new labelling Order This cost factor alone for changes proposed to lower risk listed
medicines is considered an unnecessary additional regulatory burden that would not
necessarily equate to any consumer self-medication benefit
CMA submits that the focus of the TGA be one of reducing the regulatory burden enhancing
efficiencies in existing process whilst upholding the safety and quality of complementary
medicines available to consumers For these reasons CMA submits that further refinements
to TGO 92 be made to accommodate lower risk medicines
Schedule 1 Substances or groups of substances present in medicines -
that are required to be declared on the label of medicines
It appears that some inconsistencies remain in the declaration statement of certain
substances in Schedule 1 of TGO 92 compared to warning statements generated on the
ARTG
Ethanolalcohol
This group of substances to be declared on the label is not consistent with the ARTG
generated warning for ethanolalcohol
bull Contains alcohol vs contains ethanol (vv)
Ethanol as one of the substances required to be declared on the label can carry the
declaration contains alcohol However the same ingredient warning that is generated on
the ARTG for use if this ingredient is in the formula as a listed excipient is ETHAN contains
ethanol (or words to that effect)
Recommendations
Page 18 of 23
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is consistent
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label if the situation arises where there is already an ARTG
generated ethanol warning
Other ingredients such as potassium sorbate already generate ARTG warnings if listed as
excipients and is also in the group of substances required to be declared on the label
Again the wording used is inconsistent
ARTG warning SORB8 (If the medicine contains one sorbate) Contains [insert name of
sorbate] OR (if medicine contains two or more sorbates) Contains sorbates [or words to that
effect]
bull Contains sorbates vs contains [inse1i name of sorbate] (if the medicine contains one sorbate) or contains sorbates (if the medicine contains two or more sorbates) in the
event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have Contains potassium sorbate
whilst it would read Contains sorbates to comply with schedule 1 of TGO 92
Recommendations
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is
consistent If the product contains one sorbate eg potassium sorbate ARTG warning
is Contains potassium sorbate however TGO 92 declaration is Contains sorbates
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label in these situations
Phenylalanine
Many mineral amino acid chelates contain phenylalanine as part of the amino acid portion
of the mineral and ingredients such as Spirulina whole cell powder would contain
phenylalanine as part of its protein profile CMA proposes that the schedule 1 list include
additional information as to what ingredients the phenylalanine warning applies to or
outline the ingredients such as those mentioned above that are exempt from the
requirement
Imposing such requirements to all ingredients may cause unnecessary concern to the
consumer
Page 19 of 23
PU
Schedule 2 Specified Units for Enzymes -
bull CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients Papain Units Bromelain
Currently the TBS only allows the quantity of the ingredient to be expressed in milligrams
(mg) Pervious considerations of this issue has identified that the per mg expression is not
the most appropriate for the material Whilst GOU (gelatine digesting unit) is acknowledged
to be the unit most commonly used for the material papain unit is proposed as this is the
specified unit from bromelain by the joint FAOWHO expert committee on Food Additives
(JECFA) the Food Chemical Codex and the unit adopted by Health Canada in its
monographs for Stem bromelian and fruit bromelian We note also that there is a simple
conversion factor that can be applied to quantities expressed as GOU
CMA comment on the Guideline for medicine labels draft version 10
October 2015
bull 3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA proposes the
removal (of Camellia sinensis) after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation
and herbal material and quantity of standardised constituent) would be expressed
together This reiteration appears to be redundant and would take up more space on the
label
bull Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] Ingredients Uses or What this medicine is used for Warnings Directions for use and Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a
specified order) needs to be followed for listed medicines
Page 2 0 of 23
Labelling
Labelling packaging Complementary
Labelling Packaging
CMA interprets the revised TGO 92 update to mean that this would no longer be a
requirement However we have provided a mock up label at appendix 1 example 4 to
demonstrate how this requirement if relevant would impact multi ingredient herbal
medicines
CMA resources in reference to the labelling of complementary
medicines
bull CMA submission Consultation Draft TGO 79 Standards for the of Medicines
(November 2014) bull CMA submission and of Medicines (12 April
2013) bull CMA submission on the Medicine and Review (24 August 2012)
Page 21of23
CMA detailed table of reform recommendations and impact of TGO 92
Page 22 of 23
Appendix 1 - mock up labels to TGO 92 requirements
Page 23 of 23
CMA response to TGO 92- Standards for the labels of non-prescription medicines
Proposed Requirement TGO 92 Industry response
Text size In principle CMA agrees with the change that reverts back to the current TGO 69 definition of text size This is in comparison to the consultation draft TGO79 that proposed a range of sizes for listed and registered
ldquoText size equivalent to Arial fontrdquo complementary medicines based on Arial point size font has been removed from TGO 92 The definition for letter height is the same as the definition in TGO 69
Sec 7 General requirements including As stated in the CMA 2014 submission ambiguous and subjective requirements should on principle not be included in a label presentation legislative instrument (2)(e) Considering the guidance document elaborates on the proposed requirement CMA reiterates that we are not aware of there Labels must be in a colour or colours being consumer safety issues of this nature reported for CM products which are of a lower risk and hence consider the contrasting strongly with the mandatory requirement unjustified background Sec 8(2) Labels of registered medicines must provide information in a consistent order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important information access to other information is also necessary for consumers to make an informed purchasing decision CMA is of the position that for lower risk registered medicines such as registered complementary medicines there should be flexibility to present mandatory information in a clear and concise manner without the constraint of a medicine information panel (MIP) This will minimise cost to the CM industry associated with resizing labels or providing goods in larger container sizes with increased headspace Section 155 of the Guidance document outlines that ldquoa medicine information panel is not required for certain lower risk
Proposed Requirement TGO 92 Industry response
registered medicines ndash these are detailed in subsection 8(2) of TGO 92rdquo Subsection 8(2) however does not appear to detail specifically what types of lower risk registered medicines would not require a MIP CMA suggests that this part of the guidance is expanded to include specific guidance that registered complementary medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the amendment impact registered complementary medicines mock up labels have been provided to demonstrate that the requirement would necessitate a change to label sizes for complementary medicines which is considered unjustified
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of a MIP would not work and necessitate labelling complications and medicine container size considerations
Sec 8 (1) (k) (ii) (B) Pregnancy database
Requirements related tot his section should be incorporated on an ingredient by ingredient basis within the 26BB list of permissible ingredients instrument Pregnancy database - Add link httpswwwtgagovauprescribing-medicines-pregnancy-database
Sec 9 (2) CMA considers the proposed requirements to orientate all text in the same direction on the main label and for medicine names to be presented in a continuous and uninterrupted manner would not have a meaningful impact upon consumer
The name of the medicine on the main safety and as such the change is considered unjustified for lower risk medicines label must be presented in a continuous uninterrupted manner and Feedback from our members indicates that medicine labels are often developed as a result of consumer testing not be broken up by additional In addition CMA has not been presented with information that consumers have any usability difficulties with the information or background text presentation of information on complementary medicine labels Sec 9 (5) All text required by this Order to It is well documented that consumers generally select complementary medicines and non-prescription medicines by brand appear on the main label must be and category and seek out brands they know Branding is important for complementary medicines and consumers are orientated in the same direction familiar with many well-known brands of medicines for general wellbeing cough and cold allergy skincare and many
other categories Limited label space is therefore an important issue particularly for certain product and label types
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 2 of 12
Proposed Requirement TGO 92 Industry response
Such a change would impact upon brand recognition for many companies As such CMA considers this as an unjustified change to requirements adding to unnecessary regulatory burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact on branding and does not require consequential changes to dimensions of packs or labels or changes to the packaging details of a medicine
Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 30millimeters on the front panel directly under the trade name
Since consumers use complementary medicines as part of self-care the label of these medicines is the primary source of information for consumers This requirement would mean that a large portion of the label would be used to display the active ingredients Information on active ingredients is not always the most meaningful aspect in consumer self selection of these goods rather information sought by consumers tends to be focused around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space and there will be reduced space to indicate the intended purpose of the product on the front of pack If the container and label size are increased as a result of this without increasing the number of tablets or capsules in the bottle this could give the consumer a negative perception due to the increased head space of the container Ultimately this would also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations
Sec 9 (6) CMArsquos position on the number of active ingredients that may appear on the front of a label for listed goods is that TGO 69 If the medicine is intended to be or is requirements be maintained listed goods By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active ingredients to four or more (b) if there are four or more active active ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for ingredients in the medicine - the name these lower risk listed medicines without any evidence of consumer benefit being presented of every active ingredient together with the quantity or proportion of CMA suggests the following amendment to TGO 92 every active ingredient may appear on
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 3 of 12
Proposed Requirement TGO 92 Industry response
a side panel or side label or on a rear panel or rear label
If the medicine is intended to be or is listed goods 6 b) if the medicine is a listed complementary medicine ndash the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO 69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014 CMA includes specific examples where for listed CMs containing three active ingredients to be displayed on the front of the label where previously they would be detailed at the side or rear how this would impact on label size being inappropriate for the packaging
Sec 9 (7) CMA proposed that TGO 69 requirements be maintained If the medicine is intended to be or is registered goods then By imposing subsection 9(7)(b) would mean a requirement to go from two or more active ingredients to four or more active
ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for (a) where the medicine contains three registered complementary medicines without any specific evidence of consumer benefit relating to this lower risk class of or four active ingredients the name of good being presented the active ingredient(s) and the quantity or proportion of active Within the complementary medicine category listed and registered complementary medicines will be presented (depending ingredient(s) must be displayed on the on the number of active ingredients present) in a different manner That is some will detail active ingredients at the front of main label in a text size of not less the pack while others (with 4 or more active ingredients) will detail the ingredients at the side or rear of the pack CMA than 3 millimetres submits that for the purposes of standardisation of where to find information consumers should be encouraged to refer to
the backside of the pack for ingredient information (b) where the medicine contains four or more active ingredients and the CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of requirements of subsection 8(2) do not 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations apply then the names and the See comments at Sec 9 (7)(a) above quantities or proportion of the active ingredients may be included on a side panellabel or rear panellabel when
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 4 of 12
Proposed Requirement TGO 92 Industry response
displayed in a text size of not less than 25mm
Sec 10(3) amp Sec 10 (4)(a) CMA does not support any additional change to this lower risk category of medicine
Homeopathic medicines No explanation or justification has been provided as to why there is a new mandatory requirement to include a statement on Where all the active ingredients in a the main label that the medicine is a homeopathic medicine or contains homeopathic preparations in an increased font size to medicine are homoeopathic that of a general listed complementary medicine preparations the main label on the No real explanation has been provided as to why an increase to the font size for the statement ldquohomeopathic medicinerdquo was container and the main label on the considered a requirement based on a consumer safety perspective primary pack (if any) must in addition to the requirements referred Previous explanations for this addition has centred around that the statement is intended to assist consumers with an to in sections 8 and 9 above include a appropriate selection for a medicine and minimise confusion that may arise with self-selection However the current statement to the effect that the labelling Order requires there to be a declaration that clearly states the product is homeopathic and contains homeopathic medicine is a homoeopathic medicine ingredients on the front of the pack and the additional detail of this information on the back of the pack in the ingredients in text size that is not less than 50 and indications section would clearly justify the medicine as being based in the homoeopathic paradigm of the text size of the name of the As such CMA proposes that this section be removed from the Order medicine and (in any event) not less than 2millimeters
Sec 6 CMA submitted in May 2013 via the International Harmonisation of Ingredient Names consultation that there appeared to be no mention of the naming of homoeopathic ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS)
Interpretation in this Order traditional naming or the application of new AAN homoeopathic names As such we resubmit information for consideration here
Homoeopathic medicines ndash naming conventions
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 5 of 12
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation (i) either the name of the active ingredient or the substance from which the dilution was prepared that is accepted for inclusion in the Australian Approved Names (AAN) List together with a statement of the homeopathic potency or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency
It is suggested that an amendment be made to allow for homeopathic medicines The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
To implement this CMA proposes the following amendment to the definition of the name of the active ingredient
(b) where the ingredient is a homoeopathic preparation
1 the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency in brackets the name that is also accepted for inclusion in the Australian Approved Names List
2 for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
That is the traditional homeopathic name to be used as the primary name including the AAN unless on ldquosmall containersrdquo Both the traditional names and AAN could be included on full website information which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required)
It is in the consumersrsquo interest that traditional pharmacopeial names be amended as the primary name The concern here is
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
Contents
PART 1 - CMA RESPONSE ON THE DRAFT TGO 92 5
Standard for the Labels of Non-Prescription Medicines 5
EXECUTIVE SUMMARY 6
General overview of comments on TGO 92 7
Section 7 General requirements including label presentation 7
Section 8 Info1mation to be included on the label 8
Section 9 Info1mation to be included on the main label 9
Section 10 Qualifications and special requirements 11
International hannonisation considerations - homeopathic naming conventions 13
Section 11 - How Info1mation is to be expressed 15
Use of appropriate rnetric units 15
Expression of quantity or propo1tion of active ingredients 15
Regulatory Impact Statement (RIS)- general requirements for labels of medicines version 10
August 2014 16
Transition a1Tange1nents 17
Schedule 1 - Substances or groups of substances present in medicines that are required to be declared on the label of medicines18
Schedule 2 - Specified Units for Enzymes 20
CMA comment on the Guideline for medicine labels draft version 10 October 2015 20
CMA resomces in reference to the labelling of complementa1y medicines 21
CMA detailed table of refo1m recommendations and impact of TGO 92 22
Appendix 1 - mock up labels to TGO 92 requirements 23
Page 3 of 23
PART 1- CMA RESPONSE ON THE DRAFT TGO 92
Standard for the Labels of Non-Prescription Medicines
Page 5 of 23
EXECUTIVE SUMMARY
Complementary Medicines Australia (CMA) welcomes the opportunity to provide a response
to the Therapeutic Goods Administration on its targeted consultation draft TGO 92 -
Standard for the labels of non-prescription medicines and related guidance document dated
October 2015 This submission follows from CMAs response to the Therapeutic Goods
Order for medicine labels (TGO 79) 2014 and the Medicine Labelling and Packaging Review
2012
In general complementary medicines (CMs) are lower-risk medicines As such the majority
of complementary medicines are self-selected by consumers necessitating the medicine
label as a vital information source allowing consumers to make informed purchasing
decisions and to use the medicine safely It is therefore in the interest of the community
that complementary medicine labelling be well designed and effective for its intended
purpose
Overall CMA supports the revision of the labelling Order into two separate Orders for
prescription medicines and non-prescription medicines including complementary
medicines This approach was supported in recognition that different types of medicines
present different levels of risk Following from this CMA also supports that these different
levels of risk are relevant within the registered non prescription type for example lower
risk registered complementary medicines
We support that the guidance document details a tiered approach in the recognition of
levels of risk within the registered medicine category and we have provided additional
comment around how this could be further clarified in the Order itself
CMA supports the aims of the review to the Labelling Order as outlined in the 2014
Regulatory Impact Statement1 are to address and prevent confusion and accidents such as
overdosing under medicating or medicating with the incorrect medicines that are
associated with unclear labelling on medicines It is important that label requirements aim
to ensure medicines supplied in Australia provide healthcare professionals and consumers
with access to information on the medicine including the active ingredient name and in the
case of over-the-counter medicines proper and safe usage
However our sector continues to outline that the increased regulatory requirements
required to implement TGO 92 outweigh the perceived benefit to the community in the
absence of any usage testing or extensive RIS calculations
CMA believes the cost to the complementary sector is disproportionate to the risk arising
from the sector particularly when weighing the likely benefit arising from the proposed
changes One of CMAs members estimates these changes will cost their business alone in
excess of $2 million for their complementary medicine range over the granted transition
period Overall CMA supports further improvements to processes be made within the
context of the existing framework
1 Regulation Impact Statement (RIS) - General requirements for labels for medicines 2014
httpswwwtgagovau sites defaultfilesconsult-labelling-medicines-140822-rispdf
Page 6 of 23
General overview of comments on TGO 92
We reiterate that the labelling of complementary medicines should be well designed and
effective for its intended purpose This has been explored during a number of labelling
consultations undertaken over the years however no evidence of consumer misuse due to
labelling of complementary medicines has been presented to CMA to indicate a change
required to the way in which these lower risk medicines (including homeopathic medicines)
should be labelled
Sponsors of listed medicines are already required to certify that the medicines meet a range
of requirements In particular they must certify that bull the medicine is eligible for Listing bull the presentation is not unacceptable bull the medicine is safe for the purposes for which it is to be used and bull evidence is held to support any claim made in relation to the medicine
As such there remains a number of requirements proposed in the redrafted Order that
appear unjustified and result in an unnecessary increase to the regulatory burden for this
sector
The Labelling Order as a legislative instrument will be legally enforceable by the TGA under
powers provided by the Therapeutic Goods Act 1989 The labelling Order will be supported
by best practice principles outlined in the Australian Regulatory Guidelines for
Complementary Medicines (ARGCM)
Aspects of the proposed Order could arguably be seen to be open to a level of
interpretation For example that the name of the medicine on the main label must be
presented in a continuous uninterrupted manner and not be broken up by additional
information or background text CMA considers any requirements that could be open to
interpretation should not be included in a legislative instrument as this is legally
enforceable rather it should be articulated clearly in best practice guidelines
CMA supports that the current mechanisms in place for the labelling of complementary
medicines are sufficient to promote the quality use of these medicines by consumers CMA
supports where not further indicated in this submission that the current labelling
requirements of TGO 69 be maintained for listed low risk medicines including homeopathic
medicines
Section 7 General requirements including label presentation
bull Labels must be in a colour or colours contrasting strongly with the background
As stated in the CMA 2014 submission ambiguous and subjective requirements should on
principle not be included in a legislative instrument
Page 7 of 23
Considering the guidance document elaborates on the proposed requirement CMA
reiterates that we are not aware of there being consumer safety issues of this nature
reported for CM products which are of a lower risk and hence consider the mandatory
requirement unjustified for this sector of goods
TGO 92 should be amended to include this as a best practice principle only in the guideline
for registered non prescriptions medicines excluding listed medicines and registered
complementary medicines
Section 8 Information to be included on the label
bull Section 8(2) Labels of registered medicines must provide information in a consistent -
order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important
information access to other information is also necessary for consumers to make an
informed purchasing decision
CMA is of the position that for lower risk registered medicines such as registered
complementary medicines there should be flexibility to present mandatory information in a
clear and concise manner without the constraint of a medicine information panel (MIP)
This will minimise unnecessary costs to the CM industry associated with resizing labels or
providing goods in larger container sizes with increased headspace
Section 155 of the Guidance document outlines that a medicine information panel is not
required for certain lower risk registered medicines - these are detailed in subsection 8(2)
of TGO 92 Subsection 8(2) however does not appear to detail specifically what types of
lower risk registered medicines would not require a MIP CMA suggests that this part of the
Order and guidance is expanded to include specifically that registered complementary
medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the
amendment impact registered complementary medicines mock up labels have been
provided to demonstrate that the requirement would necessitate a change to label sizes for
complementary medicines which is considered unjustified
CMA provides at the appendix example 1 a mock up of a registered complementary
medicine to demonstrate how the inclusion of a MIP would not work and necessitate
labelling complications and medicine container size considerations
Page 8 of 23
Section 9 Information to be included on the main label
bull Section 9(2) The name of medicine on the main label must be presented in a continuous uninterrupted manner and not be broken up by additional information or background text
bull Section 9(S) All text required by this Order to appear on the main label must be orientated in the same direction
CMA submits that the proposed requirements to orientate all text in the same direction on
the main label and for medicine names to be presented in a continuous and uninterrupted
manner would not for lower risk medicines have any meaningful impact upon consumer
safety and as such the change is considered unjustified for lower risk medicines
Feedback from our members indicates that medicine labels are often developed as a result
of consumer testing In addition CMA has not been presented with information that
consumers have any usability difficulties with the presentation of information on
complementary medicine labels
It is well documented that consumers generally select complementary medicines and nonshy
prescription medicines by brand and category and seek out brands that they know
Branding is important for complementary medicines and consumers are familiar with many
well-known brands of medicines for general well being cough and cold joint health bone
health and many other categories Limited label space is therefore an important issue
particularly for certain products and label types
Such a change would impact upon brand recognition for many companies As such CMA
considers this an unjustified change to requirements adding to unnecessary regulatory
burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact
on branding and does not require consequential changes to dimensions of packs or labels or
changes to the packaging details of a medicine
bull Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
bull Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 3 0millimeters on the front panel directly under the trade name
Given consumers use complementary medicines as part of self-care the label of these
medicines is the primary source of information for consumers This requirement would
mean that a large portion of the main label would be used to display the active ingredients
which are detailed on the label elsewhere
Page 9 of 23
Information on active ingredients is not always the most meaningful aspect in consumer self
selection of these goods rather information sought by consumers tends to be focused
around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space
and there will be reduced space to indicate the intended purpose of the product on the
front of pack If the container and label size are increased as a result of this without
increasing the number of tablets or capsules in the bottle this could give the consumer a
negative perception due to the increased head space of the container Ultimately this would
also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at the appendix example 1 a mock up of a registered complementary
medicine to demonstrate how the inclusion of 9 7)(a) would not work and necessitate
labelling complications and medicine container size considerations
bull Sec 9 (6) If the medicine is intended to be or is listed goods
(b) if there are four or more active ingredients in the medicine - the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on
As outlined in our 2014 submission subsection 9(6)(b) is not supported for inclusion in the
labelling Order The requirement for change to listed and registered complementary
medicines was not adequately justified from a risk perspective rather the requirements
appear to be a hangover from the risks perceived from the prescription and registered nonshy
prescription medicine sector
CMAs position on the number of active ingredients that may appear on the front of a label
for listed goods is that TGO 69 requirements be maintained
By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active
ingredients to four or more active ingredients that may be declared on a side panellabel or
rear panellabel This would increase the regulatory cost for these lower risk listed
medicines without any evidence of consumer benefit being presented
CMA suggests the following amendment to TGO 92
If the medicine is intended to be or is listed goods
6 b) if the medicine is a listed complementary medicine - the name of every active
ingredient together with the quantity or proportion of every active ingredient may appear
on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO
69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014
Page 10 of 23
CMA includes specific examples at appendix 1 example 2 impact on label size for listed
complementary medicines containing three active ingredients to be displayed on the front
of the label (currently they may be detailed at the side or rear)
bull Sec 9 (7) If the medicine is intended to be or is registered goods then
(a) where the medicine contains three or four active ingredients the name of the active
ingredient(s) and the quantity or proportion of active ingredient(s) must be displayed on
the main label in a text size of not less than 3 millimetres
(b) where the medicine contains four or more active ingredients and the requirements of
subsection 8(2) do not apply then the names and the quantities or proportion of the
active ingredients may be included on a side panellabel or rear panellabel when
displayed in a text size of not less than 2Smm
CMAs position on this section is that TGO 69 requirements be maintained
By imposing subsection 9(7)(b) would mean a requirement to go from two or more active
ingredients to four or more active ingredients that may be declared on a side panellabel or
rear panellabel This would increase the regulatory costs for registered complementary
medicines without any specific evidence of consumer benefit relating to this lower risk class
of good being presented
Within the complementary medicine category listed and registered complementary
medicines will be presented (depending on the number of active ingredients present) in a
different manner That is some will detail active ingredients at the front of the pack while
others (with 4 or more active ingredients) will detail the ingredients at the side or rear of
the pack CMA submits that for the purposes of standardisation and consistency on where
to find information for lower risk goods consumers should be encouraged to refer to the
backside of the pack for ingredient information
CMA provides a mock up of a registered CM provided to demonstrate how the inclusion of
9 (7)(a) would not work and necessitate labelling complications and medicine container size
considerations
Section 10 Qualifications and special requirements
Sec 10(3) amp Sec 10 (4)(a) where all the active ingredients in a medicine are homoeopathic
preparations the main label on the container and the main label on the primary pack (if
any) must in addition to the requirements referred to in sections 8 and 9 above include a
statement to the effect that the medicine is a homoeopathic medicine in text size that is
not less than 50 of the text size of the name of the medicine and (in any event) not less
than 2millimeters
Page 11of23
CMA does not support any additional change to this lower risk category of medicine
No explanation or justification has been provided during the course of labelling
consultations as to why there is a new mandatory requirement to include a statement on
the main label that the medicine is a homeopathic medicine or contains homeopathic
preparations in an increased font size to that of a general listed complementary medicine
No real explanation has been provided as to why an increase to the font size for the
statement homeopathic medicine was considered a requirement based on a consumer
safety perspective
Previous explanations for this addition has centred on factors that the statement is intended
to assist consumers with an appropriate selection for a medicine and minimise confusion
that may arise with self-selection However the current labelling Order requires there to
be a declaration that clearly states the product is homeopathic and contains homeopathic
ingredients on the front of the pack and the additional detail of this information on the back
of the pack in the ingredients and indications section would clearly justify the medicine as
being based in the homoeopathic paradigm As such CMA proposes that this section be
removed from the Order
bull Section 6 Interpretation in the Order Homeopathic medicines - naming conventions
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic
preparation (i) either the name of the active ingredient or the substance from which the
dilution was prepared that is accepted for inclusion in the Australian Approved Names
(AAN) List together with a statement of the homeopathic potency or (ii) until such time
as a name is accepted for inclusion in the Australian Approved Names List a traditional
homoeopathic name in full or as traditionally abbreviated with a statement of
homeopathic potency
Given the recent redraft of the labelling Order it is an opportune time to explore potential
amendments that aim to increase the clarity for requirements around homeopathic
medicines for both industry and the regulator
CMA submitted in May 2013 via the International Harmonisation of Ingredient Names
consultation that there appeared to be no mention of the naming of homoeopathic
ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS) traditional naming or
the application of new AAN homoeopathic names As such we resubmit information for
consideration here
It is suggested that an amendment be made to allow for homeopathic medicines
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
Page 12 of 23
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
That is the traditional homeopathic name is to be used as the primary name including the
AAN unless on small containers Both the traditional names and AANs could be included
on full website information which would allow additional space to elaborate on the naming
of traditional homeopathic ingredients (where required)
To implement this CMA proposes the following amendment to the definition of the name
of the active ingredient
(b) where the ingredient is a homoeopathic preparation
(i) the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency and the name that is also accepted for inclusion in the Australian Approved Names List (if available) in brackets
(ii) for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
It is in the consumers interest that traditional pharmacopeial names be amended so as to
be the primary name The concern here is that by enforcing the current definition and taking
the AAN name alone outside of the traditional context the consumer may only get the
name in its full chemicalnon homeopathic form causing potential confusion and or safety
concerns Additionally the AAN name alone (due to small label space requirements) may
appear as a different active ingredient all together causing consumer alarm
For example False Unicorn Root
Traditional homeopathic name AAN name
Helonias dioica Chamaelirium luteum
If a consumer wishes to know more about a homeopathic medicine ingredient many
sources of information (pharmacopoeias texts materia medica) refer to the traditional
name as the primary point of reference To elaborate further examples have been provided
(Appendix 1 example 5) with this submission
International harmonisation considerations - homeopathic naming
conventions
ACSS Consortium
Page 13 of 23
website
(httpwebprodhc-scgccanhpidshy
bdipsnatRegdoatid=homeopathy)
(httpljwwwhc-scgccadhp-mpsprodnaturlegislationdocsehmg-nprhshy
engphpaS)
The TGA is part of the ACSS Consortium along with Health Canada Health Sciences Authority of Singapore and Swissmedic According to the TGA the ACSS Consortium
was formed in 2007 by like-minded regulatory authorities to promote greater regulatory
collaboration and alignment of regulatory requirements with the goal of maximising
international cooperation reduce duplication and increase each agencys capacity to
ensure consumers have timely access to high quality safe and effective therapeutic
products
Heath Canada
The Health Canada website
provides guidance to industry for the preparation of
Product Licence Applications (PLAs) and labels for natural health product market
authorization for homeopathic products (updated July 2015) It states
bull The proper name(s) common name(s) and source material(s) must be as per the homeopathic
monograph referenced as the Standard or Grade (please refer to the specifications)
bull The medicinal ingredient(s) must be a permitted substance with a homeopathic monograph in one
of the Natural and Non-Prescription Health Products Directorate (NNHPD) accepted homeopathic
pharmacopoeia
The Standards or Grades refers to a list of homeopathic pharmacopoeias containing the
traditional homeopathic names
Health Canada also includes guidance for the labelling of homeopathic medicines on its
website
It includes the following guidance for labelling for small packages
53 Labels for Small Packages
The NNHPD recognizes that small packages such as those used by some homeopathic medicine manufacturers
may not have an area large enough for the inner labelling requirements Therefore separate small package
labelling requirements have been developed Please see the Labelling guidance document for infonnation
specific to small package labelling
SwissMedic
In Switzerland homeopathy has been fully integrated into the Swiss medical system
SwissMedics HAS (Homeopathic and Anthroposophical medicines) list includes both Latin
chemical names and their homeopathic synonyms It appears that homeopathic products in
Switzerland also allow for the use of homeopathic names on products labels (noting the
strong tradition of use of homeopathy in the region)
FDA
The FDA also recognises the traditional homeopathic names with HPUS as the standard The HPUS has labelling guidelines for homeopathic medicines2 that links in with the labelling
2 httpwwwhpuscomRevised-Labeling-Guidelines-04-14pdf
Page 14 of 23
provisions of Sections 502 and 503 of the Federal Food Drug and Cosmetic Act Part 201
Title 21 of the Code of Federal Regulations (CFR) and the FDAs Compliance Policy Guide
400400
Section 11 How Information is to be expressed -
Use of appropriate metric units
bull Sec 11 (l)(b) The abbreviations to mg and g can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation microg may be used
Where several ingredients are presented on a label statement in microgram microliter
quantities the repetition of expressing the unit in full greatly expands the length of the text
and hence label space becomes an important issue
Further CMA questions if the requirement is mandatory given it is expressed as should in
the standard compared to must in the guideline
This proposed requirement if mandatory does not allow for consistency on the label and
increased label space is required CMA submits that an abbreviated form of microgram
should be permitted in the standard
Expression of quantity or proportion of active ingredients
Sec 11 (2) Expression of quantity or propo1iion of active ingredients
11(2)(i) states that in addition to the requirements of paragraphs 1 1(2)(a)-1 1(2)(h) and
therefore includes 1 1 (2)( a) the quantity of the active ingredient
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the
herbal material from which the preparation was derived except
This amendment appears to propose that herbal ingredients include the actual amount of
herbal extract in addition to the equivalent amount of starting herbal material from which
the preparation was derived
As detailed in our 2014 submission we do not support the increased information
requirements for the expression of herbal medicines to be expanded on the medicine label
(section 11(2))
The 2014 consultation suggested the reasoning for the additional requirement to include
the input amount of the herbal material on the label was that it enables the consumer to
Page lS of 23
version
gain meaningful information in relation to the strength concentration or quantified levels
in general of the herbal ingredients in the medicine
To implement this requirement however it would require the addition of an extra line of
information for each herbal material ingredient to express both quantities on the medicine
label The majority of complementary medicines are multi ingredient formulations
sometimes with as many as 25 ingredients in a product The addition of at least two lines to
express each herbal ingredient would for the average consumer most likely only create
confusion as to which line of expression to draw a meaningful conclusion from
The main concern is that this would lead to two quantification values for the same inputted
ingredient which would be open to misunderstanding and if other than the native extract
amount potentially no more helpful to the consumer Additionally this requirement does
not appear to impact upon the safe or proper usage of the medicine if used within the
context outlined on the label
CMA considers that this requirement would significantly increase the regulatory burden of
lower risk medicines by increasing the amount of information required on a label and hence
label size Label space will become an issue and an impracticality pushed to some degree
and with an obscure label this could lead to other potentially misleading packaging issues
We again provide mock up labels at the appendix to demonstrate this significant increase in
requirement
Clear concise labelling of ingredients with one quantity the extract equivalent of the herb
provides consumers with satisfactory information that allows comparison with other
products
CMA requests that TGA provides a detailed reasoning behind the proposed amendment
including evidence that the current requirement is impacting on the safe and proper usage
of listed medicines if that is the case In the absence of this information CMA does not
support implementing this section of the labelling Order and that it be drafted without this
specific requirement
CMA provides a mock up label at the appendix 1 example 3 to demonstrate the increased
requirements to listed low risk medicines
Regulatory Impact Statement (RIS)- general requirements for labels of medicines version 10 August 2014
The TGA provided a regulatory impact statement and other supporting documents3 as
evidence in support of a change to the labelling of medicines the proposed changes were
however largely based on the risk profile associated with prescription and registered over
the counter medicines with no direct reference to misuse of complementary medicines in
3 Labelling and packaging practices 10 January 2013 fileCUserstechnicalDownloadsconsultshy
labelling-packaging-review-1205 24-an alysis-evidencepdf
Page 16 of 23
the context of self-selection being outlined The extra regulatory requirements for labelling
and packaging of complementary medicines are considered to be out of proportion to the
risk classifications of these medicines
The 2014 consultation highlighted that due to lower risk medicines being available for self selection this factor alone poses a risk as the consumer receives no additional information
except the instructions on the label Indeed while this highlights the importance of the
information on the medicine label no evidence has been provided that the proposed
changes would contribute to the provision of better consumer information or safety A
change to the amount of active ingredients that can be included on the front of the
medicine label and additional information around the expression of herbal ingredients for
example are proposals for change that are not supported by CMA as they have not been
evidenced to be a safety issue nor undergone consumer use testing to demonstrate any
improvement on the status quo would be gained In summary they will have little affect on
consumers self-selection
The 2014 labelling consultation included a regulatory impact statement which from an
industry point of view grossly underestimated the cost of changes
Copy from the RIS
The labour burden for businesses who need to change a label would be
approximately 20 hours (includes reading the current guidance and applying it to
their design work and the small amount of labour involved in providing new label
information as part of the application to vary the entry) at a labour rate of $42 per
hour
The additional requirements proposed in the Order and schedule 1 will result in all
companies conducting a review of each medicine formulation checking for compliance to
these revised requirements It is estimated that the $42 per hour labour rate above would
increase to approximately $60 per hour for the time required to carry out the review One
member estimates that the labour hours would increase from 20 to 30 hours and takes into
account that different sections within an organisation and external organisations are
involved in obtaining documentation for example suppliers distributors manufacturers
Testing may also be required to confirm if any allergen residue remains in the raw material
Transition arrangements
CMA notes that the proposed transition arrangement includes a four year period where by
compliance with the current labelling Order (TGO 69) or the revised TGO 92 would be
permitted By 2020 full compliance with TGO 92 would be required While this is an
improvement from the 2014 proposal CMA highlights that further refinements to TGO 92 is
required to reduce the regulatory burden for complementary medicines
Page 17 of 23
Should the Order be implemented as currently drafted there will be many complementary
medicine businesses that would be negatively impacted Not in the lest many small ownershy
operator complementary medicine businesses would not generally be in the practice of
changing their medicine labels every few years as indicated in the TGA RIS document
The transition period will also be particularly problematic where the labelled information
will differ despite no change in formulation eg change in apparent quantification
ingredient name or ingredient placement
The RIS document also detailed that the new labelling Order would be a one-off cost for
those businesses that would not be changing their labels during the transition period
The 2014 participants in the TGA industry survey included larger CM company
representatives and therefore is only indicative of that sector of the industry
Specifically the RIS did not look at the fact that smaller companies would employ the skills
of professional consultants to carry out the work required to ensure compliance with the
new labelling Order This cost factor alone for changes proposed to lower risk listed
medicines is considered an unnecessary additional regulatory burden that would not
necessarily equate to any consumer self-medication benefit
CMA submits that the focus of the TGA be one of reducing the regulatory burden enhancing
efficiencies in existing process whilst upholding the safety and quality of complementary
medicines available to consumers For these reasons CMA submits that further refinements
to TGO 92 be made to accommodate lower risk medicines
Schedule 1 Substances or groups of substances present in medicines -
that are required to be declared on the label of medicines
It appears that some inconsistencies remain in the declaration statement of certain
substances in Schedule 1 of TGO 92 compared to warning statements generated on the
ARTG
Ethanolalcohol
This group of substances to be declared on the label is not consistent with the ARTG
generated warning for ethanolalcohol
bull Contains alcohol vs contains ethanol (vv)
Ethanol as one of the substances required to be declared on the label can carry the
declaration contains alcohol However the same ingredient warning that is generated on
the ARTG for use if this ingredient is in the formula as a listed excipient is ETHAN contains
ethanol (or words to that effect)
Recommendations
Page 18 of 23
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is consistent
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label if the situation arises where there is already an ARTG
generated ethanol warning
Other ingredients such as potassium sorbate already generate ARTG warnings if listed as
excipients and is also in the group of substances required to be declared on the label
Again the wording used is inconsistent
ARTG warning SORB8 (If the medicine contains one sorbate) Contains [insert name of
sorbate] OR (if medicine contains two or more sorbates) Contains sorbates [or words to that
effect]
bull Contains sorbates vs contains [inse1i name of sorbate] (if the medicine contains one sorbate) or contains sorbates (if the medicine contains two or more sorbates) in the
event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have Contains potassium sorbate
whilst it would read Contains sorbates to comply with schedule 1 of TGO 92
Recommendations
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is
consistent If the product contains one sorbate eg potassium sorbate ARTG warning
is Contains potassium sorbate however TGO 92 declaration is Contains sorbates
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label in these situations
Phenylalanine
Many mineral amino acid chelates contain phenylalanine as part of the amino acid portion
of the mineral and ingredients such as Spirulina whole cell powder would contain
phenylalanine as part of its protein profile CMA proposes that the schedule 1 list include
additional information as to what ingredients the phenylalanine warning applies to or
outline the ingredients such as those mentioned above that are exempt from the
requirement
Imposing such requirements to all ingredients may cause unnecessary concern to the
consumer
Page 19 of 23
PU
Schedule 2 Specified Units for Enzymes -
bull CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients Papain Units Bromelain
Currently the TBS only allows the quantity of the ingredient to be expressed in milligrams
(mg) Pervious considerations of this issue has identified that the per mg expression is not
the most appropriate for the material Whilst GOU (gelatine digesting unit) is acknowledged
to be the unit most commonly used for the material papain unit is proposed as this is the
specified unit from bromelain by the joint FAOWHO expert committee on Food Additives
(JECFA) the Food Chemical Codex and the unit adopted by Health Canada in its
monographs for Stem bromelian and fruit bromelian We note also that there is a simple
conversion factor that can be applied to quantities expressed as GOU
CMA comment on the Guideline for medicine labels draft version 10
October 2015
bull 3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA proposes the
removal (of Camellia sinensis) after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation
and herbal material and quantity of standardised constituent) would be expressed
together This reiteration appears to be redundant and would take up more space on the
label
bull Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] Ingredients Uses or What this medicine is used for Warnings Directions for use and Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a
specified order) needs to be followed for listed medicines
Page 2 0 of 23
Labelling
Labelling packaging Complementary
Labelling Packaging
CMA interprets the revised TGO 92 update to mean that this would no longer be a
requirement However we have provided a mock up label at appendix 1 example 4 to
demonstrate how this requirement if relevant would impact multi ingredient herbal
medicines
CMA resources in reference to the labelling of complementary
medicines
bull CMA submission Consultation Draft TGO 79 Standards for the of Medicines
(November 2014) bull CMA submission and of Medicines (12 April
2013) bull CMA submission on the Medicine and Review (24 August 2012)
Page 21of23
CMA detailed table of reform recommendations and impact of TGO 92
Page 22 of 23
Appendix 1 - mock up labels to TGO 92 requirements
Page 23 of 23
CMA response to TGO 92- Standards for the labels of non-prescription medicines
Proposed Requirement TGO 92 Industry response
Text size In principle CMA agrees with the change that reverts back to the current TGO 69 definition of text size This is in comparison to the consultation draft TGO79 that proposed a range of sizes for listed and registered
ldquoText size equivalent to Arial fontrdquo complementary medicines based on Arial point size font has been removed from TGO 92 The definition for letter height is the same as the definition in TGO 69
Sec 7 General requirements including As stated in the CMA 2014 submission ambiguous and subjective requirements should on principle not be included in a label presentation legislative instrument (2)(e) Considering the guidance document elaborates on the proposed requirement CMA reiterates that we are not aware of there Labels must be in a colour or colours being consumer safety issues of this nature reported for CM products which are of a lower risk and hence consider the contrasting strongly with the mandatory requirement unjustified background Sec 8(2) Labels of registered medicines must provide information in a consistent order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important information access to other information is also necessary for consumers to make an informed purchasing decision CMA is of the position that for lower risk registered medicines such as registered complementary medicines there should be flexibility to present mandatory information in a clear and concise manner without the constraint of a medicine information panel (MIP) This will minimise cost to the CM industry associated with resizing labels or providing goods in larger container sizes with increased headspace Section 155 of the Guidance document outlines that ldquoa medicine information panel is not required for certain lower risk
Proposed Requirement TGO 92 Industry response
registered medicines ndash these are detailed in subsection 8(2) of TGO 92rdquo Subsection 8(2) however does not appear to detail specifically what types of lower risk registered medicines would not require a MIP CMA suggests that this part of the guidance is expanded to include specific guidance that registered complementary medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the amendment impact registered complementary medicines mock up labels have been provided to demonstrate that the requirement would necessitate a change to label sizes for complementary medicines which is considered unjustified
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of a MIP would not work and necessitate labelling complications and medicine container size considerations
Sec 8 (1) (k) (ii) (B) Pregnancy database
Requirements related tot his section should be incorporated on an ingredient by ingredient basis within the 26BB list of permissible ingredients instrument Pregnancy database - Add link httpswwwtgagovauprescribing-medicines-pregnancy-database
Sec 9 (2) CMA considers the proposed requirements to orientate all text in the same direction on the main label and for medicine names to be presented in a continuous and uninterrupted manner would not have a meaningful impact upon consumer
The name of the medicine on the main safety and as such the change is considered unjustified for lower risk medicines label must be presented in a continuous uninterrupted manner and Feedback from our members indicates that medicine labels are often developed as a result of consumer testing not be broken up by additional In addition CMA has not been presented with information that consumers have any usability difficulties with the information or background text presentation of information on complementary medicine labels Sec 9 (5) All text required by this Order to It is well documented that consumers generally select complementary medicines and non-prescription medicines by brand appear on the main label must be and category and seek out brands they know Branding is important for complementary medicines and consumers are orientated in the same direction familiar with many well-known brands of medicines for general wellbeing cough and cold allergy skincare and many
other categories Limited label space is therefore an important issue particularly for certain product and label types
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 2 of 12
Proposed Requirement TGO 92 Industry response
Such a change would impact upon brand recognition for many companies As such CMA considers this as an unjustified change to requirements adding to unnecessary regulatory burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact on branding and does not require consequential changes to dimensions of packs or labels or changes to the packaging details of a medicine
Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 30millimeters on the front panel directly under the trade name
Since consumers use complementary medicines as part of self-care the label of these medicines is the primary source of information for consumers This requirement would mean that a large portion of the label would be used to display the active ingredients Information on active ingredients is not always the most meaningful aspect in consumer self selection of these goods rather information sought by consumers tends to be focused around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space and there will be reduced space to indicate the intended purpose of the product on the front of pack If the container and label size are increased as a result of this without increasing the number of tablets or capsules in the bottle this could give the consumer a negative perception due to the increased head space of the container Ultimately this would also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations
Sec 9 (6) CMArsquos position on the number of active ingredients that may appear on the front of a label for listed goods is that TGO 69 If the medicine is intended to be or is requirements be maintained listed goods By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active ingredients to four or more (b) if there are four or more active active ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for ingredients in the medicine - the name these lower risk listed medicines without any evidence of consumer benefit being presented of every active ingredient together with the quantity or proportion of CMA suggests the following amendment to TGO 92 every active ingredient may appear on
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 3 of 12
Proposed Requirement TGO 92 Industry response
a side panel or side label or on a rear panel or rear label
If the medicine is intended to be or is listed goods 6 b) if the medicine is a listed complementary medicine ndash the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO 69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014 CMA includes specific examples where for listed CMs containing three active ingredients to be displayed on the front of the label where previously they would be detailed at the side or rear how this would impact on label size being inappropriate for the packaging
Sec 9 (7) CMA proposed that TGO 69 requirements be maintained If the medicine is intended to be or is registered goods then By imposing subsection 9(7)(b) would mean a requirement to go from two or more active ingredients to four or more active
ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for (a) where the medicine contains three registered complementary medicines without any specific evidence of consumer benefit relating to this lower risk class of or four active ingredients the name of good being presented the active ingredient(s) and the quantity or proportion of active Within the complementary medicine category listed and registered complementary medicines will be presented (depending ingredient(s) must be displayed on the on the number of active ingredients present) in a different manner That is some will detail active ingredients at the front of main label in a text size of not less the pack while others (with 4 or more active ingredients) will detail the ingredients at the side or rear of the pack CMA than 3 millimetres submits that for the purposes of standardisation of where to find information consumers should be encouraged to refer to
the backside of the pack for ingredient information (b) where the medicine contains four or more active ingredients and the CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of requirements of subsection 8(2) do not 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations apply then the names and the See comments at Sec 9 (7)(a) above quantities or proportion of the active ingredients may be included on a side panellabel or rear panellabel when
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 4 of 12
Proposed Requirement TGO 92 Industry response
displayed in a text size of not less than 25mm
Sec 10(3) amp Sec 10 (4)(a) CMA does not support any additional change to this lower risk category of medicine
Homeopathic medicines No explanation or justification has been provided as to why there is a new mandatory requirement to include a statement on Where all the active ingredients in a the main label that the medicine is a homeopathic medicine or contains homeopathic preparations in an increased font size to medicine are homoeopathic that of a general listed complementary medicine preparations the main label on the No real explanation has been provided as to why an increase to the font size for the statement ldquohomeopathic medicinerdquo was container and the main label on the considered a requirement based on a consumer safety perspective primary pack (if any) must in addition to the requirements referred Previous explanations for this addition has centred around that the statement is intended to assist consumers with an to in sections 8 and 9 above include a appropriate selection for a medicine and minimise confusion that may arise with self-selection However the current statement to the effect that the labelling Order requires there to be a declaration that clearly states the product is homeopathic and contains homeopathic medicine is a homoeopathic medicine ingredients on the front of the pack and the additional detail of this information on the back of the pack in the ingredients in text size that is not less than 50 and indications section would clearly justify the medicine as being based in the homoeopathic paradigm of the text size of the name of the As such CMA proposes that this section be removed from the Order medicine and (in any event) not less than 2millimeters
Sec 6 CMA submitted in May 2013 via the International Harmonisation of Ingredient Names consultation that there appeared to be no mention of the naming of homoeopathic ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS)
Interpretation in this Order traditional naming or the application of new AAN homoeopathic names As such we resubmit information for consideration here
Homoeopathic medicines ndash naming conventions
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 5 of 12
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation (i) either the name of the active ingredient or the substance from which the dilution was prepared that is accepted for inclusion in the Australian Approved Names (AAN) List together with a statement of the homeopathic potency or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency
It is suggested that an amendment be made to allow for homeopathic medicines The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
To implement this CMA proposes the following amendment to the definition of the name of the active ingredient
(b) where the ingredient is a homoeopathic preparation
1 the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency in brackets the name that is also accepted for inclusion in the Australian Approved Names List
2 for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
That is the traditional homeopathic name to be used as the primary name including the AAN unless on ldquosmall containersrdquo Both the traditional names and AAN could be included on full website information which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required)
It is in the consumersrsquo interest that traditional pharmacopeial names be amended as the primary name The concern here is
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
PART 1- CMA RESPONSE ON THE DRAFT TGO 92
Standard for the Labels of Non-Prescription Medicines
Page 5 of 23
EXECUTIVE SUMMARY
Complementary Medicines Australia (CMA) welcomes the opportunity to provide a response
to the Therapeutic Goods Administration on its targeted consultation draft TGO 92 -
Standard for the labels of non-prescription medicines and related guidance document dated
October 2015 This submission follows from CMAs response to the Therapeutic Goods
Order for medicine labels (TGO 79) 2014 and the Medicine Labelling and Packaging Review
2012
In general complementary medicines (CMs) are lower-risk medicines As such the majority
of complementary medicines are self-selected by consumers necessitating the medicine
label as a vital information source allowing consumers to make informed purchasing
decisions and to use the medicine safely It is therefore in the interest of the community
that complementary medicine labelling be well designed and effective for its intended
purpose
Overall CMA supports the revision of the labelling Order into two separate Orders for
prescription medicines and non-prescription medicines including complementary
medicines This approach was supported in recognition that different types of medicines
present different levels of risk Following from this CMA also supports that these different
levels of risk are relevant within the registered non prescription type for example lower
risk registered complementary medicines
We support that the guidance document details a tiered approach in the recognition of
levels of risk within the registered medicine category and we have provided additional
comment around how this could be further clarified in the Order itself
CMA supports the aims of the review to the Labelling Order as outlined in the 2014
Regulatory Impact Statement1 are to address and prevent confusion and accidents such as
overdosing under medicating or medicating with the incorrect medicines that are
associated with unclear labelling on medicines It is important that label requirements aim
to ensure medicines supplied in Australia provide healthcare professionals and consumers
with access to information on the medicine including the active ingredient name and in the
case of over-the-counter medicines proper and safe usage
However our sector continues to outline that the increased regulatory requirements
required to implement TGO 92 outweigh the perceived benefit to the community in the
absence of any usage testing or extensive RIS calculations
CMA believes the cost to the complementary sector is disproportionate to the risk arising
from the sector particularly when weighing the likely benefit arising from the proposed
changes One of CMAs members estimates these changes will cost their business alone in
excess of $2 million for their complementary medicine range over the granted transition
period Overall CMA supports further improvements to processes be made within the
context of the existing framework
1 Regulation Impact Statement (RIS) - General requirements for labels for medicines 2014
httpswwwtgagovau sites defaultfilesconsult-labelling-medicines-140822-rispdf
Page 6 of 23
General overview of comments on TGO 92
We reiterate that the labelling of complementary medicines should be well designed and
effective for its intended purpose This has been explored during a number of labelling
consultations undertaken over the years however no evidence of consumer misuse due to
labelling of complementary medicines has been presented to CMA to indicate a change
required to the way in which these lower risk medicines (including homeopathic medicines)
should be labelled
Sponsors of listed medicines are already required to certify that the medicines meet a range
of requirements In particular they must certify that bull the medicine is eligible for Listing bull the presentation is not unacceptable bull the medicine is safe for the purposes for which it is to be used and bull evidence is held to support any claim made in relation to the medicine
As such there remains a number of requirements proposed in the redrafted Order that
appear unjustified and result in an unnecessary increase to the regulatory burden for this
sector
The Labelling Order as a legislative instrument will be legally enforceable by the TGA under
powers provided by the Therapeutic Goods Act 1989 The labelling Order will be supported
by best practice principles outlined in the Australian Regulatory Guidelines for
Complementary Medicines (ARGCM)
Aspects of the proposed Order could arguably be seen to be open to a level of
interpretation For example that the name of the medicine on the main label must be
presented in a continuous uninterrupted manner and not be broken up by additional
information or background text CMA considers any requirements that could be open to
interpretation should not be included in a legislative instrument as this is legally
enforceable rather it should be articulated clearly in best practice guidelines
CMA supports that the current mechanisms in place for the labelling of complementary
medicines are sufficient to promote the quality use of these medicines by consumers CMA
supports where not further indicated in this submission that the current labelling
requirements of TGO 69 be maintained for listed low risk medicines including homeopathic
medicines
Section 7 General requirements including label presentation
bull Labels must be in a colour or colours contrasting strongly with the background
As stated in the CMA 2014 submission ambiguous and subjective requirements should on
principle not be included in a legislative instrument
Page 7 of 23
Considering the guidance document elaborates on the proposed requirement CMA
reiterates that we are not aware of there being consumer safety issues of this nature
reported for CM products which are of a lower risk and hence consider the mandatory
requirement unjustified for this sector of goods
TGO 92 should be amended to include this as a best practice principle only in the guideline
for registered non prescriptions medicines excluding listed medicines and registered
complementary medicines
Section 8 Information to be included on the label
bull Section 8(2) Labels of registered medicines must provide information in a consistent -
order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important
information access to other information is also necessary for consumers to make an
informed purchasing decision
CMA is of the position that for lower risk registered medicines such as registered
complementary medicines there should be flexibility to present mandatory information in a
clear and concise manner without the constraint of a medicine information panel (MIP)
This will minimise unnecessary costs to the CM industry associated with resizing labels or
providing goods in larger container sizes with increased headspace
Section 155 of the Guidance document outlines that a medicine information panel is not
required for certain lower risk registered medicines - these are detailed in subsection 8(2)
of TGO 92 Subsection 8(2) however does not appear to detail specifically what types of
lower risk registered medicines would not require a MIP CMA suggests that this part of the
Order and guidance is expanded to include specifically that registered complementary
medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the
amendment impact registered complementary medicines mock up labels have been
provided to demonstrate that the requirement would necessitate a change to label sizes for
complementary medicines which is considered unjustified
CMA provides at the appendix example 1 a mock up of a registered complementary
medicine to demonstrate how the inclusion of a MIP would not work and necessitate
labelling complications and medicine container size considerations
Page 8 of 23
Section 9 Information to be included on the main label
bull Section 9(2) The name of medicine on the main label must be presented in a continuous uninterrupted manner and not be broken up by additional information or background text
bull Section 9(S) All text required by this Order to appear on the main label must be orientated in the same direction
CMA submits that the proposed requirements to orientate all text in the same direction on
the main label and for medicine names to be presented in a continuous and uninterrupted
manner would not for lower risk medicines have any meaningful impact upon consumer
safety and as such the change is considered unjustified for lower risk medicines
Feedback from our members indicates that medicine labels are often developed as a result
of consumer testing In addition CMA has not been presented with information that
consumers have any usability difficulties with the presentation of information on
complementary medicine labels
It is well documented that consumers generally select complementary medicines and nonshy
prescription medicines by brand and category and seek out brands that they know
Branding is important for complementary medicines and consumers are familiar with many
well-known brands of medicines for general well being cough and cold joint health bone
health and many other categories Limited label space is therefore an important issue
particularly for certain products and label types
Such a change would impact upon brand recognition for many companies As such CMA
considers this an unjustified change to requirements adding to unnecessary regulatory
burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact
on branding and does not require consequential changes to dimensions of packs or labels or
changes to the packaging details of a medicine
bull Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
bull Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 3 0millimeters on the front panel directly under the trade name
Given consumers use complementary medicines as part of self-care the label of these
medicines is the primary source of information for consumers This requirement would
mean that a large portion of the main label would be used to display the active ingredients
which are detailed on the label elsewhere
Page 9 of 23
Information on active ingredients is not always the most meaningful aspect in consumer self
selection of these goods rather information sought by consumers tends to be focused
around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space
and there will be reduced space to indicate the intended purpose of the product on the
front of pack If the container and label size are increased as a result of this without
increasing the number of tablets or capsules in the bottle this could give the consumer a
negative perception due to the increased head space of the container Ultimately this would
also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at the appendix example 1 a mock up of a registered complementary
medicine to demonstrate how the inclusion of 9 7)(a) would not work and necessitate
labelling complications and medicine container size considerations
bull Sec 9 (6) If the medicine is intended to be or is listed goods
(b) if there are four or more active ingredients in the medicine - the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on
As outlined in our 2014 submission subsection 9(6)(b) is not supported for inclusion in the
labelling Order The requirement for change to listed and registered complementary
medicines was not adequately justified from a risk perspective rather the requirements
appear to be a hangover from the risks perceived from the prescription and registered nonshy
prescription medicine sector
CMAs position on the number of active ingredients that may appear on the front of a label
for listed goods is that TGO 69 requirements be maintained
By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active
ingredients to four or more active ingredients that may be declared on a side panellabel or
rear panellabel This would increase the regulatory cost for these lower risk listed
medicines without any evidence of consumer benefit being presented
CMA suggests the following amendment to TGO 92
If the medicine is intended to be or is listed goods
6 b) if the medicine is a listed complementary medicine - the name of every active
ingredient together with the quantity or proportion of every active ingredient may appear
on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO
69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014
Page 10 of 23
CMA includes specific examples at appendix 1 example 2 impact on label size for listed
complementary medicines containing three active ingredients to be displayed on the front
of the label (currently they may be detailed at the side or rear)
bull Sec 9 (7) If the medicine is intended to be or is registered goods then
(a) where the medicine contains three or four active ingredients the name of the active
ingredient(s) and the quantity or proportion of active ingredient(s) must be displayed on
the main label in a text size of not less than 3 millimetres
(b) where the medicine contains four or more active ingredients and the requirements of
subsection 8(2) do not apply then the names and the quantities or proportion of the
active ingredients may be included on a side panellabel or rear panellabel when
displayed in a text size of not less than 2Smm
CMAs position on this section is that TGO 69 requirements be maintained
By imposing subsection 9(7)(b) would mean a requirement to go from two or more active
ingredients to four or more active ingredients that may be declared on a side panellabel or
rear panellabel This would increase the regulatory costs for registered complementary
medicines without any specific evidence of consumer benefit relating to this lower risk class
of good being presented
Within the complementary medicine category listed and registered complementary
medicines will be presented (depending on the number of active ingredients present) in a
different manner That is some will detail active ingredients at the front of the pack while
others (with 4 or more active ingredients) will detail the ingredients at the side or rear of
the pack CMA submits that for the purposes of standardisation and consistency on where
to find information for lower risk goods consumers should be encouraged to refer to the
backside of the pack for ingredient information
CMA provides a mock up of a registered CM provided to demonstrate how the inclusion of
9 (7)(a) would not work and necessitate labelling complications and medicine container size
considerations
Section 10 Qualifications and special requirements
Sec 10(3) amp Sec 10 (4)(a) where all the active ingredients in a medicine are homoeopathic
preparations the main label on the container and the main label on the primary pack (if
any) must in addition to the requirements referred to in sections 8 and 9 above include a
statement to the effect that the medicine is a homoeopathic medicine in text size that is
not less than 50 of the text size of the name of the medicine and (in any event) not less
than 2millimeters
Page 11of23
CMA does not support any additional change to this lower risk category of medicine
No explanation or justification has been provided during the course of labelling
consultations as to why there is a new mandatory requirement to include a statement on
the main label that the medicine is a homeopathic medicine or contains homeopathic
preparations in an increased font size to that of a general listed complementary medicine
No real explanation has been provided as to why an increase to the font size for the
statement homeopathic medicine was considered a requirement based on a consumer
safety perspective
Previous explanations for this addition has centred on factors that the statement is intended
to assist consumers with an appropriate selection for a medicine and minimise confusion
that may arise with self-selection However the current labelling Order requires there to
be a declaration that clearly states the product is homeopathic and contains homeopathic
ingredients on the front of the pack and the additional detail of this information on the back
of the pack in the ingredients and indications section would clearly justify the medicine as
being based in the homoeopathic paradigm As such CMA proposes that this section be
removed from the Order
bull Section 6 Interpretation in the Order Homeopathic medicines - naming conventions
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic
preparation (i) either the name of the active ingredient or the substance from which the
dilution was prepared that is accepted for inclusion in the Australian Approved Names
(AAN) List together with a statement of the homeopathic potency or (ii) until such time
as a name is accepted for inclusion in the Australian Approved Names List a traditional
homoeopathic name in full or as traditionally abbreviated with a statement of
homeopathic potency
Given the recent redraft of the labelling Order it is an opportune time to explore potential
amendments that aim to increase the clarity for requirements around homeopathic
medicines for both industry and the regulator
CMA submitted in May 2013 via the International Harmonisation of Ingredient Names
consultation that there appeared to be no mention of the naming of homoeopathic
ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS) traditional naming or
the application of new AAN homoeopathic names As such we resubmit information for
consideration here
It is suggested that an amendment be made to allow for homeopathic medicines
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
Page 12 of 23
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
That is the traditional homeopathic name is to be used as the primary name including the
AAN unless on small containers Both the traditional names and AANs could be included
on full website information which would allow additional space to elaborate on the naming
of traditional homeopathic ingredients (where required)
To implement this CMA proposes the following amendment to the definition of the name
of the active ingredient
(b) where the ingredient is a homoeopathic preparation
(i) the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency and the name that is also accepted for inclusion in the Australian Approved Names List (if available) in brackets
(ii) for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
It is in the consumers interest that traditional pharmacopeial names be amended so as to
be the primary name The concern here is that by enforcing the current definition and taking
the AAN name alone outside of the traditional context the consumer may only get the
name in its full chemicalnon homeopathic form causing potential confusion and or safety
concerns Additionally the AAN name alone (due to small label space requirements) may
appear as a different active ingredient all together causing consumer alarm
For example False Unicorn Root
Traditional homeopathic name AAN name
Helonias dioica Chamaelirium luteum
If a consumer wishes to know more about a homeopathic medicine ingredient many
sources of information (pharmacopoeias texts materia medica) refer to the traditional
name as the primary point of reference To elaborate further examples have been provided
(Appendix 1 example 5) with this submission
International harmonisation considerations - homeopathic naming
conventions
ACSS Consortium
Page 13 of 23
website
(httpwebprodhc-scgccanhpidshy
bdipsnatRegdoatid=homeopathy)
(httpljwwwhc-scgccadhp-mpsprodnaturlegislationdocsehmg-nprhshy
engphpaS)
The TGA is part of the ACSS Consortium along with Health Canada Health Sciences Authority of Singapore and Swissmedic According to the TGA the ACSS Consortium
was formed in 2007 by like-minded regulatory authorities to promote greater regulatory
collaboration and alignment of regulatory requirements with the goal of maximising
international cooperation reduce duplication and increase each agencys capacity to
ensure consumers have timely access to high quality safe and effective therapeutic
products
Heath Canada
The Health Canada website
provides guidance to industry for the preparation of
Product Licence Applications (PLAs) and labels for natural health product market
authorization for homeopathic products (updated July 2015) It states
bull The proper name(s) common name(s) and source material(s) must be as per the homeopathic
monograph referenced as the Standard or Grade (please refer to the specifications)
bull The medicinal ingredient(s) must be a permitted substance with a homeopathic monograph in one
of the Natural and Non-Prescription Health Products Directorate (NNHPD) accepted homeopathic
pharmacopoeia
The Standards or Grades refers to a list of homeopathic pharmacopoeias containing the
traditional homeopathic names
Health Canada also includes guidance for the labelling of homeopathic medicines on its
website
It includes the following guidance for labelling for small packages
53 Labels for Small Packages
The NNHPD recognizes that small packages such as those used by some homeopathic medicine manufacturers
may not have an area large enough for the inner labelling requirements Therefore separate small package
labelling requirements have been developed Please see the Labelling guidance document for infonnation
specific to small package labelling
SwissMedic
In Switzerland homeopathy has been fully integrated into the Swiss medical system
SwissMedics HAS (Homeopathic and Anthroposophical medicines) list includes both Latin
chemical names and their homeopathic synonyms It appears that homeopathic products in
Switzerland also allow for the use of homeopathic names on products labels (noting the
strong tradition of use of homeopathy in the region)
FDA
The FDA also recognises the traditional homeopathic names with HPUS as the standard The HPUS has labelling guidelines for homeopathic medicines2 that links in with the labelling
2 httpwwwhpuscomRevised-Labeling-Guidelines-04-14pdf
Page 14 of 23
provisions of Sections 502 and 503 of the Federal Food Drug and Cosmetic Act Part 201
Title 21 of the Code of Federal Regulations (CFR) and the FDAs Compliance Policy Guide
400400
Section 11 How Information is to be expressed -
Use of appropriate metric units
bull Sec 11 (l)(b) The abbreviations to mg and g can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation microg may be used
Where several ingredients are presented on a label statement in microgram microliter
quantities the repetition of expressing the unit in full greatly expands the length of the text
and hence label space becomes an important issue
Further CMA questions if the requirement is mandatory given it is expressed as should in
the standard compared to must in the guideline
This proposed requirement if mandatory does not allow for consistency on the label and
increased label space is required CMA submits that an abbreviated form of microgram
should be permitted in the standard
Expression of quantity or proportion of active ingredients
Sec 11 (2) Expression of quantity or propo1iion of active ingredients
11(2)(i) states that in addition to the requirements of paragraphs 1 1(2)(a)-1 1(2)(h) and
therefore includes 1 1 (2)( a) the quantity of the active ingredient
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the
herbal material from which the preparation was derived except
This amendment appears to propose that herbal ingredients include the actual amount of
herbal extract in addition to the equivalent amount of starting herbal material from which
the preparation was derived
As detailed in our 2014 submission we do not support the increased information
requirements for the expression of herbal medicines to be expanded on the medicine label
(section 11(2))
The 2014 consultation suggested the reasoning for the additional requirement to include
the input amount of the herbal material on the label was that it enables the consumer to
Page lS of 23
version
gain meaningful information in relation to the strength concentration or quantified levels
in general of the herbal ingredients in the medicine
To implement this requirement however it would require the addition of an extra line of
information for each herbal material ingredient to express both quantities on the medicine
label The majority of complementary medicines are multi ingredient formulations
sometimes with as many as 25 ingredients in a product The addition of at least two lines to
express each herbal ingredient would for the average consumer most likely only create
confusion as to which line of expression to draw a meaningful conclusion from
The main concern is that this would lead to two quantification values for the same inputted
ingredient which would be open to misunderstanding and if other than the native extract
amount potentially no more helpful to the consumer Additionally this requirement does
not appear to impact upon the safe or proper usage of the medicine if used within the
context outlined on the label
CMA considers that this requirement would significantly increase the regulatory burden of
lower risk medicines by increasing the amount of information required on a label and hence
label size Label space will become an issue and an impracticality pushed to some degree
and with an obscure label this could lead to other potentially misleading packaging issues
We again provide mock up labels at the appendix to demonstrate this significant increase in
requirement
Clear concise labelling of ingredients with one quantity the extract equivalent of the herb
provides consumers with satisfactory information that allows comparison with other
products
CMA requests that TGA provides a detailed reasoning behind the proposed amendment
including evidence that the current requirement is impacting on the safe and proper usage
of listed medicines if that is the case In the absence of this information CMA does not
support implementing this section of the labelling Order and that it be drafted without this
specific requirement
CMA provides a mock up label at the appendix 1 example 3 to demonstrate the increased
requirements to listed low risk medicines
Regulatory Impact Statement (RIS)- general requirements for labels of medicines version 10 August 2014
The TGA provided a regulatory impact statement and other supporting documents3 as
evidence in support of a change to the labelling of medicines the proposed changes were
however largely based on the risk profile associated with prescription and registered over
the counter medicines with no direct reference to misuse of complementary medicines in
3 Labelling and packaging practices 10 January 2013 fileCUserstechnicalDownloadsconsultshy
labelling-packaging-review-1205 24-an alysis-evidencepdf
Page 16 of 23
the context of self-selection being outlined The extra regulatory requirements for labelling
and packaging of complementary medicines are considered to be out of proportion to the
risk classifications of these medicines
The 2014 consultation highlighted that due to lower risk medicines being available for self selection this factor alone poses a risk as the consumer receives no additional information
except the instructions on the label Indeed while this highlights the importance of the
information on the medicine label no evidence has been provided that the proposed
changes would contribute to the provision of better consumer information or safety A
change to the amount of active ingredients that can be included on the front of the
medicine label and additional information around the expression of herbal ingredients for
example are proposals for change that are not supported by CMA as they have not been
evidenced to be a safety issue nor undergone consumer use testing to demonstrate any
improvement on the status quo would be gained In summary they will have little affect on
consumers self-selection
The 2014 labelling consultation included a regulatory impact statement which from an
industry point of view grossly underestimated the cost of changes
Copy from the RIS
The labour burden for businesses who need to change a label would be
approximately 20 hours (includes reading the current guidance and applying it to
their design work and the small amount of labour involved in providing new label
information as part of the application to vary the entry) at a labour rate of $42 per
hour
The additional requirements proposed in the Order and schedule 1 will result in all
companies conducting a review of each medicine formulation checking for compliance to
these revised requirements It is estimated that the $42 per hour labour rate above would
increase to approximately $60 per hour for the time required to carry out the review One
member estimates that the labour hours would increase from 20 to 30 hours and takes into
account that different sections within an organisation and external organisations are
involved in obtaining documentation for example suppliers distributors manufacturers
Testing may also be required to confirm if any allergen residue remains in the raw material
Transition arrangements
CMA notes that the proposed transition arrangement includes a four year period where by
compliance with the current labelling Order (TGO 69) or the revised TGO 92 would be
permitted By 2020 full compliance with TGO 92 would be required While this is an
improvement from the 2014 proposal CMA highlights that further refinements to TGO 92 is
required to reduce the regulatory burden for complementary medicines
Page 17 of 23
Should the Order be implemented as currently drafted there will be many complementary
medicine businesses that would be negatively impacted Not in the lest many small ownershy
operator complementary medicine businesses would not generally be in the practice of
changing their medicine labels every few years as indicated in the TGA RIS document
The transition period will also be particularly problematic where the labelled information
will differ despite no change in formulation eg change in apparent quantification
ingredient name or ingredient placement
The RIS document also detailed that the new labelling Order would be a one-off cost for
those businesses that would not be changing their labels during the transition period
The 2014 participants in the TGA industry survey included larger CM company
representatives and therefore is only indicative of that sector of the industry
Specifically the RIS did not look at the fact that smaller companies would employ the skills
of professional consultants to carry out the work required to ensure compliance with the
new labelling Order This cost factor alone for changes proposed to lower risk listed
medicines is considered an unnecessary additional regulatory burden that would not
necessarily equate to any consumer self-medication benefit
CMA submits that the focus of the TGA be one of reducing the regulatory burden enhancing
efficiencies in existing process whilst upholding the safety and quality of complementary
medicines available to consumers For these reasons CMA submits that further refinements
to TGO 92 be made to accommodate lower risk medicines
Schedule 1 Substances or groups of substances present in medicines -
that are required to be declared on the label of medicines
It appears that some inconsistencies remain in the declaration statement of certain
substances in Schedule 1 of TGO 92 compared to warning statements generated on the
ARTG
Ethanolalcohol
This group of substances to be declared on the label is not consistent with the ARTG
generated warning for ethanolalcohol
bull Contains alcohol vs contains ethanol (vv)
Ethanol as one of the substances required to be declared on the label can carry the
declaration contains alcohol However the same ingredient warning that is generated on
the ARTG for use if this ingredient is in the formula as a listed excipient is ETHAN contains
ethanol (or words to that effect)
Recommendations
Page 18 of 23
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is consistent
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label if the situation arises where there is already an ARTG
generated ethanol warning
Other ingredients such as potassium sorbate already generate ARTG warnings if listed as
excipients and is also in the group of substances required to be declared on the label
Again the wording used is inconsistent
ARTG warning SORB8 (If the medicine contains one sorbate) Contains [insert name of
sorbate] OR (if medicine contains two or more sorbates) Contains sorbates [or words to that
effect]
bull Contains sorbates vs contains [inse1i name of sorbate] (if the medicine contains one sorbate) or contains sorbates (if the medicine contains two or more sorbates) in the
event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have Contains potassium sorbate
whilst it would read Contains sorbates to comply with schedule 1 of TGO 92
Recommendations
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is
consistent If the product contains one sorbate eg potassium sorbate ARTG warning
is Contains potassium sorbate however TGO 92 declaration is Contains sorbates
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label in these situations
Phenylalanine
Many mineral amino acid chelates contain phenylalanine as part of the amino acid portion
of the mineral and ingredients such as Spirulina whole cell powder would contain
phenylalanine as part of its protein profile CMA proposes that the schedule 1 list include
additional information as to what ingredients the phenylalanine warning applies to or
outline the ingredients such as those mentioned above that are exempt from the
requirement
Imposing such requirements to all ingredients may cause unnecessary concern to the
consumer
Page 19 of 23
PU
Schedule 2 Specified Units for Enzymes -
bull CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients Papain Units Bromelain
Currently the TBS only allows the quantity of the ingredient to be expressed in milligrams
(mg) Pervious considerations of this issue has identified that the per mg expression is not
the most appropriate for the material Whilst GOU (gelatine digesting unit) is acknowledged
to be the unit most commonly used for the material papain unit is proposed as this is the
specified unit from bromelain by the joint FAOWHO expert committee on Food Additives
(JECFA) the Food Chemical Codex and the unit adopted by Health Canada in its
monographs for Stem bromelian and fruit bromelian We note also that there is a simple
conversion factor that can be applied to quantities expressed as GOU
CMA comment on the Guideline for medicine labels draft version 10
October 2015
bull 3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA proposes the
removal (of Camellia sinensis) after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation
and herbal material and quantity of standardised constituent) would be expressed
together This reiteration appears to be redundant and would take up more space on the
label
bull Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] Ingredients Uses or What this medicine is used for Warnings Directions for use and Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a
specified order) needs to be followed for listed medicines
Page 2 0 of 23
Labelling
Labelling packaging Complementary
Labelling Packaging
CMA interprets the revised TGO 92 update to mean that this would no longer be a
requirement However we have provided a mock up label at appendix 1 example 4 to
demonstrate how this requirement if relevant would impact multi ingredient herbal
medicines
CMA resources in reference to the labelling of complementary
medicines
bull CMA submission Consultation Draft TGO 79 Standards for the of Medicines
(November 2014) bull CMA submission and of Medicines (12 April
2013) bull CMA submission on the Medicine and Review (24 August 2012)
Page 21of23
CMA detailed table of reform recommendations and impact of TGO 92
Page 22 of 23
Appendix 1 - mock up labels to TGO 92 requirements
Page 23 of 23
CMA response to TGO 92- Standards for the labels of non-prescription medicines
Proposed Requirement TGO 92 Industry response
Text size In principle CMA agrees with the change that reverts back to the current TGO 69 definition of text size This is in comparison to the consultation draft TGO79 that proposed a range of sizes for listed and registered
ldquoText size equivalent to Arial fontrdquo complementary medicines based on Arial point size font has been removed from TGO 92 The definition for letter height is the same as the definition in TGO 69
Sec 7 General requirements including As stated in the CMA 2014 submission ambiguous and subjective requirements should on principle not be included in a label presentation legislative instrument (2)(e) Considering the guidance document elaborates on the proposed requirement CMA reiterates that we are not aware of there Labels must be in a colour or colours being consumer safety issues of this nature reported for CM products which are of a lower risk and hence consider the contrasting strongly with the mandatory requirement unjustified background Sec 8(2) Labels of registered medicines must provide information in a consistent order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important information access to other information is also necessary for consumers to make an informed purchasing decision CMA is of the position that for lower risk registered medicines such as registered complementary medicines there should be flexibility to present mandatory information in a clear and concise manner without the constraint of a medicine information panel (MIP) This will minimise cost to the CM industry associated with resizing labels or providing goods in larger container sizes with increased headspace Section 155 of the Guidance document outlines that ldquoa medicine information panel is not required for certain lower risk
Proposed Requirement TGO 92 Industry response
registered medicines ndash these are detailed in subsection 8(2) of TGO 92rdquo Subsection 8(2) however does not appear to detail specifically what types of lower risk registered medicines would not require a MIP CMA suggests that this part of the guidance is expanded to include specific guidance that registered complementary medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the amendment impact registered complementary medicines mock up labels have been provided to demonstrate that the requirement would necessitate a change to label sizes for complementary medicines which is considered unjustified
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of a MIP would not work and necessitate labelling complications and medicine container size considerations
Sec 8 (1) (k) (ii) (B) Pregnancy database
Requirements related tot his section should be incorporated on an ingredient by ingredient basis within the 26BB list of permissible ingredients instrument Pregnancy database - Add link httpswwwtgagovauprescribing-medicines-pregnancy-database
Sec 9 (2) CMA considers the proposed requirements to orientate all text in the same direction on the main label and for medicine names to be presented in a continuous and uninterrupted manner would not have a meaningful impact upon consumer
The name of the medicine on the main safety and as such the change is considered unjustified for lower risk medicines label must be presented in a continuous uninterrupted manner and Feedback from our members indicates that medicine labels are often developed as a result of consumer testing not be broken up by additional In addition CMA has not been presented with information that consumers have any usability difficulties with the information or background text presentation of information on complementary medicine labels Sec 9 (5) All text required by this Order to It is well documented that consumers generally select complementary medicines and non-prescription medicines by brand appear on the main label must be and category and seek out brands they know Branding is important for complementary medicines and consumers are orientated in the same direction familiar with many well-known brands of medicines for general wellbeing cough and cold allergy skincare and many
other categories Limited label space is therefore an important issue particularly for certain product and label types
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 2 of 12
Proposed Requirement TGO 92 Industry response
Such a change would impact upon brand recognition for many companies As such CMA considers this as an unjustified change to requirements adding to unnecessary regulatory burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact on branding and does not require consequential changes to dimensions of packs or labels or changes to the packaging details of a medicine
Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 30millimeters on the front panel directly under the trade name
Since consumers use complementary medicines as part of self-care the label of these medicines is the primary source of information for consumers This requirement would mean that a large portion of the label would be used to display the active ingredients Information on active ingredients is not always the most meaningful aspect in consumer self selection of these goods rather information sought by consumers tends to be focused around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space and there will be reduced space to indicate the intended purpose of the product on the front of pack If the container and label size are increased as a result of this without increasing the number of tablets or capsules in the bottle this could give the consumer a negative perception due to the increased head space of the container Ultimately this would also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations
Sec 9 (6) CMArsquos position on the number of active ingredients that may appear on the front of a label for listed goods is that TGO 69 If the medicine is intended to be or is requirements be maintained listed goods By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active ingredients to four or more (b) if there are four or more active active ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for ingredients in the medicine - the name these lower risk listed medicines without any evidence of consumer benefit being presented of every active ingredient together with the quantity or proportion of CMA suggests the following amendment to TGO 92 every active ingredient may appear on
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 3 of 12
Proposed Requirement TGO 92 Industry response
a side panel or side label or on a rear panel or rear label
If the medicine is intended to be or is listed goods 6 b) if the medicine is a listed complementary medicine ndash the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO 69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014 CMA includes specific examples where for listed CMs containing three active ingredients to be displayed on the front of the label where previously they would be detailed at the side or rear how this would impact on label size being inappropriate for the packaging
Sec 9 (7) CMA proposed that TGO 69 requirements be maintained If the medicine is intended to be or is registered goods then By imposing subsection 9(7)(b) would mean a requirement to go from two or more active ingredients to four or more active
ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for (a) where the medicine contains three registered complementary medicines without any specific evidence of consumer benefit relating to this lower risk class of or four active ingredients the name of good being presented the active ingredient(s) and the quantity or proportion of active Within the complementary medicine category listed and registered complementary medicines will be presented (depending ingredient(s) must be displayed on the on the number of active ingredients present) in a different manner That is some will detail active ingredients at the front of main label in a text size of not less the pack while others (with 4 or more active ingredients) will detail the ingredients at the side or rear of the pack CMA than 3 millimetres submits that for the purposes of standardisation of where to find information consumers should be encouraged to refer to
the backside of the pack for ingredient information (b) where the medicine contains four or more active ingredients and the CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of requirements of subsection 8(2) do not 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations apply then the names and the See comments at Sec 9 (7)(a) above quantities or proportion of the active ingredients may be included on a side panellabel or rear panellabel when
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 4 of 12
Proposed Requirement TGO 92 Industry response
displayed in a text size of not less than 25mm
Sec 10(3) amp Sec 10 (4)(a) CMA does not support any additional change to this lower risk category of medicine
Homeopathic medicines No explanation or justification has been provided as to why there is a new mandatory requirement to include a statement on Where all the active ingredients in a the main label that the medicine is a homeopathic medicine or contains homeopathic preparations in an increased font size to medicine are homoeopathic that of a general listed complementary medicine preparations the main label on the No real explanation has been provided as to why an increase to the font size for the statement ldquohomeopathic medicinerdquo was container and the main label on the considered a requirement based on a consumer safety perspective primary pack (if any) must in addition to the requirements referred Previous explanations for this addition has centred around that the statement is intended to assist consumers with an to in sections 8 and 9 above include a appropriate selection for a medicine and minimise confusion that may arise with self-selection However the current statement to the effect that the labelling Order requires there to be a declaration that clearly states the product is homeopathic and contains homeopathic medicine is a homoeopathic medicine ingredients on the front of the pack and the additional detail of this information on the back of the pack in the ingredients in text size that is not less than 50 and indications section would clearly justify the medicine as being based in the homoeopathic paradigm of the text size of the name of the As such CMA proposes that this section be removed from the Order medicine and (in any event) not less than 2millimeters
Sec 6 CMA submitted in May 2013 via the International Harmonisation of Ingredient Names consultation that there appeared to be no mention of the naming of homoeopathic ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS)
Interpretation in this Order traditional naming or the application of new AAN homoeopathic names As such we resubmit information for consideration here
Homoeopathic medicines ndash naming conventions
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 5 of 12
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation (i) either the name of the active ingredient or the substance from which the dilution was prepared that is accepted for inclusion in the Australian Approved Names (AAN) List together with a statement of the homeopathic potency or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency
It is suggested that an amendment be made to allow for homeopathic medicines The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
To implement this CMA proposes the following amendment to the definition of the name of the active ingredient
(b) where the ingredient is a homoeopathic preparation
1 the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency in brackets the name that is also accepted for inclusion in the Australian Approved Names List
2 for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
That is the traditional homeopathic name to be used as the primary name including the AAN unless on ldquosmall containersrdquo Both the traditional names and AAN could be included on full website information which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required)
It is in the consumersrsquo interest that traditional pharmacopeial names be amended as the primary name The concern here is
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
EXECUTIVE SUMMARY
Complementary Medicines Australia (CMA) welcomes the opportunity to provide a response
to the Therapeutic Goods Administration on its targeted consultation draft TGO 92 -
Standard for the labels of non-prescription medicines and related guidance document dated
October 2015 This submission follows from CMAs response to the Therapeutic Goods
Order for medicine labels (TGO 79) 2014 and the Medicine Labelling and Packaging Review
2012
In general complementary medicines (CMs) are lower-risk medicines As such the majority
of complementary medicines are self-selected by consumers necessitating the medicine
label as a vital information source allowing consumers to make informed purchasing
decisions and to use the medicine safely It is therefore in the interest of the community
that complementary medicine labelling be well designed and effective for its intended
purpose
Overall CMA supports the revision of the labelling Order into two separate Orders for
prescription medicines and non-prescription medicines including complementary
medicines This approach was supported in recognition that different types of medicines
present different levels of risk Following from this CMA also supports that these different
levels of risk are relevant within the registered non prescription type for example lower
risk registered complementary medicines
We support that the guidance document details a tiered approach in the recognition of
levels of risk within the registered medicine category and we have provided additional
comment around how this could be further clarified in the Order itself
CMA supports the aims of the review to the Labelling Order as outlined in the 2014
Regulatory Impact Statement1 are to address and prevent confusion and accidents such as
overdosing under medicating or medicating with the incorrect medicines that are
associated with unclear labelling on medicines It is important that label requirements aim
to ensure medicines supplied in Australia provide healthcare professionals and consumers
with access to information on the medicine including the active ingredient name and in the
case of over-the-counter medicines proper and safe usage
However our sector continues to outline that the increased regulatory requirements
required to implement TGO 92 outweigh the perceived benefit to the community in the
absence of any usage testing or extensive RIS calculations
CMA believes the cost to the complementary sector is disproportionate to the risk arising
from the sector particularly when weighing the likely benefit arising from the proposed
changes One of CMAs members estimates these changes will cost their business alone in
excess of $2 million for their complementary medicine range over the granted transition
period Overall CMA supports further improvements to processes be made within the
context of the existing framework
1 Regulation Impact Statement (RIS) - General requirements for labels for medicines 2014
httpswwwtgagovau sites defaultfilesconsult-labelling-medicines-140822-rispdf
Page 6 of 23
General overview of comments on TGO 92
We reiterate that the labelling of complementary medicines should be well designed and
effective for its intended purpose This has been explored during a number of labelling
consultations undertaken over the years however no evidence of consumer misuse due to
labelling of complementary medicines has been presented to CMA to indicate a change
required to the way in which these lower risk medicines (including homeopathic medicines)
should be labelled
Sponsors of listed medicines are already required to certify that the medicines meet a range
of requirements In particular they must certify that bull the medicine is eligible for Listing bull the presentation is not unacceptable bull the medicine is safe for the purposes for which it is to be used and bull evidence is held to support any claim made in relation to the medicine
As such there remains a number of requirements proposed in the redrafted Order that
appear unjustified and result in an unnecessary increase to the regulatory burden for this
sector
The Labelling Order as a legislative instrument will be legally enforceable by the TGA under
powers provided by the Therapeutic Goods Act 1989 The labelling Order will be supported
by best practice principles outlined in the Australian Regulatory Guidelines for
Complementary Medicines (ARGCM)
Aspects of the proposed Order could arguably be seen to be open to a level of
interpretation For example that the name of the medicine on the main label must be
presented in a continuous uninterrupted manner and not be broken up by additional
information or background text CMA considers any requirements that could be open to
interpretation should not be included in a legislative instrument as this is legally
enforceable rather it should be articulated clearly in best practice guidelines
CMA supports that the current mechanisms in place for the labelling of complementary
medicines are sufficient to promote the quality use of these medicines by consumers CMA
supports where not further indicated in this submission that the current labelling
requirements of TGO 69 be maintained for listed low risk medicines including homeopathic
medicines
Section 7 General requirements including label presentation
bull Labels must be in a colour or colours contrasting strongly with the background
As stated in the CMA 2014 submission ambiguous and subjective requirements should on
principle not be included in a legislative instrument
Page 7 of 23
Considering the guidance document elaborates on the proposed requirement CMA
reiterates that we are not aware of there being consumer safety issues of this nature
reported for CM products which are of a lower risk and hence consider the mandatory
requirement unjustified for this sector of goods
TGO 92 should be amended to include this as a best practice principle only in the guideline
for registered non prescriptions medicines excluding listed medicines and registered
complementary medicines
Section 8 Information to be included on the label
bull Section 8(2) Labels of registered medicines must provide information in a consistent -
order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important
information access to other information is also necessary for consumers to make an
informed purchasing decision
CMA is of the position that for lower risk registered medicines such as registered
complementary medicines there should be flexibility to present mandatory information in a
clear and concise manner without the constraint of a medicine information panel (MIP)
This will minimise unnecessary costs to the CM industry associated with resizing labels or
providing goods in larger container sizes with increased headspace
Section 155 of the Guidance document outlines that a medicine information panel is not
required for certain lower risk registered medicines - these are detailed in subsection 8(2)
of TGO 92 Subsection 8(2) however does not appear to detail specifically what types of
lower risk registered medicines would not require a MIP CMA suggests that this part of the
Order and guidance is expanded to include specifically that registered complementary
medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the
amendment impact registered complementary medicines mock up labels have been
provided to demonstrate that the requirement would necessitate a change to label sizes for
complementary medicines which is considered unjustified
CMA provides at the appendix example 1 a mock up of a registered complementary
medicine to demonstrate how the inclusion of a MIP would not work and necessitate
labelling complications and medicine container size considerations
Page 8 of 23
Section 9 Information to be included on the main label
bull Section 9(2) The name of medicine on the main label must be presented in a continuous uninterrupted manner and not be broken up by additional information or background text
bull Section 9(S) All text required by this Order to appear on the main label must be orientated in the same direction
CMA submits that the proposed requirements to orientate all text in the same direction on
the main label and for medicine names to be presented in a continuous and uninterrupted
manner would not for lower risk medicines have any meaningful impact upon consumer
safety and as such the change is considered unjustified for lower risk medicines
Feedback from our members indicates that medicine labels are often developed as a result
of consumer testing In addition CMA has not been presented with information that
consumers have any usability difficulties with the presentation of information on
complementary medicine labels
It is well documented that consumers generally select complementary medicines and nonshy
prescription medicines by brand and category and seek out brands that they know
Branding is important for complementary medicines and consumers are familiar with many
well-known brands of medicines for general well being cough and cold joint health bone
health and many other categories Limited label space is therefore an important issue
particularly for certain products and label types
Such a change would impact upon brand recognition for many companies As such CMA
considers this an unjustified change to requirements adding to unnecessary regulatory
burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact
on branding and does not require consequential changes to dimensions of packs or labels or
changes to the packaging details of a medicine
bull Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
bull Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 3 0millimeters on the front panel directly under the trade name
Given consumers use complementary medicines as part of self-care the label of these
medicines is the primary source of information for consumers This requirement would
mean that a large portion of the main label would be used to display the active ingredients
which are detailed on the label elsewhere
Page 9 of 23
Information on active ingredients is not always the most meaningful aspect in consumer self
selection of these goods rather information sought by consumers tends to be focused
around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space
and there will be reduced space to indicate the intended purpose of the product on the
front of pack If the container and label size are increased as a result of this without
increasing the number of tablets or capsules in the bottle this could give the consumer a
negative perception due to the increased head space of the container Ultimately this would
also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at the appendix example 1 a mock up of a registered complementary
medicine to demonstrate how the inclusion of 9 7)(a) would not work and necessitate
labelling complications and medicine container size considerations
bull Sec 9 (6) If the medicine is intended to be or is listed goods
(b) if there are four or more active ingredients in the medicine - the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on
As outlined in our 2014 submission subsection 9(6)(b) is not supported for inclusion in the
labelling Order The requirement for change to listed and registered complementary
medicines was not adequately justified from a risk perspective rather the requirements
appear to be a hangover from the risks perceived from the prescription and registered nonshy
prescription medicine sector
CMAs position on the number of active ingredients that may appear on the front of a label
for listed goods is that TGO 69 requirements be maintained
By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active
ingredients to four or more active ingredients that may be declared on a side panellabel or
rear panellabel This would increase the regulatory cost for these lower risk listed
medicines without any evidence of consumer benefit being presented
CMA suggests the following amendment to TGO 92
If the medicine is intended to be or is listed goods
6 b) if the medicine is a listed complementary medicine - the name of every active
ingredient together with the quantity or proportion of every active ingredient may appear
on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO
69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014
Page 10 of 23
CMA includes specific examples at appendix 1 example 2 impact on label size for listed
complementary medicines containing three active ingredients to be displayed on the front
of the label (currently they may be detailed at the side or rear)
bull Sec 9 (7) If the medicine is intended to be or is registered goods then
(a) where the medicine contains three or four active ingredients the name of the active
ingredient(s) and the quantity or proportion of active ingredient(s) must be displayed on
the main label in a text size of not less than 3 millimetres
(b) where the medicine contains four or more active ingredients and the requirements of
subsection 8(2) do not apply then the names and the quantities or proportion of the
active ingredients may be included on a side panellabel or rear panellabel when
displayed in a text size of not less than 2Smm
CMAs position on this section is that TGO 69 requirements be maintained
By imposing subsection 9(7)(b) would mean a requirement to go from two or more active
ingredients to four or more active ingredients that may be declared on a side panellabel or
rear panellabel This would increase the regulatory costs for registered complementary
medicines without any specific evidence of consumer benefit relating to this lower risk class
of good being presented
Within the complementary medicine category listed and registered complementary
medicines will be presented (depending on the number of active ingredients present) in a
different manner That is some will detail active ingredients at the front of the pack while
others (with 4 or more active ingredients) will detail the ingredients at the side or rear of
the pack CMA submits that for the purposes of standardisation and consistency on where
to find information for lower risk goods consumers should be encouraged to refer to the
backside of the pack for ingredient information
CMA provides a mock up of a registered CM provided to demonstrate how the inclusion of
9 (7)(a) would not work and necessitate labelling complications and medicine container size
considerations
Section 10 Qualifications and special requirements
Sec 10(3) amp Sec 10 (4)(a) where all the active ingredients in a medicine are homoeopathic
preparations the main label on the container and the main label on the primary pack (if
any) must in addition to the requirements referred to in sections 8 and 9 above include a
statement to the effect that the medicine is a homoeopathic medicine in text size that is
not less than 50 of the text size of the name of the medicine and (in any event) not less
than 2millimeters
Page 11of23
CMA does not support any additional change to this lower risk category of medicine
No explanation or justification has been provided during the course of labelling
consultations as to why there is a new mandatory requirement to include a statement on
the main label that the medicine is a homeopathic medicine or contains homeopathic
preparations in an increased font size to that of a general listed complementary medicine
No real explanation has been provided as to why an increase to the font size for the
statement homeopathic medicine was considered a requirement based on a consumer
safety perspective
Previous explanations for this addition has centred on factors that the statement is intended
to assist consumers with an appropriate selection for a medicine and minimise confusion
that may arise with self-selection However the current labelling Order requires there to
be a declaration that clearly states the product is homeopathic and contains homeopathic
ingredients on the front of the pack and the additional detail of this information on the back
of the pack in the ingredients and indications section would clearly justify the medicine as
being based in the homoeopathic paradigm As such CMA proposes that this section be
removed from the Order
bull Section 6 Interpretation in the Order Homeopathic medicines - naming conventions
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic
preparation (i) either the name of the active ingredient or the substance from which the
dilution was prepared that is accepted for inclusion in the Australian Approved Names
(AAN) List together with a statement of the homeopathic potency or (ii) until such time
as a name is accepted for inclusion in the Australian Approved Names List a traditional
homoeopathic name in full or as traditionally abbreviated with a statement of
homeopathic potency
Given the recent redraft of the labelling Order it is an opportune time to explore potential
amendments that aim to increase the clarity for requirements around homeopathic
medicines for both industry and the regulator
CMA submitted in May 2013 via the International Harmonisation of Ingredient Names
consultation that there appeared to be no mention of the naming of homoeopathic
ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS) traditional naming or
the application of new AAN homoeopathic names As such we resubmit information for
consideration here
It is suggested that an amendment be made to allow for homeopathic medicines
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
Page 12 of 23
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
That is the traditional homeopathic name is to be used as the primary name including the
AAN unless on small containers Both the traditional names and AANs could be included
on full website information which would allow additional space to elaborate on the naming
of traditional homeopathic ingredients (where required)
To implement this CMA proposes the following amendment to the definition of the name
of the active ingredient
(b) where the ingredient is a homoeopathic preparation
(i) the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency and the name that is also accepted for inclusion in the Australian Approved Names List (if available) in brackets
(ii) for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
It is in the consumers interest that traditional pharmacopeial names be amended so as to
be the primary name The concern here is that by enforcing the current definition and taking
the AAN name alone outside of the traditional context the consumer may only get the
name in its full chemicalnon homeopathic form causing potential confusion and or safety
concerns Additionally the AAN name alone (due to small label space requirements) may
appear as a different active ingredient all together causing consumer alarm
For example False Unicorn Root
Traditional homeopathic name AAN name
Helonias dioica Chamaelirium luteum
If a consumer wishes to know more about a homeopathic medicine ingredient many
sources of information (pharmacopoeias texts materia medica) refer to the traditional
name as the primary point of reference To elaborate further examples have been provided
(Appendix 1 example 5) with this submission
International harmonisation considerations - homeopathic naming
conventions
ACSS Consortium
Page 13 of 23
website
(httpwebprodhc-scgccanhpidshy
bdipsnatRegdoatid=homeopathy)
(httpljwwwhc-scgccadhp-mpsprodnaturlegislationdocsehmg-nprhshy
engphpaS)
The TGA is part of the ACSS Consortium along with Health Canada Health Sciences Authority of Singapore and Swissmedic According to the TGA the ACSS Consortium
was formed in 2007 by like-minded regulatory authorities to promote greater regulatory
collaboration and alignment of regulatory requirements with the goal of maximising
international cooperation reduce duplication and increase each agencys capacity to
ensure consumers have timely access to high quality safe and effective therapeutic
products
Heath Canada
The Health Canada website
provides guidance to industry for the preparation of
Product Licence Applications (PLAs) and labels for natural health product market
authorization for homeopathic products (updated July 2015) It states
bull The proper name(s) common name(s) and source material(s) must be as per the homeopathic
monograph referenced as the Standard or Grade (please refer to the specifications)
bull The medicinal ingredient(s) must be a permitted substance with a homeopathic monograph in one
of the Natural and Non-Prescription Health Products Directorate (NNHPD) accepted homeopathic
pharmacopoeia
The Standards or Grades refers to a list of homeopathic pharmacopoeias containing the
traditional homeopathic names
Health Canada also includes guidance for the labelling of homeopathic medicines on its
website
It includes the following guidance for labelling for small packages
53 Labels for Small Packages
The NNHPD recognizes that small packages such as those used by some homeopathic medicine manufacturers
may not have an area large enough for the inner labelling requirements Therefore separate small package
labelling requirements have been developed Please see the Labelling guidance document for infonnation
specific to small package labelling
SwissMedic
In Switzerland homeopathy has been fully integrated into the Swiss medical system
SwissMedics HAS (Homeopathic and Anthroposophical medicines) list includes both Latin
chemical names and their homeopathic synonyms It appears that homeopathic products in
Switzerland also allow for the use of homeopathic names on products labels (noting the
strong tradition of use of homeopathy in the region)
FDA
The FDA also recognises the traditional homeopathic names with HPUS as the standard The HPUS has labelling guidelines for homeopathic medicines2 that links in with the labelling
2 httpwwwhpuscomRevised-Labeling-Guidelines-04-14pdf
Page 14 of 23
provisions of Sections 502 and 503 of the Federal Food Drug and Cosmetic Act Part 201
Title 21 of the Code of Federal Regulations (CFR) and the FDAs Compliance Policy Guide
400400
Section 11 How Information is to be expressed -
Use of appropriate metric units
bull Sec 11 (l)(b) The abbreviations to mg and g can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation microg may be used
Where several ingredients are presented on a label statement in microgram microliter
quantities the repetition of expressing the unit in full greatly expands the length of the text
and hence label space becomes an important issue
Further CMA questions if the requirement is mandatory given it is expressed as should in
the standard compared to must in the guideline
This proposed requirement if mandatory does not allow for consistency on the label and
increased label space is required CMA submits that an abbreviated form of microgram
should be permitted in the standard
Expression of quantity or proportion of active ingredients
Sec 11 (2) Expression of quantity or propo1iion of active ingredients
11(2)(i) states that in addition to the requirements of paragraphs 1 1(2)(a)-1 1(2)(h) and
therefore includes 1 1 (2)( a) the quantity of the active ingredient
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the
herbal material from which the preparation was derived except
This amendment appears to propose that herbal ingredients include the actual amount of
herbal extract in addition to the equivalent amount of starting herbal material from which
the preparation was derived
As detailed in our 2014 submission we do not support the increased information
requirements for the expression of herbal medicines to be expanded on the medicine label
(section 11(2))
The 2014 consultation suggested the reasoning for the additional requirement to include
the input amount of the herbal material on the label was that it enables the consumer to
Page lS of 23
version
gain meaningful information in relation to the strength concentration or quantified levels
in general of the herbal ingredients in the medicine
To implement this requirement however it would require the addition of an extra line of
information for each herbal material ingredient to express both quantities on the medicine
label The majority of complementary medicines are multi ingredient formulations
sometimes with as many as 25 ingredients in a product The addition of at least two lines to
express each herbal ingredient would for the average consumer most likely only create
confusion as to which line of expression to draw a meaningful conclusion from
The main concern is that this would lead to two quantification values for the same inputted
ingredient which would be open to misunderstanding and if other than the native extract
amount potentially no more helpful to the consumer Additionally this requirement does
not appear to impact upon the safe or proper usage of the medicine if used within the
context outlined on the label
CMA considers that this requirement would significantly increase the regulatory burden of
lower risk medicines by increasing the amount of information required on a label and hence
label size Label space will become an issue and an impracticality pushed to some degree
and with an obscure label this could lead to other potentially misleading packaging issues
We again provide mock up labels at the appendix to demonstrate this significant increase in
requirement
Clear concise labelling of ingredients with one quantity the extract equivalent of the herb
provides consumers with satisfactory information that allows comparison with other
products
CMA requests that TGA provides a detailed reasoning behind the proposed amendment
including evidence that the current requirement is impacting on the safe and proper usage
of listed medicines if that is the case In the absence of this information CMA does not
support implementing this section of the labelling Order and that it be drafted without this
specific requirement
CMA provides a mock up label at the appendix 1 example 3 to demonstrate the increased
requirements to listed low risk medicines
Regulatory Impact Statement (RIS)- general requirements for labels of medicines version 10 August 2014
The TGA provided a regulatory impact statement and other supporting documents3 as
evidence in support of a change to the labelling of medicines the proposed changes were
however largely based on the risk profile associated with prescription and registered over
the counter medicines with no direct reference to misuse of complementary medicines in
3 Labelling and packaging practices 10 January 2013 fileCUserstechnicalDownloadsconsultshy
labelling-packaging-review-1205 24-an alysis-evidencepdf
Page 16 of 23
the context of self-selection being outlined The extra regulatory requirements for labelling
and packaging of complementary medicines are considered to be out of proportion to the
risk classifications of these medicines
The 2014 consultation highlighted that due to lower risk medicines being available for self selection this factor alone poses a risk as the consumer receives no additional information
except the instructions on the label Indeed while this highlights the importance of the
information on the medicine label no evidence has been provided that the proposed
changes would contribute to the provision of better consumer information or safety A
change to the amount of active ingredients that can be included on the front of the
medicine label and additional information around the expression of herbal ingredients for
example are proposals for change that are not supported by CMA as they have not been
evidenced to be a safety issue nor undergone consumer use testing to demonstrate any
improvement on the status quo would be gained In summary they will have little affect on
consumers self-selection
The 2014 labelling consultation included a regulatory impact statement which from an
industry point of view grossly underestimated the cost of changes
Copy from the RIS
The labour burden for businesses who need to change a label would be
approximately 20 hours (includes reading the current guidance and applying it to
their design work and the small amount of labour involved in providing new label
information as part of the application to vary the entry) at a labour rate of $42 per
hour
The additional requirements proposed in the Order and schedule 1 will result in all
companies conducting a review of each medicine formulation checking for compliance to
these revised requirements It is estimated that the $42 per hour labour rate above would
increase to approximately $60 per hour for the time required to carry out the review One
member estimates that the labour hours would increase from 20 to 30 hours and takes into
account that different sections within an organisation and external organisations are
involved in obtaining documentation for example suppliers distributors manufacturers
Testing may also be required to confirm if any allergen residue remains in the raw material
Transition arrangements
CMA notes that the proposed transition arrangement includes a four year period where by
compliance with the current labelling Order (TGO 69) or the revised TGO 92 would be
permitted By 2020 full compliance with TGO 92 would be required While this is an
improvement from the 2014 proposal CMA highlights that further refinements to TGO 92 is
required to reduce the regulatory burden for complementary medicines
Page 17 of 23
Should the Order be implemented as currently drafted there will be many complementary
medicine businesses that would be negatively impacted Not in the lest many small ownershy
operator complementary medicine businesses would not generally be in the practice of
changing their medicine labels every few years as indicated in the TGA RIS document
The transition period will also be particularly problematic where the labelled information
will differ despite no change in formulation eg change in apparent quantification
ingredient name or ingredient placement
The RIS document also detailed that the new labelling Order would be a one-off cost for
those businesses that would not be changing their labels during the transition period
The 2014 participants in the TGA industry survey included larger CM company
representatives and therefore is only indicative of that sector of the industry
Specifically the RIS did not look at the fact that smaller companies would employ the skills
of professional consultants to carry out the work required to ensure compliance with the
new labelling Order This cost factor alone for changes proposed to lower risk listed
medicines is considered an unnecessary additional regulatory burden that would not
necessarily equate to any consumer self-medication benefit
CMA submits that the focus of the TGA be one of reducing the regulatory burden enhancing
efficiencies in existing process whilst upholding the safety and quality of complementary
medicines available to consumers For these reasons CMA submits that further refinements
to TGO 92 be made to accommodate lower risk medicines
Schedule 1 Substances or groups of substances present in medicines -
that are required to be declared on the label of medicines
It appears that some inconsistencies remain in the declaration statement of certain
substances in Schedule 1 of TGO 92 compared to warning statements generated on the
ARTG
Ethanolalcohol
This group of substances to be declared on the label is not consistent with the ARTG
generated warning for ethanolalcohol
bull Contains alcohol vs contains ethanol (vv)
Ethanol as one of the substances required to be declared on the label can carry the
declaration contains alcohol However the same ingredient warning that is generated on
the ARTG for use if this ingredient is in the formula as a listed excipient is ETHAN contains
ethanol (or words to that effect)
Recommendations
Page 18 of 23
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is consistent
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label if the situation arises where there is already an ARTG
generated ethanol warning
Other ingredients such as potassium sorbate already generate ARTG warnings if listed as
excipients and is also in the group of substances required to be declared on the label
Again the wording used is inconsistent
ARTG warning SORB8 (If the medicine contains one sorbate) Contains [insert name of
sorbate] OR (if medicine contains two or more sorbates) Contains sorbates [or words to that
effect]
bull Contains sorbates vs contains [inse1i name of sorbate] (if the medicine contains one sorbate) or contains sorbates (if the medicine contains two or more sorbates) in the
event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have Contains potassium sorbate
whilst it would read Contains sorbates to comply with schedule 1 of TGO 92
Recommendations
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is
consistent If the product contains one sorbate eg potassium sorbate ARTG warning
is Contains potassium sorbate however TGO 92 declaration is Contains sorbates
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label in these situations
Phenylalanine
Many mineral amino acid chelates contain phenylalanine as part of the amino acid portion
of the mineral and ingredients such as Spirulina whole cell powder would contain
phenylalanine as part of its protein profile CMA proposes that the schedule 1 list include
additional information as to what ingredients the phenylalanine warning applies to or
outline the ingredients such as those mentioned above that are exempt from the
requirement
Imposing such requirements to all ingredients may cause unnecessary concern to the
consumer
Page 19 of 23
PU
Schedule 2 Specified Units for Enzymes -
bull CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients Papain Units Bromelain
Currently the TBS only allows the quantity of the ingredient to be expressed in milligrams
(mg) Pervious considerations of this issue has identified that the per mg expression is not
the most appropriate for the material Whilst GOU (gelatine digesting unit) is acknowledged
to be the unit most commonly used for the material papain unit is proposed as this is the
specified unit from bromelain by the joint FAOWHO expert committee on Food Additives
(JECFA) the Food Chemical Codex and the unit adopted by Health Canada in its
monographs for Stem bromelian and fruit bromelian We note also that there is a simple
conversion factor that can be applied to quantities expressed as GOU
CMA comment on the Guideline for medicine labels draft version 10
October 2015
bull 3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA proposes the
removal (of Camellia sinensis) after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation
and herbal material and quantity of standardised constituent) would be expressed
together This reiteration appears to be redundant and would take up more space on the
label
bull Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] Ingredients Uses or What this medicine is used for Warnings Directions for use and Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a
specified order) needs to be followed for listed medicines
Page 2 0 of 23
Labelling
Labelling packaging Complementary
Labelling Packaging
CMA interprets the revised TGO 92 update to mean that this would no longer be a
requirement However we have provided a mock up label at appendix 1 example 4 to
demonstrate how this requirement if relevant would impact multi ingredient herbal
medicines
CMA resources in reference to the labelling of complementary
medicines
bull CMA submission Consultation Draft TGO 79 Standards for the of Medicines
(November 2014) bull CMA submission and of Medicines (12 April
2013) bull CMA submission on the Medicine and Review (24 August 2012)
Page 21of23
CMA detailed table of reform recommendations and impact of TGO 92
Page 22 of 23
Appendix 1 - mock up labels to TGO 92 requirements
Page 23 of 23
CMA response to TGO 92- Standards for the labels of non-prescription medicines
Proposed Requirement TGO 92 Industry response
Text size In principle CMA agrees with the change that reverts back to the current TGO 69 definition of text size This is in comparison to the consultation draft TGO79 that proposed a range of sizes for listed and registered
ldquoText size equivalent to Arial fontrdquo complementary medicines based on Arial point size font has been removed from TGO 92 The definition for letter height is the same as the definition in TGO 69
Sec 7 General requirements including As stated in the CMA 2014 submission ambiguous and subjective requirements should on principle not be included in a label presentation legislative instrument (2)(e) Considering the guidance document elaborates on the proposed requirement CMA reiterates that we are not aware of there Labels must be in a colour or colours being consumer safety issues of this nature reported for CM products which are of a lower risk and hence consider the contrasting strongly with the mandatory requirement unjustified background Sec 8(2) Labels of registered medicines must provide information in a consistent order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important information access to other information is also necessary for consumers to make an informed purchasing decision CMA is of the position that for lower risk registered medicines such as registered complementary medicines there should be flexibility to present mandatory information in a clear and concise manner without the constraint of a medicine information panel (MIP) This will minimise cost to the CM industry associated with resizing labels or providing goods in larger container sizes with increased headspace Section 155 of the Guidance document outlines that ldquoa medicine information panel is not required for certain lower risk
Proposed Requirement TGO 92 Industry response
registered medicines ndash these are detailed in subsection 8(2) of TGO 92rdquo Subsection 8(2) however does not appear to detail specifically what types of lower risk registered medicines would not require a MIP CMA suggests that this part of the guidance is expanded to include specific guidance that registered complementary medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the amendment impact registered complementary medicines mock up labels have been provided to demonstrate that the requirement would necessitate a change to label sizes for complementary medicines which is considered unjustified
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of a MIP would not work and necessitate labelling complications and medicine container size considerations
Sec 8 (1) (k) (ii) (B) Pregnancy database
Requirements related tot his section should be incorporated on an ingredient by ingredient basis within the 26BB list of permissible ingredients instrument Pregnancy database - Add link httpswwwtgagovauprescribing-medicines-pregnancy-database
Sec 9 (2) CMA considers the proposed requirements to orientate all text in the same direction on the main label and for medicine names to be presented in a continuous and uninterrupted manner would not have a meaningful impact upon consumer
The name of the medicine on the main safety and as such the change is considered unjustified for lower risk medicines label must be presented in a continuous uninterrupted manner and Feedback from our members indicates that medicine labels are often developed as a result of consumer testing not be broken up by additional In addition CMA has not been presented with information that consumers have any usability difficulties with the information or background text presentation of information on complementary medicine labels Sec 9 (5) All text required by this Order to It is well documented that consumers generally select complementary medicines and non-prescription medicines by brand appear on the main label must be and category and seek out brands they know Branding is important for complementary medicines and consumers are orientated in the same direction familiar with many well-known brands of medicines for general wellbeing cough and cold allergy skincare and many
other categories Limited label space is therefore an important issue particularly for certain product and label types
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 2 of 12
Proposed Requirement TGO 92 Industry response
Such a change would impact upon brand recognition for many companies As such CMA considers this as an unjustified change to requirements adding to unnecessary regulatory burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact on branding and does not require consequential changes to dimensions of packs or labels or changes to the packaging details of a medicine
Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 30millimeters on the front panel directly under the trade name
Since consumers use complementary medicines as part of self-care the label of these medicines is the primary source of information for consumers This requirement would mean that a large portion of the label would be used to display the active ingredients Information on active ingredients is not always the most meaningful aspect in consumer self selection of these goods rather information sought by consumers tends to be focused around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space and there will be reduced space to indicate the intended purpose of the product on the front of pack If the container and label size are increased as a result of this without increasing the number of tablets or capsules in the bottle this could give the consumer a negative perception due to the increased head space of the container Ultimately this would also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations
Sec 9 (6) CMArsquos position on the number of active ingredients that may appear on the front of a label for listed goods is that TGO 69 If the medicine is intended to be or is requirements be maintained listed goods By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active ingredients to four or more (b) if there are four or more active active ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for ingredients in the medicine - the name these lower risk listed medicines without any evidence of consumer benefit being presented of every active ingredient together with the quantity or proportion of CMA suggests the following amendment to TGO 92 every active ingredient may appear on
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 3 of 12
Proposed Requirement TGO 92 Industry response
a side panel or side label or on a rear panel or rear label
If the medicine is intended to be or is listed goods 6 b) if the medicine is a listed complementary medicine ndash the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO 69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014 CMA includes specific examples where for listed CMs containing three active ingredients to be displayed on the front of the label where previously they would be detailed at the side or rear how this would impact on label size being inappropriate for the packaging
Sec 9 (7) CMA proposed that TGO 69 requirements be maintained If the medicine is intended to be or is registered goods then By imposing subsection 9(7)(b) would mean a requirement to go from two or more active ingredients to four or more active
ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for (a) where the medicine contains three registered complementary medicines without any specific evidence of consumer benefit relating to this lower risk class of or four active ingredients the name of good being presented the active ingredient(s) and the quantity or proportion of active Within the complementary medicine category listed and registered complementary medicines will be presented (depending ingredient(s) must be displayed on the on the number of active ingredients present) in a different manner That is some will detail active ingredients at the front of main label in a text size of not less the pack while others (with 4 or more active ingredients) will detail the ingredients at the side or rear of the pack CMA than 3 millimetres submits that for the purposes of standardisation of where to find information consumers should be encouraged to refer to
the backside of the pack for ingredient information (b) where the medicine contains four or more active ingredients and the CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of requirements of subsection 8(2) do not 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations apply then the names and the See comments at Sec 9 (7)(a) above quantities or proportion of the active ingredients may be included on a side panellabel or rear panellabel when
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 4 of 12
Proposed Requirement TGO 92 Industry response
displayed in a text size of not less than 25mm
Sec 10(3) amp Sec 10 (4)(a) CMA does not support any additional change to this lower risk category of medicine
Homeopathic medicines No explanation or justification has been provided as to why there is a new mandatory requirement to include a statement on Where all the active ingredients in a the main label that the medicine is a homeopathic medicine or contains homeopathic preparations in an increased font size to medicine are homoeopathic that of a general listed complementary medicine preparations the main label on the No real explanation has been provided as to why an increase to the font size for the statement ldquohomeopathic medicinerdquo was container and the main label on the considered a requirement based on a consumer safety perspective primary pack (if any) must in addition to the requirements referred Previous explanations for this addition has centred around that the statement is intended to assist consumers with an to in sections 8 and 9 above include a appropriate selection for a medicine and minimise confusion that may arise with self-selection However the current statement to the effect that the labelling Order requires there to be a declaration that clearly states the product is homeopathic and contains homeopathic medicine is a homoeopathic medicine ingredients on the front of the pack and the additional detail of this information on the back of the pack in the ingredients in text size that is not less than 50 and indications section would clearly justify the medicine as being based in the homoeopathic paradigm of the text size of the name of the As such CMA proposes that this section be removed from the Order medicine and (in any event) not less than 2millimeters
Sec 6 CMA submitted in May 2013 via the International Harmonisation of Ingredient Names consultation that there appeared to be no mention of the naming of homoeopathic ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS)
Interpretation in this Order traditional naming or the application of new AAN homoeopathic names As such we resubmit information for consideration here
Homoeopathic medicines ndash naming conventions
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 5 of 12
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation (i) either the name of the active ingredient or the substance from which the dilution was prepared that is accepted for inclusion in the Australian Approved Names (AAN) List together with a statement of the homeopathic potency or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency
It is suggested that an amendment be made to allow for homeopathic medicines The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
To implement this CMA proposes the following amendment to the definition of the name of the active ingredient
(b) where the ingredient is a homoeopathic preparation
1 the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency in brackets the name that is also accepted for inclusion in the Australian Approved Names List
2 for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
That is the traditional homeopathic name to be used as the primary name including the AAN unless on ldquosmall containersrdquo Both the traditional names and AAN could be included on full website information which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required)
It is in the consumersrsquo interest that traditional pharmacopeial names be amended as the primary name The concern here is
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
General overview of comments on TGO 92
We reiterate that the labelling of complementary medicines should be well designed and
effective for its intended purpose This has been explored during a number of labelling
consultations undertaken over the years however no evidence of consumer misuse due to
labelling of complementary medicines has been presented to CMA to indicate a change
required to the way in which these lower risk medicines (including homeopathic medicines)
should be labelled
Sponsors of listed medicines are already required to certify that the medicines meet a range
of requirements In particular they must certify that bull the medicine is eligible for Listing bull the presentation is not unacceptable bull the medicine is safe for the purposes for which it is to be used and bull evidence is held to support any claim made in relation to the medicine
As such there remains a number of requirements proposed in the redrafted Order that
appear unjustified and result in an unnecessary increase to the regulatory burden for this
sector
The Labelling Order as a legislative instrument will be legally enforceable by the TGA under
powers provided by the Therapeutic Goods Act 1989 The labelling Order will be supported
by best practice principles outlined in the Australian Regulatory Guidelines for
Complementary Medicines (ARGCM)
Aspects of the proposed Order could arguably be seen to be open to a level of
interpretation For example that the name of the medicine on the main label must be
presented in a continuous uninterrupted manner and not be broken up by additional
information or background text CMA considers any requirements that could be open to
interpretation should not be included in a legislative instrument as this is legally
enforceable rather it should be articulated clearly in best practice guidelines
CMA supports that the current mechanisms in place for the labelling of complementary
medicines are sufficient to promote the quality use of these medicines by consumers CMA
supports where not further indicated in this submission that the current labelling
requirements of TGO 69 be maintained for listed low risk medicines including homeopathic
medicines
Section 7 General requirements including label presentation
bull Labels must be in a colour or colours contrasting strongly with the background
As stated in the CMA 2014 submission ambiguous and subjective requirements should on
principle not be included in a legislative instrument
Page 7 of 23
Considering the guidance document elaborates on the proposed requirement CMA
reiterates that we are not aware of there being consumer safety issues of this nature
reported for CM products which are of a lower risk and hence consider the mandatory
requirement unjustified for this sector of goods
TGO 92 should be amended to include this as a best practice principle only in the guideline
for registered non prescriptions medicines excluding listed medicines and registered
complementary medicines
Section 8 Information to be included on the label
bull Section 8(2) Labels of registered medicines must provide information in a consistent -
order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important
information access to other information is also necessary for consumers to make an
informed purchasing decision
CMA is of the position that for lower risk registered medicines such as registered
complementary medicines there should be flexibility to present mandatory information in a
clear and concise manner without the constraint of a medicine information panel (MIP)
This will minimise unnecessary costs to the CM industry associated with resizing labels or
providing goods in larger container sizes with increased headspace
Section 155 of the Guidance document outlines that a medicine information panel is not
required for certain lower risk registered medicines - these are detailed in subsection 8(2)
of TGO 92 Subsection 8(2) however does not appear to detail specifically what types of
lower risk registered medicines would not require a MIP CMA suggests that this part of the
Order and guidance is expanded to include specifically that registered complementary
medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the
amendment impact registered complementary medicines mock up labels have been
provided to demonstrate that the requirement would necessitate a change to label sizes for
complementary medicines which is considered unjustified
CMA provides at the appendix example 1 a mock up of a registered complementary
medicine to demonstrate how the inclusion of a MIP would not work and necessitate
labelling complications and medicine container size considerations
Page 8 of 23
Section 9 Information to be included on the main label
bull Section 9(2) The name of medicine on the main label must be presented in a continuous uninterrupted manner and not be broken up by additional information or background text
bull Section 9(S) All text required by this Order to appear on the main label must be orientated in the same direction
CMA submits that the proposed requirements to orientate all text in the same direction on
the main label and for medicine names to be presented in a continuous and uninterrupted
manner would not for lower risk medicines have any meaningful impact upon consumer
safety and as such the change is considered unjustified for lower risk medicines
Feedback from our members indicates that medicine labels are often developed as a result
of consumer testing In addition CMA has not been presented with information that
consumers have any usability difficulties with the presentation of information on
complementary medicine labels
It is well documented that consumers generally select complementary medicines and nonshy
prescription medicines by brand and category and seek out brands that they know
Branding is important for complementary medicines and consumers are familiar with many
well-known brands of medicines for general well being cough and cold joint health bone
health and many other categories Limited label space is therefore an important issue
particularly for certain products and label types
Such a change would impact upon brand recognition for many companies As such CMA
considers this an unjustified change to requirements adding to unnecessary regulatory
burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact
on branding and does not require consequential changes to dimensions of packs or labels or
changes to the packaging details of a medicine
bull Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
bull Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 3 0millimeters on the front panel directly under the trade name
Given consumers use complementary medicines as part of self-care the label of these
medicines is the primary source of information for consumers This requirement would
mean that a large portion of the main label would be used to display the active ingredients
which are detailed on the label elsewhere
Page 9 of 23
Information on active ingredients is not always the most meaningful aspect in consumer self
selection of these goods rather information sought by consumers tends to be focused
around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space
and there will be reduced space to indicate the intended purpose of the product on the
front of pack If the container and label size are increased as a result of this without
increasing the number of tablets or capsules in the bottle this could give the consumer a
negative perception due to the increased head space of the container Ultimately this would
also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at the appendix example 1 a mock up of a registered complementary
medicine to demonstrate how the inclusion of 9 7)(a) would not work and necessitate
labelling complications and medicine container size considerations
bull Sec 9 (6) If the medicine is intended to be or is listed goods
(b) if there are four or more active ingredients in the medicine - the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on
As outlined in our 2014 submission subsection 9(6)(b) is not supported for inclusion in the
labelling Order The requirement for change to listed and registered complementary
medicines was not adequately justified from a risk perspective rather the requirements
appear to be a hangover from the risks perceived from the prescription and registered nonshy
prescription medicine sector
CMAs position on the number of active ingredients that may appear on the front of a label
for listed goods is that TGO 69 requirements be maintained
By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active
ingredients to four or more active ingredients that may be declared on a side panellabel or
rear panellabel This would increase the regulatory cost for these lower risk listed
medicines without any evidence of consumer benefit being presented
CMA suggests the following amendment to TGO 92
If the medicine is intended to be or is listed goods
6 b) if the medicine is a listed complementary medicine - the name of every active
ingredient together with the quantity or proportion of every active ingredient may appear
on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO
69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014
Page 10 of 23
CMA includes specific examples at appendix 1 example 2 impact on label size for listed
complementary medicines containing three active ingredients to be displayed on the front
of the label (currently they may be detailed at the side or rear)
bull Sec 9 (7) If the medicine is intended to be or is registered goods then
(a) where the medicine contains three or four active ingredients the name of the active
ingredient(s) and the quantity or proportion of active ingredient(s) must be displayed on
the main label in a text size of not less than 3 millimetres
(b) where the medicine contains four or more active ingredients and the requirements of
subsection 8(2) do not apply then the names and the quantities or proportion of the
active ingredients may be included on a side panellabel or rear panellabel when
displayed in a text size of not less than 2Smm
CMAs position on this section is that TGO 69 requirements be maintained
By imposing subsection 9(7)(b) would mean a requirement to go from two or more active
ingredients to four or more active ingredients that may be declared on a side panellabel or
rear panellabel This would increase the regulatory costs for registered complementary
medicines without any specific evidence of consumer benefit relating to this lower risk class
of good being presented
Within the complementary medicine category listed and registered complementary
medicines will be presented (depending on the number of active ingredients present) in a
different manner That is some will detail active ingredients at the front of the pack while
others (with 4 or more active ingredients) will detail the ingredients at the side or rear of
the pack CMA submits that for the purposes of standardisation and consistency on where
to find information for lower risk goods consumers should be encouraged to refer to the
backside of the pack for ingredient information
CMA provides a mock up of a registered CM provided to demonstrate how the inclusion of
9 (7)(a) would not work and necessitate labelling complications and medicine container size
considerations
Section 10 Qualifications and special requirements
Sec 10(3) amp Sec 10 (4)(a) where all the active ingredients in a medicine are homoeopathic
preparations the main label on the container and the main label on the primary pack (if
any) must in addition to the requirements referred to in sections 8 and 9 above include a
statement to the effect that the medicine is a homoeopathic medicine in text size that is
not less than 50 of the text size of the name of the medicine and (in any event) not less
than 2millimeters
Page 11of23
CMA does not support any additional change to this lower risk category of medicine
No explanation or justification has been provided during the course of labelling
consultations as to why there is a new mandatory requirement to include a statement on
the main label that the medicine is a homeopathic medicine or contains homeopathic
preparations in an increased font size to that of a general listed complementary medicine
No real explanation has been provided as to why an increase to the font size for the
statement homeopathic medicine was considered a requirement based on a consumer
safety perspective
Previous explanations for this addition has centred on factors that the statement is intended
to assist consumers with an appropriate selection for a medicine and minimise confusion
that may arise with self-selection However the current labelling Order requires there to
be a declaration that clearly states the product is homeopathic and contains homeopathic
ingredients on the front of the pack and the additional detail of this information on the back
of the pack in the ingredients and indications section would clearly justify the medicine as
being based in the homoeopathic paradigm As such CMA proposes that this section be
removed from the Order
bull Section 6 Interpretation in the Order Homeopathic medicines - naming conventions
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic
preparation (i) either the name of the active ingredient or the substance from which the
dilution was prepared that is accepted for inclusion in the Australian Approved Names
(AAN) List together with a statement of the homeopathic potency or (ii) until such time
as a name is accepted for inclusion in the Australian Approved Names List a traditional
homoeopathic name in full or as traditionally abbreviated with a statement of
homeopathic potency
Given the recent redraft of the labelling Order it is an opportune time to explore potential
amendments that aim to increase the clarity for requirements around homeopathic
medicines for both industry and the regulator
CMA submitted in May 2013 via the International Harmonisation of Ingredient Names
consultation that there appeared to be no mention of the naming of homoeopathic
ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS) traditional naming or
the application of new AAN homoeopathic names As such we resubmit information for
consideration here
It is suggested that an amendment be made to allow for homeopathic medicines
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
Page 12 of 23
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
That is the traditional homeopathic name is to be used as the primary name including the
AAN unless on small containers Both the traditional names and AANs could be included
on full website information which would allow additional space to elaborate on the naming
of traditional homeopathic ingredients (where required)
To implement this CMA proposes the following amendment to the definition of the name
of the active ingredient
(b) where the ingredient is a homoeopathic preparation
(i) the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency and the name that is also accepted for inclusion in the Australian Approved Names List (if available) in brackets
(ii) for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
It is in the consumers interest that traditional pharmacopeial names be amended so as to
be the primary name The concern here is that by enforcing the current definition and taking
the AAN name alone outside of the traditional context the consumer may only get the
name in its full chemicalnon homeopathic form causing potential confusion and or safety
concerns Additionally the AAN name alone (due to small label space requirements) may
appear as a different active ingredient all together causing consumer alarm
For example False Unicorn Root
Traditional homeopathic name AAN name
Helonias dioica Chamaelirium luteum
If a consumer wishes to know more about a homeopathic medicine ingredient many
sources of information (pharmacopoeias texts materia medica) refer to the traditional
name as the primary point of reference To elaborate further examples have been provided
(Appendix 1 example 5) with this submission
International harmonisation considerations - homeopathic naming
conventions
ACSS Consortium
Page 13 of 23
website
(httpwebprodhc-scgccanhpidshy
bdipsnatRegdoatid=homeopathy)
(httpljwwwhc-scgccadhp-mpsprodnaturlegislationdocsehmg-nprhshy
engphpaS)
The TGA is part of the ACSS Consortium along with Health Canada Health Sciences Authority of Singapore and Swissmedic According to the TGA the ACSS Consortium
was formed in 2007 by like-minded regulatory authorities to promote greater regulatory
collaboration and alignment of regulatory requirements with the goal of maximising
international cooperation reduce duplication and increase each agencys capacity to
ensure consumers have timely access to high quality safe and effective therapeutic
products
Heath Canada
The Health Canada website
provides guidance to industry for the preparation of
Product Licence Applications (PLAs) and labels for natural health product market
authorization for homeopathic products (updated July 2015) It states
bull The proper name(s) common name(s) and source material(s) must be as per the homeopathic
monograph referenced as the Standard or Grade (please refer to the specifications)
bull The medicinal ingredient(s) must be a permitted substance with a homeopathic monograph in one
of the Natural and Non-Prescription Health Products Directorate (NNHPD) accepted homeopathic
pharmacopoeia
The Standards or Grades refers to a list of homeopathic pharmacopoeias containing the
traditional homeopathic names
Health Canada also includes guidance for the labelling of homeopathic medicines on its
website
It includes the following guidance for labelling for small packages
53 Labels for Small Packages
The NNHPD recognizes that small packages such as those used by some homeopathic medicine manufacturers
may not have an area large enough for the inner labelling requirements Therefore separate small package
labelling requirements have been developed Please see the Labelling guidance document for infonnation
specific to small package labelling
SwissMedic
In Switzerland homeopathy has been fully integrated into the Swiss medical system
SwissMedics HAS (Homeopathic and Anthroposophical medicines) list includes both Latin
chemical names and their homeopathic synonyms It appears that homeopathic products in
Switzerland also allow for the use of homeopathic names on products labels (noting the
strong tradition of use of homeopathy in the region)
FDA
The FDA also recognises the traditional homeopathic names with HPUS as the standard The HPUS has labelling guidelines for homeopathic medicines2 that links in with the labelling
2 httpwwwhpuscomRevised-Labeling-Guidelines-04-14pdf
Page 14 of 23
provisions of Sections 502 and 503 of the Federal Food Drug and Cosmetic Act Part 201
Title 21 of the Code of Federal Regulations (CFR) and the FDAs Compliance Policy Guide
400400
Section 11 How Information is to be expressed -
Use of appropriate metric units
bull Sec 11 (l)(b) The abbreviations to mg and g can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation microg may be used
Where several ingredients are presented on a label statement in microgram microliter
quantities the repetition of expressing the unit in full greatly expands the length of the text
and hence label space becomes an important issue
Further CMA questions if the requirement is mandatory given it is expressed as should in
the standard compared to must in the guideline
This proposed requirement if mandatory does not allow for consistency on the label and
increased label space is required CMA submits that an abbreviated form of microgram
should be permitted in the standard
Expression of quantity or proportion of active ingredients
Sec 11 (2) Expression of quantity or propo1iion of active ingredients
11(2)(i) states that in addition to the requirements of paragraphs 1 1(2)(a)-1 1(2)(h) and
therefore includes 1 1 (2)( a) the quantity of the active ingredient
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the
herbal material from which the preparation was derived except
This amendment appears to propose that herbal ingredients include the actual amount of
herbal extract in addition to the equivalent amount of starting herbal material from which
the preparation was derived
As detailed in our 2014 submission we do not support the increased information
requirements for the expression of herbal medicines to be expanded on the medicine label
(section 11(2))
The 2014 consultation suggested the reasoning for the additional requirement to include
the input amount of the herbal material on the label was that it enables the consumer to
Page lS of 23
version
gain meaningful information in relation to the strength concentration or quantified levels
in general of the herbal ingredients in the medicine
To implement this requirement however it would require the addition of an extra line of
information for each herbal material ingredient to express both quantities on the medicine
label The majority of complementary medicines are multi ingredient formulations
sometimes with as many as 25 ingredients in a product The addition of at least two lines to
express each herbal ingredient would for the average consumer most likely only create
confusion as to which line of expression to draw a meaningful conclusion from
The main concern is that this would lead to two quantification values for the same inputted
ingredient which would be open to misunderstanding and if other than the native extract
amount potentially no more helpful to the consumer Additionally this requirement does
not appear to impact upon the safe or proper usage of the medicine if used within the
context outlined on the label
CMA considers that this requirement would significantly increase the regulatory burden of
lower risk medicines by increasing the amount of information required on a label and hence
label size Label space will become an issue and an impracticality pushed to some degree
and with an obscure label this could lead to other potentially misleading packaging issues
We again provide mock up labels at the appendix to demonstrate this significant increase in
requirement
Clear concise labelling of ingredients with one quantity the extract equivalent of the herb
provides consumers with satisfactory information that allows comparison with other
products
CMA requests that TGA provides a detailed reasoning behind the proposed amendment
including evidence that the current requirement is impacting on the safe and proper usage
of listed medicines if that is the case In the absence of this information CMA does not
support implementing this section of the labelling Order and that it be drafted without this
specific requirement
CMA provides a mock up label at the appendix 1 example 3 to demonstrate the increased
requirements to listed low risk medicines
Regulatory Impact Statement (RIS)- general requirements for labels of medicines version 10 August 2014
The TGA provided a regulatory impact statement and other supporting documents3 as
evidence in support of a change to the labelling of medicines the proposed changes were
however largely based on the risk profile associated with prescription and registered over
the counter medicines with no direct reference to misuse of complementary medicines in
3 Labelling and packaging practices 10 January 2013 fileCUserstechnicalDownloadsconsultshy
labelling-packaging-review-1205 24-an alysis-evidencepdf
Page 16 of 23
the context of self-selection being outlined The extra regulatory requirements for labelling
and packaging of complementary medicines are considered to be out of proportion to the
risk classifications of these medicines
The 2014 consultation highlighted that due to lower risk medicines being available for self selection this factor alone poses a risk as the consumer receives no additional information
except the instructions on the label Indeed while this highlights the importance of the
information on the medicine label no evidence has been provided that the proposed
changes would contribute to the provision of better consumer information or safety A
change to the amount of active ingredients that can be included on the front of the
medicine label and additional information around the expression of herbal ingredients for
example are proposals for change that are not supported by CMA as they have not been
evidenced to be a safety issue nor undergone consumer use testing to demonstrate any
improvement on the status quo would be gained In summary they will have little affect on
consumers self-selection
The 2014 labelling consultation included a regulatory impact statement which from an
industry point of view grossly underestimated the cost of changes
Copy from the RIS
The labour burden for businesses who need to change a label would be
approximately 20 hours (includes reading the current guidance and applying it to
their design work and the small amount of labour involved in providing new label
information as part of the application to vary the entry) at a labour rate of $42 per
hour
The additional requirements proposed in the Order and schedule 1 will result in all
companies conducting a review of each medicine formulation checking for compliance to
these revised requirements It is estimated that the $42 per hour labour rate above would
increase to approximately $60 per hour for the time required to carry out the review One
member estimates that the labour hours would increase from 20 to 30 hours and takes into
account that different sections within an organisation and external organisations are
involved in obtaining documentation for example suppliers distributors manufacturers
Testing may also be required to confirm if any allergen residue remains in the raw material
Transition arrangements
CMA notes that the proposed transition arrangement includes a four year period where by
compliance with the current labelling Order (TGO 69) or the revised TGO 92 would be
permitted By 2020 full compliance with TGO 92 would be required While this is an
improvement from the 2014 proposal CMA highlights that further refinements to TGO 92 is
required to reduce the regulatory burden for complementary medicines
Page 17 of 23
Should the Order be implemented as currently drafted there will be many complementary
medicine businesses that would be negatively impacted Not in the lest many small ownershy
operator complementary medicine businesses would not generally be in the practice of
changing their medicine labels every few years as indicated in the TGA RIS document
The transition period will also be particularly problematic where the labelled information
will differ despite no change in formulation eg change in apparent quantification
ingredient name or ingredient placement
The RIS document also detailed that the new labelling Order would be a one-off cost for
those businesses that would not be changing their labels during the transition period
The 2014 participants in the TGA industry survey included larger CM company
representatives and therefore is only indicative of that sector of the industry
Specifically the RIS did not look at the fact that smaller companies would employ the skills
of professional consultants to carry out the work required to ensure compliance with the
new labelling Order This cost factor alone for changes proposed to lower risk listed
medicines is considered an unnecessary additional regulatory burden that would not
necessarily equate to any consumer self-medication benefit
CMA submits that the focus of the TGA be one of reducing the regulatory burden enhancing
efficiencies in existing process whilst upholding the safety and quality of complementary
medicines available to consumers For these reasons CMA submits that further refinements
to TGO 92 be made to accommodate lower risk medicines
Schedule 1 Substances or groups of substances present in medicines -
that are required to be declared on the label of medicines
It appears that some inconsistencies remain in the declaration statement of certain
substances in Schedule 1 of TGO 92 compared to warning statements generated on the
ARTG
Ethanolalcohol
This group of substances to be declared on the label is not consistent with the ARTG
generated warning for ethanolalcohol
bull Contains alcohol vs contains ethanol (vv)
Ethanol as one of the substances required to be declared on the label can carry the
declaration contains alcohol However the same ingredient warning that is generated on
the ARTG for use if this ingredient is in the formula as a listed excipient is ETHAN contains
ethanol (or words to that effect)
Recommendations
Page 18 of 23
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is consistent
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label if the situation arises where there is already an ARTG
generated ethanol warning
Other ingredients such as potassium sorbate already generate ARTG warnings if listed as
excipients and is also in the group of substances required to be declared on the label
Again the wording used is inconsistent
ARTG warning SORB8 (If the medicine contains one sorbate) Contains [insert name of
sorbate] OR (if medicine contains two or more sorbates) Contains sorbates [or words to that
effect]
bull Contains sorbates vs contains [inse1i name of sorbate] (if the medicine contains one sorbate) or contains sorbates (if the medicine contains two or more sorbates) in the
event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have Contains potassium sorbate
whilst it would read Contains sorbates to comply with schedule 1 of TGO 92
Recommendations
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is
consistent If the product contains one sorbate eg potassium sorbate ARTG warning
is Contains potassium sorbate however TGO 92 declaration is Contains sorbates
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label in these situations
Phenylalanine
Many mineral amino acid chelates contain phenylalanine as part of the amino acid portion
of the mineral and ingredients such as Spirulina whole cell powder would contain
phenylalanine as part of its protein profile CMA proposes that the schedule 1 list include
additional information as to what ingredients the phenylalanine warning applies to or
outline the ingredients such as those mentioned above that are exempt from the
requirement
Imposing such requirements to all ingredients may cause unnecessary concern to the
consumer
Page 19 of 23
PU
Schedule 2 Specified Units for Enzymes -
bull CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients Papain Units Bromelain
Currently the TBS only allows the quantity of the ingredient to be expressed in milligrams
(mg) Pervious considerations of this issue has identified that the per mg expression is not
the most appropriate for the material Whilst GOU (gelatine digesting unit) is acknowledged
to be the unit most commonly used for the material papain unit is proposed as this is the
specified unit from bromelain by the joint FAOWHO expert committee on Food Additives
(JECFA) the Food Chemical Codex and the unit adopted by Health Canada in its
monographs for Stem bromelian and fruit bromelian We note also that there is a simple
conversion factor that can be applied to quantities expressed as GOU
CMA comment on the Guideline for medicine labels draft version 10
October 2015
bull 3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA proposes the
removal (of Camellia sinensis) after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation
and herbal material and quantity of standardised constituent) would be expressed
together This reiteration appears to be redundant and would take up more space on the
label
bull Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] Ingredients Uses or What this medicine is used for Warnings Directions for use and Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a
specified order) needs to be followed for listed medicines
Page 2 0 of 23
Labelling
Labelling packaging Complementary
Labelling Packaging
CMA interprets the revised TGO 92 update to mean that this would no longer be a
requirement However we have provided a mock up label at appendix 1 example 4 to
demonstrate how this requirement if relevant would impact multi ingredient herbal
medicines
CMA resources in reference to the labelling of complementary
medicines
bull CMA submission Consultation Draft TGO 79 Standards for the of Medicines
(November 2014) bull CMA submission and of Medicines (12 April
2013) bull CMA submission on the Medicine and Review (24 August 2012)
Page 21of23
CMA detailed table of reform recommendations and impact of TGO 92
Page 22 of 23
Appendix 1 - mock up labels to TGO 92 requirements
Page 23 of 23
CMA response to TGO 92- Standards for the labels of non-prescription medicines
Proposed Requirement TGO 92 Industry response
Text size In principle CMA agrees with the change that reverts back to the current TGO 69 definition of text size This is in comparison to the consultation draft TGO79 that proposed a range of sizes for listed and registered
ldquoText size equivalent to Arial fontrdquo complementary medicines based on Arial point size font has been removed from TGO 92 The definition for letter height is the same as the definition in TGO 69
Sec 7 General requirements including As stated in the CMA 2014 submission ambiguous and subjective requirements should on principle not be included in a label presentation legislative instrument (2)(e) Considering the guidance document elaborates on the proposed requirement CMA reiterates that we are not aware of there Labels must be in a colour or colours being consumer safety issues of this nature reported for CM products which are of a lower risk and hence consider the contrasting strongly with the mandatory requirement unjustified background Sec 8(2) Labels of registered medicines must provide information in a consistent order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important information access to other information is also necessary for consumers to make an informed purchasing decision CMA is of the position that for lower risk registered medicines such as registered complementary medicines there should be flexibility to present mandatory information in a clear and concise manner without the constraint of a medicine information panel (MIP) This will minimise cost to the CM industry associated with resizing labels or providing goods in larger container sizes with increased headspace Section 155 of the Guidance document outlines that ldquoa medicine information panel is not required for certain lower risk
Proposed Requirement TGO 92 Industry response
registered medicines ndash these are detailed in subsection 8(2) of TGO 92rdquo Subsection 8(2) however does not appear to detail specifically what types of lower risk registered medicines would not require a MIP CMA suggests that this part of the guidance is expanded to include specific guidance that registered complementary medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the amendment impact registered complementary medicines mock up labels have been provided to demonstrate that the requirement would necessitate a change to label sizes for complementary medicines which is considered unjustified
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of a MIP would not work and necessitate labelling complications and medicine container size considerations
Sec 8 (1) (k) (ii) (B) Pregnancy database
Requirements related tot his section should be incorporated on an ingredient by ingredient basis within the 26BB list of permissible ingredients instrument Pregnancy database - Add link httpswwwtgagovauprescribing-medicines-pregnancy-database
Sec 9 (2) CMA considers the proposed requirements to orientate all text in the same direction on the main label and for medicine names to be presented in a continuous and uninterrupted manner would not have a meaningful impact upon consumer
The name of the medicine on the main safety and as such the change is considered unjustified for lower risk medicines label must be presented in a continuous uninterrupted manner and Feedback from our members indicates that medicine labels are often developed as a result of consumer testing not be broken up by additional In addition CMA has not been presented with information that consumers have any usability difficulties with the information or background text presentation of information on complementary medicine labels Sec 9 (5) All text required by this Order to It is well documented that consumers generally select complementary medicines and non-prescription medicines by brand appear on the main label must be and category and seek out brands they know Branding is important for complementary medicines and consumers are orientated in the same direction familiar with many well-known brands of medicines for general wellbeing cough and cold allergy skincare and many
other categories Limited label space is therefore an important issue particularly for certain product and label types
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 2 of 12
Proposed Requirement TGO 92 Industry response
Such a change would impact upon brand recognition for many companies As such CMA considers this as an unjustified change to requirements adding to unnecessary regulatory burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact on branding and does not require consequential changes to dimensions of packs or labels or changes to the packaging details of a medicine
Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 30millimeters on the front panel directly under the trade name
Since consumers use complementary medicines as part of self-care the label of these medicines is the primary source of information for consumers This requirement would mean that a large portion of the label would be used to display the active ingredients Information on active ingredients is not always the most meaningful aspect in consumer self selection of these goods rather information sought by consumers tends to be focused around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space and there will be reduced space to indicate the intended purpose of the product on the front of pack If the container and label size are increased as a result of this without increasing the number of tablets or capsules in the bottle this could give the consumer a negative perception due to the increased head space of the container Ultimately this would also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations
Sec 9 (6) CMArsquos position on the number of active ingredients that may appear on the front of a label for listed goods is that TGO 69 If the medicine is intended to be or is requirements be maintained listed goods By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active ingredients to four or more (b) if there are four or more active active ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for ingredients in the medicine - the name these lower risk listed medicines without any evidence of consumer benefit being presented of every active ingredient together with the quantity or proportion of CMA suggests the following amendment to TGO 92 every active ingredient may appear on
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 3 of 12
Proposed Requirement TGO 92 Industry response
a side panel or side label or on a rear panel or rear label
If the medicine is intended to be or is listed goods 6 b) if the medicine is a listed complementary medicine ndash the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO 69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014 CMA includes specific examples where for listed CMs containing three active ingredients to be displayed on the front of the label where previously they would be detailed at the side or rear how this would impact on label size being inappropriate for the packaging
Sec 9 (7) CMA proposed that TGO 69 requirements be maintained If the medicine is intended to be or is registered goods then By imposing subsection 9(7)(b) would mean a requirement to go from two or more active ingredients to four or more active
ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for (a) where the medicine contains three registered complementary medicines without any specific evidence of consumer benefit relating to this lower risk class of or four active ingredients the name of good being presented the active ingredient(s) and the quantity or proportion of active Within the complementary medicine category listed and registered complementary medicines will be presented (depending ingredient(s) must be displayed on the on the number of active ingredients present) in a different manner That is some will detail active ingredients at the front of main label in a text size of not less the pack while others (with 4 or more active ingredients) will detail the ingredients at the side or rear of the pack CMA than 3 millimetres submits that for the purposes of standardisation of where to find information consumers should be encouraged to refer to
the backside of the pack for ingredient information (b) where the medicine contains four or more active ingredients and the CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of requirements of subsection 8(2) do not 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations apply then the names and the See comments at Sec 9 (7)(a) above quantities or proportion of the active ingredients may be included on a side panellabel or rear panellabel when
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 4 of 12
Proposed Requirement TGO 92 Industry response
displayed in a text size of not less than 25mm
Sec 10(3) amp Sec 10 (4)(a) CMA does not support any additional change to this lower risk category of medicine
Homeopathic medicines No explanation or justification has been provided as to why there is a new mandatory requirement to include a statement on Where all the active ingredients in a the main label that the medicine is a homeopathic medicine or contains homeopathic preparations in an increased font size to medicine are homoeopathic that of a general listed complementary medicine preparations the main label on the No real explanation has been provided as to why an increase to the font size for the statement ldquohomeopathic medicinerdquo was container and the main label on the considered a requirement based on a consumer safety perspective primary pack (if any) must in addition to the requirements referred Previous explanations for this addition has centred around that the statement is intended to assist consumers with an to in sections 8 and 9 above include a appropriate selection for a medicine and minimise confusion that may arise with self-selection However the current statement to the effect that the labelling Order requires there to be a declaration that clearly states the product is homeopathic and contains homeopathic medicine is a homoeopathic medicine ingredients on the front of the pack and the additional detail of this information on the back of the pack in the ingredients in text size that is not less than 50 and indications section would clearly justify the medicine as being based in the homoeopathic paradigm of the text size of the name of the As such CMA proposes that this section be removed from the Order medicine and (in any event) not less than 2millimeters
Sec 6 CMA submitted in May 2013 via the International Harmonisation of Ingredient Names consultation that there appeared to be no mention of the naming of homoeopathic ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS)
Interpretation in this Order traditional naming or the application of new AAN homoeopathic names As such we resubmit information for consideration here
Homoeopathic medicines ndash naming conventions
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 5 of 12
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation (i) either the name of the active ingredient or the substance from which the dilution was prepared that is accepted for inclusion in the Australian Approved Names (AAN) List together with a statement of the homeopathic potency or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency
It is suggested that an amendment be made to allow for homeopathic medicines The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
To implement this CMA proposes the following amendment to the definition of the name of the active ingredient
(b) where the ingredient is a homoeopathic preparation
1 the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency in brackets the name that is also accepted for inclusion in the Australian Approved Names List
2 for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
That is the traditional homeopathic name to be used as the primary name including the AAN unless on ldquosmall containersrdquo Both the traditional names and AAN could be included on full website information which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required)
It is in the consumersrsquo interest that traditional pharmacopeial names be amended as the primary name The concern here is
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
Considering the guidance document elaborates on the proposed requirement CMA
reiterates that we are not aware of there being consumer safety issues of this nature
reported for CM products which are of a lower risk and hence consider the mandatory
requirement unjustified for this sector of goods
TGO 92 should be amended to include this as a best practice principle only in the guideline
for registered non prescriptions medicines excluding listed medicines and registered
complementary medicines
Section 8 Information to be included on the label
bull Section 8(2) Labels of registered medicines must provide information in a consistent -
order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important
information access to other information is also necessary for consumers to make an
informed purchasing decision
CMA is of the position that for lower risk registered medicines such as registered
complementary medicines there should be flexibility to present mandatory information in a
clear and concise manner without the constraint of a medicine information panel (MIP)
This will minimise unnecessary costs to the CM industry associated with resizing labels or
providing goods in larger container sizes with increased headspace
Section 155 of the Guidance document outlines that a medicine information panel is not
required for certain lower risk registered medicines - these are detailed in subsection 8(2)
of TGO 92 Subsection 8(2) however does not appear to detail specifically what types of
lower risk registered medicines would not require a MIP CMA suggests that this part of the
Order and guidance is expanded to include specifically that registered complementary
medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the
amendment impact registered complementary medicines mock up labels have been
provided to demonstrate that the requirement would necessitate a change to label sizes for
complementary medicines which is considered unjustified
CMA provides at the appendix example 1 a mock up of a registered complementary
medicine to demonstrate how the inclusion of a MIP would not work and necessitate
labelling complications and medicine container size considerations
Page 8 of 23
Section 9 Information to be included on the main label
bull Section 9(2) The name of medicine on the main label must be presented in a continuous uninterrupted manner and not be broken up by additional information or background text
bull Section 9(S) All text required by this Order to appear on the main label must be orientated in the same direction
CMA submits that the proposed requirements to orientate all text in the same direction on
the main label and for medicine names to be presented in a continuous and uninterrupted
manner would not for lower risk medicines have any meaningful impact upon consumer
safety and as such the change is considered unjustified for lower risk medicines
Feedback from our members indicates that medicine labels are often developed as a result
of consumer testing In addition CMA has not been presented with information that
consumers have any usability difficulties with the presentation of information on
complementary medicine labels
It is well documented that consumers generally select complementary medicines and nonshy
prescription medicines by brand and category and seek out brands that they know
Branding is important for complementary medicines and consumers are familiar with many
well-known brands of medicines for general well being cough and cold joint health bone
health and many other categories Limited label space is therefore an important issue
particularly for certain products and label types
Such a change would impact upon brand recognition for many companies As such CMA
considers this an unjustified change to requirements adding to unnecessary regulatory
burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact
on branding and does not require consequential changes to dimensions of packs or labels or
changes to the packaging details of a medicine
bull Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
bull Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 3 0millimeters on the front panel directly under the trade name
Given consumers use complementary medicines as part of self-care the label of these
medicines is the primary source of information for consumers This requirement would
mean that a large portion of the main label would be used to display the active ingredients
which are detailed on the label elsewhere
Page 9 of 23
Information on active ingredients is not always the most meaningful aspect in consumer self
selection of these goods rather information sought by consumers tends to be focused
around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space
and there will be reduced space to indicate the intended purpose of the product on the
front of pack If the container and label size are increased as a result of this without
increasing the number of tablets or capsules in the bottle this could give the consumer a
negative perception due to the increased head space of the container Ultimately this would
also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at the appendix example 1 a mock up of a registered complementary
medicine to demonstrate how the inclusion of 9 7)(a) would not work and necessitate
labelling complications and medicine container size considerations
bull Sec 9 (6) If the medicine is intended to be or is listed goods
(b) if there are four or more active ingredients in the medicine - the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on
As outlined in our 2014 submission subsection 9(6)(b) is not supported for inclusion in the
labelling Order The requirement for change to listed and registered complementary
medicines was not adequately justified from a risk perspective rather the requirements
appear to be a hangover from the risks perceived from the prescription and registered nonshy
prescription medicine sector
CMAs position on the number of active ingredients that may appear on the front of a label
for listed goods is that TGO 69 requirements be maintained
By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active
ingredients to four or more active ingredients that may be declared on a side panellabel or
rear panellabel This would increase the regulatory cost for these lower risk listed
medicines without any evidence of consumer benefit being presented
CMA suggests the following amendment to TGO 92
If the medicine is intended to be or is listed goods
6 b) if the medicine is a listed complementary medicine - the name of every active
ingredient together with the quantity or proportion of every active ingredient may appear
on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO
69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014
Page 10 of 23
CMA includes specific examples at appendix 1 example 2 impact on label size for listed
complementary medicines containing three active ingredients to be displayed on the front
of the label (currently they may be detailed at the side or rear)
bull Sec 9 (7) If the medicine is intended to be or is registered goods then
(a) where the medicine contains three or four active ingredients the name of the active
ingredient(s) and the quantity or proportion of active ingredient(s) must be displayed on
the main label in a text size of not less than 3 millimetres
(b) where the medicine contains four or more active ingredients and the requirements of
subsection 8(2) do not apply then the names and the quantities or proportion of the
active ingredients may be included on a side panellabel or rear panellabel when
displayed in a text size of not less than 2Smm
CMAs position on this section is that TGO 69 requirements be maintained
By imposing subsection 9(7)(b) would mean a requirement to go from two or more active
ingredients to four or more active ingredients that may be declared on a side panellabel or
rear panellabel This would increase the regulatory costs for registered complementary
medicines without any specific evidence of consumer benefit relating to this lower risk class
of good being presented
Within the complementary medicine category listed and registered complementary
medicines will be presented (depending on the number of active ingredients present) in a
different manner That is some will detail active ingredients at the front of the pack while
others (with 4 or more active ingredients) will detail the ingredients at the side or rear of
the pack CMA submits that for the purposes of standardisation and consistency on where
to find information for lower risk goods consumers should be encouraged to refer to the
backside of the pack for ingredient information
CMA provides a mock up of a registered CM provided to demonstrate how the inclusion of
9 (7)(a) would not work and necessitate labelling complications and medicine container size
considerations
Section 10 Qualifications and special requirements
Sec 10(3) amp Sec 10 (4)(a) where all the active ingredients in a medicine are homoeopathic
preparations the main label on the container and the main label on the primary pack (if
any) must in addition to the requirements referred to in sections 8 and 9 above include a
statement to the effect that the medicine is a homoeopathic medicine in text size that is
not less than 50 of the text size of the name of the medicine and (in any event) not less
than 2millimeters
Page 11of23
CMA does not support any additional change to this lower risk category of medicine
No explanation or justification has been provided during the course of labelling
consultations as to why there is a new mandatory requirement to include a statement on
the main label that the medicine is a homeopathic medicine or contains homeopathic
preparations in an increased font size to that of a general listed complementary medicine
No real explanation has been provided as to why an increase to the font size for the
statement homeopathic medicine was considered a requirement based on a consumer
safety perspective
Previous explanations for this addition has centred on factors that the statement is intended
to assist consumers with an appropriate selection for a medicine and minimise confusion
that may arise with self-selection However the current labelling Order requires there to
be a declaration that clearly states the product is homeopathic and contains homeopathic
ingredients on the front of the pack and the additional detail of this information on the back
of the pack in the ingredients and indications section would clearly justify the medicine as
being based in the homoeopathic paradigm As such CMA proposes that this section be
removed from the Order
bull Section 6 Interpretation in the Order Homeopathic medicines - naming conventions
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic
preparation (i) either the name of the active ingredient or the substance from which the
dilution was prepared that is accepted for inclusion in the Australian Approved Names
(AAN) List together with a statement of the homeopathic potency or (ii) until such time
as a name is accepted for inclusion in the Australian Approved Names List a traditional
homoeopathic name in full or as traditionally abbreviated with a statement of
homeopathic potency
Given the recent redraft of the labelling Order it is an opportune time to explore potential
amendments that aim to increase the clarity for requirements around homeopathic
medicines for both industry and the regulator
CMA submitted in May 2013 via the International Harmonisation of Ingredient Names
consultation that there appeared to be no mention of the naming of homoeopathic
ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS) traditional naming or
the application of new AAN homoeopathic names As such we resubmit information for
consideration here
It is suggested that an amendment be made to allow for homeopathic medicines
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
Page 12 of 23
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
That is the traditional homeopathic name is to be used as the primary name including the
AAN unless on small containers Both the traditional names and AANs could be included
on full website information which would allow additional space to elaborate on the naming
of traditional homeopathic ingredients (where required)
To implement this CMA proposes the following amendment to the definition of the name
of the active ingredient
(b) where the ingredient is a homoeopathic preparation
(i) the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency and the name that is also accepted for inclusion in the Australian Approved Names List (if available) in brackets
(ii) for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
It is in the consumers interest that traditional pharmacopeial names be amended so as to
be the primary name The concern here is that by enforcing the current definition and taking
the AAN name alone outside of the traditional context the consumer may only get the
name in its full chemicalnon homeopathic form causing potential confusion and or safety
concerns Additionally the AAN name alone (due to small label space requirements) may
appear as a different active ingredient all together causing consumer alarm
For example False Unicorn Root
Traditional homeopathic name AAN name
Helonias dioica Chamaelirium luteum
If a consumer wishes to know more about a homeopathic medicine ingredient many
sources of information (pharmacopoeias texts materia medica) refer to the traditional
name as the primary point of reference To elaborate further examples have been provided
(Appendix 1 example 5) with this submission
International harmonisation considerations - homeopathic naming
conventions
ACSS Consortium
Page 13 of 23
website
(httpwebprodhc-scgccanhpidshy
bdipsnatRegdoatid=homeopathy)
(httpljwwwhc-scgccadhp-mpsprodnaturlegislationdocsehmg-nprhshy
engphpaS)
The TGA is part of the ACSS Consortium along with Health Canada Health Sciences Authority of Singapore and Swissmedic According to the TGA the ACSS Consortium
was formed in 2007 by like-minded regulatory authorities to promote greater regulatory
collaboration and alignment of regulatory requirements with the goal of maximising
international cooperation reduce duplication and increase each agencys capacity to
ensure consumers have timely access to high quality safe and effective therapeutic
products
Heath Canada
The Health Canada website
provides guidance to industry for the preparation of
Product Licence Applications (PLAs) and labels for natural health product market
authorization for homeopathic products (updated July 2015) It states
bull The proper name(s) common name(s) and source material(s) must be as per the homeopathic
monograph referenced as the Standard or Grade (please refer to the specifications)
bull The medicinal ingredient(s) must be a permitted substance with a homeopathic monograph in one
of the Natural and Non-Prescription Health Products Directorate (NNHPD) accepted homeopathic
pharmacopoeia
The Standards or Grades refers to a list of homeopathic pharmacopoeias containing the
traditional homeopathic names
Health Canada also includes guidance for the labelling of homeopathic medicines on its
website
It includes the following guidance for labelling for small packages
53 Labels for Small Packages
The NNHPD recognizes that small packages such as those used by some homeopathic medicine manufacturers
may not have an area large enough for the inner labelling requirements Therefore separate small package
labelling requirements have been developed Please see the Labelling guidance document for infonnation
specific to small package labelling
SwissMedic
In Switzerland homeopathy has been fully integrated into the Swiss medical system
SwissMedics HAS (Homeopathic and Anthroposophical medicines) list includes both Latin
chemical names and their homeopathic synonyms It appears that homeopathic products in
Switzerland also allow for the use of homeopathic names on products labels (noting the
strong tradition of use of homeopathy in the region)
FDA
The FDA also recognises the traditional homeopathic names with HPUS as the standard The HPUS has labelling guidelines for homeopathic medicines2 that links in with the labelling
2 httpwwwhpuscomRevised-Labeling-Guidelines-04-14pdf
Page 14 of 23
provisions of Sections 502 and 503 of the Federal Food Drug and Cosmetic Act Part 201
Title 21 of the Code of Federal Regulations (CFR) and the FDAs Compliance Policy Guide
400400
Section 11 How Information is to be expressed -
Use of appropriate metric units
bull Sec 11 (l)(b) The abbreviations to mg and g can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation microg may be used
Where several ingredients are presented on a label statement in microgram microliter
quantities the repetition of expressing the unit in full greatly expands the length of the text
and hence label space becomes an important issue
Further CMA questions if the requirement is mandatory given it is expressed as should in
the standard compared to must in the guideline
This proposed requirement if mandatory does not allow for consistency on the label and
increased label space is required CMA submits that an abbreviated form of microgram
should be permitted in the standard
Expression of quantity or proportion of active ingredients
Sec 11 (2) Expression of quantity or propo1iion of active ingredients
11(2)(i) states that in addition to the requirements of paragraphs 1 1(2)(a)-1 1(2)(h) and
therefore includes 1 1 (2)( a) the quantity of the active ingredient
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the
herbal material from which the preparation was derived except
This amendment appears to propose that herbal ingredients include the actual amount of
herbal extract in addition to the equivalent amount of starting herbal material from which
the preparation was derived
As detailed in our 2014 submission we do not support the increased information
requirements for the expression of herbal medicines to be expanded on the medicine label
(section 11(2))
The 2014 consultation suggested the reasoning for the additional requirement to include
the input amount of the herbal material on the label was that it enables the consumer to
Page lS of 23
version
gain meaningful information in relation to the strength concentration or quantified levels
in general of the herbal ingredients in the medicine
To implement this requirement however it would require the addition of an extra line of
information for each herbal material ingredient to express both quantities on the medicine
label The majority of complementary medicines are multi ingredient formulations
sometimes with as many as 25 ingredients in a product The addition of at least two lines to
express each herbal ingredient would for the average consumer most likely only create
confusion as to which line of expression to draw a meaningful conclusion from
The main concern is that this would lead to two quantification values for the same inputted
ingredient which would be open to misunderstanding and if other than the native extract
amount potentially no more helpful to the consumer Additionally this requirement does
not appear to impact upon the safe or proper usage of the medicine if used within the
context outlined on the label
CMA considers that this requirement would significantly increase the regulatory burden of
lower risk medicines by increasing the amount of information required on a label and hence
label size Label space will become an issue and an impracticality pushed to some degree
and with an obscure label this could lead to other potentially misleading packaging issues
We again provide mock up labels at the appendix to demonstrate this significant increase in
requirement
Clear concise labelling of ingredients with one quantity the extract equivalent of the herb
provides consumers with satisfactory information that allows comparison with other
products
CMA requests that TGA provides a detailed reasoning behind the proposed amendment
including evidence that the current requirement is impacting on the safe and proper usage
of listed medicines if that is the case In the absence of this information CMA does not
support implementing this section of the labelling Order and that it be drafted without this
specific requirement
CMA provides a mock up label at the appendix 1 example 3 to demonstrate the increased
requirements to listed low risk medicines
Regulatory Impact Statement (RIS)- general requirements for labels of medicines version 10 August 2014
The TGA provided a regulatory impact statement and other supporting documents3 as
evidence in support of a change to the labelling of medicines the proposed changes were
however largely based on the risk profile associated with prescription and registered over
the counter medicines with no direct reference to misuse of complementary medicines in
3 Labelling and packaging practices 10 January 2013 fileCUserstechnicalDownloadsconsultshy
labelling-packaging-review-1205 24-an alysis-evidencepdf
Page 16 of 23
the context of self-selection being outlined The extra regulatory requirements for labelling
and packaging of complementary medicines are considered to be out of proportion to the
risk classifications of these medicines
The 2014 consultation highlighted that due to lower risk medicines being available for self selection this factor alone poses a risk as the consumer receives no additional information
except the instructions on the label Indeed while this highlights the importance of the
information on the medicine label no evidence has been provided that the proposed
changes would contribute to the provision of better consumer information or safety A
change to the amount of active ingredients that can be included on the front of the
medicine label and additional information around the expression of herbal ingredients for
example are proposals for change that are not supported by CMA as they have not been
evidenced to be a safety issue nor undergone consumer use testing to demonstrate any
improvement on the status quo would be gained In summary they will have little affect on
consumers self-selection
The 2014 labelling consultation included a regulatory impact statement which from an
industry point of view grossly underestimated the cost of changes
Copy from the RIS
The labour burden for businesses who need to change a label would be
approximately 20 hours (includes reading the current guidance and applying it to
their design work and the small amount of labour involved in providing new label
information as part of the application to vary the entry) at a labour rate of $42 per
hour
The additional requirements proposed in the Order and schedule 1 will result in all
companies conducting a review of each medicine formulation checking for compliance to
these revised requirements It is estimated that the $42 per hour labour rate above would
increase to approximately $60 per hour for the time required to carry out the review One
member estimates that the labour hours would increase from 20 to 30 hours and takes into
account that different sections within an organisation and external organisations are
involved in obtaining documentation for example suppliers distributors manufacturers
Testing may also be required to confirm if any allergen residue remains in the raw material
Transition arrangements
CMA notes that the proposed transition arrangement includes a four year period where by
compliance with the current labelling Order (TGO 69) or the revised TGO 92 would be
permitted By 2020 full compliance with TGO 92 would be required While this is an
improvement from the 2014 proposal CMA highlights that further refinements to TGO 92 is
required to reduce the regulatory burden for complementary medicines
Page 17 of 23
Should the Order be implemented as currently drafted there will be many complementary
medicine businesses that would be negatively impacted Not in the lest many small ownershy
operator complementary medicine businesses would not generally be in the practice of
changing their medicine labels every few years as indicated in the TGA RIS document
The transition period will also be particularly problematic where the labelled information
will differ despite no change in formulation eg change in apparent quantification
ingredient name or ingredient placement
The RIS document also detailed that the new labelling Order would be a one-off cost for
those businesses that would not be changing their labels during the transition period
The 2014 participants in the TGA industry survey included larger CM company
representatives and therefore is only indicative of that sector of the industry
Specifically the RIS did not look at the fact that smaller companies would employ the skills
of professional consultants to carry out the work required to ensure compliance with the
new labelling Order This cost factor alone for changes proposed to lower risk listed
medicines is considered an unnecessary additional regulatory burden that would not
necessarily equate to any consumer self-medication benefit
CMA submits that the focus of the TGA be one of reducing the regulatory burden enhancing
efficiencies in existing process whilst upholding the safety and quality of complementary
medicines available to consumers For these reasons CMA submits that further refinements
to TGO 92 be made to accommodate lower risk medicines
Schedule 1 Substances or groups of substances present in medicines -
that are required to be declared on the label of medicines
It appears that some inconsistencies remain in the declaration statement of certain
substances in Schedule 1 of TGO 92 compared to warning statements generated on the
ARTG
Ethanolalcohol
This group of substances to be declared on the label is not consistent with the ARTG
generated warning for ethanolalcohol
bull Contains alcohol vs contains ethanol (vv)
Ethanol as one of the substances required to be declared on the label can carry the
declaration contains alcohol However the same ingredient warning that is generated on
the ARTG for use if this ingredient is in the formula as a listed excipient is ETHAN contains
ethanol (or words to that effect)
Recommendations
Page 18 of 23
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is consistent
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label if the situation arises where there is already an ARTG
generated ethanol warning
Other ingredients such as potassium sorbate already generate ARTG warnings if listed as
excipients and is also in the group of substances required to be declared on the label
Again the wording used is inconsistent
ARTG warning SORB8 (If the medicine contains one sorbate) Contains [insert name of
sorbate] OR (if medicine contains two or more sorbates) Contains sorbates [or words to that
effect]
bull Contains sorbates vs contains [inse1i name of sorbate] (if the medicine contains one sorbate) or contains sorbates (if the medicine contains two or more sorbates) in the
event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have Contains potassium sorbate
whilst it would read Contains sorbates to comply with schedule 1 of TGO 92
Recommendations
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is
consistent If the product contains one sorbate eg potassium sorbate ARTG warning
is Contains potassium sorbate however TGO 92 declaration is Contains sorbates
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label in these situations
Phenylalanine
Many mineral amino acid chelates contain phenylalanine as part of the amino acid portion
of the mineral and ingredients such as Spirulina whole cell powder would contain
phenylalanine as part of its protein profile CMA proposes that the schedule 1 list include
additional information as to what ingredients the phenylalanine warning applies to or
outline the ingredients such as those mentioned above that are exempt from the
requirement
Imposing such requirements to all ingredients may cause unnecessary concern to the
consumer
Page 19 of 23
PU
Schedule 2 Specified Units for Enzymes -
bull CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients Papain Units Bromelain
Currently the TBS only allows the quantity of the ingredient to be expressed in milligrams
(mg) Pervious considerations of this issue has identified that the per mg expression is not
the most appropriate for the material Whilst GOU (gelatine digesting unit) is acknowledged
to be the unit most commonly used for the material papain unit is proposed as this is the
specified unit from bromelain by the joint FAOWHO expert committee on Food Additives
(JECFA) the Food Chemical Codex and the unit adopted by Health Canada in its
monographs for Stem bromelian and fruit bromelian We note also that there is a simple
conversion factor that can be applied to quantities expressed as GOU
CMA comment on the Guideline for medicine labels draft version 10
October 2015
bull 3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA proposes the
removal (of Camellia sinensis) after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation
and herbal material and quantity of standardised constituent) would be expressed
together This reiteration appears to be redundant and would take up more space on the
label
bull Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] Ingredients Uses or What this medicine is used for Warnings Directions for use and Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a
specified order) needs to be followed for listed medicines
Page 2 0 of 23
Labelling
Labelling packaging Complementary
Labelling Packaging
CMA interprets the revised TGO 92 update to mean that this would no longer be a
requirement However we have provided a mock up label at appendix 1 example 4 to
demonstrate how this requirement if relevant would impact multi ingredient herbal
medicines
CMA resources in reference to the labelling of complementary
medicines
bull CMA submission Consultation Draft TGO 79 Standards for the of Medicines
(November 2014) bull CMA submission and of Medicines (12 April
2013) bull CMA submission on the Medicine and Review (24 August 2012)
Page 21of23
CMA detailed table of reform recommendations and impact of TGO 92
Page 22 of 23
Appendix 1 - mock up labels to TGO 92 requirements
Page 23 of 23
CMA response to TGO 92- Standards for the labels of non-prescription medicines
Proposed Requirement TGO 92 Industry response
Text size In principle CMA agrees with the change that reverts back to the current TGO 69 definition of text size This is in comparison to the consultation draft TGO79 that proposed a range of sizes for listed and registered
ldquoText size equivalent to Arial fontrdquo complementary medicines based on Arial point size font has been removed from TGO 92 The definition for letter height is the same as the definition in TGO 69
Sec 7 General requirements including As stated in the CMA 2014 submission ambiguous and subjective requirements should on principle not be included in a label presentation legislative instrument (2)(e) Considering the guidance document elaborates on the proposed requirement CMA reiterates that we are not aware of there Labels must be in a colour or colours being consumer safety issues of this nature reported for CM products which are of a lower risk and hence consider the contrasting strongly with the mandatory requirement unjustified background Sec 8(2) Labels of registered medicines must provide information in a consistent order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important information access to other information is also necessary for consumers to make an informed purchasing decision CMA is of the position that for lower risk registered medicines such as registered complementary medicines there should be flexibility to present mandatory information in a clear and concise manner without the constraint of a medicine information panel (MIP) This will minimise cost to the CM industry associated with resizing labels or providing goods in larger container sizes with increased headspace Section 155 of the Guidance document outlines that ldquoa medicine information panel is not required for certain lower risk
Proposed Requirement TGO 92 Industry response
registered medicines ndash these are detailed in subsection 8(2) of TGO 92rdquo Subsection 8(2) however does not appear to detail specifically what types of lower risk registered medicines would not require a MIP CMA suggests that this part of the guidance is expanded to include specific guidance that registered complementary medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the amendment impact registered complementary medicines mock up labels have been provided to demonstrate that the requirement would necessitate a change to label sizes for complementary medicines which is considered unjustified
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of a MIP would not work and necessitate labelling complications and medicine container size considerations
Sec 8 (1) (k) (ii) (B) Pregnancy database
Requirements related tot his section should be incorporated on an ingredient by ingredient basis within the 26BB list of permissible ingredients instrument Pregnancy database - Add link httpswwwtgagovauprescribing-medicines-pregnancy-database
Sec 9 (2) CMA considers the proposed requirements to orientate all text in the same direction on the main label and for medicine names to be presented in a continuous and uninterrupted manner would not have a meaningful impact upon consumer
The name of the medicine on the main safety and as such the change is considered unjustified for lower risk medicines label must be presented in a continuous uninterrupted manner and Feedback from our members indicates that medicine labels are often developed as a result of consumer testing not be broken up by additional In addition CMA has not been presented with information that consumers have any usability difficulties with the information or background text presentation of information on complementary medicine labels Sec 9 (5) All text required by this Order to It is well documented that consumers generally select complementary medicines and non-prescription medicines by brand appear on the main label must be and category and seek out brands they know Branding is important for complementary medicines and consumers are orientated in the same direction familiar with many well-known brands of medicines for general wellbeing cough and cold allergy skincare and many
other categories Limited label space is therefore an important issue particularly for certain product and label types
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 2 of 12
Proposed Requirement TGO 92 Industry response
Such a change would impact upon brand recognition for many companies As such CMA considers this as an unjustified change to requirements adding to unnecessary regulatory burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact on branding and does not require consequential changes to dimensions of packs or labels or changes to the packaging details of a medicine
Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 30millimeters on the front panel directly under the trade name
Since consumers use complementary medicines as part of self-care the label of these medicines is the primary source of information for consumers This requirement would mean that a large portion of the label would be used to display the active ingredients Information on active ingredients is not always the most meaningful aspect in consumer self selection of these goods rather information sought by consumers tends to be focused around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space and there will be reduced space to indicate the intended purpose of the product on the front of pack If the container and label size are increased as a result of this without increasing the number of tablets or capsules in the bottle this could give the consumer a negative perception due to the increased head space of the container Ultimately this would also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations
Sec 9 (6) CMArsquos position on the number of active ingredients that may appear on the front of a label for listed goods is that TGO 69 If the medicine is intended to be or is requirements be maintained listed goods By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active ingredients to four or more (b) if there are four or more active active ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for ingredients in the medicine - the name these lower risk listed medicines without any evidence of consumer benefit being presented of every active ingredient together with the quantity or proportion of CMA suggests the following amendment to TGO 92 every active ingredient may appear on
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 3 of 12
Proposed Requirement TGO 92 Industry response
a side panel or side label or on a rear panel or rear label
If the medicine is intended to be or is listed goods 6 b) if the medicine is a listed complementary medicine ndash the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO 69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014 CMA includes specific examples where for listed CMs containing three active ingredients to be displayed on the front of the label where previously they would be detailed at the side or rear how this would impact on label size being inappropriate for the packaging
Sec 9 (7) CMA proposed that TGO 69 requirements be maintained If the medicine is intended to be or is registered goods then By imposing subsection 9(7)(b) would mean a requirement to go from two or more active ingredients to four or more active
ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for (a) where the medicine contains three registered complementary medicines without any specific evidence of consumer benefit relating to this lower risk class of or four active ingredients the name of good being presented the active ingredient(s) and the quantity or proportion of active Within the complementary medicine category listed and registered complementary medicines will be presented (depending ingredient(s) must be displayed on the on the number of active ingredients present) in a different manner That is some will detail active ingredients at the front of main label in a text size of not less the pack while others (with 4 or more active ingredients) will detail the ingredients at the side or rear of the pack CMA than 3 millimetres submits that for the purposes of standardisation of where to find information consumers should be encouraged to refer to
the backside of the pack for ingredient information (b) where the medicine contains four or more active ingredients and the CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of requirements of subsection 8(2) do not 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations apply then the names and the See comments at Sec 9 (7)(a) above quantities or proportion of the active ingredients may be included on a side panellabel or rear panellabel when
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 4 of 12
Proposed Requirement TGO 92 Industry response
displayed in a text size of not less than 25mm
Sec 10(3) amp Sec 10 (4)(a) CMA does not support any additional change to this lower risk category of medicine
Homeopathic medicines No explanation or justification has been provided as to why there is a new mandatory requirement to include a statement on Where all the active ingredients in a the main label that the medicine is a homeopathic medicine or contains homeopathic preparations in an increased font size to medicine are homoeopathic that of a general listed complementary medicine preparations the main label on the No real explanation has been provided as to why an increase to the font size for the statement ldquohomeopathic medicinerdquo was container and the main label on the considered a requirement based on a consumer safety perspective primary pack (if any) must in addition to the requirements referred Previous explanations for this addition has centred around that the statement is intended to assist consumers with an to in sections 8 and 9 above include a appropriate selection for a medicine and minimise confusion that may arise with self-selection However the current statement to the effect that the labelling Order requires there to be a declaration that clearly states the product is homeopathic and contains homeopathic medicine is a homoeopathic medicine ingredients on the front of the pack and the additional detail of this information on the back of the pack in the ingredients in text size that is not less than 50 and indications section would clearly justify the medicine as being based in the homoeopathic paradigm of the text size of the name of the As such CMA proposes that this section be removed from the Order medicine and (in any event) not less than 2millimeters
Sec 6 CMA submitted in May 2013 via the International Harmonisation of Ingredient Names consultation that there appeared to be no mention of the naming of homoeopathic ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS)
Interpretation in this Order traditional naming or the application of new AAN homoeopathic names As such we resubmit information for consideration here
Homoeopathic medicines ndash naming conventions
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 5 of 12
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation (i) either the name of the active ingredient or the substance from which the dilution was prepared that is accepted for inclusion in the Australian Approved Names (AAN) List together with a statement of the homeopathic potency or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency
It is suggested that an amendment be made to allow for homeopathic medicines The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
To implement this CMA proposes the following amendment to the definition of the name of the active ingredient
(b) where the ingredient is a homoeopathic preparation
1 the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency in brackets the name that is also accepted for inclusion in the Australian Approved Names List
2 for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
That is the traditional homeopathic name to be used as the primary name including the AAN unless on ldquosmall containersrdquo Both the traditional names and AAN could be included on full website information which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required)
It is in the consumersrsquo interest that traditional pharmacopeial names be amended as the primary name The concern here is
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
Section 9 Information to be included on the main label
bull Section 9(2) The name of medicine on the main label must be presented in a continuous uninterrupted manner and not be broken up by additional information or background text
bull Section 9(S) All text required by this Order to appear on the main label must be orientated in the same direction
CMA submits that the proposed requirements to orientate all text in the same direction on
the main label and for medicine names to be presented in a continuous and uninterrupted
manner would not for lower risk medicines have any meaningful impact upon consumer
safety and as such the change is considered unjustified for lower risk medicines
Feedback from our members indicates that medicine labels are often developed as a result
of consumer testing In addition CMA has not been presented with information that
consumers have any usability difficulties with the presentation of information on
complementary medicine labels
It is well documented that consumers generally select complementary medicines and nonshy
prescription medicines by brand and category and seek out brands that they know
Branding is important for complementary medicines and consumers are familiar with many
well-known brands of medicines for general well being cough and cold joint health bone
health and many other categories Limited label space is therefore an important issue
particularly for certain products and label types
Such a change would impact upon brand recognition for many companies As such CMA
considers this an unjustified change to requirements adding to unnecessary regulatory
burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact
on branding and does not require consequential changes to dimensions of packs or labels or
changes to the packaging details of a medicine
bull Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
bull Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 3 0millimeters on the front panel directly under the trade name
Given consumers use complementary medicines as part of self-care the label of these
medicines is the primary source of information for consumers This requirement would
mean that a large portion of the main label would be used to display the active ingredients
which are detailed on the label elsewhere
Page 9 of 23
Information on active ingredients is not always the most meaningful aspect in consumer self
selection of these goods rather information sought by consumers tends to be focused
around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space
and there will be reduced space to indicate the intended purpose of the product on the
front of pack If the container and label size are increased as a result of this without
increasing the number of tablets or capsules in the bottle this could give the consumer a
negative perception due to the increased head space of the container Ultimately this would
also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at the appendix example 1 a mock up of a registered complementary
medicine to demonstrate how the inclusion of 9 7)(a) would not work and necessitate
labelling complications and medicine container size considerations
bull Sec 9 (6) If the medicine is intended to be or is listed goods
(b) if there are four or more active ingredients in the medicine - the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on
As outlined in our 2014 submission subsection 9(6)(b) is not supported for inclusion in the
labelling Order The requirement for change to listed and registered complementary
medicines was not adequately justified from a risk perspective rather the requirements
appear to be a hangover from the risks perceived from the prescription and registered nonshy
prescription medicine sector
CMAs position on the number of active ingredients that may appear on the front of a label
for listed goods is that TGO 69 requirements be maintained
By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active
ingredients to four or more active ingredients that may be declared on a side panellabel or
rear panellabel This would increase the regulatory cost for these lower risk listed
medicines without any evidence of consumer benefit being presented
CMA suggests the following amendment to TGO 92
If the medicine is intended to be or is listed goods
6 b) if the medicine is a listed complementary medicine - the name of every active
ingredient together with the quantity or proportion of every active ingredient may appear
on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO
69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014
Page 10 of 23
CMA includes specific examples at appendix 1 example 2 impact on label size for listed
complementary medicines containing three active ingredients to be displayed on the front
of the label (currently they may be detailed at the side or rear)
bull Sec 9 (7) If the medicine is intended to be or is registered goods then
(a) where the medicine contains three or four active ingredients the name of the active
ingredient(s) and the quantity or proportion of active ingredient(s) must be displayed on
the main label in a text size of not less than 3 millimetres
(b) where the medicine contains four or more active ingredients and the requirements of
subsection 8(2) do not apply then the names and the quantities or proportion of the
active ingredients may be included on a side panellabel or rear panellabel when
displayed in a text size of not less than 2Smm
CMAs position on this section is that TGO 69 requirements be maintained
By imposing subsection 9(7)(b) would mean a requirement to go from two or more active
ingredients to four or more active ingredients that may be declared on a side panellabel or
rear panellabel This would increase the regulatory costs for registered complementary
medicines without any specific evidence of consumer benefit relating to this lower risk class
of good being presented
Within the complementary medicine category listed and registered complementary
medicines will be presented (depending on the number of active ingredients present) in a
different manner That is some will detail active ingredients at the front of the pack while
others (with 4 or more active ingredients) will detail the ingredients at the side or rear of
the pack CMA submits that for the purposes of standardisation and consistency on where
to find information for lower risk goods consumers should be encouraged to refer to the
backside of the pack for ingredient information
CMA provides a mock up of a registered CM provided to demonstrate how the inclusion of
9 (7)(a) would not work and necessitate labelling complications and medicine container size
considerations
Section 10 Qualifications and special requirements
Sec 10(3) amp Sec 10 (4)(a) where all the active ingredients in a medicine are homoeopathic
preparations the main label on the container and the main label on the primary pack (if
any) must in addition to the requirements referred to in sections 8 and 9 above include a
statement to the effect that the medicine is a homoeopathic medicine in text size that is
not less than 50 of the text size of the name of the medicine and (in any event) not less
than 2millimeters
Page 11of23
CMA does not support any additional change to this lower risk category of medicine
No explanation or justification has been provided during the course of labelling
consultations as to why there is a new mandatory requirement to include a statement on
the main label that the medicine is a homeopathic medicine or contains homeopathic
preparations in an increased font size to that of a general listed complementary medicine
No real explanation has been provided as to why an increase to the font size for the
statement homeopathic medicine was considered a requirement based on a consumer
safety perspective
Previous explanations for this addition has centred on factors that the statement is intended
to assist consumers with an appropriate selection for a medicine and minimise confusion
that may arise with self-selection However the current labelling Order requires there to
be a declaration that clearly states the product is homeopathic and contains homeopathic
ingredients on the front of the pack and the additional detail of this information on the back
of the pack in the ingredients and indications section would clearly justify the medicine as
being based in the homoeopathic paradigm As such CMA proposes that this section be
removed from the Order
bull Section 6 Interpretation in the Order Homeopathic medicines - naming conventions
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic
preparation (i) either the name of the active ingredient or the substance from which the
dilution was prepared that is accepted for inclusion in the Australian Approved Names
(AAN) List together with a statement of the homeopathic potency or (ii) until such time
as a name is accepted for inclusion in the Australian Approved Names List a traditional
homoeopathic name in full or as traditionally abbreviated with a statement of
homeopathic potency
Given the recent redraft of the labelling Order it is an opportune time to explore potential
amendments that aim to increase the clarity for requirements around homeopathic
medicines for both industry and the regulator
CMA submitted in May 2013 via the International Harmonisation of Ingredient Names
consultation that there appeared to be no mention of the naming of homoeopathic
ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS) traditional naming or
the application of new AAN homoeopathic names As such we resubmit information for
consideration here
It is suggested that an amendment be made to allow for homeopathic medicines
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
Page 12 of 23
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
That is the traditional homeopathic name is to be used as the primary name including the
AAN unless on small containers Both the traditional names and AANs could be included
on full website information which would allow additional space to elaborate on the naming
of traditional homeopathic ingredients (where required)
To implement this CMA proposes the following amendment to the definition of the name
of the active ingredient
(b) where the ingredient is a homoeopathic preparation
(i) the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency and the name that is also accepted for inclusion in the Australian Approved Names List (if available) in brackets
(ii) for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
It is in the consumers interest that traditional pharmacopeial names be amended so as to
be the primary name The concern here is that by enforcing the current definition and taking
the AAN name alone outside of the traditional context the consumer may only get the
name in its full chemicalnon homeopathic form causing potential confusion and or safety
concerns Additionally the AAN name alone (due to small label space requirements) may
appear as a different active ingredient all together causing consumer alarm
For example False Unicorn Root
Traditional homeopathic name AAN name
Helonias dioica Chamaelirium luteum
If a consumer wishes to know more about a homeopathic medicine ingredient many
sources of information (pharmacopoeias texts materia medica) refer to the traditional
name as the primary point of reference To elaborate further examples have been provided
(Appendix 1 example 5) with this submission
International harmonisation considerations - homeopathic naming
conventions
ACSS Consortium
Page 13 of 23
website
(httpwebprodhc-scgccanhpidshy
bdipsnatRegdoatid=homeopathy)
(httpljwwwhc-scgccadhp-mpsprodnaturlegislationdocsehmg-nprhshy
engphpaS)
The TGA is part of the ACSS Consortium along with Health Canada Health Sciences Authority of Singapore and Swissmedic According to the TGA the ACSS Consortium
was formed in 2007 by like-minded regulatory authorities to promote greater regulatory
collaboration and alignment of regulatory requirements with the goal of maximising
international cooperation reduce duplication and increase each agencys capacity to
ensure consumers have timely access to high quality safe and effective therapeutic
products
Heath Canada
The Health Canada website
provides guidance to industry for the preparation of
Product Licence Applications (PLAs) and labels for natural health product market
authorization for homeopathic products (updated July 2015) It states
bull The proper name(s) common name(s) and source material(s) must be as per the homeopathic
monograph referenced as the Standard or Grade (please refer to the specifications)
bull The medicinal ingredient(s) must be a permitted substance with a homeopathic monograph in one
of the Natural and Non-Prescription Health Products Directorate (NNHPD) accepted homeopathic
pharmacopoeia
The Standards or Grades refers to a list of homeopathic pharmacopoeias containing the
traditional homeopathic names
Health Canada also includes guidance for the labelling of homeopathic medicines on its
website
It includes the following guidance for labelling for small packages
53 Labels for Small Packages
The NNHPD recognizes that small packages such as those used by some homeopathic medicine manufacturers
may not have an area large enough for the inner labelling requirements Therefore separate small package
labelling requirements have been developed Please see the Labelling guidance document for infonnation
specific to small package labelling
SwissMedic
In Switzerland homeopathy has been fully integrated into the Swiss medical system
SwissMedics HAS (Homeopathic and Anthroposophical medicines) list includes both Latin
chemical names and their homeopathic synonyms It appears that homeopathic products in
Switzerland also allow for the use of homeopathic names on products labels (noting the
strong tradition of use of homeopathy in the region)
FDA
The FDA also recognises the traditional homeopathic names with HPUS as the standard The HPUS has labelling guidelines for homeopathic medicines2 that links in with the labelling
2 httpwwwhpuscomRevised-Labeling-Guidelines-04-14pdf
Page 14 of 23
provisions of Sections 502 and 503 of the Federal Food Drug and Cosmetic Act Part 201
Title 21 of the Code of Federal Regulations (CFR) and the FDAs Compliance Policy Guide
400400
Section 11 How Information is to be expressed -
Use of appropriate metric units
bull Sec 11 (l)(b) The abbreviations to mg and g can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation microg may be used
Where several ingredients are presented on a label statement in microgram microliter
quantities the repetition of expressing the unit in full greatly expands the length of the text
and hence label space becomes an important issue
Further CMA questions if the requirement is mandatory given it is expressed as should in
the standard compared to must in the guideline
This proposed requirement if mandatory does not allow for consistency on the label and
increased label space is required CMA submits that an abbreviated form of microgram
should be permitted in the standard
Expression of quantity or proportion of active ingredients
Sec 11 (2) Expression of quantity or propo1iion of active ingredients
11(2)(i) states that in addition to the requirements of paragraphs 1 1(2)(a)-1 1(2)(h) and
therefore includes 1 1 (2)( a) the quantity of the active ingredient
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the
herbal material from which the preparation was derived except
This amendment appears to propose that herbal ingredients include the actual amount of
herbal extract in addition to the equivalent amount of starting herbal material from which
the preparation was derived
As detailed in our 2014 submission we do not support the increased information
requirements for the expression of herbal medicines to be expanded on the medicine label
(section 11(2))
The 2014 consultation suggested the reasoning for the additional requirement to include
the input amount of the herbal material on the label was that it enables the consumer to
Page lS of 23
version
gain meaningful information in relation to the strength concentration or quantified levels
in general of the herbal ingredients in the medicine
To implement this requirement however it would require the addition of an extra line of
information for each herbal material ingredient to express both quantities on the medicine
label The majority of complementary medicines are multi ingredient formulations
sometimes with as many as 25 ingredients in a product The addition of at least two lines to
express each herbal ingredient would for the average consumer most likely only create
confusion as to which line of expression to draw a meaningful conclusion from
The main concern is that this would lead to two quantification values for the same inputted
ingredient which would be open to misunderstanding and if other than the native extract
amount potentially no more helpful to the consumer Additionally this requirement does
not appear to impact upon the safe or proper usage of the medicine if used within the
context outlined on the label
CMA considers that this requirement would significantly increase the regulatory burden of
lower risk medicines by increasing the amount of information required on a label and hence
label size Label space will become an issue and an impracticality pushed to some degree
and with an obscure label this could lead to other potentially misleading packaging issues
We again provide mock up labels at the appendix to demonstrate this significant increase in
requirement
Clear concise labelling of ingredients with one quantity the extract equivalent of the herb
provides consumers with satisfactory information that allows comparison with other
products
CMA requests that TGA provides a detailed reasoning behind the proposed amendment
including evidence that the current requirement is impacting on the safe and proper usage
of listed medicines if that is the case In the absence of this information CMA does not
support implementing this section of the labelling Order and that it be drafted without this
specific requirement
CMA provides a mock up label at the appendix 1 example 3 to demonstrate the increased
requirements to listed low risk medicines
Regulatory Impact Statement (RIS)- general requirements for labels of medicines version 10 August 2014
The TGA provided a regulatory impact statement and other supporting documents3 as
evidence in support of a change to the labelling of medicines the proposed changes were
however largely based on the risk profile associated with prescription and registered over
the counter medicines with no direct reference to misuse of complementary medicines in
3 Labelling and packaging practices 10 January 2013 fileCUserstechnicalDownloadsconsultshy
labelling-packaging-review-1205 24-an alysis-evidencepdf
Page 16 of 23
the context of self-selection being outlined The extra regulatory requirements for labelling
and packaging of complementary medicines are considered to be out of proportion to the
risk classifications of these medicines
The 2014 consultation highlighted that due to lower risk medicines being available for self selection this factor alone poses a risk as the consumer receives no additional information
except the instructions on the label Indeed while this highlights the importance of the
information on the medicine label no evidence has been provided that the proposed
changes would contribute to the provision of better consumer information or safety A
change to the amount of active ingredients that can be included on the front of the
medicine label and additional information around the expression of herbal ingredients for
example are proposals for change that are not supported by CMA as they have not been
evidenced to be a safety issue nor undergone consumer use testing to demonstrate any
improvement on the status quo would be gained In summary they will have little affect on
consumers self-selection
The 2014 labelling consultation included a regulatory impact statement which from an
industry point of view grossly underestimated the cost of changes
Copy from the RIS
The labour burden for businesses who need to change a label would be
approximately 20 hours (includes reading the current guidance and applying it to
their design work and the small amount of labour involved in providing new label
information as part of the application to vary the entry) at a labour rate of $42 per
hour
The additional requirements proposed in the Order and schedule 1 will result in all
companies conducting a review of each medicine formulation checking for compliance to
these revised requirements It is estimated that the $42 per hour labour rate above would
increase to approximately $60 per hour for the time required to carry out the review One
member estimates that the labour hours would increase from 20 to 30 hours and takes into
account that different sections within an organisation and external organisations are
involved in obtaining documentation for example suppliers distributors manufacturers
Testing may also be required to confirm if any allergen residue remains in the raw material
Transition arrangements
CMA notes that the proposed transition arrangement includes a four year period where by
compliance with the current labelling Order (TGO 69) or the revised TGO 92 would be
permitted By 2020 full compliance with TGO 92 would be required While this is an
improvement from the 2014 proposal CMA highlights that further refinements to TGO 92 is
required to reduce the regulatory burden for complementary medicines
Page 17 of 23
Should the Order be implemented as currently drafted there will be many complementary
medicine businesses that would be negatively impacted Not in the lest many small ownershy
operator complementary medicine businesses would not generally be in the practice of
changing their medicine labels every few years as indicated in the TGA RIS document
The transition period will also be particularly problematic where the labelled information
will differ despite no change in formulation eg change in apparent quantification
ingredient name or ingredient placement
The RIS document also detailed that the new labelling Order would be a one-off cost for
those businesses that would not be changing their labels during the transition period
The 2014 participants in the TGA industry survey included larger CM company
representatives and therefore is only indicative of that sector of the industry
Specifically the RIS did not look at the fact that smaller companies would employ the skills
of professional consultants to carry out the work required to ensure compliance with the
new labelling Order This cost factor alone for changes proposed to lower risk listed
medicines is considered an unnecessary additional regulatory burden that would not
necessarily equate to any consumer self-medication benefit
CMA submits that the focus of the TGA be one of reducing the regulatory burden enhancing
efficiencies in existing process whilst upholding the safety and quality of complementary
medicines available to consumers For these reasons CMA submits that further refinements
to TGO 92 be made to accommodate lower risk medicines
Schedule 1 Substances or groups of substances present in medicines -
that are required to be declared on the label of medicines
It appears that some inconsistencies remain in the declaration statement of certain
substances in Schedule 1 of TGO 92 compared to warning statements generated on the
ARTG
Ethanolalcohol
This group of substances to be declared on the label is not consistent with the ARTG
generated warning for ethanolalcohol
bull Contains alcohol vs contains ethanol (vv)
Ethanol as one of the substances required to be declared on the label can carry the
declaration contains alcohol However the same ingredient warning that is generated on
the ARTG for use if this ingredient is in the formula as a listed excipient is ETHAN contains
ethanol (or words to that effect)
Recommendations
Page 18 of 23
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is consistent
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label if the situation arises where there is already an ARTG
generated ethanol warning
Other ingredients such as potassium sorbate already generate ARTG warnings if listed as
excipients and is also in the group of substances required to be declared on the label
Again the wording used is inconsistent
ARTG warning SORB8 (If the medicine contains one sorbate) Contains [insert name of
sorbate] OR (if medicine contains two or more sorbates) Contains sorbates [or words to that
effect]
bull Contains sorbates vs contains [inse1i name of sorbate] (if the medicine contains one sorbate) or contains sorbates (if the medicine contains two or more sorbates) in the
event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have Contains potassium sorbate
whilst it would read Contains sorbates to comply with schedule 1 of TGO 92
Recommendations
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is
consistent If the product contains one sorbate eg potassium sorbate ARTG warning
is Contains potassium sorbate however TGO 92 declaration is Contains sorbates
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label in these situations
Phenylalanine
Many mineral amino acid chelates contain phenylalanine as part of the amino acid portion
of the mineral and ingredients such as Spirulina whole cell powder would contain
phenylalanine as part of its protein profile CMA proposes that the schedule 1 list include
additional information as to what ingredients the phenylalanine warning applies to or
outline the ingredients such as those mentioned above that are exempt from the
requirement
Imposing such requirements to all ingredients may cause unnecessary concern to the
consumer
Page 19 of 23
PU
Schedule 2 Specified Units for Enzymes -
bull CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients Papain Units Bromelain
Currently the TBS only allows the quantity of the ingredient to be expressed in milligrams
(mg) Pervious considerations of this issue has identified that the per mg expression is not
the most appropriate for the material Whilst GOU (gelatine digesting unit) is acknowledged
to be the unit most commonly used for the material papain unit is proposed as this is the
specified unit from bromelain by the joint FAOWHO expert committee on Food Additives
(JECFA) the Food Chemical Codex and the unit adopted by Health Canada in its
monographs for Stem bromelian and fruit bromelian We note also that there is a simple
conversion factor that can be applied to quantities expressed as GOU
CMA comment on the Guideline for medicine labels draft version 10
October 2015
bull 3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA proposes the
removal (of Camellia sinensis) after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation
and herbal material and quantity of standardised constituent) would be expressed
together This reiteration appears to be redundant and would take up more space on the
label
bull Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] Ingredients Uses or What this medicine is used for Warnings Directions for use and Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a
specified order) needs to be followed for listed medicines
Page 2 0 of 23
Labelling
Labelling packaging Complementary
Labelling Packaging
CMA interprets the revised TGO 92 update to mean that this would no longer be a
requirement However we have provided a mock up label at appendix 1 example 4 to
demonstrate how this requirement if relevant would impact multi ingredient herbal
medicines
CMA resources in reference to the labelling of complementary
medicines
bull CMA submission Consultation Draft TGO 79 Standards for the of Medicines
(November 2014) bull CMA submission and of Medicines (12 April
2013) bull CMA submission on the Medicine and Review (24 August 2012)
Page 21of23
CMA detailed table of reform recommendations and impact of TGO 92
Page 22 of 23
Appendix 1 - mock up labels to TGO 92 requirements
Page 23 of 23
CMA response to TGO 92- Standards for the labels of non-prescription medicines
Proposed Requirement TGO 92 Industry response
Text size In principle CMA agrees with the change that reverts back to the current TGO 69 definition of text size This is in comparison to the consultation draft TGO79 that proposed a range of sizes for listed and registered
ldquoText size equivalent to Arial fontrdquo complementary medicines based on Arial point size font has been removed from TGO 92 The definition for letter height is the same as the definition in TGO 69
Sec 7 General requirements including As stated in the CMA 2014 submission ambiguous and subjective requirements should on principle not be included in a label presentation legislative instrument (2)(e) Considering the guidance document elaborates on the proposed requirement CMA reiterates that we are not aware of there Labels must be in a colour or colours being consumer safety issues of this nature reported for CM products which are of a lower risk and hence consider the contrasting strongly with the mandatory requirement unjustified background Sec 8(2) Labels of registered medicines must provide information in a consistent order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important information access to other information is also necessary for consumers to make an informed purchasing decision CMA is of the position that for lower risk registered medicines such as registered complementary medicines there should be flexibility to present mandatory information in a clear and concise manner without the constraint of a medicine information panel (MIP) This will minimise cost to the CM industry associated with resizing labels or providing goods in larger container sizes with increased headspace Section 155 of the Guidance document outlines that ldquoa medicine information panel is not required for certain lower risk
Proposed Requirement TGO 92 Industry response
registered medicines ndash these are detailed in subsection 8(2) of TGO 92rdquo Subsection 8(2) however does not appear to detail specifically what types of lower risk registered medicines would not require a MIP CMA suggests that this part of the guidance is expanded to include specific guidance that registered complementary medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the amendment impact registered complementary medicines mock up labels have been provided to demonstrate that the requirement would necessitate a change to label sizes for complementary medicines which is considered unjustified
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of a MIP would not work and necessitate labelling complications and medicine container size considerations
Sec 8 (1) (k) (ii) (B) Pregnancy database
Requirements related tot his section should be incorporated on an ingredient by ingredient basis within the 26BB list of permissible ingredients instrument Pregnancy database - Add link httpswwwtgagovauprescribing-medicines-pregnancy-database
Sec 9 (2) CMA considers the proposed requirements to orientate all text in the same direction on the main label and for medicine names to be presented in a continuous and uninterrupted manner would not have a meaningful impact upon consumer
The name of the medicine on the main safety and as such the change is considered unjustified for lower risk medicines label must be presented in a continuous uninterrupted manner and Feedback from our members indicates that medicine labels are often developed as a result of consumer testing not be broken up by additional In addition CMA has not been presented with information that consumers have any usability difficulties with the information or background text presentation of information on complementary medicine labels Sec 9 (5) All text required by this Order to It is well documented that consumers generally select complementary medicines and non-prescription medicines by brand appear on the main label must be and category and seek out brands they know Branding is important for complementary medicines and consumers are orientated in the same direction familiar with many well-known brands of medicines for general wellbeing cough and cold allergy skincare and many
other categories Limited label space is therefore an important issue particularly for certain product and label types
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 2 of 12
Proposed Requirement TGO 92 Industry response
Such a change would impact upon brand recognition for many companies As such CMA considers this as an unjustified change to requirements adding to unnecessary regulatory burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact on branding and does not require consequential changes to dimensions of packs or labels or changes to the packaging details of a medicine
Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 30millimeters on the front panel directly under the trade name
Since consumers use complementary medicines as part of self-care the label of these medicines is the primary source of information for consumers This requirement would mean that a large portion of the label would be used to display the active ingredients Information on active ingredients is not always the most meaningful aspect in consumer self selection of these goods rather information sought by consumers tends to be focused around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space and there will be reduced space to indicate the intended purpose of the product on the front of pack If the container and label size are increased as a result of this without increasing the number of tablets or capsules in the bottle this could give the consumer a negative perception due to the increased head space of the container Ultimately this would also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations
Sec 9 (6) CMArsquos position on the number of active ingredients that may appear on the front of a label for listed goods is that TGO 69 If the medicine is intended to be or is requirements be maintained listed goods By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active ingredients to four or more (b) if there are four or more active active ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for ingredients in the medicine - the name these lower risk listed medicines without any evidence of consumer benefit being presented of every active ingredient together with the quantity or proportion of CMA suggests the following amendment to TGO 92 every active ingredient may appear on
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 3 of 12
Proposed Requirement TGO 92 Industry response
a side panel or side label or on a rear panel or rear label
If the medicine is intended to be or is listed goods 6 b) if the medicine is a listed complementary medicine ndash the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO 69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014 CMA includes specific examples where for listed CMs containing three active ingredients to be displayed on the front of the label where previously they would be detailed at the side or rear how this would impact on label size being inappropriate for the packaging
Sec 9 (7) CMA proposed that TGO 69 requirements be maintained If the medicine is intended to be or is registered goods then By imposing subsection 9(7)(b) would mean a requirement to go from two or more active ingredients to four or more active
ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for (a) where the medicine contains three registered complementary medicines without any specific evidence of consumer benefit relating to this lower risk class of or four active ingredients the name of good being presented the active ingredient(s) and the quantity or proportion of active Within the complementary medicine category listed and registered complementary medicines will be presented (depending ingredient(s) must be displayed on the on the number of active ingredients present) in a different manner That is some will detail active ingredients at the front of main label in a text size of not less the pack while others (with 4 or more active ingredients) will detail the ingredients at the side or rear of the pack CMA than 3 millimetres submits that for the purposes of standardisation of where to find information consumers should be encouraged to refer to
the backside of the pack for ingredient information (b) where the medicine contains four or more active ingredients and the CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of requirements of subsection 8(2) do not 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations apply then the names and the See comments at Sec 9 (7)(a) above quantities or proportion of the active ingredients may be included on a side panellabel or rear panellabel when
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 4 of 12
Proposed Requirement TGO 92 Industry response
displayed in a text size of not less than 25mm
Sec 10(3) amp Sec 10 (4)(a) CMA does not support any additional change to this lower risk category of medicine
Homeopathic medicines No explanation or justification has been provided as to why there is a new mandatory requirement to include a statement on Where all the active ingredients in a the main label that the medicine is a homeopathic medicine or contains homeopathic preparations in an increased font size to medicine are homoeopathic that of a general listed complementary medicine preparations the main label on the No real explanation has been provided as to why an increase to the font size for the statement ldquohomeopathic medicinerdquo was container and the main label on the considered a requirement based on a consumer safety perspective primary pack (if any) must in addition to the requirements referred Previous explanations for this addition has centred around that the statement is intended to assist consumers with an to in sections 8 and 9 above include a appropriate selection for a medicine and minimise confusion that may arise with self-selection However the current statement to the effect that the labelling Order requires there to be a declaration that clearly states the product is homeopathic and contains homeopathic medicine is a homoeopathic medicine ingredients on the front of the pack and the additional detail of this information on the back of the pack in the ingredients in text size that is not less than 50 and indications section would clearly justify the medicine as being based in the homoeopathic paradigm of the text size of the name of the As such CMA proposes that this section be removed from the Order medicine and (in any event) not less than 2millimeters
Sec 6 CMA submitted in May 2013 via the International Harmonisation of Ingredient Names consultation that there appeared to be no mention of the naming of homoeopathic ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS)
Interpretation in this Order traditional naming or the application of new AAN homoeopathic names As such we resubmit information for consideration here
Homoeopathic medicines ndash naming conventions
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 5 of 12
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation (i) either the name of the active ingredient or the substance from which the dilution was prepared that is accepted for inclusion in the Australian Approved Names (AAN) List together with a statement of the homeopathic potency or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency
It is suggested that an amendment be made to allow for homeopathic medicines The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
To implement this CMA proposes the following amendment to the definition of the name of the active ingredient
(b) where the ingredient is a homoeopathic preparation
1 the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency in brackets the name that is also accepted for inclusion in the Australian Approved Names List
2 for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
That is the traditional homeopathic name to be used as the primary name including the AAN unless on ldquosmall containersrdquo Both the traditional names and AAN could be included on full website information which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required)
It is in the consumersrsquo interest that traditional pharmacopeial names be amended as the primary name The concern here is
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
Information on active ingredients is not always the most meaningful aspect in consumer self
selection of these goods rather information sought by consumers tends to be focused
around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space
and there will be reduced space to indicate the intended purpose of the product on the
front of pack If the container and label size are increased as a result of this without
increasing the number of tablets or capsules in the bottle this could give the consumer a
negative perception due to the increased head space of the container Ultimately this would
also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at the appendix example 1 a mock up of a registered complementary
medicine to demonstrate how the inclusion of 9 7)(a) would not work and necessitate
labelling complications and medicine container size considerations
bull Sec 9 (6) If the medicine is intended to be or is listed goods
(b) if there are four or more active ingredients in the medicine - the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on
As outlined in our 2014 submission subsection 9(6)(b) is not supported for inclusion in the
labelling Order The requirement for change to listed and registered complementary
medicines was not adequately justified from a risk perspective rather the requirements
appear to be a hangover from the risks perceived from the prescription and registered nonshy
prescription medicine sector
CMAs position on the number of active ingredients that may appear on the front of a label
for listed goods is that TGO 69 requirements be maintained
By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active
ingredients to four or more active ingredients that may be declared on a side panellabel or
rear panellabel This would increase the regulatory cost for these lower risk listed
medicines without any evidence of consumer benefit being presented
CMA suggests the following amendment to TGO 92
If the medicine is intended to be or is listed goods
6 b) if the medicine is a listed complementary medicine - the name of every active
ingredient together with the quantity or proportion of every active ingredient may appear
on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO
69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014
Page 10 of 23
CMA includes specific examples at appendix 1 example 2 impact on label size for listed
complementary medicines containing three active ingredients to be displayed on the front
of the label (currently they may be detailed at the side or rear)
bull Sec 9 (7) If the medicine is intended to be or is registered goods then
(a) where the medicine contains three or four active ingredients the name of the active
ingredient(s) and the quantity or proportion of active ingredient(s) must be displayed on
the main label in a text size of not less than 3 millimetres
(b) where the medicine contains four or more active ingredients and the requirements of
subsection 8(2) do not apply then the names and the quantities or proportion of the
active ingredients may be included on a side panellabel or rear panellabel when
displayed in a text size of not less than 2Smm
CMAs position on this section is that TGO 69 requirements be maintained
By imposing subsection 9(7)(b) would mean a requirement to go from two or more active
ingredients to four or more active ingredients that may be declared on a side panellabel or
rear panellabel This would increase the regulatory costs for registered complementary
medicines without any specific evidence of consumer benefit relating to this lower risk class
of good being presented
Within the complementary medicine category listed and registered complementary
medicines will be presented (depending on the number of active ingredients present) in a
different manner That is some will detail active ingredients at the front of the pack while
others (with 4 or more active ingredients) will detail the ingredients at the side or rear of
the pack CMA submits that for the purposes of standardisation and consistency on where
to find information for lower risk goods consumers should be encouraged to refer to the
backside of the pack for ingredient information
CMA provides a mock up of a registered CM provided to demonstrate how the inclusion of
9 (7)(a) would not work and necessitate labelling complications and medicine container size
considerations
Section 10 Qualifications and special requirements
Sec 10(3) amp Sec 10 (4)(a) where all the active ingredients in a medicine are homoeopathic
preparations the main label on the container and the main label on the primary pack (if
any) must in addition to the requirements referred to in sections 8 and 9 above include a
statement to the effect that the medicine is a homoeopathic medicine in text size that is
not less than 50 of the text size of the name of the medicine and (in any event) not less
than 2millimeters
Page 11of23
CMA does not support any additional change to this lower risk category of medicine
No explanation or justification has been provided during the course of labelling
consultations as to why there is a new mandatory requirement to include a statement on
the main label that the medicine is a homeopathic medicine or contains homeopathic
preparations in an increased font size to that of a general listed complementary medicine
No real explanation has been provided as to why an increase to the font size for the
statement homeopathic medicine was considered a requirement based on a consumer
safety perspective
Previous explanations for this addition has centred on factors that the statement is intended
to assist consumers with an appropriate selection for a medicine and minimise confusion
that may arise with self-selection However the current labelling Order requires there to
be a declaration that clearly states the product is homeopathic and contains homeopathic
ingredients on the front of the pack and the additional detail of this information on the back
of the pack in the ingredients and indications section would clearly justify the medicine as
being based in the homoeopathic paradigm As such CMA proposes that this section be
removed from the Order
bull Section 6 Interpretation in the Order Homeopathic medicines - naming conventions
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic
preparation (i) either the name of the active ingredient or the substance from which the
dilution was prepared that is accepted for inclusion in the Australian Approved Names
(AAN) List together with a statement of the homeopathic potency or (ii) until such time
as a name is accepted for inclusion in the Australian Approved Names List a traditional
homoeopathic name in full or as traditionally abbreviated with a statement of
homeopathic potency
Given the recent redraft of the labelling Order it is an opportune time to explore potential
amendments that aim to increase the clarity for requirements around homeopathic
medicines for both industry and the regulator
CMA submitted in May 2013 via the International Harmonisation of Ingredient Names
consultation that there appeared to be no mention of the naming of homoeopathic
ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS) traditional naming or
the application of new AAN homoeopathic names As such we resubmit information for
consideration here
It is suggested that an amendment be made to allow for homeopathic medicines
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
Page 12 of 23
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
That is the traditional homeopathic name is to be used as the primary name including the
AAN unless on small containers Both the traditional names and AANs could be included
on full website information which would allow additional space to elaborate on the naming
of traditional homeopathic ingredients (where required)
To implement this CMA proposes the following amendment to the definition of the name
of the active ingredient
(b) where the ingredient is a homoeopathic preparation
(i) the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency and the name that is also accepted for inclusion in the Australian Approved Names List (if available) in brackets
(ii) for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
It is in the consumers interest that traditional pharmacopeial names be amended so as to
be the primary name The concern here is that by enforcing the current definition and taking
the AAN name alone outside of the traditional context the consumer may only get the
name in its full chemicalnon homeopathic form causing potential confusion and or safety
concerns Additionally the AAN name alone (due to small label space requirements) may
appear as a different active ingredient all together causing consumer alarm
For example False Unicorn Root
Traditional homeopathic name AAN name
Helonias dioica Chamaelirium luteum
If a consumer wishes to know more about a homeopathic medicine ingredient many
sources of information (pharmacopoeias texts materia medica) refer to the traditional
name as the primary point of reference To elaborate further examples have been provided
(Appendix 1 example 5) with this submission
International harmonisation considerations - homeopathic naming
conventions
ACSS Consortium
Page 13 of 23
website
(httpwebprodhc-scgccanhpidshy
bdipsnatRegdoatid=homeopathy)
(httpljwwwhc-scgccadhp-mpsprodnaturlegislationdocsehmg-nprhshy
engphpaS)
The TGA is part of the ACSS Consortium along with Health Canada Health Sciences Authority of Singapore and Swissmedic According to the TGA the ACSS Consortium
was formed in 2007 by like-minded regulatory authorities to promote greater regulatory
collaboration and alignment of regulatory requirements with the goal of maximising
international cooperation reduce duplication and increase each agencys capacity to
ensure consumers have timely access to high quality safe and effective therapeutic
products
Heath Canada
The Health Canada website
provides guidance to industry for the preparation of
Product Licence Applications (PLAs) and labels for natural health product market
authorization for homeopathic products (updated July 2015) It states
bull The proper name(s) common name(s) and source material(s) must be as per the homeopathic
monograph referenced as the Standard or Grade (please refer to the specifications)
bull The medicinal ingredient(s) must be a permitted substance with a homeopathic monograph in one
of the Natural and Non-Prescription Health Products Directorate (NNHPD) accepted homeopathic
pharmacopoeia
The Standards or Grades refers to a list of homeopathic pharmacopoeias containing the
traditional homeopathic names
Health Canada also includes guidance for the labelling of homeopathic medicines on its
website
It includes the following guidance for labelling for small packages
53 Labels for Small Packages
The NNHPD recognizes that small packages such as those used by some homeopathic medicine manufacturers
may not have an area large enough for the inner labelling requirements Therefore separate small package
labelling requirements have been developed Please see the Labelling guidance document for infonnation
specific to small package labelling
SwissMedic
In Switzerland homeopathy has been fully integrated into the Swiss medical system
SwissMedics HAS (Homeopathic and Anthroposophical medicines) list includes both Latin
chemical names and their homeopathic synonyms It appears that homeopathic products in
Switzerland also allow for the use of homeopathic names on products labels (noting the
strong tradition of use of homeopathy in the region)
FDA
The FDA also recognises the traditional homeopathic names with HPUS as the standard The HPUS has labelling guidelines for homeopathic medicines2 that links in with the labelling
2 httpwwwhpuscomRevised-Labeling-Guidelines-04-14pdf
Page 14 of 23
provisions of Sections 502 and 503 of the Federal Food Drug and Cosmetic Act Part 201
Title 21 of the Code of Federal Regulations (CFR) and the FDAs Compliance Policy Guide
400400
Section 11 How Information is to be expressed -
Use of appropriate metric units
bull Sec 11 (l)(b) The abbreviations to mg and g can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation microg may be used
Where several ingredients are presented on a label statement in microgram microliter
quantities the repetition of expressing the unit in full greatly expands the length of the text
and hence label space becomes an important issue
Further CMA questions if the requirement is mandatory given it is expressed as should in
the standard compared to must in the guideline
This proposed requirement if mandatory does not allow for consistency on the label and
increased label space is required CMA submits that an abbreviated form of microgram
should be permitted in the standard
Expression of quantity or proportion of active ingredients
Sec 11 (2) Expression of quantity or propo1iion of active ingredients
11(2)(i) states that in addition to the requirements of paragraphs 1 1(2)(a)-1 1(2)(h) and
therefore includes 1 1 (2)( a) the quantity of the active ingredient
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the
herbal material from which the preparation was derived except
This amendment appears to propose that herbal ingredients include the actual amount of
herbal extract in addition to the equivalent amount of starting herbal material from which
the preparation was derived
As detailed in our 2014 submission we do not support the increased information
requirements for the expression of herbal medicines to be expanded on the medicine label
(section 11(2))
The 2014 consultation suggested the reasoning for the additional requirement to include
the input amount of the herbal material on the label was that it enables the consumer to
Page lS of 23
version
gain meaningful information in relation to the strength concentration or quantified levels
in general of the herbal ingredients in the medicine
To implement this requirement however it would require the addition of an extra line of
information for each herbal material ingredient to express both quantities on the medicine
label The majority of complementary medicines are multi ingredient formulations
sometimes with as many as 25 ingredients in a product The addition of at least two lines to
express each herbal ingredient would for the average consumer most likely only create
confusion as to which line of expression to draw a meaningful conclusion from
The main concern is that this would lead to two quantification values for the same inputted
ingredient which would be open to misunderstanding and if other than the native extract
amount potentially no more helpful to the consumer Additionally this requirement does
not appear to impact upon the safe or proper usage of the medicine if used within the
context outlined on the label
CMA considers that this requirement would significantly increase the regulatory burden of
lower risk medicines by increasing the amount of information required on a label and hence
label size Label space will become an issue and an impracticality pushed to some degree
and with an obscure label this could lead to other potentially misleading packaging issues
We again provide mock up labels at the appendix to demonstrate this significant increase in
requirement
Clear concise labelling of ingredients with one quantity the extract equivalent of the herb
provides consumers with satisfactory information that allows comparison with other
products
CMA requests that TGA provides a detailed reasoning behind the proposed amendment
including evidence that the current requirement is impacting on the safe and proper usage
of listed medicines if that is the case In the absence of this information CMA does not
support implementing this section of the labelling Order and that it be drafted without this
specific requirement
CMA provides a mock up label at the appendix 1 example 3 to demonstrate the increased
requirements to listed low risk medicines
Regulatory Impact Statement (RIS)- general requirements for labels of medicines version 10 August 2014
The TGA provided a regulatory impact statement and other supporting documents3 as
evidence in support of a change to the labelling of medicines the proposed changes were
however largely based on the risk profile associated with prescription and registered over
the counter medicines with no direct reference to misuse of complementary medicines in
3 Labelling and packaging practices 10 January 2013 fileCUserstechnicalDownloadsconsultshy
labelling-packaging-review-1205 24-an alysis-evidencepdf
Page 16 of 23
the context of self-selection being outlined The extra regulatory requirements for labelling
and packaging of complementary medicines are considered to be out of proportion to the
risk classifications of these medicines
The 2014 consultation highlighted that due to lower risk medicines being available for self selection this factor alone poses a risk as the consumer receives no additional information
except the instructions on the label Indeed while this highlights the importance of the
information on the medicine label no evidence has been provided that the proposed
changes would contribute to the provision of better consumer information or safety A
change to the amount of active ingredients that can be included on the front of the
medicine label and additional information around the expression of herbal ingredients for
example are proposals for change that are not supported by CMA as they have not been
evidenced to be a safety issue nor undergone consumer use testing to demonstrate any
improvement on the status quo would be gained In summary they will have little affect on
consumers self-selection
The 2014 labelling consultation included a regulatory impact statement which from an
industry point of view grossly underestimated the cost of changes
Copy from the RIS
The labour burden for businesses who need to change a label would be
approximately 20 hours (includes reading the current guidance and applying it to
their design work and the small amount of labour involved in providing new label
information as part of the application to vary the entry) at a labour rate of $42 per
hour
The additional requirements proposed in the Order and schedule 1 will result in all
companies conducting a review of each medicine formulation checking for compliance to
these revised requirements It is estimated that the $42 per hour labour rate above would
increase to approximately $60 per hour for the time required to carry out the review One
member estimates that the labour hours would increase from 20 to 30 hours and takes into
account that different sections within an organisation and external organisations are
involved in obtaining documentation for example suppliers distributors manufacturers
Testing may also be required to confirm if any allergen residue remains in the raw material
Transition arrangements
CMA notes that the proposed transition arrangement includes a four year period where by
compliance with the current labelling Order (TGO 69) or the revised TGO 92 would be
permitted By 2020 full compliance with TGO 92 would be required While this is an
improvement from the 2014 proposal CMA highlights that further refinements to TGO 92 is
required to reduce the regulatory burden for complementary medicines
Page 17 of 23
Should the Order be implemented as currently drafted there will be many complementary
medicine businesses that would be negatively impacted Not in the lest many small ownershy
operator complementary medicine businesses would not generally be in the practice of
changing their medicine labels every few years as indicated in the TGA RIS document
The transition period will also be particularly problematic where the labelled information
will differ despite no change in formulation eg change in apparent quantification
ingredient name or ingredient placement
The RIS document also detailed that the new labelling Order would be a one-off cost for
those businesses that would not be changing their labels during the transition period
The 2014 participants in the TGA industry survey included larger CM company
representatives and therefore is only indicative of that sector of the industry
Specifically the RIS did not look at the fact that smaller companies would employ the skills
of professional consultants to carry out the work required to ensure compliance with the
new labelling Order This cost factor alone for changes proposed to lower risk listed
medicines is considered an unnecessary additional regulatory burden that would not
necessarily equate to any consumer self-medication benefit
CMA submits that the focus of the TGA be one of reducing the regulatory burden enhancing
efficiencies in existing process whilst upholding the safety and quality of complementary
medicines available to consumers For these reasons CMA submits that further refinements
to TGO 92 be made to accommodate lower risk medicines
Schedule 1 Substances or groups of substances present in medicines -
that are required to be declared on the label of medicines
It appears that some inconsistencies remain in the declaration statement of certain
substances in Schedule 1 of TGO 92 compared to warning statements generated on the
ARTG
Ethanolalcohol
This group of substances to be declared on the label is not consistent with the ARTG
generated warning for ethanolalcohol
bull Contains alcohol vs contains ethanol (vv)
Ethanol as one of the substances required to be declared on the label can carry the
declaration contains alcohol However the same ingredient warning that is generated on
the ARTG for use if this ingredient is in the formula as a listed excipient is ETHAN contains
ethanol (or words to that effect)
Recommendations
Page 18 of 23
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is consistent
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label if the situation arises where there is already an ARTG
generated ethanol warning
Other ingredients such as potassium sorbate already generate ARTG warnings if listed as
excipients and is also in the group of substances required to be declared on the label
Again the wording used is inconsistent
ARTG warning SORB8 (If the medicine contains one sorbate) Contains [insert name of
sorbate] OR (if medicine contains two or more sorbates) Contains sorbates [or words to that
effect]
bull Contains sorbates vs contains [inse1i name of sorbate] (if the medicine contains one sorbate) or contains sorbates (if the medicine contains two or more sorbates) in the
event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have Contains potassium sorbate
whilst it would read Contains sorbates to comply with schedule 1 of TGO 92
Recommendations
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is
consistent If the product contains one sorbate eg potassium sorbate ARTG warning
is Contains potassium sorbate however TGO 92 declaration is Contains sorbates
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label in these situations
Phenylalanine
Many mineral amino acid chelates contain phenylalanine as part of the amino acid portion
of the mineral and ingredients such as Spirulina whole cell powder would contain
phenylalanine as part of its protein profile CMA proposes that the schedule 1 list include
additional information as to what ingredients the phenylalanine warning applies to or
outline the ingredients such as those mentioned above that are exempt from the
requirement
Imposing such requirements to all ingredients may cause unnecessary concern to the
consumer
Page 19 of 23
PU
Schedule 2 Specified Units for Enzymes -
bull CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients Papain Units Bromelain
Currently the TBS only allows the quantity of the ingredient to be expressed in milligrams
(mg) Pervious considerations of this issue has identified that the per mg expression is not
the most appropriate for the material Whilst GOU (gelatine digesting unit) is acknowledged
to be the unit most commonly used for the material papain unit is proposed as this is the
specified unit from bromelain by the joint FAOWHO expert committee on Food Additives
(JECFA) the Food Chemical Codex and the unit adopted by Health Canada in its
monographs for Stem bromelian and fruit bromelian We note also that there is a simple
conversion factor that can be applied to quantities expressed as GOU
CMA comment on the Guideline for medicine labels draft version 10
October 2015
bull 3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA proposes the
removal (of Camellia sinensis) after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation
and herbal material and quantity of standardised constituent) would be expressed
together This reiteration appears to be redundant and would take up more space on the
label
bull Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] Ingredients Uses or What this medicine is used for Warnings Directions for use and Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a
specified order) needs to be followed for listed medicines
Page 2 0 of 23
Labelling
Labelling packaging Complementary
Labelling Packaging
CMA interprets the revised TGO 92 update to mean that this would no longer be a
requirement However we have provided a mock up label at appendix 1 example 4 to
demonstrate how this requirement if relevant would impact multi ingredient herbal
medicines
CMA resources in reference to the labelling of complementary
medicines
bull CMA submission Consultation Draft TGO 79 Standards for the of Medicines
(November 2014) bull CMA submission and of Medicines (12 April
2013) bull CMA submission on the Medicine and Review (24 August 2012)
Page 21of23
CMA detailed table of reform recommendations and impact of TGO 92
Page 22 of 23
Appendix 1 - mock up labels to TGO 92 requirements
Page 23 of 23
CMA response to TGO 92- Standards for the labels of non-prescription medicines
Proposed Requirement TGO 92 Industry response
Text size In principle CMA agrees with the change that reverts back to the current TGO 69 definition of text size This is in comparison to the consultation draft TGO79 that proposed a range of sizes for listed and registered
ldquoText size equivalent to Arial fontrdquo complementary medicines based on Arial point size font has been removed from TGO 92 The definition for letter height is the same as the definition in TGO 69
Sec 7 General requirements including As stated in the CMA 2014 submission ambiguous and subjective requirements should on principle not be included in a label presentation legislative instrument (2)(e) Considering the guidance document elaborates on the proposed requirement CMA reiterates that we are not aware of there Labels must be in a colour or colours being consumer safety issues of this nature reported for CM products which are of a lower risk and hence consider the contrasting strongly with the mandatory requirement unjustified background Sec 8(2) Labels of registered medicines must provide information in a consistent order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important information access to other information is also necessary for consumers to make an informed purchasing decision CMA is of the position that for lower risk registered medicines such as registered complementary medicines there should be flexibility to present mandatory information in a clear and concise manner without the constraint of a medicine information panel (MIP) This will minimise cost to the CM industry associated with resizing labels or providing goods in larger container sizes with increased headspace Section 155 of the Guidance document outlines that ldquoa medicine information panel is not required for certain lower risk
Proposed Requirement TGO 92 Industry response
registered medicines ndash these are detailed in subsection 8(2) of TGO 92rdquo Subsection 8(2) however does not appear to detail specifically what types of lower risk registered medicines would not require a MIP CMA suggests that this part of the guidance is expanded to include specific guidance that registered complementary medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the amendment impact registered complementary medicines mock up labels have been provided to demonstrate that the requirement would necessitate a change to label sizes for complementary medicines which is considered unjustified
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of a MIP would not work and necessitate labelling complications and medicine container size considerations
Sec 8 (1) (k) (ii) (B) Pregnancy database
Requirements related tot his section should be incorporated on an ingredient by ingredient basis within the 26BB list of permissible ingredients instrument Pregnancy database - Add link httpswwwtgagovauprescribing-medicines-pregnancy-database
Sec 9 (2) CMA considers the proposed requirements to orientate all text in the same direction on the main label and for medicine names to be presented in a continuous and uninterrupted manner would not have a meaningful impact upon consumer
The name of the medicine on the main safety and as such the change is considered unjustified for lower risk medicines label must be presented in a continuous uninterrupted manner and Feedback from our members indicates that medicine labels are often developed as a result of consumer testing not be broken up by additional In addition CMA has not been presented with information that consumers have any usability difficulties with the information or background text presentation of information on complementary medicine labels Sec 9 (5) All text required by this Order to It is well documented that consumers generally select complementary medicines and non-prescription medicines by brand appear on the main label must be and category and seek out brands they know Branding is important for complementary medicines and consumers are orientated in the same direction familiar with many well-known brands of medicines for general wellbeing cough and cold allergy skincare and many
other categories Limited label space is therefore an important issue particularly for certain product and label types
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 2 of 12
Proposed Requirement TGO 92 Industry response
Such a change would impact upon brand recognition for many companies As such CMA considers this as an unjustified change to requirements adding to unnecessary regulatory burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact on branding and does not require consequential changes to dimensions of packs or labels or changes to the packaging details of a medicine
Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 30millimeters on the front panel directly under the trade name
Since consumers use complementary medicines as part of self-care the label of these medicines is the primary source of information for consumers This requirement would mean that a large portion of the label would be used to display the active ingredients Information on active ingredients is not always the most meaningful aspect in consumer self selection of these goods rather information sought by consumers tends to be focused around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space and there will be reduced space to indicate the intended purpose of the product on the front of pack If the container and label size are increased as a result of this without increasing the number of tablets or capsules in the bottle this could give the consumer a negative perception due to the increased head space of the container Ultimately this would also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations
Sec 9 (6) CMArsquos position on the number of active ingredients that may appear on the front of a label for listed goods is that TGO 69 If the medicine is intended to be or is requirements be maintained listed goods By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active ingredients to four or more (b) if there are four or more active active ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for ingredients in the medicine - the name these lower risk listed medicines without any evidence of consumer benefit being presented of every active ingredient together with the quantity or proportion of CMA suggests the following amendment to TGO 92 every active ingredient may appear on
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 3 of 12
Proposed Requirement TGO 92 Industry response
a side panel or side label or on a rear panel or rear label
If the medicine is intended to be or is listed goods 6 b) if the medicine is a listed complementary medicine ndash the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO 69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014 CMA includes specific examples where for listed CMs containing three active ingredients to be displayed on the front of the label where previously they would be detailed at the side or rear how this would impact on label size being inappropriate for the packaging
Sec 9 (7) CMA proposed that TGO 69 requirements be maintained If the medicine is intended to be or is registered goods then By imposing subsection 9(7)(b) would mean a requirement to go from two or more active ingredients to four or more active
ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for (a) where the medicine contains three registered complementary medicines without any specific evidence of consumer benefit relating to this lower risk class of or four active ingredients the name of good being presented the active ingredient(s) and the quantity or proportion of active Within the complementary medicine category listed and registered complementary medicines will be presented (depending ingredient(s) must be displayed on the on the number of active ingredients present) in a different manner That is some will detail active ingredients at the front of main label in a text size of not less the pack while others (with 4 or more active ingredients) will detail the ingredients at the side or rear of the pack CMA than 3 millimetres submits that for the purposes of standardisation of where to find information consumers should be encouraged to refer to
the backside of the pack for ingredient information (b) where the medicine contains four or more active ingredients and the CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of requirements of subsection 8(2) do not 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations apply then the names and the See comments at Sec 9 (7)(a) above quantities or proportion of the active ingredients may be included on a side panellabel or rear panellabel when
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 4 of 12
Proposed Requirement TGO 92 Industry response
displayed in a text size of not less than 25mm
Sec 10(3) amp Sec 10 (4)(a) CMA does not support any additional change to this lower risk category of medicine
Homeopathic medicines No explanation or justification has been provided as to why there is a new mandatory requirement to include a statement on Where all the active ingredients in a the main label that the medicine is a homeopathic medicine or contains homeopathic preparations in an increased font size to medicine are homoeopathic that of a general listed complementary medicine preparations the main label on the No real explanation has been provided as to why an increase to the font size for the statement ldquohomeopathic medicinerdquo was container and the main label on the considered a requirement based on a consumer safety perspective primary pack (if any) must in addition to the requirements referred Previous explanations for this addition has centred around that the statement is intended to assist consumers with an to in sections 8 and 9 above include a appropriate selection for a medicine and minimise confusion that may arise with self-selection However the current statement to the effect that the labelling Order requires there to be a declaration that clearly states the product is homeopathic and contains homeopathic medicine is a homoeopathic medicine ingredients on the front of the pack and the additional detail of this information on the back of the pack in the ingredients in text size that is not less than 50 and indications section would clearly justify the medicine as being based in the homoeopathic paradigm of the text size of the name of the As such CMA proposes that this section be removed from the Order medicine and (in any event) not less than 2millimeters
Sec 6 CMA submitted in May 2013 via the International Harmonisation of Ingredient Names consultation that there appeared to be no mention of the naming of homoeopathic ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS)
Interpretation in this Order traditional naming or the application of new AAN homoeopathic names As such we resubmit information for consideration here
Homoeopathic medicines ndash naming conventions
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 5 of 12
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation (i) either the name of the active ingredient or the substance from which the dilution was prepared that is accepted for inclusion in the Australian Approved Names (AAN) List together with a statement of the homeopathic potency or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency
It is suggested that an amendment be made to allow for homeopathic medicines The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
To implement this CMA proposes the following amendment to the definition of the name of the active ingredient
(b) where the ingredient is a homoeopathic preparation
1 the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency in brackets the name that is also accepted for inclusion in the Australian Approved Names List
2 for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
That is the traditional homeopathic name to be used as the primary name including the AAN unless on ldquosmall containersrdquo Both the traditional names and AAN could be included on full website information which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required)
It is in the consumersrsquo interest that traditional pharmacopeial names be amended as the primary name The concern here is
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
CMA includes specific examples at appendix 1 example 2 impact on label size for listed
complementary medicines containing three active ingredients to be displayed on the front
of the label (currently they may be detailed at the side or rear)
bull Sec 9 (7) If the medicine is intended to be or is registered goods then
(a) where the medicine contains three or four active ingredients the name of the active
ingredient(s) and the quantity or proportion of active ingredient(s) must be displayed on
the main label in a text size of not less than 3 millimetres
(b) where the medicine contains four or more active ingredients and the requirements of
subsection 8(2) do not apply then the names and the quantities or proportion of the
active ingredients may be included on a side panellabel or rear panellabel when
displayed in a text size of not less than 2Smm
CMAs position on this section is that TGO 69 requirements be maintained
By imposing subsection 9(7)(b) would mean a requirement to go from two or more active
ingredients to four or more active ingredients that may be declared on a side panellabel or
rear panellabel This would increase the regulatory costs for registered complementary
medicines without any specific evidence of consumer benefit relating to this lower risk class
of good being presented
Within the complementary medicine category listed and registered complementary
medicines will be presented (depending on the number of active ingredients present) in a
different manner That is some will detail active ingredients at the front of the pack while
others (with 4 or more active ingredients) will detail the ingredients at the side or rear of
the pack CMA submits that for the purposes of standardisation and consistency on where
to find information for lower risk goods consumers should be encouraged to refer to the
backside of the pack for ingredient information
CMA provides a mock up of a registered CM provided to demonstrate how the inclusion of
9 (7)(a) would not work and necessitate labelling complications and medicine container size
considerations
Section 10 Qualifications and special requirements
Sec 10(3) amp Sec 10 (4)(a) where all the active ingredients in a medicine are homoeopathic
preparations the main label on the container and the main label on the primary pack (if
any) must in addition to the requirements referred to in sections 8 and 9 above include a
statement to the effect that the medicine is a homoeopathic medicine in text size that is
not less than 50 of the text size of the name of the medicine and (in any event) not less
than 2millimeters
Page 11of23
CMA does not support any additional change to this lower risk category of medicine
No explanation or justification has been provided during the course of labelling
consultations as to why there is a new mandatory requirement to include a statement on
the main label that the medicine is a homeopathic medicine or contains homeopathic
preparations in an increased font size to that of a general listed complementary medicine
No real explanation has been provided as to why an increase to the font size for the
statement homeopathic medicine was considered a requirement based on a consumer
safety perspective
Previous explanations for this addition has centred on factors that the statement is intended
to assist consumers with an appropriate selection for a medicine and minimise confusion
that may arise with self-selection However the current labelling Order requires there to
be a declaration that clearly states the product is homeopathic and contains homeopathic
ingredients on the front of the pack and the additional detail of this information on the back
of the pack in the ingredients and indications section would clearly justify the medicine as
being based in the homoeopathic paradigm As such CMA proposes that this section be
removed from the Order
bull Section 6 Interpretation in the Order Homeopathic medicines - naming conventions
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic
preparation (i) either the name of the active ingredient or the substance from which the
dilution was prepared that is accepted for inclusion in the Australian Approved Names
(AAN) List together with a statement of the homeopathic potency or (ii) until such time
as a name is accepted for inclusion in the Australian Approved Names List a traditional
homoeopathic name in full or as traditionally abbreviated with a statement of
homeopathic potency
Given the recent redraft of the labelling Order it is an opportune time to explore potential
amendments that aim to increase the clarity for requirements around homeopathic
medicines for both industry and the regulator
CMA submitted in May 2013 via the International Harmonisation of Ingredient Names
consultation that there appeared to be no mention of the naming of homoeopathic
ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS) traditional naming or
the application of new AAN homoeopathic names As such we resubmit information for
consideration here
It is suggested that an amendment be made to allow for homeopathic medicines
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
Page 12 of 23
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
That is the traditional homeopathic name is to be used as the primary name including the
AAN unless on small containers Both the traditional names and AANs could be included
on full website information which would allow additional space to elaborate on the naming
of traditional homeopathic ingredients (where required)
To implement this CMA proposes the following amendment to the definition of the name
of the active ingredient
(b) where the ingredient is a homoeopathic preparation
(i) the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency and the name that is also accepted for inclusion in the Australian Approved Names List (if available) in brackets
(ii) for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
It is in the consumers interest that traditional pharmacopeial names be amended so as to
be the primary name The concern here is that by enforcing the current definition and taking
the AAN name alone outside of the traditional context the consumer may only get the
name in its full chemicalnon homeopathic form causing potential confusion and or safety
concerns Additionally the AAN name alone (due to small label space requirements) may
appear as a different active ingredient all together causing consumer alarm
For example False Unicorn Root
Traditional homeopathic name AAN name
Helonias dioica Chamaelirium luteum
If a consumer wishes to know more about a homeopathic medicine ingredient many
sources of information (pharmacopoeias texts materia medica) refer to the traditional
name as the primary point of reference To elaborate further examples have been provided
(Appendix 1 example 5) with this submission
International harmonisation considerations - homeopathic naming
conventions
ACSS Consortium
Page 13 of 23
website
(httpwebprodhc-scgccanhpidshy
bdipsnatRegdoatid=homeopathy)
(httpljwwwhc-scgccadhp-mpsprodnaturlegislationdocsehmg-nprhshy
engphpaS)
The TGA is part of the ACSS Consortium along with Health Canada Health Sciences Authority of Singapore and Swissmedic According to the TGA the ACSS Consortium
was formed in 2007 by like-minded regulatory authorities to promote greater regulatory
collaboration and alignment of regulatory requirements with the goal of maximising
international cooperation reduce duplication and increase each agencys capacity to
ensure consumers have timely access to high quality safe and effective therapeutic
products
Heath Canada
The Health Canada website
provides guidance to industry for the preparation of
Product Licence Applications (PLAs) and labels for natural health product market
authorization for homeopathic products (updated July 2015) It states
bull The proper name(s) common name(s) and source material(s) must be as per the homeopathic
monograph referenced as the Standard or Grade (please refer to the specifications)
bull The medicinal ingredient(s) must be a permitted substance with a homeopathic monograph in one
of the Natural and Non-Prescription Health Products Directorate (NNHPD) accepted homeopathic
pharmacopoeia
The Standards or Grades refers to a list of homeopathic pharmacopoeias containing the
traditional homeopathic names
Health Canada also includes guidance for the labelling of homeopathic medicines on its
website
It includes the following guidance for labelling for small packages
53 Labels for Small Packages
The NNHPD recognizes that small packages such as those used by some homeopathic medicine manufacturers
may not have an area large enough for the inner labelling requirements Therefore separate small package
labelling requirements have been developed Please see the Labelling guidance document for infonnation
specific to small package labelling
SwissMedic
In Switzerland homeopathy has been fully integrated into the Swiss medical system
SwissMedics HAS (Homeopathic and Anthroposophical medicines) list includes both Latin
chemical names and their homeopathic synonyms It appears that homeopathic products in
Switzerland also allow for the use of homeopathic names on products labels (noting the
strong tradition of use of homeopathy in the region)
FDA
The FDA also recognises the traditional homeopathic names with HPUS as the standard The HPUS has labelling guidelines for homeopathic medicines2 that links in with the labelling
2 httpwwwhpuscomRevised-Labeling-Guidelines-04-14pdf
Page 14 of 23
provisions of Sections 502 and 503 of the Federal Food Drug and Cosmetic Act Part 201
Title 21 of the Code of Federal Regulations (CFR) and the FDAs Compliance Policy Guide
400400
Section 11 How Information is to be expressed -
Use of appropriate metric units
bull Sec 11 (l)(b) The abbreviations to mg and g can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation microg may be used
Where several ingredients are presented on a label statement in microgram microliter
quantities the repetition of expressing the unit in full greatly expands the length of the text
and hence label space becomes an important issue
Further CMA questions if the requirement is mandatory given it is expressed as should in
the standard compared to must in the guideline
This proposed requirement if mandatory does not allow for consistency on the label and
increased label space is required CMA submits that an abbreviated form of microgram
should be permitted in the standard
Expression of quantity or proportion of active ingredients
Sec 11 (2) Expression of quantity or propo1iion of active ingredients
11(2)(i) states that in addition to the requirements of paragraphs 1 1(2)(a)-1 1(2)(h) and
therefore includes 1 1 (2)( a) the quantity of the active ingredient
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the
herbal material from which the preparation was derived except
This amendment appears to propose that herbal ingredients include the actual amount of
herbal extract in addition to the equivalent amount of starting herbal material from which
the preparation was derived
As detailed in our 2014 submission we do not support the increased information
requirements for the expression of herbal medicines to be expanded on the medicine label
(section 11(2))
The 2014 consultation suggested the reasoning for the additional requirement to include
the input amount of the herbal material on the label was that it enables the consumer to
Page lS of 23
version
gain meaningful information in relation to the strength concentration or quantified levels
in general of the herbal ingredients in the medicine
To implement this requirement however it would require the addition of an extra line of
information for each herbal material ingredient to express both quantities on the medicine
label The majority of complementary medicines are multi ingredient formulations
sometimes with as many as 25 ingredients in a product The addition of at least two lines to
express each herbal ingredient would for the average consumer most likely only create
confusion as to which line of expression to draw a meaningful conclusion from
The main concern is that this would lead to two quantification values for the same inputted
ingredient which would be open to misunderstanding and if other than the native extract
amount potentially no more helpful to the consumer Additionally this requirement does
not appear to impact upon the safe or proper usage of the medicine if used within the
context outlined on the label
CMA considers that this requirement would significantly increase the regulatory burden of
lower risk medicines by increasing the amount of information required on a label and hence
label size Label space will become an issue and an impracticality pushed to some degree
and with an obscure label this could lead to other potentially misleading packaging issues
We again provide mock up labels at the appendix to demonstrate this significant increase in
requirement
Clear concise labelling of ingredients with one quantity the extract equivalent of the herb
provides consumers with satisfactory information that allows comparison with other
products
CMA requests that TGA provides a detailed reasoning behind the proposed amendment
including evidence that the current requirement is impacting on the safe and proper usage
of listed medicines if that is the case In the absence of this information CMA does not
support implementing this section of the labelling Order and that it be drafted without this
specific requirement
CMA provides a mock up label at the appendix 1 example 3 to demonstrate the increased
requirements to listed low risk medicines
Regulatory Impact Statement (RIS)- general requirements for labels of medicines version 10 August 2014
The TGA provided a regulatory impact statement and other supporting documents3 as
evidence in support of a change to the labelling of medicines the proposed changes were
however largely based on the risk profile associated with prescription and registered over
the counter medicines with no direct reference to misuse of complementary medicines in
3 Labelling and packaging practices 10 January 2013 fileCUserstechnicalDownloadsconsultshy
labelling-packaging-review-1205 24-an alysis-evidencepdf
Page 16 of 23
the context of self-selection being outlined The extra regulatory requirements for labelling
and packaging of complementary medicines are considered to be out of proportion to the
risk classifications of these medicines
The 2014 consultation highlighted that due to lower risk medicines being available for self selection this factor alone poses a risk as the consumer receives no additional information
except the instructions on the label Indeed while this highlights the importance of the
information on the medicine label no evidence has been provided that the proposed
changes would contribute to the provision of better consumer information or safety A
change to the amount of active ingredients that can be included on the front of the
medicine label and additional information around the expression of herbal ingredients for
example are proposals for change that are not supported by CMA as they have not been
evidenced to be a safety issue nor undergone consumer use testing to demonstrate any
improvement on the status quo would be gained In summary they will have little affect on
consumers self-selection
The 2014 labelling consultation included a regulatory impact statement which from an
industry point of view grossly underestimated the cost of changes
Copy from the RIS
The labour burden for businesses who need to change a label would be
approximately 20 hours (includes reading the current guidance and applying it to
their design work and the small amount of labour involved in providing new label
information as part of the application to vary the entry) at a labour rate of $42 per
hour
The additional requirements proposed in the Order and schedule 1 will result in all
companies conducting a review of each medicine formulation checking for compliance to
these revised requirements It is estimated that the $42 per hour labour rate above would
increase to approximately $60 per hour for the time required to carry out the review One
member estimates that the labour hours would increase from 20 to 30 hours and takes into
account that different sections within an organisation and external organisations are
involved in obtaining documentation for example suppliers distributors manufacturers
Testing may also be required to confirm if any allergen residue remains in the raw material
Transition arrangements
CMA notes that the proposed transition arrangement includes a four year period where by
compliance with the current labelling Order (TGO 69) or the revised TGO 92 would be
permitted By 2020 full compliance with TGO 92 would be required While this is an
improvement from the 2014 proposal CMA highlights that further refinements to TGO 92 is
required to reduce the regulatory burden for complementary medicines
Page 17 of 23
Should the Order be implemented as currently drafted there will be many complementary
medicine businesses that would be negatively impacted Not in the lest many small ownershy
operator complementary medicine businesses would not generally be in the practice of
changing their medicine labels every few years as indicated in the TGA RIS document
The transition period will also be particularly problematic where the labelled information
will differ despite no change in formulation eg change in apparent quantification
ingredient name or ingredient placement
The RIS document also detailed that the new labelling Order would be a one-off cost for
those businesses that would not be changing their labels during the transition period
The 2014 participants in the TGA industry survey included larger CM company
representatives and therefore is only indicative of that sector of the industry
Specifically the RIS did not look at the fact that smaller companies would employ the skills
of professional consultants to carry out the work required to ensure compliance with the
new labelling Order This cost factor alone for changes proposed to lower risk listed
medicines is considered an unnecessary additional regulatory burden that would not
necessarily equate to any consumer self-medication benefit
CMA submits that the focus of the TGA be one of reducing the regulatory burden enhancing
efficiencies in existing process whilst upholding the safety and quality of complementary
medicines available to consumers For these reasons CMA submits that further refinements
to TGO 92 be made to accommodate lower risk medicines
Schedule 1 Substances or groups of substances present in medicines -
that are required to be declared on the label of medicines
It appears that some inconsistencies remain in the declaration statement of certain
substances in Schedule 1 of TGO 92 compared to warning statements generated on the
ARTG
Ethanolalcohol
This group of substances to be declared on the label is not consistent with the ARTG
generated warning for ethanolalcohol
bull Contains alcohol vs contains ethanol (vv)
Ethanol as one of the substances required to be declared on the label can carry the
declaration contains alcohol However the same ingredient warning that is generated on
the ARTG for use if this ingredient is in the formula as a listed excipient is ETHAN contains
ethanol (or words to that effect)
Recommendations
Page 18 of 23
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is consistent
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label if the situation arises where there is already an ARTG
generated ethanol warning
Other ingredients such as potassium sorbate already generate ARTG warnings if listed as
excipients and is also in the group of substances required to be declared on the label
Again the wording used is inconsistent
ARTG warning SORB8 (If the medicine contains one sorbate) Contains [insert name of
sorbate] OR (if medicine contains two or more sorbates) Contains sorbates [or words to that
effect]
bull Contains sorbates vs contains [inse1i name of sorbate] (if the medicine contains one sorbate) or contains sorbates (if the medicine contains two or more sorbates) in the
event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have Contains potassium sorbate
whilst it would read Contains sorbates to comply with schedule 1 of TGO 92
Recommendations
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is
consistent If the product contains one sorbate eg potassium sorbate ARTG warning
is Contains potassium sorbate however TGO 92 declaration is Contains sorbates
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label in these situations
Phenylalanine
Many mineral amino acid chelates contain phenylalanine as part of the amino acid portion
of the mineral and ingredients such as Spirulina whole cell powder would contain
phenylalanine as part of its protein profile CMA proposes that the schedule 1 list include
additional information as to what ingredients the phenylalanine warning applies to or
outline the ingredients such as those mentioned above that are exempt from the
requirement
Imposing such requirements to all ingredients may cause unnecessary concern to the
consumer
Page 19 of 23
PU
Schedule 2 Specified Units for Enzymes -
bull CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients Papain Units Bromelain
Currently the TBS only allows the quantity of the ingredient to be expressed in milligrams
(mg) Pervious considerations of this issue has identified that the per mg expression is not
the most appropriate for the material Whilst GOU (gelatine digesting unit) is acknowledged
to be the unit most commonly used for the material papain unit is proposed as this is the
specified unit from bromelain by the joint FAOWHO expert committee on Food Additives
(JECFA) the Food Chemical Codex and the unit adopted by Health Canada in its
monographs for Stem bromelian and fruit bromelian We note also that there is a simple
conversion factor that can be applied to quantities expressed as GOU
CMA comment on the Guideline for medicine labels draft version 10
October 2015
bull 3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA proposes the
removal (of Camellia sinensis) after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation
and herbal material and quantity of standardised constituent) would be expressed
together This reiteration appears to be redundant and would take up more space on the
label
bull Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] Ingredients Uses or What this medicine is used for Warnings Directions for use and Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a
specified order) needs to be followed for listed medicines
Page 2 0 of 23
Labelling
Labelling packaging Complementary
Labelling Packaging
CMA interprets the revised TGO 92 update to mean that this would no longer be a
requirement However we have provided a mock up label at appendix 1 example 4 to
demonstrate how this requirement if relevant would impact multi ingredient herbal
medicines
CMA resources in reference to the labelling of complementary
medicines
bull CMA submission Consultation Draft TGO 79 Standards for the of Medicines
(November 2014) bull CMA submission and of Medicines (12 April
2013) bull CMA submission on the Medicine and Review (24 August 2012)
Page 21of23
CMA detailed table of reform recommendations and impact of TGO 92
Page 22 of 23
Appendix 1 - mock up labels to TGO 92 requirements
Page 23 of 23
CMA response to TGO 92- Standards for the labels of non-prescription medicines
Proposed Requirement TGO 92 Industry response
Text size In principle CMA agrees with the change that reverts back to the current TGO 69 definition of text size This is in comparison to the consultation draft TGO79 that proposed a range of sizes for listed and registered
ldquoText size equivalent to Arial fontrdquo complementary medicines based on Arial point size font has been removed from TGO 92 The definition for letter height is the same as the definition in TGO 69
Sec 7 General requirements including As stated in the CMA 2014 submission ambiguous and subjective requirements should on principle not be included in a label presentation legislative instrument (2)(e) Considering the guidance document elaborates on the proposed requirement CMA reiterates that we are not aware of there Labels must be in a colour or colours being consumer safety issues of this nature reported for CM products which are of a lower risk and hence consider the contrasting strongly with the mandatory requirement unjustified background Sec 8(2) Labels of registered medicines must provide information in a consistent order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important information access to other information is also necessary for consumers to make an informed purchasing decision CMA is of the position that for lower risk registered medicines such as registered complementary medicines there should be flexibility to present mandatory information in a clear and concise manner without the constraint of a medicine information panel (MIP) This will minimise cost to the CM industry associated with resizing labels or providing goods in larger container sizes with increased headspace Section 155 of the Guidance document outlines that ldquoa medicine information panel is not required for certain lower risk
Proposed Requirement TGO 92 Industry response
registered medicines ndash these are detailed in subsection 8(2) of TGO 92rdquo Subsection 8(2) however does not appear to detail specifically what types of lower risk registered medicines would not require a MIP CMA suggests that this part of the guidance is expanded to include specific guidance that registered complementary medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the amendment impact registered complementary medicines mock up labels have been provided to demonstrate that the requirement would necessitate a change to label sizes for complementary medicines which is considered unjustified
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of a MIP would not work and necessitate labelling complications and medicine container size considerations
Sec 8 (1) (k) (ii) (B) Pregnancy database
Requirements related tot his section should be incorporated on an ingredient by ingredient basis within the 26BB list of permissible ingredients instrument Pregnancy database - Add link httpswwwtgagovauprescribing-medicines-pregnancy-database
Sec 9 (2) CMA considers the proposed requirements to orientate all text in the same direction on the main label and for medicine names to be presented in a continuous and uninterrupted manner would not have a meaningful impact upon consumer
The name of the medicine on the main safety and as such the change is considered unjustified for lower risk medicines label must be presented in a continuous uninterrupted manner and Feedback from our members indicates that medicine labels are often developed as a result of consumer testing not be broken up by additional In addition CMA has not been presented with information that consumers have any usability difficulties with the information or background text presentation of information on complementary medicine labels Sec 9 (5) All text required by this Order to It is well documented that consumers generally select complementary medicines and non-prescription medicines by brand appear on the main label must be and category and seek out brands they know Branding is important for complementary medicines and consumers are orientated in the same direction familiar with many well-known brands of medicines for general wellbeing cough and cold allergy skincare and many
other categories Limited label space is therefore an important issue particularly for certain product and label types
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 2 of 12
Proposed Requirement TGO 92 Industry response
Such a change would impact upon brand recognition for many companies As such CMA considers this as an unjustified change to requirements adding to unnecessary regulatory burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact on branding and does not require consequential changes to dimensions of packs or labels or changes to the packaging details of a medicine
Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 30millimeters on the front panel directly under the trade name
Since consumers use complementary medicines as part of self-care the label of these medicines is the primary source of information for consumers This requirement would mean that a large portion of the label would be used to display the active ingredients Information on active ingredients is not always the most meaningful aspect in consumer self selection of these goods rather information sought by consumers tends to be focused around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space and there will be reduced space to indicate the intended purpose of the product on the front of pack If the container and label size are increased as a result of this without increasing the number of tablets or capsules in the bottle this could give the consumer a negative perception due to the increased head space of the container Ultimately this would also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations
Sec 9 (6) CMArsquos position on the number of active ingredients that may appear on the front of a label for listed goods is that TGO 69 If the medicine is intended to be or is requirements be maintained listed goods By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active ingredients to four or more (b) if there are four or more active active ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for ingredients in the medicine - the name these lower risk listed medicines without any evidence of consumer benefit being presented of every active ingredient together with the quantity or proportion of CMA suggests the following amendment to TGO 92 every active ingredient may appear on
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 3 of 12
Proposed Requirement TGO 92 Industry response
a side panel or side label or on a rear panel or rear label
If the medicine is intended to be or is listed goods 6 b) if the medicine is a listed complementary medicine ndash the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO 69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014 CMA includes specific examples where for listed CMs containing three active ingredients to be displayed on the front of the label where previously they would be detailed at the side or rear how this would impact on label size being inappropriate for the packaging
Sec 9 (7) CMA proposed that TGO 69 requirements be maintained If the medicine is intended to be or is registered goods then By imposing subsection 9(7)(b) would mean a requirement to go from two or more active ingredients to four or more active
ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for (a) where the medicine contains three registered complementary medicines without any specific evidence of consumer benefit relating to this lower risk class of or four active ingredients the name of good being presented the active ingredient(s) and the quantity or proportion of active Within the complementary medicine category listed and registered complementary medicines will be presented (depending ingredient(s) must be displayed on the on the number of active ingredients present) in a different manner That is some will detail active ingredients at the front of main label in a text size of not less the pack while others (with 4 or more active ingredients) will detail the ingredients at the side or rear of the pack CMA than 3 millimetres submits that for the purposes of standardisation of where to find information consumers should be encouraged to refer to
the backside of the pack for ingredient information (b) where the medicine contains four or more active ingredients and the CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of requirements of subsection 8(2) do not 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations apply then the names and the See comments at Sec 9 (7)(a) above quantities or proportion of the active ingredients may be included on a side panellabel or rear panellabel when
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 4 of 12
Proposed Requirement TGO 92 Industry response
displayed in a text size of not less than 25mm
Sec 10(3) amp Sec 10 (4)(a) CMA does not support any additional change to this lower risk category of medicine
Homeopathic medicines No explanation or justification has been provided as to why there is a new mandatory requirement to include a statement on Where all the active ingredients in a the main label that the medicine is a homeopathic medicine or contains homeopathic preparations in an increased font size to medicine are homoeopathic that of a general listed complementary medicine preparations the main label on the No real explanation has been provided as to why an increase to the font size for the statement ldquohomeopathic medicinerdquo was container and the main label on the considered a requirement based on a consumer safety perspective primary pack (if any) must in addition to the requirements referred Previous explanations for this addition has centred around that the statement is intended to assist consumers with an to in sections 8 and 9 above include a appropriate selection for a medicine and minimise confusion that may arise with self-selection However the current statement to the effect that the labelling Order requires there to be a declaration that clearly states the product is homeopathic and contains homeopathic medicine is a homoeopathic medicine ingredients on the front of the pack and the additional detail of this information on the back of the pack in the ingredients in text size that is not less than 50 and indications section would clearly justify the medicine as being based in the homoeopathic paradigm of the text size of the name of the As such CMA proposes that this section be removed from the Order medicine and (in any event) not less than 2millimeters
Sec 6 CMA submitted in May 2013 via the International Harmonisation of Ingredient Names consultation that there appeared to be no mention of the naming of homoeopathic ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS)
Interpretation in this Order traditional naming or the application of new AAN homoeopathic names As such we resubmit information for consideration here
Homoeopathic medicines ndash naming conventions
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 5 of 12
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation (i) either the name of the active ingredient or the substance from which the dilution was prepared that is accepted for inclusion in the Australian Approved Names (AAN) List together with a statement of the homeopathic potency or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency
It is suggested that an amendment be made to allow for homeopathic medicines The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
To implement this CMA proposes the following amendment to the definition of the name of the active ingredient
(b) where the ingredient is a homoeopathic preparation
1 the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency in brackets the name that is also accepted for inclusion in the Australian Approved Names List
2 for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
That is the traditional homeopathic name to be used as the primary name including the AAN unless on ldquosmall containersrdquo Both the traditional names and AAN could be included on full website information which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required)
It is in the consumersrsquo interest that traditional pharmacopeial names be amended as the primary name The concern here is
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
CMA does not support any additional change to this lower risk category of medicine
No explanation or justification has been provided during the course of labelling
consultations as to why there is a new mandatory requirement to include a statement on
the main label that the medicine is a homeopathic medicine or contains homeopathic
preparations in an increased font size to that of a general listed complementary medicine
No real explanation has been provided as to why an increase to the font size for the
statement homeopathic medicine was considered a requirement based on a consumer
safety perspective
Previous explanations for this addition has centred on factors that the statement is intended
to assist consumers with an appropriate selection for a medicine and minimise confusion
that may arise with self-selection However the current labelling Order requires there to
be a declaration that clearly states the product is homeopathic and contains homeopathic
ingredients on the front of the pack and the additional detail of this information on the back
of the pack in the ingredients and indications section would clearly justify the medicine as
being based in the homoeopathic paradigm As such CMA proposes that this section be
removed from the Order
bull Section 6 Interpretation in the Order Homeopathic medicines - naming conventions
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic
preparation (i) either the name of the active ingredient or the substance from which the
dilution was prepared that is accepted for inclusion in the Australian Approved Names
(AAN) List together with a statement of the homeopathic potency or (ii) until such time
as a name is accepted for inclusion in the Australian Approved Names List a traditional
homoeopathic name in full or as traditionally abbreviated with a statement of
homeopathic potency
Given the recent redraft of the labelling Order it is an opportune time to explore potential
amendments that aim to increase the clarity for requirements around homeopathic
medicines for both industry and the regulator
CMA submitted in May 2013 via the International Harmonisation of Ingredient Names
consultation that there appeared to be no mention of the naming of homoeopathic
ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS) traditional naming or
the application of new AAN homoeopathic names As such we resubmit information for
consideration here
It is suggested that an amendment be made to allow for homeopathic medicines
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
Page 12 of 23
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
That is the traditional homeopathic name is to be used as the primary name including the
AAN unless on small containers Both the traditional names and AANs could be included
on full website information which would allow additional space to elaborate on the naming
of traditional homeopathic ingredients (where required)
To implement this CMA proposes the following amendment to the definition of the name
of the active ingredient
(b) where the ingredient is a homoeopathic preparation
(i) the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency and the name that is also accepted for inclusion in the Australian Approved Names List (if available) in brackets
(ii) for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
It is in the consumers interest that traditional pharmacopeial names be amended so as to
be the primary name The concern here is that by enforcing the current definition and taking
the AAN name alone outside of the traditional context the consumer may only get the
name in its full chemicalnon homeopathic form causing potential confusion and or safety
concerns Additionally the AAN name alone (due to small label space requirements) may
appear as a different active ingredient all together causing consumer alarm
For example False Unicorn Root
Traditional homeopathic name AAN name
Helonias dioica Chamaelirium luteum
If a consumer wishes to know more about a homeopathic medicine ingredient many
sources of information (pharmacopoeias texts materia medica) refer to the traditional
name as the primary point of reference To elaborate further examples have been provided
(Appendix 1 example 5) with this submission
International harmonisation considerations - homeopathic naming
conventions
ACSS Consortium
Page 13 of 23
website
(httpwebprodhc-scgccanhpidshy
bdipsnatRegdoatid=homeopathy)
(httpljwwwhc-scgccadhp-mpsprodnaturlegislationdocsehmg-nprhshy
engphpaS)
The TGA is part of the ACSS Consortium along with Health Canada Health Sciences Authority of Singapore and Swissmedic According to the TGA the ACSS Consortium
was formed in 2007 by like-minded regulatory authorities to promote greater regulatory
collaboration and alignment of regulatory requirements with the goal of maximising
international cooperation reduce duplication and increase each agencys capacity to
ensure consumers have timely access to high quality safe and effective therapeutic
products
Heath Canada
The Health Canada website
provides guidance to industry for the preparation of
Product Licence Applications (PLAs) and labels for natural health product market
authorization for homeopathic products (updated July 2015) It states
bull The proper name(s) common name(s) and source material(s) must be as per the homeopathic
monograph referenced as the Standard or Grade (please refer to the specifications)
bull The medicinal ingredient(s) must be a permitted substance with a homeopathic monograph in one
of the Natural and Non-Prescription Health Products Directorate (NNHPD) accepted homeopathic
pharmacopoeia
The Standards or Grades refers to a list of homeopathic pharmacopoeias containing the
traditional homeopathic names
Health Canada also includes guidance for the labelling of homeopathic medicines on its
website
It includes the following guidance for labelling for small packages
53 Labels for Small Packages
The NNHPD recognizes that small packages such as those used by some homeopathic medicine manufacturers
may not have an area large enough for the inner labelling requirements Therefore separate small package
labelling requirements have been developed Please see the Labelling guidance document for infonnation
specific to small package labelling
SwissMedic
In Switzerland homeopathy has been fully integrated into the Swiss medical system
SwissMedics HAS (Homeopathic and Anthroposophical medicines) list includes both Latin
chemical names and their homeopathic synonyms It appears that homeopathic products in
Switzerland also allow for the use of homeopathic names on products labels (noting the
strong tradition of use of homeopathy in the region)
FDA
The FDA also recognises the traditional homeopathic names with HPUS as the standard The HPUS has labelling guidelines for homeopathic medicines2 that links in with the labelling
2 httpwwwhpuscomRevised-Labeling-Guidelines-04-14pdf
Page 14 of 23
provisions of Sections 502 and 503 of the Federal Food Drug and Cosmetic Act Part 201
Title 21 of the Code of Federal Regulations (CFR) and the FDAs Compliance Policy Guide
400400
Section 11 How Information is to be expressed -
Use of appropriate metric units
bull Sec 11 (l)(b) The abbreviations to mg and g can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation microg may be used
Where several ingredients are presented on a label statement in microgram microliter
quantities the repetition of expressing the unit in full greatly expands the length of the text
and hence label space becomes an important issue
Further CMA questions if the requirement is mandatory given it is expressed as should in
the standard compared to must in the guideline
This proposed requirement if mandatory does not allow for consistency on the label and
increased label space is required CMA submits that an abbreviated form of microgram
should be permitted in the standard
Expression of quantity or proportion of active ingredients
Sec 11 (2) Expression of quantity or propo1iion of active ingredients
11(2)(i) states that in addition to the requirements of paragraphs 1 1(2)(a)-1 1(2)(h) and
therefore includes 1 1 (2)( a) the quantity of the active ingredient
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the
herbal material from which the preparation was derived except
This amendment appears to propose that herbal ingredients include the actual amount of
herbal extract in addition to the equivalent amount of starting herbal material from which
the preparation was derived
As detailed in our 2014 submission we do not support the increased information
requirements for the expression of herbal medicines to be expanded on the medicine label
(section 11(2))
The 2014 consultation suggested the reasoning for the additional requirement to include
the input amount of the herbal material on the label was that it enables the consumer to
Page lS of 23
version
gain meaningful information in relation to the strength concentration or quantified levels
in general of the herbal ingredients in the medicine
To implement this requirement however it would require the addition of an extra line of
information for each herbal material ingredient to express both quantities on the medicine
label The majority of complementary medicines are multi ingredient formulations
sometimes with as many as 25 ingredients in a product The addition of at least two lines to
express each herbal ingredient would for the average consumer most likely only create
confusion as to which line of expression to draw a meaningful conclusion from
The main concern is that this would lead to two quantification values for the same inputted
ingredient which would be open to misunderstanding and if other than the native extract
amount potentially no more helpful to the consumer Additionally this requirement does
not appear to impact upon the safe or proper usage of the medicine if used within the
context outlined on the label
CMA considers that this requirement would significantly increase the regulatory burden of
lower risk medicines by increasing the amount of information required on a label and hence
label size Label space will become an issue and an impracticality pushed to some degree
and with an obscure label this could lead to other potentially misleading packaging issues
We again provide mock up labels at the appendix to demonstrate this significant increase in
requirement
Clear concise labelling of ingredients with one quantity the extract equivalent of the herb
provides consumers with satisfactory information that allows comparison with other
products
CMA requests that TGA provides a detailed reasoning behind the proposed amendment
including evidence that the current requirement is impacting on the safe and proper usage
of listed medicines if that is the case In the absence of this information CMA does not
support implementing this section of the labelling Order and that it be drafted without this
specific requirement
CMA provides a mock up label at the appendix 1 example 3 to demonstrate the increased
requirements to listed low risk medicines
Regulatory Impact Statement (RIS)- general requirements for labels of medicines version 10 August 2014
The TGA provided a regulatory impact statement and other supporting documents3 as
evidence in support of a change to the labelling of medicines the proposed changes were
however largely based on the risk profile associated with prescription and registered over
the counter medicines with no direct reference to misuse of complementary medicines in
3 Labelling and packaging practices 10 January 2013 fileCUserstechnicalDownloadsconsultshy
labelling-packaging-review-1205 24-an alysis-evidencepdf
Page 16 of 23
the context of self-selection being outlined The extra regulatory requirements for labelling
and packaging of complementary medicines are considered to be out of proportion to the
risk classifications of these medicines
The 2014 consultation highlighted that due to lower risk medicines being available for self selection this factor alone poses a risk as the consumer receives no additional information
except the instructions on the label Indeed while this highlights the importance of the
information on the medicine label no evidence has been provided that the proposed
changes would contribute to the provision of better consumer information or safety A
change to the amount of active ingredients that can be included on the front of the
medicine label and additional information around the expression of herbal ingredients for
example are proposals for change that are not supported by CMA as they have not been
evidenced to be a safety issue nor undergone consumer use testing to demonstrate any
improvement on the status quo would be gained In summary they will have little affect on
consumers self-selection
The 2014 labelling consultation included a regulatory impact statement which from an
industry point of view grossly underestimated the cost of changes
Copy from the RIS
The labour burden for businesses who need to change a label would be
approximately 20 hours (includes reading the current guidance and applying it to
their design work and the small amount of labour involved in providing new label
information as part of the application to vary the entry) at a labour rate of $42 per
hour
The additional requirements proposed in the Order and schedule 1 will result in all
companies conducting a review of each medicine formulation checking for compliance to
these revised requirements It is estimated that the $42 per hour labour rate above would
increase to approximately $60 per hour for the time required to carry out the review One
member estimates that the labour hours would increase from 20 to 30 hours and takes into
account that different sections within an organisation and external organisations are
involved in obtaining documentation for example suppliers distributors manufacturers
Testing may also be required to confirm if any allergen residue remains in the raw material
Transition arrangements
CMA notes that the proposed transition arrangement includes a four year period where by
compliance with the current labelling Order (TGO 69) or the revised TGO 92 would be
permitted By 2020 full compliance with TGO 92 would be required While this is an
improvement from the 2014 proposal CMA highlights that further refinements to TGO 92 is
required to reduce the regulatory burden for complementary medicines
Page 17 of 23
Should the Order be implemented as currently drafted there will be many complementary
medicine businesses that would be negatively impacted Not in the lest many small ownershy
operator complementary medicine businesses would not generally be in the practice of
changing their medicine labels every few years as indicated in the TGA RIS document
The transition period will also be particularly problematic where the labelled information
will differ despite no change in formulation eg change in apparent quantification
ingredient name or ingredient placement
The RIS document also detailed that the new labelling Order would be a one-off cost for
those businesses that would not be changing their labels during the transition period
The 2014 participants in the TGA industry survey included larger CM company
representatives and therefore is only indicative of that sector of the industry
Specifically the RIS did not look at the fact that smaller companies would employ the skills
of professional consultants to carry out the work required to ensure compliance with the
new labelling Order This cost factor alone for changes proposed to lower risk listed
medicines is considered an unnecessary additional regulatory burden that would not
necessarily equate to any consumer self-medication benefit
CMA submits that the focus of the TGA be one of reducing the regulatory burden enhancing
efficiencies in existing process whilst upholding the safety and quality of complementary
medicines available to consumers For these reasons CMA submits that further refinements
to TGO 92 be made to accommodate lower risk medicines
Schedule 1 Substances or groups of substances present in medicines -
that are required to be declared on the label of medicines
It appears that some inconsistencies remain in the declaration statement of certain
substances in Schedule 1 of TGO 92 compared to warning statements generated on the
ARTG
Ethanolalcohol
This group of substances to be declared on the label is not consistent with the ARTG
generated warning for ethanolalcohol
bull Contains alcohol vs contains ethanol (vv)
Ethanol as one of the substances required to be declared on the label can carry the
declaration contains alcohol However the same ingredient warning that is generated on
the ARTG for use if this ingredient is in the formula as a listed excipient is ETHAN contains
ethanol (or words to that effect)
Recommendations
Page 18 of 23
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is consistent
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label if the situation arises where there is already an ARTG
generated ethanol warning
Other ingredients such as potassium sorbate already generate ARTG warnings if listed as
excipients and is also in the group of substances required to be declared on the label
Again the wording used is inconsistent
ARTG warning SORB8 (If the medicine contains one sorbate) Contains [insert name of
sorbate] OR (if medicine contains two or more sorbates) Contains sorbates [or words to that
effect]
bull Contains sorbates vs contains [inse1i name of sorbate] (if the medicine contains one sorbate) or contains sorbates (if the medicine contains two or more sorbates) in the
event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have Contains potassium sorbate
whilst it would read Contains sorbates to comply with schedule 1 of TGO 92
Recommendations
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is
consistent If the product contains one sorbate eg potassium sorbate ARTG warning
is Contains potassium sorbate however TGO 92 declaration is Contains sorbates
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label in these situations
Phenylalanine
Many mineral amino acid chelates contain phenylalanine as part of the amino acid portion
of the mineral and ingredients such as Spirulina whole cell powder would contain
phenylalanine as part of its protein profile CMA proposes that the schedule 1 list include
additional information as to what ingredients the phenylalanine warning applies to or
outline the ingredients such as those mentioned above that are exempt from the
requirement
Imposing such requirements to all ingredients may cause unnecessary concern to the
consumer
Page 19 of 23
PU
Schedule 2 Specified Units for Enzymes -
bull CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients Papain Units Bromelain
Currently the TBS only allows the quantity of the ingredient to be expressed in milligrams
(mg) Pervious considerations of this issue has identified that the per mg expression is not
the most appropriate for the material Whilst GOU (gelatine digesting unit) is acknowledged
to be the unit most commonly used for the material papain unit is proposed as this is the
specified unit from bromelain by the joint FAOWHO expert committee on Food Additives
(JECFA) the Food Chemical Codex and the unit adopted by Health Canada in its
monographs for Stem bromelian and fruit bromelian We note also that there is a simple
conversion factor that can be applied to quantities expressed as GOU
CMA comment on the Guideline for medicine labels draft version 10
October 2015
bull 3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA proposes the
removal (of Camellia sinensis) after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation
and herbal material and quantity of standardised constituent) would be expressed
together This reiteration appears to be redundant and would take up more space on the
label
bull Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] Ingredients Uses or What this medicine is used for Warnings Directions for use and Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a
specified order) needs to be followed for listed medicines
Page 2 0 of 23
Labelling
Labelling packaging Complementary
Labelling Packaging
CMA interprets the revised TGO 92 update to mean that this would no longer be a
requirement However we have provided a mock up label at appendix 1 example 4 to
demonstrate how this requirement if relevant would impact multi ingredient herbal
medicines
CMA resources in reference to the labelling of complementary
medicines
bull CMA submission Consultation Draft TGO 79 Standards for the of Medicines
(November 2014) bull CMA submission and of Medicines (12 April
2013) bull CMA submission on the Medicine and Review (24 August 2012)
Page 21of23
CMA detailed table of reform recommendations and impact of TGO 92
Page 22 of 23
Appendix 1 - mock up labels to TGO 92 requirements
Page 23 of 23
CMA response to TGO 92- Standards for the labels of non-prescription medicines
Proposed Requirement TGO 92 Industry response
Text size In principle CMA agrees with the change that reverts back to the current TGO 69 definition of text size This is in comparison to the consultation draft TGO79 that proposed a range of sizes for listed and registered
ldquoText size equivalent to Arial fontrdquo complementary medicines based on Arial point size font has been removed from TGO 92 The definition for letter height is the same as the definition in TGO 69
Sec 7 General requirements including As stated in the CMA 2014 submission ambiguous and subjective requirements should on principle not be included in a label presentation legislative instrument (2)(e) Considering the guidance document elaborates on the proposed requirement CMA reiterates that we are not aware of there Labels must be in a colour or colours being consumer safety issues of this nature reported for CM products which are of a lower risk and hence consider the contrasting strongly with the mandatory requirement unjustified background Sec 8(2) Labels of registered medicines must provide information in a consistent order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important information access to other information is also necessary for consumers to make an informed purchasing decision CMA is of the position that for lower risk registered medicines such as registered complementary medicines there should be flexibility to present mandatory information in a clear and concise manner without the constraint of a medicine information panel (MIP) This will minimise cost to the CM industry associated with resizing labels or providing goods in larger container sizes with increased headspace Section 155 of the Guidance document outlines that ldquoa medicine information panel is not required for certain lower risk
Proposed Requirement TGO 92 Industry response
registered medicines ndash these are detailed in subsection 8(2) of TGO 92rdquo Subsection 8(2) however does not appear to detail specifically what types of lower risk registered medicines would not require a MIP CMA suggests that this part of the guidance is expanded to include specific guidance that registered complementary medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the amendment impact registered complementary medicines mock up labels have been provided to demonstrate that the requirement would necessitate a change to label sizes for complementary medicines which is considered unjustified
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of a MIP would not work and necessitate labelling complications and medicine container size considerations
Sec 8 (1) (k) (ii) (B) Pregnancy database
Requirements related tot his section should be incorporated on an ingredient by ingredient basis within the 26BB list of permissible ingredients instrument Pregnancy database - Add link httpswwwtgagovauprescribing-medicines-pregnancy-database
Sec 9 (2) CMA considers the proposed requirements to orientate all text in the same direction on the main label and for medicine names to be presented in a continuous and uninterrupted manner would not have a meaningful impact upon consumer
The name of the medicine on the main safety and as such the change is considered unjustified for lower risk medicines label must be presented in a continuous uninterrupted manner and Feedback from our members indicates that medicine labels are often developed as a result of consumer testing not be broken up by additional In addition CMA has not been presented with information that consumers have any usability difficulties with the information or background text presentation of information on complementary medicine labels Sec 9 (5) All text required by this Order to It is well documented that consumers generally select complementary medicines and non-prescription medicines by brand appear on the main label must be and category and seek out brands they know Branding is important for complementary medicines and consumers are orientated in the same direction familiar with many well-known brands of medicines for general wellbeing cough and cold allergy skincare and many
other categories Limited label space is therefore an important issue particularly for certain product and label types
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 2 of 12
Proposed Requirement TGO 92 Industry response
Such a change would impact upon brand recognition for many companies As such CMA considers this as an unjustified change to requirements adding to unnecessary regulatory burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact on branding and does not require consequential changes to dimensions of packs or labels or changes to the packaging details of a medicine
Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 30millimeters on the front panel directly under the trade name
Since consumers use complementary medicines as part of self-care the label of these medicines is the primary source of information for consumers This requirement would mean that a large portion of the label would be used to display the active ingredients Information on active ingredients is not always the most meaningful aspect in consumer self selection of these goods rather information sought by consumers tends to be focused around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space and there will be reduced space to indicate the intended purpose of the product on the front of pack If the container and label size are increased as a result of this without increasing the number of tablets or capsules in the bottle this could give the consumer a negative perception due to the increased head space of the container Ultimately this would also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations
Sec 9 (6) CMArsquos position on the number of active ingredients that may appear on the front of a label for listed goods is that TGO 69 If the medicine is intended to be or is requirements be maintained listed goods By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active ingredients to four or more (b) if there are four or more active active ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for ingredients in the medicine - the name these lower risk listed medicines without any evidence of consumer benefit being presented of every active ingredient together with the quantity or proportion of CMA suggests the following amendment to TGO 92 every active ingredient may appear on
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 3 of 12
Proposed Requirement TGO 92 Industry response
a side panel or side label or on a rear panel or rear label
If the medicine is intended to be or is listed goods 6 b) if the medicine is a listed complementary medicine ndash the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO 69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014 CMA includes specific examples where for listed CMs containing three active ingredients to be displayed on the front of the label where previously they would be detailed at the side or rear how this would impact on label size being inappropriate for the packaging
Sec 9 (7) CMA proposed that TGO 69 requirements be maintained If the medicine is intended to be or is registered goods then By imposing subsection 9(7)(b) would mean a requirement to go from two or more active ingredients to four or more active
ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for (a) where the medicine contains three registered complementary medicines without any specific evidence of consumer benefit relating to this lower risk class of or four active ingredients the name of good being presented the active ingredient(s) and the quantity or proportion of active Within the complementary medicine category listed and registered complementary medicines will be presented (depending ingredient(s) must be displayed on the on the number of active ingredients present) in a different manner That is some will detail active ingredients at the front of main label in a text size of not less the pack while others (with 4 or more active ingredients) will detail the ingredients at the side or rear of the pack CMA than 3 millimetres submits that for the purposes of standardisation of where to find information consumers should be encouraged to refer to
the backside of the pack for ingredient information (b) where the medicine contains four or more active ingredients and the CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of requirements of subsection 8(2) do not 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations apply then the names and the See comments at Sec 9 (7)(a) above quantities or proportion of the active ingredients may be included on a side panellabel or rear panellabel when
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 4 of 12
Proposed Requirement TGO 92 Industry response
displayed in a text size of not less than 25mm
Sec 10(3) amp Sec 10 (4)(a) CMA does not support any additional change to this lower risk category of medicine
Homeopathic medicines No explanation or justification has been provided as to why there is a new mandatory requirement to include a statement on Where all the active ingredients in a the main label that the medicine is a homeopathic medicine or contains homeopathic preparations in an increased font size to medicine are homoeopathic that of a general listed complementary medicine preparations the main label on the No real explanation has been provided as to why an increase to the font size for the statement ldquohomeopathic medicinerdquo was container and the main label on the considered a requirement based on a consumer safety perspective primary pack (if any) must in addition to the requirements referred Previous explanations for this addition has centred around that the statement is intended to assist consumers with an to in sections 8 and 9 above include a appropriate selection for a medicine and minimise confusion that may arise with self-selection However the current statement to the effect that the labelling Order requires there to be a declaration that clearly states the product is homeopathic and contains homeopathic medicine is a homoeopathic medicine ingredients on the front of the pack and the additional detail of this information on the back of the pack in the ingredients in text size that is not less than 50 and indications section would clearly justify the medicine as being based in the homoeopathic paradigm of the text size of the name of the As such CMA proposes that this section be removed from the Order medicine and (in any event) not less than 2millimeters
Sec 6 CMA submitted in May 2013 via the International Harmonisation of Ingredient Names consultation that there appeared to be no mention of the naming of homoeopathic ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS)
Interpretation in this Order traditional naming or the application of new AAN homoeopathic names As such we resubmit information for consideration here
Homoeopathic medicines ndash naming conventions
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 5 of 12
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation (i) either the name of the active ingredient or the substance from which the dilution was prepared that is accepted for inclusion in the Australian Approved Names (AAN) List together with a statement of the homeopathic potency or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency
It is suggested that an amendment be made to allow for homeopathic medicines The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
To implement this CMA proposes the following amendment to the definition of the name of the active ingredient
(b) where the ingredient is a homoeopathic preparation
1 the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency in brackets the name that is also accepted for inclusion in the Australian Approved Names List
2 for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
That is the traditional homeopathic name to be used as the primary name including the AAN unless on ldquosmall containersrdquo Both the traditional names and AAN could be included on full website information which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required)
It is in the consumersrsquo interest that traditional pharmacopeial names be amended as the primary name The concern here is
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
That is the traditional homeopathic name is to be used as the primary name including the
AAN unless on small containers Both the traditional names and AANs could be included
on full website information which would allow additional space to elaborate on the naming
of traditional homeopathic ingredients (where required)
To implement this CMA proposes the following amendment to the definition of the name
of the active ingredient
(b) where the ingredient is a homoeopathic preparation
(i) the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency and the name that is also accepted for inclusion in the Australian Approved Names List (if available) in brackets
(ii) for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
It is in the consumers interest that traditional pharmacopeial names be amended so as to
be the primary name The concern here is that by enforcing the current definition and taking
the AAN name alone outside of the traditional context the consumer may only get the
name in its full chemicalnon homeopathic form causing potential confusion and or safety
concerns Additionally the AAN name alone (due to small label space requirements) may
appear as a different active ingredient all together causing consumer alarm
For example False Unicorn Root
Traditional homeopathic name AAN name
Helonias dioica Chamaelirium luteum
If a consumer wishes to know more about a homeopathic medicine ingredient many
sources of information (pharmacopoeias texts materia medica) refer to the traditional
name as the primary point of reference To elaborate further examples have been provided
(Appendix 1 example 5) with this submission
International harmonisation considerations - homeopathic naming
conventions
ACSS Consortium
Page 13 of 23
website
(httpwebprodhc-scgccanhpidshy
bdipsnatRegdoatid=homeopathy)
(httpljwwwhc-scgccadhp-mpsprodnaturlegislationdocsehmg-nprhshy
engphpaS)
The TGA is part of the ACSS Consortium along with Health Canada Health Sciences Authority of Singapore and Swissmedic According to the TGA the ACSS Consortium
was formed in 2007 by like-minded regulatory authorities to promote greater regulatory
collaboration and alignment of regulatory requirements with the goal of maximising
international cooperation reduce duplication and increase each agencys capacity to
ensure consumers have timely access to high quality safe and effective therapeutic
products
Heath Canada
The Health Canada website
provides guidance to industry for the preparation of
Product Licence Applications (PLAs) and labels for natural health product market
authorization for homeopathic products (updated July 2015) It states
bull The proper name(s) common name(s) and source material(s) must be as per the homeopathic
monograph referenced as the Standard or Grade (please refer to the specifications)
bull The medicinal ingredient(s) must be a permitted substance with a homeopathic monograph in one
of the Natural and Non-Prescription Health Products Directorate (NNHPD) accepted homeopathic
pharmacopoeia
The Standards or Grades refers to a list of homeopathic pharmacopoeias containing the
traditional homeopathic names
Health Canada also includes guidance for the labelling of homeopathic medicines on its
website
It includes the following guidance for labelling for small packages
53 Labels for Small Packages
The NNHPD recognizes that small packages such as those used by some homeopathic medicine manufacturers
may not have an area large enough for the inner labelling requirements Therefore separate small package
labelling requirements have been developed Please see the Labelling guidance document for infonnation
specific to small package labelling
SwissMedic
In Switzerland homeopathy has been fully integrated into the Swiss medical system
SwissMedics HAS (Homeopathic and Anthroposophical medicines) list includes both Latin
chemical names and their homeopathic synonyms It appears that homeopathic products in
Switzerland also allow for the use of homeopathic names on products labels (noting the
strong tradition of use of homeopathy in the region)
FDA
The FDA also recognises the traditional homeopathic names with HPUS as the standard The HPUS has labelling guidelines for homeopathic medicines2 that links in with the labelling
2 httpwwwhpuscomRevised-Labeling-Guidelines-04-14pdf
Page 14 of 23
provisions of Sections 502 and 503 of the Federal Food Drug and Cosmetic Act Part 201
Title 21 of the Code of Federal Regulations (CFR) and the FDAs Compliance Policy Guide
400400
Section 11 How Information is to be expressed -
Use of appropriate metric units
bull Sec 11 (l)(b) The abbreviations to mg and g can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation microg may be used
Where several ingredients are presented on a label statement in microgram microliter
quantities the repetition of expressing the unit in full greatly expands the length of the text
and hence label space becomes an important issue
Further CMA questions if the requirement is mandatory given it is expressed as should in
the standard compared to must in the guideline
This proposed requirement if mandatory does not allow for consistency on the label and
increased label space is required CMA submits that an abbreviated form of microgram
should be permitted in the standard
Expression of quantity or proportion of active ingredients
Sec 11 (2) Expression of quantity or propo1iion of active ingredients
11(2)(i) states that in addition to the requirements of paragraphs 1 1(2)(a)-1 1(2)(h) and
therefore includes 1 1 (2)( a) the quantity of the active ingredient
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the
herbal material from which the preparation was derived except
This amendment appears to propose that herbal ingredients include the actual amount of
herbal extract in addition to the equivalent amount of starting herbal material from which
the preparation was derived
As detailed in our 2014 submission we do not support the increased information
requirements for the expression of herbal medicines to be expanded on the medicine label
(section 11(2))
The 2014 consultation suggested the reasoning for the additional requirement to include
the input amount of the herbal material on the label was that it enables the consumer to
Page lS of 23
version
gain meaningful information in relation to the strength concentration or quantified levels
in general of the herbal ingredients in the medicine
To implement this requirement however it would require the addition of an extra line of
information for each herbal material ingredient to express both quantities on the medicine
label The majority of complementary medicines are multi ingredient formulations
sometimes with as many as 25 ingredients in a product The addition of at least two lines to
express each herbal ingredient would for the average consumer most likely only create
confusion as to which line of expression to draw a meaningful conclusion from
The main concern is that this would lead to two quantification values for the same inputted
ingredient which would be open to misunderstanding and if other than the native extract
amount potentially no more helpful to the consumer Additionally this requirement does
not appear to impact upon the safe or proper usage of the medicine if used within the
context outlined on the label
CMA considers that this requirement would significantly increase the regulatory burden of
lower risk medicines by increasing the amount of information required on a label and hence
label size Label space will become an issue and an impracticality pushed to some degree
and with an obscure label this could lead to other potentially misleading packaging issues
We again provide mock up labels at the appendix to demonstrate this significant increase in
requirement
Clear concise labelling of ingredients with one quantity the extract equivalent of the herb
provides consumers with satisfactory information that allows comparison with other
products
CMA requests that TGA provides a detailed reasoning behind the proposed amendment
including evidence that the current requirement is impacting on the safe and proper usage
of listed medicines if that is the case In the absence of this information CMA does not
support implementing this section of the labelling Order and that it be drafted without this
specific requirement
CMA provides a mock up label at the appendix 1 example 3 to demonstrate the increased
requirements to listed low risk medicines
Regulatory Impact Statement (RIS)- general requirements for labels of medicines version 10 August 2014
The TGA provided a regulatory impact statement and other supporting documents3 as
evidence in support of a change to the labelling of medicines the proposed changes were
however largely based on the risk profile associated with prescription and registered over
the counter medicines with no direct reference to misuse of complementary medicines in
3 Labelling and packaging practices 10 January 2013 fileCUserstechnicalDownloadsconsultshy
labelling-packaging-review-1205 24-an alysis-evidencepdf
Page 16 of 23
the context of self-selection being outlined The extra regulatory requirements for labelling
and packaging of complementary medicines are considered to be out of proportion to the
risk classifications of these medicines
The 2014 consultation highlighted that due to lower risk medicines being available for self selection this factor alone poses a risk as the consumer receives no additional information
except the instructions on the label Indeed while this highlights the importance of the
information on the medicine label no evidence has been provided that the proposed
changes would contribute to the provision of better consumer information or safety A
change to the amount of active ingredients that can be included on the front of the
medicine label and additional information around the expression of herbal ingredients for
example are proposals for change that are not supported by CMA as they have not been
evidenced to be a safety issue nor undergone consumer use testing to demonstrate any
improvement on the status quo would be gained In summary they will have little affect on
consumers self-selection
The 2014 labelling consultation included a regulatory impact statement which from an
industry point of view grossly underestimated the cost of changes
Copy from the RIS
The labour burden for businesses who need to change a label would be
approximately 20 hours (includes reading the current guidance and applying it to
their design work and the small amount of labour involved in providing new label
information as part of the application to vary the entry) at a labour rate of $42 per
hour
The additional requirements proposed in the Order and schedule 1 will result in all
companies conducting a review of each medicine formulation checking for compliance to
these revised requirements It is estimated that the $42 per hour labour rate above would
increase to approximately $60 per hour for the time required to carry out the review One
member estimates that the labour hours would increase from 20 to 30 hours and takes into
account that different sections within an organisation and external organisations are
involved in obtaining documentation for example suppliers distributors manufacturers
Testing may also be required to confirm if any allergen residue remains in the raw material
Transition arrangements
CMA notes that the proposed transition arrangement includes a four year period where by
compliance with the current labelling Order (TGO 69) or the revised TGO 92 would be
permitted By 2020 full compliance with TGO 92 would be required While this is an
improvement from the 2014 proposal CMA highlights that further refinements to TGO 92 is
required to reduce the regulatory burden for complementary medicines
Page 17 of 23
Should the Order be implemented as currently drafted there will be many complementary
medicine businesses that would be negatively impacted Not in the lest many small ownershy
operator complementary medicine businesses would not generally be in the practice of
changing their medicine labels every few years as indicated in the TGA RIS document
The transition period will also be particularly problematic where the labelled information
will differ despite no change in formulation eg change in apparent quantification
ingredient name or ingredient placement
The RIS document also detailed that the new labelling Order would be a one-off cost for
those businesses that would not be changing their labels during the transition period
The 2014 participants in the TGA industry survey included larger CM company
representatives and therefore is only indicative of that sector of the industry
Specifically the RIS did not look at the fact that smaller companies would employ the skills
of professional consultants to carry out the work required to ensure compliance with the
new labelling Order This cost factor alone for changes proposed to lower risk listed
medicines is considered an unnecessary additional regulatory burden that would not
necessarily equate to any consumer self-medication benefit
CMA submits that the focus of the TGA be one of reducing the regulatory burden enhancing
efficiencies in existing process whilst upholding the safety and quality of complementary
medicines available to consumers For these reasons CMA submits that further refinements
to TGO 92 be made to accommodate lower risk medicines
Schedule 1 Substances or groups of substances present in medicines -
that are required to be declared on the label of medicines
It appears that some inconsistencies remain in the declaration statement of certain
substances in Schedule 1 of TGO 92 compared to warning statements generated on the
ARTG
Ethanolalcohol
This group of substances to be declared on the label is not consistent with the ARTG
generated warning for ethanolalcohol
bull Contains alcohol vs contains ethanol (vv)
Ethanol as one of the substances required to be declared on the label can carry the
declaration contains alcohol However the same ingredient warning that is generated on
the ARTG for use if this ingredient is in the formula as a listed excipient is ETHAN contains
ethanol (or words to that effect)
Recommendations
Page 18 of 23
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is consistent
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label if the situation arises where there is already an ARTG
generated ethanol warning
Other ingredients such as potassium sorbate already generate ARTG warnings if listed as
excipients and is also in the group of substances required to be declared on the label
Again the wording used is inconsistent
ARTG warning SORB8 (If the medicine contains one sorbate) Contains [insert name of
sorbate] OR (if medicine contains two or more sorbates) Contains sorbates [or words to that
effect]
bull Contains sorbates vs contains [inse1i name of sorbate] (if the medicine contains one sorbate) or contains sorbates (if the medicine contains two or more sorbates) in the
event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have Contains potassium sorbate
whilst it would read Contains sorbates to comply with schedule 1 of TGO 92
Recommendations
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is
consistent If the product contains one sorbate eg potassium sorbate ARTG warning
is Contains potassium sorbate however TGO 92 declaration is Contains sorbates
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label in these situations
Phenylalanine
Many mineral amino acid chelates contain phenylalanine as part of the amino acid portion
of the mineral and ingredients such as Spirulina whole cell powder would contain
phenylalanine as part of its protein profile CMA proposes that the schedule 1 list include
additional information as to what ingredients the phenylalanine warning applies to or
outline the ingredients such as those mentioned above that are exempt from the
requirement
Imposing such requirements to all ingredients may cause unnecessary concern to the
consumer
Page 19 of 23
PU
Schedule 2 Specified Units for Enzymes -
bull CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients Papain Units Bromelain
Currently the TBS only allows the quantity of the ingredient to be expressed in milligrams
(mg) Pervious considerations of this issue has identified that the per mg expression is not
the most appropriate for the material Whilst GOU (gelatine digesting unit) is acknowledged
to be the unit most commonly used for the material papain unit is proposed as this is the
specified unit from bromelain by the joint FAOWHO expert committee on Food Additives
(JECFA) the Food Chemical Codex and the unit adopted by Health Canada in its
monographs for Stem bromelian and fruit bromelian We note also that there is a simple
conversion factor that can be applied to quantities expressed as GOU
CMA comment on the Guideline for medicine labels draft version 10
October 2015
bull 3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA proposes the
removal (of Camellia sinensis) after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation
and herbal material and quantity of standardised constituent) would be expressed
together This reiteration appears to be redundant and would take up more space on the
label
bull Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] Ingredients Uses or What this medicine is used for Warnings Directions for use and Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a
specified order) needs to be followed for listed medicines
Page 2 0 of 23
Labelling
Labelling packaging Complementary
Labelling Packaging
CMA interprets the revised TGO 92 update to mean that this would no longer be a
requirement However we have provided a mock up label at appendix 1 example 4 to
demonstrate how this requirement if relevant would impact multi ingredient herbal
medicines
CMA resources in reference to the labelling of complementary
medicines
bull CMA submission Consultation Draft TGO 79 Standards for the of Medicines
(November 2014) bull CMA submission and of Medicines (12 April
2013) bull CMA submission on the Medicine and Review (24 August 2012)
Page 21of23
CMA detailed table of reform recommendations and impact of TGO 92
Page 22 of 23
Appendix 1 - mock up labels to TGO 92 requirements
Page 23 of 23
CMA response to TGO 92- Standards for the labels of non-prescription medicines
Proposed Requirement TGO 92 Industry response
Text size In principle CMA agrees with the change that reverts back to the current TGO 69 definition of text size This is in comparison to the consultation draft TGO79 that proposed a range of sizes for listed and registered
ldquoText size equivalent to Arial fontrdquo complementary medicines based on Arial point size font has been removed from TGO 92 The definition for letter height is the same as the definition in TGO 69
Sec 7 General requirements including As stated in the CMA 2014 submission ambiguous and subjective requirements should on principle not be included in a label presentation legislative instrument (2)(e) Considering the guidance document elaborates on the proposed requirement CMA reiterates that we are not aware of there Labels must be in a colour or colours being consumer safety issues of this nature reported for CM products which are of a lower risk and hence consider the contrasting strongly with the mandatory requirement unjustified background Sec 8(2) Labels of registered medicines must provide information in a consistent order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important information access to other information is also necessary for consumers to make an informed purchasing decision CMA is of the position that for lower risk registered medicines such as registered complementary medicines there should be flexibility to present mandatory information in a clear and concise manner without the constraint of a medicine information panel (MIP) This will minimise cost to the CM industry associated with resizing labels or providing goods in larger container sizes with increased headspace Section 155 of the Guidance document outlines that ldquoa medicine information panel is not required for certain lower risk
Proposed Requirement TGO 92 Industry response
registered medicines ndash these are detailed in subsection 8(2) of TGO 92rdquo Subsection 8(2) however does not appear to detail specifically what types of lower risk registered medicines would not require a MIP CMA suggests that this part of the guidance is expanded to include specific guidance that registered complementary medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the amendment impact registered complementary medicines mock up labels have been provided to demonstrate that the requirement would necessitate a change to label sizes for complementary medicines which is considered unjustified
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of a MIP would not work and necessitate labelling complications and medicine container size considerations
Sec 8 (1) (k) (ii) (B) Pregnancy database
Requirements related tot his section should be incorporated on an ingredient by ingredient basis within the 26BB list of permissible ingredients instrument Pregnancy database - Add link httpswwwtgagovauprescribing-medicines-pregnancy-database
Sec 9 (2) CMA considers the proposed requirements to orientate all text in the same direction on the main label and for medicine names to be presented in a continuous and uninterrupted manner would not have a meaningful impact upon consumer
The name of the medicine on the main safety and as such the change is considered unjustified for lower risk medicines label must be presented in a continuous uninterrupted manner and Feedback from our members indicates that medicine labels are often developed as a result of consumer testing not be broken up by additional In addition CMA has not been presented with information that consumers have any usability difficulties with the information or background text presentation of information on complementary medicine labels Sec 9 (5) All text required by this Order to It is well documented that consumers generally select complementary medicines and non-prescription medicines by brand appear on the main label must be and category and seek out brands they know Branding is important for complementary medicines and consumers are orientated in the same direction familiar with many well-known brands of medicines for general wellbeing cough and cold allergy skincare and many
other categories Limited label space is therefore an important issue particularly for certain product and label types
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 2 of 12
Proposed Requirement TGO 92 Industry response
Such a change would impact upon brand recognition for many companies As such CMA considers this as an unjustified change to requirements adding to unnecessary regulatory burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact on branding and does not require consequential changes to dimensions of packs or labels or changes to the packaging details of a medicine
Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 30millimeters on the front panel directly under the trade name
Since consumers use complementary medicines as part of self-care the label of these medicines is the primary source of information for consumers This requirement would mean that a large portion of the label would be used to display the active ingredients Information on active ingredients is not always the most meaningful aspect in consumer self selection of these goods rather information sought by consumers tends to be focused around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space and there will be reduced space to indicate the intended purpose of the product on the front of pack If the container and label size are increased as a result of this without increasing the number of tablets or capsules in the bottle this could give the consumer a negative perception due to the increased head space of the container Ultimately this would also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations
Sec 9 (6) CMArsquos position on the number of active ingredients that may appear on the front of a label for listed goods is that TGO 69 If the medicine is intended to be or is requirements be maintained listed goods By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active ingredients to four or more (b) if there are four or more active active ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for ingredients in the medicine - the name these lower risk listed medicines without any evidence of consumer benefit being presented of every active ingredient together with the quantity or proportion of CMA suggests the following amendment to TGO 92 every active ingredient may appear on
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 3 of 12
Proposed Requirement TGO 92 Industry response
a side panel or side label or on a rear panel or rear label
If the medicine is intended to be or is listed goods 6 b) if the medicine is a listed complementary medicine ndash the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO 69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014 CMA includes specific examples where for listed CMs containing three active ingredients to be displayed on the front of the label where previously they would be detailed at the side or rear how this would impact on label size being inappropriate for the packaging
Sec 9 (7) CMA proposed that TGO 69 requirements be maintained If the medicine is intended to be or is registered goods then By imposing subsection 9(7)(b) would mean a requirement to go from two or more active ingredients to four or more active
ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for (a) where the medicine contains three registered complementary medicines without any specific evidence of consumer benefit relating to this lower risk class of or four active ingredients the name of good being presented the active ingredient(s) and the quantity or proportion of active Within the complementary medicine category listed and registered complementary medicines will be presented (depending ingredient(s) must be displayed on the on the number of active ingredients present) in a different manner That is some will detail active ingredients at the front of main label in a text size of not less the pack while others (with 4 or more active ingredients) will detail the ingredients at the side or rear of the pack CMA than 3 millimetres submits that for the purposes of standardisation of where to find information consumers should be encouraged to refer to
the backside of the pack for ingredient information (b) where the medicine contains four or more active ingredients and the CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of requirements of subsection 8(2) do not 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations apply then the names and the See comments at Sec 9 (7)(a) above quantities or proportion of the active ingredients may be included on a side panellabel or rear panellabel when
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 4 of 12
Proposed Requirement TGO 92 Industry response
displayed in a text size of not less than 25mm
Sec 10(3) amp Sec 10 (4)(a) CMA does not support any additional change to this lower risk category of medicine
Homeopathic medicines No explanation or justification has been provided as to why there is a new mandatory requirement to include a statement on Where all the active ingredients in a the main label that the medicine is a homeopathic medicine or contains homeopathic preparations in an increased font size to medicine are homoeopathic that of a general listed complementary medicine preparations the main label on the No real explanation has been provided as to why an increase to the font size for the statement ldquohomeopathic medicinerdquo was container and the main label on the considered a requirement based on a consumer safety perspective primary pack (if any) must in addition to the requirements referred Previous explanations for this addition has centred around that the statement is intended to assist consumers with an to in sections 8 and 9 above include a appropriate selection for a medicine and minimise confusion that may arise with self-selection However the current statement to the effect that the labelling Order requires there to be a declaration that clearly states the product is homeopathic and contains homeopathic medicine is a homoeopathic medicine ingredients on the front of the pack and the additional detail of this information on the back of the pack in the ingredients in text size that is not less than 50 and indications section would clearly justify the medicine as being based in the homoeopathic paradigm of the text size of the name of the As such CMA proposes that this section be removed from the Order medicine and (in any event) not less than 2millimeters
Sec 6 CMA submitted in May 2013 via the International Harmonisation of Ingredient Names consultation that there appeared to be no mention of the naming of homoeopathic ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS)
Interpretation in this Order traditional naming or the application of new AAN homoeopathic names As such we resubmit information for consideration here
Homoeopathic medicines ndash naming conventions
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 5 of 12
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation (i) either the name of the active ingredient or the substance from which the dilution was prepared that is accepted for inclusion in the Australian Approved Names (AAN) List together with a statement of the homeopathic potency or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency
It is suggested that an amendment be made to allow for homeopathic medicines The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
To implement this CMA proposes the following amendment to the definition of the name of the active ingredient
(b) where the ingredient is a homoeopathic preparation
1 the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency in brackets the name that is also accepted for inclusion in the Australian Approved Names List
2 for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
That is the traditional homeopathic name to be used as the primary name including the AAN unless on ldquosmall containersrdquo Both the traditional names and AAN could be included on full website information which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required)
It is in the consumersrsquo interest that traditional pharmacopeial names be amended as the primary name The concern here is
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
website
(httpwebprodhc-scgccanhpidshy
bdipsnatRegdoatid=homeopathy)
(httpljwwwhc-scgccadhp-mpsprodnaturlegislationdocsehmg-nprhshy
engphpaS)
The TGA is part of the ACSS Consortium along with Health Canada Health Sciences Authority of Singapore and Swissmedic According to the TGA the ACSS Consortium
was formed in 2007 by like-minded regulatory authorities to promote greater regulatory
collaboration and alignment of regulatory requirements with the goal of maximising
international cooperation reduce duplication and increase each agencys capacity to
ensure consumers have timely access to high quality safe and effective therapeutic
products
Heath Canada
The Health Canada website
provides guidance to industry for the preparation of
Product Licence Applications (PLAs) and labels for natural health product market
authorization for homeopathic products (updated July 2015) It states
bull The proper name(s) common name(s) and source material(s) must be as per the homeopathic
monograph referenced as the Standard or Grade (please refer to the specifications)
bull The medicinal ingredient(s) must be a permitted substance with a homeopathic monograph in one
of the Natural and Non-Prescription Health Products Directorate (NNHPD) accepted homeopathic
pharmacopoeia
The Standards or Grades refers to a list of homeopathic pharmacopoeias containing the
traditional homeopathic names
Health Canada also includes guidance for the labelling of homeopathic medicines on its
website
It includes the following guidance for labelling for small packages
53 Labels for Small Packages
The NNHPD recognizes that small packages such as those used by some homeopathic medicine manufacturers
may not have an area large enough for the inner labelling requirements Therefore separate small package
labelling requirements have been developed Please see the Labelling guidance document for infonnation
specific to small package labelling
SwissMedic
In Switzerland homeopathy has been fully integrated into the Swiss medical system
SwissMedics HAS (Homeopathic and Anthroposophical medicines) list includes both Latin
chemical names and their homeopathic synonyms It appears that homeopathic products in
Switzerland also allow for the use of homeopathic names on products labels (noting the
strong tradition of use of homeopathy in the region)
FDA
The FDA also recognises the traditional homeopathic names with HPUS as the standard The HPUS has labelling guidelines for homeopathic medicines2 that links in with the labelling
2 httpwwwhpuscomRevised-Labeling-Guidelines-04-14pdf
Page 14 of 23
provisions of Sections 502 and 503 of the Federal Food Drug and Cosmetic Act Part 201
Title 21 of the Code of Federal Regulations (CFR) and the FDAs Compliance Policy Guide
400400
Section 11 How Information is to be expressed -
Use of appropriate metric units
bull Sec 11 (l)(b) The abbreviations to mg and g can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation microg may be used
Where several ingredients are presented on a label statement in microgram microliter
quantities the repetition of expressing the unit in full greatly expands the length of the text
and hence label space becomes an important issue
Further CMA questions if the requirement is mandatory given it is expressed as should in
the standard compared to must in the guideline
This proposed requirement if mandatory does not allow for consistency on the label and
increased label space is required CMA submits that an abbreviated form of microgram
should be permitted in the standard
Expression of quantity or proportion of active ingredients
Sec 11 (2) Expression of quantity or propo1iion of active ingredients
11(2)(i) states that in addition to the requirements of paragraphs 1 1(2)(a)-1 1(2)(h) and
therefore includes 1 1 (2)( a) the quantity of the active ingredient
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the
herbal material from which the preparation was derived except
This amendment appears to propose that herbal ingredients include the actual amount of
herbal extract in addition to the equivalent amount of starting herbal material from which
the preparation was derived
As detailed in our 2014 submission we do not support the increased information
requirements for the expression of herbal medicines to be expanded on the medicine label
(section 11(2))
The 2014 consultation suggested the reasoning for the additional requirement to include
the input amount of the herbal material on the label was that it enables the consumer to
Page lS of 23
version
gain meaningful information in relation to the strength concentration or quantified levels
in general of the herbal ingredients in the medicine
To implement this requirement however it would require the addition of an extra line of
information for each herbal material ingredient to express both quantities on the medicine
label The majority of complementary medicines are multi ingredient formulations
sometimes with as many as 25 ingredients in a product The addition of at least two lines to
express each herbal ingredient would for the average consumer most likely only create
confusion as to which line of expression to draw a meaningful conclusion from
The main concern is that this would lead to two quantification values for the same inputted
ingredient which would be open to misunderstanding and if other than the native extract
amount potentially no more helpful to the consumer Additionally this requirement does
not appear to impact upon the safe or proper usage of the medicine if used within the
context outlined on the label
CMA considers that this requirement would significantly increase the regulatory burden of
lower risk medicines by increasing the amount of information required on a label and hence
label size Label space will become an issue and an impracticality pushed to some degree
and with an obscure label this could lead to other potentially misleading packaging issues
We again provide mock up labels at the appendix to demonstrate this significant increase in
requirement
Clear concise labelling of ingredients with one quantity the extract equivalent of the herb
provides consumers with satisfactory information that allows comparison with other
products
CMA requests that TGA provides a detailed reasoning behind the proposed amendment
including evidence that the current requirement is impacting on the safe and proper usage
of listed medicines if that is the case In the absence of this information CMA does not
support implementing this section of the labelling Order and that it be drafted without this
specific requirement
CMA provides a mock up label at the appendix 1 example 3 to demonstrate the increased
requirements to listed low risk medicines
Regulatory Impact Statement (RIS)- general requirements for labels of medicines version 10 August 2014
The TGA provided a regulatory impact statement and other supporting documents3 as
evidence in support of a change to the labelling of medicines the proposed changes were
however largely based on the risk profile associated with prescription and registered over
the counter medicines with no direct reference to misuse of complementary medicines in
3 Labelling and packaging practices 10 January 2013 fileCUserstechnicalDownloadsconsultshy
labelling-packaging-review-1205 24-an alysis-evidencepdf
Page 16 of 23
the context of self-selection being outlined The extra regulatory requirements for labelling
and packaging of complementary medicines are considered to be out of proportion to the
risk classifications of these medicines
The 2014 consultation highlighted that due to lower risk medicines being available for self selection this factor alone poses a risk as the consumer receives no additional information
except the instructions on the label Indeed while this highlights the importance of the
information on the medicine label no evidence has been provided that the proposed
changes would contribute to the provision of better consumer information or safety A
change to the amount of active ingredients that can be included on the front of the
medicine label and additional information around the expression of herbal ingredients for
example are proposals for change that are not supported by CMA as they have not been
evidenced to be a safety issue nor undergone consumer use testing to demonstrate any
improvement on the status quo would be gained In summary they will have little affect on
consumers self-selection
The 2014 labelling consultation included a regulatory impact statement which from an
industry point of view grossly underestimated the cost of changes
Copy from the RIS
The labour burden for businesses who need to change a label would be
approximately 20 hours (includes reading the current guidance and applying it to
their design work and the small amount of labour involved in providing new label
information as part of the application to vary the entry) at a labour rate of $42 per
hour
The additional requirements proposed in the Order and schedule 1 will result in all
companies conducting a review of each medicine formulation checking for compliance to
these revised requirements It is estimated that the $42 per hour labour rate above would
increase to approximately $60 per hour for the time required to carry out the review One
member estimates that the labour hours would increase from 20 to 30 hours and takes into
account that different sections within an organisation and external organisations are
involved in obtaining documentation for example suppliers distributors manufacturers
Testing may also be required to confirm if any allergen residue remains in the raw material
Transition arrangements
CMA notes that the proposed transition arrangement includes a four year period where by
compliance with the current labelling Order (TGO 69) or the revised TGO 92 would be
permitted By 2020 full compliance with TGO 92 would be required While this is an
improvement from the 2014 proposal CMA highlights that further refinements to TGO 92 is
required to reduce the regulatory burden for complementary medicines
Page 17 of 23
Should the Order be implemented as currently drafted there will be many complementary
medicine businesses that would be negatively impacted Not in the lest many small ownershy
operator complementary medicine businesses would not generally be in the practice of
changing their medicine labels every few years as indicated in the TGA RIS document
The transition period will also be particularly problematic where the labelled information
will differ despite no change in formulation eg change in apparent quantification
ingredient name or ingredient placement
The RIS document also detailed that the new labelling Order would be a one-off cost for
those businesses that would not be changing their labels during the transition period
The 2014 participants in the TGA industry survey included larger CM company
representatives and therefore is only indicative of that sector of the industry
Specifically the RIS did not look at the fact that smaller companies would employ the skills
of professional consultants to carry out the work required to ensure compliance with the
new labelling Order This cost factor alone for changes proposed to lower risk listed
medicines is considered an unnecessary additional regulatory burden that would not
necessarily equate to any consumer self-medication benefit
CMA submits that the focus of the TGA be one of reducing the regulatory burden enhancing
efficiencies in existing process whilst upholding the safety and quality of complementary
medicines available to consumers For these reasons CMA submits that further refinements
to TGO 92 be made to accommodate lower risk medicines
Schedule 1 Substances or groups of substances present in medicines -
that are required to be declared on the label of medicines
It appears that some inconsistencies remain in the declaration statement of certain
substances in Schedule 1 of TGO 92 compared to warning statements generated on the
ARTG
Ethanolalcohol
This group of substances to be declared on the label is not consistent with the ARTG
generated warning for ethanolalcohol
bull Contains alcohol vs contains ethanol (vv)
Ethanol as one of the substances required to be declared on the label can carry the
declaration contains alcohol However the same ingredient warning that is generated on
the ARTG for use if this ingredient is in the formula as a listed excipient is ETHAN contains
ethanol (or words to that effect)
Recommendations
Page 18 of 23
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is consistent
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label if the situation arises where there is already an ARTG
generated ethanol warning
Other ingredients such as potassium sorbate already generate ARTG warnings if listed as
excipients and is also in the group of substances required to be declared on the label
Again the wording used is inconsistent
ARTG warning SORB8 (If the medicine contains one sorbate) Contains [insert name of
sorbate] OR (if medicine contains two or more sorbates) Contains sorbates [or words to that
effect]
bull Contains sorbates vs contains [inse1i name of sorbate] (if the medicine contains one sorbate) or contains sorbates (if the medicine contains two or more sorbates) in the
event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have Contains potassium sorbate
whilst it would read Contains sorbates to comply with schedule 1 of TGO 92
Recommendations
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is
consistent If the product contains one sorbate eg potassium sorbate ARTG warning
is Contains potassium sorbate however TGO 92 declaration is Contains sorbates
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label in these situations
Phenylalanine
Many mineral amino acid chelates contain phenylalanine as part of the amino acid portion
of the mineral and ingredients such as Spirulina whole cell powder would contain
phenylalanine as part of its protein profile CMA proposes that the schedule 1 list include
additional information as to what ingredients the phenylalanine warning applies to or
outline the ingredients such as those mentioned above that are exempt from the
requirement
Imposing such requirements to all ingredients may cause unnecessary concern to the
consumer
Page 19 of 23
PU
Schedule 2 Specified Units for Enzymes -
bull CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients Papain Units Bromelain
Currently the TBS only allows the quantity of the ingredient to be expressed in milligrams
(mg) Pervious considerations of this issue has identified that the per mg expression is not
the most appropriate for the material Whilst GOU (gelatine digesting unit) is acknowledged
to be the unit most commonly used for the material papain unit is proposed as this is the
specified unit from bromelain by the joint FAOWHO expert committee on Food Additives
(JECFA) the Food Chemical Codex and the unit adopted by Health Canada in its
monographs for Stem bromelian and fruit bromelian We note also that there is a simple
conversion factor that can be applied to quantities expressed as GOU
CMA comment on the Guideline for medicine labels draft version 10
October 2015
bull 3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA proposes the
removal (of Camellia sinensis) after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation
and herbal material and quantity of standardised constituent) would be expressed
together This reiteration appears to be redundant and would take up more space on the
label
bull Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] Ingredients Uses or What this medicine is used for Warnings Directions for use and Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a
specified order) needs to be followed for listed medicines
Page 2 0 of 23
Labelling
Labelling packaging Complementary
Labelling Packaging
CMA interprets the revised TGO 92 update to mean that this would no longer be a
requirement However we have provided a mock up label at appendix 1 example 4 to
demonstrate how this requirement if relevant would impact multi ingredient herbal
medicines
CMA resources in reference to the labelling of complementary
medicines
bull CMA submission Consultation Draft TGO 79 Standards for the of Medicines
(November 2014) bull CMA submission and of Medicines (12 April
2013) bull CMA submission on the Medicine and Review (24 August 2012)
Page 21of23
CMA detailed table of reform recommendations and impact of TGO 92
Page 22 of 23
Appendix 1 - mock up labels to TGO 92 requirements
Page 23 of 23
CMA response to TGO 92- Standards for the labels of non-prescription medicines
Proposed Requirement TGO 92 Industry response
Text size In principle CMA agrees with the change that reverts back to the current TGO 69 definition of text size This is in comparison to the consultation draft TGO79 that proposed a range of sizes for listed and registered
ldquoText size equivalent to Arial fontrdquo complementary medicines based on Arial point size font has been removed from TGO 92 The definition for letter height is the same as the definition in TGO 69
Sec 7 General requirements including As stated in the CMA 2014 submission ambiguous and subjective requirements should on principle not be included in a label presentation legislative instrument (2)(e) Considering the guidance document elaborates on the proposed requirement CMA reiterates that we are not aware of there Labels must be in a colour or colours being consumer safety issues of this nature reported for CM products which are of a lower risk and hence consider the contrasting strongly with the mandatory requirement unjustified background Sec 8(2) Labels of registered medicines must provide information in a consistent order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important information access to other information is also necessary for consumers to make an informed purchasing decision CMA is of the position that for lower risk registered medicines such as registered complementary medicines there should be flexibility to present mandatory information in a clear and concise manner without the constraint of a medicine information panel (MIP) This will minimise cost to the CM industry associated with resizing labels or providing goods in larger container sizes with increased headspace Section 155 of the Guidance document outlines that ldquoa medicine information panel is not required for certain lower risk
Proposed Requirement TGO 92 Industry response
registered medicines ndash these are detailed in subsection 8(2) of TGO 92rdquo Subsection 8(2) however does not appear to detail specifically what types of lower risk registered medicines would not require a MIP CMA suggests that this part of the guidance is expanded to include specific guidance that registered complementary medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the amendment impact registered complementary medicines mock up labels have been provided to demonstrate that the requirement would necessitate a change to label sizes for complementary medicines which is considered unjustified
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of a MIP would not work and necessitate labelling complications and medicine container size considerations
Sec 8 (1) (k) (ii) (B) Pregnancy database
Requirements related tot his section should be incorporated on an ingredient by ingredient basis within the 26BB list of permissible ingredients instrument Pregnancy database - Add link httpswwwtgagovauprescribing-medicines-pregnancy-database
Sec 9 (2) CMA considers the proposed requirements to orientate all text in the same direction on the main label and for medicine names to be presented in a continuous and uninterrupted manner would not have a meaningful impact upon consumer
The name of the medicine on the main safety and as such the change is considered unjustified for lower risk medicines label must be presented in a continuous uninterrupted manner and Feedback from our members indicates that medicine labels are often developed as a result of consumer testing not be broken up by additional In addition CMA has not been presented with information that consumers have any usability difficulties with the information or background text presentation of information on complementary medicine labels Sec 9 (5) All text required by this Order to It is well documented that consumers generally select complementary medicines and non-prescription medicines by brand appear on the main label must be and category and seek out brands they know Branding is important for complementary medicines and consumers are orientated in the same direction familiar with many well-known brands of medicines for general wellbeing cough and cold allergy skincare and many
other categories Limited label space is therefore an important issue particularly for certain product and label types
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 2 of 12
Proposed Requirement TGO 92 Industry response
Such a change would impact upon brand recognition for many companies As such CMA considers this as an unjustified change to requirements adding to unnecessary regulatory burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact on branding and does not require consequential changes to dimensions of packs or labels or changes to the packaging details of a medicine
Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 30millimeters on the front panel directly under the trade name
Since consumers use complementary medicines as part of self-care the label of these medicines is the primary source of information for consumers This requirement would mean that a large portion of the label would be used to display the active ingredients Information on active ingredients is not always the most meaningful aspect in consumer self selection of these goods rather information sought by consumers tends to be focused around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space and there will be reduced space to indicate the intended purpose of the product on the front of pack If the container and label size are increased as a result of this without increasing the number of tablets or capsules in the bottle this could give the consumer a negative perception due to the increased head space of the container Ultimately this would also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations
Sec 9 (6) CMArsquos position on the number of active ingredients that may appear on the front of a label for listed goods is that TGO 69 If the medicine is intended to be or is requirements be maintained listed goods By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active ingredients to four or more (b) if there are four or more active active ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for ingredients in the medicine - the name these lower risk listed medicines without any evidence of consumer benefit being presented of every active ingredient together with the quantity or proportion of CMA suggests the following amendment to TGO 92 every active ingredient may appear on
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 3 of 12
Proposed Requirement TGO 92 Industry response
a side panel or side label or on a rear panel or rear label
If the medicine is intended to be or is listed goods 6 b) if the medicine is a listed complementary medicine ndash the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO 69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014 CMA includes specific examples where for listed CMs containing three active ingredients to be displayed on the front of the label where previously they would be detailed at the side or rear how this would impact on label size being inappropriate for the packaging
Sec 9 (7) CMA proposed that TGO 69 requirements be maintained If the medicine is intended to be or is registered goods then By imposing subsection 9(7)(b) would mean a requirement to go from two or more active ingredients to four or more active
ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for (a) where the medicine contains three registered complementary medicines without any specific evidence of consumer benefit relating to this lower risk class of or four active ingredients the name of good being presented the active ingredient(s) and the quantity or proportion of active Within the complementary medicine category listed and registered complementary medicines will be presented (depending ingredient(s) must be displayed on the on the number of active ingredients present) in a different manner That is some will detail active ingredients at the front of main label in a text size of not less the pack while others (with 4 or more active ingredients) will detail the ingredients at the side or rear of the pack CMA than 3 millimetres submits that for the purposes of standardisation of where to find information consumers should be encouraged to refer to
the backside of the pack for ingredient information (b) where the medicine contains four or more active ingredients and the CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of requirements of subsection 8(2) do not 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations apply then the names and the See comments at Sec 9 (7)(a) above quantities or proportion of the active ingredients may be included on a side panellabel or rear panellabel when
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 4 of 12
Proposed Requirement TGO 92 Industry response
displayed in a text size of not less than 25mm
Sec 10(3) amp Sec 10 (4)(a) CMA does not support any additional change to this lower risk category of medicine
Homeopathic medicines No explanation or justification has been provided as to why there is a new mandatory requirement to include a statement on Where all the active ingredients in a the main label that the medicine is a homeopathic medicine or contains homeopathic preparations in an increased font size to medicine are homoeopathic that of a general listed complementary medicine preparations the main label on the No real explanation has been provided as to why an increase to the font size for the statement ldquohomeopathic medicinerdquo was container and the main label on the considered a requirement based on a consumer safety perspective primary pack (if any) must in addition to the requirements referred Previous explanations for this addition has centred around that the statement is intended to assist consumers with an to in sections 8 and 9 above include a appropriate selection for a medicine and minimise confusion that may arise with self-selection However the current statement to the effect that the labelling Order requires there to be a declaration that clearly states the product is homeopathic and contains homeopathic medicine is a homoeopathic medicine ingredients on the front of the pack and the additional detail of this information on the back of the pack in the ingredients in text size that is not less than 50 and indications section would clearly justify the medicine as being based in the homoeopathic paradigm of the text size of the name of the As such CMA proposes that this section be removed from the Order medicine and (in any event) not less than 2millimeters
Sec 6 CMA submitted in May 2013 via the International Harmonisation of Ingredient Names consultation that there appeared to be no mention of the naming of homoeopathic ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS)
Interpretation in this Order traditional naming or the application of new AAN homoeopathic names As such we resubmit information for consideration here
Homoeopathic medicines ndash naming conventions
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 5 of 12
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation (i) either the name of the active ingredient or the substance from which the dilution was prepared that is accepted for inclusion in the Australian Approved Names (AAN) List together with a statement of the homeopathic potency or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency
It is suggested that an amendment be made to allow for homeopathic medicines The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
To implement this CMA proposes the following amendment to the definition of the name of the active ingredient
(b) where the ingredient is a homoeopathic preparation
1 the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency in brackets the name that is also accepted for inclusion in the Australian Approved Names List
2 for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
That is the traditional homeopathic name to be used as the primary name including the AAN unless on ldquosmall containersrdquo Both the traditional names and AAN could be included on full website information which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required)
It is in the consumersrsquo interest that traditional pharmacopeial names be amended as the primary name The concern here is
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
provisions of Sections 502 and 503 of the Federal Food Drug and Cosmetic Act Part 201
Title 21 of the Code of Federal Regulations (CFR) and the FDAs Compliance Policy Guide
400400
Section 11 How Information is to be expressed -
Use of appropriate metric units
bull Sec 11 (l)(b) The abbreviations to mg and g can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation microg may be used
Where several ingredients are presented on a label statement in microgram microliter
quantities the repetition of expressing the unit in full greatly expands the length of the text
and hence label space becomes an important issue
Further CMA questions if the requirement is mandatory given it is expressed as should in
the standard compared to must in the guideline
This proposed requirement if mandatory does not allow for consistency on the label and
increased label space is required CMA submits that an abbreviated form of microgram
should be permitted in the standard
Expression of quantity or proportion of active ingredients
Sec 11 (2) Expression of quantity or propo1iion of active ingredients
11(2)(i) states that in addition to the requirements of paragraphs 1 1(2)(a)-1 1(2)(h) and
therefore includes 1 1 (2)( a) the quantity of the active ingredient
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the
herbal material from which the preparation was derived except
This amendment appears to propose that herbal ingredients include the actual amount of
herbal extract in addition to the equivalent amount of starting herbal material from which
the preparation was derived
As detailed in our 2014 submission we do not support the increased information
requirements for the expression of herbal medicines to be expanded on the medicine label
(section 11(2))
The 2014 consultation suggested the reasoning for the additional requirement to include
the input amount of the herbal material on the label was that it enables the consumer to
Page lS of 23
version
gain meaningful information in relation to the strength concentration or quantified levels
in general of the herbal ingredients in the medicine
To implement this requirement however it would require the addition of an extra line of
information for each herbal material ingredient to express both quantities on the medicine
label The majority of complementary medicines are multi ingredient formulations
sometimes with as many as 25 ingredients in a product The addition of at least two lines to
express each herbal ingredient would for the average consumer most likely only create
confusion as to which line of expression to draw a meaningful conclusion from
The main concern is that this would lead to two quantification values for the same inputted
ingredient which would be open to misunderstanding and if other than the native extract
amount potentially no more helpful to the consumer Additionally this requirement does
not appear to impact upon the safe or proper usage of the medicine if used within the
context outlined on the label
CMA considers that this requirement would significantly increase the regulatory burden of
lower risk medicines by increasing the amount of information required on a label and hence
label size Label space will become an issue and an impracticality pushed to some degree
and with an obscure label this could lead to other potentially misleading packaging issues
We again provide mock up labels at the appendix to demonstrate this significant increase in
requirement
Clear concise labelling of ingredients with one quantity the extract equivalent of the herb
provides consumers with satisfactory information that allows comparison with other
products
CMA requests that TGA provides a detailed reasoning behind the proposed amendment
including evidence that the current requirement is impacting on the safe and proper usage
of listed medicines if that is the case In the absence of this information CMA does not
support implementing this section of the labelling Order and that it be drafted without this
specific requirement
CMA provides a mock up label at the appendix 1 example 3 to demonstrate the increased
requirements to listed low risk medicines
Regulatory Impact Statement (RIS)- general requirements for labels of medicines version 10 August 2014
The TGA provided a regulatory impact statement and other supporting documents3 as
evidence in support of a change to the labelling of medicines the proposed changes were
however largely based on the risk profile associated with prescription and registered over
the counter medicines with no direct reference to misuse of complementary medicines in
3 Labelling and packaging practices 10 January 2013 fileCUserstechnicalDownloadsconsultshy
labelling-packaging-review-1205 24-an alysis-evidencepdf
Page 16 of 23
the context of self-selection being outlined The extra regulatory requirements for labelling
and packaging of complementary medicines are considered to be out of proportion to the
risk classifications of these medicines
The 2014 consultation highlighted that due to lower risk medicines being available for self selection this factor alone poses a risk as the consumer receives no additional information
except the instructions on the label Indeed while this highlights the importance of the
information on the medicine label no evidence has been provided that the proposed
changes would contribute to the provision of better consumer information or safety A
change to the amount of active ingredients that can be included on the front of the
medicine label and additional information around the expression of herbal ingredients for
example are proposals for change that are not supported by CMA as they have not been
evidenced to be a safety issue nor undergone consumer use testing to demonstrate any
improvement on the status quo would be gained In summary they will have little affect on
consumers self-selection
The 2014 labelling consultation included a regulatory impact statement which from an
industry point of view grossly underestimated the cost of changes
Copy from the RIS
The labour burden for businesses who need to change a label would be
approximately 20 hours (includes reading the current guidance and applying it to
their design work and the small amount of labour involved in providing new label
information as part of the application to vary the entry) at a labour rate of $42 per
hour
The additional requirements proposed in the Order and schedule 1 will result in all
companies conducting a review of each medicine formulation checking for compliance to
these revised requirements It is estimated that the $42 per hour labour rate above would
increase to approximately $60 per hour for the time required to carry out the review One
member estimates that the labour hours would increase from 20 to 30 hours and takes into
account that different sections within an organisation and external organisations are
involved in obtaining documentation for example suppliers distributors manufacturers
Testing may also be required to confirm if any allergen residue remains in the raw material
Transition arrangements
CMA notes that the proposed transition arrangement includes a four year period where by
compliance with the current labelling Order (TGO 69) or the revised TGO 92 would be
permitted By 2020 full compliance with TGO 92 would be required While this is an
improvement from the 2014 proposal CMA highlights that further refinements to TGO 92 is
required to reduce the regulatory burden for complementary medicines
Page 17 of 23
Should the Order be implemented as currently drafted there will be many complementary
medicine businesses that would be negatively impacted Not in the lest many small ownershy
operator complementary medicine businesses would not generally be in the practice of
changing their medicine labels every few years as indicated in the TGA RIS document
The transition period will also be particularly problematic where the labelled information
will differ despite no change in formulation eg change in apparent quantification
ingredient name or ingredient placement
The RIS document also detailed that the new labelling Order would be a one-off cost for
those businesses that would not be changing their labels during the transition period
The 2014 participants in the TGA industry survey included larger CM company
representatives and therefore is only indicative of that sector of the industry
Specifically the RIS did not look at the fact that smaller companies would employ the skills
of professional consultants to carry out the work required to ensure compliance with the
new labelling Order This cost factor alone for changes proposed to lower risk listed
medicines is considered an unnecessary additional regulatory burden that would not
necessarily equate to any consumer self-medication benefit
CMA submits that the focus of the TGA be one of reducing the regulatory burden enhancing
efficiencies in existing process whilst upholding the safety and quality of complementary
medicines available to consumers For these reasons CMA submits that further refinements
to TGO 92 be made to accommodate lower risk medicines
Schedule 1 Substances or groups of substances present in medicines -
that are required to be declared on the label of medicines
It appears that some inconsistencies remain in the declaration statement of certain
substances in Schedule 1 of TGO 92 compared to warning statements generated on the
ARTG
Ethanolalcohol
This group of substances to be declared on the label is not consistent with the ARTG
generated warning for ethanolalcohol
bull Contains alcohol vs contains ethanol (vv)
Ethanol as one of the substances required to be declared on the label can carry the
declaration contains alcohol However the same ingredient warning that is generated on
the ARTG for use if this ingredient is in the formula as a listed excipient is ETHAN contains
ethanol (or words to that effect)
Recommendations
Page 18 of 23
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is consistent
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label if the situation arises where there is already an ARTG
generated ethanol warning
Other ingredients such as potassium sorbate already generate ARTG warnings if listed as
excipients and is also in the group of substances required to be declared on the label
Again the wording used is inconsistent
ARTG warning SORB8 (If the medicine contains one sorbate) Contains [insert name of
sorbate] OR (if medicine contains two or more sorbates) Contains sorbates [or words to that
effect]
bull Contains sorbates vs contains [inse1i name of sorbate] (if the medicine contains one sorbate) or contains sorbates (if the medicine contains two or more sorbates) in the
event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have Contains potassium sorbate
whilst it would read Contains sorbates to comply with schedule 1 of TGO 92
Recommendations
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is
consistent If the product contains one sorbate eg potassium sorbate ARTG warning
is Contains potassium sorbate however TGO 92 declaration is Contains sorbates
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label in these situations
Phenylalanine
Many mineral amino acid chelates contain phenylalanine as part of the amino acid portion
of the mineral and ingredients such as Spirulina whole cell powder would contain
phenylalanine as part of its protein profile CMA proposes that the schedule 1 list include
additional information as to what ingredients the phenylalanine warning applies to or
outline the ingredients such as those mentioned above that are exempt from the
requirement
Imposing such requirements to all ingredients may cause unnecessary concern to the
consumer
Page 19 of 23
PU
Schedule 2 Specified Units for Enzymes -
bull CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients Papain Units Bromelain
Currently the TBS only allows the quantity of the ingredient to be expressed in milligrams
(mg) Pervious considerations of this issue has identified that the per mg expression is not
the most appropriate for the material Whilst GOU (gelatine digesting unit) is acknowledged
to be the unit most commonly used for the material papain unit is proposed as this is the
specified unit from bromelain by the joint FAOWHO expert committee on Food Additives
(JECFA) the Food Chemical Codex and the unit adopted by Health Canada in its
monographs for Stem bromelian and fruit bromelian We note also that there is a simple
conversion factor that can be applied to quantities expressed as GOU
CMA comment on the Guideline for medicine labels draft version 10
October 2015
bull 3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA proposes the
removal (of Camellia sinensis) after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation
and herbal material and quantity of standardised constituent) would be expressed
together This reiteration appears to be redundant and would take up more space on the
label
bull Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] Ingredients Uses or What this medicine is used for Warnings Directions for use and Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a
specified order) needs to be followed for listed medicines
Page 2 0 of 23
Labelling
Labelling packaging Complementary
Labelling Packaging
CMA interprets the revised TGO 92 update to mean that this would no longer be a
requirement However we have provided a mock up label at appendix 1 example 4 to
demonstrate how this requirement if relevant would impact multi ingredient herbal
medicines
CMA resources in reference to the labelling of complementary
medicines
bull CMA submission Consultation Draft TGO 79 Standards for the of Medicines
(November 2014) bull CMA submission and of Medicines (12 April
2013) bull CMA submission on the Medicine and Review (24 August 2012)
Page 21of23
CMA detailed table of reform recommendations and impact of TGO 92
Page 22 of 23
Appendix 1 - mock up labels to TGO 92 requirements
Page 23 of 23
CMA response to TGO 92- Standards for the labels of non-prescription medicines
Proposed Requirement TGO 92 Industry response
Text size In principle CMA agrees with the change that reverts back to the current TGO 69 definition of text size This is in comparison to the consultation draft TGO79 that proposed a range of sizes for listed and registered
ldquoText size equivalent to Arial fontrdquo complementary medicines based on Arial point size font has been removed from TGO 92 The definition for letter height is the same as the definition in TGO 69
Sec 7 General requirements including As stated in the CMA 2014 submission ambiguous and subjective requirements should on principle not be included in a label presentation legislative instrument (2)(e) Considering the guidance document elaborates on the proposed requirement CMA reiterates that we are not aware of there Labels must be in a colour or colours being consumer safety issues of this nature reported for CM products which are of a lower risk and hence consider the contrasting strongly with the mandatory requirement unjustified background Sec 8(2) Labels of registered medicines must provide information in a consistent order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important information access to other information is also necessary for consumers to make an informed purchasing decision CMA is of the position that for lower risk registered medicines such as registered complementary medicines there should be flexibility to present mandatory information in a clear and concise manner without the constraint of a medicine information panel (MIP) This will minimise cost to the CM industry associated with resizing labels or providing goods in larger container sizes with increased headspace Section 155 of the Guidance document outlines that ldquoa medicine information panel is not required for certain lower risk
Proposed Requirement TGO 92 Industry response
registered medicines ndash these are detailed in subsection 8(2) of TGO 92rdquo Subsection 8(2) however does not appear to detail specifically what types of lower risk registered medicines would not require a MIP CMA suggests that this part of the guidance is expanded to include specific guidance that registered complementary medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the amendment impact registered complementary medicines mock up labels have been provided to demonstrate that the requirement would necessitate a change to label sizes for complementary medicines which is considered unjustified
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of a MIP would not work and necessitate labelling complications and medicine container size considerations
Sec 8 (1) (k) (ii) (B) Pregnancy database
Requirements related tot his section should be incorporated on an ingredient by ingredient basis within the 26BB list of permissible ingredients instrument Pregnancy database - Add link httpswwwtgagovauprescribing-medicines-pregnancy-database
Sec 9 (2) CMA considers the proposed requirements to orientate all text in the same direction on the main label and for medicine names to be presented in a continuous and uninterrupted manner would not have a meaningful impact upon consumer
The name of the medicine on the main safety and as such the change is considered unjustified for lower risk medicines label must be presented in a continuous uninterrupted manner and Feedback from our members indicates that medicine labels are often developed as a result of consumer testing not be broken up by additional In addition CMA has not been presented with information that consumers have any usability difficulties with the information or background text presentation of information on complementary medicine labels Sec 9 (5) All text required by this Order to It is well documented that consumers generally select complementary medicines and non-prescription medicines by brand appear on the main label must be and category and seek out brands they know Branding is important for complementary medicines and consumers are orientated in the same direction familiar with many well-known brands of medicines for general wellbeing cough and cold allergy skincare and many
other categories Limited label space is therefore an important issue particularly for certain product and label types
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 2 of 12
Proposed Requirement TGO 92 Industry response
Such a change would impact upon brand recognition for many companies As such CMA considers this as an unjustified change to requirements adding to unnecessary regulatory burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact on branding and does not require consequential changes to dimensions of packs or labels or changes to the packaging details of a medicine
Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 30millimeters on the front panel directly under the trade name
Since consumers use complementary medicines as part of self-care the label of these medicines is the primary source of information for consumers This requirement would mean that a large portion of the label would be used to display the active ingredients Information on active ingredients is not always the most meaningful aspect in consumer self selection of these goods rather information sought by consumers tends to be focused around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space and there will be reduced space to indicate the intended purpose of the product on the front of pack If the container and label size are increased as a result of this without increasing the number of tablets or capsules in the bottle this could give the consumer a negative perception due to the increased head space of the container Ultimately this would also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations
Sec 9 (6) CMArsquos position on the number of active ingredients that may appear on the front of a label for listed goods is that TGO 69 If the medicine is intended to be or is requirements be maintained listed goods By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active ingredients to four or more (b) if there are four or more active active ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for ingredients in the medicine - the name these lower risk listed medicines without any evidence of consumer benefit being presented of every active ingredient together with the quantity or proportion of CMA suggests the following amendment to TGO 92 every active ingredient may appear on
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 3 of 12
Proposed Requirement TGO 92 Industry response
a side panel or side label or on a rear panel or rear label
If the medicine is intended to be or is listed goods 6 b) if the medicine is a listed complementary medicine ndash the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO 69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014 CMA includes specific examples where for listed CMs containing three active ingredients to be displayed on the front of the label where previously they would be detailed at the side or rear how this would impact on label size being inappropriate for the packaging
Sec 9 (7) CMA proposed that TGO 69 requirements be maintained If the medicine is intended to be or is registered goods then By imposing subsection 9(7)(b) would mean a requirement to go from two or more active ingredients to four or more active
ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for (a) where the medicine contains three registered complementary medicines without any specific evidence of consumer benefit relating to this lower risk class of or four active ingredients the name of good being presented the active ingredient(s) and the quantity or proportion of active Within the complementary medicine category listed and registered complementary medicines will be presented (depending ingredient(s) must be displayed on the on the number of active ingredients present) in a different manner That is some will detail active ingredients at the front of main label in a text size of not less the pack while others (with 4 or more active ingredients) will detail the ingredients at the side or rear of the pack CMA than 3 millimetres submits that for the purposes of standardisation of where to find information consumers should be encouraged to refer to
the backside of the pack for ingredient information (b) where the medicine contains four or more active ingredients and the CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of requirements of subsection 8(2) do not 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations apply then the names and the See comments at Sec 9 (7)(a) above quantities or proportion of the active ingredients may be included on a side panellabel or rear panellabel when
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 4 of 12
Proposed Requirement TGO 92 Industry response
displayed in a text size of not less than 25mm
Sec 10(3) amp Sec 10 (4)(a) CMA does not support any additional change to this lower risk category of medicine
Homeopathic medicines No explanation or justification has been provided as to why there is a new mandatory requirement to include a statement on Where all the active ingredients in a the main label that the medicine is a homeopathic medicine or contains homeopathic preparations in an increased font size to medicine are homoeopathic that of a general listed complementary medicine preparations the main label on the No real explanation has been provided as to why an increase to the font size for the statement ldquohomeopathic medicinerdquo was container and the main label on the considered a requirement based on a consumer safety perspective primary pack (if any) must in addition to the requirements referred Previous explanations for this addition has centred around that the statement is intended to assist consumers with an to in sections 8 and 9 above include a appropriate selection for a medicine and minimise confusion that may arise with self-selection However the current statement to the effect that the labelling Order requires there to be a declaration that clearly states the product is homeopathic and contains homeopathic medicine is a homoeopathic medicine ingredients on the front of the pack and the additional detail of this information on the back of the pack in the ingredients in text size that is not less than 50 and indications section would clearly justify the medicine as being based in the homoeopathic paradigm of the text size of the name of the As such CMA proposes that this section be removed from the Order medicine and (in any event) not less than 2millimeters
Sec 6 CMA submitted in May 2013 via the International Harmonisation of Ingredient Names consultation that there appeared to be no mention of the naming of homoeopathic ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS)
Interpretation in this Order traditional naming or the application of new AAN homoeopathic names As such we resubmit information for consideration here
Homoeopathic medicines ndash naming conventions
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 5 of 12
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation (i) either the name of the active ingredient or the substance from which the dilution was prepared that is accepted for inclusion in the Australian Approved Names (AAN) List together with a statement of the homeopathic potency or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency
It is suggested that an amendment be made to allow for homeopathic medicines The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
To implement this CMA proposes the following amendment to the definition of the name of the active ingredient
(b) where the ingredient is a homoeopathic preparation
1 the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency in brackets the name that is also accepted for inclusion in the Australian Approved Names List
2 for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
That is the traditional homeopathic name to be used as the primary name including the AAN unless on ldquosmall containersrdquo Both the traditional names and AAN could be included on full website information which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required)
It is in the consumersrsquo interest that traditional pharmacopeial names be amended as the primary name The concern here is
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
version
gain meaningful information in relation to the strength concentration or quantified levels
in general of the herbal ingredients in the medicine
To implement this requirement however it would require the addition of an extra line of
information for each herbal material ingredient to express both quantities on the medicine
label The majority of complementary medicines are multi ingredient formulations
sometimes with as many as 25 ingredients in a product The addition of at least two lines to
express each herbal ingredient would for the average consumer most likely only create
confusion as to which line of expression to draw a meaningful conclusion from
The main concern is that this would lead to two quantification values for the same inputted
ingredient which would be open to misunderstanding and if other than the native extract
amount potentially no more helpful to the consumer Additionally this requirement does
not appear to impact upon the safe or proper usage of the medicine if used within the
context outlined on the label
CMA considers that this requirement would significantly increase the regulatory burden of
lower risk medicines by increasing the amount of information required on a label and hence
label size Label space will become an issue and an impracticality pushed to some degree
and with an obscure label this could lead to other potentially misleading packaging issues
We again provide mock up labels at the appendix to demonstrate this significant increase in
requirement
Clear concise labelling of ingredients with one quantity the extract equivalent of the herb
provides consumers with satisfactory information that allows comparison with other
products
CMA requests that TGA provides a detailed reasoning behind the proposed amendment
including evidence that the current requirement is impacting on the safe and proper usage
of listed medicines if that is the case In the absence of this information CMA does not
support implementing this section of the labelling Order and that it be drafted without this
specific requirement
CMA provides a mock up label at the appendix 1 example 3 to demonstrate the increased
requirements to listed low risk medicines
Regulatory Impact Statement (RIS)- general requirements for labels of medicines version 10 August 2014
The TGA provided a regulatory impact statement and other supporting documents3 as
evidence in support of a change to the labelling of medicines the proposed changes were
however largely based on the risk profile associated with prescription and registered over
the counter medicines with no direct reference to misuse of complementary medicines in
3 Labelling and packaging practices 10 January 2013 fileCUserstechnicalDownloadsconsultshy
labelling-packaging-review-1205 24-an alysis-evidencepdf
Page 16 of 23
the context of self-selection being outlined The extra regulatory requirements for labelling
and packaging of complementary medicines are considered to be out of proportion to the
risk classifications of these medicines
The 2014 consultation highlighted that due to lower risk medicines being available for self selection this factor alone poses a risk as the consumer receives no additional information
except the instructions on the label Indeed while this highlights the importance of the
information on the medicine label no evidence has been provided that the proposed
changes would contribute to the provision of better consumer information or safety A
change to the amount of active ingredients that can be included on the front of the
medicine label and additional information around the expression of herbal ingredients for
example are proposals for change that are not supported by CMA as they have not been
evidenced to be a safety issue nor undergone consumer use testing to demonstrate any
improvement on the status quo would be gained In summary they will have little affect on
consumers self-selection
The 2014 labelling consultation included a regulatory impact statement which from an
industry point of view grossly underestimated the cost of changes
Copy from the RIS
The labour burden for businesses who need to change a label would be
approximately 20 hours (includes reading the current guidance and applying it to
their design work and the small amount of labour involved in providing new label
information as part of the application to vary the entry) at a labour rate of $42 per
hour
The additional requirements proposed in the Order and schedule 1 will result in all
companies conducting a review of each medicine formulation checking for compliance to
these revised requirements It is estimated that the $42 per hour labour rate above would
increase to approximately $60 per hour for the time required to carry out the review One
member estimates that the labour hours would increase from 20 to 30 hours and takes into
account that different sections within an organisation and external organisations are
involved in obtaining documentation for example suppliers distributors manufacturers
Testing may also be required to confirm if any allergen residue remains in the raw material
Transition arrangements
CMA notes that the proposed transition arrangement includes a four year period where by
compliance with the current labelling Order (TGO 69) or the revised TGO 92 would be
permitted By 2020 full compliance with TGO 92 would be required While this is an
improvement from the 2014 proposal CMA highlights that further refinements to TGO 92 is
required to reduce the regulatory burden for complementary medicines
Page 17 of 23
Should the Order be implemented as currently drafted there will be many complementary
medicine businesses that would be negatively impacted Not in the lest many small ownershy
operator complementary medicine businesses would not generally be in the practice of
changing their medicine labels every few years as indicated in the TGA RIS document
The transition period will also be particularly problematic where the labelled information
will differ despite no change in formulation eg change in apparent quantification
ingredient name or ingredient placement
The RIS document also detailed that the new labelling Order would be a one-off cost for
those businesses that would not be changing their labels during the transition period
The 2014 participants in the TGA industry survey included larger CM company
representatives and therefore is only indicative of that sector of the industry
Specifically the RIS did not look at the fact that smaller companies would employ the skills
of professional consultants to carry out the work required to ensure compliance with the
new labelling Order This cost factor alone for changes proposed to lower risk listed
medicines is considered an unnecessary additional regulatory burden that would not
necessarily equate to any consumer self-medication benefit
CMA submits that the focus of the TGA be one of reducing the regulatory burden enhancing
efficiencies in existing process whilst upholding the safety and quality of complementary
medicines available to consumers For these reasons CMA submits that further refinements
to TGO 92 be made to accommodate lower risk medicines
Schedule 1 Substances or groups of substances present in medicines -
that are required to be declared on the label of medicines
It appears that some inconsistencies remain in the declaration statement of certain
substances in Schedule 1 of TGO 92 compared to warning statements generated on the
ARTG
Ethanolalcohol
This group of substances to be declared on the label is not consistent with the ARTG
generated warning for ethanolalcohol
bull Contains alcohol vs contains ethanol (vv)
Ethanol as one of the substances required to be declared on the label can carry the
declaration contains alcohol However the same ingredient warning that is generated on
the ARTG for use if this ingredient is in the formula as a listed excipient is ETHAN contains
ethanol (or words to that effect)
Recommendations
Page 18 of 23
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is consistent
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label if the situation arises where there is already an ARTG
generated ethanol warning
Other ingredients such as potassium sorbate already generate ARTG warnings if listed as
excipients and is also in the group of substances required to be declared on the label
Again the wording used is inconsistent
ARTG warning SORB8 (If the medicine contains one sorbate) Contains [insert name of
sorbate] OR (if medicine contains two or more sorbates) Contains sorbates [or words to that
effect]
bull Contains sorbates vs contains [inse1i name of sorbate] (if the medicine contains one sorbate) or contains sorbates (if the medicine contains two or more sorbates) in the
event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have Contains potassium sorbate
whilst it would read Contains sorbates to comply with schedule 1 of TGO 92
Recommendations
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is
consistent If the product contains one sorbate eg potassium sorbate ARTG warning
is Contains potassium sorbate however TGO 92 declaration is Contains sorbates
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label in these situations
Phenylalanine
Many mineral amino acid chelates contain phenylalanine as part of the amino acid portion
of the mineral and ingredients such as Spirulina whole cell powder would contain
phenylalanine as part of its protein profile CMA proposes that the schedule 1 list include
additional information as to what ingredients the phenylalanine warning applies to or
outline the ingredients such as those mentioned above that are exempt from the
requirement
Imposing such requirements to all ingredients may cause unnecessary concern to the
consumer
Page 19 of 23
PU
Schedule 2 Specified Units for Enzymes -
bull CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients Papain Units Bromelain
Currently the TBS only allows the quantity of the ingredient to be expressed in milligrams
(mg) Pervious considerations of this issue has identified that the per mg expression is not
the most appropriate for the material Whilst GOU (gelatine digesting unit) is acknowledged
to be the unit most commonly used for the material papain unit is proposed as this is the
specified unit from bromelain by the joint FAOWHO expert committee on Food Additives
(JECFA) the Food Chemical Codex and the unit adopted by Health Canada in its
monographs for Stem bromelian and fruit bromelian We note also that there is a simple
conversion factor that can be applied to quantities expressed as GOU
CMA comment on the Guideline for medicine labels draft version 10
October 2015
bull 3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA proposes the
removal (of Camellia sinensis) after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation
and herbal material and quantity of standardised constituent) would be expressed
together This reiteration appears to be redundant and would take up more space on the
label
bull Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] Ingredients Uses or What this medicine is used for Warnings Directions for use and Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a
specified order) needs to be followed for listed medicines
Page 2 0 of 23
Labelling
Labelling packaging Complementary
Labelling Packaging
CMA interprets the revised TGO 92 update to mean that this would no longer be a
requirement However we have provided a mock up label at appendix 1 example 4 to
demonstrate how this requirement if relevant would impact multi ingredient herbal
medicines
CMA resources in reference to the labelling of complementary
medicines
bull CMA submission Consultation Draft TGO 79 Standards for the of Medicines
(November 2014) bull CMA submission and of Medicines (12 April
2013) bull CMA submission on the Medicine and Review (24 August 2012)
Page 21of23
CMA detailed table of reform recommendations and impact of TGO 92
Page 22 of 23
Appendix 1 - mock up labels to TGO 92 requirements
Page 23 of 23
CMA response to TGO 92- Standards for the labels of non-prescription medicines
Proposed Requirement TGO 92 Industry response
Text size In principle CMA agrees with the change that reverts back to the current TGO 69 definition of text size This is in comparison to the consultation draft TGO79 that proposed a range of sizes for listed and registered
ldquoText size equivalent to Arial fontrdquo complementary medicines based on Arial point size font has been removed from TGO 92 The definition for letter height is the same as the definition in TGO 69
Sec 7 General requirements including As stated in the CMA 2014 submission ambiguous and subjective requirements should on principle not be included in a label presentation legislative instrument (2)(e) Considering the guidance document elaborates on the proposed requirement CMA reiterates that we are not aware of there Labels must be in a colour or colours being consumer safety issues of this nature reported for CM products which are of a lower risk and hence consider the contrasting strongly with the mandatory requirement unjustified background Sec 8(2) Labels of registered medicines must provide information in a consistent order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important information access to other information is also necessary for consumers to make an informed purchasing decision CMA is of the position that for lower risk registered medicines such as registered complementary medicines there should be flexibility to present mandatory information in a clear and concise manner without the constraint of a medicine information panel (MIP) This will minimise cost to the CM industry associated with resizing labels or providing goods in larger container sizes with increased headspace Section 155 of the Guidance document outlines that ldquoa medicine information panel is not required for certain lower risk
Proposed Requirement TGO 92 Industry response
registered medicines ndash these are detailed in subsection 8(2) of TGO 92rdquo Subsection 8(2) however does not appear to detail specifically what types of lower risk registered medicines would not require a MIP CMA suggests that this part of the guidance is expanded to include specific guidance that registered complementary medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the amendment impact registered complementary medicines mock up labels have been provided to demonstrate that the requirement would necessitate a change to label sizes for complementary medicines which is considered unjustified
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of a MIP would not work and necessitate labelling complications and medicine container size considerations
Sec 8 (1) (k) (ii) (B) Pregnancy database
Requirements related tot his section should be incorporated on an ingredient by ingredient basis within the 26BB list of permissible ingredients instrument Pregnancy database - Add link httpswwwtgagovauprescribing-medicines-pregnancy-database
Sec 9 (2) CMA considers the proposed requirements to orientate all text in the same direction on the main label and for medicine names to be presented in a continuous and uninterrupted manner would not have a meaningful impact upon consumer
The name of the medicine on the main safety and as such the change is considered unjustified for lower risk medicines label must be presented in a continuous uninterrupted manner and Feedback from our members indicates that medicine labels are often developed as a result of consumer testing not be broken up by additional In addition CMA has not been presented with information that consumers have any usability difficulties with the information or background text presentation of information on complementary medicine labels Sec 9 (5) All text required by this Order to It is well documented that consumers generally select complementary medicines and non-prescription medicines by brand appear on the main label must be and category and seek out brands they know Branding is important for complementary medicines and consumers are orientated in the same direction familiar with many well-known brands of medicines for general wellbeing cough and cold allergy skincare and many
other categories Limited label space is therefore an important issue particularly for certain product and label types
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 2 of 12
Proposed Requirement TGO 92 Industry response
Such a change would impact upon brand recognition for many companies As such CMA considers this as an unjustified change to requirements adding to unnecessary regulatory burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact on branding and does not require consequential changes to dimensions of packs or labels or changes to the packaging details of a medicine
Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 30millimeters on the front panel directly under the trade name
Since consumers use complementary medicines as part of self-care the label of these medicines is the primary source of information for consumers This requirement would mean that a large portion of the label would be used to display the active ingredients Information on active ingredients is not always the most meaningful aspect in consumer self selection of these goods rather information sought by consumers tends to be focused around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space and there will be reduced space to indicate the intended purpose of the product on the front of pack If the container and label size are increased as a result of this without increasing the number of tablets or capsules in the bottle this could give the consumer a negative perception due to the increased head space of the container Ultimately this would also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations
Sec 9 (6) CMArsquos position on the number of active ingredients that may appear on the front of a label for listed goods is that TGO 69 If the medicine is intended to be or is requirements be maintained listed goods By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active ingredients to four or more (b) if there are four or more active active ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for ingredients in the medicine - the name these lower risk listed medicines without any evidence of consumer benefit being presented of every active ingredient together with the quantity or proportion of CMA suggests the following amendment to TGO 92 every active ingredient may appear on
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 3 of 12
Proposed Requirement TGO 92 Industry response
a side panel or side label or on a rear panel or rear label
If the medicine is intended to be or is listed goods 6 b) if the medicine is a listed complementary medicine ndash the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO 69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014 CMA includes specific examples where for listed CMs containing three active ingredients to be displayed on the front of the label where previously they would be detailed at the side or rear how this would impact on label size being inappropriate for the packaging
Sec 9 (7) CMA proposed that TGO 69 requirements be maintained If the medicine is intended to be or is registered goods then By imposing subsection 9(7)(b) would mean a requirement to go from two or more active ingredients to four or more active
ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for (a) where the medicine contains three registered complementary medicines without any specific evidence of consumer benefit relating to this lower risk class of or four active ingredients the name of good being presented the active ingredient(s) and the quantity or proportion of active Within the complementary medicine category listed and registered complementary medicines will be presented (depending ingredient(s) must be displayed on the on the number of active ingredients present) in a different manner That is some will detail active ingredients at the front of main label in a text size of not less the pack while others (with 4 or more active ingredients) will detail the ingredients at the side or rear of the pack CMA than 3 millimetres submits that for the purposes of standardisation of where to find information consumers should be encouraged to refer to
the backside of the pack for ingredient information (b) where the medicine contains four or more active ingredients and the CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of requirements of subsection 8(2) do not 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations apply then the names and the See comments at Sec 9 (7)(a) above quantities or proportion of the active ingredients may be included on a side panellabel or rear panellabel when
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 4 of 12
Proposed Requirement TGO 92 Industry response
displayed in a text size of not less than 25mm
Sec 10(3) amp Sec 10 (4)(a) CMA does not support any additional change to this lower risk category of medicine
Homeopathic medicines No explanation or justification has been provided as to why there is a new mandatory requirement to include a statement on Where all the active ingredients in a the main label that the medicine is a homeopathic medicine or contains homeopathic preparations in an increased font size to medicine are homoeopathic that of a general listed complementary medicine preparations the main label on the No real explanation has been provided as to why an increase to the font size for the statement ldquohomeopathic medicinerdquo was container and the main label on the considered a requirement based on a consumer safety perspective primary pack (if any) must in addition to the requirements referred Previous explanations for this addition has centred around that the statement is intended to assist consumers with an to in sections 8 and 9 above include a appropriate selection for a medicine and minimise confusion that may arise with self-selection However the current statement to the effect that the labelling Order requires there to be a declaration that clearly states the product is homeopathic and contains homeopathic medicine is a homoeopathic medicine ingredients on the front of the pack and the additional detail of this information on the back of the pack in the ingredients in text size that is not less than 50 and indications section would clearly justify the medicine as being based in the homoeopathic paradigm of the text size of the name of the As such CMA proposes that this section be removed from the Order medicine and (in any event) not less than 2millimeters
Sec 6 CMA submitted in May 2013 via the International Harmonisation of Ingredient Names consultation that there appeared to be no mention of the naming of homoeopathic ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS)
Interpretation in this Order traditional naming or the application of new AAN homoeopathic names As such we resubmit information for consideration here
Homoeopathic medicines ndash naming conventions
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 5 of 12
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation (i) either the name of the active ingredient or the substance from which the dilution was prepared that is accepted for inclusion in the Australian Approved Names (AAN) List together with a statement of the homeopathic potency or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency
It is suggested that an amendment be made to allow for homeopathic medicines The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
To implement this CMA proposes the following amendment to the definition of the name of the active ingredient
(b) where the ingredient is a homoeopathic preparation
1 the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency in brackets the name that is also accepted for inclusion in the Australian Approved Names List
2 for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
That is the traditional homeopathic name to be used as the primary name including the AAN unless on ldquosmall containersrdquo Both the traditional names and AAN could be included on full website information which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required)
It is in the consumersrsquo interest that traditional pharmacopeial names be amended as the primary name The concern here is
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
the context of self-selection being outlined The extra regulatory requirements for labelling
and packaging of complementary medicines are considered to be out of proportion to the
risk classifications of these medicines
The 2014 consultation highlighted that due to lower risk medicines being available for self selection this factor alone poses a risk as the consumer receives no additional information
except the instructions on the label Indeed while this highlights the importance of the
information on the medicine label no evidence has been provided that the proposed
changes would contribute to the provision of better consumer information or safety A
change to the amount of active ingredients that can be included on the front of the
medicine label and additional information around the expression of herbal ingredients for
example are proposals for change that are not supported by CMA as they have not been
evidenced to be a safety issue nor undergone consumer use testing to demonstrate any
improvement on the status quo would be gained In summary they will have little affect on
consumers self-selection
The 2014 labelling consultation included a regulatory impact statement which from an
industry point of view grossly underestimated the cost of changes
Copy from the RIS
The labour burden for businesses who need to change a label would be
approximately 20 hours (includes reading the current guidance and applying it to
their design work and the small amount of labour involved in providing new label
information as part of the application to vary the entry) at a labour rate of $42 per
hour
The additional requirements proposed in the Order and schedule 1 will result in all
companies conducting a review of each medicine formulation checking for compliance to
these revised requirements It is estimated that the $42 per hour labour rate above would
increase to approximately $60 per hour for the time required to carry out the review One
member estimates that the labour hours would increase from 20 to 30 hours and takes into
account that different sections within an organisation and external organisations are
involved in obtaining documentation for example suppliers distributors manufacturers
Testing may also be required to confirm if any allergen residue remains in the raw material
Transition arrangements
CMA notes that the proposed transition arrangement includes a four year period where by
compliance with the current labelling Order (TGO 69) or the revised TGO 92 would be
permitted By 2020 full compliance with TGO 92 would be required While this is an
improvement from the 2014 proposal CMA highlights that further refinements to TGO 92 is
required to reduce the regulatory burden for complementary medicines
Page 17 of 23
Should the Order be implemented as currently drafted there will be many complementary
medicine businesses that would be negatively impacted Not in the lest many small ownershy
operator complementary medicine businesses would not generally be in the practice of
changing their medicine labels every few years as indicated in the TGA RIS document
The transition period will also be particularly problematic where the labelled information
will differ despite no change in formulation eg change in apparent quantification
ingredient name or ingredient placement
The RIS document also detailed that the new labelling Order would be a one-off cost for
those businesses that would not be changing their labels during the transition period
The 2014 participants in the TGA industry survey included larger CM company
representatives and therefore is only indicative of that sector of the industry
Specifically the RIS did not look at the fact that smaller companies would employ the skills
of professional consultants to carry out the work required to ensure compliance with the
new labelling Order This cost factor alone for changes proposed to lower risk listed
medicines is considered an unnecessary additional regulatory burden that would not
necessarily equate to any consumer self-medication benefit
CMA submits that the focus of the TGA be one of reducing the regulatory burden enhancing
efficiencies in existing process whilst upholding the safety and quality of complementary
medicines available to consumers For these reasons CMA submits that further refinements
to TGO 92 be made to accommodate lower risk medicines
Schedule 1 Substances or groups of substances present in medicines -
that are required to be declared on the label of medicines
It appears that some inconsistencies remain in the declaration statement of certain
substances in Schedule 1 of TGO 92 compared to warning statements generated on the
ARTG
Ethanolalcohol
This group of substances to be declared on the label is not consistent with the ARTG
generated warning for ethanolalcohol
bull Contains alcohol vs contains ethanol (vv)
Ethanol as one of the substances required to be declared on the label can carry the
declaration contains alcohol However the same ingredient warning that is generated on
the ARTG for use if this ingredient is in the formula as a listed excipient is ETHAN contains
ethanol (or words to that effect)
Recommendations
Page 18 of 23
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is consistent
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label if the situation arises where there is already an ARTG
generated ethanol warning
Other ingredients such as potassium sorbate already generate ARTG warnings if listed as
excipients and is also in the group of substances required to be declared on the label
Again the wording used is inconsistent
ARTG warning SORB8 (If the medicine contains one sorbate) Contains [insert name of
sorbate] OR (if medicine contains two or more sorbates) Contains sorbates [or words to that
effect]
bull Contains sorbates vs contains [inse1i name of sorbate] (if the medicine contains one sorbate) or contains sorbates (if the medicine contains two or more sorbates) in the
event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have Contains potassium sorbate
whilst it would read Contains sorbates to comply with schedule 1 of TGO 92
Recommendations
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is
consistent If the product contains one sorbate eg potassium sorbate ARTG warning
is Contains potassium sorbate however TGO 92 declaration is Contains sorbates
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label in these situations
Phenylalanine
Many mineral amino acid chelates contain phenylalanine as part of the amino acid portion
of the mineral and ingredients such as Spirulina whole cell powder would contain
phenylalanine as part of its protein profile CMA proposes that the schedule 1 list include
additional information as to what ingredients the phenylalanine warning applies to or
outline the ingredients such as those mentioned above that are exempt from the
requirement
Imposing such requirements to all ingredients may cause unnecessary concern to the
consumer
Page 19 of 23
PU
Schedule 2 Specified Units for Enzymes -
bull CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients Papain Units Bromelain
Currently the TBS only allows the quantity of the ingredient to be expressed in milligrams
(mg) Pervious considerations of this issue has identified that the per mg expression is not
the most appropriate for the material Whilst GOU (gelatine digesting unit) is acknowledged
to be the unit most commonly used for the material papain unit is proposed as this is the
specified unit from bromelain by the joint FAOWHO expert committee on Food Additives
(JECFA) the Food Chemical Codex and the unit adopted by Health Canada in its
monographs for Stem bromelian and fruit bromelian We note also that there is a simple
conversion factor that can be applied to quantities expressed as GOU
CMA comment on the Guideline for medicine labels draft version 10
October 2015
bull 3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA proposes the
removal (of Camellia sinensis) after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation
and herbal material and quantity of standardised constituent) would be expressed
together This reiteration appears to be redundant and would take up more space on the
label
bull Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] Ingredients Uses or What this medicine is used for Warnings Directions for use and Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a
specified order) needs to be followed for listed medicines
Page 2 0 of 23
Labelling
Labelling packaging Complementary
Labelling Packaging
CMA interprets the revised TGO 92 update to mean that this would no longer be a
requirement However we have provided a mock up label at appendix 1 example 4 to
demonstrate how this requirement if relevant would impact multi ingredient herbal
medicines
CMA resources in reference to the labelling of complementary
medicines
bull CMA submission Consultation Draft TGO 79 Standards for the of Medicines
(November 2014) bull CMA submission and of Medicines (12 April
2013) bull CMA submission on the Medicine and Review (24 August 2012)
Page 21of23
CMA detailed table of reform recommendations and impact of TGO 92
Page 22 of 23
Appendix 1 - mock up labels to TGO 92 requirements
Page 23 of 23
CMA response to TGO 92- Standards for the labels of non-prescription medicines
Proposed Requirement TGO 92 Industry response
Text size In principle CMA agrees with the change that reverts back to the current TGO 69 definition of text size This is in comparison to the consultation draft TGO79 that proposed a range of sizes for listed and registered
ldquoText size equivalent to Arial fontrdquo complementary medicines based on Arial point size font has been removed from TGO 92 The definition for letter height is the same as the definition in TGO 69
Sec 7 General requirements including As stated in the CMA 2014 submission ambiguous and subjective requirements should on principle not be included in a label presentation legislative instrument (2)(e) Considering the guidance document elaborates on the proposed requirement CMA reiterates that we are not aware of there Labels must be in a colour or colours being consumer safety issues of this nature reported for CM products which are of a lower risk and hence consider the contrasting strongly with the mandatory requirement unjustified background Sec 8(2) Labels of registered medicines must provide information in a consistent order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important information access to other information is also necessary for consumers to make an informed purchasing decision CMA is of the position that for lower risk registered medicines such as registered complementary medicines there should be flexibility to present mandatory information in a clear and concise manner without the constraint of a medicine information panel (MIP) This will minimise cost to the CM industry associated with resizing labels or providing goods in larger container sizes with increased headspace Section 155 of the Guidance document outlines that ldquoa medicine information panel is not required for certain lower risk
Proposed Requirement TGO 92 Industry response
registered medicines ndash these are detailed in subsection 8(2) of TGO 92rdquo Subsection 8(2) however does not appear to detail specifically what types of lower risk registered medicines would not require a MIP CMA suggests that this part of the guidance is expanded to include specific guidance that registered complementary medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the amendment impact registered complementary medicines mock up labels have been provided to demonstrate that the requirement would necessitate a change to label sizes for complementary medicines which is considered unjustified
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of a MIP would not work and necessitate labelling complications and medicine container size considerations
Sec 8 (1) (k) (ii) (B) Pregnancy database
Requirements related tot his section should be incorporated on an ingredient by ingredient basis within the 26BB list of permissible ingredients instrument Pregnancy database - Add link httpswwwtgagovauprescribing-medicines-pregnancy-database
Sec 9 (2) CMA considers the proposed requirements to orientate all text in the same direction on the main label and for medicine names to be presented in a continuous and uninterrupted manner would not have a meaningful impact upon consumer
The name of the medicine on the main safety and as such the change is considered unjustified for lower risk medicines label must be presented in a continuous uninterrupted manner and Feedback from our members indicates that medicine labels are often developed as a result of consumer testing not be broken up by additional In addition CMA has not been presented with information that consumers have any usability difficulties with the information or background text presentation of information on complementary medicine labels Sec 9 (5) All text required by this Order to It is well documented that consumers generally select complementary medicines and non-prescription medicines by brand appear on the main label must be and category and seek out brands they know Branding is important for complementary medicines and consumers are orientated in the same direction familiar with many well-known brands of medicines for general wellbeing cough and cold allergy skincare and many
other categories Limited label space is therefore an important issue particularly for certain product and label types
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 2 of 12
Proposed Requirement TGO 92 Industry response
Such a change would impact upon brand recognition for many companies As such CMA considers this as an unjustified change to requirements adding to unnecessary regulatory burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact on branding and does not require consequential changes to dimensions of packs or labels or changes to the packaging details of a medicine
Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 30millimeters on the front panel directly under the trade name
Since consumers use complementary medicines as part of self-care the label of these medicines is the primary source of information for consumers This requirement would mean that a large portion of the label would be used to display the active ingredients Information on active ingredients is not always the most meaningful aspect in consumer self selection of these goods rather information sought by consumers tends to be focused around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space and there will be reduced space to indicate the intended purpose of the product on the front of pack If the container and label size are increased as a result of this without increasing the number of tablets or capsules in the bottle this could give the consumer a negative perception due to the increased head space of the container Ultimately this would also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations
Sec 9 (6) CMArsquos position on the number of active ingredients that may appear on the front of a label for listed goods is that TGO 69 If the medicine is intended to be or is requirements be maintained listed goods By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active ingredients to four or more (b) if there are four or more active active ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for ingredients in the medicine - the name these lower risk listed medicines without any evidence of consumer benefit being presented of every active ingredient together with the quantity or proportion of CMA suggests the following amendment to TGO 92 every active ingredient may appear on
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 3 of 12
Proposed Requirement TGO 92 Industry response
a side panel or side label or on a rear panel or rear label
If the medicine is intended to be or is listed goods 6 b) if the medicine is a listed complementary medicine ndash the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO 69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014 CMA includes specific examples where for listed CMs containing three active ingredients to be displayed on the front of the label where previously they would be detailed at the side or rear how this would impact on label size being inappropriate for the packaging
Sec 9 (7) CMA proposed that TGO 69 requirements be maintained If the medicine is intended to be or is registered goods then By imposing subsection 9(7)(b) would mean a requirement to go from two or more active ingredients to four or more active
ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for (a) where the medicine contains three registered complementary medicines without any specific evidence of consumer benefit relating to this lower risk class of or four active ingredients the name of good being presented the active ingredient(s) and the quantity or proportion of active Within the complementary medicine category listed and registered complementary medicines will be presented (depending ingredient(s) must be displayed on the on the number of active ingredients present) in a different manner That is some will detail active ingredients at the front of main label in a text size of not less the pack while others (with 4 or more active ingredients) will detail the ingredients at the side or rear of the pack CMA than 3 millimetres submits that for the purposes of standardisation of where to find information consumers should be encouraged to refer to
the backside of the pack for ingredient information (b) where the medicine contains four or more active ingredients and the CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of requirements of subsection 8(2) do not 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations apply then the names and the See comments at Sec 9 (7)(a) above quantities or proportion of the active ingredients may be included on a side panellabel or rear panellabel when
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 4 of 12
Proposed Requirement TGO 92 Industry response
displayed in a text size of not less than 25mm
Sec 10(3) amp Sec 10 (4)(a) CMA does not support any additional change to this lower risk category of medicine
Homeopathic medicines No explanation or justification has been provided as to why there is a new mandatory requirement to include a statement on Where all the active ingredients in a the main label that the medicine is a homeopathic medicine or contains homeopathic preparations in an increased font size to medicine are homoeopathic that of a general listed complementary medicine preparations the main label on the No real explanation has been provided as to why an increase to the font size for the statement ldquohomeopathic medicinerdquo was container and the main label on the considered a requirement based on a consumer safety perspective primary pack (if any) must in addition to the requirements referred Previous explanations for this addition has centred around that the statement is intended to assist consumers with an to in sections 8 and 9 above include a appropriate selection for a medicine and minimise confusion that may arise with self-selection However the current statement to the effect that the labelling Order requires there to be a declaration that clearly states the product is homeopathic and contains homeopathic medicine is a homoeopathic medicine ingredients on the front of the pack and the additional detail of this information on the back of the pack in the ingredients in text size that is not less than 50 and indications section would clearly justify the medicine as being based in the homoeopathic paradigm of the text size of the name of the As such CMA proposes that this section be removed from the Order medicine and (in any event) not less than 2millimeters
Sec 6 CMA submitted in May 2013 via the International Harmonisation of Ingredient Names consultation that there appeared to be no mention of the naming of homoeopathic ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS)
Interpretation in this Order traditional naming or the application of new AAN homoeopathic names As such we resubmit information for consideration here
Homoeopathic medicines ndash naming conventions
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 5 of 12
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation (i) either the name of the active ingredient or the substance from which the dilution was prepared that is accepted for inclusion in the Australian Approved Names (AAN) List together with a statement of the homeopathic potency or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency
It is suggested that an amendment be made to allow for homeopathic medicines The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
To implement this CMA proposes the following amendment to the definition of the name of the active ingredient
(b) where the ingredient is a homoeopathic preparation
1 the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency in brackets the name that is also accepted for inclusion in the Australian Approved Names List
2 for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
That is the traditional homeopathic name to be used as the primary name including the AAN unless on ldquosmall containersrdquo Both the traditional names and AAN could be included on full website information which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required)
It is in the consumersrsquo interest that traditional pharmacopeial names be amended as the primary name The concern here is
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
Should the Order be implemented as currently drafted there will be many complementary
medicine businesses that would be negatively impacted Not in the lest many small ownershy
operator complementary medicine businesses would not generally be in the practice of
changing their medicine labels every few years as indicated in the TGA RIS document
The transition period will also be particularly problematic where the labelled information
will differ despite no change in formulation eg change in apparent quantification
ingredient name or ingredient placement
The RIS document also detailed that the new labelling Order would be a one-off cost for
those businesses that would not be changing their labels during the transition period
The 2014 participants in the TGA industry survey included larger CM company
representatives and therefore is only indicative of that sector of the industry
Specifically the RIS did not look at the fact that smaller companies would employ the skills
of professional consultants to carry out the work required to ensure compliance with the
new labelling Order This cost factor alone for changes proposed to lower risk listed
medicines is considered an unnecessary additional regulatory burden that would not
necessarily equate to any consumer self-medication benefit
CMA submits that the focus of the TGA be one of reducing the regulatory burden enhancing
efficiencies in existing process whilst upholding the safety and quality of complementary
medicines available to consumers For these reasons CMA submits that further refinements
to TGO 92 be made to accommodate lower risk medicines
Schedule 1 Substances or groups of substances present in medicines -
that are required to be declared on the label of medicines
It appears that some inconsistencies remain in the declaration statement of certain
substances in Schedule 1 of TGO 92 compared to warning statements generated on the
ARTG
Ethanolalcohol
This group of substances to be declared on the label is not consistent with the ARTG
generated warning for ethanolalcohol
bull Contains alcohol vs contains ethanol (vv)
Ethanol as one of the substances required to be declared on the label can carry the
declaration contains alcohol However the same ingredient warning that is generated on
the ARTG for use if this ingredient is in the formula as a listed excipient is ETHAN contains
ethanol (or words to that effect)
Recommendations
Page 18 of 23
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is consistent
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label if the situation arises where there is already an ARTG
generated ethanol warning
Other ingredients such as potassium sorbate already generate ARTG warnings if listed as
excipients and is also in the group of substances required to be declared on the label
Again the wording used is inconsistent
ARTG warning SORB8 (If the medicine contains one sorbate) Contains [insert name of
sorbate] OR (if medicine contains two or more sorbates) Contains sorbates [or words to that
effect]
bull Contains sorbates vs contains [inse1i name of sorbate] (if the medicine contains one sorbate) or contains sorbates (if the medicine contains two or more sorbates) in the
event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have Contains potassium sorbate
whilst it would read Contains sorbates to comply with schedule 1 of TGO 92
Recommendations
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is
consistent If the product contains one sorbate eg potassium sorbate ARTG warning
is Contains potassium sorbate however TGO 92 declaration is Contains sorbates
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label in these situations
Phenylalanine
Many mineral amino acid chelates contain phenylalanine as part of the amino acid portion
of the mineral and ingredients such as Spirulina whole cell powder would contain
phenylalanine as part of its protein profile CMA proposes that the schedule 1 list include
additional information as to what ingredients the phenylalanine warning applies to or
outline the ingredients such as those mentioned above that are exempt from the
requirement
Imposing such requirements to all ingredients may cause unnecessary concern to the
consumer
Page 19 of 23
PU
Schedule 2 Specified Units for Enzymes -
bull CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients Papain Units Bromelain
Currently the TBS only allows the quantity of the ingredient to be expressed in milligrams
(mg) Pervious considerations of this issue has identified that the per mg expression is not
the most appropriate for the material Whilst GOU (gelatine digesting unit) is acknowledged
to be the unit most commonly used for the material papain unit is proposed as this is the
specified unit from bromelain by the joint FAOWHO expert committee on Food Additives
(JECFA) the Food Chemical Codex and the unit adopted by Health Canada in its
monographs for Stem bromelian and fruit bromelian We note also that there is a simple
conversion factor that can be applied to quantities expressed as GOU
CMA comment on the Guideline for medicine labels draft version 10
October 2015
bull 3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA proposes the
removal (of Camellia sinensis) after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation
and herbal material and quantity of standardised constituent) would be expressed
together This reiteration appears to be redundant and would take up more space on the
label
bull Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] Ingredients Uses or What this medicine is used for Warnings Directions for use and Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a
specified order) needs to be followed for listed medicines
Page 2 0 of 23
Labelling
Labelling packaging Complementary
Labelling Packaging
CMA interprets the revised TGO 92 update to mean that this would no longer be a
requirement However we have provided a mock up label at appendix 1 example 4 to
demonstrate how this requirement if relevant would impact multi ingredient herbal
medicines
CMA resources in reference to the labelling of complementary
medicines
bull CMA submission Consultation Draft TGO 79 Standards for the of Medicines
(November 2014) bull CMA submission and of Medicines (12 April
2013) bull CMA submission on the Medicine and Review (24 August 2012)
Page 21of23
CMA detailed table of reform recommendations and impact of TGO 92
Page 22 of 23
Appendix 1 - mock up labels to TGO 92 requirements
Page 23 of 23
CMA response to TGO 92- Standards for the labels of non-prescription medicines
Proposed Requirement TGO 92 Industry response
Text size In principle CMA agrees with the change that reverts back to the current TGO 69 definition of text size This is in comparison to the consultation draft TGO79 that proposed a range of sizes for listed and registered
ldquoText size equivalent to Arial fontrdquo complementary medicines based on Arial point size font has been removed from TGO 92 The definition for letter height is the same as the definition in TGO 69
Sec 7 General requirements including As stated in the CMA 2014 submission ambiguous and subjective requirements should on principle not be included in a label presentation legislative instrument (2)(e) Considering the guidance document elaborates on the proposed requirement CMA reiterates that we are not aware of there Labels must be in a colour or colours being consumer safety issues of this nature reported for CM products which are of a lower risk and hence consider the contrasting strongly with the mandatory requirement unjustified background Sec 8(2) Labels of registered medicines must provide information in a consistent order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important information access to other information is also necessary for consumers to make an informed purchasing decision CMA is of the position that for lower risk registered medicines such as registered complementary medicines there should be flexibility to present mandatory information in a clear and concise manner without the constraint of a medicine information panel (MIP) This will minimise cost to the CM industry associated with resizing labels or providing goods in larger container sizes with increased headspace Section 155 of the Guidance document outlines that ldquoa medicine information panel is not required for certain lower risk
Proposed Requirement TGO 92 Industry response
registered medicines ndash these are detailed in subsection 8(2) of TGO 92rdquo Subsection 8(2) however does not appear to detail specifically what types of lower risk registered medicines would not require a MIP CMA suggests that this part of the guidance is expanded to include specific guidance that registered complementary medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the amendment impact registered complementary medicines mock up labels have been provided to demonstrate that the requirement would necessitate a change to label sizes for complementary medicines which is considered unjustified
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of a MIP would not work and necessitate labelling complications and medicine container size considerations
Sec 8 (1) (k) (ii) (B) Pregnancy database
Requirements related tot his section should be incorporated on an ingredient by ingredient basis within the 26BB list of permissible ingredients instrument Pregnancy database - Add link httpswwwtgagovauprescribing-medicines-pregnancy-database
Sec 9 (2) CMA considers the proposed requirements to orientate all text in the same direction on the main label and for medicine names to be presented in a continuous and uninterrupted manner would not have a meaningful impact upon consumer
The name of the medicine on the main safety and as such the change is considered unjustified for lower risk medicines label must be presented in a continuous uninterrupted manner and Feedback from our members indicates that medicine labels are often developed as a result of consumer testing not be broken up by additional In addition CMA has not been presented with information that consumers have any usability difficulties with the information or background text presentation of information on complementary medicine labels Sec 9 (5) All text required by this Order to It is well documented that consumers generally select complementary medicines and non-prescription medicines by brand appear on the main label must be and category and seek out brands they know Branding is important for complementary medicines and consumers are orientated in the same direction familiar with many well-known brands of medicines for general wellbeing cough and cold allergy skincare and many
other categories Limited label space is therefore an important issue particularly for certain product and label types
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 2 of 12
Proposed Requirement TGO 92 Industry response
Such a change would impact upon brand recognition for many companies As such CMA considers this as an unjustified change to requirements adding to unnecessary regulatory burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact on branding and does not require consequential changes to dimensions of packs or labels or changes to the packaging details of a medicine
Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 30millimeters on the front panel directly under the trade name
Since consumers use complementary medicines as part of self-care the label of these medicines is the primary source of information for consumers This requirement would mean that a large portion of the label would be used to display the active ingredients Information on active ingredients is not always the most meaningful aspect in consumer self selection of these goods rather information sought by consumers tends to be focused around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space and there will be reduced space to indicate the intended purpose of the product on the front of pack If the container and label size are increased as a result of this without increasing the number of tablets or capsules in the bottle this could give the consumer a negative perception due to the increased head space of the container Ultimately this would also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations
Sec 9 (6) CMArsquos position on the number of active ingredients that may appear on the front of a label for listed goods is that TGO 69 If the medicine is intended to be or is requirements be maintained listed goods By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active ingredients to four or more (b) if there are four or more active active ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for ingredients in the medicine - the name these lower risk listed medicines without any evidence of consumer benefit being presented of every active ingredient together with the quantity or proportion of CMA suggests the following amendment to TGO 92 every active ingredient may appear on
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 3 of 12
Proposed Requirement TGO 92 Industry response
a side panel or side label or on a rear panel or rear label
If the medicine is intended to be or is listed goods 6 b) if the medicine is a listed complementary medicine ndash the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO 69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014 CMA includes specific examples where for listed CMs containing three active ingredients to be displayed on the front of the label where previously they would be detailed at the side or rear how this would impact on label size being inappropriate for the packaging
Sec 9 (7) CMA proposed that TGO 69 requirements be maintained If the medicine is intended to be or is registered goods then By imposing subsection 9(7)(b) would mean a requirement to go from two or more active ingredients to four or more active
ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for (a) where the medicine contains three registered complementary medicines without any specific evidence of consumer benefit relating to this lower risk class of or four active ingredients the name of good being presented the active ingredient(s) and the quantity or proportion of active Within the complementary medicine category listed and registered complementary medicines will be presented (depending ingredient(s) must be displayed on the on the number of active ingredients present) in a different manner That is some will detail active ingredients at the front of main label in a text size of not less the pack while others (with 4 or more active ingredients) will detail the ingredients at the side or rear of the pack CMA than 3 millimetres submits that for the purposes of standardisation of where to find information consumers should be encouraged to refer to
the backside of the pack for ingredient information (b) where the medicine contains four or more active ingredients and the CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of requirements of subsection 8(2) do not 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations apply then the names and the See comments at Sec 9 (7)(a) above quantities or proportion of the active ingredients may be included on a side panellabel or rear panellabel when
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 4 of 12
Proposed Requirement TGO 92 Industry response
displayed in a text size of not less than 25mm
Sec 10(3) amp Sec 10 (4)(a) CMA does not support any additional change to this lower risk category of medicine
Homeopathic medicines No explanation or justification has been provided as to why there is a new mandatory requirement to include a statement on Where all the active ingredients in a the main label that the medicine is a homeopathic medicine or contains homeopathic preparations in an increased font size to medicine are homoeopathic that of a general listed complementary medicine preparations the main label on the No real explanation has been provided as to why an increase to the font size for the statement ldquohomeopathic medicinerdquo was container and the main label on the considered a requirement based on a consumer safety perspective primary pack (if any) must in addition to the requirements referred Previous explanations for this addition has centred around that the statement is intended to assist consumers with an to in sections 8 and 9 above include a appropriate selection for a medicine and minimise confusion that may arise with self-selection However the current statement to the effect that the labelling Order requires there to be a declaration that clearly states the product is homeopathic and contains homeopathic medicine is a homoeopathic medicine ingredients on the front of the pack and the additional detail of this information on the back of the pack in the ingredients in text size that is not less than 50 and indications section would clearly justify the medicine as being based in the homoeopathic paradigm of the text size of the name of the As such CMA proposes that this section be removed from the Order medicine and (in any event) not less than 2millimeters
Sec 6 CMA submitted in May 2013 via the International Harmonisation of Ingredient Names consultation that there appeared to be no mention of the naming of homoeopathic ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS)
Interpretation in this Order traditional naming or the application of new AAN homoeopathic names As such we resubmit information for consideration here
Homoeopathic medicines ndash naming conventions
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 5 of 12
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation (i) either the name of the active ingredient or the substance from which the dilution was prepared that is accepted for inclusion in the Australian Approved Names (AAN) List together with a statement of the homeopathic potency or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency
It is suggested that an amendment be made to allow for homeopathic medicines The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
To implement this CMA proposes the following amendment to the definition of the name of the active ingredient
(b) where the ingredient is a homoeopathic preparation
1 the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency in brackets the name that is also accepted for inclusion in the Australian Approved Names List
2 for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
That is the traditional homeopathic name to be used as the primary name including the AAN unless on ldquosmall containersrdquo Both the traditional names and AAN could be included on full website information which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required)
It is in the consumersrsquo interest that traditional pharmacopeial names be amended as the primary name The concern here is
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is consistent
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label if the situation arises where there is already an ARTG
generated ethanol warning
Other ingredients such as potassium sorbate already generate ARTG warnings if listed as
excipients and is also in the group of substances required to be declared on the label
Again the wording used is inconsistent
ARTG warning SORB8 (If the medicine contains one sorbate) Contains [insert name of
sorbate] OR (if medicine contains two or more sorbates) Contains sorbates [or words to that
effect]
bull Contains sorbates vs contains [inse1i name of sorbate] (if the medicine contains one sorbate) or contains sorbates (if the medicine contains two or more sorbates) in the
event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have Contains potassium sorbate
whilst it would read Contains sorbates to comply with schedule 1 of TGO 92
Recommendations
bull Streamline the ARTG warning and TGO 92 declaration so that the wording is
consistent If the product contains one sorbate eg potassium sorbate ARTG warning
is Contains potassium sorbate however TGO 92 declaration is Contains sorbates
bull Need to clarify if both the ARTG warning and the TGO 92 declaration are both
required on the label in these situations
Phenylalanine
Many mineral amino acid chelates contain phenylalanine as part of the amino acid portion
of the mineral and ingredients such as Spirulina whole cell powder would contain
phenylalanine as part of its protein profile CMA proposes that the schedule 1 list include
additional information as to what ingredients the phenylalanine warning applies to or
outline the ingredients such as those mentioned above that are exempt from the
requirement
Imposing such requirements to all ingredients may cause unnecessary concern to the
consumer
Page 19 of 23
PU
Schedule 2 Specified Units for Enzymes -
bull CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients Papain Units Bromelain
Currently the TBS only allows the quantity of the ingredient to be expressed in milligrams
(mg) Pervious considerations of this issue has identified that the per mg expression is not
the most appropriate for the material Whilst GOU (gelatine digesting unit) is acknowledged
to be the unit most commonly used for the material papain unit is proposed as this is the
specified unit from bromelain by the joint FAOWHO expert committee on Food Additives
(JECFA) the Food Chemical Codex and the unit adopted by Health Canada in its
monographs for Stem bromelian and fruit bromelian We note also that there is a simple
conversion factor that can be applied to quantities expressed as GOU
CMA comment on the Guideline for medicine labels draft version 10
October 2015
bull 3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA proposes the
removal (of Camellia sinensis) after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation
and herbal material and quantity of standardised constituent) would be expressed
together This reiteration appears to be redundant and would take up more space on the
label
bull Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] Ingredients Uses or What this medicine is used for Warnings Directions for use and Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a
specified order) needs to be followed for listed medicines
Page 2 0 of 23
Labelling
Labelling packaging Complementary
Labelling Packaging
CMA interprets the revised TGO 92 update to mean that this would no longer be a
requirement However we have provided a mock up label at appendix 1 example 4 to
demonstrate how this requirement if relevant would impact multi ingredient herbal
medicines
CMA resources in reference to the labelling of complementary
medicines
bull CMA submission Consultation Draft TGO 79 Standards for the of Medicines
(November 2014) bull CMA submission and of Medicines (12 April
2013) bull CMA submission on the Medicine and Review (24 August 2012)
Page 21of23
CMA detailed table of reform recommendations and impact of TGO 92
Page 22 of 23
Appendix 1 - mock up labels to TGO 92 requirements
Page 23 of 23
CMA response to TGO 92- Standards for the labels of non-prescription medicines
Proposed Requirement TGO 92 Industry response
Text size In principle CMA agrees with the change that reverts back to the current TGO 69 definition of text size This is in comparison to the consultation draft TGO79 that proposed a range of sizes for listed and registered
ldquoText size equivalent to Arial fontrdquo complementary medicines based on Arial point size font has been removed from TGO 92 The definition for letter height is the same as the definition in TGO 69
Sec 7 General requirements including As stated in the CMA 2014 submission ambiguous and subjective requirements should on principle not be included in a label presentation legislative instrument (2)(e) Considering the guidance document elaborates on the proposed requirement CMA reiterates that we are not aware of there Labels must be in a colour or colours being consumer safety issues of this nature reported for CM products which are of a lower risk and hence consider the contrasting strongly with the mandatory requirement unjustified background Sec 8(2) Labels of registered medicines must provide information in a consistent order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important information access to other information is also necessary for consumers to make an informed purchasing decision CMA is of the position that for lower risk registered medicines such as registered complementary medicines there should be flexibility to present mandatory information in a clear and concise manner without the constraint of a medicine information panel (MIP) This will minimise cost to the CM industry associated with resizing labels or providing goods in larger container sizes with increased headspace Section 155 of the Guidance document outlines that ldquoa medicine information panel is not required for certain lower risk
Proposed Requirement TGO 92 Industry response
registered medicines ndash these are detailed in subsection 8(2) of TGO 92rdquo Subsection 8(2) however does not appear to detail specifically what types of lower risk registered medicines would not require a MIP CMA suggests that this part of the guidance is expanded to include specific guidance that registered complementary medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the amendment impact registered complementary medicines mock up labels have been provided to demonstrate that the requirement would necessitate a change to label sizes for complementary medicines which is considered unjustified
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of a MIP would not work and necessitate labelling complications and medicine container size considerations
Sec 8 (1) (k) (ii) (B) Pregnancy database
Requirements related tot his section should be incorporated on an ingredient by ingredient basis within the 26BB list of permissible ingredients instrument Pregnancy database - Add link httpswwwtgagovauprescribing-medicines-pregnancy-database
Sec 9 (2) CMA considers the proposed requirements to orientate all text in the same direction on the main label and for medicine names to be presented in a continuous and uninterrupted manner would not have a meaningful impact upon consumer
The name of the medicine on the main safety and as such the change is considered unjustified for lower risk medicines label must be presented in a continuous uninterrupted manner and Feedback from our members indicates that medicine labels are often developed as a result of consumer testing not be broken up by additional In addition CMA has not been presented with information that consumers have any usability difficulties with the information or background text presentation of information on complementary medicine labels Sec 9 (5) All text required by this Order to It is well documented that consumers generally select complementary medicines and non-prescription medicines by brand appear on the main label must be and category and seek out brands they know Branding is important for complementary medicines and consumers are orientated in the same direction familiar with many well-known brands of medicines for general wellbeing cough and cold allergy skincare and many
other categories Limited label space is therefore an important issue particularly for certain product and label types
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 2 of 12
Proposed Requirement TGO 92 Industry response
Such a change would impact upon brand recognition for many companies As such CMA considers this as an unjustified change to requirements adding to unnecessary regulatory burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact on branding and does not require consequential changes to dimensions of packs or labels or changes to the packaging details of a medicine
Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 30millimeters on the front panel directly under the trade name
Since consumers use complementary medicines as part of self-care the label of these medicines is the primary source of information for consumers This requirement would mean that a large portion of the label would be used to display the active ingredients Information on active ingredients is not always the most meaningful aspect in consumer self selection of these goods rather information sought by consumers tends to be focused around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space and there will be reduced space to indicate the intended purpose of the product on the front of pack If the container and label size are increased as a result of this without increasing the number of tablets or capsules in the bottle this could give the consumer a negative perception due to the increased head space of the container Ultimately this would also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations
Sec 9 (6) CMArsquos position on the number of active ingredients that may appear on the front of a label for listed goods is that TGO 69 If the medicine is intended to be or is requirements be maintained listed goods By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active ingredients to four or more (b) if there are four or more active active ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for ingredients in the medicine - the name these lower risk listed medicines without any evidence of consumer benefit being presented of every active ingredient together with the quantity or proportion of CMA suggests the following amendment to TGO 92 every active ingredient may appear on
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 3 of 12
Proposed Requirement TGO 92 Industry response
a side panel or side label or on a rear panel or rear label
If the medicine is intended to be or is listed goods 6 b) if the medicine is a listed complementary medicine ndash the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO 69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014 CMA includes specific examples where for listed CMs containing three active ingredients to be displayed on the front of the label where previously they would be detailed at the side or rear how this would impact on label size being inappropriate for the packaging
Sec 9 (7) CMA proposed that TGO 69 requirements be maintained If the medicine is intended to be or is registered goods then By imposing subsection 9(7)(b) would mean a requirement to go from two or more active ingredients to four or more active
ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for (a) where the medicine contains three registered complementary medicines without any specific evidence of consumer benefit relating to this lower risk class of or four active ingredients the name of good being presented the active ingredient(s) and the quantity or proportion of active Within the complementary medicine category listed and registered complementary medicines will be presented (depending ingredient(s) must be displayed on the on the number of active ingredients present) in a different manner That is some will detail active ingredients at the front of main label in a text size of not less the pack while others (with 4 or more active ingredients) will detail the ingredients at the side or rear of the pack CMA than 3 millimetres submits that for the purposes of standardisation of where to find information consumers should be encouraged to refer to
the backside of the pack for ingredient information (b) where the medicine contains four or more active ingredients and the CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of requirements of subsection 8(2) do not 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations apply then the names and the See comments at Sec 9 (7)(a) above quantities or proportion of the active ingredients may be included on a side panellabel or rear panellabel when
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 4 of 12
Proposed Requirement TGO 92 Industry response
displayed in a text size of not less than 25mm
Sec 10(3) amp Sec 10 (4)(a) CMA does not support any additional change to this lower risk category of medicine
Homeopathic medicines No explanation or justification has been provided as to why there is a new mandatory requirement to include a statement on Where all the active ingredients in a the main label that the medicine is a homeopathic medicine or contains homeopathic preparations in an increased font size to medicine are homoeopathic that of a general listed complementary medicine preparations the main label on the No real explanation has been provided as to why an increase to the font size for the statement ldquohomeopathic medicinerdquo was container and the main label on the considered a requirement based on a consumer safety perspective primary pack (if any) must in addition to the requirements referred Previous explanations for this addition has centred around that the statement is intended to assist consumers with an to in sections 8 and 9 above include a appropriate selection for a medicine and minimise confusion that may arise with self-selection However the current statement to the effect that the labelling Order requires there to be a declaration that clearly states the product is homeopathic and contains homeopathic medicine is a homoeopathic medicine ingredients on the front of the pack and the additional detail of this information on the back of the pack in the ingredients in text size that is not less than 50 and indications section would clearly justify the medicine as being based in the homoeopathic paradigm of the text size of the name of the As such CMA proposes that this section be removed from the Order medicine and (in any event) not less than 2millimeters
Sec 6 CMA submitted in May 2013 via the International Harmonisation of Ingredient Names consultation that there appeared to be no mention of the naming of homoeopathic ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS)
Interpretation in this Order traditional naming or the application of new AAN homoeopathic names As such we resubmit information for consideration here
Homoeopathic medicines ndash naming conventions
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 5 of 12
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation (i) either the name of the active ingredient or the substance from which the dilution was prepared that is accepted for inclusion in the Australian Approved Names (AAN) List together with a statement of the homeopathic potency or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency
It is suggested that an amendment be made to allow for homeopathic medicines The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
To implement this CMA proposes the following amendment to the definition of the name of the active ingredient
(b) where the ingredient is a homoeopathic preparation
1 the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency in brackets the name that is also accepted for inclusion in the Australian Approved Names List
2 for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
That is the traditional homeopathic name to be used as the primary name including the AAN unless on ldquosmall containersrdquo Both the traditional names and AAN could be included on full website information which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required)
It is in the consumersrsquo interest that traditional pharmacopeial names be amended as the primary name The concern here is
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
PU
Schedule 2 Specified Units for Enzymes -
bull CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients Papain Units Bromelain
Currently the TBS only allows the quantity of the ingredient to be expressed in milligrams
(mg) Pervious considerations of this issue has identified that the per mg expression is not
the most appropriate for the material Whilst GOU (gelatine digesting unit) is acknowledged
to be the unit most commonly used for the material papain unit is proposed as this is the
specified unit from bromelain by the joint FAOWHO expert committee on Food Additives
(JECFA) the Food Chemical Codex and the unit adopted by Health Canada in its
monographs for Stem bromelian and fruit bromelian We note also that there is a simple
conversion factor that can be applied to quantities expressed as GOU
CMA comment on the Guideline for medicine labels draft version 10
October 2015
bull 3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA proposes the
removal (of Camellia sinensis) after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation
and herbal material and quantity of standardised constituent) would be expressed
together This reiteration appears to be redundant and would take up more space on the
label
bull Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] Ingredients Uses or What this medicine is used for Warnings Directions for use and Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a
specified order) needs to be followed for listed medicines
Page 2 0 of 23
Labelling
Labelling packaging Complementary
Labelling Packaging
CMA interprets the revised TGO 92 update to mean that this would no longer be a
requirement However we have provided a mock up label at appendix 1 example 4 to
demonstrate how this requirement if relevant would impact multi ingredient herbal
medicines
CMA resources in reference to the labelling of complementary
medicines
bull CMA submission Consultation Draft TGO 79 Standards for the of Medicines
(November 2014) bull CMA submission and of Medicines (12 April
2013) bull CMA submission on the Medicine and Review (24 August 2012)
Page 21of23
CMA detailed table of reform recommendations and impact of TGO 92
Page 22 of 23
Appendix 1 - mock up labels to TGO 92 requirements
Page 23 of 23
CMA response to TGO 92- Standards for the labels of non-prescription medicines
Proposed Requirement TGO 92 Industry response
Text size In principle CMA agrees with the change that reverts back to the current TGO 69 definition of text size This is in comparison to the consultation draft TGO79 that proposed a range of sizes for listed and registered
ldquoText size equivalent to Arial fontrdquo complementary medicines based on Arial point size font has been removed from TGO 92 The definition for letter height is the same as the definition in TGO 69
Sec 7 General requirements including As stated in the CMA 2014 submission ambiguous and subjective requirements should on principle not be included in a label presentation legislative instrument (2)(e) Considering the guidance document elaborates on the proposed requirement CMA reiterates that we are not aware of there Labels must be in a colour or colours being consumer safety issues of this nature reported for CM products which are of a lower risk and hence consider the contrasting strongly with the mandatory requirement unjustified background Sec 8(2) Labels of registered medicines must provide information in a consistent order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important information access to other information is also necessary for consumers to make an informed purchasing decision CMA is of the position that for lower risk registered medicines such as registered complementary medicines there should be flexibility to present mandatory information in a clear and concise manner without the constraint of a medicine information panel (MIP) This will minimise cost to the CM industry associated with resizing labels or providing goods in larger container sizes with increased headspace Section 155 of the Guidance document outlines that ldquoa medicine information panel is not required for certain lower risk
Proposed Requirement TGO 92 Industry response
registered medicines ndash these are detailed in subsection 8(2) of TGO 92rdquo Subsection 8(2) however does not appear to detail specifically what types of lower risk registered medicines would not require a MIP CMA suggests that this part of the guidance is expanded to include specific guidance that registered complementary medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the amendment impact registered complementary medicines mock up labels have been provided to demonstrate that the requirement would necessitate a change to label sizes for complementary medicines which is considered unjustified
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of a MIP would not work and necessitate labelling complications and medicine container size considerations
Sec 8 (1) (k) (ii) (B) Pregnancy database
Requirements related tot his section should be incorporated on an ingredient by ingredient basis within the 26BB list of permissible ingredients instrument Pregnancy database - Add link httpswwwtgagovauprescribing-medicines-pregnancy-database
Sec 9 (2) CMA considers the proposed requirements to orientate all text in the same direction on the main label and for medicine names to be presented in a continuous and uninterrupted manner would not have a meaningful impact upon consumer
The name of the medicine on the main safety and as such the change is considered unjustified for lower risk medicines label must be presented in a continuous uninterrupted manner and Feedback from our members indicates that medicine labels are often developed as a result of consumer testing not be broken up by additional In addition CMA has not been presented with information that consumers have any usability difficulties with the information or background text presentation of information on complementary medicine labels Sec 9 (5) All text required by this Order to It is well documented that consumers generally select complementary medicines and non-prescription medicines by brand appear on the main label must be and category and seek out brands they know Branding is important for complementary medicines and consumers are orientated in the same direction familiar with many well-known brands of medicines for general wellbeing cough and cold allergy skincare and many
other categories Limited label space is therefore an important issue particularly for certain product and label types
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 2 of 12
Proposed Requirement TGO 92 Industry response
Such a change would impact upon brand recognition for many companies As such CMA considers this as an unjustified change to requirements adding to unnecessary regulatory burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact on branding and does not require consequential changes to dimensions of packs or labels or changes to the packaging details of a medicine
Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 30millimeters on the front panel directly under the trade name
Since consumers use complementary medicines as part of self-care the label of these medicines is the primary source of information for consumers This requirement would mean that a large portion of the label would be used to display the active ingredients Information on active ingredients is not always the most meaningful aspect in consumer self selection of these goods rather information sought by consumers tends to be focused around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space and there will be reduced space to indicate the intended purpose of the product on the front of pack If the container and label size are increased as a result of this without increasing the number of tablets or capsules in the bottle this could give the consumer a negative perception due to the increased head space of the container Ultimately this would also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations
Sec 9 (6) CMArsquos position on the number of active ingredients that may appear on the front of a label for listed goods is that TGO 69 If the medicine is intended to be or is requirements be maintained listed goods By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active ingredients to four or more (b) if there are four or more active active ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for ingredients in the medicine - the name these lower risk listed medicines without any evidence of consumer benefit being presented of every active ingredient together with the quantity or proportion of CMA suggests the following amendment to TGO 92 every active ingredient may appear on
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 3 of 12
Proposed Requirement TGO 92 Industry response
a side panel or side label or on a rear panel or rear label
If the medicine is intended to be or is listed goods 6 b) if the medicine is a listed complementary medicine ndash the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO 69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014 CMA includes specific examples where for listed CMs containing three active ingredients to be displayed on the front of the label where previously they would be detailed at the side or rear how this would impact on label size being inappropriate for the packaging
Sec 9 (7) CMA proposed that TGO 69 requirements be maintained If the medicine is intended to be or is registered goods then By imposing subsection 9(7)(b) would mean a requirement to go from two or more active ingredients to four or more active
ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for (a) where the medicine contains three registered complementary medicines without any specific evidence of consumer benefit relating to this lower risk class of or four active ingredients the name of good being presented the active ingredient(s) and the quantity or proportion of active Within the complementary medicine category listed and registered complementary medicines will be presented (depending ingredient(s) must be displayed on the on the number of active ingredients present) in a different manner That is some will detail active ingredients at the front of main label in a text size of not less the pack while others (with 4 or more active ingredients) will detail the ingredients at the side or rear of the pack CMA than 3 millimetres submits that for the purposes of standardisation of where to find information consumers should be encouraged to refer to
the backside of the pack for ingredient information (b) where the medicine contains four or more active ingredients and the CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of requirements of subsection 8(2) do not 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations apply then the names and the See comments at Sec 9 (7)(a) above quantities or proportion of the active ingredients may be included on a side panellabel or rear panellabel when
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 4 of 12
Proposed Requirement TGO 92 Industry response
displayed in a text size of not less than 25mm
Sec 10(3) amp Sec 10 (4)(a) CMA does not support any additional change to this lower risk category of medicine
Homeopathic medicines No explanation or justification has been provided as to why there is a new mandatory requirement to include a statement on Where all the active ingredients in a the main label that the medicine is a homeopathic medicine or contains homeopathic preparations in an increased font size to medicine are homoeopathic that of a general listed complementary medicine preparations the main label on the No real explanation has been provided as to why an increase to the font size for the statement ldquohomeopathic medicinerdquo was container and the main label on the considered a requirement based on a consumer safety perspective primary pack (if any) must in addition to the requirements referred Previous explanations for this addition has centred around that the statement is intended to assist consumers with an to in sections 8 and 9 above include a appropriate selection for a medicine and minimise confusion that may arise with self-selection However the current statement to the effect that the labelling Order requires there to be a declaration that clearly states the product is homeopathic and contains homeopathic medicine is a homoeopathic medicine ingredients on the front of the pack and the additional detail of this information on the back of the pack in the ingredients in text size that is not less than 50 and indications section would clearly justify the medicine as being based in the homoeopathic paradigm of the text size of the name of the As such CMA proposes that this section be removed from the Order medicine and (in any event) not less than 2millimeters
Sec 6 CMA submitted in May 2013 via the International Harmonisation of Ingredient Names consultation that there appeared to be no mention of the naming of homoeopathic ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS)
Interpretation in this Order traditional naming or the application of new AAN homoeopathic names As such we resubmit information for consideration here
Homoeopathic medicines ndash naming conventions
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 5 of 12
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation (i) either the name of the active ingredient or the substance from which the dilution was prepared that is accepted for inclusion in the Australian Approved Names (AAN) List together with a statement of the homeopathic potency or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency
It is suggested that an amendment be made to allow for homeopathic medicines The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
To implement this CMA proposes the following amendment to the definition of the name of the active ingredient
(b) where the ingredient is a homoeopathic preparation
1 the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency in brackets the name that is also accepted for inclusion in the Australian Approved Names List
2 for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
That is the traditional homeopathic name to be used as the primary name including the AAN unless on ldquosmall containersrdquo Both the traditional names and AAN could be included on full website information which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required)
It is in the consumersrsquo interest that traditional pharmacopeial names be amended as the primary name The concern here is
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
Labelling
Labelling packaging Complementary
Labelling Packaging
CMA interprets the revised TGO 92 update to mean that this would no longer be a
requirement However we have provided a mock up label at appendix 1 example 4 to
demonstrate how this requirement if relevant would impact multi ingredient herbal
medicines
CMA resources in reference to the labelling of complementary
medicines
bull CMA submission Consultation Draft TGO 79 Standards for the of Medicines
(November 2014) bull CMA submission and of Medicines (12 April
2013) bull CMA submission on the Medicine and Review (24 August 2012)
Page 21of23
CMA detailed table of reform recommendations and impact of TGO 92
Page 22 of 23
Appendix 1 - mock up labels to TGO 92 requirements
Page 23 of 23
CMA response to TGO 92- Standards for the labels of non-prescription medicines
Proposed Requirement TGO 92 Industry response
Text size In principle CMA agrees with the change that reverts back to the current TGO 69 definition of text size This is in comparison to the consultation draft TGO79 that proposed a range of sizes for listed and registered
ldquoText size equivalent to Arial fontrdquo complementary medicines based on Arial point size font has been removed from TGO 92 The definition for letter height is the same as the definition in TGO 69
Sec 7 General requirements including As stated in the CMA 2014 submission ambiguous and subjective requirements should on principle not be included in a label presentation legislative instrument (2)(e) Considering the guidance document elaborates on the proposed requirement CMA reiterates that we are not aware of there Labels must be in a colour or colours being consumer safety issues of this nature reported for CM products which are of a lower risk and hence consider the contrasting strongly with the mandatory requirement unjustified background Sec 8(2) Labels of registered medicines must provide information in a consistent order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important information access to other information is also necessary for consumers to make an informed purchasing decision CMA is of the position that for lower risk registered medicines such as registered complementary medicines there should be flexibility to present mandatory information in a clear and concise manner without the constraint of a medicine information panel (MIP) This will minimise cost to the CM industry associated with resizing labels or providing goods in larger container sizes with increased headspace Section 155 of the Guidance document outlines that ldquoa medicine information panel is not required for certain lower risk
Proposed Requirement TGO 92 Industry response
registered medicines ndash these are detailed in subsection 8(2) of TGO 92rdquo Subsection 8(2) however does not appear to detail specifically what types of lower risk registered medicines would not require a MIP CMA suggests that this part of the guidance is expanded to include specific guidance that registered complementary medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the amendment impact registered complementary medicines mock up labels have been provided to demonstrate that the requirement would necessitate a change to label sizes for complementary medicines which is considered unjustified
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of a MIP would not work and necessitate labelling complications and medicine container size considerations
Sec 8 (1) (k) (ii) (B) Pregnancy database
Requirements related tot his section should be incorporated on an ingredient by ingredient basis within the 26BB list of permissible ingredients instrument Pregnancy database - Add link httpswwwtgagovauprescribing-medicines-pregnancy-database
Sec 9 (2) CMA considers the proposed requirements to orientate all text in the same direction on the main label and for medicine names to be presented in a continuous and uninterrupted manner would not have a meaningful impact upon consumer
The name of the medicine on the main safety and as such the change is considered unjustified for lower risk medicines label must be presented in a continuous uninterrupted manner and Feedback from our members indicates that medicine labels are often developed as a result of consumer testing not be broken up by additional In addition CMA has not been presented with information that consumers have any usability difficulties with the information or background text presentation of information on complementary medicine labels Sec 9 (5) All text required by this Order to It is well documented that consumers generally select complementary medicines and non-prescription medicines by brand appear on the main label must be and category and seek out brands they know Branding is important for complementary medicines and consumers are orientated in the same direction familiar with many well-known brands of medicines for general wellbeing cough and cold allergy skincare and many
other categories Limited label space is therefore an important issue particularly for certain product and label types
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 2 of 12
Proposed Requirement TGO 92 Industry response
Such a change would impact upon brand recognition for many companies As such CMA considers this as an unjustified change to requirements adding to unnecessary regulatory burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact on branding and does not require consequential changes to dimensions of packs or labels or changes to the packaging details of a medicine
Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 30millimeters on the front panel directly under the trade name
Since consumers use complementary medicines as part of self-care the label of these medicines is the primary source of information for consumers This requirement would mean that a large portion of the label would be used to display the active ingredients Information on active ingredients is not always the most meaningful aspect in consumer self selection of these goods rather information sought by consumers tends to be focused around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space and there will be reduced space to indicate the intended purpose of the product on the front of pack If the container and label size are increased as a result of this without increasing the number of tablets or capsules in the bottle this could give the consumer a negative perception due to the increased head space of the container Ultimately this would also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations
Sec 9 (6) CMArsquos position on the number of active ingredients that may appear on the front of a label for listed goods is that TGO 69 If the medicine is intended to be or is requirements be maintained listed goods By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active ingredients to four or more (b) if there are four or more active active ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for ingredients in the medicine - the name these lower risk listed medicines without any evidence of consumer benefit being presented of every active ingredient together with the quantity or proportion of CMA suggests the following amendment to TGO 92 every active ingredient may appear on
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 3 of 12
Proposed Requirement TGO 92 Industry response
a side panel or side label or on a rear panel or rear label
If the medicine is intended to be or is listed goods 6 b) if the medicine is a listed complementary medicine ndash the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO 69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014 CMA includes specific examples where for listed CMs containing three active ingredients to be displayed on the front of the label where previously they would be detailed at the side or rear how this would impact on label size being inappropriate for the packaging
Sec 9 (7) CMA proposed that TGO 69 requirements be maintained If the medicine is intended to be or is registered goods then By imposing subsection 9(7)(b) would mean a requirement to go from two or more active ingredients to four or more active
ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for (a) where the medicine contains three registered complementary medicines without any specific evidence of consumer benefit relating to this lower risk class of or four active ingredients the name of good being presented the active ingredient(s) and the quantity or proportion of active Within the complementary medicine category listed and registered complementary medicines will be presented (depending ingredient(s) must be displayed on the on the number of active ingredients present) in a different manner That is some will detail active ingredients at the front of main label in a text size of not less the pack while others (with 4 or more active ingredients) will detail the ingredients at the side or rear of the pack CMA than 3 millimetres submits that for the purposes of standardisation of where to find information consumers should be encouraged to refer to
the backside of the pack for ingredient information (b) where the medicine contains four or more active ingredients and the CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of requirements of subsection 8(2) do not 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations apply then the names and the See comments at Sec 9 (7)(a) above quantities or proportion of the active ingredients may be included on a side panellabel or rear panellabel when
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 4 of 12
Proposed Requirement TGO 92 Industry response
displayed in a text size of not less than 25mm
Sec 10(3) amp Sec 10 (4)(a) CMA does not support any additional change to this lower risk category of medicine
Homeopathic medicines No explanation or justification has been provided as to why there is a new mandatory requirement to include a statement on Where all the active ingredients in a the main label that the medicine is a homeopathic medicine or contains homeopathic preparations in an increased font size to medicine are homoeopathic that of a general listed complementary medicine preparations the main label on the No real explanation has been provided as to why an increase to the font size for the statement ldquohomeopathic medicinerdquo was container and the main label on the considered a requirement based on a consumer safety perspective primary pack (if any) must in addition to the requirements referred Previous explanations for this addition has centred around that the statement is intended to assist consumers with an to in sections 8 and 9 above include a appropriate selection for a medicine and minimise confusion that may arise with self-selection However the current statement to the effect that the labelling Order requires there to be a declaration that clearly states the product is homeopathic and contains homeopathic medicine is a homoeopathic medicine ingredients on the front of the pack and the additional detail of this information on the back of the pack in the ingredients in text size that is not less than 50 and indications section would clearly justify the medicine as being based in the homoeopathic paradigm of the text size of the name of the As such CMA proposes that this section be removed from the Order medicine and (in any event) not less than 2millimeters
Sec 6 CMA submitted in May 2013 via the International Harmonisation of Ingredient Names consultation that there appeared to be no mention of the naming of homoeopathic ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS)
Interpretation in this Order traditional naming or the application of new AAN homoeopathic names As such we resubmit information for consideration here
Homoeopathic medicines ndash naming conventions
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 5 of 12
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation (i) either the name of the active ingredient or the substance from which the dilution was prepared that is accepted for inclusion in the Australian Approved Names (AAN) List together with a statement of the homeopathic potency or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency
It is suggested that an amendment be made to allow for homeopathic medicines The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
To implement this CMA proposes the following amendment to the definition of the name of the active ingredient
(b) where the ingredient is a homoeopathic preparation
1 the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency in brackets the name that is also accepted for inclusion in the Australian Approved Names List
2 for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
That is the traditional homeopathic name to be used as the primary name including the AAN unless on ldquosmall containersrdquo Both the traditional names and AAN could be included on full website information which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required)
It is in the consumersrsquo interest that traditional pharmacopeial names be amended as the primary name The concern here is
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
CMA detailed table of reform recommendations and impact of TGO 92
Page 22 of 23
Appendix 1 - mock up labels to TGO 92 requirements
Page 23 of 23
CMA response to TGO 92- Standards for the labels of non-prescription medicines
Proposed Requirement TGO 92 Industry response
Text size In principle CMA agrees with the change that reverts back to the current TGO 69 definition of text size This is in comparison to the consultation draft TGO79 that proposed a range of sizes for listed and registered
ldquoText size equivalent to Arial fontrdquo complementary medicines based on Arial point size font has been removed from TGO 92 The definition for letter height is the same as the definition in TGO 69
Sec 7 General requirements including As stated in the CMA 2014 submission ambiguous and subjective requirements should on principle not be included in a label presentation legislative instrument (2)(e) Considering the guidance document elaborates on the proposed requirement CMA reiterates that we are not aware of there Labels must be in a colour or colours being consumer safety issues of this nature reported for CM products which are of a lower risk and hence consider the contrasting strongly with the mandatory requirement unjustified background Sec 8(2) Labels of registered medicines must provide information in a consistent order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important information access to other information is also necessary for consumers to make an informed purchasing decision CMA is of the position that for lower risk registered medicines such as registered complementary medicines there should be flexibility to present mandatory information in a clear and concise manner without the constraint of a medicine information panel (MIP) This will minimise cost to the CM industry associated with resizing labels or providing goods in larger container sizes with increased headspace Section 155 of the Guidance document outlines that ldquoa medicine information panel is not required for certain lower risk
Proposed Requirement TGO 92 Industry response
registered medicines ndash these are detailed in subsection 8(2) of TGO 92rdquo Subsection 8(2) however does not appear to detail specifically what types of lower risk registered medicines would not require a MIP CMA suggests that this part of the guidance is expanded to include specific guidance that registered complementary medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the amendment impact registered complementary medicines mock up labels have been provided to demonstrate that the requirement would necessitate a change to label sizes for complementary medicines which is considered unjustified
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of a MIP would not work and necessitate labelling complications and medicine container size considerations
Sec 8 (1) (k) (ii) (B) Pregnancy database
Requirements related tot his section should be incorporated on an ingredient by ingredient basis within the 26BB list of permissible ingredients instrument Pregnancy database - Add link httpswwwtgagovauprescribing-medicines-pregnancy-database
Sec 9 (2) CMA considers the proposed requirements to orientate all text in the same direction on the main label and for medicine names to be presented in a continuous and uninterrupted manner would not have a meaningful impact upon consumer
The name of the medicine on the main safety and as such the change is considered unjustified for lower risk medicines label must be presented in a continuous uninterrupted manner and Feedback from our members indicates that medicine labels are often developed as a result of consumer testing not be broken up by additional In addition CMA has not been presented with information that consumers have any usability difficulties with the information or background text presentation of information on complementary medicine labels Sec 9 (5) All text required by this Order to It is well documented that consumers generally select complementary medicines and non-prescription medicines by brand appear on the main label must be and category and seek out brands they know Branding is important for complementary medicines and consumers are orientated in the same direction familiar with many well-known brands of medicines for general wellbeing cough and cold allergy skincare and many
other categories Limited label space is therefore an important issue particularly for certain product and label types
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 2 of 12
Proposed Requirement TGO 92 Industry response
Such a change would impact upon brand recognition for many companies As such CMA considers this as an unjustified change to requirements adding to unnecessary regulatory burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact on branding and does not require consequential changes to dimensions of packs or labels or changes to the packaging details of a medicine
Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 30millimeters on the front panel directly under the trade name
Since consumers use complementary medicines as part of self-care the label of these medicines is the primary source of information for consumers This requirement would mean that a large portion of the label would be used to display the active ingredients Information on active ingredients is not always the most meaningful aspect in consumer self selection of these goods rather information sought by consumers tends to be focused around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space and there will be reduced space to indicate the intended purpose of the product on the front of pack If the container and label size are increased as a result of this without increasing the number of tablets or capsules in the bottle this could give the consumer a negative perception due to the increased head space of the container Ultimately this would also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations
Sec 9 (6) CMArsquos position on the number of active ingredients that may appear on the front of a label for listed goods is that TGO 69 If the medicine is intended to be or is requirements be maintained listed goods By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active ingredients to four or more (b) if there are four or more active active ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for ingredients in the medicine - the name these lower risk listed medicines without any evidence of consumer benefit being presented of every active ingredient together with the quantity or proportion of CMA suggests the following amendment to TGO 92 every active ingredient may appear on
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 3 of 12
Proposed Requirement TGO 92 Industry response
a side panel or side label or on a rear panel or rear label
If the medicine is intended to be or is listed goods 6 b) if the medicine is a listed complementary medicine ndash the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO 69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014 CMA includes specific examples where for listed CMs containing three active ingredients to be displayed on the front of the label where previously they would be detailed at the side or rear how this would impact on label size being inappropriate for the packaging
Sec 9 (7) CMA proposed that TGO 69 requirements be maintained If the medicine is intended to be or is registered goods then By imposing subsection 9(7)(b) would mean a requirement to go from two or more active ingredients to four or more active
ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for (a) where the medicine contains three registered complementary medicines without any specific evidence of consumer benefit relating to this lower risk class of or four active ingredients the name of good being presented the active ingredient(s) and the quantity or proportion of active Within the complementary medicine category listed and registered complementary medicines will be presented (depending ingredient(s) must be displayed on the on the number of active ingredients present) in a different manner That is some will detail active ingredients at the front of main label in a text size of not less the pack while others (with 4 or more active ingredients) will detail the ingredients at the side or rear of the pack CMA than 3 millimetres submits that for the purposes of standardisation of where to find information consumers should be encouraged to refer to
the backside of the pack for ingredient information (b) where the medicine contains four or more active ingredients and the CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of requirements of subsection 8(2) do not 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations apply then the names and the See comments at Sec 9 (7)(a) above quantities or proportion of the active ingredients may be included on a side panellabel or rear panellabel when
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 4 of 12
Proposed Requirement TGO 92 Industry response
displayed in a text size of not less than 25mm
Sec 10(3) amp Sec 10 (4)(a) CMA does not support any additional change to this lower risk category of medicine
Homeopathic medicines No explanation or justification has been provided as to why there is a new mandatory requirement to include a statement on Where all the active ingredients in a the main label that the medicine is a homeopathic medicine or contains homeopathic preparations in an increased font size to medicine are homoeopathic that of a general listed complementary medicine preparations the main label on the No real explanation has been provided as to why an increase to the font size for the statement ldquohomeopathic medicinerdquo was container and the main label on the considered a requirement based on a consumer safety perspective primary pack (if any) must in addition to the requirements referred Previous explanations for this addition has centred around that the statement is intended to assist consumers with an to in sections 8 and 9 above include a appropriate selection for a medicine and minimise confusion that may arise with self-selection However the current statement to the effect that the labelling Order requires there to be a declaration that clearly states the product is homeopathic and contains homeopathic medicine is a homoeopathic medicine ingredients on the front of the pack and the additional detail of this information on the back of the pack in the ingredients in text size that is not less than 50 and indications section would clearly justify the medicine as being based in the homoeopathic paradigm of the text size of the name of the As such CMA proposes that this section be removed from the Order medicine and (in any event) not less than 2millimeters
Sec 6 CMA submitted in May 2013 via the International Harmonisation of Ingredient Names consultation that there appeared to be no mention of the naming of homoeopathic ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS)
Interpretation in this Order traditional naming or the application of new AAN homoeopathic names As such we resubmit information for consideration here
Homoeopathic medicines ndash naming conventions
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 5 of 12
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation (i) either the name of the active ingredient or the substance from which the dilution was prepared that is accepted for inclusion in the Australian Approved Names (AAN) List together with a statement of the homeopathic potency or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency
It is suggested that an amendment be made to allow for homeopathic medicines The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
To implement this CMA proposes the following amendment to the definition of the name of the active ingredient
(b) where the ingredient is a homoeopathic preparation
1 the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency in brackets the name that is also accepted for inclusion in the Australian Approved Names List
2 for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
That is the traditional homeopathic name to be used as the primary name including the AAN unless on ldquosmall containersrdquo Both the traditional names and AAN could be included on full website information which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required)
It is in the consumersrsquo interest that traditional pharmacopeial names be amended as the primary name The concern here is
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
Appendix 1 - mock up labels to TGO 92 requirements
Page 23 of 23
CMA response to TGO 92- Standards for the labels of non-prescription medicines
Proposed Requirement TGO 92 Industry response
Text size In principle CMA agrees with the change that reverts back to the current TGO 69 definition of text size This is in comparison to the consultation draft TGO79 that proposed a range of sizes for listed and registered
ldquoText size equivalent to Arial fontrdquo complementary medicines based on Arial point size font has been removed from TGO 92 The definition for letter height is the same as the definition in TGO 69
Sec 7 General requirements including As stated in the CMA 2014 submission ambiguous and subjective requirements should on principle not be included in a label presentation legislative instrument (2)(e) Considering the guidance document elaborates on the proposed requirement CMA reiterates that we are not aware of there Labels must be in a colour or colours being consumer safety issues of this nature reported for CM products which are of a lower risk and hence consider the contrasting strongly with the mandatory requirement unjustified background Sec 8(2) Labels of registered medicines must provide information in a consistent order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important information access to other information is also necessary for consumers to make an informed purchasing decision CMA is of the position that for lower risk registered medicines such as registered complementary medicines there should be flexibility to present mandatory information in a clear and concise manner without the constraint of a medicine information panel (MIP) This will minimise cost to the CM industry associated with resizing labels or providing goods in larger container sizes with increased headspace Section 155 of the Guidance document outlines that ldquoa medicine information panel is not required for certain lower risk
Proposed Requirement TGO 92 Industry response
registered medicines ndash these are detailed in subsection 8(2) of TGO 92rdquo Subsection 8(2) however does not appear to detail specifically what types of lower risk registered medicines would not require a MIP CMA suggests that this part of the guidance is expanded to include specific guidance that registered complementary medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the amendment impact registered complementary medicines mock up labels have been provided to demonstrate that the requirement would necessitate a change to label sizes for complementary medicines which is considered unjustified
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of a MIP would not work and necessitate labelling complications and medicine container size considerations
Sec 8 (1) (k) (ii) (B) Pregnancy database
Requirements related tot his section should be incorporated on an ingredient by ingredient basis within the 26BB list of permissible ingredients instrument Pregnancy database - Add link httpswwwtgagovauprescribing-medicines-pregnancy-database
Sec 9 (2) CMA considers the proposed requirements to orientate all text in the same direction on the main label and for medicine names to be presented in a continuous and uninterrupted manner would not have a meaningful impact upon consumer
The name of the medicine on the main safety and as such the change is considered unjustified for lower risk medicines label must be presented in a continuous uninterrupted manner and Feedback from our members indicates that medicine labels are often developed as a result of consumer testing not be broken up by additional In addition CMA has not been presented with information that consumers have any usability difficulties with the information or background text presentation of information on complementary medicine labels Sec 9 (5) All text required by this Order to It is well documented that consumers generally select complementary medicines and non-prescription medicines by brand appear on the main label must be and category and seek out brands they know Branding is important for complementary medicines and consumers are orientated in the same direction familiar with many well-known brands of medicines for general wellbeing cough and cold allergy skincare and many
other categories Limited label space is therefore an important issue particularly for certain product and label types
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 2 of 12
Proposed Requirement TGO 92 Industry response
Such a change would impact upon brand recognition for many companies As such CMA considers this as an unjustified change to requirements adding to unnecessary regulatory burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact on branding and does not require consequential changes to dimensions of packs or labels or changes to the packaging details of a medicine
Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 30millimeters on the front panel directly under the trade name
Since consumers use complementary medicines as part of self-care the label of these medicines is the primary source of information for consumers This requirement would mean that a large portion of the label would be used to display the active ingredients Information on active ingredients is not always the most meaningful aspect in consumer self selection of these goods rather information sought by consumers tends to be focused around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space and there will be reduced space to indicate the intended purpose of the product on the front of pack If the container and label size are increased as a result of this without increasing the number of tablets or capsules in the bottle this could give the consumer a negative perception due to the increased head space of the container Ultimately this would also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations
Sec 9 (6) CMArsquos position on the number of active ingredients that may appear on the front of a label for listed goods is that TGO 69 If the medicine is intended to be or is requirements be maintained listed goods By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active ingredients to four or more (b) if there are four or more active active ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for ingredients in the medicine - the name these lower risk listed medicines without any evidence of consumer benefit being presented of every active ingredient together with the quantity or proportion of CMA suggests the following amendment to TGO 92 every active ingredient may appear on
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 3 of 12
Proposed Requirement TGO 92 Industry response
a side panel or side label or on a rear panel or rear label
If the medicine is intended to be or is listed goods 6 b) if the medicine is a listed complementary medicine ndash the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO 69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014 CMA includes specific examples where for listed CMs containing three active ingredients to be displayed on the front of the label where previously they would be detailed at the side or rear how this would impact on label size being inappropriate for the packaging
Sec 9 (7) CMA proposed that TGO 69 requirements be maintained If the medicine is intended to be or is registered goods then By imposing subsection 9(7)(b) would mean a requirement to go from two or more active ingredients to four or more active
ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for (a) where the medicine contains three registered complementary medicines without any specific evidence of consumer benefit relating to this lower risk class of or four active ingredients the name of good being presented the active ingredient(s) and the quantity or proportion of active Within the complementary medicine category listed and registered complementary medicines will be presented (depending ingredient(s) must be displayed on the on the number of active ingredients present) in a different manner That is some will detail active ingredients at the front of main label in a text size of not less the pack while others (with 4 or more active ingredients) will detail the ingredients at the side or rear of the pack CMA than 3 millimetres submits that for the purposes of standardisation of where to find information consumers should be encouraged to refer to
the backside of the pack for ingredient information (b) where the medicine contains four or more active ingredients and the CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of requirements of subsection 8(2) do not 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations apply then the names and the See comments at Sec 9 (7)(a) above quantities or proportion of the active ingredients may be included on a side panellabel or rear panellabel when
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 4 of 12
Proposed Requirement TGO 92 Industry response
displayed in a text size of not less than 25mm
Sec 10(3) amp Sec 10 (4)(a) CMA does not support any additional change to this lower risk category of medicine
Homeopathic medicines No explanation or justification has been provided as to why there is a new mandatory requirement to include a statement on Where all the active ingredients in a the main label that the medicine is a homeopathic medicine or contains homeopathic preparations in an increased font size to medicine are homoeopathic that of a general listed complementary medicine preparations the main label on the No real explanation has been provided as to why an increase to the font size for the statement ldquohomeopathic medicinerdquo was container and the main label on the considered a requirement based on a consumer safety perspective primary pack (if any) must in addition to the requirements referred Previous explanations for this addition has centred around that the statement is intended to assist consumers with an to in sections 8 and 9 above include a appropriate selection for a medicine and minimise confusion that may arise with self-selection However the current statement to the effect that the labelling Order requires there to be a declaration that clearly states the product is homeopathic and contains homeopathic medicine is a homoeopathic medicine ingredients on the front of the pack and the additional detail of this information on the back of the pack in the ingredients in text size that is not less than 50 and indications section would clearly justify the medicine as being based in the homoeopathic paradigm of the text size of the name of the As such CMA proposes that this section be removed from the Order medicine and (in any event) not less than 2millimeters
Sec 6 CMA submitted in May 2013 via the International Harmonisation of Ingredient Names consultation that there appeared to be no mention of the naming of homoeopathic ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS)
Interpretation in this Order traditional naming or the application of new AAN homoeopathic names As such we resubmit information for consideration here
Homoeopathic medicines ndash naming conventions
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 5 of 12
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation (i) either the name of the active ingredient or the substance from which the dilution was prepared that is accepted for inclusion in the Australian Approved Names (AAN) List together with a statement of the homeopathic potency or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency
It is suggested that an amendment be made to allow for homeopathic medicines The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
To implement this CMA proposes the following amendment to the definition of the name of the active ingredient
(b) where the ingredient is a homoeopathic preparation
1 the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency in brackets the name that is also accepted for inclusion in the Australian Approved Names List
2 for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
That is the traditional homeopathic name to be used as the primary name including the AAN unless on ldquosmall containersrdquo Both the traditional names and AAN could be included on full website information which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required)
It is in the consumersrsquo interest that traditional pharmacopeial names be amended as the primary name The concern here is
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
CMA response to TGO 92- Standards for the labels of non-prescription medicines
Proposed Requirement TGO 92 Industry response
Text size In principle CMA agrees with the change that reverts back to the current TGO 69 definition of text size This is in comparison to the consultation draft TGO79 that proposed a range of sizes for listed and registered
ldquoText size equivalent to Arial fontrdquo complementary medicines based on Arial point size font has been removed from TGO 92 The definition for letter height is the same as the definition in TGO 69
Sec 7 General requirements including As stated in the CMA 2014 submission ambiguous and subjective requirements should on principle not be included in a label presentation legislative instrument (2)(e) Considering the guidance document elaborates on the proposed requirement CMA reiterates that we are not aware of there Labels must be in a colour or colours being consumer safety issues of this nature reported for CM products which are of a lower risk and hence consider the contrasting strongly with the mandatory requirement unjustified background Sec 8(2) Labels of registered medicines must provide information in a consistent order and manner in a medicine information panel (MIP)
While CMA agrees that directions warnings and allergen information are all important information access to other information is also necessary for consumers to make an informed purchasing decision CMA is of the position that for lower risk registered medicines such as registered complementary medicines there should be flexibility to present mandatory information in a clear and concise manner without the constraint of a medicine information panel (MIP) This will minimise cost to the CM industry associated with resizing labels or providing goods in larger container sizes with increased headspace Section 155 of the Guidance document outlines that ldquoa medicine information panel is not required for certain lower risk
Proposed Requirement TGO 92 Industry response
registered medicines ndash these are detailed in subsection 8(2) of TGO 92rdquo Subsection 8(2) however does not appear to detail specifically what types of lower risk registered medicines would not require a MIP CMA suggests that this part of the guidance is expanded to include specific guidance that registered complementary medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the amendment impact registered complementary medicines mock up labels have been provided to demonstrate that the requirement would necessitate a change to label sizes for complementary medicines which is considered unjustified
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of a MIP would not work and necessitate labelling complications and medicine container size considerations
Sec 8 (1) (k) (ii) (B) Pregnancy database
Requirements related tot his section should be incorporated on an ingredient by ingredient basis within the 26BB list of permissible ingredients instrument Pregnancy database - Add link httpswwwtgagovauprescribing-medicines-pregnancy-database
Sec 9 (2) CMA considers the proposed requirements to orientate all text in the same direction on the main label and for medicine names to be presented in a continuous and uninterrupted manner would not have a meaningful impact upon consumer
The name of the medicine on the main safety and as such the change is considered unjustified for lower risk medicines label must be presented in a continuous uninterrupted manner and Feedback from our members indicates that medicine labels are often developed as a result of consumer testing not be broken up by additional In addition CMA has not been presented with information that consumers have any usability difficulties with the information or background text presentation of information on complementary medicine labels Sec 9 (5) All text required by this Order to It is well documented that consumers generally select complementary medicines and non-prescription medicines by brand appear on the main label must be and category and seek out brands they know Branding is important for complementary medicines and consumers are orientated in the same direction familiar with many well-known brands of medicines for general wellbeing cough and cold allergy skincare and many
other categories Limited label space is therefore an important issue particularly for certain product and label types
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 2 of 12
Proposed Requirement TGO 92 Industry response
Such a change would impact upon brand recognition for many companies As such CMA considers this as an unjustified change to requirements adding to unnecessary regulatory burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact on branding and does not require consequential changes to dimensions of packs or labels or changes to the packaging details of a medicine
Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 30millimeters on the front panel directly under the trade name
Since consumers use complementary medicines as part of self-care the label of these medicines is the primary source of information for consumers This requirement would mean that a large portion of the label would be used to display the active ingredients Information on active ingredients is not always the most meaningful aspect in consumer self selection of these goods rather information sought by consumers tends to be focused around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space and there will be reduced space to indicate the intended purpose of the product on the front of pack If the container and label size are increased as a result of this without increasing the number of tablets or capsules in the bottle this could give the consumer a negative perception due to the increased head space of the container Ultimately this would also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations
Sec 9 (6) CMArsquos position on the number of active ingredients that may appear on the front of a label for listed goods is that TGO 69 If the medicine is intended to be or is requirements be maintained listed goods By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active ingredients to four or more (b) if there are four or more active active ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for ingredients in the medicine - the name these lower risk listed medicines without any evidence of consumer benefit being presented of every active ingredient together with the quantity or proportion of CMA suggests the following amendment to TGO 92 every active ingredient may appear on
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 3 of 12
Proposed Requirement TGO 92 Industry response
a side panel or side label or on a rear panel or rear label
If the medicine is intended to be or is listed goods 6 b) if the medicine is a listed complementary medicine ndash the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO 69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014 CMA includes specific examples where for listed CMs containing three active ingredients to be displayed on the front of the label where previously they would be detailed at the side or rear how this would impact on label size being inappropriate for the packaging
Sec 9 (7) CMA proposed that TGO 69 requirements be maintained If the medicine is intended to be or is registered goods then By imposing subsection 9(7)(b) would mean a requirement to go from two or more active ingredients to four or more active
ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for (a) where the medicine contains three registered complementary medicines without any specific evidence of consumer benefit relating to this lower risk class of or four active ingredients the name of good being presented the active ingredient(s) and the quantity or proportion of active Within the complementary medicine category listed and registered complementary medicines will be presented (depending ingredient(s) must be displayed on the on the number of active ingredients present) in a different manner That is some will detail active ingredients at the front of main label in a text size of not less the pack while others (with 4 or more active ingredients) will detail the ingredients at the side or rear of the pack CMA than 3 millimetres submits that for the purposes of standardisation of where to find information consumers should be encouraged to refer to
the backside of the pack for ingredient information (b) where the medicine contains four or more active ingredients and the CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of requirements of subsection 8(2) do not 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations apply then the names and the See comments at Sec 9 (7)(a) above quantities or proportion of the active ingredients may be included on a side panellabel or rear panellabel when
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 4 of 12
Proposed Requirement TGO 92 Industry response
displayed in a text size of not less than 25mm
Sec 10(3) amp Sec 10 (4)(a) CMA does not support any additional change to this lower risk category of medicine
Homeopathic medicines No explanation or justification has been provided as to why there is a new mandatory requirement to include a statement on Where all the active ingredients in a the main label that the medicine is a homeopathic medicine or contains homeopathic preparations in an increased font size to medicine are homoeopathic that of a general listed complementary medicine preparations the main label on the No real explanation has been provided as to why an increase to the font size for the statement ldquohomeopathic medicinerdquo was container and the main label on the considered a requirement based on a consumer safety perspective primary pack (if any) must in addition to the requirements referred Previous explanations for this addition has centred around that the statement is intended to assist consumers with an to in sections 8 and 9 above include a appropriate selection for a medicine and minimise confusion that may arise with self-selection However the current statement to the effect that the labelling Order requires there to be a declaration that clearly states the product is homeopathic and contains homeopathic medicine is a homoeopathic medicine ingredients on the front of the pack and the additional detail of this information on the back of the pack in the ingredients in text size that is not less than 50 and indications section would clearly justify the medicine as being based in the homoeopathic paradigm of the text size of the name of the As such CMA proposes that this section be removed from the Order medicine and (in any event) not less than 2millimeters
Sec 6 CMA submitted in May 2013 via the International Harmonisation of Ingredient Names consultation that there appeared to be no mention of the naming of homoeopathic ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS)
Interpretation in this Order traditional naming or the application of new AAN homoeopathic names As such we resubmit information for consideration here
Homoeopathic medicines ndash naming conventions
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 5 of 12
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation (i) either the name of the active ingredient or the substance from which the dilution was prepared that is accepted for inclusion in the Australian Approved Names (AAN) List together with a statement of the homeopathic potency or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency
It is suggested that an amendment be made to allow for homeopathic medicines The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
To implement this CMA proposes the following amendment to the definition of the name of the active ingredient
(b) where the ingredient is a homoeopathic preparation
1 the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency in brackets the name that is also accepted for inclusion in the Australian Approved Names List
2 for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
That is the traditional homeopathic name to be used as the primary name including the AAN unless on ldquosmall containersrdquo Both the traditional names and AAN could be included on full website information which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required)
It is in the consumersrsquo interest that traditional pharmacopeial names be amended as the primary name The concern here is
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
Proposed Requirement TGO 92 Industry response
registered medicines ndash these are detailed in subsection 8(2) of TGO 92rdquo Subsection 8(2) however does not appear to detail specifically what types of lower risk registered medicines would not require a MIP CMA suggests that this part of the guidance is expanded to include specific guidance that registered complementary medicines are not required to include a MIP
Based on the proposed requirement for a medicine information panel should the amendment impact registered complementary medicines mock up labels have been provided to demonstrate that the requirement would necessitate a change to label sizes for complementary medicines which is considered unjustified
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of a MIP would not work and necessitate labelling complications and medicine container size considerations
Sec 8 (1) (k) (ii) (B) Pregnancy database
Requirements related tot his section should be incorporated on an ingredient by ingredient basis within the 26BB list of permissible ingredients instrument Pregnancy database - Add link httpswwwtgagovauprescribing-medicines-pregnancy-database
Sec 9 (2) CMA considers the proposed requirements to orientate all text in the same direction on the main label and for medicine names to be presented in a continuous and uninterrupted manner would not have a meaningful impact upon consumer
The name of the medicine on the main safety and as such the change is considered unjustified for lower risk medicines label must be presented in a continuous uninterrupted manner and Feedback from our members indicates that medicine labels are often developed as a result of consumer testing not be broken up by additional In addition CMA has not been presented with information that consumers have any usability difficulties with the information or background text presentation of information on complementary medicine labels Sec 9 (5) All text required by this Order to It is well documented that consumers generally select complementary medicines and non-prescription medicines by brand appear on the main label must be and category and seek out brands they know Branding is important for complementary medicines and consumers are orientated in the same direction familiar with many well-known brands of medicines for general wellbeing cough and cold allergy skincare and many
other categories Limited label space is therefore an important issue particularly for certain product and label types
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 2 of 12
Proposed Requirement TGO 92 Industry response
Such a change would impact upon brand recognition for many companies As such CMA considers this as an unjustified change to requirements adding to unnecessary regulatory burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact on branding and does not require consequential changes to dimensions of packs or labels or changes to the packaging details of a medicine
Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 30millimeters on the front panel directly under the trade name
Since consumers use complementary medicines as part of self-care the label of these medicines is the primary source of information for consumers This requirement would mean that a large portion of the label would be used to display the active ingredients Information on active ingredients is not always the most meaningful aspect in consumer self selection of these goods rather information sought by consumers tends to be focused around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space and there will be reduced space to indicate the intended purpose of the product on the front of pack If the container and label size are increased as a result of this without increasing the number of tablets or capsules in the bottle this could give the consumer a negative perception due to the increased head space of the container Ultimately this would also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations
Sec 9 (6) CMArsquos position on the number of active ingredients that may appear on the front of a label for listed goods is that TGO 69 If the medicine is intended to be or is requirements be maintained listed goods By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active ingredients to four or more (b) if there are four or more active active ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for ingredients in the medicine - the name these lower risk listed medicines without any evidence of consumer benefit being presented of every active ingredient together with the quantity or proportion of CMA suggests the following amendment to TGO 92 every active ingredient may appear on
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 3 of 12
Proposed Requirement TGO 92 Industry response
a side panel or side label or on a rear panel or rear label
If the medicine is intended to be or is listed goods 6 b) if the medicine is a listed complementary medicine ndash the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO 69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014 CMA includes specific examples where for listed CMs containing three active ingredients to be displayed on the front of the label where previously they would be detailed at the side or rear how this would impact on label size being inappropriate for the packaging
Sec 9 (7) CMA proposed that TGO 69 requirements be maintained If the medicine is intended to be or is registered goods then By imposing subsection 9(7)(b) would mean a requirement to go from two or more active ingredients to four or more active
ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for (a) where the medicine contains three registered complementary medicines without any specific evidence of consumer benefit relating to this lower risk class of or four active ingredients the name of good being presented the active ingredient(s) and the quantity or proportion of active Within the complementary medicine category listed and registered complementary medicines will be presented (depending ingredient(s) must be displayed on the on the number of active ingredients present) in a different manner That is some will detail active ingredients at the front of main label in a text size of not less the pack while others (with 4 or more active ingredients) will detail the ingredients at the side or rear of the pack CMA than 3 millimetres submits that for the purposes of standardisation of where to find information consumers should be encouraged to refer to
the backside of the pack for ingredient information (b) where the medicine contains four or more active ingredients and the CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of requirements of subsection 8(2) do not 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations apply then the names and the See comments at Sec 9 (7)(a) above quantities or proportion of the active ingredients may be included on a side panellabel or rear panellabel when
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 4 of 12
Proposed Requirement TGO 92 Industry response
displayed in a text size of not less than 25mm
Sec 10(3) amp Sec 10 (4)(a) CMA does not support any additional change to this lower risk category of medicine
Homeopathic medicines No explanation or justification has been provided as to why there is a new mandatory requirement to include a statement on Where all the active ingredients in a the main label that the medicine is a homeopathic medicine or contains homeopathic preparations in an increased font size to medicine are homoeopathic that of a general listed complementary medicine preparations the main label on the No real explanation has been provided as to why an increase to the font size for the statement ldquohomeopathic medicinerdquo was container and the main label on the considered a requirement based on a consumer safety perspective primary pack (if any) must in addition to the requirements referred Previous explanations for this addition has centred around that the statement is intended to assist consumers with an to in sections 8 and 9 above include a appropriate selection for a medicine and minimise confusion that may arise with self-selection However the current statement to the effect that the labelling Order requires there to be a declaration that clearly states the product is homeopathic and contains homeopathic medicine is a homoeopathic medicine ingredients on the front of the pack and the additional detail of this information on the back of the pack in the ingredients in text size that is not less than 50 and indications section would clearly justify the medicine as being based in the homoeopathic paradigm of the text size of the name of the As such CMA proposes that this section be removed from the Order medicine and (in any event) not less than 2millimeters
Sec 6 CMA submitted in May 2013 via the International Harmonisation of Ingredient Names consultation that there appeared to be no mention of the naming of homoeopathic ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS)
Interpretation in this Order traditional naming or the application of new AAN homoeopathic names As such we resubmit information for consideration here
Homoeopathic medicines ndash naming conventions
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 5 of 12
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation (i) either the name of the active ingredient or the substance from which the dilution was prepared that is accepted for inclusion in the Australian Approved Names (AAN) List together with a statement of the homeopathic potency or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency
It is suggested that an amendment be made to allow for homeopathic medicines The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
To implement this CMA proposes the following amendment to the definition of the name of the active ingredient
(b) where the ingredient is a homoeopathic preparation
1 the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency in brackets the name that is also accepted for inclusion in the Australian Approved Names List
2 for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
That is the traditional homeopathic name to be used as the primary name including the AAN unless on ldquosmall containersrdquo Both the traditional names and AAN could be included on full website information which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required)
It is in the consumersrsquo interest that traditional pharmacopeial names be amended as the primary name The concern here is
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
Proposed Requirement TGO 92 Industry response
Such a change would impact upon brand recognition for many companies As such CMA considers this as an unjustified change to requirements adding to unnecessary regulatory burden
Industry requires the revised labelling Order to be implemented in a way that avoids impact on branding and does not require consequential changes to dimensions of packs or labels or changes to the packaging details of a medicine
Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines
Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 30millimeters on the front panel directly under the trade name
Since consumers use complementary medicines as part of self-care the label of these medicines is the primary source of information for consumers This requirement would mean that a large portion of the label would be used to display the active ingredients Information on active ingredients is not always the most meaningful aspect in consumer self selection of these goods rather information sought by consumers tends to be focused around what the product can be used for
Due to the increase in font size active ingredients will take up a larger portion of label space and there will be reduced space to indicate the intended purpose of the product on the front of pack If the container and label size are increased as a result of this without increasing the number of tablets or capsules in the bottle this could give the consumer a negative perception due to the increased head space of the container Ultimately this would also impact on rework to shelf space and environmental impact to carbon footprint
CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations
Sec 9 (6) CMArsquos position on the number of active ingredients that may appear on the front of a label for listed goods is that TGO 69 If the medicine is intended to be or is requirements be maintained listed goods By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active ingredients to four or more (b) if there are four or more active active ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for ingredients in the medicine - the name these lower risk listed medicines without any evidence of consumer benefit being presented of every active ingredient together with the quantity or proportion of CMA suggests the following amendment to TGO 92 every active ingredient may appear on
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 3 of 12
Proposed Requirement TGO 92 Industry response
a side panel or side label or on a rear panel or rear label
If the medicine is intended to be or is listed goods 6 b) if the medicine is a listed complementary medicine ndash the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO 69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014 CMA includes specific examples where for listed CMs containing three active ingredients to be displayed on the front of the label where previously they would be detailed at the side or rear how this would impact on label size being inappropriate for the packaging
Sec 9 (7) CMA proposed that TGO 69 requirements be maintained If the medicine is intended to be or is registered goods then By imposing subsection 9(7)(b) would mean a requirement to go from two or more active ingredients to four or more active
ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for (a) where the medicine contains three registered complementary medicines without any specific evidence of consumer benefit relating to this lower risk class of or four active ingredients the name of good being presented the active ingredient(s) and the quantity or proportion of active Within the complementary medicine category listed and registered complementary medicines will be presented (depending ingredient(s) must be displayed on the on the number of active ingredients present) in a different manner That is some will detail active ingredients at the front of main label in a text size of not less the pack while others (with 4 or more active ingredients) will detail the ingredients at the side or rear of the pack CMA than 3 millimetres submits that for the purposes of standardisation of where to find information consumers should be encouraged to refer to
the backside of the pack for ingredient information (b) where the medicine contains four or more active ingredients and the CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of requirements of subsection 8(2) do not 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations apply then the names and the See comments at Sec 9 (7)(a) above quantities or proportion of the active ingredients may be included on a side panellabel or rear panellabel when
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 4 of 12
Proposed Requirement TGO 92 Industry response
displayed in a text size of not less than 25mm
Sec 10(3) amp Sec 10 (4)(a) CMA does not support any additional change to this lower risk category of medicine
Homeopathic medicines No explanation or justification has been provided as to why there is a new mandatory requirement to include a statement on Where all the active ingredients in a the main label that the medicine is a homeopathic medicine or contains homeopathic preparations in an increased font size to medicine are homoeopathic that of a general listed complementary medicine preparations the main label on the No real explanation has been provided as to why an increase to the font size for the statement ldquohomeopathic medicinerdquo was container and the main label on the considered a requirement based on a consumer safety perspective primary pack (if any) must in addition to the requirements referred Previous explanations for this addition has centred around that the statement is intended to assist consumers with an to in sections 8 and 9 above include a appropriate selection for a medicine and minimise confusion that may arise with self-selection However the current statement to the effect that the labelling Order requires there to be a declaration that clearly states the product is homeopathic and contains homeopathic medicine is a homoeopathic medicine ingredients on the front of the pack and the additional detail of this information on the back of the pack in the ingredients in text size that is not less than 50 and indications section would clearly justify the medicine as being based in the homoeopathic paradigm of the text size of the name of the As such CMA proposes that this section be removed from the Order medicine and (in any event) not less than 2millimeters
Sec 6 CMA submitted in May 2013 via the International Harmonisation of Ingredient Names consultation that there appeared to be no mention of the naming of homoeopathic ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS)
Interpretation in this Order traditional naming or the application of new AAN homoeopathic names As such we resubmit information for consideration here
Homoeopathic medicines ndash naming conventions
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 5 of 12
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation (i) either the name of the active ingredient or the substance from which the dilution was prepared that is accepted for inclusion in the Australian Approved Names (AAN) List together with a statement of the homeopathic potency or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency
It is suggested that an amendment be made to allow for homeopathic medicines The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
To implement this CMA proposes the following amendment to the definition of the name of the active ingredient
(b) where the ingredient is a homoeopathic preparation
1 the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency in brackets the name that is also accepted for inclusion in the Australian Approved Names List
2 for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
That is the traditional homeopathic name to be used as the primary name including the AAN unless on ldquosmall containersrdquo Both the traditional names and AAN could be included on full website information which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required)
It is in the consumersrsquo interest that traditional pharmacopeial names be amended as the primary name The concern here is
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
Proposed Requirement TGO 92 Industry response
a side panel or side label or on a rear panel or rear label
If the medicine is intended to be or is listed goods 6 b) if the medicine is a listed complementary medicine ndash the name of every active ingredient together with the quantity or proportion of every active ingredient may appear on a side panel or side label or on a rear panel or rear label
CMA provides this suggested amendment based on previous requirements outlined in TGO 69 and on a risk appropriate basis To elaborate further on mock up labels provided in 2014 CMA includes specific examples where for listed CMs containing three active ingredients to be displayed on the front of the label where previously they would be detailed at the side or rear how this would impact on label size being inappropriate for the packaging
Sec 9 (7) CMA proposed that TGO 69 requirements be maintained If the medicine is intended to be or is registered goods then By imposing subsection 9(7)(b) would mean a requirement to go from two or more active ingredients to four or more active
ingredients that may be declared on a side panellabel or rear panellabel This would increase the regulatory cost for (a) where the medicine contains three registered complementary medicines without any specific evidence of consumer benefit relating to this lower risk class of or four active ingredients the name of good being presented the active ingredient(s) and the quantity or proportion of active Within the complementary medicine category listed and registered complementary medicines will be presented (depending ingredient(s) must be displayed on the on the number of active ingredients present) in a different manner That is some will detail active ingredients at the front of main label in a text size of not less the pack while others (with 4 or more active ingredients) will detail the ingredients at the side or rear of the pack CMA than 3 millimetres submits that for the purposes of standardisation of where to find information consumers should be encouraged to refer to
the backside of the pack for ingredient information (b) where the medicine contains four or more active ingredients and the CMA provides at appendix 1 example 1 a mock up of a registered CM provided to demonstrates how the inclusion of requirements of subsection 8(2) do not 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations apply then the names and the See comments at Sec 9 (7)(a) above quantities or proportion of the active ingredients may be included on a side panellabel or rear panellabel when
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 4 of 12
Proposed Requirement TGO 92 Industry response
displayed in a text size of not less than 25mm
Sec 10(3) amp Sec 10 (4)(a) CMA does not support any additional change to this lower risk category of medicine
Homeopathic medicines No explanation or justification has been provided as to why there is a new mandatory requirement to include a statement on Where all the active ingredients in a the main label that the medicine is a homeopathic medicine or contains homeopathic preparations in an increased font size to medicine are homoeopathic that of a general listed complementary medicine preparations the main label on the No real explanation has been provided as to why an increase to the font size for the statement ldquohomeopathic medicinerdquo was container and the main label on the considered a requirement based on a consumer safety perspective primary pack (if any) must in addition to the requirements referred Previous explanations for this addition has centred around that the statement is intended to assist consumers with an to in sections 8 and 9 above include a appropriate selection for a medicine and minimise confusion that may arise with self-selection However the current statement to the effect that the labelling Order requires there to be a declaration that clearly states the product is homeopathic and contains homeopathic medicine is a homoeopathic medicine ingredients on the front of the pack and the additional detail of this information on the back of the pack in the ingredients in text size that is not less than 50 and indications section would clearly justify the medicine as being based in the homoeopathic paradigm of the text size of the name of the As such CMA proposes that this section be removed from the Order medicine and (in any event) not less than 2millimeters
Sec 6 CMA submitted in May 2013 via the International Harmonisation of Ingredient Names consultation that there appeared to be no mention of the naming of homoeopathic ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS)
Interpretation in this Order traditional naming or the application of new AAN homoeopathic names As such we resubmit information for consideration here
Homoeopathic medicines ndash naming conventions
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 5 of 12
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation (i) either the name of the active ingredient or the substance from which the dilution was prepared that is accepted for inclusion in the Australian Approved Names (AAN) List together with a statement of the homeopathic potency or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency
It is suggested that an amendment be made to allow for homeopathic medicines The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
To implement this CMA proposes the following amendment to the definition of the name of the active ingredient
(b) where the ingredient is a homoeopathic preparation
1 the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency in brackets the name that is also accepted for inclusion in the Australian Approved Names List
2 for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
That is the traditional homeopathic name to be used as the primary name including the AAN unless on ldquosmall containersrdquo Both the traditional names and AAN could be included on full website information which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required)
It is in the consumersrsquo interest that traditional pharmacopeial names be amended as the primary name The concern here is
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
Proposed Requirement TGO 92 Industry response
displayed in a text size of not less than 25mm
Sec 10(3) amp Sec 10 (4)(a) CMA does not support any additional change to this lower risk category of medicine
Homeopathic medicines No explanation or justification has been provided as to why there is a new mandatory requirement to include a statement on Where all the active ingredients in a the main label that the medicine is a homeopathic medicine or contains homeopathic preparations in an increased font size to medicine are homoeopathic that of a general listed complementary medicine preparations the main label on the No real explanation has been provided as to why an increase to the font size for the statement ldquohomeopathic medicinerdquo was container and the main label on the considered a requirement based on a consumer safety perspective primary pack (if any) must in addition to the requirements referred Previous explanations for this addition has centred around that the statement is intended to assist consumers with an to in sections 8 and 9 above include a appropriate selection for a medicine and minimise confusion that may arise with self-selection However the current statement to the effect that the labelling Order requires there to be a declaration that clearly states the product is homeopathic and contains homeopathic medicine is a homoeopathic medicine ingredients on the front of the pack and the additional detail of this information on the back of the pack in the ingredients in text size that is not less than 50 and indications section would clearly justify the medicine as being based in the homoeopathic paradigm of the text size of the name of the As such CMA proposes that this section be removed from the Order medicine and (in any event) not less than 2millimeters
Sec 6 CMA submitted in May 2013 via the International Harmonisation of Ingredient Names consultation that there appeared to be no mention of the naming of homoeopathic ingredients That is the use of Homoeopathic Pharmacopoeia (HPUS)
Interpretation in this Order traditional naming or the application of new AAN homoeopathic names As such we resubmit information for consideration here
Homoeopathic medicines ndash naming conventions
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 5 of 12
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation (i) either the name of the active ingredient or the substance from which the dilution was prepared that is accepted for inclusion in the Australian Approved Names (AAN) List together with a statement of the homeopathic potency or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency
It is suggested that an amendment be made to allow for homeopathic medicines The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
To implement this CMA proposes the following amendment to the definition of the name of the active ingredient
(b) where the ingredient is a homoeopathic preparation
1 the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency in brackets the name that is also accepted for inclusion in the Australian Approved Names List
2 for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
That is the traditional homeopathic name to be used as the primary name including the AAN unless on ldquosmall containersrdquo Both the traditional names and AAN could be included on full website information which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required)
It is in the consumersrsquo interest that traditional pharmacopeial names be amended as the primary name The concern here is
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
(line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation (i) either the name of the active ingredient or the substance from which the dilution was prepared that is accepted for inclusion in the Australian Approved Names (AAN) List together with a statement of the homeopathic potency or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency
It is suggested that an amendment be made to allow for homeopathic medicines The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets
1 The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets together with a statement of the homeopathic potency
a Eg Sinapis nigra (Brassica nigra) 6X
2 For small containers the traditional homeopathic pharmacopeia name only together with the a statement of the homeopathic potency
a Eg Sinapis nigra 6X
To implement this CMA proposes the following amendment to the definition of the name of the active ingredient
(b) where the ingredient is a homoeopathic preparation
1 the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency in brackets the name that is also accepted for inclusion in the Australian Approved Names List
2 for small containers the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency
That is the traditional homeopathic name to be used as the primary name including the AAN unless on ldquosmall containersrdquo Both the traditional names and AAN could be included on full website information which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required)
It is in the consumersrsquo interest that traditional pharmacopeial names be amended as the primary name The concern here is
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
that by enforcing the current definition and taking the AAN name alone outside of the traditional context the consumer may only get the name in its full chemicalnon homeopathic form causing potential confusion and or safety concerns Additionally the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm
To elaborate examples have been appended and provided with this submission
Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm the names of all active ingredient(s) in the medicine unless there are four or more active ingredients
Sec 10 (d)(e) Following text size of not less than 15mm -where four or more active ingredients the names of the active ingredients
Amended to accommodate where four or more ingredients
Amended to accommodate where four or more ingredients
Medicine Kits
The label on the package that together with medicines constitutes a medicine kit must include the following information
(a) The name given to the kit and (b) The name and contact details of
This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit which CMA supports
CMA stated - Based on the requirement in subsection 12(f) complementary medicine kits would be Required to state the functionality of each of the medicines within a kit Being multi ingredient based with ingredients that often overlap in their therapeutic approach it would be very repetitive to list the functionality of each medicine and take up considerable space on the label
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
the sponsor of the kit and (c) The name of each of the medicines within the kit and its dosage form and (d)The name and quantity or proportion of all the active ingredients in each of the medicines within the kit and helliphelliphellip
Very small containers
Removed from TGO 92 These requirements were drafted with regard to medicines such as vaccines they are not required in the draft TGO 92
Agree with removal
Sec 11 (1)(b) The abbreviations to lsquomgrsquo and lsquogrsquo can be used on all labels but microgram should be used in full unless the medicine is in a small container Then abbreviation lsquo μg may be used
Where several ingredients are presented on a label statement in microgram microliter quantities the repetition of expressing the unit in full greatly expands the length of the text
This proposed requirement if mandatory does not allow for consistency on the label and increase label space required An abbreviated form of microgram should be permitted CMA questions if the requirement is mandatory given it is expressed as lsquoshouldrsquo in the standard compared to lsquomustrsquo in the guideline
Expression of herbal active ingredients
Sec 11 (2) Expression of quantity or proportion of active ingredients
This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived
The 2014 consultation suggested the reasoning that it ldquoenables the consumer to gain meaningful information from the label in relation to the lsquostrengthrsquo lsquoconcentrationrsquo or quantified levels in general of the herbal ingredients in the medicinerdquo
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)-11(2)(h) and therefore includes 11(2)(a) hellipthe quantity of the active ingredientrdquo
11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived exceptrdquohellip
To implement this it would require at least two lines for each herbal material ingredient on the medicine label to express both quantities If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size
CMA stresses that the addition of this extra information for the average consumer would most likely create confusion as to which line of expression to draw a meaningful conclusion from Additionally the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information
Transitional arrangements
Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply
1 January 2020 TGO 92 applies
CMA supports that additional time has been provided for implementation of the final Labelling Order We do however highlight that even with these timeframes there will still be a burden placed upon any small owner-operator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document)
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from glutenndashcontaining grain Circumstance where gluten is present in a concentration of 20 parts per million or more
Accepted CMA recommendation
CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory TGO 79 ndash required declaration lsquoContains glutenrsquo where gluten or an ingredient derived from gluten-containing grain is present (No provision for gluten being below certain ppm)
TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more This is to align with Food Standards Australia New Zealand
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label
Sulphite declaration
All gelatine capsules contain sulphite CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm)
Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2
Unit Unit description Permitted ingredients
PU Papain Units Bromelain
Specific comment in relation to the guideline for medicine labels draft version 10 October 2015
Proposed Requirement the
guideline for medicine labels
Industry response
3333 Where standardisation of a herbal material or preparation is claimed
In the given example of Camellia sinensis leaf standardised to cetechins CMA propose the removal ldquo(of Camellia sinensis)rdquo after the standardised component name
[standardised to contain cetechins (of Camellia sinensis) 30mg]
This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material and
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
Proposed Requirement the
guideline for medicine labels
Industry response
quantity of standardised constituent) would be expressed together This reiteration appears to be redundant and would take up more space on the label
Schedule 1 Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG Contains alcohol vs contains ethanol (vv) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if
the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate according to the warning statement required on the ARTG the label would have lsquoContains potassium sorbatersquo whilst it would read ldquoContains sorbatesrsquo to comply with schedule 1 of TG0 92
Schedule 1 Phenylalanine CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to
It is proposed that ingredients to which the declaration of phenylalanine is required be included or to provide exemptions where the declaration is not required eg mineral amino acid chelates spirulina where phenylalanine is naturally present as part of the amino acid profile Imposing such requirements to all ingredients may cause unnecessary concern to the consumer
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
Proposed Requirement the
guideline for medicine labels
Industry response
Previous TGO 79 guidance 627 Order of information Previous TGO 79 guidance 627 Order of information
Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)] bull Ingredients bull lsquoUsesrsquo or lsquoWhat this medicine is used forrsquo bull Warnings bull Directions for use bull Other information
CMA understands that a MIP is not required for listed medicines however it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines
CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement
CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()
Scndcrd tColtYgtL o S ze oJ )rod CC) C2 I e middotdo fo- i-
Label Size 135 x 35 mm
Each tablet contains the active lngredlent(s) Sodium phosphate dibasic anhydrous 200 milligrams (equrv sodium 648 milligrams) Galcium phosphate 100 milligrams Iron phosphate 12 milligrams Also contains lactose and fructose What the medicine is used for Mineral supplement
BLACKMORES CELLO IDdeg COMPOUNDS
SODICAL PLUS middot Sodium phosphate 200 mg
dibasic anhydrous Calcium phosphate Iron phosphate
100mg 12mg
No added sail yeast gluten wheat preservatives artificial colours flavours and sweeteners Contains lactDse fructose and Sodium 648 miIDgrams
Do notnrr-----------1 Ask a doctor or pharmacist before use If
__ _ _ ___ jSto xxxxx
Directions for use bull1---------j------------------_=_ EXP bull
Adutts Take 1 tablet 2 times a day with meals or as professionally prescribed Children under 12 ears onl as rofessionall rescribed
Store blow 30C in a dry place -wdj from direct sunlight Blackmores Ltd 20 Jubilee Avenue Warriewood NSW 2102 AUSTRALIA Auckland NEW ZEALAND Visit wwwblackmoneseomcuprofessional Gall 1800 803 760 (Aus) 0508 757 473 (NZ)
For practitioner dispensing only PR OFESSIO N AL
84 TABLETS Dielory Supplement I AUST R 20265
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
gt
(1
-
9
pound
g
er
g
Cl
5
3
pound r
vi
f
rv
3
a-3
r -
-
0
0
s
V1
0 0
3
E
-3
r
u
- middot
==-gt
(
_
g
p
0
7
3 5 -- g _e 10
--r-
ampmiddot lImiddot1 r
11
c
N3
011H
W
O
AVM
V d3
3gtl
middotS
Z M01
38 3
01S
c 0
22
0
-g r-
ag
g 5
aQ
c
lt -
0
-
-
r -
-g
ltO
Ogt
ltD
Ogt
r -
CD
cmiddota-
ro
-CD
CD
cr
r
lJl
0
tO
-
J
Slgt
Elde1h
c Ec
hinac
ca amp
Olive
Lgrf is a
cold and
Hu t
WfrY
n31
r
J
wh
e am 1y
includi
ng lng
rndien
ts
Each
1 OmL
cont a
ins
Sambuc
us nigra
(Elderbe
rry) fruit
extract
wft 3
34mg
deri
ved from
Samb
ucus
rngra fr
uit fresh
4g O J
Jofr
a
ir
I f
iir9middot 1s
1mg
Echin
acea
purpu
rea (Ec
h inacea
) root ex
act
wft
125mg
N r
e
ru
2area
r oot dry
SOOmg
Nso con
tains so
rbales
Uses
I R
educe
tl)e se bullte
rity and
duratio
n of cold
s nu
and
uppe
r respira
tory tract
infection
1
alhti
er
m
l1g
pound
o1ds inn
gtium
wrbale
Not to
be used
in ch
ldren
rsg
ii1r1
iJifi1
tltcuone
r
i1
11 g
us
e Ad
ults -
Take
10mL t
hree time
s daly
Child
ren 6
middot12 ye
ars -
Tallte
SmL
2middot3 tim
es daily
Chi
ldren 2-
6 yea
rs -T
allte 3
mL 2
middot 3 Lime
s daily
i t
ie
Mc
Y your he
allhcare
practitio
ner
OU1cr
infom
tation
Doe
s no con
tai nd
ded e
rri pey
nut soy
tre
ori
g J
oails
e_l_g_I
_e_n_
ac_1o_s
e __aru _middot_
1c _ia1)
BATC
H amp
EXPI
RY
096middot
2
i lt
-
_
-
11gt
gt
=gt
-r
-
-T--
-r
ol -
cshy middot
ltJ
)
- J
1) f
w
g
8
2middot c
(6
U
sect 1
-0
a c
-
middot
6
g
O 6
p
s L
(I
Q_
-h
1 z
-3
S-J_
-
-a
--
() ltc l
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
0
0
3 r
C1
r
)gt
l)
l)
w
gt
3 3 x
l)
3 3
fiIJ
c
N3
ll011H
O VjQ
ll AV
MV d3
3gt1
middotosz
M01
38 3ll
OlS
0 0 lt gmiddot a i b_
I g
WP---1
Elderber
ry Echin
acea amp
Olive Le
af is a co
ld and O
u twr
r cr1
who
le family
Includin
g Gltfi
irfhinac
ea amp Oli
ve Leaf
may be
I Redu
cing the
severity
and dur
ation of
colds flu
and
upper re
spirator
y act in
fections
Elde
rberry m
ay be be
neficial
due to
I Its ad
itional u
se in reli
eving th
e sympt
oms of
colds an
d flu suc
h as fev
er and m
ucous
conges
tion
How to u
se Elder
berry E
chinace
a amp Oliv
e Leaf
e hree tim
es daitv
-Ta
ke 5ml
-3 times d
aily
-middot
-
_
_
tfl4by
fu
etimM
r
Take m
water o
r JUiee
Not to be
used in
children
under 2
years o
f age
0
rp1om
s persist
consult
Each 10
ml con
tains
f9
fe1$tr
utt
4g
Olea eu
rOgtaea (
Oiive) le
af
1g
and her
lgta1 ex
tract
equiv
to dry
Ech
inacea p
urpurea
(Echinac
ea) root
5
00mg
Naturally
sweeten
ed wilh S
levia C
ontains p
otassium
sorb
ate
=
grr1en
I=
ftavocmgs
096-2
r ()
lt
ro (] 9
0
r - - (
6 O
lL t
(
rt Q 3 -
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
ltJl
3
r
G)
r
)gt
(fJ
(fJ
ltJl
ltJl
3
3
gtlt
ltJl
0
3
3
OlUJCgtYptO
OJOSQJbulllfhlml
VllVlilSn
V Zt
llM
Stldeg
VnlDI
middotlCT
irl ll
middotu
aoJ
q SJ
lsJ
tg
1Jl
31
nlSIO
W WO
10
3101
d middoto
oc
M01
3B 3
101S
0 j CT
J
ro
- cr
Ul
0
lD
0
a
n
En
Je
==
=
ph
capa
ci1y
ring tim
es of
men
tal or
physica
l stres
s
Help
ing to
reliev
e faligue
and ex
haustion
and the
stres
s of
shxfyorw
orllt
H
elping to
resto
re vital
ity
i n
s
n
b
kJitio
o al Ch
ilese
medlcine
to su
pport sla
mina a
nd en
duranc
e
Ciu
sed as a
tonK l
o
)rad
itiooal C
hinese
herbs
whKh
help ma
inlain a
heall
hy mm
une s
ystem
Ho
w to
use G
insen
g 4 En
ergy G
old
Adults
-Tak
e 1 la
blel once
or twice
daiy
with fo
od or as
dir
ected
by yo
ur he
allhcare
practitioner
Ch
ildren
unde
r 12 y
ears-
Take
on a
s direct
ed by
your
heallhca
re practi
lioner
Ea
ch ta
blet c
onta i
ns
slanltf
to Rb
1Rb
Eleulhe
nx
125
mg
G insef19
) rool
1g
1) root
lg
P
q
rona
in fiise
OOsides
w
ni
de
Tlh=
1
As
traga
lus me
mbrana
ceus
(Astra
galus)
root
45Q
TO
TAL G
INSE
NOSI
OES CA
LCULA
TE DA
S Rg1
42Smg
II symptoms
pers
isl con
sult you
r heallhca
re practiti
oner Doe
s not con
lain ad
ded egg m
1k pe
aoot so
y oom tr
ee nut
or
animalprod
ucts ye
as glUf
en lact
ose a rtifici
al colouri
ngs
ftavou
nngs or
preser
valJVes
658-
1
l
0 b
J
1
( middot - 3 c
- J r u - J
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
--
--
(Jl
3
r
G)
r
)gt
()
()
(Jl
(Jl
3
3
x
(Jl
0
3
3
nE lli1l1
l1f 1i1ll1l1l1i
11f 111r
middotua
OJq
SI 1e
as i
uap1
Aa-J
adw
e1 j l
asn
JOU
oa
tMR1W
cJWfY
J1fl
middoti o
c Mo
13a
3iro
ls
T
ro
- cr
lJ1
0
WlO
0
ff
50m
g
100m
g
1 50mg
Warnin
gs
If syl
flllo
ms p
ersis
t cons
ul y
our h
ealll
lcw
e p
rncti
tione
r Di
rect
ions
for u
se
A
dul
ts -
Take
1 ta
blet
onc
e or
tvli
dai
ly w
illl foo
d or
as
dire
cted
by yo
ur he
allll
cwe
prac
tition
er
Ch
ildre
n u
nder
12 ye
ars -
Take
only
as di
rect
ed b
y you
r h
ealll
lc-
e pr
actiti
oner
ea a5i
cfcr
J
658middot
1
11
) I
c(
( C(
-vrt9i
CJ_fGJ
y t
fsR
tace
IA
1- f
e
t
i
0 6 w
c
D
- - (
3
-0
c
-
iO
1
-middot
fr 0
J
_
u
e t
LJ
Q
0
a
g
P-
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
UJ
)gt
I
I Cj (lJ
m
I
co
3
3
x
jgt
01
3
3
11
111111 li
llf
cc
--
0
0
r
ro
_
middot
c c
cr
l11
0
lD
0
a
gj OL
1bull
Ec
hin
ac
ea
20
QOt
blend
s Ech
inace
a ang
uslifolia
and
purpu
rea
roots co
ntain
ing po
tent
alkyla
mides
Ec
hina
cea 2
00
0t
may
be be
nefic
ial fo
r
r y=
s rediioog seve
nty
of col
ds
andft
u
Red
ucing the
nsllt of
uppe
r res
piralo
y tra
ct in
fectio
ns
How
lo us
e Ec
hina
cea
200o+
Sh
ake w
ell b
efor
e us
e
Adu
lts a
nd c
hild
ren
over
12 ye
ars-
Take
5ml l twice
daily Jn
1ate
r or ju
ice o
r as
ditected
b YOIX
hea lhca
re pa
ltliiio
oer
For ma
ximum
bene
fit ta
ke im
med
iately
at
onse
t of a
cute
symp
tom
s No
l to be
used
i1 chid
ren
under
ye
ars of
age w
ithou
t rneltf
JCal a
dvice
If sy
mptom
s pe
rsist
cons
ult you
r he
althca
re pracliti
orier
Eac
h 5
ml co
ntai
ns
herbal e
xtracts eq
uiv lo
dry
Echin
acea
purpu
rea JE
chin
acea
) root
12
8g Ec
hinac
ea ang
uslifoli
a (EciVnace
a) ro
ot
850mJ
Natur
ally s
weet
ened
with
Slev
ia
=
rTKljdeg=
middot =
afiveS
fi
LOl
tlCIP
lpoundIT
ST
OR
E B
EL
OW
30
C
KE
EP
AW
AY
FR
OM
CH
ILD
RE
N
Do not
use n ta
mper-e
viden
t sea
l Is brollt
en
337-
1
r0 f
j
w
P-
s (
0 J Q- i 3 D A
(__ 0 I
cc 5 _E_
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
9 r-
0-cl
c
9
SL-
I
( -
t
-
V
)
0 i
r-
1bull U1
-C-)
0
0
-lt(
j gt
gt-r
ltt (Q
-x
middot
r-
iJ
0 9-
-
) ()
9
( f
18 3 r
CI j VI
VI
w
3 3 x
V1 3 3
fi middott l
f l lf
_o p
ru
11 22
a a
1 0
3 r
0 c 0 c a -
g ns
n i(Jgt
0 ()
r
2pound
3 0
r l 9
2
n2agtr-
-
g
0
J i
li
g +
i
t 0
3 0
30r
g
gco
()
n s
CD
$
Ol
t
l
I -
0 -
0 0
-2
lngrc
dienl
s Ea
ch 5m
L con
tain
s
r
ro
- cr
Ul
0
lD
0
a I
Echin
acea
purpu
rea (
Echina
cea)
root
O
ffiE
ChlriB
Ceamiddot
pup
urea
r1
middotem
g
angu
stfo
lia (E
china
cea)
root
c
nmiddotEc
iilnac
eamiddota
iiiius
ff101a
1rit
9 Na
turar
se9e
tene
d with
Ste
via
Also
cont
ains
alco
hol
etha
nol) 4
22
vv
Uses
SuRp
orts
immu
ne fu
nctio
n
Re
lieve
s sym
_plom
s an
d re
duce
s se
verity
of
colds
and
flu
I
Redu
ces t
he ris
k of u
pper
resp
irato
ry tra
ct
mfec
trons
Wa
rnin
gs
Cont
ains
eth
anol
Not
to be
use
d in
child
ren
unde
r two
year
s of a
ge w
ithou
t med
ical
advi
ce J
I sym
ptom
s per
sist c
onsu
lt you
r he
althc
are
prac
tition
er
Dire
ction
s for
use
Sh
ake
wel
l bef
ore
use
Adu
lts a
nd c
hild
ren
over
12 y
ears
-Ta
ke
Sml
twice
dail
y in
wate
r or j
uice
or a
s
0x
b
r
Cfi
111i7
s0t
of ac
ute s
ympt
oms
Oth
er in
form
atio
n
a
g1
a
tagp
iri
Pklt
9
st
glut
en la
ctose
arti
ficial
colou
rings
fla
vour
ings o
r pre
servat
ives
ST
ORE
BELO
W 3
0C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not u
se if
tamp
er-e
viden
t sea
l is b
roke
n
Q
(
D
fflt
lt
--
-
f
0
_
__
__
-[
-
ll lt-
3
-
c
gt
5gt v
f
r
337-
t
VI
s
)gt
r
r
r
)gt
ogt
m
r
()) 3 3 x
-gt
V1 3 3
lt
o
=_ll
-ig-o
igmiddot
B
tuamp
Ci
r
pOCi
c
middot
c
ltIgt r
] 0
Ingre
dient
s Ea
ch 5m
L con
tain
s Ec
hinac
ea p
urpu
rea
(Ech
inace
a) roo
t e xJ
fJe53
ommiddotE
diiri
8C0a
middotpu-p
urea
r1
middotemg
dry 1
28g
Ech1
nace
a ang
uslifo
lia (E
china
cea)
root
e bullJ
fJ5d
cnmiddot
ia1
0c
middot
9usil1
0ii1
rt
9 dr
y 85
0mg
c
Jtiii
t7cohi
t
rifj 4
22
vv
Uses
SuRp
Orts
imm
une f
uncti
on
I Re
lieve
s sy
mpt
oms
and
redu
ces sev
erity
or
colds
and
fiu
e
duce
s the
risk
or u
pper
resp
irato
ry tr
a ct
1nfec
t1ons
W
nmin
gs
Cont
ains e
than
ol N
ot to
be
used
in ch
ildre
n un
der t w
o ye
ars o
f age
with
out m
edica
l
i1fc
rrc2
76g
[rsist
con
sult y
our
Dire
ction
s for u
se
Shak
e wel
l bef
ore
use
A
dults
and
chi
ldre
n ov
er 1
2 ye
ars
-Tak
e 5m
l t
vice
daily
in w
ater
or ju
1ce1 o
r as
1
tit
=
1ri
gfit
ti7r
K
t of
acu
te y
mpt
ms
Cn g
c Ja
a g rai
J8
middotp
fta
middotst
glute
n lactas
e ar
tificia
l_colo
uring
s fla
vour
ings o
r pre
serv
ative
s
STOR
E BE
LOW
30C
KE
EP AW
AY FR
OM C
HILD
REN
Do
not u
se if
tampe
rmiddotevid
ent s
eal is
bro
ken
BA
TC
H amp
EX
PIR
Y
ww
rnIPIEif
33
7-1
-5 3
lt
-B-
r
ltF 0
(tgt
1
gt
--
--
lt
9
7
gt
f 0
-
)
--
r-
f V
Cbull
=-
3
gt r
C
Cbull
-
(()
pound-
flt
QJ
f Y q t - -0
c
l
f-gt
-
0 [J_
f
(Igt
-
-
gt (
r
-
J
[
t a [ l z_ f=- a ])
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
9 o
middot cl
c j p
I
-
-
V)
Cgt
1
r r-
=-r--
()1
0 0
3
-r - fa
9- ) 9
t 9
0
0
3 r
cf Cl
r
)gt
--
V1
6 V1
L
w
I -1gt
3 -t
3 x
-1gt
Ln
It
3 x
3
I)
0 -lt
r- ()
- gtl f
ln
grcd
ienl
s
Each
5mL
cont
ains
r
ro
- cr
lJl
0
lD
0
a bull
Echin
acea
pur
pure
a (E
china
cea)
root
e xd
i
3Vro
mmiddote
ch1nac
eamiddotpurp
urea
Z
emg
dry
12 eg
Ech1na
cea an
gustfo
lia (E
china
cea)
root
e xd
fJidi
omEc
iiiiiac
eamiddotaii
gusil
fci1i1
rtgt9
dr
y 850
mg
Natu
ral s
weet
ened
with
Ste
via
Also
con
tains a
lcoho
l (et
hano
l) 42
2
vv
Uses
t
SuRp
ors
imm
une f
unction
I
Relie
ves
sym
ptom
s an
d re
duce
s se
verit
y of c
olds
and
flu
bull
t fle
due
s the
risk o
f upp
er re
spira
tory
trac
t mr
ect1o
ns
Warn
ings
C
onta
ins e
than
un
der tw
o ye
ars
advic
e If
sym
pt
healt
hcar
e pr
ac1
Dire
ctio
ns fo
r use
t to
be u
sed
in ch
ildre
n wi
thou
t med
ical
sist c
onsu
lt yo
ur
Shak
e well b
efor
e use
A
dults
and
child
ren
over
12 ye
ars
-Ta
ke
Sml
twice
dail
y in w
ater
or j
uice
or a
s
0x1
bh
hC
1
C
fi11i7
f
t
of acu
te sy
mpt
oms
Olhc
r inf
orm
ation
o
g
1aA
1agp
i
middotPu
ampa9
s1
glute
n la
ctos
e art
ificial
colou
rings
fla
vour
ings
or pre
servat
ives
ST
ORE
BELO
W 30
C
KEEP
AWA
Y FR
OM C
HILD
REN
Do
not
use
if ta
mpe
r-evid
ent s
eal is
brok
en
o
cmiddot
o
() F
-lt
---
--
0
_
_
___
S
( -lt
-p
-Q
-
3 c-
--
k-c
(
f
r
=
W UCTP 1E lfl
33
7-t
V1
s
)gt
r
r
r
)gt
co
m
r
Cf) 3 3 x
-1gt
Ul 3 3
if
amiddot g
g- emiddot
-9
z
G)
P-Ugtm2
g c
)gtP-p
c
ii
c ii
Ingred
ient
s
Each
5mL
con
tain
s
r
ro
cr
Ul
0
lB
0 a
Echin
acea
pur
pure
a (E
china
cea)
root
e xJ
fJi3
ommiddotea
inac
eamiddotpu
purea
r1yamg
dr
y 12
8g
Ech1n
acea
ang
ustifo
lia (E
chinac
ea) r
oot
e xl
rJgr
cn middot
a1
c middot a
iiiius
iil61i
1rF
9 dr
y esom
g Na
lura
l swe
eten
ed w
ith S
tevia
Al
so con
tains a
lcoho
l (et
hano
l) 42
2 v
v Us
es
SU
Pport
s im
mun
e fu
nclio
n
Re
lieve
s sym_ pl
oms
and re
duce
s sev
erity
or
colds
and
flu
t fle
duce
s the
risk
of u
pper
resp
irato
ry tra
ct mf
ect1o
ns
War
nings
Co
ntain
s et
hano
l No
t to
be u
sed in ch
ildre
n un
der tv1
0 yea
rs or
age
with
out m
edica
l g
fJ
i
fdampt
grsis
t con
sult yo
ur
Dire
ctio
ns fo
r use
Sh
ake w
ell b
efore
use
A
dults
and c
hild
ren
over
12 y
ears
-Ta
ke
5ml
twice
dail
y in
wate
r or ju
ice o
r as
x
i
t
fitt1
r
1
of a
cut
ym
ptm
s
ggtr
g 1
aArtagp
i
l8middotp
JkuJl
9
st
glute
n lac
tose
artific
ialco
lourin
gs
flavo
uring
s or p
rese
rvat
ives
STOR
E BE
LOW
30C
KE
EP AWA
Y FR
OM C
HILDR
EN
Do n
ot us
e if t
ampe
r-evid
ent s
eal is
brok
en
BATC
H amp
EXPIR
Y U
l lIUlIP
ll NT
337middot
1
--ygt 3
lt
-lt
c
--
1 gt
--gt
-
(
9
r
f
cf -
-
v f
-C
bull -- --
3
r
c
rn
1 i
b
(ii
cf
()
I- k- i C
+-
g [
-
D [J__
i (1gt
-
gt -
f
J-
V
T
i
J b 3-
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
1-090
D
-0
01
l_
0
ll
0
-
c
I 1111 9 313923 030858
STO
RE
BE
LOW
30C
PR
OTE
CT
FR
OM
MO
ISTU
RE
K
EE
P A
WA
Y F
RO
M C
HILD
RE
N
Do
not use ff tamper-e
vident
seals are broken
4 bull hertgtso
fgokllaquogtm
au
E E N
()
x
E E (V)
()
()
()
lt
_J
CJ
_J
E 0
l)
-
-
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
chv0 11 d-P lt) I CO --w DgtC )VI _JS)
p1d 1 v 1qo YlC
I VOf7lt ftrCJ 1
A P0)
ltl1 lt l) Q)Z VO 1 -) l
l _J01_
(-lt-ltlt [J-llr cfY 2 C ltdegID
1xoI JO- J
WLUQL X WWQ6 SSVl8 lW09G
PIDDJDSqJa
wwog x ww9a SS118 iwooz
middot Ogtda
flt 0()JJO fJ i )Iodltl
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i
c__s C
I Q lti)
(
m
g m lt
0060 a_g a1u g -
a _[
n a
amp
Qi i
l Qj
WLLIQL X WW06bull SSVlEl lWOSl
cegg 1 usn C)gt m3E
If i lJI 0 -g 11 t
J t -middot QG) 30
if bull g itl 5 gto o 88
I 3a 2
ij-gg-1middot PIDDJDSqJa4
wwog x wwsa SSVlEl lWOOl
PIDDJDSqJa4
ry QAX)j 3 l(JJJJf t )2i