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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 [email protected] From: Complementary Medicines Australia PO Box 450 MAWSON ACT 2607 23 December 2015

CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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Page 1: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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-

0

0

s

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0 0

3

E

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r

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(

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p

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7

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ampmiddot lImiddot1 r

11

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W

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middotS

Z M01

38 3

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CD

cmiddota-

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cr

r

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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

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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

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allhcare

practitio

ner

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infom

tation

Doe

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nut soy

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oails

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sect 1

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middotosz

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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

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(fJ

ltJl

ltJl

3

3

gtlt

ltJl

0

3

3

OlUJCgtYptO

OJOSQJbulllfhlml

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V Zt

llM

Stldeg

VnlDI

middotlCT

irl ll

middotu

aoJ

q SJ

lsJ

tg

1Jl

31

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10

3101

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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

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elping to

resto

re vital

ity

i n

s

n

b

kJitio

o al Ch

ilese

medlcine

to su

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Page 2: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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er

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cold and

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e am 1y

includi

ng lng

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Each

1 OmL

cont a

ins

Sambuc

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(Elderbe

rry) fruit

extract

wft 3

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deri

ved from

Samb

ucus

rngra fr

uit fresh

4g O J

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a

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Echin

acea

purpu

rea (Ec

h inacea

) root ex

act

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N r

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2area

r oot dry

SOOmg

Nso con

tains so

rbales

Uses

I R

educe

tl)e se bullte

rity and

duratio

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and

uppe

r respira

tory tract

infection

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alhti

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pound

o1ds inn

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wrbale

Not to

be used

in ch

ldren

rsg

ii1r1

iJifi1

tltcuone

r

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11 g

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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

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mL 2

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ner

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tation

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nut soy

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oails

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sect 1

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fiIJ

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Elderber

ry Echin

acea amp

Olive Le

af is a co

ld and O

u twr

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who

le family

Includin

g Gltfi

irfhinac

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may be

I Redu

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severity

and dur

ation of

colds flu

and

upper re

spirator

y act in

fections

Elde

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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

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er and m

ucous

conges

tion

How to u

se Elder

berry E

chinace

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e Leaf

e hree tim

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ke 5ml

-3 times d

aily

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-

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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

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lt

ro (] 9

0

r - - (

6 O

lL t

(

rt Q 3 -

ltJl

3

r

G)

r

)gt

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(fJ

ltJl

ltJl

3

3

gtlt

ltJl

0

3

3

OlUJCgtYptO

OJOSQJbulllfhlml

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V Zt

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Stldeg

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middotlCT

irl ll

middotu

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lsJ

tg

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31

nlSIO

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10

3101

d middoto

oc

M01

3B 3

101S

0 j CT

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ro

- cr

Ul

0

lD

0

a

n

En

Je

==

=

ph

capa

ci1y

ring tim

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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

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Page 3: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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er

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cr

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Slgt

Elde1h

c Ec

hinac

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Olive

Lgrf is a

cold and

Hu t

WfrY

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r

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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

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Echin

acea

purpu

rea (Ec

h inacea

) root ex

act

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125mg

N r

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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-

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rs -T

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mL 2

middot 3 Lime

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ie

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tation

Doe

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rri pey

nut soy

tre

ori

g J

oails

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RY

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1) f

w

g

8

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U

sect 1

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a c

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g

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p

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(I

Q_

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1 z

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--

() ltc l

0

0

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C1

r

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l)

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w

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l)

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fiIJ

c

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O VjQ

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middotosz

M01

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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

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ke 5ml

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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

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J

ro

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Ul

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lD

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a

n

En

Je

==

=

ph

capa

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ring tim

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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

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N

Do not

use n ta

mper-e

viden

t sea

l Is brollt

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r-

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gt-r

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middot

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VI

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fi middott l

f l lf

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ru

11 22

a a

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2

n2agtr-

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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

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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

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iiiius

ff101a

1rit

9 Na

turar

se9e

tene

d with

Ste

via

Also

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Page 4: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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(1

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9

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g

er

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Cl

5

3

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3

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W

O

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V d3

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middotS

Z M01

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22

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aQ

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0

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Ogt

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CD

cmiddota-

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cr

r

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tO

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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

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infom

tation

Doe

s no con

tai nd

ded e

rri pey

nut soy

tre

ori

g J

oails

e_l_g_I

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ac_1o_s

e __aru _middot_

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EXPI

RY

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i lt

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ol -

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1) f

w

g

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sect 1

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Q_

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l)

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fiIJ

c

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MV d3

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M01

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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

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(

rt Q 3 -

ltJl

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r

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ltJl

ltJl

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3

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0

3

3

OlUJCgtYptO

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middotlCT

irl ll

middotu

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lsJ

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1Jl

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nlSIO

W WO

10

3101

d middoto

oc

M01

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101S

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J

ro

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Ul

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lD

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a

n

En

Je

==

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ph

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es of

men

tal or

physica

l stres

s

Help

ing to

reliev

e faligue

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haustion

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stres

s of

shxfyorw

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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-

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0 J Q- i 3 D A

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cc 5 _E_

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t

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V

)

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r-

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0

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gt-r

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middot

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iJ

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9

( f

18 3 r

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VI

w

3 3 x

V1 3 3

fi middott l

f l lf

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ru

11 22

a a

1 0

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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

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Page 5: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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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

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RY

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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

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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

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ke 5ml

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aily

-middot

-

_

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fu

etimM

r

Take m

water o

r JUiee

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used in

children

under 2

years o

f age

0

rp1om

s persist

consult

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ml con

tains

f9

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utt

4g

Olea eu

rOgtaea (

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af

1g

and her

lgta1 ex

tract

equiv

to dry

Ech

inacea p

urpurea

(Echinac

ea) root

5

00mg

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sweeten

ed wilh S

levia C

ontains p

otassium

sorb

ate

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capa

ci1y

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es of

men

tal or

physica

l stres

s

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ing to

reliev

e faligue

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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

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--

--

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r

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r

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3

x

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0

3

3

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as i

uap1

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asn

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ro

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lJ1

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ff

50m

g

100m

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1 50mg

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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

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c(

( C(

-vrt9i

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e

t

i

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c

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3

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iO

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-middot

fr 0

J

_

u

e t

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Q

0

a

g

P-

UJ

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I Cj (lJ

m

I

co

3

3

x

jgt

01

3

3

11

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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_

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c

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t

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V

)

0 i

r-

1bull U1

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0

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middot

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iJ

0 9-

-

) ()

9

( f

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fi middott l

f l lf

_o p

ru

11 22

a a

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3 r

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g ns

n i(Jgt

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r

2pound

3 0

r l 9

2

n2agtr-

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li

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t 0

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n s

CD

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Ol

t

l

I -

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dienl

s Ea

ch 5m

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tain

s

r

ro

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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

_

__

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ll lt-

3

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r

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)gt

r

r

r

)gt

ogt

m

r

()) 3 3 x

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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

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lt

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gt

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lt

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7

gt

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-

)

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gt r

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(()

pound-

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c

l

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t 9

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6 V1

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3 x

3

I)

0 -lt

r- ()

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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

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Page 6: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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er

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5

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cr

r

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Slgt

Elde1h

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hinac

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Olive

Lgrf is a

cold and

Hu t

WfrY

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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

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and

uppe

r respira

tory tract

infection

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alhti

er

m

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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

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infom

tation

Doe

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ded e

rri pey

nut soy

tre

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g J

oails

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RY

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sect 1

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WP---1

Elderber

ry Echin

acea amp

Olive Le

af is a co

ld and O

u twr

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who

le family

Includin

g Gltfi

irfhinac

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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

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er and m

ucous

conges

tion

How to u

se Elder

berry E

chinace

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e Leaf

e hree tim

es daitv

-Ta

ke 5ml

-3 times d

aily

-middot

-

_

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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

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(fJ

ltJl

ltJl

3

3

gtlt

ltJl

0

3

3

OlUJCgtYptO

OJOSQJbulllfhlml

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V Zt

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Stldeg

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middotlCT

irl ll

middotu

aoJ

q SJ

lsJ

tg

1Jl

31

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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

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Page 7: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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rv

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r -

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0

0

s

V1

0 0

3

E

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r

u

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(

_

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 -

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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

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i lt

-

_

-

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gt

=gt

-r

-

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ol -

cshy middot

ltJ

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1) f

w

g

8

2middot c

(6

U

sect 1

-0

a c

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middot

6

g

O 6

p

s L

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Q_

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1 z

-3

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() ltc l

0

0

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C1

r

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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

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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

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Page 8: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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rv

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E

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--r-

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Olive

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cold and

Hu t

WfrY

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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

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I f

iir9middot 1s

1mg

Echin

acea

purpu

rea (Ec

h inacea

) root ex

act

wft

125mg

N r

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ru

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r oot dry

SOOmg

Nso con

tains so

rbales

Uses

I R

educe

tl)e se bullte

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and

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infection

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pound

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Not to

be used

in ch

ldren

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ii1r1

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tltcuone

r

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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

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ner

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infom

tation

Doe

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ded e

rri pey

nut soy

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oails

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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

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unde

r 12 y

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ni

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INSE

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pers

isl con

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r heallhca

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nefic

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ct in

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ns

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lo us

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hina

cea

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ake w

ell b

efor

e us

e

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lts a

nd c

hild

ren

over

12 ye

ars-

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5ml l twice

daily Jn

1ate

r or ju

ice o

r as

ditected

b YOIX

hea lhca

re pa

ltliiio

oer

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ximum

bene

fit ta

ke im

med

iately

at

onse

t of a

cute

symp

tom

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l to be

used

i1 chid

ren

under

ye

ars of

age w

ithou

t rneltf

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dvice

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mptom

s pe

rsist

cons

ult you

r he

althca

re pracliti

orier

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h 5

ml co

ntai

ns

herbal e

xtracts eq

uiv lo

dry

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acea

purpu

rea JE

chin

acea

) root

12

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angu

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turar

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via

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ains

alco

hol

etha

nol) 4

22

vv

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orts

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ne fu

nctio

n

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lieve

s sym

_plom

s an

d re

duce

s se

verity

of

colds

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flu

I

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ces t

he ris

k of u

pper

resp

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ct

mfec

trons

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rnin

gs

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ains

eth

anol

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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

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ction

s for

use

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ake

wel

l bef

ore

use

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lts a

nd c

hild

ren

over

12 y

ears

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ke

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twice

dail

y in

wate

r or j

uice

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s

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b

r

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ute s

ympt

oms

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er in

form

atio

n

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g1

a

tagp

iri

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9

st

glut

en la

ctose

arti

ficial

colou

rings

fla

vour

ings o

r pre

servat

ives

ST

ORE

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0C

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OM C

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se if

tamp

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t sea

l is b

roke

n

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une f

uncti

on

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lieve

s sy

mpt

oms

and

redu

ces sev

erity

or

colds

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fiu

e

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risk

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pper

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ry tr

a ct

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nmin

gs

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ains e

than

ol N

ot to

be

used

in ch

ildre

n un

der t w

o ye

ars o

f age

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out m

edica

l

i1fc

rrc2

76g

[rsist

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sult y

our

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ction

s for u

se

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e wel

l bef

ore

use

A

dults

and

chi

ldre

n ov

er 1

2 ye

ars

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e 5m

l t

vice

daily

in w

ater

or ju

1ce1 o

r as

1

tit

=

1ri

gfit

ti7r

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t of

acu

te y

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ms

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c Ja

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fta

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n lactas

e ar

tificia

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uring

s fla

vour

ings o

r pre

serv

ative

s

STOR

E BE

LOW

30C

KE

EP AW

AY FR

OM C

HILD

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Do

not u

se if

tampe

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ent s

eal is

bro

ken

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c

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ln

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ienl

s

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5mL

cont

ains

r

ro

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lJl

0

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0

a bull

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acea

pur

pure

a (E

china

cea)

root

e xd

i

3Vro

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ch1nac

eamiddotpurp

urea

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emg

dry

12 eg

Ech1na

cea an

gustfo

lia (E

china

cea)

root

e xd

fJidi

omEc

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eamiddotaii

gusil

fci1i1

rtgt9

dr

y 850

mg

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ral s

weet

ened

with

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via

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tains a

lcoho

l (et

hano

l) 42

2

vv

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t

SuRp

ors

imm

une f

unction

I

Relie

ves

sym

ptom

s an

d re

duce

s se

verit

y of c

olds

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flu

bull

t fle

due

s the

risk o

f upp

er re

spira

tory

trac

t mr

ect1o

ns

Warn

ings

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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

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dults

and

child

ren

over

12 ye

ars

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ke

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twice

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y in w

ater

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uice

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s

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t

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te sy

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e art

ificial

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vour

ings

or pre

servat

ives

ST

ORE

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W 30

C

KEEP

AWA

Y FR

OM C

HILD

REN

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not

use

if ta

mpe

r-evid

ent s

eal is

brok

en

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o

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0

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r

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c ii

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s

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5mL

con

tain

s

r

ro

cr

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0

lB

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acea

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pure

a (E

china

cea)

root

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fJi3

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inac

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purea

r1yamg

dr

y 12

8g

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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

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so con

tains a

lcoho

l (et

hano

l) 42

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v Us

es

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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

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ke

5ml

twice

dail

y in

wate

r or ju

ice o

r as

x

i

t

fitt1

r

1

of a

cut

ym

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s

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st

glute

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artific

ialco

lourin

gs

flavo

uring

s or p

rese

rvat

ives

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E BE

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EP AWA

Y FR

OM C

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EN

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e if t

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Page 9: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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vi

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r -

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0

0

s

V1

0 0

3

E

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u

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(

_

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p

0

7

3 5 -- g _e 10

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11

c

N3

011H

W

O

AVM

V d3

3gtl

middotS

Z M01

38 3

01S

c 0

22

0

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ag

g 5

aQ

c

lt -

0

-

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r -

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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

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i lt

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=gt

-r

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ol -

cshy middot

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1) f

w

g

8

2middot c

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U

sect 1

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a c

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g

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p

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Q_

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() ltc l

0

0

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C1

r

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l)

l)

w

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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

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cc 5 _E_

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9

SL-

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( -

t

-

V

)

0 i

r-

1bull U1

-C-)

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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

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Page 10: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

(

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g

p

0

7

3 5 -- g _e 10

--r-

ampmiddot lImiddot1 r

11

c

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W

O

AVM

V d3

3gtl

middotS

Z M01

38 3

01S

c 0

22

0

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ag

g 5

aQ

c

lt -

0

-

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r -

-g

ltO

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ltD

Ogt

r -

CD

cmiddota-

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-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

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ac_1o_s

e __aru _middot_

1c _ia1)

BATC

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EXPI

RY

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11gt

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=gt

-r

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)

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1) f

w

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8

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(6

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sect 1

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0

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C1

r

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l)

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gt

3 3 x

l)

3 3

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N3

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ll AV

MV d3

3gt1

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M01

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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

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1ate

r or ju

ice o

r as

ditected

b YOIX

hea lhca

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ltliiio

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ximum

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med

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onse

t of a

cute

symp

tom

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l to be

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i1 chid

ren

under

ye

ars of

age w

ithou

t rneltf

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dvice

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mptom

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rsist

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ult you

r he

althca

re pracliti

orier

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h 5

ml co

ntai

ns

herbal e

xtracts eq

uiv lo

dry

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acea

purpu

rea JE

chin

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hinac

ea ang

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a (EciVnace

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850mJ

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weet

ened

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ia

=

rTKljdeg=

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OR

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ffiE

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g

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ff101a

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via

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ct

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ge w

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ptom

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l bef

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china

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t

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imm

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unction

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ect1o

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pt

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ctio

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ildre

n wi

thou

t med

ical

sist c

onsu

lt yo

ur

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e well b

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dults

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ORE

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china

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y 12

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ustifo

lia (E

chinac

ea) r

oot

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iiiius

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lura

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eten

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ith S

tevia

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so con

tains a

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hano

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v Us

es

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mun

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nclio

n

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lieve

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risk

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resp

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ct mf

ect1o

ns

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nings

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ntain

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t to

be u

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ildre

n un

der tv1

0 yea

rs or

age

with

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edica

l g

fJ

i

fdampt

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t con

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ur

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ctio

ns fo

r use

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ake w

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efore

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dults

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Page 11: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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Page 12: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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(1

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er

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5

3

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3

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V d3

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22

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CD

cmiddota-

ro

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cr

r

lJl

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tO

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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

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Y your he

allhcare

practitio

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infom

tation

Doe

s no con

tai nd

ded e

rri pey

nut soy

tre

ori

g J

oails

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ac_1o_s

e __aru _middot_

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EXPI

RY

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1) f

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sect 1

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Q_

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0

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l)

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fiIJ

c

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middotosz

M01

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OlS

0 0 lt gmiddot a i b_

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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

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J

ro

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Ul

0

lD

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a

n

En

Je

==

=

ph

capa

ci1y

ring tim

es of

men

tal or

physica

l stres

s

Help

ing to

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e faligue

and ex

haustion

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stres

s of

shxfyorw

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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

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N

Do not

use n ta

mper-e

viden

t sea

l Is brollt

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337-

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r0 f

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)

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r-

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11 22

a a

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li

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i

t 0

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30r

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()

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CD

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Ol

t

l

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0 -

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-2

lngrc

dienl

s Ea

ch 5m

L con

tain

s

r

ro

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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

_

__

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-[

-

ll lt-

3

-

c

gt

5gt v

f

r

337-

t

VI

s

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r

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Page 13: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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pound

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er

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5

3

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7

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V d3

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middotS

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CD

cmiddota-

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cr

r

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0

tO

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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)

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EXPI

RY

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=gt

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cshy middot

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)

- J

1) f

w

g

8

2middot c

(6

U

sect 1

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a c

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middot

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g

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p

s L

(I

Q_

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1 z

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--

() ltc l

0

0

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C1

r

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l)

l)

w

gt

3 3 x

l)

3 3

fiIJ

c

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O VjQ

ll AV

MV d3

3gt1

middotosz

M01

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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

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Page 14: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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cr

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Elde1h

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hinac

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Olive

Lgrf is a

cold and

Hu t

WfrY

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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

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and

uppe

r respira

tory tract

infection

1

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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

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allhcare

practitio

ner

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infom

tation

Doe

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nut soy

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oails

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Elderber

ry Echin

acea amp

Olive Le

af is a co

ld and O

u twr

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who

le family

Includin

g Gltfi

irfhinac

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ve Leaf

may be

I Redu

cing the

severity

and dur

ation of

colds flu

and

upper re

spirator

y act in

fections

Elde

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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

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er and m

ucous

conges

tion

How to u

se Elder

berry E

chinace

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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

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(fJ

ltJl

ltJl

3

3

gtlt

ltJl

0

3

3

OlUJCgtYptO

OJOSQJbulllfhlml

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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

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Page 15: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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r

u

- middot

==-gt

(

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p

0

7

3 5 -- g _e 10

--r-

ampmiddot lImiddot1 r

11

c

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W

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AVM

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middotS

Z M01

38 3

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22

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cr

r

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0

tO

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J

Slgt

Elde1h

c Ec

hinac

ca amp

Olive

Lgrf is a

cold and

Hu t

WfrY

n31

r

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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

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and

uppe

r respira

tory tract

infection

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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

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allte 3

mL 2

middot 3 Lime

s daily

i t

ie

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allhcare

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ner

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tation

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nut soy

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oails

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)

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sect 1

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MV d3

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middotosz

M01

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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

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Page 16: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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22

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ag

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aQ

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lt -

0

-

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r -

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ltO

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ltD

Ogt

r -

CD

cmiddota-

ro

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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

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1c _ia1)

BATC

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EXPI

RY

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11gt

gt

=gt

-r

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)

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1) f

w

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8

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sect 1

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l)

3 3

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N3

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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

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blel once

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dir

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unde

r 12 y

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s direct

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your

heallhca

re practi

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ch ta

blet c

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ns

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ni

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S Rg1

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pers

isl con

sult you

r heallhca

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allll

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hin

ac

ea

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blend

s Ech

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a ang

uslifolia

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purpu

rea

roots co

ntain

ing po

tent

alkyla

mides

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hina

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nefic

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r

r y=

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nty

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andft

u

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uppe

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piralo

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ct in

fectio

ns

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lo us

e Ec

hina

cea

200o+

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ake w

ell b

efor

e us

e

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lts a

nd c

hild

ren

over

12 ye

ars-

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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

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ally s

weet

ened

with

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ia

=

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fi

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OW

30

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AY

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OM

CH

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l Is brollt

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ffiE

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urea

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g

angu

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lia (E

china

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c

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iilnac

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ff101a

1rit

9 Na

turar

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tene

d with

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via

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cont

ains

alco

hol

etha

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22

vv

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ne fu

nctio

n

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lieve

s sym

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d re

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verity

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flu

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pper

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ct

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rnin

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eth

anol

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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

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ction

s for

use

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ake

wel

l bef

ore

use

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lts a

nd c

hild

ren

over

12 y

ears

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ke

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twice

dail

y in

wate

r or j

uice

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s

0x

b

r

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111i7

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ute s

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atio

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iri

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glut

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ctose

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ficial

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r pre

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se if

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roke

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9 dr

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c

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rifj 4

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imm

une f

uncti

on

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lieve

s sy

mpt

oms

and

redu

ces sev

erity

or

colds

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fiu

e

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risk

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pper

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irato

ry tr

a ct

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nmin

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ains e

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ot to

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in ch

ildre

n un

der t w

o ye

ars o

f age

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out m

edica

l

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[rsist

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our

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se

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e wel

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ore

use

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dults

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chi

ldre

n ov

er 1

2 ye

ars

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e 5m

l t

vice

daily

in w

ater

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1ce1 o

r as

1

tit

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gfit

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t of

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vour

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s

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AY FR

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s

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5mL

cont

ains

r

ro

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lJl

0

lD

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a bull

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acea

pur

pure

a (E

china

cea)

root

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china

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root

e xd

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gusil

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rtgt9

dr

y 850

mg

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ral s

weet

ened

with

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via

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con

tains a

lcoho

l (et

hano

l) 42

2

vv

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t

SuRp

ors

imm

une f

unction

I

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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

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ings

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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

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dults

and

child

ren

over

12 ye

ars

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ke

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twice

dail

y in w

ater

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uice

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s

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bh

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1

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fi11i7

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t

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te sy

mpt

oms

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r inf

orm

ation

o

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i

middotPu

ampa9

s1

glute

n la

ctos

e art

ificial

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rings

fla

vour

ings

or pre

servat

ives

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ORE

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W 30

C

KEEP

AWA

Y FR

OM C

HILD

REN

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not

use

if ta

mpe

r-evid

ent s

eal is

brok

en

o

cmiddot

o

() F

-lt

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--

0

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r

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c

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c ii

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s

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5mL

con

tain

s

r

ro

cr

Ul

0

lB

0 a

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acea

pur

pure

a (E

china

cea)

root

e xJ

fJi3

ommiddotea

inac

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purea

r1yamg

dr

y 12

8g

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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

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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

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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

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i

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st

glute

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ialco

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flavo

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s or p

rese

rvat

ives

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E BE

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KE

EP AWA

Y FR

OM C

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EN

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e if t

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bull -- --

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r

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Page 17: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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-

0

0

s

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0 0

3

E

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r

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(

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p

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7

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ampmiddot lImiddot1 r

11

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W

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middotS

Z M01

38 3

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CD

cmiddota-

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cr

r

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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

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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

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allhcare

practitio

ner

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infom

tation

Doe

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nut soy

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oails

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sect 1

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middotosz

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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

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(fJ

ltJl

ltJl

3

3

gtlt

ltJl

0

3

3

OlUJCgtYptO

OJOSQJbulllfhlml

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V Zt

llM

Stldeg

VnlDI

middotlCT

irl ll

middotu

aoJ

q SJ

lsJ

tg

1Jl

31

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10

3101

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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

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elping to

resto

re vital

ity

i n

s

n

b

kJitio

o al Ch

ilese

medlcine

to su

pport sla

mina a

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e

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sed as a

tonK l

o

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itiooal C

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heall

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ystem

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w to

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insen

g 4 En

ergy G

old

Adults

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blel once

or twice

daiy

with fo

od or as

dir

ected

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allhcare

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unde

r 12 y

ears-

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re practi

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ni

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INSE

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S Rg1

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pers

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sult you

r heallhca

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oner Doe

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1k pe

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y oom tr

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ake w

ell b

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e

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lts a

nd c

hild

ren

over

12 ye

ars-

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5ml l twice

daily Jn

1ate

r or ju

ice o

r as

ditected

b YOIX

hea lhca

re pa

ltliiio

oer

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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

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mptom

s pe

rsist

cons

ult you

r he

althca

re pracliti

orier

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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

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ia

=

rTKljdeg=

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fi

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OR

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Page 18: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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er

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5

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cr

r

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Slgt

Elde1h

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hinac

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Olive

Lgrf is a

cold and

Hu t

WfrY

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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

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and

uppe

r respira

tory tract

infection

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alhti

er

m

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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

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infom

tation

Doe

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ded e

rri pey

nut soy

tre

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g J

oails

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RY

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sect 1

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WP---1

Elderber

ry Echin

acea amp

Olive Le

af is a co

ld and O

u twr

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who

le family

Includin

g Gltfi

irfhinac

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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

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er and m

ucous

conges

tion

How to u

se Elder

berry E

chinace

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e Leaf

e hree tim

es daitv

-Ta

ke 5ml

-3 times d

aily

-middot

-

_

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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

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(fJ

ltJl

ltJl

3

3

gtlt

ltJl

0

3

3

OlUJCgtYptO

OJOSQJbulllfhlml

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V Zt

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Stldeg

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middotlCT

irl ll

middotu

aoJ

q SJ

lsJ

tg

1Jl

31

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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

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Page 19: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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9

pound

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er

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5

3

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7

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11

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W

O

AVM

V d3

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middotS

Z M01

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01S

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22

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aQ

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0

-

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CD

cmiddota-

ro

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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

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Y your he

allhcare

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ner

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infom

tation

Doe

s no con

tai nd

ded e

rri pey

nut soy

tre

ori

g J

oails

e_l_g_I

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ac_1o_s

e __aru _middot_

1c _ia1)

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EXPI

RY

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-r

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)

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1) f

w

g

8

2middot c

(6

U

sect 1

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a c

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6

g

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p

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(I

Q_

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0

0

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C1

r

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l)

l)

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3 3 x

l)

3 3

fiIJ

c

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middotosz

M01

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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

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Page 20: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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vi

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0

s

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3

E

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u

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_

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p

0

7

3 5 -- g _e 10

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11

c

N3

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W

O

AVM

V d3

3gtl

middotS

Z M01

38 3

01S

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22

0

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ag

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aQ

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lt -

0

-

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r -

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ltO

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ltD

Ogt

r -

CD

cmiddota-

ro

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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

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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

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EXPI

RY

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i lt

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=gt

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ol -

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1) f

w

g

8

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sect 1

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a c

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Q_

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0

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C1

r

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l)

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l)

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fiIJ

c

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O VjQ

ll AV

MV d3

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middotosz

M01

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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

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cc 5 _E_

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9

SL-

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( -

t

-

V

)

0 i

r-

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-C-)

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0

-lt(

j gt

gt-r

ltt (Q

-x

middot

r-

iJ

0 9-

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) ()

9

( f

18 3 r

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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 -

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n i(Jgt

0 ()

r

2pound

3 0

r l 9

2

n2agtr-

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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

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ur

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8g

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acea

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chinac

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so con

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r use

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Page 21: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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Olive

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cold and

Hu t

WfrY

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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

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ved from

Samb

ucus

rngra fr

uit fresh

4g O J

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a

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I f

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Echin

acea

purpu

rea (Ec

h inacea

) root ex

act

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e

ru

2area

r oot dry

SOOmg

Nso con

tains so

rbales

Uses

I R

educe

tl)e se bullte

rity and

duratio

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and

uppe

r respira

tory tract

infection

1

alhti

er

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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

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es daily

Chi

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Doe

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RY

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WP---1

Elderber

ry Echin

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Olive Le

af is a co

ld and O

u twr

r cr1

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le family

Includin

g Gltfi

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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

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Take m

water o

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children

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years o

f age

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consult

Each 10

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to dry

Ech

inacea p

urpurea

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ea) root

5

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levia C

ontains p

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I=

ftavocmgs

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nd en

duranc

e

Ciu

sed as a

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o

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itiooal C

hinese

herbs

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help ma

inlain a

heall

hy mm

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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

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Ch

ildren

unde

r 12 y

ears-

Take

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s direct

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re practi

lioner

Ea

ch ta

blet c

onta i

ns

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to Rb

1Rb

Eleulhe

nx

125

mg

G insef19

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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

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oner Doe

s not con

lain ad

ded egg m

1k pe

aoot so

y oom tr

ee nut

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ucts ye

as glUf

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3

3

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3

3

nE lli1l1

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uap1

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asn

JOU

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middoti o

c Mo

13a

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T

ro

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lJ1

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WlO

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ff

50m

g

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g

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Warnin

gs

If syl

flllo

ms p

ersis

t cons

ul y

our h

ealll

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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

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c(

( C(

-vrt9i

CJ_fGJ

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fsR

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1- f

e

t

i

0 6 w

c

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3

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c

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iO

1

-middot

fr 0

J

_

u

e t

LJ

Q

0

a

g

P-

UJ

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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

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)

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r-

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g +

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t 0

3 0

30r

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()

n s

CD

$

Ol

t

l

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0 -

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-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

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t of

acu

te y

mpt

ms

Cn g

c Ja

a g rai

J8

middotp

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glute

n lactas

e ar

tificia

l_colo

uring

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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

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EX

PIR

Y

ww

rnIPIEif

33

7-1

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lt

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r

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(tgt

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gt

--

--

lt

9

7

gt

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-

)

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r-

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3

gt r

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pound-

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c

l

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3 x

3

I)

0 -lt

r- ()

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ln

grcd

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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

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mpt

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s sym_ pl

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Page 22: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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rv

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a-3

r -

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0

s

V1

0 0

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E

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r

u

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==-gt

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0

7

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ampmiddot lImiddot1 r

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Z M01

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cr

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Elde1h

c Ec

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Olive

Lgrf is a

cold and

Hu t

WfrY

n31

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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

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e Ad

ults -

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hree time

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Child

ren 6

middot12 ye

ars -

Tallte

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es daily

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ldren 2-

6 yea

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s daily

i t

ie

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allhcare

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ner

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u twr

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le family

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g Gltfi

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I Redu

cing the

severity

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colds flu

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upper re

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fections

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rberry m

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neficial

due to

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se in reli

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e sympt

oms of

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se Elder

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chinace

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f age

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tains

f9

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af

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tract

equiv

to dry

Ech

inacea p

urpurea

(Echinac

ea) root

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sweeten

ed wilh S

levia C

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tal or

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l stres

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shxfyorw

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b

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tonK l

o

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heall

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w to

use G

insen

g 4 En

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old

Adults

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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-

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on a

s direct

ed by

your

heallhca

re practi

lioner

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ch ta

blet c

onta i

ns

slanltf

to Rb

1Rb

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nx

125

mg

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1g

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lg

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q

rona

in fiise

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w

ni

de

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1

As

traga

lus me

mbrana

ceus

(Astra

galus)

root

45Q

TO

TAL G

INSE

NOSI

OES CA

LCULA

TE DA

S Rg1

42Smg

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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

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animalprod

ucts ye

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gs

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flllo

ms p

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t cons

ul y

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ealll

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e p

rncti

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r Di

rect

ions

for u

se

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dul

ts -

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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

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ildre

n u

nder

12 ye

ars -

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only

as di

rect

ed b

y you

r h

ealll

lc-

e pr

actiti

oner

ea a5i

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llf

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r

ro

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c c

cr

l11

0

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0

a

gj OL

1bull

Ec

hin

ac

ea

20

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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

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ucing the

nsllt of

uppe

r res

piralo

y tra

ct in

fectio

ns

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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

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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

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ia

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rTKljdeg=

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fi

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ST

OR

E B

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OW

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AY

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OM

CH

ILD

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t sea

l Is brollt

en

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t

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r

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Echin

acea

purpu

rea (

Echina

cea)

root

O

ffiE

ChlriB

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pup

urea

r1

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g

angu

stfo

lia (E

china

cea)

root

c

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iilnac

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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

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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

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r

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r

r

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m

r

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o

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igmiddot

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tuamp

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r

pOCi

c

middot

c

ltIgt r

] 0

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dient

s Ea

ch 5m

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tain

s Ec

hinac

ea p

urpu

rea

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inace

a) roo

t e xJ

fJe53

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diiri

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urea

r1

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dry 1

28g

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a ang

uslifo

lia (E

china

cea)

root

e bullJ

fJ5d

cnmiddot

ia1

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middot

9usil1

0ii1

rt

9 dr

y 85

0mg

c

Jtiii

t7cohi

t

rifj 4

22

vv

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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

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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

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TC

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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

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emg

dry

12 eg

Ech1na

cea an

gustfo

lia (E

china

cea)

root

e xd

fJidi

omEc

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eamiddotaii

gusil

fci1i1

rtgt9

dr

y 850

mg

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ral s

weet

ened

with

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via

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con

tains a

lcoho

l (et

hano

l) 42

2

vv

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t

SuRp

ors

imm

une f

unction

I

Relie

ves

sym

ptom

s an

d re

duce

s se

verit

y of c

olds

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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

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r inf

orm

ation

o

g

1aA

1agp

i

middotPu

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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

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-lt

---

--

0

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( -lt

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k-c

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f

r

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7-t

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r

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g- emiddot

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z

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c

ii

c ii

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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

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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

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1

--ygt 3

lt

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c

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r

f

cf -

-

v f

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bull -- --

3

r

c

rn

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b

(ii

cf

()

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Page 23: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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5

3

pound r

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middotS

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CD

cmiddota-

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cr

r

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0

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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

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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

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allhcare

practitio

ner

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infom

tation

Doe

s no con

tai nd

ded e

rri pey

nut soy

tre

ori

g J

oails

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8

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sect 1

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0 0 lt gmiddot a i b_

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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

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Page 24: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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er

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cr

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Slgt

Elde1h

c Ec

hinac

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Olive

Lgrf is a

cold and

Hu t

WfrY

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r

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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

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Echin

acea

purpu

rea (Ec

h inacea

) root ex

act

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125mg

N r

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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-

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rs -T

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mL 2

middot 3 Lime

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ie

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tation

Doe

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rri pey

nut soy

tre

ori

g J

oails

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RY

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1) f

w

g

8

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U

sect 1

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a c

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g

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p

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(I

Q_

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1 z

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--

() ltc l

0

0

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C1

r

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l)

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w

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l)

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fiIJ

c

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O VjQ

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middotosz

M01

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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

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ke 5ml

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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

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J

ro

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Ul

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lD

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a

n

En

Je

==

=

ph

capa

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ring tim

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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

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N

Do not

use n ta

mper-e

viden

t sea

l Is brollt

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r-

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gt-r

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middot

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VI

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fi middott l

f l lf

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ru

11 22

a a

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2

n2agtr-

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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

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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

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iiiius

ff101a

1rit

9 Na

turar

se9e

tene

d with

Ste

via

Also

cont

ains

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o ye

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out m

edica

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Dire

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se

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e wel

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er 1

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e 5m

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daily

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1ce1 o

r as

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t of

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tificia

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OM C

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t a [ l z_ f=- a ])

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Each

5mL

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ains

r

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china

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china

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ral s

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ened

with

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via

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tains a

lcoho

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2

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SuRp

ors

imm

une f

unction

I

Relie

ves

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ptom

s an

d re

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olds

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t fle

due

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risk o

f upp

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spira

tory

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t mr

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ns

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ins e

than

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der tw

o ye

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e If

sym

pt

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e pr

ac1

Dire

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ns fo

r use

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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

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ke

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twice

dail

y in w

ater

or j

uice

or a

s

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1

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mpt

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r inf

orm

ation

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ctos

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or pre

servat

ives

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ORE

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W 30

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KEEP

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Y FR

OM C

HILD

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Do

not

use

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mpe

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eal is

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c ii

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ient

s

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5mL

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tain

s

r

ro

cr

Ul

0

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0 a

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pure

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china

cea)

root

e xJ

fJi3

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y 12

8g

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acea

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ustifo

lia (E

chinac

ea) r

oot

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cn middot

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9 dr

y esom

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lura

l swe

eten

ed w

ith S

tevia

Al

so con

tains a

lcoho

l (et

hano

l) 42

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v Us

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Pport

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mun

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nclio

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Re

lieve

s sym_ pl

oms

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duce

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erity

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colds

and

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t fle

duce

s the

risk

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pper

resp

irato

ry tra

ct mf

ect1o

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nings

Co

ntain

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hano

l No

t to

be u

sed in ch

ildre

n un

der tv1

0 yea

rs or

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with

out m

edica

l g

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ur

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Page 25: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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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

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-

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9

r

f

cf -

-

v f

-C

bull -- --

3

r

c

rn

1 i

b

(ii

cf

()

I- k- i C

+-

g [

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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)

()

()

()

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I VOf7lt ftrCJ 1

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l _J01_

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1xoI JO- J

WLUQL X WWQ6 SSVl8 lW09G

PIDDJDSqJa

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a _[

n a

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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

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PIDDJDSqJa4

ry QAX)j 3 l(JJJJf t )2i

Page 26: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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ea a5i

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ct in

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ake w

ell b

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e

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lts a

nd c

hild

ren

over

12 ye

ars-

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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

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acea

purpu

rea JE

chin

acea

) root

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8g Ec

hinac

ea ang

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a (EciVnace

a) ro

ot

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Natur

ally s

weet

ened

with

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ia

=

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OR

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EL

OW

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C

KE

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AY

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OM

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ILD

RE

N

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l Is brollt

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337-

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root

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ffiE

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g

angu

stfo

lia (E

china

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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

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SuRp

orts

immu

ne fu

nctio

n

Re

lieve

s sym

_plom

s an

d re

duce

s se

verity

of

colds

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flu

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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

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tition

er

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ction

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use

Sh

ake

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l bef

ore

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lts a

nd c

hild

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over

12 y

ears

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ke

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r or j

uice

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r

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ute s

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iri

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ctose

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rings

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r pre

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ORE

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W 3

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Y FR

OM C

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se if

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t sea

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roke

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ch 5m

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lieve

s sy

mpt

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ces sev

erity

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pper

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nmin

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than

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ot to

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ildre

n un

der t w

o ye

ars o

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l

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sult y

our

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ction

s for u

se

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e wel

l bef

ore

use

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dults

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chi

ldre

n ov

er 1

2 ye

ars

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e 5m

l t

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daily

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ater

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1ce1 o

r as

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tit

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gfit

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t of

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te y

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tificia

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ings o

r pre

serv

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E BE

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KE

EP AW

AY FR

OM C

HILD

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Do

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se if

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ent s

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ains

r

ro

- cr

lJl

0

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0

a bull

Echin

acea

pur

pure

a (E

china

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e xd

i

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mmiddote

ch1nac

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urea

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emg

dry

12 eg

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lia (E

china

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root

e xd

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omEc

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gusil

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dr

y 850

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ral s

weet

ened

with

Ste

via

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tains a

lcoho

l (et

hano

l) 42

2

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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

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t fle

due

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risk o

f upp

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tory

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t mr

ect1o

ns

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ings

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ins e

than

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der tw

o ye

ars

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sym

pt

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hcar

e pr

ac1

Dire

ctio

ns fo

r use

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be u

sed

in ch

ildre

n wi

thou

t med

ical

sist c

onsu

lt yo

ur

Shak

e well b

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e use

A

dults

and

child

ren

over

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ars

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ke

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y in w

ater

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uice

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bh

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1

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fi11i7

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t

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te sy

mpt

oms

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r inf

orm

ation

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or pre

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ORE

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W 30

C

KEEP

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Y FR

OM C

HILD

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Do

not

use

if ta

mpe

r-evid

ent s

eal is

brok

en

o

cmiddot

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-lt

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ient

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ro

cr

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0

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pure

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china

cea)

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fJi3

ommiddotea

inac

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purea

r1yamg

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y 12

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ustifo

lia (E

chinac

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oot

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cn middot

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c middot a

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9 dr

y esom

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l swe

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ed w

ith S

tevia

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so con

tains a

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hano

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v Us

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mun

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nclio

n

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lieve

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duce

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erity

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duce

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nings

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ntain

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hano

l No

t to

be u

sed in ch

ildre

n un

der tv1

0 yea

rs or

age

with

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edica

l g

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ur

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r use

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Page 27: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

(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

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Cl

5

3

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vi

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0

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3

E

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r

u

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p

0

7

3 5 -- g _e 10

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11

c

N3

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W

O

AVM

V d3

3gtl

middotS

Z M01

38 3

01S

c 0

22

0

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ag

g 5

aQ

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0

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r -

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Ogt

r -

CD

cmiddota-

ro

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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--

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ol -

cshy middot

ltJ

)

- J

1) f

w

g

8

2middot c

(6

U

sect 1

-0

a c

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middot

6

g

O 6

p

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Q_

-h

1 z

-3

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() ltc l

0

0

3 r

C1

r

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l)

l)

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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

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ltJl

ltJl

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3

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0

3

3

OlUJCgtYptO

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V Zt

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VnlDI

middotlCT

irl ll

middotu

aoJ

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lsJ

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1Jl

31

nlSIO

W WO

10

3101

d middoto

oc

M01

3B 3

101S

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J

ro

- cr

Ul

0

lD

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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

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--

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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

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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

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()

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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

Page 28: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

-

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gt

5gt v

f

r

337-

t

VI

s

)gt

r

r

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)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

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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

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twice

dail

y in

wate

r or ju

ice o

r as

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i

t

fitt1

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1

of a

cut

ym

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s

ggtr

g 1

aArtagp

i

l8middotp

JkuJl

9

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glute

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gs

flavo

uring

s or p

rese

rvat

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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

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BATC

H amp

EXPIR

Y U

l lIUlIP

ll NT

337middot

1

--ygt 3

lt

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r

f

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-

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-C

bull -- --

3

r

c

rn

1 i

b

(ii

cf

()

I- k- i C

+-

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J-

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T

i

J b 3-

1-090

D

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I 1111 9 313923 030858

STO

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BE

LOW

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PR

OTE

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OM

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WA

Y F

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M C

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N

Do

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vident

seals are broken

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au

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l Qj

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If i lJI 0 -g 11 t

J t -middot QG) 30

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I 3a 2

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PIDDJDSqJa4

ry QAX)j 3 l(JJJJf t )2i

Page 29: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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cold and

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wh

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includi

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uit fresh

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Echin

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act

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e

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l1g

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ldren

rsg

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e Ad

ults -

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10mL t

hree time

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ren 6

middot12 ye

ars -

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es daily

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ldren 2-

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i t

ie

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allhcare

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ner

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infom

tation

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u twr

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who

le family

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severity

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colds flu

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upper re

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Ech

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shxfyorw

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tonK l

o

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hinese

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heall

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ystem

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w to

use G

insen

g 4 En

ergy G

old

Adults

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e 1 la

blel once

or twice

daiy

with fo

od or as

dir

ected

by yo

ur he

allhcare

practitioner

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ildren

unde

r 12 y

ears-

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on a

s direct

ed by

your

heallhca

re practi

lioner

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ch ta

blet c

onta i

ns

slanltf

to Rb

1Rb

Eleulhe

nx

125

mg

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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

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preser

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J

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ro

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gs

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flllo

ms p

ersis

t cons

ul y

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ealll

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e p

rncti

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r Di

rect

ions

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se

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dul

ts -

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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

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ildre

n u

nder

12 ye

ars -

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only

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rect

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y you

r h

ealll

lc-

e pr

actiti

oner

ea a5i

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J

658middot

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e t

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g

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I

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3

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llf

cc

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0

0

r

ro

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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

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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

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ia

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rTKljdeg=

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fi

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E B

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OW

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AY

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OM

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t sea

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t

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ch 5m

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r

ro

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a I

Echin

acea

purpu

rea (

Echina

cea)

root

O

ffiE

ChlriB

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pup

urea

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g

angu

stfo

lia (E

china

cea)

root

c

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iilnac

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iiiius

ff101a

1rit

9 Na

turar

se9e

tene

d with

Ste

via

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cont

ains

alco

hol

etha

nol) 4

22

vv

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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

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ct

mfec

trons

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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

_

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r

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m

r

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lt

o

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igmiddot

B

tuamp

Ci

r

pOCi

c

middot

c

ltIgt r

] 0

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dient

s Ea

ch 5m

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tain

s Ec

hinac

ea p

urpu

rea

(Ech

inace

a) roo

t e xJ

fJe53

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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

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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

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t of

acu

te y

mpt

ms

Cn g

c Ja

a g rai

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middotp

fta

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glute

n lactas

e ar

tificia

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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

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ent s

eal is

bro

ken

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TC

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33

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ln

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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

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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

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ral s

weet

ened

with

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via

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con

tains a

lcoho

l (et

hano

l) 42

2

vv

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t

SuRp

ors

imm

une f

unction

I

Relie

ves

sym

ptom

s an

d re

duce

s se

verit

y of c

olds

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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

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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

_

_

___

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( -lt

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3 c-

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k-c

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f

r

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g- emiddot

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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)

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-

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p1d 1 v 1qo YlC

I VOf7lt ftrCJ 1

A P0)

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l _J01_

(-lt-ltlt [J-llr cfY 2 C ltdegID

1xoI JO- J

WLUQL X WWQ6 SSVl8 lW09G

PIDDJDSqJa

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c__s C

I Q lti)

(

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g m lt

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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

Page 30: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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vi

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0

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3

E

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r

u

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_

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p

0

7

3 5 -- g _e 10

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11

c

N3

011H

W

O

AVM

V d3

3gtl

middotS

Z M01

38 3

01S

c 0

22

0

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ag

g 5

aQ

c

lt -

0

-

-

r -

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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

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11gt

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=gt

-r

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ol -

cshy middot

ltJ

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1) f

w

g

8

2middot c

(6

U

sect 1

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a c

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middot

6

g

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p

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(I

Q_

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-3

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() ltc l

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C1

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l)

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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

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(

rt Q 3 -

ltJl

3

r

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(fJ

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ltJl

ltJl

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3

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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

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a

n

En

Je

==

=

ph

capa

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es of

men

tal or

physica

l stres

s

Help

ing to

reliev

e faligue

and ex

haustion

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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

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t sea

l Is brollt

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337-

1

r0 f

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P-

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cc 5 _E_

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V

)

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r-

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0

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gt-r

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middot

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9

( f

18 3 r

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3 3 x

V1 3 3

fi middott l

f l lf

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ru

11 22

a a

1 0

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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

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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

Page 31: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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()

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()

()

()

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Page 32: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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ren 6

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ars -

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es daily

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ldren 2-

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i t

ie

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allhcare

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ner

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severity

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Ech

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old

Adults

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e 1 la

blel once

or twice

daiy

with fo

od or as

dir

ected

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ur he

allhcare

practitioner

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ildren

unde

r 12 y

ears-

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s direct

ed by

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heallhca

re practi

lioner

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ch ta

blet c

onta i

ns

slanltf

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nx

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lg

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q

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w

ni

de

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traga

lus me

mbrana

ceus

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galus)

root

45Q

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INSE

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LCULA

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S Rg1

42Smg

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pers

isl con

sult you

r heallhca

re practiti

oner Doe

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ded egg m

1k pe

aoot so

y oom tr

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flllo

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dul

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blet

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e or

tvli

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ly w

illl foo

d or

as

dire

cted

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ur he

allll

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prac

tition

er

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ildre

n u

nder

12 ye

ars -

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y you

r h

ealll

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actiti

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a

gj OL

1bull

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hin

ac

ea

20

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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

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r

r y=

s rediioog seve

nty

of col

ds

andft

u

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ucing the

nsllt of

uppe

r res

piralo

y tra

ct in

fectio

ns

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lo us

e Ec

hina

cea

200o+

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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

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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

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mptom

s pe

rsist

cons

ult you

r he

althca

re pracliti

orier

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h 5

ml co

ntai

ns

herbal e

xtracts eq

uiv lo

dry

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acea

purpu

rea JE

chin

acea

) root

12

8g Ec

hinac

ea ang

uslifoli

a (EciVnace

a) ro

ot

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ally s

weet

ened

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ia

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Echina

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root

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ffiE

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g

angu

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china

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turar

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tene

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via

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cont

ains

alco

hol

etha

nol) 4

22

vv

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orts

immu

ne fu

nctio

n

Re

lieve

s sym

_plom

s an

d re

duce

s se

verity

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colds

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flu

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ces t

he ris

k of u

pper

resp

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ct

mfec

trons

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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

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er in

form

atio

n

a

g1

a

tagp

iri

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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

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fflt

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f

0

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tuamp

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r

pOCi

c

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s Ea

ch 5m

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tain

s Ec

hinac

ea p

urpu

rea

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t e xJ

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uslifo

lia (E

china

cea)

root

e bullJ

fJ5d

cnmiddot

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middot

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0ii1

rt

9 dr

y 85

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c

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t7cohi

t

rifj 4

22

vv

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imm

une f

uncti

on

I Re

lieve

s sy

mpt

oms

and

redu

ces sev

erity

or

colds

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fiu

e

duce

s the

risk

or u

pper

resp

irato

ry tr

a ct

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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

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t of

acu

te y

mpt

ms

Cn g

c Ja

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fta

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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

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Do

not u

se if

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ent s

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bro

ken

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5mL

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ains

r

ro

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lJl

0

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0

a bull

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acea

pur

pure

a (E

china

cea)

root

e xd

i

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mmiddote

ch1nac

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dry

12 eg

Ech1na

cea an

gustfo

lia (E

china

cea)

root

e xd

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dr

y 850

mg

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ral s

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ened

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via

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tains a

lcoho

l (et

hano

l) 42

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t

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une f

unction

I

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ves

sym

ptom

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duce

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verit

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due

s the

risk o

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er re

spira

tory

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t mr

ect1o

ns

Warn

ings

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onta

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than

un

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o ye

ars

advic

e If

sym

pt

healt

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ac1

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ctio

ns fo

r use

t to

be u

sed

in ch

ildre

n wi

thou

t med

ical

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lt yo

ur

Shak

e well b

efor

e use

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dults

and

child

ren

over

12 ye

ars

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ke

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twice

dail

y in w

ater

or j

uice

or a

s

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bh

hC

1

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fi11i7

f

t

of acu

te sy

mpt

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r inf

orm

ation

o

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e art

ificial

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rings

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vour

ings

or pre

servat

ives

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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

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o

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---

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r

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c

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c ii

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ient

s

Each

5mL

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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

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acea

ang

ustifo

lia (E

chinac

ea) r

oot

e xl

rJgr

cn middot

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c middot a

iiiius

iil61i

1rF

9 dr

y esom

g Na

lura

l swe

eten

ed w

ith S

tevia

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so con

tains a

lcoho

l (et

hano

l) 42

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es

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Pport

s im

mun

e fu

nclio

n

Re

lieve

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oms

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duce

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erity

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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

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bull -- --

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Page 33: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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)

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ake w

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ren

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b YOIX

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ne fu

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n

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lieve

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ral s

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tains a

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t

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une f

unction

I

Relie

ves

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ptom

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d re

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verit

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due

s the

risk o

f upp

er re

spira

tory

trac

t mr

ect1o

ns

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ings

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onta

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than

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o ye

ars

advic

e If

sym

pt

healt

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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

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e well b

efor

e use

A

dults

and

child

ren

over

12 ye

ars

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ke

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twice

dail

y in w

ater

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uice

or a

s

0x1

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1

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ST

ORE

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age

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fJ

i

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ur

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ns fo

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ake w

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use

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dults

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hild

ren

over

12 y

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r as

x

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Page 34: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

Se_c_ g(z) 9 g S12_c 0 l--+) Q) a_(_tJ-euro Jei ede1t- slt-e 3 ()

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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

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b YOIX

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ical

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ptom

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hild

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ears

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ke

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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

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c__s C

I Q lti)

(

m

g m lt

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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

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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

Page 35: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

gt

(1

-

9

pound

g

er

g

Cl

5

3

pound r

vi

f

rv

3

a-3

r -

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0

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E

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==-gt

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7

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c

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W

O

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ro

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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

-

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-r

ol -

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ltJ

)

- J

1) f

w

g

8

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U

sect 1

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a c

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6

g

O 6

p

s L

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-

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0

0

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C1

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l)

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fiIJ

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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 - - (

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0

3

3

OlUJCgtYptO

OJOSQJbulllfhlml

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10

3101

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oc

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101S

0 j CT

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ro

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0

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0

a

n

En

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==

=

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)

-

-

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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

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c__s C

I Q lti)

(

m

g m lt

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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

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Page 36: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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

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(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_

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c

9

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t

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V

)

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r-

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0

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iJ

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9

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fi middott l

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11 22

a a

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n i(Jgt

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r

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3 0

r l 9

2

n2agtr-

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g

0

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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)

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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

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x

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lt

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Page 37: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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itiooal C

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heall

hy mm

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Ho

w to

use G

insen

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old

Adults

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e 1 la

blel once

or twice

daiy

with fo

od or as

dir

ected

by yo

ur he

allhcare

practitioner

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ildren

unde

r 12 y

ears-

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on a

s direct

ed by

your

heallhca

re practi

lioner

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ch ta

blet c

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ns

slanltf

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w

ni

de

Tlh=

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As

traga

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mbrana

ceus

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galus)

root

45Q

TO

TAL G

INSE

NOSI

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LCULA

TE DA

S Rg1

42Smg

II symptoms

pers

isl con

sult you

r heallhca

re practiti

oner Doe

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lain ad

ded egg m

1k pe

aoot so

y oom tr

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or

animalprod

ucts ye

as glUf

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100m

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gs

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flllo

ms p

ersis

t cons

ul y

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ealll

lcw

e p

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tione

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rect

ions

for u

se

A

dul

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blet

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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 -

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rect

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y you

r h

ealll

lc-

e pr

actiti

oner

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llf

cc

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0

0

r

ro

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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

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j

w

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s (

0 J Q- i 3 D A

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cc 5 _E_

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t

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r-

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0

0

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j gt

gt-r

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ne fu

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lieve

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duce

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verity

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he ris

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pper

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ct

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rnin

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ains

eth

anol

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use

d in

child

ren

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year

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ge w

ithou

t med

ical

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ce J

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ptom

s per

sist c

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lt you

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althc

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tition

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ction

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ake

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l bef

ore

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ren

over

12 y

ears

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ke

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r or j

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our

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ro

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unction

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ves

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sym

pt

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ac1

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thou

t med

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ars

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C

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erity

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nings

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ntain

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l No

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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

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ctio

ns fo

r use

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ake w

ell b

efore

use

A

dults

and c

hild

ren

over

12 y

ears

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ke

5ml

twice

dail

y in

wate

r or ju

ice o

r as

x

i

t

fitt1

r

1

of a

cut

ym

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glute

n lac

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artific

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lourin

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flavo

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s or p

rese

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ives

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E BE

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EP AWA

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Page 38: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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Re

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verity

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colds

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flu

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Redu

ces t

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pper

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irato

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ct

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Cont

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Not

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use

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child

ren

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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

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use

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ake

wel

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ore

use

Adu

lts a

nd c

hild

ren

over

12 y

ears

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ke

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twice

dail

y in

wate

r or j

uice

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r

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er in

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atio

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rings

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OM C

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erity

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risk

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ains e

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used

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ildre

n un

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ars o

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with

out m

edica

l

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76g

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con

sult y

our

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ction

s for u

se

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e wel

l bef

ore

use

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dults

and

chi

ldre

n ov

er 1

2 ye

ars

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e 5m

l t

vice

daily

in w

ater

or ju

1ce1 o

r as

1

tit

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e ar

tificia

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s

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E BE

LOW

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EP AW

AY FR

OM C

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se if

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ro

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pure

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y 850

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ral s

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via

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tains a

lcoho

l (et

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l) 42

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t

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une f

unction

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ves

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ptom

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verit

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risk o

f upp

er re

spira

tory

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t mr

ect1o

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onta

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than

un

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o ye

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e If

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pt

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e pr

ac1

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ctio

ns fo

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t to

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sed

in ch

ildre

n wi

thou

t med

ical

sist c

onsu

lt yo

ur

Shak

e well b

efor

e use

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dults

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child

ren

over

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ars

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ke

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dail

y in w

ater

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uice

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s

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r inf

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ives

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ORE

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Y FR

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ro

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china

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root

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y 12

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ustifo

lia (E

chinac

ea) r

oot

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ed w

ith S

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tains a

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l (et

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l) 42

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es

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mun

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Re

lieve

s sym_ pl

oms

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duce

s sev

erity

or

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and

flu

t fle

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s the

risk

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pper

resp

irato

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ct mf

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ns

War

nings

Co

ntain

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l No

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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

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ctio

ns fo

r use

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ake w

ell b

efore

use

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dults

and c

hild

ren

over

12 y

ears

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ke

5ml

twice

dail

y in

wate

r or ju

ice o

r as

x

i

t

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r

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cut

ym

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i

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artific

ialco

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gs

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s or p

rese

rvat

ives

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E BE

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KE

EP AWA

Y FR

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purpu

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roots co

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ake w

ell b

efor

e us

e

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lts a

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ren

over

12 ye

ars-

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5ml l twice

daily Jn

1ate

r or ju

ice o

r as

ditected

b YOIX

hea lhca

re pa

ltliiio

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ximum

bene

fit ta

ke im

med

iately

at

onse

t of a

cute

symp

tom

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l to be

used

i1 chid

ren

under

ye

ars of

age w

ithou

t rneltf

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mptom

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ult you

r he

althca

re pracliti

orier

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h 5

ml co

ntai

ns

herbal e

xtracts eq

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dry

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acea

purpu

rea JE

chin

acea

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12

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root

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ffiE

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pup

urea

r1

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g

angu

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lia (E

china

cea)

root

c

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iilnac

eamiddota

iiiius

ff101a

1rit

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turar

se9e

tene

d with

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via

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cont

ains

alco

hol

etha

nol) 4

22

vv

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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

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ake

wel

l bef

ore

use

Adu

lts a

nd c

hild

ren

over

12 y

ears

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ke

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twice

dail

y in

wate

r or j

uice

or a

s

0x

b

r

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111i7

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of ac

ute s

ympt

oms

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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

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W 3

0C

KEEP

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Y FR

OM C

HILD

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Do

not u

se if

tamp

er-e

viden

t sea

l is b

roke

n

Q

(

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fflt

lt

--

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0

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r

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tuamp

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r

pOCi

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ch 5m

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tain

s Ec

hinac

ea p

urpu

rea

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china

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root

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fJ5d

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rt

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c

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t7cohi

t

rifj 4

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imm

une f

uncti

on

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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

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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

=

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gfit

ti7r

K

t of

acu

te y

mpt

ms

Cn g

c Ja

a g rai

J8

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fta

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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

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lt

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c

l

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ln

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s

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ains

r

ro

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lJl

0

lD

0

a bull

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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

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ral s

weet

ened

with

Ste

via

Also

con

tains a

lcoho

l (et

hano

l) 42

2

vv

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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

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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

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not

use

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mpe

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ent s

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o

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s

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if

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g- emiddot

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z

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g c

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c

ii

c ii

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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

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ur

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Page 41: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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Page 42: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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Page 43: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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Page 44: CMA Submission to TGA on Consultation Draft TGO 92 ... · CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should

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