Consultation: Proposed Medicines Advisory · Web viewConsultation: Proposed Medicines Advisory Statements Amendment Specification 2015 (corrections and minor changes to the RASML)V1.0

Therapeutic Goods Administration

Version 1.0, March 2015

About the Therapeutic Goods Administration (TGA) The Therapeutic Goods Administration (TGA) is part of the Australian Government

Department of Health, and is responsible for regulating medicines and medical devices.

The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary.

The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices.

The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action.

To report a problem with a medicine or medical device, please see the information on the TGA website <http://www.tga.gov.au>.

Document title Page 2 of 18V1.0 Month 2012

http://www.tga.gov.au/


Copyright© Commonwealth of Australia 2015This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to <[email protected]>

ConfidentialityAll submissions received will be placed on the TGA’s Internet site, unless marked confidential. Any confidential material contained within your submission should be provided under a separate cover and clearly marked “IN CONFIDENCE”. Reasons for a claim to confidentiality must be included in the space provided on the TGA submission coversheet. For submission made by individuals, all personal details, other than your name, will be removed from your submission before it is published on the TGA’s Internet site. In addition, a list of parties making submissions will be published. If you do not wish to be identified with your submission you must specifically request this in the space provided on the submission coversheet.

Version historyVersion Description of change Author Effective date

V1.0 Original publication OTC Medicines Evaluation Section/ Medicines Authorisation Branch

March 2015

Document title Page 3 of 18V1.0 Month 2012

mailto:[email protected]


ContentsConsultation: Proposed Medicines Advisory Statements Amendment Specification 2015 (corrections and minor changes to the RASML)___________________________5

Invitation to comment__________________________________________________________5

Timetable_________________________________________________________________________5

About the consultation__________________________________________________________5

Background_______________________________________________________________________6

Scheduling of medicines--------------------------------------------------------------------6

Advisory statements-------------------------------------------------------------------------6

The RASML--------------------------------------------------------------------------------------7

Background to the proposal---------------------------------------------------------------8

Proposal_________________________________________________________________________11

Content of submissions--------------------------------------------------------------------16

How to respond_________________________________________________________________16

What will happen______________________________________________________________17

Privacy information___________________________________________________________17

Enquiries________________________________________________________________________17

Consultation: Proposed Medicines Advisory Statements Amendment Specification 2015 (corrections and minor changes to the RASML)V1.0 March 2015

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Consultation: Proposed Medicines Advisory Statements Amendment Specification 2015 (corrections and minor changes to the RASML)

Invitation to commentThe TGA is seeking comments from interested parties on proposed minor changes and corrections to the Required Advisory Statements for Medicine Labels (RASML) documents.

No change will be required to any currently approved medicine label as a result of these proposals.

TimetableDocument released for consultation on Monday 16 March 2015.

Interested parties should respond by close of business on Friday 10 April 2015.

Feedback will be released following consideration of submissions. (see 'What will happen').

About the consultationThe TGA proposes to correct some minor errors and inconsistencies in the current RASML documents, and make associated changes that improve the consistency and useability.

It is proposed that the corrections and changes listed under the heading Proposal , below, will be published as the Medicines Advisory Statements Amendment Specification 2015 (No. 1), which will amend Schedule 1 (‘RASML No. 1’) and Schedule 2 (‘RASML No. 2’) to the current Medicines Advisory Statements Specification 2014.

In summary, the corrections and changes are as follows:

RASML No.2: correction of the ‘Conditions’ for the entries for non-steroidal anti-inflammatory drugs (NSAIDs) indicated for use in children, to include the age of the affected children (under 12 years of age)

RASML No.2: correction of the entries for dermal/external indomethacin and ketoprofen preparations to include the correct wording ‘Unless a doctor or pharmacist has told you to, do not use this product with other medicines that you are taking regularly’ for the statement regarding use with other medicines

RASML No. 2: correction of the entries for selenium compounds to require the correct statement ‘A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded’ (instead of ‘A daily dose of 100 micrograms for adults of selenium from dietary supplements should not be exceeded. Not suitable for use by children under 15 years’)

RASML No. 2: correction of the entries for hydroxyanthracene derivatives from ‘Not recommended for use by children aged 12 years or under’ to ‘Not recommended for use by children under 12 years of age’


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http://www.comlaw.gov.au/Details/F2014L00693


http://www.tga.gov.au/industry/labelling-rasml.htm


RASML No. 1 and RASML No. 2: removal of ‘Additional Presentation’ requirement [j] where it requires the affected statement(s) to be grouped immediately preceding the directions for use (this requirement is currently inconsistently applied, and incorrectly applied in a few cases)

RASML No. 1 and RASML No. 2: editorial changes in regards to the way the requirements currently indicated by ‘Additional Presentation’ requirements [a], [e] and [h] are indicated in the RASML (removal of these square bracketed letters from the RASML – but with no actual change to the respective requirements).

No new requirements will be introduced by these proposed amendments.

With this consultation the TGA is requesting stakeholder comment to help ensure that the identified errors and inconsistencies in the RASML are corrected in the most convenient, cost-effective way.

Background

Scheduling of medicinesThe Standard for Uniform Scheduling of Medicines and Poisons (SUSMP) 1 sets out classifications (‘Schedules’) which determine the level of control on the availability of medicines and poisons in Australia. The majority of medicines that are included in the SUSMP fall under either Schedule 2, 3, 4, 5 or 6, as shown below.

Schedule 2 - available from a pharmacy without a prescription (PHARMACY MEDICINE)

Schedule 3 - available from a pharmacist without a prescription (PHARMACIST ONLY MEDICINE)

Schedule 4 - available from a pharmacist with a prescription (PRESCRIPTION MEDICINE)

Schedule 5 –substances with low potential for causing harm (CAUTION)

Schedule 6 –Substances with moderate potential for causing harm (POISON)

The SUSMP requires that these medicines are labelled on the first line of the main label with the appropriate ‘signal heading’, indicating the medicine’s schedule (e.g. PHARMACY MEDICINE), together with the words KEEP OUT OF REACH OF CHILDREN written immediately below the signal heading.

Medicines that are not included in the SUSMP may be available from both pharmacies and other general retail outlets, and are referred to as 'unscheduled' medicines.

Medicines that are either unscheduled or included in Schedule 2, 3, 5 or 6 of the SUSMP are collectively referred to as 'non-prescription' or 'over-the-counter' (OTC) medicines.

Advisory statementsConsumers rely on information from their health practitioner, pharmacist and/or medicine label in order to use medicines safely and effectively. The enhanced access and availability of OTC medicines means that consumers may not always receive comprehensive advice from a health practitioner or pharmacist. Therefore, the label needs to contain the directions and advisory statements that are appropriate for the safe and effective use of the medicine.

1 previously known as the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP)


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https://www.tga.gov.au/publication/poisons-standard-susmp


The need for new advisory statements to be present on the labels of particular medicines is typically identified as a result of circumstances such as the registration of a new medicine, or a review of the safety of an existing medicine; or a change in the SUSMP scheduling that reduces the level of control and makes the medicine more widely available to consumers for self-selection or available without a prescription.

The RASMLThe RASML was established in July 2004 so that there could be one single source document that other items of legislation such as the Labelling Order2 could refer to when specifying mandatory advisory statements for medicine labels.

The RASML is defined in the legislation as ‘the document made under section 3(5A) of the Therapeutic Goods Act 1989 by the Therapeutic Goods Administration’. This section 3(5A) Legislative Instrument, the Medicines Advisory Statements Specification 2014 was registered on the Federal Register of Legislative Instruments (FRLI) in June 2014. The instrument incorporates the RASML No. 1 and RASML No. 2 as its Schedules 1 and 2, respectively.

RASML ‘Additional presentation requirements for some advisory statements’

In some cases the RASML applies specific presentation requirements to advisory statements - such as font, letter size etc. Where such additional requirements apply to a statement in a RASML entry, they may be indicated by letters in square brackets shown next to the statement (the reader of the RASML needs to cross-reference to the introductory section titled ‘Addition presentation requirements for some advisory statements’ on the first page of the RASML to find the meaning of each of these letters).

The square-bracketed letters [a], [e], [h] and [j] are affected by the currently proposed RASML amendment. The meaning of these square-bracketed letters, as currently stated in the RASML, is set out below:

[a]: Statement(s) must be included on the label in capital letters.

[e]: Statement(s) must be included on the label in bold face letters.

[h]: The heading ‘SAFETY DIRECTIONS’, written in bold-face capital letters, must preface this/these statements, which are to be grouped together as a distinct section of the label.

[j]: Statement(s) must:

(i) be grouped with any other statements marked with this additional requirement; and

(ii) if the heading ‘SAFETY DIRECTIONS’ is required on the label, be included immediately after that heading; or

(iii) if the heading ‘SAFETY DIRECTIONS’ is not required on the label, be included immediately preceding the directions for use.

The RASML also includes requirements designated by the letters [c], [f], [g], [k] and [l] that are not affected by this current proposal.

2 currently Therapeutic Goods Order 69 General requirements for labels for medicines (TGO 69)


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http://www.comlaw.gov.au/



In other cases the RASML simply indicates the requirement in the statement itself, for example by use of the relevant fonts (e.g. ‘WARNING – This medication may be dangerous when used in large amounts or for a long period’).

Background to the proposalThe background to the proposed corrections and changes is as follows.

Oral NSAIDs indicated for use in children – correction of error in RASML No. 2

The RASML No. 2 currently requires the OTC NSAIDs diclofenac, flurbiprofen, ibuprofen, ketoprofen and naproxen to carry the advisory statement ‘Ask your doctor or pharmacist before use of the medicine in children suffering from dehydration through diarrhoea and vomiting’ if they are for oral use in children. The TGA proposes to correct this to only require this statement if the medicine is for oral use in children under 12 years of age.

This age limit was inadvertently omitted from the ‘Conditions’ in column 2 of the entries in RASML No. 2. Its inclusion will be consistent with advice the TGA gave to industry during consultation (in the 2012 TGA response to submissions for RASML updates 5 & 6), that the statement would only apply to medicines that have paediatric doses.

To correct this error in column 2 of RASML No. 2, it is now proposed that

the word ‘children’ will be replaced with ‘children under 12 years of age’, and

the word ‘adults’ will be replaced with ‘adults and children 12 years of age and over’ (or similar wording as appropriate).

The TGA already interprets ‘children’ to mean ‘children under 12 years of age’ in the context of the application of this statement. Therefore, any currently approved labels that are labelled in accordance with the current conditions should already comply with this proposal.

Indomethacin and ketoprofen – correction of error in RASML No. 2

In the 2012 TGA response to submissions for RASML updates 5 & 6, it was agreed that the statement ‘Unless a doctor has told you to, do not use [this product /insert name of product] with other medicines that you are taking regularly’ would apply to diclofenac, ibuprofen, indomethacin and ketoprofen, in medicines for dermal/external use.

However, for indomethacin and ketoprofen the RASML No. 2 unintentionally substituted the more extensive statement that is required for oral NSAID medicines (‘Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] with products containing indomethacin/ketoprofen, aspirin, or other anti-inflammatory medicines, or with medicines that you are taking regularly’ ).

It is now proposed to correct this statement, in line with the current wording for the other dermal/external NSAID entries (diclofenac and ibuprofen), to

‘Unless a doctor or pharmacist has told you to, do not use this product with other medicines that you are taking regularly’.

The proposed corrected statement is less extensive that the current statement, but is in line with it. Consequently any labels that include the more extensive statement will be considered to already comply with this proposal.


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https://www.tga.gov.au/rasml-updates-5-6-submissions-tga-response-submissions



Selenium – correction of error in RASML No. 2

In relation to selenium compounds, the RASML No. 2 has inadvertently incorporated the outdated requirements of the 2004 RASML instead of the updated requirements of the 2008 RASML.

It is now proposed to correct the statements from ‘A daily dose of 100 micrograms for adults of selenium from dietary supplements should not be exceeded’ and ‘Not suitable for use by children under 15 years’ to

‘A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded’

Correction of this error is not expected to have any impact, as the correct statements were in force for six years between 2008 and June 2014.

In the unlikely case that any sponsor has changed a selenium medicine label since July 2014 to be compliant with the incorrect requirements, the TGA would consider the label to also be compliant with the correct (less restrictive) requirements.

Hydroxyanthracene derivatives

In relation to hydroxyanthracene derivatives, the RASML No. 2 incorrectly includes the statement ‘Not recommended for children aged 12 years and under’ rather than the correct statement ‘Not recommended for children under 12 years of age’.

The requirement for a statement to the effect that ‘Use in children under 12 years is not recommended’ was originally recommended by the TGA’s Complementary Medicines Evaluation Committee (CMEC) in August 2006, and proposed in the RASML Update 5 consultation. In the 2012 TGA response to submissions for RASML updates 5 & 6 it was then concluded that the following statement would be adopted:

‘RASML statement 4: “Use in children under 12 years is not recommended”.

Consequently, ‘statement 4’ of the 2008 RASML was adopted in RASML No. 2. However, the definition of statement 4 in the 2008 RASML is ‘Not recommended for children aged 12 years and under’ . This error was unintentional.

The proposed corrected statement is less restrictive that the current statement, but is in line with it. Consequently any labels that include the more restrictive statement will be considered to already comply with this proposal.

Removal of [j] - where it requires the affected statements to be grouped immediately preceding the directions for use

The [j] requirement is incorrectly applied in RASML No. 2 in a few cases. In particular, it has inadvertently been incorrectly omitted from ibuprofen entries 1, 3 and 5, as well as from oxymetazoline entries 3 and 4, and from the entry for pantoprazole. It has also incorrectly been included in the entry for cetirizine.

The [j] requirement is also inconsistently applied in the RASML. This situation has arisen because the [j] requirements have their origins in the SUSDP. Consequently they typically apply to statements for SUSMP-scheduled medicines, or to medicines that are specifically excluded from the schedules to the SUSMP. RASML entries and statements that do not have their origins in the SUSDP are typically not subject to these requirements.


Page 9 of 18

https://www.tga.gov.au/sites/default/files/labelling-rasml-0809.pdf


https://www.tga.gov.au/committee-meeting-info/cmec-meeting-58-16-august-2006

https://www.tga.gov.au/committee-meeting-info/cmec-meeting-58-16-august-2006


The TGA and its Expert Committees have not considered it necessary to apply the [j] requirement to other advisory statements that were included in the original version of the RASML in 2004, or to any statements that have been subsequently included.

Consistency with the requirements of the SUSDP was necessary in 2004 because the SUSDP Appendix F (the list of warning statements required by the SUSDP) had not yet adopted the exclusion in relation to ‘medicines for human use when compliant with the RASML’ that applies to these requirements in Appendix F of the current SUSMP. This need for consistency no longer applies in the context of the current SUSMP and the Medicines Advisory Statements Specification.

The function of the [j] requirement is to ensure that warning statements relating to the use of the product are grouped together, and placed in a position on the label where they are likely to be read by the consumer prior to use. The TGA does not intend that removal of the [j] should imply a change to the expectation that statements are appropriately placed and grouped on medicine labels. However, the position immediately before the directions for use is not the only location on a medicine label that can serve this function.

Appropriate placement of advisory statements is important for all medicines. The current inconsistent application of the [j] requirement in the RASML could be taken to imply that the need for appropriate placement and grouping of statements is only important for the scheduled medicines to which the [j] requirement currently applies. This implication is unintentional - and is not the case.

OTC medicine labels are typically complex in design, and subject to multiple requirements for mandatory content. In the absence of comprehensive guidelines regarding labelling design, the most appropriate placement of any required advisory statements is expected to be considered by the applicant when the label is designed, and is assessed by the TGA prior to approval.

Consequently the TGA proposes to take this opportunity to remove the [j] requirements completely from the RASML (both RASML No. 1 and RASML No. 2) rather than correcting the identified errors individually. However, the statements are expected to continue to be appropriately placed and grouped.

In relation to statements that are safety directions for SUSMP Schedule 5 or Schedule 6 medicines it is appropriate and necessary to continue to group these directions after the heading SAFETY DIRECTIONS. However, the format of the current RASML makes this clear without the need for the cross-referenced [j] instruction.

Removal of [h]

Requirement [h] has essentially the same meaning as requirement [j], in relation to statements that are safety directions. Therefore, for consistency with the removal of the [j] requirements (detailed above), it is proposed to also remove the square-bracketed letter [h], as well as the cross-referenced instructions that currently appear in the introductory section headed ‘Additional presentation requirements for some advisory statements’.

The explicit cross-referenced statement of the [h] requirement is not necessary; as the relevant requirements for placement of the affected statements (grouped after the SAFETY DIRECTIONS heading) are self-evident from the placement and grouping of the actual statements in the RASML.


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Removal of [a] and [e]

It is also proposed to remove the square-bracketed letters [a] and [e], and replace the specific cross-referenced instructions that currently appear in the introductory section headed ‘Additional presentation requirements for some advisory statements’ with a general instruction to the effect that the statements that are written in capital letters/bold face letters in the RASML should be written in this font on the medicine labels.

The letter [a], which indicates that the statement(s) must be included on the label in capital letters, is currently only used for the statements ‘KEEP OUT OF REACH OF CHILDREN’ and ‘NOT TO BE TAKEN’. This is inconsistent with the situation in other cases where capital letters are required (e.g. statements such as ‘DERIVED FROM SEAFOOD’ [see entry for squid oil] or ‘WARNING – This medication may be dangerous when used in large amounts or for a long period’ [see entry for zinc compounds]).

The letter [e], which indicates that the statement(s) must be included on the label in bold face text, is currently only used for the statements that are required for medicines containing Vitamin A.

The explicit cross-referenced instructions for [a] and[e] are not necessary in the context of the current RASML format (the required font is self-evident from the bold and/or uppercase font is used in the actual statements in the RASML).

This change will make the method of indicating requirements for the use of upper case font and bold font simple and more consistent throughout the RASML.

ProposalThe proposed amendments to RASML No. 1 and RASML No. 2 (‘Schedule 1’ and ‘Schedule 2’, respectively, to the Medicines Advisory Statements Specification 2014) are set out in the numbered list below.

It is proposed that this list of amendments will be published on the FRLI as the Medicines Advisory Statements Amendment Specification 2015.

No change will be required to any currently approved medicine label as a result of these proposals.

[1] Schedules 1 and 2, Advisory statements

After the words ‘next to the statement’, insert ‘or, in the case of a requirement to use upper case and/or bold face, by use of upper case and/or bold face letters in the statement itself’.

[2] Schedules 1 and 2, Additional presentation requirements for some advisory statements

Omit ‘Where such additional requirements apply, they are indicated by a letter in square brackets (e.g. [a]) shown in column 3 of the Table 1 below’,

substitute ‘Where such additional requirements apply, they are indicated in Column 3 of Table 1 below either by a letter in square brackets (e.g. [c]) or, in the case of a requirement to use upper case and/or bold face, by use of upper case and/or bold face letters in the statement itself’.



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Omit ‘[a]: Statement(s) must be included on the label in capital letters.’


Omit ‘[e]: Statement(s) must be included on the label in bold face letters.’


Omit ‘[h]: The heading ‘SAFETY DIRECTIONS’, written in bold-face capital letters, must preface this/these statements, which are to be grouped together as a distinct section of the label.’


Omit ‘[j]: Statement(s) must:

(i) be grouped with any other statements marked with this additional requirement; and

(ii) if the heading ‘SAFETY DIRECTIONS’ is required on the label, be included immediately after that heading; or

(iii) if the heading ‘SAFETY DIRECTIONS’ is not required on the label, be included immediately preceding the directions for use.’

[7] Schedules 1 and 2, Table 1: Medicines to which advisory statements apply

Omit ‘[a]’, ‘[e]’, ‘[h]’ and ‘[j]’, wherever occurring.

[8] Schedule 2, Table 1: Medicines to which advisory statements apply, Diclofenac (Entry 2 of 4), Column 2 Conditions

Omit ‘In preparations for oral use in adults when NOT indicated exclusively for the treatment of dysmenorrhoea’,

substitute ‘In preparations for oral use in adults and children aged 12 years and over, when NOT indicated exclusively for the treatment of dysmenorrhoea’.

[9] Schedule 2, Table 1: Medicines to which advisory statements apply, Diclofenac (Entry 3 of 4), Column 2 Conditions

Omit ‘In preparations indicated for oral use in children’,

substitute ‘In preparations indicated for oral use in children under 12 years of age’.

[10] Schedule 2, Table 1: Medicines to which advisory statements apply, Flurbiprofen (Entry 1 of 2), Column 2 Conditions

Omit ‘In oral preparations for use in exclusively in adults’,

substitute ‘In oral preparations that do NOT include indications for use in children under 12 years of age’.

[11] Schedule 2, Table 1: Medicines to which advisory statements apply, Flurbiprofen (Entry 2 of 2), Column 2 Conditions

Omit ‘In oral preparations that include indications for use in children’,


Page 12 of 18


substitute ‘In oral preparations that include indications for use in children under 12 years of age’.

[12] Schedule 2, Table 1, Medicines to which advisory statements apply, Hydroxyanthracene derivatives such as those from: - Aloe -Buckthorn -Cascara -Frangula -Rhubarb -Senna (Entry 1 of 3), Column 3 Required Statement(s)

Omit ‘Not recommended for use by children aged 12 years or under’,

substitute ‘Not recommended for use by children under 12 years of age’.







[15] Schedule 2, Table 1: Medicines to which advisory statements apply, Ibuprofen (Entry 2 of 6), Column 2 Conditions

Omit ‘a. NOT indicated for use in children’,

substitute ‘b. NOT indicated for use in children under 12 years of age’.


Omit ‘b. NOT indicated for use in children’,



Omit ‘a. the preparation includes indications for use in children’,

substitute ‘a. the preparation includes indications for use in children under 12 years of age’.


Omit ‘a. the preparation includes indications for use in children’,

substitute ‘a. the preparation includes indications for use in children under 12 years of age’.

[19] Schedule 2, Table 1: Medicines to which advisory statements apply, Ketoprofen (Entry 2 of 4), Column 2 Conditions




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[20] Schedule 2, Table 1: Medicines to which advisory statements apply, Ketoprofen (Entry 3 of 4), Column 2 Conditions

Omit ‘When the preparation is for oral use and includes indications for use in children’,

substitute ‘When the preparation is for oral use and includes indications for use in children under 12 years of age’.

[21] Schedule 2, Table 1: Medicines to which advisory statements apply, Naproxen (Entry 2 of 3), Column 2 Conditions



[22] Schedule 2, Table 1: Medicines to which advisory statements apply, Naproxen (Entry 3 of 3), Column 2 Conditions

Omit ‘When the preparation includes indications for oral use in children’,

substitute ‘When the preparation includes indications for oral use in children under 12 years of age’

[23] Schedule 2, Table 1: Medicines to which advisory statements apply, Indomethacin in preparations for external use, Column 3 Required statement(s)

Omit ‘Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] with products containing indomethacin, aspirin, or other anti-inflammatory medicines, or with medicines that you are taking regularly’,

substitute ‘Unless a doctor or pharmacist has told you to, do not use this product with other medicines that you are taking regularly’.

[24] Schedule 2, Table 1: Medicines to which advisory statements apply, Ketoprofen in preparations for dermal use, Entry 4 of 4, Column 3 Required statement(s)

Omit ‘Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] with other products containing ketoprofen, aspirin, or other anti-inflammatory medicines or with medicines that you are taking regularly’,

substitute ‘Unless a doctor or pharmacist has told you to, do not use this product with other medicines that you are taking regularly’.

[25] Schedule 2, Table 1: Medicines to which advisory statements apply, High selenium yeast, Column 3 Required statement(s)

Omit

‘A daily dose of 100 micrograms for adults of selenium from dietary supplements should not be exceeded.

Not suitable for use by children under 15 years’

substitute

‘A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.’

[26] Schedule 2, Table 1: Medicines to which advisory statements apply, Selenium yeast – high, Column 3 Required statement(s)


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Omit



substitute


[27] Schedule 2, Table 1: Medicines to which advisory statements apply, Selenocysteine, Column 3 Required statement(s)

Omit



substitute


[28] Schedule 2, Table 1: Medicines to which advisory statements apply, Selenomethionine, Column 3 Required statement(s)

Omit



substitute


[29] Schedule 2, Table 1: Medicines to which advisory statements apply, Sodium selenate, Column 3 Required statement(s)

Omit



substitute


[30] Schedule 2, Table 1: Medicines to which advisory statements apply, Sodium selenite, Column 3 Required statement(s)

Omit


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substitute


[31] Schedule 2, Table 1: Medicines to which advisory statements apply, Yeast – high selenium, Column 3 Required statement(s)

Omit



substitute


Content of submissionsSubmissions may address the proposed changes and other identified issues. In addition, submissions might include:

Whether or not you support the proposed changes. If you do not support the changes you may make suggestions for an alternative acceptable to you.

An assessment of how the proposed change will impact on you. That is, what do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.

How to respondAll submissions should be accompanied by a TGA submission cover sheet;. Submissions must include full personal or organizational contact details (including address, telephone number and email).

Electronic submissions are preferred and should be emailed to [email protected]. Please include ‘Consultation: Proposed Medicines Advisory Statements Amendment Specification 2015 (corrections and minor changes to the RASML)’ in the subject line of the email.

Alternatively, hard copy submissions may be mailed to:

RASML OfficerOTC Medicines EvaluationMedicines Authorisation BranchTherapeutic Goods AdministrationPO Box 100WODEN ACT 2606


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https://www.tga.gov.au/consultation/consultation-proposed-medicines-advisory-statements-amendment-specification-2015-corrections-and-minor-changes-rasml#enquiries


What will happenAll submissions will be placed on the TGA Internet site unless marked confidential or indicated otherwise in the submission cover sheet (see Privacy information).

Submissions will be reviewed by the TGA and feedback on submissions will be provided through the TGA Internet site.

It is proposed that the advisory statements will then be included in the next update of the RASML.

Privacy informationThe TGA collects your personal information in this submission in order to:

contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.

help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).

The TGA will disclose your name and (if applicable) your designation/work title on the TGA Internet site (i.e. make this information publicly available) if you consent to the publication of your name on the TGA Internet site (please complete the cover sheet).

Any text within the body of your submission that you want to remain confidential should be clearly marked 'IN CONFIDENCE'.

Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.

EnquiriesEnquiries should be directed via email to [email protected].


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https://www.tga.gov.au/consultation/consultation-proposed-medicines-advisory-statements-amendment-specification-2015-corrections-and-minor-changes-rasml#enquiries

Therapeutic Goods AdministrationPO Box 100 Woden ACT 2606 Australia

Email: [email protected] Phone: 1800 020 653 Fax: 02 6232 8605http://www.tga.gov.au

Reference/Publication #

http://www.tga.gov.au/


Documents

Consultation: Proposed Medicines Advisory · Web viewConsultation: Proposed Medicines Advisory Statements Amendment Specification 2015 (corrections and minor changes to the RASML)V1.0