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

Related information

15 March 2015

This consultation closed on 10 April 2015.

The TGA sought 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.

Consultation documents

How to access a pdf or Word document

Timetable

Document 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 consultation

The 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 list of corrections and changes that are detailed under the heading 'Proposal' in the attached consultation documents 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.

The proposed corrections and changes are summarised below.

  • 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 third statement in the entries for dermal/external indomethacin and ketoprofen preparations to include the correct wording for NSAIDs for dermal/external use: 'Unless a doctor or pharmacist has told you to, do not use this product with other medicines that you are taking regularly' (instead of 'Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] with other products containing indomethacin/ketoprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly')
  • 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'
  • 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

General background information in regards to scheduling of medicines, advisory statements, and the RASML, as well as background to each of the proposed RASML corrections and changes, is set out in the consultation documents.

Submissions

Submissions 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.

What will happen

All 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 information

The 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.

Enquiries

Enquiries should be directed via email to rasml@tga.gov.au.