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Required Advisory Statements for Medicine Labels - proposed update 5


16 July 2009

This consultation closed on 20 August 2009.


This document is to advise stakeholders of the proposed changes to the Required Advisory Statements for Medicine Labels (Edition 1, including update 4) dated September 2008 (RASML).

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Request to stakeholders

Stakeholders were requested to review and comment on the proposed changes. Responses should include:

  • Whether or not you support the proposed changes. If you do not support a change, 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.


The TGA specifically invited comments on the proposed amendments from the following organisations.

  • Australian Self-Medication Industry Inc. (ASMI)
  • Complementary Healthcare Council of Australia (CHC)
  • Consumers' Health Forum
  • Medicines Australia
  • Pharmaceutical Society of Australia
  • Pharmacy Guild of Australia

Notes on submissions

A list of names of parties making submissions will be published on the TGA website.

All submissions will be placed on the TGA's website unless marked confidential. For submissions made by individuals, all personal details other than your name will be removed from your submission before it is published on the TGA's website. Confidential material should be provided under a separate cover and clearly marked 'IN CONFIDENCE'. Reasons for a claim to confidentiality must be included in the submission coversheet.