In accordance with the procedural matters for amendments to the document that are specified as part of the RASML process, the proposal for the previous update (No. 3.0 dated 10 March 2006) was not accepted following TGA's consideration of responses from key stakeholders at the conclusion of the consultation period.

Purpose

This document is to advise stakeholders of proposed changes to the Required Advisory Statements for Medicine Labels (edition 1, including update 2) dated April 2006 (RASML) <http://www.tga.gov.au/meds/rasml.htm>.

How to access a pdf document

Required Advisory Statements for Medicine Labels - Proposed update 3.1 (pdf,175kb)

Request to stakeholders

Stakeholders are 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.