Purpose

The consultation document Required Advisory Statement for Medicine Labels - proposed update 4 (RASML) is to advise stakeholders of the proposed changes to the Required Advisory Statements for Medicine Labels (Edition 1, including update 3.1) dated April 2008 (RASML).

• Required Advisory Statements for Medicine Labels - proposed update 4 (pdf,111kb)
  <http://www.tga.gov.au/meds/drrasmlupd4.pdf>

Request

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.

The TGA has specifically invited comment on the proposed amendments from the following organisations. You may wish to consider submitting your response to one of these organisations, for incorporation in its overall response, rather than submission direct to the TGA.

• 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