ASMI welcomes clarity provided by TGA’s medicines labeling update

11 October 2011

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The Australian Self-Medication Industry (ASMI), the industry body representing non-prescription consumer healthcare products, today welcomed from the Therapeutic Goods Administration (TGA) its intended approach to the latest proposed revisions to the Required Advisory Statements for Medicines Labelling (RASML).

This follows the release by the TGA of the Outcomes of the Consultation on RASML updates 5 and 6, which provides the final format of the advisory statements to be included on medicines labels.

The Executive Director of ASMI, Dr Deon Schoombie said he was pleased that the TGA had taken on board the majority of ASMI's recommendations to the consultation process.

"This has been a very complex consultation process involving the TGA and industry, and it is pleasing that many of the views that we have put on behalf of our members have been accepted in the latest update.

"The issue of medicines labeling is critical for consumers so that they receive the most accurate and timely advice and can make informed judgments about non-prescription medicines.

"As the TGA has indicated, there have been a number of significant changes to the draft warning statements due to the comments and suggestions made in the submissions to the consultation.

"ASMI is grateful that the TGA has issued this update in advance of moving toward establishing RASML as a legislative instrument, in order to enable manufacturers to plan ahead with confidence, given the large number of medicine labels that will require change and the long lead times associated with implementing packaging changes for OTC products.

"We will continue to work with the TGA and our members to ensure that consumers benefit from the most accurate and informative advisory statements, consistent with the Quality Use of Medicines," Dr Schoombie said.
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About ASMI: The Australian Self-Medication Industry (ASMI) is the peak industry body for the Australian self care industry representing consumer healthcare products including over-the-counter medicines and complementary medicines. ASMI's mission is to promote better health through responsible self-care. This means ensuring that safe and effective self-care products are readily available to all Australians at a reasonable cost. ASMI works to encourage responsible use by consumers and an increasing role for cost-effective self-medication products as part of the broad national health strategy. www.asmi.com.au

Media contact: Bob Bowden, Foresight Communications (02) 9241 2811, 0412 753 298