Medicine Labelling Requirements Are Underway

Australia & New Zealand Medicine Labelling Requirements Are Currently Underway

MEETING OUTCOMES STATEMENT

Agreement has been reached between Australia and New Zealand to identify and coordinate reviews of labelling requirements for medicines and to develop and implement the requirements in both countries.

Common labelling requirements will have benefits for consumers and industry in both countries.

The New Zealand Minister of Health, Annette King and the Australian Parliamentary Secretary for Health, Trish Worth agreed that this is a positive step both for consumers and the pharmaceutical industry.

At the fourth meeting of the Therapeutic Products Interim Ministerial Council held in Melbourne on 28 May 2004 between the Health Ministers, both governments endorsed the establishment of a new joint expert committee to consider and make recommendations on standards for the labelling of medicines to be applied by the new joint therapeutic products agency which will replace Australia’s Therapeutic Goods Administration (TGA) and New Zealand’s Medsafe.

There are a number of activities currently underway within the TGA and Medsafe that may impact on labelling requirements for medicines under a trans Tasman agency.

Ms King and Ms Worth agreed that those activities now near completion should be coordinated, consolidated and continued as part of the development of trans Tasman labelling requirements, including the development of a draft Trans Tasman Labelling Order for consultation and finalisation in Australia and New Zealand prior to 1 July 2005.

This means that consumers will be able to make informed decisions about the medicines they are taking. Industry will know the labelling requirements for medicines under the joint regulatory scheme ahead of I July 2005, which will assist in a smooth transition.

There will be benefits to industry from the joint scheme because there will be a single set of regulatory requirements, such as labelling, for both markets.

Officials from both countries are identifying current labelling requirements in Australia and New Zealand (legislated and administrative) to ensure the requirements of both countries and the needs of the consumer are addressed.

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