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.