19 July 2004

Therapeutic Products Interim Ministerial Council

Meeting Outcomes Statement

New Initiatives For Joint Australia / NZ Agency

Representatives of the Australian and New Zealand Governments held the fifth meeting of the Therapeutic Products Interim Ministerial Council on July 5 2004 and agreed on a range of new initiatives that would be undertaken by the new, joint therapeutic products agency which will replace Australia’s Therapeutic Goods Administration (TGA) and New Zealand's Medsafe in 2005.

At the meeting, the New Zealand Minister of Health, Annette King, and the Australian Parliamentary Secretary for Health, Trish Worth agreed:

- that both New Zealand and Australian mutual recognition agreements (MRAs) with the European Community, covering medical devices and good manufacturing practice (GMP) for medicinal products, be aligned.

Ms King and Ms Worth said this was a positive step as use of the MRAs should reduce the need for regulatory duplication and result in significant cost savings for both Australian and New Zealand manufacturers and importers.

- that the new joint therapeutic products agency will be responsible for the pre-market conformity assessment of the safety, quality and performance of medical devices.

Ms King and Ms Worth agreed that, given the attendant risks to public health and safety, conformity assessment should not be outsourced to the private sector. International best practice dictates that regulatory decision making should occur at arms length from commercial interests.

-on the membership and terms of reference for a new joint expert committee on medicine labelling. The committee will consider, and make recommendations on, standards for the labelling of medicines under the trans-Tasman joint therapeutic products regulatory scheme.

Membership of this expert committee has been drawn from both countries and comprises people with the requisite skills and expertise in the use and labelling of medicines.

Both Ministers wanted the committee to be mindful of the need for better information on labels to facilitate identification of recalled products, compliance costs, lead times needed by the medicines industry to implement any required label changes, and the needs of consumers and health professionals.

The Committee’s work programme will include development of a trans Tasman labelling Order for consultation early next year.

ENDS

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