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New therapeutic products exposure Bill released.



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SENATOR THE HON BRETT MASON Parliamentary Secretary to the Minister for Health and Ageing

MEDIA RELEASE

Parliament House Canberra ACT 2600 • Telephone: (02) 6277 4842 Facsimile: (02) 6277 8581

2 April2007 BM03/07

New therapeutic products exposure Bill released

The public is invited to comment on an exposure draft of the Australian Therapeutic Products Bill 2007, released today by the Parliamentary Secretary to the Minister for Health and Ageing, Senator Brett Mason.

“This legislation proposes to establish in Australia the Australia New Zealand Therapeutic Products Authority (ANZTPA), which will replace Australia’s Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe),” Senator Mason said.

“ANZTPA will regulate the quality, safety and efficacy of prescription medicines, complementary and over-the-counter medicines, medical devices, blood and blood products and tissues and cellular therapies for both Australia and New Zealand.

“The new authority will be accountable to the Australian and New Zealand Governments, recognised in law in both countries, and have offices in both Australia and New Zealand.”

New Zealand has similar draft legislation before its parliament. This is the first Bill in the Australian set of Bills to establish ANZTPA in Australia. The Government will be releasing shortly two other pieces of legislation dealing with transitional arrangements and charges.

Senator Mason said the new agency would offer a number of benefits for both countries by creating a single market for drugs and therapeutic products regulation, which should ensure that consumers had early access to new products entering the market while maintaining confidence in public health and safety.

Details regarding the consultation process and electronic copies of the draft legislation are available at www.health.gov.au/internet/wcms/publishing.nsf/Content/Legislation-2. Information on the proposed regulatory scheme can be found on the Australia New Zealand Therapeutic Products Authority website: www.anztpa.org.

Submissions, to be made by 4 May 2007, can be sent to: tpsubs@health.gov.au

Media Contact: Kay McNiece, Department of Health andAgeing, 0412 132 585