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Establishment of a Joint Scheme for the Regulation of Therapeutic Products

New Zealand and Australia have been working together since the late 1990s on the proposal to establish a joint scheme to regulate Therapeutic Products under the Australia New Zealand Therapeutic Products Authority (ANZTPA).

The overall aim of the proposal is to protect the health and safety of both New Zealanders and Australians by regulating the quality, safety and effectiveness of therapeutic products including therapeutic-type dietary supplement products, which are currently sold under the Dietary Supplement Regulations 1985.

Under the proposals, most therapeutic-type dietary supplements would fall into the low risk complementary medicine category and would be subject to a light level of regulatory control. Complementary medicines include herbal medicines, homoeopathic medicines, traditional medicines, aromatherapy products, vitamins and minerals.

In New Zealand there is currently no requirement for these products to undergo any independent scrutiny of quality and safety before they enter the marketplace.

In line with international best practice, under an effective regulatory scheme consumers would have an assurance of the quality and safety of these products. In addition, to aid consumers in making more informed choices it is proposed that information about the therapeutic health benefits of complementary medicines be included on product labels and product advertising.

Consultation with industry, consumers and other stakeholders on the proposed joint regulatory scheme is occurring three phases beginning 23 May 2006, mid-September 2006 and March 2007.

Food type dietary supplements currently sold under the Dietary Supplement Regulations are likely or expected to be regulated under the Food Standards Code. This will be subject to separate consultation.

Details of the Australia New Zealand Therapeutic Products Authority project, the proposed joint regulatory scheme, and consultation documents can be found at: http://www.anztpa.org/ or for more information, email: consultation@anztpa.org