22 February 2005

Update: New Trans Tasman therapeutic products regulatory agency start up delayed until 1 July 2006

The Australian and New Zealand Governments have agreed to defer for a year the start-up of the new Trans Tasman Therapeutic Products Agency. The new agency will be operational on 1 July 2006, although if the scheme is ready before then, it could start earlier.

The joint regulatory agency will replace Australia's Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe).   It will regulate the quality, safety and efficacy or performance of therapeutic products in both Australia and New Zealand. This includes prescription and over the counter medicines, complimentary medicines, medical devices and blood.

More information about the proposed Trans Tasman regulatory agency can be found on www.jtaproject.com

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New Zealand manufacturers and suppliers of complementary and homeopathic medicines should already be aware of the moves by the Australian and New Zealand Governments to harmonise the regulatory arrangements for therapeutic products between the two countries. 

The joint scheme will regulate medicines and medical devices and is expected to come into force in July 2005 (now 1 July 2006), subject to the passage of legislation and ratification of the treaty. 

Under the joint Australia New Zealand therapeutic products agency, products represented to be for therapeutic use are to be regulated as therapeutic products. This includes complementary medicines such as herbal substances, homoeopathic and related medicines, vitamin and mineral supplements, other nutritional supplements, traditional medicines and aromatherapy oils.

Three Consultation Papers are available for stakeholder comment. The Papers propose new regulatory definitions for complementary medicines and homoeopathic medicines, and identify issues relating to the regulation of herbal substances, and the regulation of homoeopathic and related medicines, under the joint Agency. The Consultation Papers focus on the development of an appropriate regulatory system for these medicines which meets the needs of consumers, industry, health professionals and regulators, while protecting and enhancing public health and safety in Australia and New Zealand. 

Comment from interested parties is invited on the matters addressed in the Consultation Papers. In particular, comments are sought on the proposed regulatory definitions for a complementary medicine and a homoeopathic medicine, and on the regulation of herbal substances and homoeopathic and related medicines. 

The New Zealand Self-Medication Industry (NZSMI) have agreed to distribute the Consultation Papers and coordinate responses on behalf of their members. The Papers can also be downloaded from the joint agency’s website: www.jtaproject.com. 

The deadline for receipt of submissions is close of business, Friday 11 March 2005. 

By New Zealand Trade and Enterprise