Annex 1: Therapeutic Goods
1.1 A Cooperation Programme covering regulatory Requirements for Therapeutic Goods will be pursued under the auspices of this Arrangement and in conformance with the provisions of Part IX. For the purposes of the Arrangement, "Therapeutic Goods" means those Goods as defined in the Commonwealth Therapeutic Goods Act 1989. The two main options for cooperation are mutual recognition or harmonisation.
1.2 The Parties note that it may not be possible to put in place cooperative arrangements within the existing timeframe for commencement of the Arrangement, including extensions available through the Temporary Exemption mechanism, and that additional time to complete the Cooperation Programme will be needed. This possibility is in part due to the pending introduction of new legislation in New Zealand covering therapeutic products and potential changes to regulatory arrangements in Australia arising out of Australian Governments' response to the Industry Commission inquiry into the Pharmaceutical Industry.
Coverage of Existing Regulatory Requirements
1.3 The regulatory Requirements for Therapeutic Goods falling within the scope of this annex include, but are not limited to:
- product standards;
- manufacturing standards;
- conformance assessment requirements; and
- packaging and labelling standards.
1.4 The Cooperation Programme will also cover Requirements for the registration or listing of all products on the Australian Register of Therapeutic Goods and any similar New Zealand Requirements.
Institutional Arrangements
1.5 A Memorandum of Understanding (MOU) was signed in 1993 between the Commonwealth Department of Human Services and Health and the New Zealand Ministry of Health. The Parties agree that the inclusion of Therapeutic Goods under the TTMRA and the Cooperation Programme outlined in this annex constitutes a logical extension of the MOU. The Parties to the MOU will determine what, if any, further institutional arrangements need to be put in place to assist in achieving the objectives set out in this Annex.
1.6 Consistent with the Arrangement, New Zealand will participate fully in all relevant Ministerial Councils and related committees in respect of TTMRA issues. New Zealand is already a full member of the Australian Health Ministers Conference (AHMC), which deals with matters relating to Therapeutic Goods, as well as the related committee of officials, the Australian Health Ministers Advisory Committee (AHMAC). New Zealand will be a full member of the National Coordinating Committee on Therapeutic Goods, a standing committee of AHMAC, as well as the Australian Therapeutic Goods Committee. Classification, as well as some labelling and packaging Requirements for therapeutic drugs, is the responsibility of the National Drugs and Poisons Schedule Committee (NDPSC) which also reports to the Australian Health Ministers' Advisory Council (AHMAC). New Zealand is represented on NDPSC.
Legislation Subject to Special Exemption
Australia
Therapeutic Goods Act 1989 (Commonwealth).
Therapeutic Goods (Charges) Act 1989 (Commonwealth).
The following laws are subject to Special Exemption to the extent that they deal with packaging and
labelling of pharmaceutical drugs and would be affected by this Arrangement:
Poisons Act 1966 (New South Wales);
Drugs Poisons and Controlled Substances Act 1981 (Victoria)
Poisons Regulations 1973 under the Health Act 1937 (Queensland);
Controlled Substances Act 1984 (South Australia);
Poisons Act 1964 (Western Australia);
Poisons Act 1971 (Tasmania);
Poisons and Dangerous Drugs Act (Northern Territory); and
Poisons and Drugs Act 1978 (Australian Capital Territory).
New Zealand
Medicines Act 1981.
Misuse of Drugs Act 1975.
Dietary Supplements Regulations 1985.
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