Regulation of herbal substances in a joint Australia New Zealand therapeutic products agency
December 2004
- This consultation closed on 11 March 2005.
This consultation paper outlines how herbal substances are currently regulated in Australia and New Zealand, and examines problems that have emerged under the existing regulations. A key aim of this paper is to seek comments on the mechanisms proposed to address these problems and the impact such changes may have on stakeholders.
The Australian and New Zealand Governments have agreed to harmonise the regulatory arrangements for therapeutic goods between both countries. Under the new joint Australia New Zealand therapeutic products agency (the Agency), complementary medicines will be regulated as medicines. This includes herbal substances and medicinal products containing herbal substances.
All medicines will be regulated by the joint Agency using a risk-based approach. This means that the level of control applied is consistent with the risk associated with the product. Medicines will be classified as either Class I or Class II medicines. The class will determine the level of regulatory control applied and the manner in which product licenses are obtained.