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Medicines and TGA classifications

Related information

22 October 2012

Australia has a two-tiered system for the regulation of medicines, including complementary medicines:

  • Higher risk medicines must be registered on the ARTG, which involves individually evaluating the quality, safety and effectiveness of the product.
  • Lower risk medicines containing pre-approved, low-risk ingredients and that make limited claims can be listed on the ARTG.

Within the regulatory framework, medicines are classified as either registered or listed:

Assistance in preparing applications

Professional agents are available to assist in the preparation of applications for listing or registering medicines in the Australian Register of Therapeutic Goods. These can be found through ARCS Australia or the relevant industry association. See: Regulatory affairs consultants.

Please note that the TGA makes no representations as to the suitability or performance of consultants listed by ARCS or the relevant industry association.

Content last updated: Wednesday, 5 March 2014

Content last reviewed: Monday, 22 October 2012

Web page last updated: Wednesday, 9 April 2014

URL: http://www.tga.gov.au/industry/regulation-basics-medicines-classifications.htm