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Medicines and TGA classifications

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

  • Higher risk medicines must be registered on the Australian Register of Therapeutic Goods (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:

Registered medicines

Registered medicines are assessed by the TGA for quality, safety and efficacy.

Listed medicines

Listed medicines are assessed by the TGA for quality and safety but not efficacy.

  • Some over-the-counter medicines are listed.
  • Most complementary medicines are listed.

Content last updated: Wednesday, 23 April 2014

Content last reviewed: Wednesday, 23 April 2014

Web page last updated: Wednesday, 23 April 2014

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