Medicines and TGA classifications
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:
- Registered medicines
- 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.
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