You are here

Australian Regulatory Guidelines for Listed Medicines and Registered Complementary Medicines

Other resources

A collection of resources for sponsors of listed medicines and registered complementary medicines, including:

Feedback

Standards, guidelines & publications

20 May 2020

The Australian regulatory guidelines for listed medicines and registered complementary medicines (published May 2020) replaces ARGCM V8.0. The new version reflects recent reforms to the regulatory framework and presents guidance in separate documents to facilitate timely updates. This is an interim step towards a new landing page, which will be modelled on the Australian Guidelines for Prescription Medicines.

We welcome your feedback on the revised guidance, using the feedback form on this page.

Guidance applicable to all listed medicines and registered complementary medicines

Guidelines on herbal materials & extracts

International guidelines adopted by the TGA

Guidance specific to sunscreen therapeutic products

Guidance specific to listed medicines

Guidance for both listed and assessed listed medicines

Guidance specific to AUST L listed medicines

Guidance specific to AUST L(A) assessed listed medicines

Guidance specific to registered complementary medicines