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What do I require to have a listed medicine in the ARTG?

20 June 2019

Foundation

This tool helps sponsors of listed medicines (AUST L) understand what is required to have their listed medicine in the Australian Register of Therapeutic Goods (ARTG). To supply your medicine in Australia, you need to have it entered in the ARTG by the TGA and be assigned a unique AUST L number.

This guidance is not intended for sponsors of assessed listed medicines (AUST L(A)) or registered complementary medicines (AUST R). For more information about these medicines, see the Australian Regulatory Guidelines for Complementary Medicines (ARGCM).

Some sunscreens are regulated as listed medicines. This tool helps sponsors of listed sunscreens understand their general regulatory requirements. For specific requirements relating to sunscreens please see the Australian Regulatory Guidelines for Sunscreens (ARGS).

New to regulation? The SME Assist section of our website is dedicated to those who are new or unfamiliar with how therapeutic goods are regulated in Australia.