Complementary medicine regulation basics

An overview of the regulation of complementary medicines in Australia
In Australia, complementary medicines can either be listed (AUST L or AUST L(A)) or registered on the Australian Register of Therapeutic Goods depending on ingredients and claims made for the medicines
Pathways for complementary medicines
Help determining the type of complementary medicine you have or whether your product is more likely to fall under a food or a cosmetic regulatory framework

Listed complementary medicines

Listed complementary medicines
An overview of the regulation of listed complementary medicines, including how to list a medicine on the ARTG
Compliance and education for listed medicines
The information to provide sponsors with a better understanding of common compliance issues and how they can be avoided
Listed medicine compliance reviews
The TGA undertakes random and targeted compliance reviews of listed medicines
What do I require to have a listed medicine in the ARTG?
Help to understand what is required to have a medicine listed in the Australian Register of Therapeutic Goods (ARTG)

Assessed listed medicines pathway
Medicines listed through the assessed listed medicines pathway will be included in the ARTG following self-certification of the safety and quality of the product, and TGA pre-market assessment of efficacy evidence supporting the proposed indications
TGA assessed claim for assessed listed and registered complementary medicines
An overview on the implementation arrangements for the TGA assessed claim for assessed listed medicines and registered complementary medicines

Changes to the Permissible Ingredients Determination
An overview of how and when changes are enacted to the list of low-risk permitted ingredients for listed and assessed listed medicines

Registered complementary medicines
An overview of the regulation of registered complementary medicines, including how to register a complementary medicine and a list of evaluated registered complementary medicines