Overview of the regulation of listed medicines and registered complementary medicines

Formerly ARGCM V.8 Part A

Last updated

20 July 2021

Provides general guidance on the regulation of listed medicines and registered complementary medicines in Australia:

Classification of medicines as registered or listed
Legislation and requirements for listed medicines and registered complementary medicines
Medicine interface issues
Ingredients in listed medicines and registered complementary medicines
Exemptions from legislative requirements for certain products and practitioners
ARTG entry pathways
Supplying medicines packaged with other goods
Post-market monitoring of medicines in Australia

Contents

Overview of the regulation of medicines in Australia
- Australian Register of Therapeutic Goods (ARTG)
- Classification of medicines as registered or listed
- Legislation and guidance
- What are complementary medicines?
- Medicine interface issues
- Types of ingredients in listed medicines and registered complementary medicines
- Approved terminology for listed medicines and registered complementary medicines
Supplying medicines in Australia
- Medicines exempt from certain TGA regulation
- Entering medicines in the ARTG
- Supplying medicines packaged with other goods
- Administrative information
Post-market monitoring of medicines in Australia

Supporting documents

Topics