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Overview of the regulation of listed medicines and registered complementary medicines
Formerly ARGCM V.8 Part A
Last updated
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