Overview of the regulation of listed medicines and registered complementary medicines
General Guidance on the regulation of listed medicines and registered complementary medicines (RCM) in Australia.
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Purpose
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
Page history
Information on Active Herbal Extracts and proprietary ingredients updated.
This document, ‘Overview of the regulation of listed medicines and registered complementary medicines’, has been extracted from ARGCM v.8 April 2018 pages11 to 44 (previously named ‘ARGCM Part A’).
The document has been simplified to be an overview of the regulatory framework. The sequence of information, headings and formatting have been changed from the original content for consistency and easier navigation. References to outdated forms have been removed.
The introduction has been modified to provide an overview of the regulatory framework for medicines and explanatory information on the classification of listed and registered medicines.
New guidance has been included on changes to the regulatory framework for listed medicines, including:
- permitted indications
- the assessed listed pathway
The following technical content has been extracted to be new standalone guidance documents:
- Literature-based submissions for listed medicines and registered complementary medicines: guidance for sponsors (extracted from ARGCM Part A pages 41 -43)
- Listed medicine presentation and labels: guidance for sponsors (extracted from ARGCM v8 Part A pages 27 -29)
Information on changing listed medicines and registered complementary medicines have been moved in to the relevant new guidance for these goods.
Information on proprietary ingredients clarified and links provided to Supplier assessment, approval and qualification for listed and complementary medicines.
Information on Active Herbal Extracts and proprietary ingredients updated.
This document, ‘Overview of the regulation of listed medicines and registered complementary medicines’, has been extracted from ARGCM v.8 April 2018 pages11 to 44 (previously named ‘ARGCM Part A’).
The document has been simplified to be an overview of the regulatory framework. The sequence of information, headings and formatting have been changed from the original content for consistency and easier navigation. References to outdated forms have been removed.
The introduction has been modified to provide an overview of the regulatory framework for medicines and explanatory information on the classification of listed and registered medicines.
New guidance has been included on changes to the regulatory framework for listed medicines, including:
- permitted indications
- the assessed listed pathway
The following technical content has been extracted to be new standalone guidance documents:
- Literature-based submissions for listed medicines and registered complementary medicines: guidance for sponsors (extracted from ARGCM Part A pages 41 -43)
- Listed medicine presentation and labels: guidance for sponsors (extracted from ARGCM v8 Part A pages 27 -29)
Information on changing listed medicines and registered complementary medicines have been moved in to the relevant new guidance for these goods.
Information on proprietary ingredients clarified and links provided to Supplier assessment, approval and qualification for listed and complementary medicines.