Standards, guidelines & publications (complementary medicines)
Related information
Guidelines
- Australian regulatory guidelines for complementary medicines (ARGCM)
The current Australian requirements for the regulation of complementary medicines - Analytical procedure validation for complementary medicines
The minimum approach to achieve validation of the test procedures and starting materials - Compositional guidelines
Provides clarity to the specific form or type of substances for use in listed medicines - Colourings used in medicines for topical and oral use
Colourings that may be used in topical and oral medicines and the regulatory and data requirements for new colourings - Evidence guidelines
The type of evidence required to support indications for listed complementary medicines - European Union guidelines used by the Office of Complementary Medicines
European Union guidelines adopted in Australia used by the Office of Complementary Medicines - Herbal materials & extracts
Guidelines on herbal materials and extracts - Ingredients/excipients in Listed medicines
Links to information about the regulation of ingredients and excipients - Online applications for registered complementary medicines
Guidance for registered complementary medicine applications - Proposed new notifications process: registered medicines
Guidance on proposed new notifications process for registered medicines to support anticipated changes to legislation - Stability testing of Listed complementary medicines
Questions and answers on stability testing of complementary medicines
Related guidance
- Guidance on product changes in ELF3
How to change certain details previously advised to the TGA - Information sources that could assist regulators with market authorisation of complementary/herbal medicine ingredients
Resource on the regulatory framework of herbal and other complementary medicine ingredients in a number of regulatory agencies - Listed medicines application and submission user guide
Training guide for the Electronic Listing Facility for listed and soley for export medicines - Section 7 declarations - is it a therapeutic good?
Section 7 declarations provide clarity in determining whether a product is a food or a therapeutic good - TGA approved terminology for medicines
Lists of approved terminology that ensure accuracy and consistency in the information compiled in the ARTG