On this page: Guidelines | Related guidance

Guidelines

• Comparable overseas bodies (COBs) for complementary medicines
  Criteria and overview of the COB report-based process
• Guidelines for using the TGA assessed claim on medicine labels
  Listed assessed medicines and registered complementary medicines
• Australian regulatory guidelines for complementary medicines (ARGCM)
  The current Australian requirements for the regulation of complementary medicines
• Guidance materials for permitted indications for listed medicines
  Guidance for listed medicine sponsors on permitted indications for listed 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
• Guidelines for assessed listed medicines
  The guidance required to support applications for assessed listed medicines
• European Union guidelines used by the Office of Complementary Medicines
  European Union guidelines adopted in Australia as part of the regulation of Complementary Medicines
• Herbal materials & extracts
  Guidelines on herbal materials and extracts
• Mandatory requirements for an effective registered complementary medicine application
  Describes the information (and the form of that information) that must be submitted to the TGA in order for an application to register a complementary medicine in the ARTG
• Evaluation of substances for use in listed medicines: application user guide
  This guidance is intended to assist applicants using the online application form when applying under section 26BE of the Act to request that the TGA evaluates a new substance or change in requirements of an existing ingredient permitted for use in listed medicines
• 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 and assessed listed medicines: Application and submission user guide
  User guide for the Electronic Listing Facility for listed and assessed listed 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
• Scientific guidelines
  Lists of European Union Guidelines relating to medicines, both those published as adopted in Australia and those published as not adopted in Australia