Australian regulatory guidelines for complementary medicines (ARGCM)

Version 6.0, October 2016

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13 October 2016

Introduction to the ARGCM

The Australian regulatory guidelines for complementary medicines (ARGCM) provide information for manufacturers, sponsors, healthcare professionals and the general public on the regulation of complementary medicines in Australia.

If you want to supply a complementary medicine in Australia, you may choose to employ a regulatory affairs consultant (for a list of consultants, refer to the following websites: Complementary Medicines Australia, the Australian Self Medication Industry and the Association of Therapeutic Goods Consultants).

The ARGCM October 2016 is structured as follows:

Part A: General guidance on complementary medicine regulation in Australia

Part A provides an overview of the regulatory framework for complementary medicines in Australia. The guidance is provided for sponsors, healthcare professionals and the general public.

Information is provided on:

  • what complementary medicines are
  • legislation applicable to complementary medicines
  • the different types of complementary medicines and ingredients
  • approved terminology
  • exempt medicines
  • practitioner medicines and exemptions
  • medicine presentation
  • changes to information in the Australian Register of Therapeutic Goods (ARTG) for complementary medicines
  • post market regulatory activity
  • complementary medicine interface issues
  • appeal mechanisms for decisions made under the Therapeutic Goods Act 1989.

Part B: Listed complementary medicines

Part B provides guidance on the regulatory framework for ‘low risk’ listed complementary medicines. The guidance is mainly directed at sponsors and manufacturers of listed medicines.

Information is provided on:

  • ingredients and indications permitted for use in listed medicines
  • legislative requirements for listed medicines
  • quality of listed medicines
  • guidance on how to list a medicine on the ARTG.

Part C: Evaluation of new complementary medicine substances for use in listed medicines

Part C provides guidance on the evaluation process for a new complementary substance. This guidance is for applicants requesting the evaluation of a new substance for potential use in listed medicines.

Information is provided on:

  • the substances that are eligible for evaluation as a new complementary medicine substance
  • the application phases
  • the information required to be submitted in an application for evaluation for a new complementary medicine substance.

Part D: Registered complementary medicines

Part D provides guidance on the evaluation process for registered complementary medicines. This guidance is for sponsors, manufacturers and applicants of/for proposed new registered complementary medicines.

Information is provided on:

  • what complementary medicines can be registered on the ARTG
  • the application phases
  • the information to be submitted in an application for registration of a new complementary medicine.

ARGCM additional guidance

The following additional guidance is provided for sponsors, manufacturers and applicants on technical details and requirements relevant to the procedural information:

  • Compositional guidelines for complementary medicine substances
  • Finished product specifications, certificates of analysis
  • Guidance on use of the term ‘quantified by input’ for listed complementary medicines
  • Literature search and evaluation
  • Changes tables for registered complementary medicines.

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