Australian regulatory guidelines for complementary medicines (ARGCM)

Version 7.1, November 2017

4 December 2017

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.

Version 7.0 of the ARGCM has been re-structured to increase accessibility. As part of the Government's complementary medicines reforms, TGA will be consulting on recommendations to support the use of new assessment and application pathways in 2017. We anticipate publishing new versions of the ARGCM to reflect these reforms.

New substance evaluation

This guidance is for applicants proposing new substances for use as an ingredient in listed medicines. You can submit an application for evaluation for suitability for use in listed medicines for:

  • a new complementary medicine substance not currently a permitted ingredient; or
  • a proposed new role or a change to a regulatory requirement of use for a permitted ingredient, for example: a proposal for an ingredient permitted for use as an excipient to be used as an active ingredient; or change to the permitted level of use; or change the permitted route of administration.

A request for evaluation of a new complementary medicine substance is considered under Regulation 16GA of the Therapeutic Goods Regulations 1990 (the Regulations). There is an associated fee.

The primary reason for the evaluation of a substance is to determine whether it is of appropriate quality and safety to be permitted for use as an ingredient in listed complementary medicines.

Once permitted for use in listed medicines, an ingredient may be used in a listed medicine by any sponsor.


Print version of Australian regulatory guidelines for complementary medicines (ARGCM) (pdf,3.25Mb)*

How to access a pdf document

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Refer to the TGA acronyms & glossary for terms, definitions and acronyms used in the ARGCM.

Version history

Version Description of change Author Effective date
V5.0 ARGCM V5 is a revision and restructure of ARGCM V4.2. Changes to the original document include formatting, corrections and clarification of information. While the revised document does not introduce any new procedures or procedural changes, the ARGCM V4.2 contained outdated information which has been amended to reflect current regulatory practice. Office of Complementary Medicines November 2013
V5.1

Correction of hyperlinks throughout document.

Update references to Evidence guidelines for listed medicines.

Update information on Approved terminology for medicines.

Update information on Complementary medicine interface issues. Include link to Food Medicine Interface Tool on the TGA website.

Instructions for searching the ingredient database via the TGA eBusiness Services (eBS) website.

Clarification of information on indications for listed medicines.

Insertion of reference to ARGCM Part D Table 6 in relation to changes in excipient ingredients for listed medicines.

Under 'Manufacturing changes', minor modification to MUS code (GMP clearance number update). Deletion of MST code (Change to manufacturing site and/or process of sterile product).

TGA August 2014
V5.2

Updated commercially confidential information

Updated organisational names

Updated hyperlinks and minor formatting changes

Update information on National Code of Conduct for unregistered healthcare practitioners

Update information on compositional guidelines to consolidate information available on website

TGA May 2015
V5.2

Updated commercially confidential information

Updated organisational names

Updated hyperlinks and minor formatting changes

Update information on National Code of Conduct for unregistered healthcare practitioners

Update information on compositional guidelines to consolidate information available on website

TGA May 2015
V5.3 Information on compositional guidelines updated to reflect changes in process TGA July 2015
V6.0

Update information referring to ingredients permitted in listed medicines to reflect changes in legislation (26 BB legislative instrument).

Update references to TGO 69 to include information on new labelling order (TGO 92).

Update information on Approved terminology for medicines.

Update information on National Code of Conduct for unregistered healthcare practitioners.

Update information on homoeopathic medicines.

Review information on consent to supply goods that are not compliant with prescribed standards.

Update guidance on changes to registered medicines, including updated ode tables.

Updated hyperlinks and minor formatting changes.

TGA October 2016
V7.0

Updated Part D.

Additional guidance material redistributed into other parts of the ARGCM.

Updated hyperlinks

TGA October 2017
V7.1 Update to change codes to include further notifications, commencing 4 December 2017 TGA December 2017