Australian regulatory guidelines for complementary medicines (ARGCM)

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Version 8.0, April 2018

3 May 2018

This guideline is currently under review.

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.

ARGCM Version 8 includes amendments to ARGCM Part C to incorporate legislative changes for substance evaluations.Other parts of the ARGCM will be amended in 2018 to reflect other legislative changes arising from the Government's complementary medicines reforms.


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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 complete 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 While the revised document does not introduce any new procedures or procedural changes, the ARGCM V4.2 contained outdated information which has been amended to reflect current regulatory practice.

TGA

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 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

V5.3

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 to include notification changes

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

V7.2

Minor update to Proprietary ingredients in complementary medicines.

TGA

February 2018

V8.0

Amended to incorporate legislative changes for substance evaluations.

Title changed from 'New complementary medicine substance evaluation' to 'Evaluation of a substance for use in listed complementary medicines'.

'New complementary medicine substance' changed to 'substance for use in listed complementary medicines' throughout document.

References to the form 'Application for evaluation of a new complementary medicine substance' changed to 'Application for evaluation of a substance for use in listed complementary medicines'.

Information in overview amended to clarify that applications for substances are made under 26BE the Act.

The following new sections have been included:

  • Application categories for evaluation of substances
  • Timeframes and fees
  • Exclusive use of new approved ingredients

Information on safety data page count removed from the section entitled 'Phase 2: Lodgement of application'.

Section on 'Clarification of information' changed to 'Requests for information' and information reviewed to provide clarity on timeframes.

Information on sponsor's ability to appeal decisions included under 'Phase 5: Delegate determination'. Minor updates to Chart C1 e.g. include information on market exclusivity.

Table numbering amended to be consecutive C1 to C5.

Table C2 (renamed C4) moved up higher in document.

TGA

April 2018

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