Australian regulatory guidelines for complementary medicines (ARGCM)

Version 6.0, October 2016

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13 October 2016

Version history

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 While the revised document does not introduce any new procedures or procedural changes, the ARGCM V4.2 contained outdated information which has been amended to reflect current regulatory practice.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

TGA August 2014
  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).    
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

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