Australian regulatory guidelines for complementary medicines (ARGCM)

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Version 5.2 May 2015

13 May 2015
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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 Complementary Medicines Australia, the Australian Self Medication Industry and the Association of Therapeutic Goods Consultants).

Contents

Abbreviations

Refer to the TGA acronyms & glossary for terms, definitions & acronyms used in the Australian Regulatory Guidelines for Complementary Medicines (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 While the revised document does not introduce any new procedures or procedural changes, the ARGCM V4.2 contained outdated information which has been amended to reflect current regulatory practice.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

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