Contact TGA: info@tga.gov.au | 1800 020 653 | More contact info Translate | Subscribe

Australian regulatory guidelines for complementary medicines (ARGCM)

Version 5.1 August 2014

*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.

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 While the revised document does not introduce any new procedures or procedural changes, the ARGCM V4.2 contained outdated information which has been amended to reflect current regulatory practice.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

About the Therapeutic Goods Administration (TGA)

  • The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating medicines and medical devices.
  • The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance) when necessary.
  • The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices.
  • The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action.
  • To report a problem with a medicine or medical device, please see the information on the TGA website <http://www.tga.gov.au>.

© Commonwealth of Australia 2014

This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to <tga.copyright@tga.gov.au>

Content last updated: Friday, 29 August 2014

Content last reviewed: Friday, 29 August 2014

Web page last updated: Friday, 5 September 2014

URL: http://www.tga.gov.au/industry/cm-argcm.htm