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Australian regulatory guidelines for OTC medicines (ARGOM) (Nov 2012)

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Version 1.4

9 November 2012

The current Australian Regulatory Guidelines for Over-the-counter Medicines (ARGOM) is being reviewed and updated by the TGA.

Selected chapters have been removed and replaced with references to the appendices. This document will remain as the guidance document until it can be fully replaced by the updated ARGOM, i.e. chapters such as Chapter 2, 3, 7, 8 and 11 will remain in effect until such time it is replaced.

Version history

Version Description of change Author Effective date
V1.0 First Publication ONPM 01/07/2003
V1.1 Transferred to new template
Corrected hyperlinks
OPSS 04/05/2011
V1.2 Amended Chapter 5C MAG - OTCME 02/06/2011
V1.3
  1. Transfered to new template;
  2. Removal of 'July 2003' from cover page and footer;
  3. Removal of Foreword; and
  4. Replacement of the following chapters with appendices

(The appendices referred to below have been published as separate documents on the TGA website).

  • 4 Quality
  • 4A Manufacture
  • 4B Formulation
  • 4C Starting material specification
  • 4D Finished product specification
  • 4E Stability testing
  • 4F Microbioloigcal testing

replaced with Appendix 2: Guidelines on Quality aspects of OTC applications.

  • 5 Presentation
  • 5A Product name
  • 5B Labelling
  • 5C Product Information
  • 5D Consumer Medicines Information
  • 5E Changes to Scheduling

replaced with Appendix 3: Guidelines on presentation aspects of OTC applications.

  • 6A Efficacy and safety

replaced with Appendix 1: Guidelines on safety and efficacy aspects of OTC applications.

  • 6B New substances

replaced with Appendix 4: Guidelines on OTC application for new substances.

  • 9 MEC Guidelines

replaced with Appendix 5: Guidelines on OTC applications for specific substances.

Chapters amended to refer to the corresponding appendices.

MAG - OTCME 12/10/2012
V1.4 10 Sunscreens replaced by Australian Regulatory Guidelines for Sunscreens (ARGS) MAG - OTCME 09/11/2012

About the Therapeutic Goods Administration

  • The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and medical devices.
  • 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 Reporting problems on the TGA website.

Copyright

© Commonwealth of Australia 2012
This work is copyright. You may download, display, print and 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 under 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>.

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