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Australian regulatory guidelines for OTC medicines (ARGOM) (Nov 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||Description of change||Author||Effective date|
|V1.1||Transferred to new template
|V1.2||Amended Chapter 5C||MAG - OTCME||02/06/2011|
(The appendices referred to below have been published as separate documents on the TGA website).
replaced with Appendix 2: Guidelines on Quality aspects of OTC applications.
replaced with Appendix 3: Guidelines on presentation aspects of OTC applications.
replaced with Appendix 1: Guidelines on safety and efficacy aspects of OTC applications.
replaced with Appendix 4: Guidelines on OTC application for new substances.
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|
- 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.
© Commonwealth of Australia 2012
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