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ARGOM Appendix 1: Guidelines on efficacy and safety aspects of OTC applications
Australian regulatory guidelines for over-the-counter medicines (ARGOM)
This guidance has been updated and this webpage will be archived on 1 March 2016.
Please go to OTC medicines - Safety and efficacy data for the updated guidance which you can commence using.
|Version||Description of change||Author||Effective date|
Update of ARGOM Chapter 6A Efficacy and safety
Re-formatting of Chapter 6A as Appendix 1 - Guidelines on efficacy and safety aspects of OTC applications.
|MAG - OTCME||October 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.
© Commonwealth of Australia 2012
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