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Therapeutic Goods Administration (TGA)
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  5. Australian regulatory guidelines for OTC medicines (ARGOM) (Nov 2012)
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Australian regulatory guidelines for OTC medicines (ARGOM) (Nov 2012)

Print version

Print version of Australian regulatory guidelines for over-the-counter medicines (ARGOM) (pdf, 485 KB)

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Contents

  • 1. Introduction
  • 2. Overview
  • 3. The application
  • 7. Review of decisions
  • 8. Post marketing surveillance
  • 11. Changes to OTC medicines
  • Appendices

Version 1.4

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9 November 2012

Appendices

  • Appendix 1: Guidelines on efficacy and safety aspects of OTC applications
  • Appendix 2: Guidelines on quality aspects of OTC applications
  • Appendix 3: Guidelines on presentation aspects of OTC applications
  • Appendix 4: Guidelines on OTC applications for new substances
  • Appendix 5: Guidelines on OTC applications for specific substances

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The Therapeutic Goods Administration is part of the Health Products Regulation Group