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Review of the Australian Regulatory Guidelines for Over-The-Counter Medicines

12 October 2012

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

The ARGOM has been substantially revised, updated and expanded by a working group composed of representatives from the Therapeutic Goods Administration (TGA) and the Australian pharmaceutical and cosmetics industry associations.

The following selected chapters of ARGOM have been re-formatted as appendices.

Previous title - Chapter New title - Appendix
  • 6A Efficacy and safety
  • 4 Quality
  • 4A Manufacture
  • 4B Formulation
  • 4C Starting material specification
  • 4D Finished product specification
  • 4E Stability testing
  • 4F Microbioloigcal testing
  • 5A Product name
  • 5B Labelling
  • 5C Product Information
  • 5D Consumer Medicines Information
  • 5E Changes to Scheduling
  • 6B New substances
  • 9 MEC Guidelines

The selected chapters have been removed from the ARGOM document and references made 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, 10 and 11 will remain in effect until such time it is replaced.

Update of the remaining ARGOM document is anticipated in 2013 and will incorporate planned changes to business processes resulting from the OTC Business Process Reform (BPR) project. Further changes to the new appendices may also be necessary in association with this further update of the ARGOM.

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