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ARGOM Appendix 2: Guidelines on quality aspects of OTC applications

Australian Regulatory Guidelines for over-the-counter Medicines (ARGOM) Appendix 2

Guidance about evidence required to substantiate the quality of the product, for over-the-counter (OTC) medicine registration applications. 

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Purpose

The Therapeutic Goods Act 1989 (the Act) requires that applications for a product registration be evaluated "having regard to whether the quality, safety and efficacy of the goods for the purposes for which they are to be used have been satisfactorily established".

All applications for over-the-counter (OTC) medicine registration must be supported by evidence to substantiate the quality of the product. 

This guidance describes the information regarding the quality of the product should be submitted for OTC medicine applications.

Guidance

This Guidance is presented as a downloadable file because of its length. 

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Page history

Show all page updates (3)

Addition of footnotes to information about intermediate products.

Update to 6.6 Colourings in medicines for topical and oral use.

Update of ARGOM Chapters:

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

Re-formatting of the above chapters as Appendix 2 - Guideline on quality aspects of OTC applications.

Addition of footnotes to information about intermediate products.

Update to 6.6 Colourings in medicines for topical and oral use.

Update of ARGOM Chapters:

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

Re-formatting of the above chapters as Appendix 2 - Guideline on quality aspects of OTC applications.