Revised: 25 March 2013


OTC medicines process

Part 2A:Over-the-counter medicines: Pre-market application and evaluation process (Word document, 2.1 MB, 30 pages)
Appendix 1: Application selection tools (Word document, 2.4 MB, 26 pages)
Appendix 2: OTC medicines changes tables (Word document, 1.7 MB, 12 pages)

The detailed guidance documents should be seen as interim and will be modified and updated as required prior to and during the 12 month period of staged implementation. Representatives of industry, health professionals and consumers are encouraged to review these documents over this period, and can submit feedback to with "OTC guideline feedback" in the subject line.


On 15 March 2013 Medsafe and the TGA published the outcomes of the consultation on the reform of the over-the-counter (OTC) medicines business processes. The publication also announced that a staged implementation of the new procedures would begin on 15 April 2013, and foreshadowed the release of detailed guidance documents.

Over-the-counter (OTC) medicines business reforms: Staged implementation plan

On 15 April 2013 Medsafe and the TGA will commence the introduction of new administrative procedures for the processing of new and changed OTC medicine applications.

The primary benefits of these reforms are the introduction of predictability in data requirements, target timelines and the streamlining of application processes. This will have a positive impact on the OTC medicine supply chain in Australia and New Zealand.

Additional information on the impact of the new administrative processes on industry, healthcare professionals and retailers, and consumers is available.

Information for industry

Information for healthcare professionals and retailers

Information for consumers

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