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OTC medicines reforms

15 April 2013

On 13 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 new implementation procedures would begin on 15 April 2013, and foreshadowed the release of detailed guidance documents.

The first phase of the staged implementation has now commenced.

The guidelines and the tools for sponsors (previously located on this page) can now be accessed at: Australian regulatory guidelines for OTC medicines (ARGOM)