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OTC medicines: guidelines and processes update 2013: Information for health professionals and retailers

22 March 2013

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

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

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There are no changes to standards employed by the regulator for assessing the benefits and risks posed by new and changed OTC medicines.

The new process applies to administrative procedures only. There will be no change to the supply of new OTC medicines on the Australian and New Zealand markets.

OTC medicines that have been assessed as part of this new process will gradually appear on the market over the coming few years, commencing in about 6 months time.
Yes. Existing OTC medicines that were approved prior to 15 April 2013 can still be supplied in accordance with the conditions of approval. The implementation of new administrative procedures does not affect the safety, efficacy or quality standards against which OTC medicines are assessed.