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Cost recovery impact statement - Over the counter medicines, 1 July 2013 - 30 June 2014

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28 June 2013

6. Periodic review

TGA is reviewing its ABC methodology to ensure that the fees and charges cover the costs of the services provided. Overall, fees and charges must cover the cost of the regulatory costs for the sector.

A business review of regulation of OTC medicines is being implemented, part of which includes evaluation processes based on the product risk. Higher risk products will attract greater scrutiny before registration on the ARTG, and evaluation fees will be set accordingly.

TGA aims to have updated OTC evaluation fees implemented by the end of the 2013-14 financial year. The updated fees and charges will be documented in a new CRIS.

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