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Process to change a registered OTC medicine

27 August 2020

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Version history

Version history
Version Description of change Author Effective date
V1.0 Original publication OTC Medicines Regulatory Guidance November 2015
V1.1 Update to steps 2, 8 and 9 of the process to reflect the new OTC fee structure commencing on 1 January 2016. COMB - OTC Medicines Evaluation Section December 2015
V1.2 Update to steps to reflect the new notification process commencing 1 July 2017. OTC Medicines Evaluation Section / Scientific Operations Management Section June 2017
V1.3 Update step 13 of the process to include information on publishing PI/CMIs on the TGA website Complementary and OTC Medicines Branch August 2020

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