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OTC new medicines registration process

27 August 2020

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Version history

Version history
Version Description of change Author Effective date

Original publication

Replaces ARGOM Guidelines on pre - market application and evaluation process for OTC medicines v1.3 09/04/2014

OTC Medicines Regulatory Guidance November 2015

Update to step 3 and step 8 of the process to reflect the new OTC fee structure commencing on 1 January 2016

COMB - OTC Medicines Evaluation Section December 2015

Update to Step 12 of the process to include information on publishing PI/CMIs on the TGA website

Complementary and OTC Medicines Branch August 2020

Book pagination