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ARGOM: Guidelines on changes to OTC medicines

V1.1, April 2013

29 November 2015

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This guidance has been updated and this webpage will be archived on 1 March 2016.

Please go to Process to change a registered OTC medicine for the updated guidance which you can commence using.

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This interim guideline on changes to OTC medicines is based largely on ARGOM's Changes to OTC medicines (version 1.3 published October 2012). It has been updated to accommodate the new process for the pre-market evaluation of OTC medicines in Australia.

The guideline will be updated and revised as needed throughout the staged implementation of the new process.

Version history

Version Description of change Author Effective date
V1.0 Original publication OMA - OTCME 15/04/2013

Clarified requirement for analytical validation summary forms and included hyperlink

Clarified requirement for applications to be in common technical document (CTD) format

Included reference to 'different strength or size' in the Groups Order - Summary section

Changed references from SUSDP to SUSMP

Added new change codes (previously referred to as TBD)

OMA - OTCME 15/04/2013


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