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ARGOM: Guidelines on the pre-market application and evaluation process for OTC medicines

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Version 1.3, April 2014

29 November 2015

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

Please go to OTC new medicines registration process for the updated guidance which you can commence using.

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Australian regulatory guideline for over-the-counter medicines

This interim guideline details the new regulatory processes for the approval of new and changed OTC medicines. The new process is to be implemented in stages.

This guideline describes the process that will apply when fully implemented and is to be read in conjunction with the guidance regarding the implementation stages for the new process.

Version history

Version Description of change Author Effective date
V1.0 Update of ARGOM application and evaluation process OMA - OTCME 15/04/2013
V1.1

Improved hyperlinks and information regarding applications for umbrella branded medicines.

Clarified requirement for analytical validation summary forms and included hyperlink.

Clarified the requirements for GMP clearance.

Clarified 'calendar days' through-out and changed from 'working days' to 'calendar days' for ACNM cut-off date.

Highlighted where requirements are subject to staged implementation.

OMA - OTCME 15/04/2013
V1.2

Minor formatting updates

Added hyperlinks to OTC N2 application requirements and OTC Medicine Monographs.

OMA - OTCME 06/09/2013
V1.3

Delete some references to staged implantation.

Update reference to 'other' change codes.

Correction and consolidation of information regarding fees.

Clarified that certification of registration is sent out after receiving the S26B certificate or notification.

OMA - OTCME 09/04/2014

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