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ARGOM: Guidelines on changes to OTC medicines
V1.1, April 2013
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.
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||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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