Australian Regulatory Guidelines for Prescription Medicines (ARGPM)

24 July 2015

The Australian Regulatory Guidelines for Prescription Medicines (ARGPM) assist applicants and sponsors to register new prescription medicines or vary existing registrations in Australia.


Updates

1 Jul 2015

New guidance and forms

See: New and updated guidance

28 Jan 2015

Updated layout

Added link to Related information, updated links to Minor Variations guidance, removed links to superseded guidance, no content changes.

Prescription medicines registration basics

Information about the prescription medicines registration process in Australia.

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CTD and general dossier requirements

Information about hard copy and electronic submission dossier formats.

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Print version

The information on this website is available in PDF and Microsoft Word format for printing.