Australian Regulatory Guidelines for Prescription Medicines (ARGPM)

18 November 2015

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


18 Nov 2015

Evidence of GMP compliance for prescription medicines

This guidance is for sponsors and applicants preparing applications and requests involving steps in the manufacture of medicines regulated as prescription medicines.

1 Jul 2015

New guidance and forms

See: New and updated guidance

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.

Specific guidance

These guidance provide information about specific technical requirements and particular types of medicine.