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Australian Regulatory Guidelines for Prescription Medicines (ARGPM)

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

We have launched a new tool to help you find information within the ARGPM. Please try it and give us your feedback.

Sponsors may now apply to register a prescription medicine under the provisional approval pathway, priority review pathway or the standard prescription medicines registration pathway.


15 December 2019

Evidence of GMP for prescription medicines

Guidance for sponsors and applicants preparing applications and requests involving steps in the manufacture of medicines regulated as prescription medicines

8 February 2019

Prescription medicine major variation: discretionary power to reduce fees in exceptional circumstances

Amendments to the Therapeutic Goods Regulations 1990 came into effect in late November 2018 that allowdiscretion to reduce application and evaluation fees for a major variation application in exceptional circumstances

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.