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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.


Updates

9 August 2013

Updates to the ARGPM

Updated specific guidance to replace the former appendices 9, 10, 11, 18 and 19 is now available. More about ARGPM updates »

31 July 2013

Updates to the ARGPM

Updated specific guidance to replace the former appendices 1, 8, 14, 16/17 and 22 is now available. More about ARGPM updates »

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Prescription medicines registration basics

Information about the prescription medicines registration process in Australia.


CTD and general dossier requirements

Information about hard copy and electronic submission dossier formats.

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.


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Content last updated: Wednesday, 31 July 2013

Content last reviewed: Wednesday, 31 July 2013

Web page last updated: Thursday, 28 November 2013

URL: http://www.tga.gov.au/industry/pm-argpm.htm