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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

08 July 2014

Guidance 15 Biopharmaceutic studies

Updated specific guidance to replace the former appendix 15 is now available.

30 May 2014

Guidance 22 Colourings used in medicines

Guidance updated to include colourings permitted in medicines for topical use, and include the following colourings for use in oral medicines: calcium carbonate, Lutein, Chlorophyllins, Riboflavin-5-phosphate and tartrazine. More about the PPF changes».

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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: Friday, 30 May 2014

Content last reviewed: Friday, 30 May 2014

Web page last updated: Wednesday, 9 July 2014

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