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Australian Regulatory Guidelines for Prescription Medicines (ARGPM) BETA

The ARGPM is a collection of guidance documents and other information about the regulation of prescription medicines. The ARGPM has been designed for use by sponsors to provide a way to search for relevant TGA guidance documents about prescription medicines from a single location. Commonly used ARGPM documents, including basic information, CTD and general dossier requirements and forms, can be found at medicine registration fundamentals.

This is a beta version of the new ARGPM and we welcome your feedback while the new tool is being tested. The previous version of the ARGPM will remain available for a short time.

To use the ARGPM, filter the list of documents by selecting topics, sub-topics or tags, or search using keywords. The search or filtered results are limited to relevant items within the ARGPM. If you cannot find the document you are looking for you can search the entire website using the main site search.

Latest updates - 20 July 2021
July
20
2021

Use this form to provide formulation details and information on a proprietary ingredient for entry into the Proprietary Ingredient Table in TGA Business Services (TBS)

July
07
2021

Guidance on the structure and processes for the compilation, review and publishing of an AusPAR

Showing 1 - 6 of 6
2 January 2019

Information about shortages of reportable medicines in Australia

Tags: 
medicine shortages
20 May 2020

Options for alternative medicines, including medicines approved for import and supply during a shortage (s. 19A approvals)

Tags: 
medicine shortages
4 January 2018

Information for industry about supplying substitute medicines during a medicines shortage

Tags: 
medicine shortages
16 June 2021

This web page provides guidance and other resources for sponsors about mandatory reporting of medicine shortages in Australia

Tags: 
medicine shortages
1 May 2019

Information about management and communication of medicine shortages and discontinuations in Australia

Tags: 
medicine shortages
1 May 2019

Guidance on the mandatory reporting scheme for medicine shortages and permanent discontinuations of supply of mostly prescription medicines

Tags: 
medicine shortages