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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 November 2020
November
20
2020

XML schema and related files to assist with compiling a NeeS or eCTD dossier

November
10
2020

Notices about electronic submissions and data review

November
06
2020

Information about pre-submission meetings and when to request one

Showing 1 - 7 of 7
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
29 September 2020

Provides links to guidance and resources about medicine shortages in Australia for sponsors

Tags: 
medicine shortages
1 May 2019

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

Tags: 
medicine shortages
21 December 2018

Guidance on how to submit shortage/discontinuation notifications to the TGA

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