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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 - 11 October 2021
September
25
2021

Information regarding the export of therapeutic medicines, medical devices and human substances

September
24
2021

This guidance is to assist entities and individuals planning to export medicines (including prescription, over-the-counter and complementary medicines) either for commercial supply, or for non-commercial purposes (for example, for a family member or friend).

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Showing 101 - 110 of 147
30 August 2017

Information to support submission of quality modules as part of registration or variation applications for influenza vaccines

Tags: 
vaccines
18 October 2017

Specifications and guidance to compile an eCTD dossier for Australia

Tags: 
CTD, eCTD
16 August 2021

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
10 July 2019

E-form specific information

Tags: 
variations
18 October 2017

Specifications and guidance to compile a NeeS dossier in Australia

Tags: 
CTD
24 October 2019

Information about how TGA makes use of assessments from comparable overseas regulators (CORs)

Tags: 
international
24 October 2019

List of countries and jurisdictions TGA will accept reports from for use in the COR report-based process

Tags: 
international
24 October 2019

Guidance on submission requirements for the COR report-based process

Tags: 
international, CORs, Pathways, electronic submissions
24 October 2019

Information about timeframes associated with COR report-based process

Tags: 
international

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