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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 131 - 140 of 147

Search for newly added or updated PI documents using TGA Business Services

Tags: 
product information

Search for a PI by medicine or trade name or active ingredient using TGA Business Services

Tags: 
product information, CMI
18 January 2019

Labelling requirements in some appendices to the Poisons Standard

Tags: 
poisons standard, medicine labels

When sponsorship changes during an application process (part of CTD Module 1 guidance)

Tags: 
ARTG
1 May 2019

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

Tags: 
medicine shortages

Use these forms to notify the Secretary when the patent certificate is not required when applying to register medicines, list export only medicines, or list assessed listed medicines

Tags: 
forms

Guidance on requirements and conditions to meet before marketing can commence (part of the post-decision phase of the prescription medicines registration process)

11 June 2021

Search database of TGA Laboratory testing results

Tags: 
testing

Search database of AusPARs

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AusPARs

Search database of European Union (EU) and International Conference on Harmonisation (ICH) Guidelines adopted in Australia

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