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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 - 16 June 2021
June
16
2021

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

June
16
2021
Guidance on how to submit shortage/discontinuation notifications to the TGA
June
16
2021
Guidance on the mandatory requirements for reporting current and anticipated reportable medicine shortages and discontinuations in Australia
Showing 11 - 17 of 17
30 April 2018

Types of change where notification is sufficient

Tags: 
variations
10 July 2019

How to make variations to existing ARTG entries for prescription medicines

Tags: 
variations, chemical entities, biological medicines, generic medicines
10 July 2019

Types of notifications and variations for biological medicines

Tags: 
variations, biological medicines, generic medicines
8 January 2020

Types of notifications and variations for chemically derived (non-biological) prescription medicines

Tags: 
variations, chemical entities, biological medicines, generic medicines
10 July 2019

Links to information on variations to prescription medicines

Tags: 
variations, chemical entities, biological medicines, generic medicines, manufacturing
10 July 2019

E-form specific information

Tags: 
variations
8 October 2020
Guidance on how to change sponsor details in PI and labels
Tags: 
product information, medicine labels, variations

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