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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

Guidance on specific criteria and paperwork required for submission to the TGA to ensure conformance with TGO 93

Showing 1 - 10 of 18
6 March 2020

Information to assist sponsors with reformatting their approved PI or preparing a new PI in the required format

Tags: 
product information, variations

Links to information about labelling and packaging

Tags: 
medicine labels
31 July 2013

Guidance on when and how to provide PI to the TGA

Tags: 
product information
18 May 2017

A code of practice for those involved in the design, selection and use of tamper-evident packaging

Tags: 
tamper-evident packaging
10 July 2019

Changing the PI of a generic medicine so that the indications match the reference medicine

Tags: 
generic medicines, product information
1 September 2020

Guidance to assist in meeting the Australian labelling requirements in TGO 91 and TGO 92

Tags: 
medicine labels
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

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