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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 - 8 of 8
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
31 July 2013

Guidance on when and how to provide PI to the TGA

Tags: 
product information
10 July 2019

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

Tags: 
generic medicines, product information
29 November 2018

Guidance on how and when to use a Boxed Warning

Tags: 
product information, CMI, side effects
27 April 2015

How to upload your PI in TGA Business Services

Tags: 
product information, CMI

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