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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 121 - 130 of 147
8 May 2018

Guidance on meeting the requirements for child-resistant packaging in TGO 95

Tags: 
children/child
28 October 2020

Your responsibilities when advertising therapeutic guides

10 November 2020

Notices about electronic submissions and data review

Tags: 
CTD, eCTD
15 August 2018

Evaluation plan estimators to approximate dates of milestones in the prescription medicine registration process

18 October 2019

How to use E2B R2 format to provide information about adverse events

Tags: 
pharmacovigilance, reporting problems
16 June 2021

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

Tags: 
medicine shortages
1 May 2019

Information about management and communication of medicine shortages and discontinuations in Australia

Tags: 
medicine shortages
29 November 2018

Guidance on how and when to use a Boxed Warning

Tags: 
product information, CMI, side effects
14 February 2020

Information on mandatory requirements and best practice recommendations to assist medicine sponsors meet their obligations

27 April 2015

How to upload your PI in TGA Business Services

Tags: 
product information, CMI

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