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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 - 23 April 2021
April
23
2021

Guidance on eligibility criteria and supporting documentation when preparing an application for orphan drug designation

April
23
2021

Guidance on criteria and supporting documentation required for a medicine to be eligible for provisional determination

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Showing 81 - 90 of 149
30 March 2020

Information about using approved names for herbal ingredients in medicines

Tags: 
herbal
30 March 2020

Approved terminology on the TBS website - code tables

Tags: 
regulatory guidance
14 January 2020

Guidance on procedure to undertake recalls and non-recall actions on therapeutic goods

Tags: 
recalls
23 March 2021

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

Tags: 
medicine labels
1 December 2020
Information about the role & members of the Advisory Committee on Medicines (ACM)
Tags: 
ACM
6 November 2020

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

Tags: 
medicinal cannabis
27 March 2017

Guidance on collecting and providing information about development of antibiotic resistance pre- and post-market

15 December 2020

The prescription medicine notification process

Tags: 
variations
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

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