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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 September 2021
September
16
2021

Information about the Australia-Canada-Singapore-Switzerland (ACSS) Consortium

September
13
2021
Information about the role & members of the Advisory Committee on Medicines (ACM)
August
26
2021

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

Filters
Showing 11 - 20 of 26
4 October 2019

Data requirements for formulation changes to inhalation and nasal spray medicines

Tags: 
generic medicines, variations
27 October 2020

This page is for industry stakeholders (e.g. manufacturers of active pharmaceutical ingredients) who provide Drug Master Files (DMF) to the TGA

Tags: 
variations, forms, drug master files, DMF, ASMF, Master file
8 October 2020

If sponsorship is transferred to you, you need to notify the TGA

Tags: 
ARTG
3 October 2018

Guidance on the process for registering new medicines with new trade names that are 'clones' of currently registered prescription medicines

Use this form to apply for an additional trade name for a registered prescription medicine

Tags: 
forms
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
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

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