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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

Showing 1 - 5 of 5
Tags: 
forms, international agreements
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
27 April 2015

How to upload your PI in TGA Business Services

Tags: 
product information, CMI

Use these forms to notify the Secretary when the patent certificate is not required when applying to register medicines, list export only medicines, or list assessed listed medicines

Tags: 
forms