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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 November 2021
November
16
2021

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

November
10
2021
Information about the role & members of the Advisory Committee on Medicines (ACM)
Showing 1 - 5 of 5

Links to information about labelling and packaging

Tags: 
medicine labels
18 May 2017

A code of practice for those involved in the design, selection and use of tamper-evident packaging

Tags: 
tamper-evident packaging
23 March 2021

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

Tags: 
medicine labels
8 May 2018

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

Tags: 
children/child
18 January 2019

Labelling requirements in some appendices to the Poisons Standard

Tags: 
poisons standard, medicine labels