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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 - 9 of 9

Use this form to notify TGA of a proposal to submit supplementary data and to submit supplementary data

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forms

Use this form to provide formulation details and information on a proprietary ingredient for entry into the Proprietary Ingredient Table in TGA Business Services (TBS)

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forms
6 March 2017

Guidance for sponsors on demonstrating stability of medicines under Australian conditions

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testing
20 January 2017

How to request reconsideration of 'reviewable' initial decisions by the Minister for Health

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regulatory actions/decisions

Use this form to apply for consent to import, supply or export therapeutic goods that do not comply with standards

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forms
5 November 2021

Information on requirements and process to apply to import, supply or export therapeutic goods that do not comply with standards

When sponsorship changes during an application process (part of CTD Module 1 guidance)

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ARTG

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

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forms

Guidance on requirements and conditions to meet before marketing can commence (part of the post-decision phase of the prescription medicines registration process)