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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 - 21 January 2021
January
21
2021

Guidance on obligations during provisional registration period, process for applying for extension of provisional registration and transition to full registration

January
21
2021

Application form to register or vary the registration of prescription medicines and checklist to determine if the application is eligible for COR-A or COR-B report-based approach

January
19
2021

Guidance on pharmacovigilance responsibilities, mandatory reporting requirements and pharmacovigilance best practice

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8 October 2020
Guidance on how to change sponsor details in PI and labels
Tags: 
product information, medicine labels, variations