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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 - 8 of 8

Forms for notifying the TGA of a change in sponsorship

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ARTG, forms
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forms, international agreements

Use this form to prepare certified product details (CPD) for biological prescription medicines

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variations, biological medicines, forms

Use this form to prepare certified product details (CPD) for chemical prescription medicines

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variations, forms

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

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variations, forms
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

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variations, forms, drug master files, DMF, ASMF, Master file

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

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forms

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