You are here

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 - 13 November 2019
November
12
2019
Information regarding the export of therapeutic medicines, medical devices and human substances
November
12
2019
Frequently asked questions (FAQs) about exporting medicines, medical devices and human substances and export certificates including the Certificate of Pharmaceutical Product (CPP), Certificate of Listed Product (CLP) and Certificate of Free Sale (CFS)

Tags

Showing 1 - 10 of 147

Forms for notifying the TGA of a change in sponsorship

Tags: 
ARTG, forms

Include these forms, as required, in CTD module 1 to support your application

Tags: 
CTD, forms

Use this form to begin the first phase of the prescription medicine registration process

Tags: 
forms

Use this form to prepare annual product reports for biological prescription medicines as part of the post-market monitoring program

Tags: 
forms, testing

Use this form to submit a summary of a bioavailability or bioequivalence study

Tags: 
forms, generic medicines

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

Tags: 
variations, biological medicines, forms

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

Tags: 
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

Tags: 
variations, forms

Use this declaration for products that are manufactured using a human embryo or a human embryonic stem cell, or any material sourced from a human embryo or human embryonic stem cell

Tags: 
stem cells, forms

Optional submission dossier checklist

Tags: 
CTD

Pages