Check the TGA website for up-to-date guidance
The most up-to-date information about prescription medicine registration in Australia is on the TGA website. Now that guidance is presented in a series of web pages, updates are likely to be more common than in the past. If you subscribe to the TGA guidelines email alert service, you will be emailed every time the TGA web guidance is updated.
TGA web pages are dated, and can be printed.
A PDF format is being provided during the transition between the former version of the ARGPM (Australian Regulatory Guidelines for Prescription Medicines) and the new web format. Please note that information in the PDF should not be relied upon to be up-to-date.
For print versions of the ARGPM, see:
- Prescription medicines registration process
- Mandatory requirements for an effective application
- CTD Module 1: Administrative information and prescribing information for Australia
Printable versions of specific guidance are also available from each web page.