You are here

Medicine registration fundamentals

The documents within the Australian Regulatory Guidelines for Prescription Medicines (ARGPM) assist applicants and sponsors to register new prescription medicines or vary existing registrations in Australia.

This page highlights some of the ARGPM documents and forms most commonly used by sponsors when working on prescription medicine registrations.

New tool for accessing ARGPM information

We have created a new tool to help you find relevant information more easily. The tool allows you to find guidance documents, forms and other resources relating to registering prescription medicines by

  • filtering content using topics, sub-topics and tags
  • searching for content within the ARGPM.

Prescription medicines registration basics

Information about the prescription medicines registration process in Australia.

Image showing flow between five blue boxes

CTD and general dossier requirements

Information about hard copy and electronic submission dossier formats.

Image showing magnifying glass over three files