Medicine registration fundamentals
Links to commonly used ARGPM documents, including basic information, CTD and general dossier requirements and forms
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.
- Overview: Prescription medicines registration process
Requirements, phases and milestones - Mandatory requirements
Requirements for an effective application - Fees and charges
Introduction to TGA fees and charges
Forms
Prescription medicines forms for applicants and sponsors.
CTD and general dossier requirements
Information about hard copy and electronic submission dossier formats.
- General dossier requirements
For electronic formats. - Common Technical Document (CTD) overview
Overview of CTD structure and organisation - CTD Module 1
Administrative information and prescribing information for Australia - Electronic submissions
Guidance on electronic submissions