Australian Regulatory Guidelines for Prescription Medicines (ARGPM)
The Australian Regulatory Guidelines for Prescription Medicines (ARGPM) assist applicants and sponsors to register new prescription medicines or vary existing registrations in Australia.
28 Jan 2015
Added link to Related information, updated links to Minor Variations guidance, removed links to superseded guidance, no content changes.
24 Sep 2014
Updated Pre-submission Planning Form (PPF) to include a hyperlink to orphan drug designation.
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
Prescription medicines forms for applicants and sponsors.
- Pre-submission Planning Form (PPF)
- CTD Module 1 forms
- Forms for minor variations to registered prescription medicines
CTD and general dossier requirements
Information about hard copy and electronic submission dossier formats.
- General dossier requirements
Dossier requirements for hard copy and electronic format submissions
- Common Technical Document (CTD) overview
Overview of CTD structure and organisation
- CTD Module 1
Administrative information and prescribing information for Australia
- Australian eCTD submissions
Australian electronic Common Technical Document submissions
The information on this website is available in PDF and Microsoft Word format for printing.
These guidance provide information about specific technical requirements and particular types of medicine.