Australian Regulatory Guidelines for OTC Medicines (ARGOM)

This user guide is for sponsors applying to change the entry in the ARTG for a registered non-prescription OTC medicine.

How to get approved PI and CMI documents for OTC medicines published on our website.

The OTC application categorisation framework defines the different OTC medicine application levels and identifies the key application criteria

Determining the route for an OTC application and assessing the risk to consumers with the umbrella brand extension.

The OTC Dossier Documents Matrix (the 'matrix') provides a summary of which documents are required for each application level (N1, N2, N3, N4, N5, C1, C2, C3 or C4)

The cover letter (letter of application) needs to provide useful information regarding the nature and scope of the application

The completed assurances form is required in Module 1.5 of your OTC new medicine N1 application

We have made templates for Product Information (PI) and Consumer Medicine Information (CMI) documents to assist sponsors lodging variation applications for solid-dose single ingredient paracetamol products affected by scheduling changes.

Information on how to compile a literature based submission (including mixed applications).

Updated form used to notify us of proprietary ingredient mixtures for use in therapeutic goods.

Change of sponsor name forms are now available