This section contains the patent certification documents for medicine applications.
Do not include the application forms for OTC medicines in Module 1. They are submitted online through business services.
Module 1.2.3 Patent certification
You will need to provide one of the following forms under section 26B of the Act for all new registrations including formulation changes, changes in trade name, extensions of indications and changes to the directions for use before a newly approved registration can be included in the ARTG.
Include the form in Module 1.2.3 if you are able to provide it when you submit your dossier.
Send the form to the TGA application entry team by email (email@example.com) at any time after you lodge the application with the submission ID clearly visible and clearly identified as Module 1.2.3 Patent certification.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.