Module 1.2 - Administrative information

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.

• Certification in relation to patents required in relation to registration or listing under Sections 25, 26 and 26A of the Therapeutic Goods Act 1989
• Notification to the Secretary that a Certification under section 26B(1) of the Therapeutic Goods Act 1989 is not required.

You can either:

• 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 (otc.medicines@tga.gov.au) at any time after you lodge the application with the submission ID clearly visible and clearly identified as Module 1.2.3 Patent certification.