Common Technical Document Module 1: OTC medicines

CTD Module 1 consists of the administrative information to support an OTC medicine application to either:

• register an OTC medicine under section 23 of the Act
• change the details of an ARTG entry for an OTC medicine under section 9D of the Act.

The information on these pages:

• explains the format and content for Module 1 of a dossier
• describes what must be included in Module 1.

Further information

OTC dossier document matrix - A summary of the CTD document requirements for each application level.