Common Technical Document Module 1: OTC medicines
Applicable for applications lodged from 1 July 2017
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.
OTC dossier document matrix - A summary of the CTD document requirements for each application level.