We are aware of an issue causing the title of some ARTG entries to disappear. We are investigating as a priority and hope to have this resolved as soon as possible.
Purpose
Module 1 of the CTD describes the administrative information and prescribing information (for example, the application form, the proposed Product Information and labelling) for Australia to support:
- the registration of a prescription medicine under section 23 of the Therapeutic Goods Act 1989 ('the Act')
- the variation of the details of an ARTG registration for a prescription medicine under section 9D of the Act.
This guidance:
- explains the format and content for Module 1 of a dossier
- describes each document in Module 1
- outlines when each document needs to be provided
- details any other requirements relating to the documents.