C1 application for over-the-counter (OTC) medicines checklist

Use this checklist to produce a high quality C1 application. You do not need to submit this checklist.

This checklist assists sponsors to prepare a change application at the C1 level for a registered OTC medicine. It is intended as an educational and self-check tool for sponsors. You do not need to submit this checklist with your application.

Preparing your applications in accordance with this checklist and the relevant guidance will assist you to:

• produce high quality C1applications
• submit applications at the correct level
• minimise the time required for the TGA’s assessment.