Get Chapter 4 - Centralised Procedure - European Commission

This guide provides a comprehensive and user-friendly approach to filling out Chapter 4 of the Centralised Procedure for the European Commission. Whether you are familiar with digital processes or new to regulatory submissions, this guide will help you navigate each section of the online form with ease.

Follow the steps to successfully complete the Chapter 4 form.

1. Click the ‘Get Form’ button to obtain the Chapter 4 Centralised Procedure form and ensure it is ready for completion.
2. Begin by entering the legal basis and scope of the application, ensuring that all details are accurate and comply with Regulation (EC) No 726/2004.
3. Provide necessary information regarding the product, including its name and details on the medicinal product's intended use, derived from both biotechnological processes and new active substances.
4. Complete sections on Orphan medicinal products and their eligibility under Regulation (EC) No 141/2000 if applicable.
5. Submit any additional documents requested in the form, such as detailed justifications for using the centralised procedure and any relevant supporting data.
6. Review the application thoroughly to ensure compliance with the outlined guidelines and that no sections are left unaddressed.
7. Finalize the application by saving changes, and proceed to download, print, or share the completed form as required.

Start completing the Chapter 4 - Centralised Procedure form online now to facilitate your application.