CAAmendment object

Notification mandatory for

Any substantial amendments

Authorisation mandatory for

Substantial amendments (as determined by CA)

Responsible for submission of SA

Sponsor

Standard notification form available

Yes

Standard notification form

Standard application form for amendments to be used: “Application form for the authorisation to make changes and amendments to the clinical investigation” available on the DHMA website in section:
Medicines & medical devices / Medical devices / Clinical investigations / Application / Amendments to Application (Forms)

Guidance on submission of SA

A list provided on DKMA website shows examples of amendments that require authorisation or notification only (Section: Medicines & medical devices / Medical devices / Clinical investigations / Application / Amendments to Application)

Further, a detailed guidance is available on the CA website in section: Medicines & medical devices / Medical devices / Legislation and Guidance / Guidance / Guidance on application

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395