B5. EudraCT notification of amendment form

In the event of substantial amendments, a signed and dated EudraCT Substantial Amendment Notification Form must be submitted to the review committee.

The competent authority must receive the notification of amendment digitally (pdf). This latter version does not need to be signed. Correct answering of question E1 of the form is essential for processing the amendment by the competent authority in ToetsingOnline.

If the substantial amendment also involves a change to the EudraCT Application Form (B3) and the ABR form (B1), these must also be altered and submitted to the reviewing committee.

The competent authority only has to receive the notification of amendment form and the the new Application form (if changed) (pdf + online), but not the revised ABR form.