Reply To: Grace period for label changes
May 21, 2024 at 6:42 pmI concur with the first response.
Additionally, our CT supply group continues to include the EudraCT number on studies that are transitioning to the EU CTR irrespective of QP release status. We consider the labels to be EU CTR compliant as the EudraCT number is additional information.
Although the EudraCT number is not relevant to the EU CTR submission, it is relevant to the overall clinical trial and is still a valid number in the EudraCT database.
During the grace period for transitioning studies, we have not received any pushback from the EU RAs on our CT applications when the EudraCT number has been included on labels.
