ECGeneralEthicalReview object
Submission for Ethical review mandatory for
Clinical IMP trials
Clinical ATMP trials
Submission to CA and EC to be performed in the following order
EC first
Positive EC opinion required for CA application/approval
Procedural interaction - Additional information
A favourable opinion is a prerequisite for the trial evaluation and authorization by the national CA.
The EC is obliged to inform the sponsor and the national Agency within 15 days after the decision has been reached!
