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

In parallel
Sequentially (in any order)
Order of submission not defined

Additional Information

Circular 619 (08/04/2015) (french version): Provides a list of Ethics Committees having full accreditation status according to the law dated 7th May 2004 related to experiments on human people.

Regulatory and ethics bodies involved in approval process

Competent Authority/-ies (CA)
Ethics committee(s)
Agency for data protection