CATrialAuthorisation object

Regulatory and ethics bodies involved in approval process

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

CA - Submission for authorisation mandatory for

Clinical IMP trials

CA - Submission required to

National CA

Specific Competent Authority for ATMP trials in place


Additional Information

NB! Specific provisions apply for non-commercial experiments as specified in Chapter XIX Art 31 Law 7 May 2004 (e.g. waiver of application and remuneration fees).