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
No
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).
