CATrialAuthorisation object
Regulatory and ethics bodies involved in approval process
Competent Authority/-ies (CA)
Ethics committee(s)
Other (e.g. in case of radiation)
CA - Submission for authorisation mandatory for
Interventional clinical trials on MP (with or without marketing authorization)
CA - Submission required to
National CA
Other (e.g. in case of radiation)
Additional Information
No notification is required for non-interventional trials meeting the criteria as specified in Section 2, Definitions and Glossary Regulation 2/2012.
If radiation is used in the clinical investigation, a safety license issued by STUK is required, unless the practice is specifically exempted.
