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.