CATrialAuthorisation object

Regulatory and ethics bodies involved in approval process

Competent Authority/-ies (CA)
Ethics committee(s)
Agency for data protection
Other (e.g. in case of radiation)

CA - Submission for authorisation mandatory for

All prospective trials
Phases I-IV clinical trials (including pilot studies)

CA - Submission required to

National CA

Applicable national legal framework/ Reference

Section 88 of Danish Medicines Act

Additional Information

Notification obligation to CA also applies to herbal medicinal products and strong vitamin and mineral preparations.

Non-interventional trials are not to be notified to the CA unless it concerns certain types of non-interventional PASS (post-authorisation safety study) studies.

NB! The use of the „Guide to assessing if a trial falls under the definition of a clinical trial“ is recommended to assess whether notification is required or not (available on the DKMA website in section: Medicines & medical devices / Medicines regulation / Clinical trials / Trials in humans).