Temporary halt or termination

Submit the notification

Please submit the notification via the E-service for notification of a clinical investigation:

You may also submit notifications by e-mail or on DVD/CD or USB by regular mail. If the temporary halt is due to safety reasons, the circumstances must be explained in the notification.

If the investigation is terminated prematurely, a justification must be included in the notification.

Restart

An approval from the Swedish Medical Products Agency (Swedish MPA) is required to restart the clinical investigation if the temporary halt was due to safety reasons. 

In the notification for restart, a justification to why the investigation can be restarted must be included together with any updated documents.

Timelines

If a clinical investigation that is conducted in Sweden is temporarily halted or terminated early due to safety reasons, the Swedish MPA shall be informed within 24 hours. If the clinical investigation is temporarily halted or terminated early for other reasons, the MPA shall be informed within 15 calendar days. 

When a clinical investigation is terminated according to plan, the Swedish MPA shall be informed within 15 calendar days after the end of investigation in Sweden. The Swedish MPA shall also be notified within 15 calendar days of the end of the clinical investigation globally.

The final report shall be submitted within a certain time after the end of investigation.