2022 deadline for submitting applications concerning marketing authorisations and clinical trials

The deadline for submitting applications concerning marketing authorisations and clinical trials is 20 December 2022.

The Danish Medicines Agency is closed for the Holiday Season, from 24 December, 2022, until 1 January, 2023, both days included.
Applications concerning marketing authorisations and clinical trials need to be submitted before 20 December, 2022. We will consider applications submitted after 20 December, 2022, as if they have been received 2 January 2023.

For applications concerning clinical trials, please note that the EU Clinical Trials Directive expires on 31 January, 2023. After this date, all applications will have to be applied through the new Clinical Trial Information System (CTIS) under the EU Clinical Trials Regulation. For more information see our webpage regarding the Regulation.

For applications concerning clinical trials applied under the Clinical Trials Regulation no assessment will be performed during the winter clock stop between 22 December, 2022 and 6 January, 2023, both days included. The deadlines for these trials are postponed.