2023 deadline for submitting applications concerning marketing authorisations and clinical trials

The deadline for submitting applications concerning marketing authorisations and clinical trials is December 20, 2023.

The Danish Medicines Agency is closed for the Holiday Season, from December 23, 2023, until January 1, 2024, both days included.

Applications concerning marketing authorisations and amendments to clinical trials need to be submitted before December 20, 2023.

We will consider applications submitted after December 20, 2023, as they have been received January 2, 2024.

For applications concerning clinical trials applied under the Clinical Trials Regulation no assessment will be performed during the winter clock stop between 22 December 2023 and 7 January 2024, both days included. The deadline for these trials is postponed.