2025 deadline for submitting applications concerning marketing authorisations and clinical trials

The Danish Medicines Agency is closed for the Holiday Season, from December 24, 2025, until January 1, 2026, both days included.

Marketing authorisations:

The deadline for submitting applications concerning marketing authorisations is December 19, 2025.

We will consider applications submitted after December 19, 2025, as they have been received January 2, 2026.

Clinical trials:

The deadline for submitting applications concerning clinical trials is December 22, 2025.

For applications concerning clinical trials no assessment will be performed during the winter clock stop between 23 December 2025 and 7 January 2026, both days included. The deadline for these trials is postponed.