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Strategy for the DKMA

The Danish Medicines Agency has formulated a strategy for 2022-26. The strategy emphasizes a vision of leading the way in national and international cooperation, and in the dialogue with citizens and society. Read more.

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Theme

Vaccines and medicines against COVID-19

Read about the current studies and development of vaccines and medicines for treatment of COVID-19, and how medicines can be approved much quicker in extraordinary situations, if patient safety is sufficiently assured.

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News and notifications

The Danish Medicines Agency requires bioequivalence data in a better data format

03 July 2025

In future, the Danish Medicines Agency will request that data from bioequivalence studies be submitted in an additional data format to that used today. Businesses applying for approval of new medicines or submitting variation applications will be required to submit data in CDISC format from 1 September 2025.

First common Nordic packages in English approved

20 March 2025

Pharmaceutical companies must ensure that the labelling on the medicine packages cannot disappear

22 January 2025

EU one step closer to electronic product information

16 January 2025