Theme

EU Presidency 2025

Denmark has assumed the EU Presidency, and for the Danish Medicines Agency, this means, among other things, that we are hosting 25 meetings within the European framework. Read more on our theme page.

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Theme

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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General public

Here you can read about reimbursement, drugs affecting the ability to drive and other topics relevant for the general public.

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Industry

Information on licensing, inspections, fees, company authorisations, clinical trials and more.

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Healthcare professionals

This section gathers information for doctors, nurses, pharmacies, dentists and other healthcare professionals.

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News

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.

Call for interest launched for COMBINE pilot exploring the feasibility of coordinated assessment across EU Member States for combined studies

16 June 2025

First common Nordic packages in English approved

20 March 2025

Remember to Enter Start Dates in CTIS

19 February 2025