Clinical trials

Clinical trials are tests on voluntary subjects of the effect and side effects of medicines, and the trials take place in several different phases. Read more in our theme about clinical trials.

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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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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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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.


Status for the project regarding the control of anti-tampering devices (ATD) on medicinal product packages

25 April 2024

Information for marketing authorisation holders (MAH). The Danish Medicines Agency's laboratory is currently working on a project to check the anti-tampering device (ATD) on selected medicinal product packages. Approx. 10% of the packages requisitioned so far had an ATD that did not work. The flawed devices are designed as a sticker, that can be removed without it being visible on the packaging. We encourage marketing authorisation holders to test their ATDs to avoid unauthorised access to the medicinal products.

Danish Medicines Agency establishes that chronic urticaria could be a side effect of the Spikevax vaccine

05 April 2024

Survey on strategy for Ph. Eur. quality standards for monoclonal antibodies

11 March 2024

Regulatory training on transitional trials in CTIS with open question and answers session

13 February 2024