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.

News

New CMDv Guidance on the Submission of G.I.18 Variations

12 June 2024

CMDv has published guidance on the submission of G.I.18 variations requiring assessment. The Danish Medicines Agency requests that all Marketing Authorisation Holders (MAHs) carefully review the principles in this document to ensure the process of submitting and obtaining approval of a G.I.18 variation is as efficient and smooth as possible.

Tidsfrister & CTIS: Tidsfrister for kliniske forsøg skal overvåges i CTIS og forordningsforsøg skal overføres til CTIS

10 June 2024

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

25 April 2024

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

05 April 2024