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.

Go to theme
indgangsikon nr 1

General public

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

indgangsikon nr 2

Industry

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

indgangsikon nr 3

Healthcare professionals

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

Report a side effect from medicines About Brexit International activities Transparency Subscribe to news in English Mission, vision and strategy Whistleblower scheme New veterinary medicinal products regulation Jobs 0

News

New regulations on Stockpiling of Critical Medicines effective on July 1 2024

01 July 2024

It will soon be mandatory for companies behind the most critical medicines to maintain stocks to cover initially six weeks’ consumption and to report stocks regularly to the Danish Medicines Agency. The affected companies will have six months to prepare for compliance, and, in August, the Danish Medicines Agency is holding information meetings about the new rules.

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

12 June 2024

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