Danish Medicines Agency

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

General public

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

Industry

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

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

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

12 September 2024

The Danish Medicines Agency's laboratory has completed a project in which the anti-tampering device (ATD) on random samples of selected medicinal product packages has been checked. Approx. 10% of the packages requisitioned 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 (MAH) to test their ATDs to prevent unauthorised access to the medicinal products without tamper evidence.

Call for Applications for Marketing Authorizations for Critical Medicines

22 August 2024

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

01 July 2024

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

12 June 2024