Marketing authorisation for a medicine Medical devices Application for general reimbursement Inspection of pharmaceutical companies Company authorisations and registrations DKMAnet Clinical trials of medicines Fees Product defects and withdrawals
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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Theme

Vaccines and medicines against COVID-19

Read about the current studies and development of vaccines and medicines for treatment of COVID-19, and how medicines can be approved much quicker in extraordinary situations, if patient safety is sufficiently assured.

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News and notifications

Control of companies' uploading of leaflets to the Danish Medicines Agency's portal DKMAnet

16 October 2024

The Danish Medicines Agency's laboratory will regularly select ATC groups and check whether readable package leaflets have been uploaded to www.indlaegsseddel.dk. The selected ATC groups will not be published in advance.

2024 deadline for submitting applications concerning marketing authorisations and clinical trials

05 November 2024

Updated version of the Danish Medicines Agency's guidance on risk-adapted recording and reporting of adverse events in clinical trials is now available on the website

23 October 2024

Nils Falk Bjerregaard new Director General of the Danish Medicines Agency

03 October 2024