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

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.

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

25 April 2024

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

11 March 2024

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

01 February 2024