Vaccines against COVID-19

Medicines agencies around the world are collaborating to approve and follow vaccines against COVID-19. Once the vaccines are approved, medicines authorities around the world follow up with monitoring of adverse drug reactions. Read about results, processes and new vaccines against COVID-19 in our three themes or in the question-and-answer below.

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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.

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