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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

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

25 April 2024

Information for marketing authorisation holders (MAH). The Danish Medicines Agency's laboratory is currently working on a project to check the anti-tampering device (ATD) on selected medicinal product packages. Approx. 10% of the packages requisitioned so far 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 to test their ATDs to avoid unauthorised access to the medicinal products.

Danish Medicines Agency establishes that chronic urticaria could be a side effect of the Spikevax vaccine

05 April 2024

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

11 March 2024

Regulatory training on transitional trials in CTIS with open question and answers session

13 February 2024