01 January 2024
  • 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 |

    The European Pharmacovigilance Risk Assessment Committee (PRAC) has reassessed if chronic urticaria could be a side effect after vaccination with the Spikevax vaccine from Moderna. This follows a review from the Danish Medicines Agency, which has investigated data and reports from patients across the European countries.