News items 2015

  • The Danish Medicines Agency will be closed on Friday 10 June 2022

    | 08 June 2022 |

    The Danish Medicines Agency will be holding its staff convention and will be closed on  Friday 10 June 2022 However, we process urgent applications for compassionate use permits (applications for d

  • New executive order raises fees in the area of the Danish Medicines Agency

    | 03 May 2022 |

    Higher fees become payable for medicinal products and pharmaceutical companies as a result of a new executive order entering into force on 1 May 2022. The last time the fees were adjusted was in 2017.

  • Management of clinical trials in light of the current situation in Ukraine

    | 06 April 2022 |

    The current situation in Ukraine can have an impact on the conduct of clinical trials. It can affect both the supply of trial-related drug products and the collection of critical data. Therefore, an initial guidance on the management of clinical trials in light of the situation have been issued by the European Commission (EC), the European Medicines Agency (EMA) and the Clinical Trials Facilitation and Coordination Group (CTCG).

  • Danish Medicines Agency presents new strategy

    | 05 April 2022 |

    Lars Bo Nielsen, Director General of the Danish Medicines Agency, announces new 2022-26 strategy for the agency. The strategy supports the Danish Ministry of Health’s joint corporate strategy and emphasises a vision to lead national and international collaboration, for example regarding better use of data and new technology and dialogue with public and society in general.

  • Crisis in Ukraine may impact review times and the prioritisation of cases

    | 07 March 2022 |

    As a result of the crisis in Ukraine, the Danish Medicines Agency performs tasks relating to the supply of medicines to the Danish market.

  • Assessment of new names of authorised veterinary medicines under the new veterinary regulation

    | 22 February 2022 |

    The assessment of names for already authorised veterinary medicines must be approved by the Danish Medicines Agency before the submission of a variation application.

  • Clarification of labelling practice for warning statements on human medicines

    | 05 January 2022 |

    During our review of applications for marketing authorisations for human medicines and variations to marketing authorisations, we have noted uncertainty about the labelling practice regarding the warning statements of schedule 2 of the Danish executive order on labelling. The question is whether these warnings are required on the packaging and in the package leaflet if the warning statements are not supported by the summary of product characteristics (SPC) of the medicinal product concerned. We therefore find it necessary to clarify the labelling practice for warning statements on human medicines.

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