Notifications for the pharmaceutical industry about licensing, supervision and monitoring of medicines

  • 2023 deadline for submitting applications concerning marketing authorisations and clinical trials

    | 13 November 2023 |

    The deadline for submitting applications concerning marketing authorisations and clinical trials is December 20, 2023. The Danish Medicines Agency is closed for the Holiday Season, from December 23, 2023, until January 1, 2024, both days included. Applications concerning marketing authorisations and amendments to clinical trials need to be submitted before December 20, 2023. We will consider applications submitted after December 20, 2023, as they have been received January 2, 2024.

  • First electronic product information published for medicines

    | 09 November 2023 |

    Four EU countries – including Denmark – have published the first versions of digital product information for selected medicines. A pilot initiative is right now testing the use of digital product information for medicines used by citizens and healthcare professionals throughout the EU.