01 January 2023
  • Invitation to contribute to the upcoming EU multi-stakeholder workshop on clinical trial methodology on 23 November 2023 in Amsterdam

    | 13 September 2023 |

    As part of the Accelerating Clinical Trials in the EU (ACT EU) programme, you will have the opportunity to participate in the upcoming EU multi-stakeholder workshop on 23 November 2023 in Amsterdam to discuss selected clinical trial methodology topics. Stakeholders are invited to express their interest for participation to the workshop via the EU survey until 17 September 2023.

  • Information on transition from NemID to MitID Erhverv

    | 15 June 2023 |

    DKMAnet is not yet ready to support MitID Erhverv. It is therefore IMPORTANT to keep your NemID employee signature, as it is the only way to access DKMAnet until the transition to MitID Erhverv is completed.

  • New criteria for the notification of medicines supply shortages

    | 06 June 2023 |

    The Danish Medicines Agency has established new criteria for when companies must notify medicines supply shortages. The new criteria make it easier for the companies to know when and for which medicinal products they must notify supply shortages, and a new form has made notification even easier.

  • EMA is introducing Multi-Factor Authentication (MFA) for the Clinical Trial Information System (CTIS) from 01 June 2023.

    | 30 May 2023 |

    Multi-factor (MFA) authentication for user logins to Clinical Trial Information Systems (CTIS), for both Sponsor and Member State workspaces, will be launched on 1 June 2023.

  • Registration of QPPV and PSMF number for veterinary medicinal products

    | 15 March 2023 |

    Under Commission Implementing Regulation EU 202116 of 8 January 2021, all Marketing Authorisation Holders of Veterinary Medicinal products in the EU, must register information on Qualified Persons for Pharmacovigilance QPPV and Pharmacovigilance System Master File PSMF in the Union Product Database UPD.

  • Multi-stakeholder platform to improve clinical trials in the EU – Public consultation

    | 07 February 2023 |

    As part of the Accelerating Clinical Trials in the EU (ACT EU) initiative, the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) and the European Commission (EC) are establishing a multi-stakeholder platform to improve clinical trials in the European Union (EU). The multi-stakeholder platform will support discussions across the clinical research landscape and facilitate the evolution of clinical trial methods and approaches.

  • Recall of the antibiotic Dicillin from Sandoz

    | 07 February 2023 |

    Patients who are treated with Dicillin Sandoz 500 mg capsules are instructed to return the medicine to a pharmacy and have it replaced. It is important not to stop treatment but to have the medicine replaced with another antibiotic. The pharmacies have been informed to dispense an alternative medicine.

  • Order books and Procedure Start Table

    | 12 January 2023 |

    In order to improve the companies' possibility to follow the status of their submitted variations, the Danish Medicines Agency is expanding its order book for variations to include all national type I

  • Updating of summaries of product characteristics due to changed ATC codes for 2023

    | 02 January 2023 |

    Marketing authorisation holders of medicinal products authorised under the national procedure, the decentralised procedure as well as the mutual recognition procedure should be aware that some ATC codes have been changed for 2023.

  • Publication of educational materials for centrally authorised medicinal products

    From January 1st 2023 and forward – and not retroactively – the Danish Medicines Agency now publishes educational material for medicinal products approved via the centralised procedure.

  • Registration of approved pack sizes in the Union Product Database

    In accordance with Commission Implementing Regulation (EU) 2021/16 of 8 January 2021, approved pack sizes for veterinary medicinal products must be registered in the Union Product Database (UPD). In connection with the registration of data in UPD, the Danish Medicines Agency has found that information on approved pack sizes in the summary of prouct characteristics (SPC) for veterinary medicinal products is not always complete. Therefore there may be missing information on approved pack sizes in the UPD for some products. Consequently, marketing authorisation holders (MAH) for veterinary medicinal products are encouraged to check the information in the UPD.