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News from the Danish Medicines Agency

  • New regulations on Stockpiling of Critical Medicines effective on July 1 2024

    | 01 July 2024 |

    It will soon be mandatory for companies behind the most critical medicines to maintain stocks to cover initially six weeks’ consumption and to report stocks regularly to the Danish Medicines Agency. The affected companies will have six months to prepare for compliance, and, in August, the Danish Medicines Agency is holding information meetings about the new rules.

  • 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.

  • Danish Medicines Agency closed over Christmas and New Year

    | 28 November 2023 |

    The Danish Medicines Agency will be closed over Christmas and New Year, from Saturday 23 December 2023 to Monday 1 January 2024, both days included. Read which deadlines apply to applications within the Danish Medicines Agency's area in 2023.

  • 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.

  • Danish Medicines Agency releases COVID-19 vaccine batch from quarantine

    | 20 October 2023 |

    On 17 October, the Danish Medicines Agency decided to quarantine a specific batch (batch HG2252) of COVID-19 vaccines from Pfizer/BioNTech. Since then, the Danish Medicines Agency and Pfizer have worked together to review the documentation of the batch in question, based on which the agency has now decided to release said batch from quarantine.

  • Covid-19 vaccine batch in quarantine

    | 18 October 2023 |

    As a precautionary measure, the Danish Medicines Agency has decided to quarantine a specific batch of COVID-19 vaccines from Pfizer/BioNTech in response to vaccine centres having observed a possible error when using a specific vaccine batch. Over the next days, some people will therefore experience having their vaccination appointment cancelled. At present, there are no signs of any impact on the efficacy and safety of the batch in question.

  • The Danish Medicines Agency suspends the Danish marketing authorisations of four generic medicines

    | 15 March 2023 |

    The European Commission has reached a decision in the case about the bioequivalence company Synchron Research, deciding that a number of generic medicines must be suspended in the EU counties where they are authorised. The Danish Medicines Agency therefore suspends the marketing authorisations of four medicines.

  • 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.

  • Operation PANGEA 2022: 500 packages seized in the customs and 35 websites reported to the police for illegal trading in pharmaceuticals

    | 28 July 2022 |

    The last days of June saw the roll out of the 2022 version of the Interpol-managed Operation Pangea XV – a global initiative targeted illegal trade with medicines and medical devices. The Danish Medic

  • 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.

  • 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.

  • Danish Medicines Agency closed over Christmas and New Year

    | 15 December 2021 |

    The Danish Medicines Agency will be closed over Christmas and New Year, from Friday 24 December 2021 to Sunday 2 January 2022, both days included. Read which deadlines apply to applications within the Danish Medicines Agency's area in 2021.

  • EMA is evaluating Moderna’s COVID-19 vaccine for children aged 6 to 11

    | 12 November 2021 |

    Moderna has submitted an application to the European Medicines Agency, EMA, to extend its conditional authorisation for its COVID-19 vaccine, Spikewax, to children aged 6 to 11.

  • Danish Medicines Agency investigates a case of inflammatory condition reported after COVID-19 vaccination

    | 26 August 2021 |

    In collaboration with the EMA, the Danish Medicines Agency is investigating whether the rare inflammatory condition of MIS-C, previously observed as an aftereffect of COVID-19 infection in children and adolescents, can also occur after vaccination. While no causality with the vaccine has been established, it cannot be excluded either.

  • New campaign aimed at doctors: High-quality ADR reports make a difference

    | 09 July 2021 |

    The monitoring of the safety of COVID-19 vaccines over the last months has shown us just how important the reports on suspected side effects from doctors are. A new campaign to promote the quality of ADR reports submitted by doctors sets out to improve the monitoring of medicine safety even further.

  • Nine million packages of illegally sold medicines and medical devices seized in Operation Pangea

    | 09 June 2021 |

    This year’s global Interpol action Operation Pangea focused particularly on the illegal sale of medicines and medical devices related to COVID-19. In Denmark, the Danish Medicines Agency identified and reported 46 websites engaged in illicit sale of medicines and medical devices.

  • Members for the Medicinal Products Committee

    | 02 June 2021 |

    The Danish Medicines Agency invites interested parties to nominate members to the Medicinal Products Committee for the term of 1 October 2021 to 30 September 2025. Anyone can nominate members to the Medicinal Products Committee, and self-nomination is also possible.

  • New EU rules on medical devices set to strengthen patient safety

    | 26 May 2021 |

    Today new EU rules on medical devices enter into force. The new rules aim to strengthen patient safety and ensure that patients can benefit from new innovative devices. Medical devices cover anything from contact lenses to state-of-the-art surgical equipment.

  • Dean of Aarhus University to join the Danish Medicines Agency as new Director General

    | 26 May 2021 |

    The Ministry of Health has appointed Lars Bo Nielsen, Dean at Aarhus University, as Director General of the Danish Medicines Agency. Lars Bo Nielsen is a qualified doctor and has extensive leadership experience within both the health and science areas.

  • Annual report of the Danish Medicines Agency: The COVID-19 pandemic had a considerable impact on our work in 2020.

    | 26 April 2021 |

    The year 2020 was a year like no other at the Danish Medicines Agency. Both internally and externally, the handling of COVID-19 had a decisive impact on much of our work. However, we managed to retain our European position and to carry through an important reinforcement of our IT landscape, so concludes the Danish Medicines Agency’s annual report for 2020.