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Notifications about medicines to healthcare professionals

  • Applications for compassionate use permits on weekdays between Christmas and New Year

    | 28 November 2023 |

    The Danish Medicines Agency is closed between Christmas and New Year, up to and including 1 January 2024. During this period, we will, however, handle urgent applications for compassionate use permits (applications for dispensing of non-marketed 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Applications for compassionate use permits on weekdays between Christmas and New Year

    | 02 December 2022 |

    The Danish Medicines Agency will be closed over Christmas and New Year, reopening on 2 January 2023. During this period, we will, however, handle urgent applications for compassionate use permits (applications for dispensing of non-marketed medicines).

  • 2022 deadline for submitting applications concerning marketing authorisations and clinical trials

    | 19 October 2022 |

    The deadline for submitting applications concerning marketing authorisations and clinical trials is 20 December 2022. The Danish Medicines Agency is closed for the Holiday Season, from 24 December, 2022, until 1 January, 2023, both days included. Applications concerning marketing authorisations and clinical trials need to be submitted before 20 December, 2022. We will consider applications submitted after 20 December, 2022, as if they have been received 2 January 2023.

  • Invitation to EMA Organisation Management Service (OMS) Trouble Shooting Sessions for CTIS users

    | 30 August 2022 |

    Before applying for clinical trials with investigational medicin products under the EU Clinical Trials Regulation no. 536/2014 (EU CTR), sponsors and trial sites have to be registered in EMAs Organizational Management Service (OMS). EMA is now inviting all sponsors and trial sites to online trouble shooting sessions, where they can submit questions in advance (see tabel below) concerning organisation and site registration in OMS.

  • Expression of interest for onsite participation in ACT EU workshop on Decentralised Clinical Trial guidance on October 4th 2022 – Response deadline is September 06th 2022.

    | 25 August 2022 |

    New and innovative clinical trial designs and methodologiesprovide opportunities and challenges for the EU clinical trials environment. The EU decentralised clinical trials (EU DCT) project aims to address some of these challenges, in line with the European Medicines Agencies Network Strategy to 2025 and European Commission’s Pharmaceutical Strategy for Europe. Since March 2022, the Clinical Trials Coordination Group (CTCG) under the Heads of Medicines Agencies (HMA) have been responsible for the project management of the EU Decentralised Clinical Trials (EU DCT) project, with Ditte Zerlang Christensen of the Danish Medicines Agency (DKMA) as the project manager. The ACT EU Programme will host a multi-stakeholder workshop on DCTs on behalf of the EU DCT project, bringing together participants from all areas of the research community to share perspectives on this type of clinical trials. The multi-stakeholder workshop will be an onsite meeting hosted by EMA on October 4th 2022. A live broadcast of the workshop’s plenary session will be provided, open to all interested parties.

  • Applications for compassionate use permits on weekdays between Christmas and New Year

    | 15 December 2021 |

    The Danish Medicines Agency will be closed over Christmas and New Year, reopening on 3 January 2022. During this period, we will, however, handle urgent applications for compassionate use permits (applications for dispensing of non-marketed medicines).

  • The Danish Medicines Agency's guideline on extraordinary measures for clinical trials due to COVID-19 will not be extended after 01 December 2021

    | 04 November 2021 |

    We have chosen not to extend the validity of our guidance on extraordinary measures for clinical trials due to COVID-19 further, why the guidance and the granted exemptions expire on 01 December 2021.

  • Updated guidance on the implementation of decentralised elements in clinical trials with medicinal products

    | 10 September 2021 |

    You can now read the updated guidance on the implementation of decentralised elements in clinical trials with medicinal products - version 2.0

  • 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.

  • Guidance on the implementation of decentralised elements in clinical trials with medicinal products is now available

    | 04 May 2021 |

    Decentralised clinical trials with medicinal products meet the patients, wherever they are, in a faster and more efficient process benefitting both patient, healthcare professionals and industry. It is therefore gratifying to be able to announce that another important milestone has been reached in the Danish Medicines Agency's project to ensure an up-to-date and robust regulatory framework for decentralisation of clinical trials.

  • EMA: Possible link between the Johnson & Johnson vaccine and unusual symptoms

    | 21 April 2021 |

    There is a possible link between the Johnson & Johnson vaccine and unusual symptoms with a combination of blood clots in unusual sites, low levels of blood platelets and several cases of bleeding. A few cases have been observed in the USA. The frequency of these unusual symptoms is still being investigated.

  • EMA to undertake a review of data as to the AstraZeneca vaccine’s efficacy in preventing COVID-19 disease

    | 15 April 2021 |

    The European Medicines Agency (EMA) is undertaking a review of vaccination data of the COVID-19 vaccine from AstraZeneca. The review will include infection rates, hospitalisations, morbidity and mortality. The EMA will also prepare a recommendation for those who have received the first dose of the vaccine.