News

  • Control of companies' uploading of leaflets to the Danish Medicines Agency's portal DKMAnet

    | 15 November 2024 |

    The Danish Medicines Agency's laboratory will regularly select ATC groups and check whether readable package leaflets have been uploaded to www.indlaegsseddel.dk. The selected ATC groups will not be published in advance.

  • 2024 deadline for submitting applications concerning marketing authorisations and clinical trials

    | 05 November 2024 |

    The deadline for submitting applications concerning marketing authorisations and clinical trials is December 20, 2024. The Danish Medicines Agency is closed for the Holiday Season, from December 23, 2024, until January 1, 2025, both days included. Applications concerning marketing authorisations and amendments to clinical trials need to be submitted before December 20, 2024. We will consider applications submitted after December 20, 2024, as they have been received January 2, 2025. For applications concerning clinical trials applied under the Clinical Trials Regulation no assessment will be performed during the winter clock stop between 23 December 2024 and 7 January 2025, both days included. The deadline for these trials is postponed.

  • Updated version of the Danish Medicines Agency's guidance on risk-adapted recording and reporting of adverse events in clinical trials is now available on the website

    | 23 October 2024 |

    The Danish Medicines Agency’s guidance on risk-based recording and reporting of adverse events in clinical trials on medicinal products under Regulation (EU) no. 536/2014 has been updated and version 2.0 is now available on the website, in both Danish and English. The guidance has been updated with further clarification on the requirements, if risk-adapted adverse event management is implemented. For an overview of the changes, please refer to the change log in the guidance document.

  • Nils Falk Bjerregaard new Director General of the Danish Medicines Agency

    | 03 October 2024 |

    The Danish Ministry of the Interior and Health has appointed Medical Director Nils Falk Bjerregaard as Director General of the Danish Medicines Agency as of 1 November 2024.

  • Completion of the project regarding the control of anti-tampering devices (ATD) on medicinal product packages

    | 12 September 2024 |

    The Danish Medicines Agency's laboratory has completed a project in which the anti-tampering device (ATD) on random samples of selected medicinal product packages has been checked. Approx. 10% of the packages requisitioned had an ATD that did not work. The flawed devices are designed as a sticker, that can be removed without it being visible on the packaging. We encourage marketing authorisation holders (MAH) to test their ATDs to prevent unauthorised access to the medicinal products without tamper evidence.

  • Call for Applications for Marketing Authorizations for Critical Medicines

    | 22 August 2024 |

    The Danish Medicines Agency is making a call for companies to apply for marketing authorizations for selected critical medicines. This initiative aims to ensure the supply of essential medicines in De

  • Instability on DKMAnet

    | 16 August 2024 |

    DKMAnet unfortunately runs unstable. This means that some users cannot see the submitted notifications on the overview in DKMAnet – even if they have been sent. The Danish Medicines Agency receiv

  • Control of companies' upload of package leaflets to the Danish Medicines Agency's portal DKMAnet

    | 01 August 2024 |

    Information for marketing authorisation holders (MAH). The Danish Medicines Agency's laboratory carries out regular control of companies’ upload of package leaflets to the Danish Medicines Agency’s portal DKMAnet (www.indlaegsseddel.dk). The control ensures, that users of medicinal products have access to an electronic package leaflet, if the physical package leaflet is not available. We check: • Whether the package leaflet is uploaded? • Whether the package leaflet is printable? • Whether the package leaflet is readable when printed out? • Whether the electronic package leaflet contains a date of latest revision? A control project was recently completed for ATC codes R01, S01-03. 5% of the uploaded package leaflets were flawed and the marketing authorization holders involved are in the process of correcting the errors. In general, we encourage marketing authorization holders to test whether the uploaded package leaflets are readable when printed to ensure user-friendliness. We made 241 searches on “Indlaegsseddel.dk” for ATC codes R01 and S01-03, which cover medicinal products for diseases of the nasal cavity and eye and ear diseases. In particular, we observed that the font size of several package leaflets was smaller than point 9 according to the Readability Guideline.

  • 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.

  • New CMDv Guidance on the Submission of G.I.18 Variations

    | 12 June 2024 |

    CMDv has published guidance on the submission of G.I.18 variations requiring assessment. The Danish Medicines Agency requests that all Marketing Authorisation Holders (MAHs) carefully review the principles in this document to ensure the process of submitting and obtaining approval of a G.I.18 variation is as efficient and smooth as possible.

  • Tidsfrister & CTIS: Tidsfrister for kliniske forsøg skal overvåges i CTIS og forordningsforsøg skal overføres til CTIS

    | 10 June 2024 |

    Læs mere om CTIS timetable med tidsfrister for kliniske forsøg samt tidsfrister for overførsel til CTIS af forsøg der er opstartet under forordningen. Alle kliniske forsøg der skal fortsætte efter 30 januar 2025 skal overføres til CTIS.

  • Status for the project regarding the control of anti-tampering devices (ATD) on medicinal product packages

    | 25 April 2024 |

    Information for marketing authorisation holders (MAH). The Danish Medicines Agency's laboratory is currently working on a project to check the anti-tampering device (ATD) on selected medicinal product packages. Approx. 10% of the packages requisitioned so far had an ATD that did not work. The flawed devices are designed as a sticker, that can be removed without it being visible on the packaging. We encourage marketing authorisation holders to test their ATDs to avoid unauthorised access to the medicinal products.

  • 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.

  • Survey on strategy for Ph. Eur. quality standards for monoclonal antibodies

    | 11 March 2024 |

    Give your valuable feedback to the European Pharmacopoeia (Ph. Eur.) in the field of setting standards for therapeutic mAbs.  The survey will take about 20 minutes.  Please complete the survey by

  • Regulatory training on transitional trials in CTIS with open question and answers session

    | 13 February 2024 |

    EMA has organized in the series of the CTIS Bitesize Talk an event related to the transitional trial in CTIS Thursday, 29 February 2024, 16:30 (CET) - 18:00 (CET).

  • ACT EU Training for non-commercial sponsors. Transitioning trials to the CTR

    | 02 February 2024 |

    ACT EU training for non-commercial sponsors Friday, 09 February 2024, from 10:00 AM (CET) to 1:00 PM (CET). The event will be live broadcast and no registration is required to follow the live broadcast on EMA’s website.

  • Continued control of companies' uploading of leaflets to the Danish Medicines Agency's portal DKMAnet

    | 01 February 2024 |

    The Danish Medicines Agency’s Department for Control and Security of Supply resumes the work of checking whether readable leaflets have been uploaded to www.indlaegsseddel.dk

  • Updating of summaries of product characteristics due to changed ATC codes for 2024

    | 02 January 2024 |

    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 2024.