News about Licensing and supervision

  • 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

  • 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.

  • 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.

  • 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.

  • 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.