News 2019

  • New concept for regulatory advice on medical devices

    | 28 August 2019 |

    The Danish Medicines Agency has launched a pilot project to offer targeted advice on rules and regulations in the area of medical advices to startups and small and medium-sized medical device manufacturers as well as educational and research units. New rules are under way throughout the EU from 2020.

  • Supply of medicines in Denmark

    | 22 July 2019 |

    The Danish Medicines Agency is receiving an increasing number of enquiries regarding problems with the supply of certain medicines in Denmark. The supply shortage is not critical but it is challenging and an inconvenience for the general public, medical professionals and pharmacies alike. The Danish Medicines Agency is monitoring developments and working with other authorities and stakeholders both in Denmark and abroad to remedy the issues.

  • Supply of cannabis oil from Stenocare affected in Denmark

    | 12 July 2019 |

    Several consignments of cannabis oil from the Danish firm Stenocare have been placed in quarantine and taken off the market because the cannabis used in the oil was cultivated in non-approved facilities. The supply of cannabis oil in Denmark will therefore be affected.

  • Danish Medicines Agency strengthens its policy on conflicts of interest

    | 05 July 2019 |

    New staff members of the Danish Medicines Agency are not permitted to own shares in pharmaceutical or medical device companies. Currently employed staff will be asked to divest any shares within two years. This appears from the agency’s internal policy on conflicts of interest, which enters into force on 4 July 2019.

  • Good progress in Denmark-China collaboration

    | 01 July 2019 |

    The Danish Medicines Agency’s collaboration with the Chinese drug regulatory authorities has entered a new phase, reaching agreement on specific collaboration projects among which a project on quality control of radiopharmaceuticals.

  • Withdrawal of vaginal mesh

    | 03 May 2019 |

    Three types of vaginal mesh for surgical treatment of pelvic organ prolapse have been withdrawn in the USA after the FDA has assessed that the evidence of the products' efficacy and safety is insufficient. As a result, the products will no longer be available in Denmark.

  • Report on suspected side effects reported for medicinal cannabis

    | 10 April 2019 |

    Dizziness, nausea and concentration problems are some of the suspected side effects that have been reported to the Danish Medicines Agency in the first year of the medicinal cannabis pilot programme.

  • End of day meeting on new EU recommendations on complex clinical trials at the Danish Medicines Agency

    | 29 March 2019 |

    The Danish Medicines Agency invites pharmaceutical companies, researchers and other interested parties to an end of day meeting on the new European recommendations on complex clinical trials which aim to support the development of personalised medicine.

  • Danish Medicines Agency to help build better drug regulatory authorities in low- and middle-income countries

    | 14 March 2019 |

    Today, the Danish Medicines Agency signed an agreement with WHO to help build up drug regulatory authorities in low- and middle-income countries, including Africa.

  • Public consultation on electronic package leaflets and summaries of product characteristics across the EU

    | 12 March 2019 |

    What should the package leaflets and labels of medicines for citizens and the summaries of product characteristics for healthcare professionals look like in the future? A public consultation on key principles about this has been launched throughout the EU, with comments to be submitted by 31 July.

  • Vaginal mesh from Bard removed from the EU markets

    | 12 March 2019 |

    The company Bard has decided to stop the sale of vaginal mesh implants on the markets in the EU. The decision is based on commercial reasons according to Bard.

  • Common European recommendations establish a framework for testing medicines of the future

    | 08 March 2019 |

    The common European subgroup for complex clinical trials with trial subjects, which is headed by Denmark, has just published a set of recommendations for the development of personalised medicine.

  • New EU report on big data paves the way for action

    | 01 March 2019 |

    A taskforce on big data in the pharmaceutical area, the HMA-EMA Joint Big Data Taskforce, has just published its first report. The report offers a definition of big data and several recommendations for European authorities that regulate medicines and medical devices.

  • New data analysis centre to open at the Danish Medicines Agency

    | 08 February 2019 |

    The Danish government today announced its decision to support the establishment of a new data analysis centre in the Danish Medicines Agency. The centre is to handle the analysis of large data quantities in the pharmaceutical and medical devices areas and will set new standards for the monitoring of the safety and efficacy of medicines and medical devices after their marketing.

  • Updating of summaries of product characteristics due to changed ATC codes for 2019

    | 18 January 2019 |

    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 2019.

  • Danish Medicines Agency to send safety information directly to healthcare professionals

    When side effects or the like is discovered for medicines, the medicine’s product information sometimes needs to be changed to the point that healthcare professionals must be informed directly. Up to

  • New report: Evaluation of the relationship reform

    The framework for collaboration between healthcare professionals and companies has just been evaluated. The evaluation concluded that the rules and administration work well, but compliance with the rules lags behind. There is a need for more information to healthcare professionals about the rules.

  • New EU rules on falsified medicines

    When new EU rules enter into force on 9 February 2019, it will be harder for falsified medicines to reach patients in the EU. The new rules, which introduce new safety features on the packaging of medicines and other measures, are to prevent falsified medicines from entering the legal supply chain of medicines – for example in pharmacies and hospitals.

  • The Danish Medicines Agency has a new and improved website

    More targeted news categories, new user-specific entry points and more user-friendly features are some of the new elements of the latest update of the Danish Medicines Agency’s website accessible from today.

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