• 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    Three types of vaginal mesh for surgical treatment of pelvic organ prolapse have been withdrawn in the USA after the FDA has assessed that the evidence of the products' efficacy and safety is insufficient.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.

  • DKMA Update December 2018

    | 23 January 2019 |

    In this issue of DKMA Update you can read about safety for medical devices; new biosimilar medicines for Humira; better conditions for clinical trials in Denmark; new front page for our website and much more

  • 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.

  • Reimbursement of medicinal cannabis of the pilot programme effective as of 1 January 2019

    | 16 January 2019 |

    On 1 January 2019, a special reimbursement scheme for medicinal cannabis in the four-year pilot programme entered into force. Reimbursement is retroactive for purchases made in 2018.

  • New report on adverse reactions reported with tramadol for pain relief

    | 20 December 2018 |

    The Danish Medicines Agency has received 830 reports of suspected adverse reactions with tramadol since the medicine was marketed in March 1993. 155 of them describe symptoms of dependence. This follows from a report that has just been published. In 2017, about 265,000 individuals received treatment with tramadol in Denmark.

  • New format requirements for Marketing Authorization submissions from 1 January 2019

    | 17 December 2018 |

    The NeeS submission format will be discontinued for all applications submitted under the national procedure (NP), i.e. applications for variations, renewals etc. This change is related to medicinal products for human use. Parallel import and parallel distribution are not affected by this change.

  • Til lægemiddelvirksomheder: Indsend variationer inden Brexit

    | 19 November 2018 |

    Storbritannien betragtes som udgangspunkt som et 3. land (udenfor EU/EEA) efter Brexit den 29. marts 2019. Lægemiddelstyrelsen opfordrer derfor lægemiddelvirksomheder til at indsende variationer snarest muligt.

  • Theme event on big data and medicine

    | 08 November 2018 |

    The U.S. Food and Drug Administration, FDA, The European Medicines Agency, EMA, and Novo Nordisk are among the speakers when The Danish Medicines Agency on 20 November 2018 puts focus on big data and medicine under the event heading “From Big Data to Real World Evidence”.

  • Three research projects to increase our knowledge of medicinal cannabis

    | 01 November 2018 |

    Three projects have just been granted funds to give us more knowledge about the efficacy of medicinal cannabis. A total of DKK 5 million have been distributed of the funds that were appropriated by the negotiating parliamentary parties under the special funds agreement 2018-2021 to accumulate scientific knowledge of medicinal cannabis.

  • Small increased risk of certain types of skin cancer associated with the use of hydrochlorothiazide

    | 30 October 2018 |

    There is a small increased risk of developing basal cell carcinoma and squamous cell carcinoma in long-term use of blood pressure medicine containing hydrochlorothiazide. This follows from a review of new studies and available data undertaken by the European Medicines Agency, EMA.

  • Brexit: Two-year implementation period for name and address changes

    | 17 October 2018 |

    During an implementation period of maximum two years, it will be permitted to sell released packs on which a UK marketing authorisation holder or a representative is indicted as well as packs on which an EEA marketing authorisation holder or a representative is indicated for the concerned D.Sp.No. (Danish speciality number).

  • Debate on research dissemination at the Danish Medicines Agency

    | 28 September 2018 |

    On 1 October, the Danish Medicines Agency and the Danish Society for Pharmacoepidemiology have invited a number of researchers, doctors and communication officers from research institutions throughout Denmark to a debate on how the findings of new health research can be disseminated most responsibly. The debate meeting can be followed live on the Danish Medicines Agency’s Facebook profile.

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