News

1 - 20 of 335 news items
  • 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    Three types of vaginal mesh for surgical treatment of pelvic organ prolapse have been withdrawn in the USA after the FDA has assessed that the evidence of the products' efficacy and safety is insufficient.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.

  • 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.

Did you get answers to your questions?

Please tell us how we can improve our website? Please note that we do not answer questions asked via this feature.