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News

1 - 20 of 498 news items
  • DKMAnet is up and running

    | 22 October 2014 |

    All services at DKMAnet are available again.

  • Updated guidelines on activities subject to a section 39 authorisation

    | 21 October 2014 |

    We have updated our guidelines on activities subject to a section 39 authorisation or a company registration.

  • Continued technical problems at DKMAnet

    | 21 October 2014 |

    DKMAnet is still unavailable due to technical issues. Applications and other communication with the Danish Health and Medicines Authority via DKMAnet may have been lost in the period from 10.15 pm on Wednesday 15 October to 2.00 pm on Thursday 16 October. We and our IT supplier are working to resolve the issues and we expect that DKMAnet will be available again on Wednesday morning, 22 October 2014.

  • Technical problems at DKMAnet

    | 17 October 2014 |

    Due to technical problems, applications and other communication with the Danish Health and Medicines Authority via DKMAnet may have been lost in the period from 10.15 pm on Wednesday 15 October to 2.00 pm on Thursday 16 October. We and our IT supplier are working to resolve the issues. We will provide an update on the situation as soon as possible.

  • PRAC recommends strengthening the restrictions on the use of valproate in women and girls

    | 17 October 2014 |

    The EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) recommends strengthening the restrictions on the use of the antiepileptic valproate due to the risk of malformations and developmental problems in children exposed to valproate in the womb.

  • Patient to be examined for Ebola at Hvidovre Hospital

    | 16 October 2014 |

    A patient has been admitted to Hvidovre Hospital in Copenhagen and is now being tested for Ebola infection according to the Danish Health and Medicines Authority's guidance on the management of Ebola virus disease. The patient will remain in hospital until the diagnosis can be denied or confirmed.

  • Management of Ebola virus disease (updated)

    | 15 October 2014 |

    The Danish Health and Medicines Authority has issued guidance on the management of the Ebola virus disease. We still assess that the risk of Ebola reaching Denmark is low, and we have efficient health preparedness plans to detect suspected cases of Ebola virus disease. The guidance is aimed at hospitals, prehospital organisations, general practitioners, emergency service doctors etc.

  • Monthly report from the EU Pharmacovigilance Risk Assessment Committee (PRAC) - October 2014

    | 14 October 2014 |

    The EU Pharmacovigilance Risk Assessment Committee (PRAC) convened on 6-9 October 2014.

  • Danish Pharmacovigilance Update, September 2014

    | 07 October 2014 |

    The September issue of Danish Pharmacovigilance Update.

  • New rules for persons collaborating with the industry

    | 07 October 2014 |

    As of 1 November 2014, new rules governing healthcare professionals' collaboration with pharmaceutical and medical companies take effect. The rules governing association will be extended to include medical companies and nurses. Doctors' association with speciality stores trading in medical devices are also covered by the rules.

  • Ebola ruled out in patient hospitalised at Hvidovre Hospital

    | 03 October 2014 |

    On Thursday night 2 October, a patient was hospitalised at Hvidovre Hospital and tested for Ebola virus. A blood sample tested at State Serum Institute ruled out the suspicion.

  • Consultation procedure about medicinal products and safety measure requirements not completed yet

    | 03 October 2014 |

    On 5 September 2014, the Danish Health and Medicines Authority submitted a draft list of the medicinal products comprised by the new safety measures rules (Directive 2001/83) for consultation. The consultation period expired on 17 September 2014, and on 3 October we were to inform the European Commission of the medicinal products we recommend including in the common EU lists. We have received 22 consultation responses. But on 24 September 2014 the European Commission amended the original guideline for how to interpret the criteria used to assess whether a medicinal product is qualified for the white list.

  • Monthly report from the EU Pharmacovigilance Risk Assessment Committee (PRAC) - September 2014

    | 23 September 2014 |

    The EU Pharmacovigilance Risk Assessment Committee (PRAC) convened on 8-11 September 2014.

  • Danish Pharmacovigilance Update, August 2014

    | 09 September 2014 |

    The August issue of Danish Pharmacovigilance Update.

  • Consultation: rules of procedure for public hearings in the EMA

    | 29 August 2014 |

    The European Medicines Agency (EMA) has launched a public consultation on draft rules of procedures for public hearings held by its Pharmacovigilance Risk Assessment Committee (PRAC).

  • Italian case about stolen medicine affects Denmark

    | 29 August 2014 |

    21 stolen packages of medicine from Italy have probably been sold on the Danish and German markets. The Danish Health and Medicines Authority has asked the company to recall the medicine (the batch).

  • Invitation to HTA 2.0 Europe – Teaming Up for Value conference

    | 21 August 2014 |

    In cooperation with the European Commission, the European network for Health Technology Assessment (EUnetHTA; DHMA is hosting the Secretariat of EUnetHTA) is organising the conference HTA 2.0 Europe – Teaming Up for Value to take place 30-31 October 2014 in Rome, Italy.

  • Change of the HPV vaccination programme to a 2-dose programme

    | 12 August 2014 |

    As part of the Danish childhood vaccination programme, girls aged around 12 years are offered HPV vaccine. In future, girls of this age only need two doses of HPV vaccine, compared with three previously.

  • Good laboratory practice in non-clinical trials

    | 29 July 2014 |

    Clinical Trials Facilitation Group (CTFG) has prepared a document describing the requirements as to good laboratory practice (GLP) in non-clinical trials.

  • Danish Pharmacovigilance Update June 2014

    | 17 July 2014 |

    The June issue of Danish Pharmacovigilance Update.