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  • 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.

  • Handling of Ebola virus disease

    | 15 August 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.

  • 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.

  • Ebola outbreak in West Africa

    | 06 August 2014 |

    The Danish Health and Medicines Authority still assesses that there is a minimum risk that the Ebola haemorrhagic fever will reach Denmark. Denmark has efficient health preparedness plans to detect suspected cases of Ebola in Denmark.

  • 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.

  • Changed procedure for information on duplicate closed and nullified closed cases (updated)

    | 15 July 2014 |

    The new process for dispatching adverse reaction reports (ASPR) will be implemented on 12 and 13 July 2014.

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

    | 15 July 2014 |

    The EU Pharmacovigilance Risk Assessment Committee (PRAC) convened on 7-10 July 2014.

  • Danish Pharmacovigilance Update May 2014

    | 14 July 2014 |

    In the May issue of Danish Pharmacovigilance Update: Assessment of risk of serious anaphylactic reactions from treatment with ferumoxytol (Rienso), ADR reports for the HPV vaccine and the Danish Health and Medicines Authority’s annual pharmacovigilance report 2013.

  • Monitoring of medicines for births

    | 07 July 2014 |

    The Danish Health and Medicines Authority has prepared a midterm review of the activities in the action plan for Danish regions' use of medicines for the induction of labour. The action plan was launched in the autumn of 2013 following a public debate about the use of these medicines, and it should be completed by the end of 2015.

  • More clinical trials to Denmark

    | 03 July 2014 |

    The number of clinical trial applications increased by 35 trials (14%) from 2012 to 2013, which is the highest level in seven years. The increase covers both companies and researchers according to the Danish Health and Medicines Authority's annual report 2013 on clinical trials of medicines in humans.

  • Focus on correct dose of Pro-Epanutin

    | 24 June 2014 |

    The Danish Health and Medicines Authority encourages hospitals to pay special attention to the risk of dose errors of the anticonvulsant medicine Pro-Epanutin.

  • Danish nursing home unit free from MRSA bacteria

    | 17 June 2014 |

    The residents and staff at a Danish nursing home unit have been tested for the MRSA bacteria. The test results from the Department of Clinical Microbiology at Odense University Hospital show that the residents and staff are all free from the resistant bacteria.

  • Report about the supervisory function of the DHMA

    | 11 June 2014 |

    The Danish Health and Medicines Authority (DHMA) has received an external report from the European Partnership of Supervising Organisations in Health Care and Social Services (EPSO) about the DHMA's supervision of healthcare professionals. The Danish Ministry of Health asked EPSO to make the report following criticism about the healthcare supervision of the DHMA brought forward by the media in 2013. The EPSO report identifies several problems and provides indications for improvement of the DHMA's supervision of healthcare professionals.

  • Falsified cancer medicine not distributed in Denmark

    | 10 June 2014 |

    Falsified batches of the cancer medicine Herceptin® from Roche have been identified in England, Germany and Finland. None of the affected batches have been distributed in Denmark.

  • Incidence of swine-related staphylococcus (MRSA CC 398) in Danish nursing home

    | 03 June 2014 |

    The Danish Health and Medicines Authority has investigated the conditions at a Danish nursing home following the death of a resident who was infected with the swine-related staphylococcus (MRSA CC 398).

  • Amendment of executive order on euphoriant substances 30 May 2014

    | 03 June 2014 |

    On 30 May 2014, the substances below were included in annex 1 of executive order no. 557 of 31 May 2011 on euphoriant substances issued by the Danish Ministry of Health.

  • Regulation on clinical trials on medicinal products adopted

    | 03 June 2014 |

    The European Commission's proposal for new European legislation on clinical trials of medicinal products was adopted in early 2014. The objective is to promote the number of clinical trials in the EU.

  • More than 10,000 websites shut down in global operation

    | 28 May 2014 |

    The recent global Operation PANGEA VII resulted in the shutdown of more than 10,000 websites. The operation focused on combating online sale of counterfeit medicines and making consumers aware that they need to take care of themselves when buying medicines online. Globally, the operation led to 237 arrests, some 540,000 parcels were inspected and over 9.4 million units containing potentially life-threatening medicines were seized – worth an estimated value of more than USD 35 million. More than 10,000 websites were shut down or had their payment facility removed.

  • Updated guidelines on requirements for the QP in a pharmaceutical company

    | 09 May 2014 |

    The Danish Health and Medicines Authority has updated the guidelines on requirements and expectations for the qualified person (QP) in a pharmaceutical company. The requirements for the QP have not been changed compared to the previous guidelines. The new guidelines have mainly been updated to include the requirements for the duration of the QP's education as specified in the applicable directives. In addition, a number of other updates and specifications have been made that you can read more about in this news item.