News

1 - 20 of 264 news items
  • New rules governing medicine packages

    | 27 June 2016 |

    The Danish Medicines Agency has amended the guideline on variations to marketing authorisations and the executive order on product numbers for medicinal products.

  • Clinical trial guidelines in public consultation

    | 28 June 2016 |

    As a result of the EU's new clinical trial regulation, the European Commission has submitted four guidelines for public consultation.

  • Use of medicine for cows suspended

    | 21 June 2016 |

    Today, the Danish Medicines Agency has decided to suspend the use of the veterinary medicine Velactis, which is used to reduce milk production (drying-off) in dairy cows.

  • Operation targets illegal medicines

    | 10 June 2016 |

    Global medicine operation just completed. Operation Pangea resulted in 393 arrests and the suspension of more than 4,900 websites.

  • Beware of falsified medicines

    | 08 June 2016 |

    Today, 8 June 2016, is the World Anti-Counterfeiting Day. The Danish Medicines Agency participates in this campaign to draw attention to the problem of illegal sale of falsified medicines.

  • Danish Pharmacovigilance Update, May 2016

    | 03 June 2016 |

    The May issue of Danish Pharmacovigilance Update with news from the EU.

  • New common EU rules on medical devices under way

    | 03 June 2016 |

    The Netherlands presidency of the Council and representatives of the European Parliament have reached political agreement on new EU rules on medical devices. The rules will strengthen patient safety and allow patients to benefit from new innovative devices.

  • New Danish act on clinical trials

    | 25 May 2016 |

    The Danish Parliament has adopted a new act on clinical trials of medicinal products, which means that new research ethics committees will be established. However, the act does not come into force until 2018.

  • Nine applications for funds earmarked for research in HPV adverse reactions

    | 12 May 2016 |

    The Danish Parliament has earmarked an amount of DKK 7 million for research into possible adverse reactions from the HPV vaccines. The deadline for applications has expired and the applications will now be reviewed by Innovation Fund Denmark.

  • Danish Pharmacovigilance Update, April 2016

    | 10 May 2016 |

    The April issue of Danish Pharmacovigilance Update with news from the EU, the DKMA and short news.

  • New video graphics about the HPV vaccine

    | 03 May 2016 |

    The Danish Medicines Agency has made a video which explains how the authorities monitor the safety of the HPV vaccine.

  • Two new directors to join the Danish Medicines Agency

    | 29 April 2016 |

    The Danish Medicines Agency has appointed Janne Lehmann Knudsen as Director of Pharmacovigilance & Medical Devices and Iben Vitved as Director of Finance.

  • Danish Pharmacovigilance Update, March 2016

    | 25 April 2016 |

    The March issue of Danish Pharmacovigilance Update with news from the EU, the DKMA and short news.

  • Promising prospects for cooperation with Mexico

    | 15 April 2016 |

    Thursday, the Danish Medicines Agency's new Director General Thomas Senderovitz signed a cooperation agreement between the Mexican drug regulatory authority and the Danish Medicines Agency.

  • Strong ambitions for the newly established Danish Medicines Agency

    | 18 March 2016 |

    The Danish Medicines Agency must stand out both nationally and internationally. This was the clear message of Danish Minister for Health Sophie Løhde, who paid a visit to the agency yesterday.

  • Practice when applying for a change in the legal status of a human medicinal product

    | 18 March 2016 |

    Practice when applying for a change in the legal status of a human medicinal product from prescription-only to OTC, when OTC status has already been given to a centrally authorised medicinal product.

  • Danish Pharmacovigilance Update, February 2016

    | 09 March 2016 |

    The February issue of Danish Pharmacovigilance Update with news from the EU, the DKMA and short news.

  • New comprehensive list of euphoriant substances regulated in Denmark

    | 26 February 2016 |

    You can now find a comprehensive list of euphoriant substances that are subject to control in Denmark via the executive order on euphoriant substances.

  • Form for notification of invoice details concerning clinical trials discontinued

    | 23 February 2016 |

    The Danish Medicines Agency has decided to discontinue the form for notification of invoice details concerning clinical trials. Instead, the cover letter should provide details of who we should send the invoice to and any comments you want us to state on the invoice.

  • Twelve new substances on the list of euphoriant substances

    | 17 February 2016 |

    As of 18 February 2016, 12 new substances are included in the Danish executive order no. 557 of 31 May 2011 on euphoriant substances issued by the Danish Ministry of Health. The information is primarily relevant to companies authorised to deal with euphoriant substances.