News

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  • 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 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.

  • Danish Pharmacovigilance Update, January 2016

    | 10 February 2016 |

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

  • EMA: No changes to the safety profile of Gardasil

    | 09 February 2016 |

    The European Medicines Agency (EMA) has recently completed its annual routine safety assessment of the HPV vaccine Gardasil®. The conclusion is that there are no changes to the safety profile.

  • Updated list of biological medicinal products

    | 04 February 2016 |

    The Danish Medicines Agency has added five new medicinal products to the list of biological and biosimilar medicinal products.

  • Summary of product characteristics and package leaflet to be updated after the establishment of DKMA

    | 03 February 2016 |

    Following the establishment of the Danish Medicines Agency (DKMA) on 8 October 2015, the section on the reporting of side effects must be updated in the summary of product characteristics (section 4.8) and the package leaflet (section 4) so that it says the Danish Medicines Agency and dkma@dkma.dk in the section about reporting of side effects.

  • Updated memo on medicinal use of Cannabis

    | 26 January 2016 |

    The Danish Medicines Agency has updated the memo on medicinal use of Cannabis, and the third edition of the memo is now available.

  • Access to results in EudraCT from 13 January

    | 13 January 2016 |

    When a clinical trial of medicinal products has ended, the trial results must be entered in the EudraCT database. The system has been unavailable for a period of time during which data could not be entered in the EudraCT database. The EMA now re-opens the database and results can be entered in EudraCT again.

  • Available time slots in 2016 for DCP applications with Denmark as reference member state

    | 12 January 2016 |

    Companies wishing to apply for a marketing authorisation for a medicinal product can request a specified submission date (time slot). Time slots are available in 2016.