News

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  • Updating of summaries of product characteristics due to changed ATC codes for 2018

    | 18 January 2018 |

    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 2018.

  • DKMA Update December 2017

    | 09 January 2018 |

    In this issue of DKMA Update, you can read about the new medicinal cannabis pilot programme, about how to read the summary of product characteristics, and about two new studies on the use of contraceptive pills and adverse reactions.

  • News on dose dispensing of medicinal products

    | 18 December 2017 |

    The Danish executive order on dose dispensing of medicinal products has been updated. Based on the update, the storage period is among other thing extended from 4 to 6 weeks for medicinal products approved for dose dispensing.

  • EMA to relocate to Amsterdam

    | 21 November 2017 |

    he Danish Medicines Agency congratulates Amsterdam on winning the hosting of the EMA and looks forward to a good and constructive cooperation.

  • The European Commission has published three recommendations for the clinical trials regulation

    | 14 November 2017 |

    In cooperation with the clinical trials expert group, the European Commission is updating and issuing new recommendations as a result of the regulation on clinical trials on medicinal products for human use.

  • New format requirements for marketing authorisation applications from 1 January 2018

    | 10 November 2017 |

    The NeeS submission format will be discontinued for applications submitted under the mutual recognition procedure (MRP). This change is related to medicinal products for human use. Parallel import and parallel distribution are not affected by this change.

  • New Director of Division for Pharmacovigilance & Medical Devices

    | 03 November 2017 |

    Jens Piero Quartarolo has been appointed new Director of Division for Pharmacovigilance & Medical Devices and will form part of the Danish Medicines Agency's leadership team.

  • Keep up with the latest updates on our website

    | 27 October 2017 |

    Now you can keep up with all updates on the Danish Medicines Agency's website and not only our news items. You can filter the overview by category and month, and the overview is structured in chronological order with the latest update first. You can find a shortcut to the overview on our home page.

  • Self-selection of OTC medicines for human use

    | 25 October 2017 |

    On 1 January 2018, new rules on self-selection of OTC medicines become effective. With the change in law, certain OTC medicines will be available for self-selection, which means that they can be sold from shop areas and not only at the counter.

  • The Danish Medicines Agency contributes to review of Chinese medicines act

    | 10 October 2017 |

    On Monday 9 October, a Chinese delegation headed by Xu Jinghe visited the Danish Medicines Agency. Xu Jinghe is Director General of the CFDA's Department of Legal Affairs and one of the main architects of the renewal of the Chinese medicines legislation.

  • DKMA Update October 2017

    | 10 October 2017 |

    In this issue of DKMA Update, you can read about the decision to change the dispensing status of a number of opioids, about the new guidelines on medicinal cannabis for doctors, and about the executive order on the import of cannabis products.

  • Collection of scientific experience for medicinal cannabis pilot programme

    | 05 October 2017 |

    One or more research projects should be carried out for the purpose of gathering scientific experience on medicinal cannabis. The projects will form part of the medicinal cannabis pilot programme.

  • The Danish Medicines Agency is preparing for launch of new EudraVigilance

    | 05 October 2017 |

    On 22 November 2017, the European Medicines Agency will launch a new and improved version of the EudraVigilance database (the European information system of suspected adverse reactions to medicines). More than 11 million reports will be transferred to the new system; consequently, the system will be unavailable for a period of ten working days (8 November to 22 November) before 'Go-live'.

  • New practice for follow-up information on adverse reaction reports

    | 29 September 2017 |

    The Danish Medicines Agency has introduced a new practice for the processing of pharmaceutical companies' requests for follow-up information on reports of suspected adverse reactions.

  • Global operation against illegal medicines

    | 25 September 2017 |

    A global operation against illegal medicines has been completed. 123 countries participated, and the operation resulted in 354 arrests or further investigations and the suspension of more than 3,500 websites.

  • Decisions on marketing authorisations will be sent electronically to Danish recipients from October 2017

    | 20 September 2017 |

    From 1 October 2017, the Danish Medicines Agency's licensing division will send decisions on marketing authorisations (including any annexes) to Danish recipients and companies by digital post.

  • E2B acknowledgment format change

    | 12 September 2017 |

    Companies that use the Danish Medicines Agency's Pharmacovigilance System should be aware that we have changed the MessageFormatRelease value from 2.0 to 1.0.

  • DKMA Update

    | 11 September 2017 |

    Our newsletter Danish Pharmacovigilance Update changes name to DKMA Update and will from now on contain information about medicinal products in general, patient safety and life science.

  • Testing the exchange of E2B files

    | 16 August 2017 |

    Testing the exchange of E2B ICSRs/SUSARs between the Danish Medicines Agency and companies/sponsors must be completed by Friday 29 September 2017.

  • Bravecto® may cause convulsions in dogs on rare occasions

    | 10 August 2017 |

    The European Medicines Agency has reviewed the adverse events of Bravecto®, a veterinary medicine used to treat flea and tick infestations in dogs. The conclusion is that the medicine may on very rare occasions cause convulsions in dogs – primarily in dogs with pre-existing epilepsy.

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