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News

1 - 20 of 311 news items
  • New Head of Division for Public Health Medical Officers East & Supervision

    | 03 March 2015 |

    The Danish Health and Medicines Authority has appointed Anette Lykke Petri as new Head of Division for Supervision as from 1 March 2015. Anette Lykke Petri will be forming the new management team for Public Health Medical Officers East & Supervision, and in cooperation with the management teams of our decentralised divisions in the western parts of Denmark she will implement our action plan for the supervisory function.

  • Send Danish package leaflet when applying for changes to product information

    | 11 February 2015 |

    When applying for changes to the product information, marketing authorisation holders must always send a Danish version of the package leaflet to the Danish Health and Medicines Authority, whether the medicinal product is marketed in Denmark or not (unless the medicinal product is subject to section 11 about omission of the package leaflet, cf. Executive order no. 869 of 21 July 2011, as amended, on the labelling etc. of medicinal products).

  • MIA format updated according to EMA's community procedures

    | 11 February 2015 |

    We have updated our IT systems and are now able to transfer Manufacturing and Importation Authorisations (MIA) to EudraGMDP via EMA's latest XML form. This implies some changes to how we will issue MIAs in future.

  • Danish Pharmacovigilance Update, January 2015

    | 10 February 2015 |

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

  • New director at the DHMA

    | 03 February 2015 |

    On 1 February 2015, Anne-Marie Vangsted, Acting Head of Division, took up the position as Director with responsibility for supervision at the Danish Health and Medicines Authority. The new position as director was created as part of our action plan aimed at modernising the supervisory function, in which Anne-Marie Vangsted has played a key role since we presented the plan on 15 September 2014.

  • Off-label use of medicines

    | 30 January 2015 |

    In a new report, the Danish Health and Medicines Authority highlights the monitoring of the safety of off-label use of medicines in Denmark.

  • DKMAnet is available again

    | 30 January 2015 |

    We apologise for any inconvenience caused.

  • Digitisation of procedure for issuing export certificates for medicinal products

    | 30 January 2015 |

    We are simplifying the procedure for issuing export certificates for medicinal products. Previously, an export certificate was sent back and forth between the company and us by ordinary post. We are now simplifying and digitising the process.

  • Consultation on transparency in clinical trials

    | 21 January 2015 |

    The European Medicines Agency (EMA) has launched a public consultation on how to implement the transparency requirements of the new EU Clinical Trials Regulation. Deadline on 18 February.

  • Updating of summaries of product characteristics due to changed ATC codes for 2015

    | 16 January 2015 |

    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 in 2015.

  • Danish Pharmacovigilance Update, December 2014

    | 12 January 2015 |

    The December issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news.

  • Fees for medical devices in 2015

    | 05 January 2015 |

    The fees for medical devices have been adjusted in accordance with Danish Government regulations, including the fees for registration of manufacturers and devices, importers and distributors, assessment of applications for the authorisation for clinical investigation of medical devices, and amendments to investigations, as well as supervision and control of notified bodies in Denmark.

  • The drug situation in Denmark

    | 19 December 2014 |

    We have prepared our national report about the drug situation in Denmark in 2014. The number of drug-related deaths is stable, while the number of poisonings is increasing.

  • Changes to the Danish childhood vaccination programme

    | 18 December 2014 |

    From 1 January 2015, children will be offered the previous childhood vaccination programme again, because Statens Serum Institut (SSI) can now provide vaccines again after one year with technical production issues.

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

    | 10 December 2014 |

    PRAC held its last meeting for this year on 1-4 December 2014. During its December meeting, the PRAC did not initiate or conclude any safety referral. The Committee focused on the broad spectrum of its responsibilities, which cover all aspects of the risk management of the use of medicines.

  • New procedure for follow up on adverse drugs reaction reports as of 15 December 2014

    | 10 December 2014 |

    The Danish Health and Medicines Authority are by 15 December 2014 implementing a new targeted procedure for collecting additional information to reports on adverse drug reactions.

  • Danish Pharmacovigilance Update, November 2014

    | 02 December 2014 |

    Five years ago, we issued Danish Pharmacovigilance Update for the first time. We are delighted to celebrate the newsletter's fifth anniversary with more than 3,000 subscribers to the Danish and the English version, and we hope the interest in Danish Pharmacovigilance Update will continue to grow. You can sign up for the newsletter on our website under News. Among the articles in this issue, you can read about how we have developed the pharmacovigilance activities in the recent years.

  • Naming of medicinal products

    | 28 November 2014 |

    In future, we will comment on medicinal product names applied for (names of human medicines applied for under the mutual recognition (MRP) and decentralised procedures (DCP)) on Day 50 for MRP and on Day 100 for DCP with Denmark as concerned member state, and on Day 70 with Denmark as reference member state.

  • Available time slots in Q1 2015 for DCP applications with Denmark as reference member state

    | 14 November 2014 |

    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 the first quarter of 2015.

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

    | 14 November 2014 |

    The EU Pharmacovigilance Risk Assessment Committee (PRAC) convened on 3-6 November 2014.