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News

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  • New advice on infant food

    | 17 March 2015 |

    Infants should not be given cow's milk, but breast milk or infant formula throughout the first year of life. This is one of our new recommendations for infant food and nutrition for young children.

  • New management at the DHMA

    | 16 March 2015 |

    As from 13 March 2015, Jakob Cold has been appointed Acting Director General of the Danish Health and Medicines Authority. Anne-Marie Vangsted will continue as Director with special responsibility for the DHMA's supervision.

  • Three Danish healthcare workers will not be quarantined for Ebola

    | 16 March 2015 |

    Defence Command Denmark and Danish Emergency Management Agency have decided to bring home three Danish healthcare workers who have worked with Ebola patients in Sierra Leone. The three healthcare workers have been examined at Aarhus University Hospital, and there is no reason to recommend quarantine.

  • Danish Pharmacovigilance Update, February 2015

    | 16 March 2015 |

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

  • Else Smith to resign as Director General of the DHMA

    | 16 March 2015 |

    We confirm that as from 12 March 2015 Else Smith is no longer Director General of the Danish Health and Medicines Authority.

  • Requirements for companies distributing and handling euphoriant substances

    | 11 March 2015 |

    We have gathered information about the requirements for authorisations, storage, accounting and reporting of euphoriant substances.

  • Warning against Slimex 15 and Slimex 15 New Formula

    | 09 March 2015 |

    The Danish Health and Medicines Authority warns against taking the weight-loss products "Slimex 15" and "Slimex 15 New Formula" that are sold on the internet. The weight-loss products contain sibutramine that may cause serious side effects.

  • Wholesale Distribution Authorisations and GDP certificates can now be transferred to EudraGMDP

    | 09 March 2015 |

    We can now transfer Wholesale Distribution Authorisations and Good Distribution Practice certificates to EudraGMDP, a Community database in the EU.

  • The MMR vaccine is a safe vaccine

    | 04 March 2015 |

    We have reviewed the reported adverse reactions from the MMR vaccine during the past five years.

  • 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.