News items 2015

  • 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.

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