News about licensing of medicines

  • 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.

  • New application forms mandatory from 1 January

    | 14 December 2015 |

    From 1 January 2016, it will be mandatory to use the eAF to apply for marketing authorisations, renewals and variations. This applies to both human and veterinary medicinal products, and it applies to all procedure types.

  • 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).

  • New format requirements for applications for authorisation of medicinal products

    | 13 July 2015 |

    On 1 July 2015, the rules governing applications for marketing authorisations for medicinal products were amended in three areas as a result of new requirements from the European Medicines Agency (EMA).

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