News about Licensing and supervision

  • DKMA Update March 2018

    | 28 March 2018 |

    In this issue of DKMA Update you can read about evidence; changes to Tramadol’s summary of product characteristics; inspections of the sale of OTC medicines outside pharmacies and much more

  • New concept for national scientific advice

    | 22 March 2018 |

    The Danish Medicines Agency will soon launch a new national scientific advice concept for companies, hospital researchers and others who require advice on requirements for marketing authorisations or clinical trials.

  • All marketing authorisation letters are now sent electronically to Danish companies

    | 01 March 2018 |

    On 20 February 2018, the Danish Medicines Agency extended its use of digital post and now sends all letters, and not just decisions, about marketing authorisations electronically to Danish companies.