Notifications for the pharmaceutical industry about licensing, supervision and monitoring of medicines

  • 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.

  • New funds for accumulation of knowledge about medicinal cannabis

    | 20 March 2018 |

    The parties negotiating the special funds have earmarked a further DKK 5 million to increase knowledge about the use and effect of medicinal cannabis. You can apply for the funds now.

  • Brexit, change of Reference Member State from UK to DK

    | 01 February 2018 |

    The Danish Medicines Agency would like to inform marketing authorisation holders that we welcome being the Reference Member State (RMS) for MRP/DCP authorised medicines, should you request Denmark as the future RMS when the UK is leaving the EU.

  • Proposal for SPC harmonisation of a veterinary medicinal product

    According to Article 69-72 of Regulation (EU) 2019/6, National Competent Authorities (NCAs) as well as Marketing Authorisation Holders (MAHs) may propose harmonisation of the SPCs of Reference Veterin