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  • 12 applications for allocation of special funds related to medicinal cannabis

    | 30 May 2018 |

    The application deadline for the second allocation of special funds for accumulation of scientific knowledge in regard to the medicinal cannabis pilot programme has now expired. The Danish Medicines Agency received 12 applications.

  • Better conditions for clinical trials in Denmark

    | 03 May 2018 |

    The Danish government, the Danish People's Party and the Danish Social-Liberal Party have agreed to exempt commercial sponsors from all fees for phase I clinical trials of medicines. The government has previously decided – in connection with the Budget Bill 2018 – to remove the Danish Medicines Agency’s fees for non-commercial (research-initiated) clinical trials of medicines.

  • Danish-Japanese collaboration on better use of health data

    | 02 May 2018 |

    The Danish Medicines Agency met today with leading representatives from the Japanese Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency at the Danish Medicines Agency in Copenhagen. The purpose of the meeting was to exchange knowledge and experience regarding regulatory work in the pharmaceutical area, and to begin a broader collaboration between the agencies.

  • Acupuncture needles with false CE marking

    | 16 April 2018 |

    Sterile acupuncture needles with false CE marking are sold online. We ask you to pay attention to these products because there is no documentation to support the product's sterility or the materials used to fabricate the device.

  • What is medicinal cannabis?

    | 12 April 2018 |

    The Danish Medicines Agency has produced a short infographic film illustrating the different types of medicinal cannabis.

  • Three new reimbursement guidelines

    | 03 April 2018 |

    The Danish Medicines Agency has issued three new guidelines on reimbursement (in Danish only). This regards Guideline on application for general reimbursement and general conditional reimbursement, Guideline on periodic reassessment of the reimbursement status of medicines and Guideline on the making of health economic analyses 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.

  • Infographic on the medicinal cannabis pilot programme

    | 21 March 2018 |

    The Danish Medicines Agency has produced a short infographic film about the medicinal cannabis pilot programme. The film gives a brief introduction to the programme and is intended for sharing on social media.

  • 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.

  • European top post for Thomas Senderovitz

    | 02 March 2018 |

    Director General of the Danish Medicines Agency, Thomas Senderovitz, was Thursday elected Chairperson of the HMA Management Group. HMA is an acronym for Heads of Medicines Agencies and is the network of the heads of the national drug regulatory authorities in Europe.

  • 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.

  • Be aware of rare but possible risk of liver injury in medical treatment of fibroids

    | 15 February 2018 |

    The Danish Medicines Agency recommends doctors not to start any new patients on the medicine Esmya (ulipristal) because of a rare, but possible, risk of developing serious liver injury.

  • 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.

  • Updating of summaries of product characteristics due to changed ATC codes for 2018

    | 18 January 2018 |

    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 for 2018.

  • DKMA Update December 2017

    | 09 January 2018 |

    In this issue of DKMA Update, you can read about the new medicinal cannabis pilot programme, about how to read the summary of product characteristics, and about two new studies on the use of contraceptive pills and adverse reactions.

  • News on dose dispensing of medicinal products

    | 18 December 2017 |

    The Danish executive order on dose dispensing of medicinal products has been updated. Based on the update, the storage period is among other thing extended from 4 to 6 weeks for medicinal products approved for dose dispensing.

  • EMA to relocate to Amsterdam

    | 21 November 2017 |

    he Danish Medicines Agency congratulates Amsterdam on winning the hosting of the EMA and looks forward to a good and constructive cooperation.

  • The European Commission has published three recommendations for the clinical trials regulation

    | 14 November 2017 |

    In cooperation with the clinical trials expert group, the European Commission is updating and issuing new recommendations as a result of the regulation on clinical trials on medicinal products for human use.

  • New format requirements for marketing authorisation applications from 1 January 2018

    | 10 November 2017 |

    The NeeS submission format will be discontinued for applications submitted under the mutual recognition procedure (MRP). This change is related to medicinal products for human use. Parallel import and parallel distribution are not affected by this change.