News from the Danish Medicines Agency

  • Medicines of the future in focus at World Economic Forum

    | 20 September 2018 |

    Medicines of the future is one of the topics being debated at the meeting of the World Economic Forum, which is currently place right now in Tianjin in China. The Danish Medicines Agency is attending.

  • Danish Medicines Agency aces European benchmark survey

    | 19 September 2018 |

    The Danish Medicines Agency has just scored 4.5 of a possible 5 in the common-European survey known as the Benchmarking of European Medicines Agencies (BEMA). ”It's a really good result that will benefit all of us and may help raise the standard throughout Europe,” said the Danish health minister.

  • Safer prescription of blood thinning agents

    | 04 September 2018 |

    A collaboration between pharmaceutical companies, pharmacies and authorities has eliminated a common cause of dosing errors involving blood thinning agents.

  • Danish Medicines Agency launches new concept for National Scientific Advice

    | 31 August 2018 |

    Today, 31 August 2018, the Danish Medicines Agency is launching a new concept for National Scientific Advice for companies, hospitals and others who request advice on the requirements applicable to clinical investigation and marketing authorisations.

  • Companies can now apply for authorisation to produce cannabis bulk and cannabis primary products

    | 21 August 2018 |

    On 1 July 2018, a new executive order entered into force which gives companies the possibility of cultivating medicinal cannabis and producing cannabis bulk and cannabis primary products from Danish-grown cannabis.

  • Danish Medicines Agency lands new European chairmanship

    | 20 August 2018 |

    Nikolai Brun, Director of Medical Evaluation & Biostatistics, has been elected chair of the Task Force on Big Data in the pharmaceutical area. The task force is a collaboration between the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) which is to identify advantages and challenges of using big data for the development of medicine.

  • DKMA Update June 2018

    | 03 July 2018 |

    In this issue of DKMA Update you can read about new rules on private individuals' import of medicines, Danish Medicines Agency being key driver in European solution for complex clinical trials and much more.

  • 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.

  • What is medicinal cannabis?

    | 12 April 2018 |

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

  • 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.

  • 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.

  • COVID-19: Restriction on OTC medicines lifted

    The Danish Medicines Agency lifts the restriction on over-the-counter (OTC), which has been in force since March. This means that pharmacies, supermarkets, kiosks and others with permission to sell OTC medicines can resume selling more than one pack of the same type of OTC medicine per customer.

  • Danish Medicines Agency shortens the review time for applications for COVID-19 medicine trials

    Drug regulatory authorities around the world are taking several steps to speed up the development and availability of medicines to treat and prevent novel COVID-19. The Danish Medicines Agency in Denmark has just implemented an emergency procedure for applications for clinical trials with human subjects.

  • Thomas Senderovitz leaves the Danish Medicines Agency

    Thomas Senderovitz has announced that he is leaving his role as Director General of the Danish Medicines Agency to pursue fresh opportunities.

  • Union Product Database: Deadlines for the Submission of Annual Volume of Sales data for veterinary medicinal products

    According to Article 58(12) of Regulation (EU) 2019/6 , all Marketing Authorisation Holders must submit the annual Volume of Sales for each veterinary medicinal product to the Union Product Datab