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

  • Updating of summaries of product characteristics due to changed ATC codes for 2020

    | 08 January 2020 |

    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 2020.

  • End of day meeting on new EU recommendations on complex clinical trials at the Danish Medicines Agency

    | 29 March 2019 |

    The Danish Medicines Agency invites pharmaceutical companies, researchers and other interested parties to an end of day meeting on the new European recommendations on complex clinical trials which aim to support the development of personalised medicine.

  • Common European recommendations establish a framework for testing medicines of the future

    | 08 March 2019 |

    The common European subgroup for complex clinical trials with trial subjects, which is headed by Denmark, has just published a set of recommendations for the development of personalised medicine.

  • New data analysis centre to open at the Danish Medicines Agency

    | 08 February 2019 |

    The Danish government today announced its decision to support the establishment of a new data analysis centre in the Danish Medicines Agency. The centre is to handle the analysis of large data quantities in the pharmaceutical and medical devices areas and will set new standards for the monitoring of the safety and efficacy of medicines and medical devices after their marketing.

  • DKMA Update December 2018

    | 23 January 2019 |

    In this issue of DKMA Update you can read about safety for medical devices; new biosimilar medicines for Humira; better conditions for clinical trials in Denmark; new front page for our website and much more

  • Updating of summaries of product characteristics due to changed ATC codes for 2019

    | 18 January 2019 |

    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 2019.

  • New report on adverse reactions reported with tramadol for pain relief

    | 20 December 2018 |

    The Danish Medicines Agency has received 830 reports of suspected adverse reactions with tramadol since the medicine was marketed in March 1993. 155 of them describe symptoms of dependence. This follows from a report that has just been published. In 2017, about 265,000 individuals received treatment with tramadol in Denmark.

  • New format requirements for Marketing Authorization submissions from 1 January 2019

    | 17 December 2018 |

    The NeeS submission format will be discontinued for all applications submitted under the national procedure (NP), i.e. applications for variations, renewals etc. This change is related to medicinal products for human use. Parallel import and parallel distribution are not affected by this change.

  • Til lægemiddelvirksomheder: Indsend variationer inden Brexit

    | 19 November 2018 |

    Storbritannien betragtes som udgangspunkt som et 3. land (udenfor EU/EEA) efter Brexit den 29. marts 2019. Lægemiddelstyrelsen opfordrer derfor lægemiddelvirksomheder til at indsende variationer snarest muligt.

  • Theme event on big data and medicine

    | 08 November 2018 |

    The U.S. Food and Drug Administration, FDA, The European Medicines Agency, EMA, and Novo Nordisk are among the speakers when The Danish Medicines Agency on 20 November 2018 puts focus on big data and medicine under the event heading “From Big Data to Real World Evidence”.

  • Three research projects to increase our knowledge of medicinal cannabis

    | 01 November 2018 |

    Three projects have just been granted funds to give us more knowledge about the efficacy of medicinal cannabis. A total of DKK 5 million have been distributed of the funds that were appropriated by the negotiating parliamentary parties under the special funds agreement 2018-2021 to accumulate scientific knowledge of medicinal cannabis.

  • Small increased risk of certain types of skin cancer associated with the use of hydrochlorothiazide

    | 30 October 2018 |

    There is a small increased risk of developing basal cell carcinoma and squamous cell carcinoma in long-term use of blood pressure medicine containing hydrochlorothiazide. This follows from a review of new studies and available data undertaken by the European Medicines Agency, EMA.

  • 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.

  • Phase I clinical trials and non-commercial clinical trials now exempt from fees

    | 11 July 2018 |

    Fees are no longer charged for Phase I clinical trials and non-commercial clinical trials of medicines. This is the result of the Growth Plan for Life Science and the Budget for 2018. The new rules entered into force on 1 July 2018.

  • 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.

  • 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.

  • 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

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