News about Licensing and supervision

  • Brexit: Two-year implementation period for name and address changes

    | 17 October 2018 |

    During an implementation period of maximum two years, it will be permitted to sell released packs on which a UK marketing authorisation holder or a representative is indicted as well as packs on which an EEA marketing authorisation holder or a representative is indicated for the concerned D.Sp.No. (Danish speciality number).

  • 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.

  • Contaminated valsartan has so far not caused an increased incidence of cancer cases in Denmark

    | 13 September 2018 |

    A Danish registry study has examined if the cancer incidence rate is higher among people treated with the blood pressure lowering medicine Valsartan, which due to the risk of contamination was recalled from the market in July 2018. The study concludes that no increased cancer incidence can be seen at present.

  • 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.

  • Recall of valsartan blood pressure medicine

    | 10 August 2018 |

    Impurities that could potentially be harmful to health have been found in variants of medicines containing the active substance valsartan. The medicine is used to treat hypertension and heart failure. Patients treated with these medicines are therefore advised to contact their doctor as soon as possible in order to to be switched to another type 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.

  • 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

  • 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.

  • 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.

  • Overview of changes requiring an inspection in the GMP area

    | 23 January 2018 |

    Companies that manufacture medicines must be authorised to perform manufacturing activities by the Danish Medicines Agency according to section 39 of the Danish Medicines Act. They must comply with the rules on good manufacturing practice (GMP) and will be inspected regularly by our GMP inspectors.

  • 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.

  • 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.

  • Self-selection of OTC medicines for human use

    | 25 October 2017 |

    On 1 January 2018, new rules on self-selection of OTC medicines become effective. With the change in law, certain OTC medicines will be available for self-selection, which means that they can be sold from shop areas and not only at the counter.

  • The Danish Medicines Agency contributes to review of Chinese medicines act

    | 10 October 2017 |

    On Monday 9 October, a Chinese delegation headed by Xu Jinghe visited the Danish Medicines Agency. Xu Jinghe is Director General of the CFDA's Department of Legal Affairs and one of the main architects of the renewal of the Chinese medicines legislation.

  • DKMA Update October 2017

    | 10 October 2017 |

    In this issue of DKMA Update, you can read about the decision to change the dispensing status of a number of opioids, about the new guidelines on medicinal cannabis for doctors, and about the executive order on the import of cannabis products.

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