News about Licensing and supervision

  • 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.

  • Global operation against illegal medicines

    | 25 September 2017 |

    A global operation against illegal medicines has been completed. 123 countries participated, and the operation resulted in 354 arrests or further investigations and the suspension of more than 3,500 websites.

  • Decisions on marketing authorisations will be sent electronically to Danish recipients from October 2017

    | 20 September 2017 |

    From 1 October 2017, the Danish Medicines Agency's licensing division will send decisions on marketing authorisations (including any annexes) to Danish recipients and companies by digital post.

  • DKMA Update

    | 11 September 2017 |

    Our newsletter Danish Pharmacovigilance Update changes name to DKMA Update and will from now on contain information about medicinal products in general, patient safety and life science.

  • Withdrawal of one more batch of counterfeit packs of the schizophrenia medicine Xeplion 150 mg

    | 01 August 2017 |

    German and Danish parallel importers and the Danish Medicines Agency are now withdrawing the fourth batch of Xeplion 150 mg from wholesale distributors, hospitals and pharmacies, because the batch contains counterfeit packs.

  • Counterfeit packs of the schizophrenia medicine Xeplion 150 mg

    | 27 July 2017 |

    One German and several Danish parallel importers and the Danish Medicines Agency have withdrawn several batches of Xeplion 150 mg from wholesale distributors, hospitals and pharmacies, because the batches contained counterfeit packs.

  • New fees for medicinal products, pharmaceutical companies and clinical trials from 1 July 2017

    | 03 July 2017 |

    On 1 July 2017, a new executive order on fees payable for medicinal products, pharmaceutical companies and clinical trials became effective. The new fees involve changes in a number of areas.

  • Eleven new substances on the list of euphoriant substances

    | 16 June 2017 |

    On 15 June 2017, 11 new substances were included in annex 1 of executive order no. 557 of 31 May 2011 on euphoriant substances issued by the Danish Ministry of Health. The information is primarily relevant to companies authorised to deal with euphoriant substances.

  • New format requirements for marketing authorisation applications

    | 15 June 2017 |

    The Danish Medicines Agency is postponing the phasing-out of NeeS and tightens the format requirements for updating the assessment report prior to MRP/RUP.

  • Annual report 2016 - Clinical trials of medicines

    | 13 June 2017 |

    LLast year, the Danish Medicines Agency received 286 clinical trial applications. This is a small decline compared to 2015. However, the number of clinical trial applications has remained stable at around 300 applications per year since 2013.

  • More batches of EpiPen® are withdrawn

    | 06 April 2017 |

    MEDA has decided to withdraw four more batches of EpiPen®. The withdrawal concerns two batches of EpiPen® 300 micrograms/dose and two batches of EpiPen® Jr 150 micrograms/dose. The latter is used for acute hypersensitivity reactions in children. The reason for the withdrawal is that there is a risk that the auto-injector does not work.

  • Withdrawal of a batch of EpiPen® 300 micrograms

    | 17 March 2017 |

    MEDA recalls a batch of the adrenaline product EpiPen® 300 micrograms/dose, which is used for sudden allergic reactions. There is a risk that the auto-injector does not work. The withdrawal concerns product number 578818 with batch number: 5FA665B and expiry date 03/2017.

  • EuropharmaDK regains its authorisation

    | 13 March 2017 |

    The Danish Medicines Agency has decided to lift the suspension of EuropharmaDK's manufacturing and importation authorisation, following the outcome of a follow-up inspection of EuropharmaDK ApS on 8 March where the Danish Medicines Agency ascertained that the critical findings had been corrected.

  • New transatlantic agreement on mutual recognition of inspections

    | 03 March 2017 |

    The EU and the USA have agreed to recognise inspections of manufacturing sites for human medicines conducted in their respective territories on both sides of the Atlantic.

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