News items 2015

  • Registration of QPPV and PSMF number for veterinary medicinal products

    | 15 March 2023 |

    Under Commission Implementing Regulation EU 202116 of 8 January 2021, all Marketing Authorisation Holders of Veterinary Medicinal products in the EU, must register information on Qualified Persons for Pharmacovigilance QPPV and Pharmacovigilance System Master File PSMF in the Union Product Database UPD.

  • The Danish Medicines Agency suspends the Danish marketing authorisations of four generic medicines

    | 15 March 2023 |

    The European Commission has reached a decision in the case about the bioequivalence company Synchron Research, deciding that a number of generic medicines must be suspended in the EU counties where they are authorised. The Danish Medicines Agency therefore suspends the marketing authorisations of four medicines.

  • Multi-stakeholder platform to improve clinical trials in the EU – Public consultation

    | 07 February 2023 |

    As part of the Accelerating Clinical Trials in the EU (ACT EU) initiative, the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) and the European Commission (EC) are establishing a multi-stakeholder platform to improve clinical trials in the European Union (EU). The multi-stakeholder platform will support discussions across the clinical research landscape and facilitate the evolution of clinical trial methods and approaches.

  • Recall of the antibiotic Dicillin from Sandoz

    | 07 February 2023 |

    Patients who are treated with Dicillin Sandoz 500 mg capsules are instructed to return the medicine to a pharmacy and have it replaced. It is important not to stop treatment but to have the medicine replaced with another antibiotic. The pharmacies have been informed to dispense an alternative medicine.

  • Order books and Procedure Start Table

    | 12 January 2023 |

    In order to improve the companies' possibility to follow the status of their submitted variations, the Danish Medicines Agency is expanding its order book for variations to include all national type I

  • Updating of summaries of product characteristics due to changed ATC codes for 2023

    | 02 January 2023 |

    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 2023.

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