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

  • Control of companies' upload of package leaflets to the Danish Medicines Agency's portal DKMAnet

    | 01 August 2024 |

    Information for marketing authorisation holders (MAH). The Danish Medicines Agency's laboratory carries out regular control of companies’ upload of package leaflets to the Danish Medicines Agency’s portal DKMAnet (www.indlaegsseddel.dk). The control ensures, that users of medicinal products have access to an electronic package leaflet, if the physical package leaflet is not available. We check: • Whether the package leaflet is uploaded? • Whether the package leaflet is printable? • Whether the package leaflet is readable when printed out? • Whether the electronic package leaflet contains a date of latest revision? A control project was recently completed for ATC codes R01, S01-03. 5% of the uploaded package leaflets were flawed and the marketing authorization holders involved are in the process of correcting the errors. In general, we encourage marketing authorization holders to test whether the uploaded package leaflets are readable when printed to ensure user-friendliness. We made 241 searches on “Indlaegsseddel.dk” for ATC codes R01 and S01-03, which cover medicinal products for diseases of the nasal cavity and eye and ear diseases. In particular, we observed that the font size of several package leaflets was smaller than point 9 according to the Readability Guideline.

  • New regulations on Stockpiling of Critical Medicines effective on July 1 2024

    | 01 July 2024 |

    It will soon be mandatory for companies behind the most critical medicines to maintain stocks to cover initially six weeks’ consumption and to report stocks regularly to the Danish Medicines Agency. The affected companies will have six months to prepare for compliance, and, in August, the Danish Medicines Agency is holding information meetings about the new rules.

  • Status for the project regarding the control of anti-tampering devices (ATD) on medicinal product packages

    | 25 April 2024 |

    Information for marketing authorisation holders (MAH). The Danish Medicines Agency's laboratory is currently working on a project to check the anti-tampering device (ATD) on selected medicinal product packages. Approx. 10% of the packages requisitioned so far had an ATD that did not work. The flawed devices are designed as a sticker, that can be removed without it being visible on the packaging. We encourage marketing authorisation holders to test their ATDs to avoid unauthorised access to the medicinal products.

  • Survey on strategy for Ph. Eur. quality standards for monoclonal antibodies

    | 11 March 2024 |

    Give your valuable feedback to the European Pharmacopoeia (Ph. Eur.) in the field of setting standards for therapeutic mAbs.  The survey will take about 20 minutes.  Please complete the survey by

  • Continued control of companies' uploading of leaflets to the Danish Medicines Agency's portal DKMAnet

    | 01 February 2024 |

    The Danish Medicines Agency’s Department for Control and Security of Supply resumes the work of checking whether readable leaflets have been uploaded to www.indlaegsseddel.dk

  • Updating of summaries of product characteristics due to changed ATC codes for 2024

    | 02 January 2024 |

    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 2024.