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

  • Clarification of labelling practice for warning statements on human medicines

    | 05 January 2022 |

    During our review of applications for marketing authorisations for human medicines and variations to marketing authorisations, we have noted uncertainty about the labelling practice regarding the warning statements of schedule 2 of the Danish executive order on labelling. The question is whether these warnings are required on the packaging and in the package leaflet if the warning statements are not supported by the summary of product characteristics (SPC) of the medicinal product concerned. We therefore find it necessary to clarify the labelling practice for warning statements on human medicines.