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Marketing authorisation > Product information requirements

Topics Marketing authorisation > Product information requirements

  • Falsified Medicines Directive
  • Implementation of agreed wording product information
  • Labelling
  • Marketing authorisations without Dutch translations of the product information and/or mock-ups
  • Nomenclature, excipients, abbreviated indications
  • Package leaflet
  • QR code
  • QRD templates
  • Summary of product characteristics (SmPC)
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