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Marketing authorisation > Product information requirements

Topics in this theme

  • F

    • Falsified Medicines Directive
  • I

    • Implementation of agreed wording
  • L

    • Labelling
  • M

    • Marketing authorisations without Dutch translations of the product information and/or mock-ups
    • Medicine pictograms
  • N

    • Nomenclature, excipients, abbreviated indications
  • P

    • Package leaflet
  • Q

    • QR code
    • QRD templates
  • S

    • Summary of product characteristics (SmPC)
  • T

    • Temporarily supply of a medicinal product in a different packaging
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