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Guideline on Summary of Product Characteristics, Patient Information Leaflet and Labelling

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  • Create Date November 1, 2023
  • Last Updated November 1, 2023

Guideline on Summary of Product Characteristics, Patient Information Leaflet and Labelling

This guideline provides guidance for applicants preparing to submit Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL), and Labelling requirements when submitting the documents during the marketing Authorisation Review.

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Guideline on Summary of Product Characteristics Patient Information Leaflet and Labelling .pdfDownload

Author

Tony Kemboi

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