Guideline on Summary of Product Characteristics, Patient Information Leaflet and Labelling
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- Download 2711
- File Size 1.00 MB
- File Count 1
- 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.
Attached Files
| File | Action |
|---|---|
| Guideline on Summary of Product Characteristics Patient Information Leaflet and Labelling .pdf | Download |
