This document provides guidance on the pharmaceutical data applicable to product information for human vaccines. It covers information to be provided for the summary of product characteristics, labeling and package leaflet.

Keywords: Vaccine, label, summary of product characteristics, patient leaflet, braille

Current effective version

Guideline on quality aspects included in the product information for vaccines for human use - Revision 1

Document history

Guideline on quality aspects included in the product information for vaccines for human use - Revision 1

Overview of comments received on 'Guideline on quality aspects included in the product information for vaccines for human use' (EMA/CHMP/BWP/133540/2017) - Revision 1

Draft guideline on quality aspects included in the product information for vaccines for human use - Revision 1

Concept paper on a revision of the guideline on pharmaceutical aspects of the product information for human vaccines (EMEA/CPMP/BWP/2758/02) - Revision 1

Guideline on pharmaceutical aspects of the product information for human vaccines - First version

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