Quality aspects included in the product information for vaccines for human use - Scientific guideline

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

Adopted Reference Number: EMA/CHMP/BWP/133540/2017

Document history

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

Adopted Reference Number: EMA/CHMP/BWP/133540/2017

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

Reference Number: EMA/CHMP/BWP/668918/2018

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

Draft: consultation closed Consultation dates: 01/02/2018 to 31/07/2018 Reference Number: EMA/CHMP/BWP/133540/2017 Summary:

This guideline describes the information on the quality aspects to be included in the Product Information (PI) of vaccines for human use.

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

Reference Number: EMEA/CHMP/BWP/290688/2009

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

Adopted Reference Number: EMEA/CPMP/BWP/2758/02 Legal effective date: 01/06/2004