Quality aspects included in the product information for vaccines for human use - Scientific guideline
HumanScientific guidelines
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
AdoptedReference Number: EMA/CHMP/BWP/133540/2017
English (EN) (171.39 KB - PDF)
First published:
Document history
Guideline on quality aspects included in the product information for vaccines for human use - Revision 1
AdoptedReference Number: EMA/CHMP/BWP/133540/2017
English (EN) (171.39 KB - PDF)
First published:
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
English (EN) (174.64 KB - PDF)
First published:
Draft guideline on quality aspects included in the product information for vaccines for human use - Revision 1
Consultation dates:
to Draft: consultation closedReference Number: EMA/CHMP/BWP/133540/2017Summary:
This guideline describes the information on the quality aspects to be included in the Product Information (PI) of vaccines for human use.
English (EN) (185 KB - PDF)
First published: Last updated:
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
English (EN) (36.1 KB - PDF)
First published: Last updated:
Guideline on pharmaceutical aspects of the product information for human vaccines - First version
AdoptedLegal effective date: Reference Number: EMEA/CPMP/BWP/2758/02
English (EN) (194.74 KB - PDF)
First published: Last updated:
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