Quality aspects included in the product information for vaccines for human use

Current effective version

PDF iconAdopted guideline

Currently under revision - see below

Reference numberCPMP/BWP/2758/02
Published26/11/2003
Effective from01/06/2004
KeywordsVaccine, label, summary of product characteristics, patient leaflet, braille
DescriptionThis 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, labelling and package lefleat.


Document history

Revision 1

In progress

Draft guideline


PDF iconConcept paper

Published: 01/02/2018
Deadline for comments: 31/07/2018

Published: 17/06/2009

First version

Current version

PDF iconAdopted guideline

In operation: 01/06/2004–present


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