Conduct of pharmacovigilance for medicines used by the paediatric population

Current effective version

PDF iconAdopted guideline

Reference numberEMEA/CHMP/235910/05
Published25/01/2007
Effective from26/01/2007
KeywordsPharmacovigilance, safety, paediatrics, children, neonates, adverse drug reaction (ADR), periodic safety update report (PSUR), risk management plan (RMP), signal detection, patient information leaflet
DescriptionThis document provides guidance on the conduct of pharmacovigilance for medicines used by paediatric population. It applies to 'off-label' and unlicensed as well as licensed use.


Document history

First version

Current version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline

PDF iconConcept paper

In operation: 01/01/2010–present


Published: 27/06/2007


Published: 27/07/2005

Published: 17/10/2002


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