Superseded - Conduct of pharmacovigilance for medicines used by the paediatric population - Scientific guideline

This 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.

Keywords: Pharmacovigilance, safety, paediatrics, children, neonates, adverse drug reaction (ADR), periodic safety update report (PSUR), risk management plan (RMP), signal detection, patient information leaflet

Document history - First version

Guideline on conduct of pharmacovigilance for medicines used by the paediatric population

Reference Number: EMEA/CHMP/PhVWP/235910/2005 Rev.1 Legal effective date: 26/01/2007

Overview of comments received on draft guideline on conduct of pharmacovigilance for medicines used by the paediatric population

Reference Number: EMEA/CHMP/PhVWP/228720/2006

Draft guideline on conduct of pharmacovigilance for medicines used by the paediatric population

Draft: consultation closed Reference Number: EMEA/CHMP/235910/2005

Concept paper on conduct of pharmacovigilance for medicines used children

Reference Number: CPMP/PhVWP/4838/02