Guideline on good pharmacovigilance practices (GVP) - Product- or population-specific considerations IV: paediatric population

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Document details

Download document Guideline on good pharmacovigilance practices (GVP) - Product- or population-specific considerations IV: paediatric population
Reference number EMA/572054/2016
Status draft: consultation open
First published 2017-08-02
Last updated 2017-08-02
Consultation start date 2017-08-02
Consultation end date 2017-10-13
Email address for submissions gvp@ema.europa.eu

Summary

The paediatric population is defined in the European Union (EU) as that part of the population aged between birth and 18 years. The paediatric population encompasses several subsets.