Pharmaceutical development of medicines for paediatric use

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Current effective version

Revision 2 - Adopted guideline

Reference numberEMA/CHMP/QWP/805880/2012 Rev. 2
Effective from15/02/2014
KeywordsPharmaceutical development, quality, child, paediatric formulation, paediatric investigation plan (PIP)
DescriptionThis document provides guidance on the pharmaceutical development of medicinal products for children between birth and 18 years of age.

Document history

Revision 2

Current version

Adopted guideline

In operation: 15/02/2014–present

Revision 1

Overview of comments

Draft guideline - Rev. 1

Published: 31/07/2013

Published: 04/01/2013

First version


Overview of comments

Draft guideline

Concept paper

Published: 04/01/2013

Published: 23/06/2011

Published: 29/07/2008

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