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
Published31/07/2013
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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