Chemistry of active substances (chemistry of new active substances)

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Current effective version

Adopted guideline

Reference numberEMA/454576/2016
Published21/11/2016
Effective from21/05/2017
KeywordsActive substance, chemistry, dossier, manufacture, quality control, impurities, specification
DescriptionThis document describes the type of information required for the manufacture and control of active substances (existing or new chemical entities) used in a medicinal product.


Document history

Superseding document
Current version

Adopted guideline

 

 

 

Overview of comments

 

Draft guideline


Concept paper

 

Published: 21/11/2016

 

Effective from: 21/05/2017

 

Published: 21/11/2016

 

Published: 24/04/2015


Published: 10/02/2014

Superseded documentAdopted guideline (new active substance)In operation: 01/02/2004-21/05/2017
Superseded document Adopted guideline (active substance)In operation: 01/10/1987-21/05/2017


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