Chemistry of active substances (chemistry of new active substances)

Current effective version

PDF iconAdopted guideline

Reference number EMA/454576/2016
Published 21/11/2016
Effective from 21/05/2017
Keywords Active substance, chemistry, dossier, manufacture, quality control, impurities, specification
Description This 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

PDF iconAdopted guideline

 

 

 

PDF iconOverview of comments

 

PDF iconDraft guideline

 

PDF iconConcept paper

 

Published: 21/11/2016

 

Effective from: 21/05/2017

 

Published: 21/11/2016

 

Published: 24/04/2015

 

Published: 10/02/2014

Superseded document PDF iconAdopted guideline (new active substance) In operation: 01/02/2004-21/05/2017
Superseded document PDF iconAdopted guideline (active substance) In operation: 01/10/1987-21/05/2017


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