Chemistry of active substances (chemistry of new active substances)
| Current effective version |
|
| 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 |
|
Published: 21/11/2016
Effective from: 21/05/2017
Published: 21/11/2016
Published: 24/04/2015 Published: 10/02/2014 |
| Superseded document |
 Adopted 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| Superseded document |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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