Chemistry of active substances for veterinary medicinal products

Current effective version

PDF iconAdopted guideline

Reference number EMA/CVMP/QWP/707366/2017
Published 19/01/2018
Effective from 19/07/2018
Keywords Active substance, chemistry, guideline
Description Guideline concerning the application of Directive 2001/82/EC with a view to the granting of a marketing authorisation for a veterinary medicinal product. This guideline replaces the 'Note for guidance on chemistry of new active substances' (EMEA/CVMP/541/03/Final) and 'Chemistry of active substances' (3AQ5a). It has been revised to cover new and existing active substances in one guideline.


Document history

Superseding document
Current version

PDF iconAdopted guideline

 

 

PDF iconOverview of comments

 

PDF iconDraft guideline
 

PDF iconConcept paper

Published: 19/01/2018

In operation: 19/07/2018-present

 

Published: 19/01/2018

 

Published: 13/02/2017
Deadline for comments: 13/08/2017

Published: 22/07/2015

Revision 1

Superseded

PDF iconAdopted guideline (new active substance) In operation: 01/02/2004-19/07/2018

Revision 1

Superseded

PDF iconAdopted guideline (active substance) In operation: 01/10/1987-19/07/2018


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