Chemistry of active substances for veterinary medicinal products - Scientific guideline
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.
Keywords: Active substance, chemistry, guideline
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Guideline on the chemistry of active substances for veterinary medicinal products (PDF/202.65 KB)
Adopted
First published: 19/01/2018
Last updated: 19/01/2018
EMA/CVMP/QWP/707366/2017 -
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Overview of comments received on 'Draft guideline on the chemistry of active substances for veterinary medicinal products' (PDF/111.97 KB)
First published: 19/01/2018
Last updated: 19/01/2018
EMA/CVMP/QWP/502315/2017 -
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Draft guideline on the chemistry of active substances (veterinary) (PDF/208.64 KB)
Draft: consultation closed
First published: 13/02/2017
Last updated: 13/02/2017
Consultation dates: 13/02/2017 to 13/08/2017
EMA/CVMP/QWP/49477/2017 -
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Concept paper on the need for a single note for guidance on the chemistry of active substances (PDF/84 KB)
Draft: consultation closed
First published: 22/07/2015
Last updated: 22/07/2015
Consultation dates: 22/07/2015 to 22/10/2015
EMA/CVMP/QWP/107359/2015
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Guideline on the chemistry of new active substances (CVMP) (PDF/209.7 KB)
Adopted
First published: 01/05/2004
Last updated: 01/05/2004
Legal effective date: 01/12/2004
EMEA/CVMP/541/03/Final -
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Chemistry of active substances - Superseded document (PDF/36.37 KB)
Adopted
First published: 01/10/2015
Last updated: 01/10/2015
Legal effective date: 01/10/2015
3AQ5A