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

Current effective version

Guideline on the chemistry of active substances for veterinary medicinal products

Adopted Reference Number: EMA/CVMP/QWP/707366/2017-Rev.1 Legal effective date: 17/02/2023

Document history - Revision 2

Guideline on the chemistry of active substances for veterinary medicinal products

Adopted Reference Number: EMA/CVMP/QWP/707366/2017 Summary:

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.

Overview of comments received on 'Draft guideline on the chemistry of active substances for veterinary medicinal products'

Reference Number: EMA/CVMP/QWP/502315/2017 Summary:

Overview of comments received on 'Draft Guideline on the chemistry of active substances (veterinary)’ (EMA/CVMP/QWP/49477/2017)

Draft guideline on the chemistry of active substances (veterinary)

Draft: consultation closed Consultation dates: 13/02/2017 to 13/08/2017 Reference Number: EMA/CVMP/QWP/49477/2017

Concept paper on the need for a single note for guidance on the chemistry of active substances

Draft: consultation closed Consultation dates: 22/07/2015 to 22/10/2015 Reference Number: EMA/CVMP/QWP/107359/2015 Summary:

This concept paper addresses the need to update and revise the guidance available on the chemistry of the active substance (new and existing active substances). There are currently two approved guidelines on the subject; EMEA/CVMP/541/03/Final guideline on the chemistry of new active substances and 3AQ5A guideline on chemistry of the active substance. It is felt appropriate to combine the two documents into a single guideline to provide better clarity for applicants.

Document history - Revision 1 (superseded)

Guideline on the chemistry of new active substances (CVMP)

Adopted Reference Number: EMEA/CVMP/541/03/Final Legal effective date: 01/12/2004

Chemistry of active substances - Superseded document

Adopted Reference Number: 3AQ5A Legal effective date: 01/10/2015