Chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances - Veterinary - Scientific guideline
Table of contents
The paper describes the chemical structure and properties criteria to be taken into account by the CVMP to qualify a chemical active substance as NAS, as well as the required elements to be submitted by applicants to substantiate their claims.
Keywords: New active substance (NAS), salts, complexes, isomers, mixtures of isomers, derivative, esters and ethers
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Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances - Veterinary (PDF/124 KB)
Adopted
First published: 23/10/2017
Last updated: 23/10/2017
EMA/CVMP/QWP/3629/2016 -
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Draft reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances - Veterinary (PDF/124.68 KB)
Draft: consultation closed
First published: 17/11/2016
Last updated: 17/11/2016
Consultation dates: 17/11/2016 to 17/02/2017
EMA/CVMP/QWP/3629/2016