Chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances - Veterinary - Scientific guideline

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

Current effective version

Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of New Active Substance (NAS) status of chemical substances for veterinary medical products

AdoptedLegal effective date: 17/02/2023Reference Number: EMA/CVMP/QWP/3629/2016-Rev.1

Document history

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

AdoptedReference Number: EMA/CVMP/QWP/3629/2016

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

Consultation dates: 17/11/2016 to 17/02/2017Draft: consultation closedReference Number: EMA/CVMP/QWP/3629/2016