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

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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

Adopted Reference Number: EMA/CVMP/QWP/3629/2016-Rev.1 Legal effective date:

English (EN) (249.63 KB - PDF)

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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

Adopted Reference Number: EMA/CVMP/QWP/3629/2016

English (EN) (124 KB - PDF)

Pubblicato per la prima volta: Ultimo aggiornamento:
Visualizza

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

Draft: consultation closed Consultation dates: to Reference Number: EMA/CVMP/QWP/3629/2016

English (EN) (124.68 KB - PDF)

Pubblicato per la prima volta: Ultimo aggiornamento:
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