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

Keywords New active substance (NAS), salts, complexes, isomers, mixtures of isomers, derivative, esters and ethers
Description This document describes the chemical structure and properties criteria to be taken into account by the CHMP to qualify a chemical active substance as NAS. It provides guidance on the required elements to be submitted by applicants to substantiate their claims.

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