Considerations given to designation of a single stereo isomeric form (enantiomer), a complex, a derivative, or a different salt or ester as new active substance in relation to the relevant reference active substance - Scientific guideline

This document outlines the scientific approach to evaluate whether enantiomers, complexes, derivatives or different salts or esters of an existing active substance should be considered as a new active substance.

Keywords: New active substance, enantiomers, complex, derivative, salt, ester, reference active substance