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
Table of contents
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
-
List item
Overview of comments received on 'reflection paper on considerations given to designation of a single stereo isomeric form (enantiomer) as new active substance in relation to a reference active substance which is a racem... (PDF/385.51 KB)
First published: 21/11/2012
Last updated: 21/11/2012
EMA/355542/2011 -
List item
Draft reflection paper on considerations given to designation of a single stereo isomeric form (enantiomer) as new active substance in relation to a reference active substance which is a racemic mixture of enantiomers (PDF/116.68 KB)
Draft: consultation closed
First published: 23/11/2010
Last updated: 23/11/2010
Consultation dates: 18/11/2010 to 28/02/2011
EMA/651649/2010