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

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Reflection paper

Reference numberEMA/651649/2010
Published21/11/2012
KeywordsNew active substance, enantiomers, complex, derivative, salt, ester, reference active substance
DescriptionThis 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.


Document history

First version

Current version

Reflection paper


Overview of comments


Draft reflection paper

In operation: 01/06/2013–present


Published: 21/11/2012


Published: 23/11/2010


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