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
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.

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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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