Requirements for selection and justification of starting materials for the manufacture of chemical active substances

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This guideline applies to human and veterinary medicines.

Current version

Reflection paper

Reference numberEMA/CHMP/CVMP/QWP/826771/2016 Corr. 1
First published10/10/2014
Updated06/07/2017
KeywordsStarting materials, active substance
DescriptionThis document clarifies some of the expectations of EU competent authorities regarding the information to be submitted in marketing authorisation dossiers to justify the selection of starting materials. Its principles should apply equally for active substances destined to treat both humans and animals.


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