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Eudralex Volume 3 Requirements for selection and justification of starting materials for the manufacture of chemical active substances (update)
Short Title:
EMA/CHMP/CVMP/QWP/826771/2016 Corr.1
Origin/Publisher:
EMA 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Content:
This document aims to clarify 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.
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