Eudralex Volume 3 Requirements for selection and justification of starting materials for the manufacture of chemical active substances (update)
Title:
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
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.