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Eudralex Volume 3 Stability Testing for Applications for Variations to a Marketing Authorisation

Short Title:
EMA/CHMP/CVMP/QWP/441071/2011 - Rev.2
Origin/Publisher:

EMA

Document Type:
Guideline
Content:
The Guideline provides guidance on the stability data which have to be generated in order to support a variaion to a Marketing Authorisation (Type I A and B and Type II Variations).

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