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

Title:
Eudralex Volume 3 Stability Testing for Applications for Variations to a Marketing Authorisation
Short Title:
EMA/CHMP/CVMP/QWP/441071/2011 - Rev.2

https://www.gmp-compliance.org/files/guidemgr/2014_EMA_Stab_Testing_Variations_WC500164972.pdf

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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