The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
Eudralex Volume 3 Stability Testing for Applications for Variations to a Marketing Authorisation
Short Title:
EMA/CHMP/CVMP/QWP/441071/2011 - Rev.2
Internet:
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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