Stability testing for applications for variations to marketing authorisation

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This guideline applies to human and veterinary medicines.

Current effective version

Revision 2 - Adopted guideline

Reference numberEMA/CHMP/CVMP/QWP/441071/2011 Rev. 2
Published09/04/2014
Effective from10/10/2014
KeywordsStability, stability testing, stability data, chemical active substance, specification, variation
DescriptionThis document provides general guidance on the stability data which have to be generated in order to support a variation to a marketing authorisation. It provides general guidance on stability testing for type IA and type IB variations and addresses the data requirements for common type II variations.


Document history

Revision 2

Current revision

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 10/10/2014–present


Published: 09/04/2014


Published: 26/06/2011


Published: 03/03/2010

Revision 1Adopted guidelineIn operation: 01/12/2005–10/10/2014


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