Stability testing for applications for variations to marketing authorisation

This guideline applies to human and veterinary medicines.

Current effective version

PDF iconRevision 2 - Adopted guideline

Reference number EMA/CHMP/CVMP/QWP/441071/2011 Rev. 2
Published 09/04/2014
Effective from 10/10/2014
Keywords Stability, stability testing, stability data, chemical active substance, specification, variation
Description This 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

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


Concept paper

In operation: 10/10/2014–present


Published: 09/04/2014


Published: 26/06/2011

Published: 03/03/2010

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

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