Stability testing for applications for variations to marketing authorisation - Scientific guideline
This guideline applies to human and veterinary medicines.
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.
Keywords: Stability, stability testing, stability data, chemical active substance, specification, variation
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Guideline on stability testing for applications for variations to a marketing authorisation - Revision 2 (PDF/166.62 KB)
Adopted
First published: 09/04/2014
Last updated: 09/04/2014
EMA/CHMP/CVMP/QWP/441071/2011- Rev.2 -
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Overview of comments received on 'Guideline on stability testing for applications for variations to a marketing authorisation' - Revision 2 (PDF/1.61 MB)
First published: 09/04/2014
Last updated: 20/08/2014
EMA/CHMP/CVMP/QWP/774027/2013 Rev. 1 -
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Draft guideline on stability testing for applications for variations to a marketing authorisation - Revision 2 (PDF/122.91 KB)
Draft: consultation closed
First published: 26/07/2011
Last updated: 26/07/2011
Consultation dates: 13/07/2011 to 31/01/2012
EMA/CHMP/CVMP/QWP/441071/2011 -
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Concept Paper on the Need for Revision of the Guideline on Stability Testing for Applications for Variations to a Marketing Authorisation (PDF/71.76 KB)
Draft: consultation closed
First published: 03/03/2010
Last updated: 03/03/2010
Consultation dates: 18/02/2010 to 30/04/2010
EMA/63033/2010