Stability testing for applications for variations to marketing authorisation - Scientific guideline

This guideline applies to human 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

Current version

Guideline on stability testing for applications for variations to a marketing authorisation - Revision 3

Adopted Reference Number: EMA/CHMP/QWP/441071/2011- Rev.3 Legal effective date: 15/01/2026

Document history - Revision 2

Guideline on stability testing for applications for variations to a marketing authorisation - Revision 2

Adopted Reference Number: EMA/CHMP/CVMP/QWP/441071/2011- Rev.2 Legal effective date: 09/10/2014

Overview of comments received on 'Guideline on stability testing for applications for variations to a marketing authorisation' - Revision 2

Reference Number: EMA/CHMP/CVMP/QWP/774027/2013 Rev. 1

Draft guideline on stability testing for applications for variations to a marketing authorisation - Revision 2

Draft: consultation closed Consultation dates: 13/07/2011 to 31/01/2012 Reference Number: EMA/CHMP/CVMP/QWP/441071/2011 Summary:

The following guideline provides guidance on the stability data which have to be generated in order to support a variation to a Marketing Authorisation. The guideline provides general guidance on stability testing in case of type I (A and B) variations and addresses the data requirements for widely encountered cases of type II variations.

Concept Paper on the Need for Revision of the Guideline on Stability Testing for Applications for Variations to a Marketing Authorisation

Draft: consultation closed Consultation dates: 18/02/2010 to 30/04/2010 Reference Number: EMA/63033/2010

Document history - Revision 1

Guideline on stability testing for applications for variations to a marketing authorisation - Revision 1

Adopted Reference Number: CPMP/QWP/576/96 Rev 1 Legal effective date: 01/12/2005