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 effective version

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

AdoptedReference Number: EMA/CHMP/CVMP/QWP/441071/2011- Rev.2

Document history - Revision 2

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

AdoptedReference Number: EMA/CHMP/CVMP/QWP/441071/2011- Rev.2

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 closedConsultation dates: 13/07/2011 to 31/01/2012Reference Number: EMA/CHMP/CVMP/QWP/441071/2011Summary:

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 closedConsultation dates: 18/02/2010 to 30/04/2010Reference Number: EMA/63033/2010

Document history - Revision 1

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

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