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

Document history - Revision 2

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