Stability testing for applications for variations to marketing authorisation

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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