Stability testing for applications for variations to a marketing authorisation for veterinary medicinal products - Scientific guideline

This guideline applies to veterinary medicines.

The guideline provides general guidance on the stability data which have to be generated in order to support a variation to a marketing authorisation for veterinary medicinal products in line with the new classification system for variations under Regulation (EU) 2019/6.

Keywords: Stability, veterinary medicinal products, variations, Regulation (EU) 2019/6

Current version

Guideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal products

Consultation dates: 02/05/2024 to 31/08/2024Draft: consultation openReference Number: EMA/CVMP/QWP/515653/2023

Document history

Concept paper on a guideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal products

Consultation dates: 13/10/2023 to 05/01/2024Draft: consultation openReference Number: EMA/CVMP/QWP/348098/2023