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

Adopted Reference Number: EMA/CVMP/QWP/515653/2023 Legal effective date: 01/06/2025

Document history

Overview of comments received on 'Guideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal products' (EMA/CVMP/QWP/515653/2023)

Reference Number: EMA/CVMP/QWP/416589/2024

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

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

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

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

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