In-use stability testing of veterinary medicinal products - Scientific guideline

This guideline replaces and merges the ‘Note for guidance on in-use stability testing of veterinary medicinal products (excluding immunological veterinary medicinal products)’ (EMEA/CVMP/424/01 – FINAL) and the ‘Note for guidance on maximum shelf-life for sterile medicinal products after first opening or following reconstitution’ (EMEA/CVMP/198/99 – FINAL). Administrative changes are made in order to align the guideline with Regulation (EU) 2019/6 and the current EMA template for Guidance. The references to the applicable legislation and other scientific guidelines have also been updated. As no changes were made to the scientific content, no concept paper or public consultation were deemed necessary.

Keywords: stability, in-use shelf-life, multidose container, sterile, maximum shelf-life, veterinary medicinal product

Current effective version

Guideline on in-use stability testing of veterinary medicinal products

Adopted Reference Number: EMA/CVMP/QWP/59158/2025 Legal effective date: 30/09/2025

Document history

Note for guidance on in-use stability testing of veterinary medicinal products (excluding immunological veterinary medicinal products)

Adopted Reference Number: EMEA/CVMP/424/01 - FINAL Legal effective date: 01/09/2002

Note for guidance: Maximum shelf-life for sterile medicinal products after first opening or following reconstitution

Adopted Reference Number: EMEA/CVMP/198/99 - FINAL Legal effective date: 01/02/2001