GMP implementation regulations for veterinary products published in the Official Journal

On October 27, 2025, the European Commission released two new implementing regulations on good manufacturing practices (GMP) in the veterinary field:

• Commission Implementing Regulation (EU) 2025/2091(for GMP of finished products)
• Commission Implementing Regulation (EU) 2025/2154(for GMP of active substances used as starting materials).

The new Implementing Regulations set out the Good Manufacturing Practice (GMP) requirements introduced by Regulation (EU) 2019/6 on veterinary medicinal products and will have to be fully applied from July 16, 2026.

The Regulations apply to manufacturers, importers, repackagers, and relabelers of active substances and medicinal products for veterinary use.

These regulations provide a specific framework and GMP requirements with their own separate legal basis within veterinary legislation, replacing the current GMP provisions for veterinary medicinal products and their active substances laid down in Volume 4 of EudraLex, which are currently aligned with the GMP framework for medicinal products for human use.

To support stakeholders, the European Commission has also issued correlation tables linking each Implementing Regulation to the existing GMP requirements for veterinary medicinal products and active substances, providing clear indication on how the new rules relate to the current regulatory framework.

The regulation applies to manufacturers, importers, repackagers, and re-labellers of active substances for veterinary use.

SOURCES:

https://eur-lex.europa.eu/oj/daily-view/L-series/default.html?&ojDate=27102025