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12.11.2025

GMP for Veterinary Products: Implementing Regulations published

Recommendation

2/3 September 2026
Copenhagen, Denmark

Root Cause Analysis
When “Human Error” isn’t enough: Successful Failure Investigation

The European Commission published new implementing Regulations for veterinary medicines good manufacturing practice (GMP) in the Official Journal in October 2025:

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 define the Good Manufacturing Practice (GMP) requirements introduced under Regulation (EU) 2019/6 on veterinary medicinal products and will take effect on 16 July 2026. They will replace the current GMP provisions for veterinary medicinal products and their active substances set out in EudraLex Volume 4, which are currently aligned with the GMP framework for human medicinal products. This alignment will continue, although the new veterinary GMP requirements will have their own dedicated legal basis under the veterinary legislation.

To support stakeholders, the European Commission has issued tables of correspondence that map each Implementing Regulation to the existing GMP requirements for veterinary medicinal products and active substances, providing clear guidance on how the new rules relate to the current framework.