In October 2025, the European Commission published two new Implementing Regulations on Good Manufacturing Practice (GMP) for Veterinary Medicinal Products and their Active Substances. These new rules represent a major regulatory transition, shifting veterinary GMP from guideline-based expectations (EudraLex Volume 4) to binding, sector-specific legislation.  

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The new Regulations, taking effect from 16 July 2026 are the following:

• Commission Implementing Regulation (EU) 2025/2091 – GMP for Veterinary Medicinal Products.

• Commission Implementing Regulation (EU) 2025/2154 – GMP for Active Substances used as starting materials in Veterinary Medicinal Products.

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These Implementing Regulations define the GMP requirements introduced under Regulation (EU) 2019/6 and will replace the current veterinary GMP provisions in EudraLex Volume 4, which are currently aligned with the framework for Human Medicinal Products and Active Substances. This alignment will be maintained, despite the new GMP requirements having a legal basis specific for veterinary.

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The European Commission has published tables of correspondence which provide an overview of the relations between the new Regulations and the current GMP requirements, supporting the organizations for a smooth and guided transition.

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The new Regulations provide greater clarity and legal enforceability, establishing more structured expectations for manufacturing operations, documentation, quality systems, and compliance oversight.

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Understanding and preparing for the new GMP requirements is essential to ensure product quality, regulatory compliance, and the continuity of veterinary medicinal products supply chain.

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