28 October 2025
European Commission Publishes Implementing Regulations on Good Manufacturing Practice for Veterinary Medicinal Products and Active Substances
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The Official Journal of the European Union published yesterday:
- Commission Implementing Regulation (EU) 2025/2091 of 17 October 2025 “laying down good manufacturing practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council”; and
- Commission Implementing Regulation (EU) 2025/2154 of 17 October 2025 “laying down good manufacturing practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council” (together, the Implementing Regulations).
The Implementing Regulations shape the requirements contained in Regulation (EU) 2019/6 on veterinary medicinal products and will apply from 16 July 2026. They will replace the current Good Manufacturing Practice (GMP) requirements for veterinary medicinal products and their active substances in EudraLex Volume 4, which are aligned with those for medicinal products for human use and their active substances. This alignment will be maintained, despite the new GMP requirements having a different legal basis specific to veterinary medicinal products.
The European Commission has published helpful tables of correspondence which provide an overview of the relations between each of the Implementing Regulations and the existing GMP requirements applicable to veterinary medicinal products and active substances.
Attached are copies of the Implementing Regulations and the tables of correspondence.
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