EU: GMP Implementing Regulations for Veterinary Medicinal Products
The European Commission has adopted new Implementing Regulations on Good Manufacturing Practice (GMP) for veterinary medicinal products and for active substances used as starting materials in these products. Both regulations will take effect on 16 July 2026.
These Implementing Regulations further specify the requirements set out in Regulation (EU) 2019/6 on veterinary medicinal products and will replace the current GMP provisions in EudraLex Volume 4. While the new rules have a distinct legal basis specific to veterinary medicines, their alignment with the GMP framework for human medicinal products will be maintained.
To support implementation, the European Commission has also published correspondence tables that clearly map the relationship between the new Implementing Regulations and the existing GMP requirements for veterinary medicinal products and their active substances.
Source:
- Implementing Regulation (EU) 2025/2091 for veterinary medicinal products
- Table of Correspondence Regulation (EU) 2025/2091
- Implementing Regulation (EU) 2025/2154 for active substances used as starting materials in veterinary medicinal products
- Table of Correspondence Regulation (EU) 2025/2154
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