EU GMP for Veterinary API and Products
- Date
- October 27, 2025
- Category
EU Regulations
- Description
On 27 October 2025 two new implementing Regulations for veterinary medicines GMP were published in the Official Journal by the European Commission.
- GMP for APIs used in Veterinary Medicinal Products, Regulation 2025/2154, see Implementing regulation - EU - 2025/2154 - EN - EUR-Lex.
- GMP for Veterinary Medicinal Products, Regulation 2025/2091, see Implementing regulation - EU - 2025/2091 - EN - EUR-Lex.
Both are Regulations that implement requirements in Regulation (EU) 2019/6 and will apply from 16 July 2026.
The publication for these new Regulations marks a very significant shift for GMP in the EU. Since EU GMP was first introduced in 1991, the model has been for a relatively short legislative document (e.g. Directive 91/412/EEC for veterinary medicines) with more detailed GMP expectations published as guidelines in EudraLex volume 4, which applied to both human and veterinary medicines. In addition, the EU GMP guidelines in EudraLex volume 4 have been aligned with the PIC/S GMP guidelines, with the only exception being the changes for ATMPs that the European Commission introduced in 2017.
These two new Regulations for veterinary medicines GMP are a complete break with the historic model in that they contain the detailed expectations within the Regulations, negating the need for separate GMP guidelines. This means that from 16 July 2026, the EudraLex volume 4 GMP guideline will only apply to human medicines, which will also break the link with the PIC/S GMP guidelines.