New EU GMP Requirements for Veterinary Medicinal Products: What Companies Should Consider before 16 July 2026

On 17 October 2025, the European Commission published two new GMP-implementing regulations for veterinary medicinal products in the Official Journal of the European Union. We reported on this in our news dated 12 November 2025.

The New Implementing Regulations

• Commission Implementing Regulation (EU) 2025/2091: Good manufacturing practice for veterinary medicinal products
• Commission Implementing Regulation (EU) 2025/2154: Good manufacturing practice for active substances used as starting materials in veterinary medicinal products.

Entry into Force and Legal Classification

The new regulations will come into force on 16 July 2026, replacing the previous GMP regulations for veterinary medicinal products and related active substances in EudraLex, Volume 4 and establishing an independent regulatory framework for veterinary GMP.

These regulations implement the requirements of Regulation (EU) 2019/6.

Tables of Correspondence by the European Commission

To support the industry, the European Commission has published the so-called Tables of Correspondence for (EU) 2025/2091 and (EU) 2025/2154. These compare the new implementing regulations with the previous GMP requirements.

What Companies Should Consider Now

With a view to the regulations coming into force in July 2026, affected companies should take the following steps at an early stage:

• Conduct a gap analysis with regard to the new implementing regulations.
• Review existing quality management systems and SOPs and adapting them if necessary.
• Inform relevant departments about the new regulations and prepare them accordingly.