Commission Implementing Regulation (EU) 2026/857

Contents

THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC^note, and in particular Article 93(2) thereof,Whereas:

(1)Commission Implementing Regulation (EU) 2025/2091^note lays down good manufacturing practice for veterinary medicinal products. It sets out rules on the retention of samples of veterinary medicinal products for the purpose of quality control.

(2)The Pharmaceutical Inspection Cooperation Scheme has recommended specific requirements as regards the retention of samples of veterinary medicinal products that are repackaged for the purpose of parallel trade. Those specific requirements have also been agreed by the Good Manufacturing Practice / Good Distribution Practice (GMP/GDP) Inspectors Working Group of the European Medicines Agency.

(3)In order to ensure that good manufacturing practice for veterinary medicinal products in the Union are consistent with those specific requirements agreed at international level by the Pharmaceutical Inspection Cooperation Scheme and at Union level by the European Medicines Agency, it is appropriate to set out those specific requirements in Implementing Regulation (EU) 2025/2091.

(4)Implementing Regulation (EU) 2025/2091 should therefore be amended accordingly.

(5)As Implementing Regulation (EU) 2025/2091 is to apply from 16 July 2026, this Regulation should apply from the same date.

(6)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,

HAS ADOPTED THIS REGULATION: