Commission Implementing Regulation (EU) 2026/857of 16 April 2026amending Implementing Regulation (EU) 2025/2091 as regards the retention of samples of veterinary medicinal products that are repackaged for the purpose of parallel trade(Text with EEA relevance)
European Union
Commission Implementing Regulation (EU) 2026/857 of 16 April 2026 amending Implementing Regulation (EU) 2025/2091 as regards the retention of samples of veterinary medicinal products that are repackaged for the purpose of parallel trade (Text with EEA relevance) 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 OJ L 4, 7.1.2019, p. 43, ELI: http://data.europa.eu/eli/reg/2019/6/oj. , and in particular Article 93(2) thereof, Whereas: (1) Commission Implementing Regulation (EU) 2025/2091 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 (OJ L, 2025/2091, 27.10.2025, ELI: http://data.europa.eu/eli/reg_impl/2025/2091/oj). 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:
Article 1
In Article 34 of Implementing Regulation (EU) 2025/2091, the following paragraphs are added: 9. For veterinary medicinal products that are parallel traded, samples shall be retained as set out in this paragraph. Physical samples of packaging materials used in the re-packaging process, such as labels, carton, patient information leaflet or other package inserts, shall be retained for the duration of the shelf-life of the re-packaged finished product. A retention sample of the re-packaged finished product shall: (a) be taken for each re-packaging operation; (b) be retained for at least one year after the expiry date of the re-packaged finished product;
(c) represent the re-packaged finished product released for the market; (d) include the immediate packaging as well as the outer packaging. By way of derogation from the third subparagraph, if the outer packaging of the veterinary medicinal product is not opened during the re-packaging process, only the outer packaging materials of the re-packaged finished product shall be retained in accordance with the second subparagraph. 10. Where it is duly justified that a physical retention sample of the re-packaged finished product cannot reasonably be retained and it has been subject to prior authorisation by the competent authority, a photographic/digital sample of it may be retained. A photographic/digital sample of the re-packaged finished product shall: (a) allow a full visual examination of the re-packaged product that is equivalent to that of a physical retention sample; (b) include all data on both the immediate and outer packaging, including the batch number and expiry date; (c) be stored in a computerised system that complies with all the requirements set out in Annex IV.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 16 July 2026. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 16 April 2026. For the Commission The President Ursula von der Leyen
Metadata
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- Forordning
- År
- 2026
- Ikrafttrædelsesdato
- 1. januar 1970