Article 1 · Commission Implementing Regulation (EU) 2026/857

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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;

(a)allow a full visual examination of the re-packaged product that is equivalent to that of a physical retention sample;

(b)be retained for at least one year after the expiry date of the re-packaged finished product;

(b)include all data on both the immediate and outer packaging, including the batch number and expiry date;

(c)represent the re-packaged finished product released for the market;

(c)be stored in a computerised system that complies with all the requirements set out in Annex IV.’

(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:

Article 1#

Article 1 #