Companies that repackage animal medicines for parallel trade across EU borders now face specific retention requirements for packaging materials and finished product samples
April 17th, 2026 – Parallel trade in veterinary medicines, where authorised products move between EU member states and get repackaged for the destination market, has long operated under general good manufacturing practice rules. A small but operationally specific amendment published today fills a gap in those rules by setting out exactly how repackagers must retain samples of the products they handle.
The change adds two new provisions to Implementing Regulation (EU) 2025/2091, which governs veterinary GMP standards and applies from 16 July 2026. Repackagers must now keep physical samples of all packaging materials used (including labels, cartons, and leaflets) for the full shelf life of the repackaged product. They must also retain a finished product sample from each repackaging batch, held for at least one year after the product’s expiry date, covering both primary and secondary packaging.
Where keeping a physical sample is genuinely impractical, and a competent authority agrees, operators can substitute a photographic or digital sample instead. That digital record must show the complete packaged product, capture all text on both primary and secondary packaging including batch number and expiry date, and be stored in a validated computerised system meeting the technical requirements of Annex IV of the parent regulation.
The rules align EU practice with recommendations already agreed internationally by the Pharmaceutical Inspection Co-operation Scheme and endorsed by the EMA’s GMP/GDP Inspectors Working Group. Both bodies had identified this as a gap in existing standards for parallel trade repackaging specifically.
The amendment applies from 16 July 2026, in line with the rest of Implementing Regulation (EU) 2025/2091. Operators involved in parallel trade repackaging of veterinary products should review their sample retention procedures ahead of that date.
