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New EU sample retention rules coming up for veterinary medicines repackaged for parallel trade

The Veterinary Medicinal Products Regulation (EU) 2019/6 has applied in the EU since 28 January 2022, replacing Directive 2001/82/EC. The new rules on good manufacturing practice (GMP) will in turn be fleshed out by Commission Implementing Regulation (EU) 2025/2091, which will apply from 16 July 2026. In addition, the European Commission is introducing new GMP requirements concerning the retention of samples for veterinary medicinal products that are repackaged for parallel trade. This blog post briefly examines what these new obligations entail.

Incoming GMP rules for veterinary medicinal products

Under the Veterinary Medicinal Products Regulation, manufacturing authorisation holders must comply with GMP. These requirements are laid down in Commission Implementing Regulation (EU) 2025/2091 (GMP Implementing Regulation), which will apply from 16 July 2026 and replace the rules under Directive 2001/82/EC. Until then, the existing Directive-based principles – largely carried over into the new framework – continue to apply.

Correct sampling is a key GMP requirement to ensure product quality. Under the GMP Implementing Regulation, two types of samples are required:

• A reference sample: a sample of a batch of materials used in the manufacture of a veterinary medicinal product or finished product which is stored for the purpose of being analysed should the need arise during the shelf life of the batch concerned.
• A retention sample: a sample of a fully packaged unit from a batch of finished product which is stored for identification purposes.

Both types should be kept as a record of the batch of finished product or of batches of materials used in the manufacture of the veterinary medicinal product and for assessment in the case of quality investigations.

While Art. 34(1)-(8) of the GMP Implementing Regulation sets out detailed sampling rules, it does not address products repackaged for parallel trade. Current guidance contains only limited references to such situations (most notably in Annex 19 of the good manufacturing practice guideline for medicinal products).

Specific rules for veterinary medicines repackaged for parallel trade

To align with international recommendations, Commission Implementing Regulation (EU) 2026/857 amends the GMP Implementing Regulation by adding paragraphs 9 and 10 to Art. 34. These provisions introduce specific sample retention rules for veterinary medicinal products repackaged for parallel trade.

For parallel-traded products (procured by a wholesale distributor in a source Member State for distribution in a destination Member State), samples must now be retained in a defined way:

• Packaging materials: Physical samples of packaging materials used in the re-packaging process (e.g. 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.
• Retention sample of re-packaged finished product:
  • must be taken for each repackaging operation.
  • must be kept for at least 1 year after expiry.
  • must represent the product as released to the market.
  • must include the immediate and outer packaging.
• Exception (outer packaging not opened): If the outer packaging is not opened during repackaging, only the outer packaging materials of the re-packaged finished product need to be retained.
• Alternative (photographic/digital sample): If justified and pre-authorised by the competent authority, a photographic/digital sample may be used instead of a physical one, provided that:
  • it allows full visual inspection equivalent to a physical sample.
  • it includes all immediate and outer packaging data (including batch number and expiry date).
  • it is stored in a computerised system that complies with Annex IV of the GMP Implementing Regulation.

As the GMP Implementing Regulation applies from 16 July 2026, these amendments will also take effect from that date. The new rules apply only to intra-EU parallel trade: veterinary medicinal products imported from outside the EU remain subject to separate sampling requirements set out in Art. 40 of the GMP Implementing Regulation

Conclusion

In sum, the upcoming amendment of the GMP Implementing Regulation clarifies and standardises sample retention obligations for veterinary medicinal products repackaged in the context of parallel trade, closing a previously un(der-)addressed gap in the GMP framework. Notably, it implies that specific GMP requirements may extend to wholesale distributors involved in such activities, even though they are typically subject only to good distribution practices (GDP).

Authors: Christophe Ronse & Bart Junior Bollen