Parallel trade of veterinary medicines: new sample preservation rules 2026

Key data

Companies with authorization for parallel trade of veterinary medicines in the European Union face a new compliance obligation: adapting their internal sample preservation protocols to the technical specifications updated by the Implementing Regulation (EU) 2026/857, published on 17 April 2026.

This regulation modifies Implementing Regulation (EU) 2025/2091 and focuses on a specific and technical aspect of the repackaging process: how samples of veterinary medicines redistributed between Member States are preserved. It is not a minor change: non-compliance can cost you your authorization to operate.

What does this regulation establish?

Regulation (EU) 2026/857 introduces specific changes to sample preservation requirements within the framework of parallel trade of veterinary medicines between EU Member States.

The key aspects it regulates are as follows:

• Update of technical storage specifications for samples of repackaged veterinary medicines.
• New traceability requirements applicable to samples during the repackaging and cross-border distribution process.
• Obligation to review internal protocols for holders of parallel trade authorizations, in order to ensure product safety and quality.

The regulation being modified is Implementing Regulation (EU) 2025/2091, which already established the general framework for parallel trade of veterinary medicines. Regulation 2026/857 updates only the part relating to sample preservation, without altering the rest of the authorization regime.

Economic and operational impact

The impact of this regulation is primarily operational: it does not establish fees or direct financial amounts, but generates indirect costs that affected companies must anticipate.

• Review of internal procedures: Holders of parallel trade authorizations will need to allocate human and technical resources to audit and update their sample storage and traceability protocols.
• Possible infrastructure adaptations: Depending on the specific new technical specifications, it may be necessary to adjust physical storage conditions for samples.
• Risk of loss of authorization: The highest cost is the regulatory risk. Withdrawal of parallel trade authorization by competent national authorities means the inability to operate in that market, with the consequent impact on revenue.
• Administrative sanctions: Non-compliance may result in sanctions by national authorities, the specific amount of which will depend on the sanctioning legislation of each Member State.

Who does it affect?

This regulation directly and exclusively affects a very specific business profile:

• Companies with authorization for parallel trade of veterinary medicines issued by competent authorities of any EU Member State.
• Distributors carrying out repackaging operations of veterinary medicines for cross-border commercialization within the European single market.
• Quality and regulatory compliance managers (Qualified Persons, technical directors) in companies in the veterinary pharmaceutical distribution sector.
• Regulatory advisors and consultants providing services to companies in the veterinary medicines sector in parallel trade.

It does not affect manufacturers of veterinary medicines that do not operate in parallel trade, nor distributors that only commercialize products within a single Member State without repackaging.

Practical example

A Spanish company holding a parallel trade authorization imports veterinary medicines from Poland, repackages them with labeling in Spanish, and distributes them in the Spanish market.

Until now, its procedures for preserving samples of repackaged batches followed the specifications of Regulation (EU) 2025/2091. With the entry into force of Regulation (EU) 2026/857, this company must:

1. Review whether its current sample storage conditions comply with the new technical specifications.
2. Update the standard operating procedure (SOP) corresponding to sample preservation.
3. Document the changes made to demonstrate compliance in the event of an inspection by the Spanish Agency for Medicines and Health Products (AEMPS) or another competent national authority.

If the company does not make this adaptation and is inspected, it is exposed to administrative sanctions or, in the worst scenario, withdrawal of its parallel trade authorization, which would prevent it from continuing with this line of business.

What should companies do now?

1. Identify if you have authorization for parallel trade of veterinary medicines: If you operate under this regime in any EU Member State, this regulation applies directly to you.
2. Locate and review Regulation (EU) 2025/2091: Compare the previous sample preservation requirements with the new ones introduced by Regulation 2026/857 to identify compliance gaps.
3. Audit internal sample storage and traceability procedures: Review current SOPs and verify whether current preservation conditions comply with the new technical specifications.
4. Update internal protocols: Modify procedures that do not comply with the new requirements and document the changes made with date and responsible party.
5. Train involved personnel: Ensure that warehouse, quality, and compliance managers know the new requirements and apply them correctly.
6. Consult a specialized regulatory advisor: Since the entry into force date has not been specified in available information, verify in the official text the exact adaptation deadline to avoid non-compliance.