#32026R0857Commission Implementing Regulation (EU) 2026/857
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This regulation defines new rules for the retention of samples of veterinary medicines that are repackaged for parallel trade. It requires companies to keep physical or digital samples of the repackaged products for quality control and compliance checks. These changes affect businesses involved in the repackaging and parallel distribution of veterinary medicinal products, requiring them to adjust their record-keeping and product sample retention practices.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Requires retention of physical or digital samples for veterinary medicinal products that are repackaged for parallel trade.
- Specifies storage duration and details required for retained samples.
- Allows digital samples if physical sample retention is not possible.
Obligations
What this law requires
Companies involved in the parallel trade of veterinary medicinal products must retain physical samples of packaging materials used in the re-packaging process for the duration of the shelf-life of the re-packaged finished product.
For each re-packaging operation, a retention sample of the re-packaged finished product must be taken and retained for at least one year after the expiry date of the re-packaged product.
The retention sample of the re-packaged finished product must represent the product released for the market and include immediate and outer packaging.
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 must be retained.
If a physical retention sample of the re-packaged finished product cannot be retained, a photographic/digital sample may be retained if authorized by the competent authority.