This document sets out regulatory framework for collecting, processing, and publishing information and statistics on the circulation and use of veterinary medicinal products. It aligns national rules with related EU acts on veterinary medicines, with a strong focus on monitoring antimicrobial use. The Food and Veterinary Service (PVD) is designated as the competent authority responsible for data collection, statistical analysis, and maintenance of the national veterinary e health information system (eVETIS).
The rules impose detailed reporting obligations on manufacturers, wholesalers, veterinary pharmacies, and veterinary practices. These actors must regularly submit standardized reports on the import, export, distribution, manufacture in pharmacies, and turnover of veterinary medicines, with specific deadlines throughout the year. Wholesalers and manufacturers also have stock-reporting obligations, including near real time updates from 2028 onward. Veterinary service providers must record and submit comprehensive data on medicines administered to animals or dispensed to animal owners, particularly antimicrobials, covering animal species, treatment details, quantities, withdrawal periods, and purpose of use (e.g. treatment, prophylaxis). Automated data exchange with eVETIS is encouraged to reduce duplication and improve data quality.
Finally, the Regulation governs the operation of eVETIS, including user access, data security, interoperability, and data retention. The system supports public statistics, regulatory oversight, policy planning, food safety controls, and EU level reporting, while ensuring data protection and traceability of veterinary medicines throughout the supply chain. Transitional provisions specify phased entry into force of certain obligations between 2026 and 2028, creating a unified and modernized framework for veterinary medicinal product monitoring in the national territory.