Through Order 472 published in Official Gazette no. 398 of May 12, 2026, new obligations for collecting and reporting data on the sale and use of antimicrobial medicines in the veterinary sector are introduced.
What does it stipulate?
The Order establishes a dual reporting system to monitor antibiotic consumption in animals. On one hand, data on sales volume is collected directly from producers and distributors. On the other hand, data on the actual use of these products is collected directly from veterinarians and veterinary pharmacies. The aim is to create a complete picture of the antimicrobial products’ journey, from market placement to administration to the animal, in accordance with European regulations.
Producers and importers (marketing authorization holders) are obliged to upload annually, by March 1, data on the total sales volume of antimicrobial products from the previous year, directly into the European Union database. Separately, wholesale distributors must inform the national authority (Institute for the Control of Biological Products and Veterinary Medicines) by January 31 about the quantities of products sold in other member states (parallel trade), so that these can be deducted from the national calculation.
A major operational change concerns veterinarians and veterinary pharmacies, whose reporting obligations come into force on January 1, 2027. They will have to upload annually, within the first 60 days of the year, detailed data on the use of antimicrobial products (both veterinary and human-use products prescribed to animals) into a new national database. Reporting will be based on records from consultation registers, prescriptions, and stock cards. Head veterinarians are obliged to authenticate themselves in this new IT system by the end of 2026.
Non-compliance with reporting obligations by veterinarians will lead to the notification of the ethics committees of the College of Veterinarians. Other violations of the norm may incur contraventional sanctions. National authorities will centralize and validate all collected data, which they will subsequently transmit to the European Medicines Agency for inclusion in annual European-level reports.
Who does it apply to?
The provisions apply directly to the following categories of economic operators:
- Marketing authorization holders for veterinary medicinal products (producers, importers).
- Wholesale distributors of veterinary medicinal products.
- Units carrying out veterinary medical assistance activities (practices, clinics, veterinary hospitals).
- Veterinary pharmacies.
Indirectly, livestock farms are also targeted, as strict monitoring of antibiotic use by veterinarians will influence treatment protocols and sanitary-veterinary management.
What should you do?
- Implement an internal process for collecting and validating annual sales data, ensuring reporting to the EU platform by the March 1 deadline and, for distributors, informing the national authority by January 31.
- Prepare management systems (practices, pharmacies) to be able to extract detailed data on the use of each antimicrobial product, including those for human use, for the annual reporting that becomes mandatory from 2027.
- Ensure the registration of head veterinarians in the new national database for antimicrobial product consumption, according to the procedure to be published, by the end of Q4 2026.
- Participate in training sessions organized by the Institute for the Control of Biological Products and Veterinary Medicines to correctly understand the reporting methodology.
Source: Official Gazette, Part I, no. 398 of May 12, 2026.
Note: This material is strictly for informational purposes and does not constitute legal, tax, or business advice. As the interpretation and application of legal provisions can vary significantly depending on the specific circumstances of each entity, we recommend seeking specialized legal assistance before adopting any operational decisions based on these changes.