From now on, veterinarians must also record data on the use of antibacterial medicinal products in cattle and all chicken and turkey species. The condition for which the medicinal product is used must also be described. In addition, the prerequisites for the use of critical antibiotics are extended to all animals, thus including companion animals and horses. Laboratories must meet new quality standards to perform antibiogram tests.
The amended Royal Decree of 21 July 2016 laying down the conditions for use of medicinal products by veterinarians and people responsible for animals, was published on 31 July 2023 and becomes effective as of 10 August 2023.
Why an amendment?
This amendment was necessary to implement the new European Regulation on veterinary medicinal products 2019/6. Moreover, the measures are part of the National Action Plan against Antimicrobial Resistance (NAP-AMR) and the renewed covenant between the relevant sector partners and the competent governments, thus endorsing the 'One World One Health' approach to the fight against antimicrobial resistance.
What are the most important changes?
The European Regulation 2019/6 mandates data collection and reporting of both sales and use of antimicrobials in animals. In Belgium, antibiotic usage data for pigs, laying and broiler hens and veal calves are currently collected on a mandatory basis in Sanitel-Med. As of 10 August 2023, the mandatory data collection in Sanitel-Med is extended to all cattle, all categories of poultry of the species chicken and turkey. The European Regulation 2019/6 requires the collection of antimicrobial usage data to gradually expand over time from food-producing animals to companion animals and horses.
For the animal species with registration requirement in Sanitel-Med, veterinarians must compulsorily register the indication or condition for which the antibacterial medicinal product was prescribed, provided or administered. The list of medical conditions can be found here.
From now on, the prerequisites for the use of critically important antibiotics (third- and fourth-generation cephalosporins and first-, second- and third-generation fluoroquinolones), such as performing antibiotic sensitivity tests, apply for all animals, thus also for companion animals and horses.
New quality standards are in place for laboratories performing antibiogram tests.
DG PRE authorisation - Medicines for Veterinary Use Division - Antimicrobial Resistance Entity