Veterinary Antimicrobial Products Classifications.

The Veterinary Antimicrobials Classification is an essential tool that helps establish antimicrobial stewardship to reduce antimicrobial resistance and emphasize the appropriate use of antimicrobials. It aims to guide the stakeholders (marketing authorization applicants and veterinarians) in classifying the veterinary antimicrobial products. This classification is updated periodically to ensure the ultimate safety and efficacy of antimicrobials among animals in Saudi Arabia, promote public health, and provide direct responses to maintain the effectiveness of antimicrobials with high importance. The classification of veterinary antimicrobial products is based on (i) their importance to human health, including whether they are among the few or only available treatments for serious human infections; (ii) the extent of their use in veterinary medicine; (iii) their spectrum of activity; (iv) the availability of alternative drugs; (v) the risk of contributing to antimicrobial resistance through animal use and transmission to humans via direct contact or animal products. Additional criteria include the route of administration, with oral and feed-based applications posing higher risks of resistance transmission than injectable or localized treatments, and whether the antimicrobial is used against bacteria that can be transmitted from animals to humans or acquire resistance genes from non-human sources.
Veterinary antimicrobial products are classified into 3 categories based on their importance to human health and their risk of contributing to antimicrobial resistance (1) prohibited antimicrobials are not allowed for animal use because they are critical in human medicine with limited or no alternatives; (2) restricted antimicrobials are authorized only for specific species, conditions, or routes of administration and should be used cautiously, preferably guided by susceptibility testing, due to their high importance for human health; (3) accessible antimicrobials are approved for animal use, have alternatives in human medicine, and are considered low risk, though their use should still be rational and avoid unnecessary or prolonged treatment. In all cases, antimicrobials should not be used for growth promotion, particularly in food-producing animals such as poultry for increasing egg production at scale, and should be reserved strictly for therapeutic use.
Two Appendices are included: (1) prohibited antibiotic substances and (2) restricted antibiotic substances.