ALIMS and veterinary antimicrobials

Abstract

Antimicrobial resistance (AMR) represents one of the most significant global challenges to public health, veterinary medicine, and food safety. Due to the possibility of transmission of resistant microorganisms and resistance genes among animals, humans, and the environment, the control of antimicrobial use in veterinary medicine has become a key component of the One Health concept. In this context, regulatory authorities play an important role through the assessment of the benefitrisk balance of veterinary medicinal products, the establishment of appropriate conditions for their use, and the monitoring of antimicrobial use patterns at the national level. The Medicines and Medical Devices Agency of Serbia (ALIMS) is responsible for granting marketing authorisations for veterinary medicinal products in accordance with the Law on Medicines and Medical Devices of the Republic of Serbia („Official Gazette of the Republic of Serbia“, No. 30/2010, 107/2012, 105/2017 - other law and 113/2017 - other law) and the associated secondary legislation. The marketing authorisation procedure includes a comprehensive assessment of documentation related to the quality, safety, and efficacy of the proposed medicinal product. During the evaluation process, not only national legislative requirements are considered, but also relevant European Union legislation, guidelines of the European Medicines Agency (EMA), and the guidelines issued by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). Marketing authorisations are granted only to medicinal products for which the benefit-risk balance has been demonstrated to be favourable for the target animal species and proposed indications. Information on all authorised veterinary medicinal products, including up-to-date Summaries of Product Characteristics (SPCs) and Package Leaflets, is publicly available on the Agency’s website (www.alims.gov.rs). For medicinal products intended for food-producing animals, a marketing authorisation may only be granted if they contain pharmacologically active substances for which maximum residue limits (MRLs) have been established in food of animal origin. Furthermore, the legislation prohibits the use of certain categories of substances, including hormones with anabolic effects, stilbenes and their derivatives, beta-agonists, as well as antimicrobial substances reserved exclusively for human medicine. These measures contribute to consumer protection, preservation of the effectiveness of important antimicrobial agents, and harmonization of the national regulatory framework with international standards. A particularly important aspect of regulatory assessment concerns veterinary antimicrobial medicinal products. During the authorisation procedure, data on pharmacological and toxicological properties, residues in food of animal origin, potential environmental impact, and the possible contribution to the development of antimicrobial resistance are thoroughly evaluated. In addition, indications, dosage regimens, treatment duration, withdrawal periods, contraindications, interactions, warnings, and precautions are defined to ensure the prudent and responsible use of the product. Following the granting of a marketing authorisation, ALIMS continuously monitors the quality, safety, and efficacy of veterinary medicinal products throughout their entire life cycle. New information regarding safety, efficacy, or antimicrobial resistance may lead to modifications of the approved documentation through appropriate regulatory procedures, ensuring that product information remains aligned with the latest scientific evidence. In addition to activities related to granting and maintaining marketing authorisations, ALIMS is also responsible for collecting, processing, and analysing data on the sales of veterinary medicinal products in the Republic of Serbia. The methodology used for data collection and analysis is harmonized with that applied within the European Union, while antimicrobial sales data are processed in accordance with the recommendations and methodology of the World Organisation for Animal Health (WOAH). These data represent an important indicator of trends in antimicrobial use and provide a basis for planning national activities aimed at preserving their effectiveness. Analysis of antimicrobial sales data in the Republic of Serbia for the period 2014– 2024 showed that annual sales ranged from 56 to 76 tonnes of active antimicrobial substances. The majority of these substances were used in food-producing animals, further emphasizing the importance of continuous monitoring of their use. During the observed period, the most represented antimicrobial classes were penicillins, tetracyclines, and aminoglycosides. From the perspective of antimicrobial resistance risk management, it is particularly important that penicillins and tetracyclines belong to Category D (“Prudent Use”) of the European Union AMEG (Antimicrobial Advice ad hoc Expert Group) classification system, representing the category associated with the lowest risk to public health and considered acceptable when their use is medically justified. Aminoglycosides are classified within Category C (“Caution”). At the same time, compared with 2014, an increase in the sales of polymyxins, macrolides, and amphenicols was observed. This finding deserves particular attention because polymyxins belong to Category B (“Restrict”), which includes antimicrobial substances whose use should be limited in order to preserve their effectiveness in human medicine. Macrolides and amphenicols are classified within Category C (“Caution”), indicating the need for prudent use following careful assessment of available therapeutic alternatives. Monitoring trends in the sales of these antimicrobial classes represents an important element of national strategies aimed at controlling antimicrobial resistance and identifying areas where additional educational, regulatory, or professional measures may be required. Continuous improvement of the regulatory system, monitoring of the veterinary medicinal products market, and analysis of antimicrobial use patterns represent key tools for promoting the responsible use of antibiotics in veterinary medicine. Data generated through the regulatory and surveillance activities of ALIMS enable timely identification of trends in antimicrobial use and provide a scientific basis for the implementation of measures aimed at preserving antimicrobial effectiveness. In this way, the regulatory system of the Republic of Serbia makes a significant contribution to national and international efforts to combat antimicrobial resistance and to protect human, animal, and environmental health in accordance with the principles of the One Health approach.