EU Veterinary Antibiotic Regulations Explained: A New Perspective on Companion Animal Treatment in the Era of Antimicrobial Resistance

Under the One Health framework, the world is responding to the challenge of Antimicrobial Resistance (AMR) at an unprecedented pace. This issue not only concerns human health but is also closely tied to animal health and environmental protection. As a global leader in regulatory standards, the European Union has introduced the Regulation (EU) 2019/6 on Veterinary Medicinal Products, along with its related provisions, which are beginning to bring profound impacts on the veterinary profession. This article provides an in-depth analysis of these regulations and explores how veterinarians can adopt innovative tools to stay ahead in this era of transformation.

1. EU Regulatory Trends: Precision Medicine and the Role of Companion Animals

Although the market authorization framework for veterinary medicines resembles that of human pharmaceuticals, significant differences exist in industry scale, markets, and target populations. Veterinary medicine must serve a highly diverse set of species, primarily divided into food-producing animals and companion animals. While food animals account for the majority of antibiotic use, the new regulations place increasing emphasis on antimicrobial use in companion animals.
The European Medicines Agency (EMA) categorizes antibiotics into four classes (A, B, C, D) based on their risk to public health and their value in veterinary medicine. These categories apply to all animal species and define clear principles for antimicrobial stewardship:

• Category A (Avoid): These antibiotics are generally prohibited for animal use. In exceptional cases—such as therapeutic gaps—they may be used in companion animals, but always under strict conditions and ideally guided by Antimicrobial Susceptibility Testing (AST).
• Category B (Restrict): Considered critically important for veterinary medicine, these antibiotics may only be prescribed if no Category C or D alternatives are effective. Their use should likewise be supported by AST results.
• Category C (Caution): These antibiotics should only be considered if no suitable Category D option is available.
• Category D (Prudence):Recommended as the first-line treatment whenever possible.

This framework demonstrates that antibiotic selection is no longer solely at a veterinarian’s discretion but must follow a stepwise hierarchy of use. Notably, EU member states such as the Netherlands, Belgium, and Denmark now require veterinarians by law to perform AST before prescribing Category B (e.g., fluoroquinolones) or Category A antibiotics (e.g., 3rd/4th generation cephalosporins). This confirms that AST prior to prescription is becoming an inevitable global trend.

2. The Urgency of AMR and the Central Role of AST

The most critical consequence of antibiotic misuse is the emergence of bacterial strains that develop co-resistance or cross-resistance to antibiotics used in human medicine, which can then spread across species. This poses serious risks not only to animal health but also to human health. Studies clearly demonstrate a positive correlation between veterinary antibiotic consumption and antimicrobial resistance in animals, as well as strong associations with resistance in WHO priority human pathogens.
For this reason, the EU emphasizes that prescriptions must be clinically justified. Any antibiotic use must follow clinical examination or health assessment, and whenever possible, pathogen identification and susceptibility testing should precede treatment. This principle applies to all antibiotic categories, not just A or B.
However, traditional AST methods are time-consuming, often requiring several days to produce results. In urgent clinical situations involving companion animals, veterinarians cannot always afford to wait, which can lead to empirical prescribing and subsequently increase the risk of resistance development.

3. Our Solution: Rapid and Accurate AST for Companion Animal Veterinarians

This is precisely the challenge that MedFluid’s NAST system was designed to address. Our diagnostic instrument and consumables for antimicrobial susceptibility testing are tailored for veterinary clinics, delivering accelerated and reliable AST results. This enables veterinarians to:

• Comply with regulatory requirements:Our solution provides rapid AST data, ensuring veterinarians remain compliant with increasingly strict regulations, particularly in regions where AST is now mandatory prior to prescribing critical antibiotics.
• Enable precision prescribing:Instead of relying solely on experience, symptoms, or medical history, our system provides sample-based susceptibility data to guide every clinical decision—optimizing treatment outcomes and potentially shortening recovery times.
• Combat AMR at its roots:By reducing unnecessary or inappropriate use of antibiotics, our platform directly helps slow the emergence and spread of resistant bacterial strains.

The evolution of EU regulations signals a global shift: antibiotic use will be subject to stricter control, while precision medicine will become the new norm. MedFluid’s NAST system stands as the ideal tool for veterinarians navigating this new era. By leveraging technology, we can empower veterinarians to safeguard companion animal health while contributing to the worldwide fight against antimicrobial resistance.

References

1. Allel, K., et al., 2023. Global antimicrobial-resistance drivers: an ecological country-level study at the human-animal interface. Lancet Planet Health 7, e291-303.
2. European Medicines Agency (EMA). (2020). Categorisation of antibiotics used in animals promotes responsible use to protect public and animal health. EMA/688114/2020.
3. European Medicines Agency (EMA). (2022a). Antimicrobial Sales and Use (ASU) data reporting protocol Part 1 Reporting volume of sales. Implementation of the requirements of Regulation (EU) 2019/6 for the collection of data on antimicrobial medicinal products used in animals. EMA/258839/2022.
4. European Medicines Agency (EMA). (2022b). Sales of veterinary antimicrobial agents in 31 European countries in 2021 – Trends from 2010-2021. Twelfth ESVAC report. Publications Office of the European Union.
5. Ministry of Health, Welfare and Sport. Animal Health Register, The Netherlands. Regelingdiergeneeskundigen.
6. Reg. (EU) 2019/6, 2019. Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC. Official Journal of the European Union, L 4, 7.1.2019.
7. Schmerold, I., Geijlswijk, I. van, & Gehring, R. (2023). European regulations on the use of antibiotics in veterinary medicine. European Journal of Pharmaceutical Sciences, 189, 106473.
8. World Health Organisation (WHO). (2017). One Health.
9. World Health Organisation (WHO). (2019). Critically Important Antimicrobials for Human Medicine – 6th revision 2018. Geneva: World Health Organization.