Antimicrobials
VeterinaryRegulatory and procedural guidanceResearch and developmentScientific guidelines
The European Medicines Agency's scientific guidelines on antimicrobials help medicine developers prepare marketing authorisation applications for veterinary medicines.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
When reading the guidelines below, please consider the definitions provided in Article 4 of Regulation (EU) 2019/6 of the following terms: ‘antimicrobial resistance’, ‘antimicrobial’, ‘antibiotic’, ‘metaphylaxis’ and ‘prophylaxis’. |
Guidelines
- Assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food-producing animals - Scientific guideline
- VICH GL27 Guidance on the pre-approval information for registration of new veterinary medicinal products for food-producing animals with respect to antimicrobial resistance - Scientific guideline
Reflection papers
- CVMP reflection paper on promoting the authorisation of alternatives to antimicrobials in the EU
- Use of aminoglycosides in animals in the European Union: development of resistance and impact on human and animal health - Scientific guideline
- Use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health
- Antimicrobial-resistance surveillance as post-marketing authorisation commitment
- Dose review and adjustment of established veterinary antibiotics in the context summary of product characteristic (SPC) harmonisation - Scientific guideline
- Off-label use of antimicrobials in veterinary medicine in the European Union
- Meticillin-resistant Staphylococcus aureus in food-producing and companion animals in the European Union: epidemiology and control options for human and animal health - Scientific guideline
- Meticillin-resistant Staphylococcus pseudintermedius
- Risk of antimicrobial resistance transfer from companion animals
- Use of macrolides, lincosamides and streptogramins in food-producing animals in the European Union: development of resistance and impact on human and animal health - Scientific guideline
- Use of pleuromutilins in food-producing animals in the European Union: development of resistance and impact on human and animal health - Scientific guideline
- Use of third- and fourth-generation cephalosporins in food-producing animals in the European Union: development of resistance and impact on human and animal health - Scientific guideline
Concept papers
- Development of a reflection paper on the availability and characteristics of diagnostic tests to improve the responsible use of antibiotics in animals
- Further guidance on interpretation of the data from VICH GL27
Public statements and scientific reports
- Joint scientific report of the European Centre for Disease Prevention and Control (ECDC), the European Food Safety Authority (EFSA) and the European Medicines Agency on meticillin-resistant Staphylococcus aureus (MRSA) in livestock, companion animals...
- Use of (fluoro)quinolones in food-producing animals in the European Union: development of resistance and impact on human and animal health - Scientific guideline