On 5 June 2026, the European Medicines Agency (EMA) published a standard operating procedure (SOP) for the preparation of annual reports under the European Surveillance of Veterinary Antimicrobial Consumption (ESUAvet) framework. The SOP aims to harmonise data collection and reporting across EU member states, impacting national competent authorities, veterinary pharmaceutical companies, and livestock producers.
The document, issued by EMA's Veterinary Medicines Division, outlines the step-by-step process for compiling, validating, and submitting annual antimicrobial consumption data. It specifies timelines, data sources, quality control measures, and roles of stakeholders. The SOP is mandatory for national authorities and sets concrete deadlines for data submission, with the first report under the new procedure expected in 2027.
Policy orientations and trade-offs
The SOP introduces stricter data validation requirements to improve accuracy, which may increase administrative burden for national agencies. It also standardises reporting formats, reducing flexibility for member states with existing national systems. The procedure prioritises data completeness and timeliness, potentially requiring additional resources for countries with limited surveillance infrastructure.
Impact on stakeholders - National competent authorities: face increased workload for data validation and harmonisation, but benefit from clearer guidelines and reduced discrepancies. - Veterinary pharmaceutical companies: must ensure their sales data align with new reporting standards, potentially requiring system updates. - Livestock producers: indirectly affected as improved surveillance may lead to targeted antimicrobial reduction policies. - EU policymakers: gain more reliable data to assess progress on antimicrobial resistance (AMR) reduction targets.
Expected institutional follow-up EMA will provide training and technical support to member states ahead of the first reporting cycle. The European Commission is expected to use the harmonised data to evaluate the effectiveness of national AMR action plans. The SOP may be revised after the initial reporting period based on feedback from stakeholders.
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