The European Medicines Agency (EMA) has received a formal request from the European Commission to prepare a report on the implementation of Article 141(1)(f) of Regulation (EU) 2019/6 on veterinary medicinal products. The request, dated 22 May 2026, asks EMA to assess the impact and effectiveness of the provision, which concerns the obligation for marketing authorisation holders to report on the sales and use of antimicrobial veterinary medicines. The report is expected to inform future policy decisions on antimicrobial resistance (AMR) in the veterinary sector.
The request follows the entry into force of Regulation (EU) 2019/6, which has been applicable since 28 January 2022. Article 141(1)(f) requires the Commission to submit a report to the European Parliament and the Council on the implementation of the obligation to collect data on the sales and use of antimicrobials in animals. EMA's role is to provide scientific and technical input for this report, including an analysis of the data collected by Member States and the feasibility of further harmonisation.
No prior coverage of this specific request exists in recent records. The document is a formal letter from the Commission to EMA, outlining the scope and timeline for the report. EMA is expected to deliver its findings within a timeframe to be agreed with the Commission, likely within the next 12 months.
Stakeholder impact
The request primarily affects veterinary pharmaceutical companies, which are required to report sales and use data under the regulation. National competent authorities in EU Member States will also be involved in data collection and validation. The report's conclusions could lead to stricter monitoring requirements or changes to the reporting framework, potentially increasing administrative burden for industry but also contributing to the EU's action plan against AMR. Veterinary professionals and animal health organisations may see enhanced surveillance of antimicrobial use, supporting responsible prescribing practices.
Expected follow-up
EMA will now establish a dedicated working group or consult its Committee for Veterinary Medicinal Products (CVMP) to draft the report. The Commission will use the report to decide whether to propose legislative amendments or additional measures under the regulation. The outcome is expected to be published by the Commission in the form of a report to the European Parliament and Council.
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