EMA publishes updated Q&A on EU-US MRA - Veterinary Medicinal Products now fully covered

The European Medicines Agency (EMA) has published the revised Q&A document 'Questions and answers on the impact of the Mutual Recognition Agreement (MRA) between the European Union and the United States as of 9th June 2026'. This revision reflects the latest developments in the implementation of the EU-US MRA, particularly with regard to veterinary medicinal products.

The MRA came into effect in November 2017 for selected human medicines, following the EU's conclusion in June 2017 that the US Food and Drug Administration (FDA) operates a system of inspections comparable to that in the EU. The FDA then proceeded to confirm individual EU Member States from 1 November 2017 onwards. Between 2018 and 2019, the FDA gradually recognized the inspection capability of all EU Member States for human medicines, resulting in comprehensive coverage by July 2019.

Decision No. 2536/2023 expanded the scope of the EU-US MRA to include GMP inspections of veterinary medicinal products. Following an assessment, the EU acknowledged the FDA as having comparable standards for GMP inspections of veterinary medicinal products on 30 May 2023. Concurrently, the FDA confirmed 16 EU Member States as capable of veterinary GMP inspections, bringing the MRA for veterinary medicinal products into effect, and between 2023 and 2025, further Member States were approved.

29 May 2026 marks the date on which veterinary medicinal products became fully covered by the EU-US MRA alongside human medicinal products, after the FDA completed its assessment of all EU national competent authorities responsible for veterinary medicinal products.

The updated Q&A document  therefore reflects the completion of the FDA's assessments and the full inclusion of veterinary medicinal products in the MRA.