Summary

This European Medicines Agency Q&A explains the scope and practical implementation of the Mutual Recognition Agreement between the European Union and the United States in the area of pharmaceutical Good Manufacturing Practice (GMP). It describes how the agreement enables the parties to rely on GMP inspections conducted by recognised authorities in each other’s territories.

The document sets out the framework for regulatory cooperation, including the recognition of competent authorities, the operation of the agreement’s sectoral provisions and the circumstances in which regulators may still conduct their own inspections. It also explains the product scope and relevant limitations.

The updated Q&A addresses the veterinary medicines provisions, which became fully operational on 29 May 2026 following completion of all EU national competent authorities responsible for veterinary products and the resulting recognitions. It explains the implications for reliance on GMP inspection results and for certain batch controls under Article 97(7) of Regulation (EU) 2019/6. The exemption from EU import controls applies to qualifying veterinary medicines manufactured in the United States, provided that the required controls have been performed there and each batch is accompanied by the prescribed manufacturer’s certificate.

The document is relevant to regulatory affairs professionals, GMP and quality teams, Qualified Persons, manufacturers and importers supplying human or veterinary medicinal products to the EU and US markets.