6 June 2023

EMA: EU – US Mutual Recognition Agreement for Veterinary Medicines Inspections

The mutual recognition of inspections of certain veterinary medicines between the European Union and the United States has reached a significant milestone. On 31st of May 2023, the US FDA recognised the capability of 16 EU Member States to carry out GMP inspections for certain veterinary products at a level equal to the US. At the same time, the EU also recognised the FDA as an equivalent authority for GMP inspections of sites manufacturing veterinary medicines (EC: Decision No. 2536/2023 United States – European Union amended Sectoral Annex for pharmaceutical good manufacturing practices (GMPs) (the ‘Annex’) on including veterinary products within the product coverage of the Annex of 11 May 2023 [2023/1044]).


The Member States whose GMP inspections for veterinary medicines are recognised by the FDA are Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Luxembourg, Netherlands, Poland, Portugal, Slovenia, and Spain. A timely assessment of the remaining 11 competent authorities of Member States is projected.


Two Q&A documents have been revised, accordingly:

Q&A on the impact of the Mutual Recognition Agreement (MRA) between the European Union and the United States as of 31 May 2023