EU and US Reach Agreement on Mutual Recognition of Results of GMP Inspections for Veterinary Products
On 31 May 2023, the European Union and the United States reached an agreement on the mutual recognition of the results of pharmaceutical Good Manufacturing Practices (GMP) inspections for veterinary products. Pursuant to the agreement, it will be possible to export and sell in the US veterinary products produced in the EU without a prior US inspection of EU producers. The same applies conversely to US products sold in the EU (see, attached press release).
The EU and the US had already concluded a similar agreement for human medicines which was rolled out gradually across the EU and became operational in all EU Member States in July 2019 (see, Van Bael & Bellis Life Sciences News and Insights of 12 July 2019).
The US Food and Drug Administration (FDA) has so far recognised the ability of 16 EU Member States to carry out pharmaceutical GMP inspections of veterinary products. For its part, the EU recognised the FDA as an equivalent authority to carry out such inspections. The US assessment of the remaining competent authorities of the Member States is under way and is scheduled to be completed by July 2024.
Both parties indicated that they also started discussions to extend the scope of the arrangement to human vaccines and plasma-derived medicinal products.
All of this results from the Sectoral Annex for pharmaceutical GMP inspections under the Mutual Recognition Agreement between the EU and the US which provides for the mutual recognition of conformity assessment activities in a range of industries.