June 6, 2023

Agreement allows EU veterinary products to be exported to US without inspection of manufacturers

In a recent EU-US Trade and Technology Council meeting, the United States and the European Union reached an agreement to mutually recognise the results of pharmaceutical Good Manufacturing Practices (GMP) inspections for veterinary products.

This means that veterinary products manufactured in the EU can now be exported to and marketed in the US without a prior US inspection of EU manufacturers and vice versa. This follows an earlier, similar decision for human medicines.

The US Food and Drug Administration (FDA) has already recognised the capacity of 16 EU member states to carry out pharmaceutical GMP inspections of veterinary products.

At the same time, the EU has recognised the US Food and Drug Administration as an equivalent authority to carry out these inspections.

The US assessment of the remaining competent authorities of EU member states continues according to a schedule agreed with the US. The target date for completion of the assessment of all EU authorities has been set for July 2024.

- European Commission