EU-US Trade and Technology Council: simpler rules for more trade in veterinary products

In EU-US Trade and Technology Council, the US and the EU 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 the 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 FDA as an equivalent authority to carry out these inspections. The US assessment of the remaining competent authorities of the 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.

Further growing transatlantic trade

EU-US trade in pharmaceutical products reached an impressive value of €123 billion in 2022. Bringing medicines to the market has become faster and less costly, to the benefit of public and animal health.

Today's agreement reduces costs resulting from duplicative inspections. It frees capacity of EU and US authorities to focus on inspections of higher risk manufacturers in other countries.

Building on today's success, the two sides have also started discussions on a decision to possibly extend the scope of the agreement to human vaccines and plasma-derived medicinal products.