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In Wednesday's 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.
May 31, 2023/ European Commission/ European Union.
https://ec.europa.eu
