18/19 October 2023
At a meeting of the EU-US Trade and Technology Council, the US and the EU agreed to mutually recognise the results of GMP inspections for veterinary medicinal product manufacturers. This means that veterinary medicines manufactured in the EU can now be exported to the US and marketed there without the EU manufacturers having to be inspected by a US authority beforehand, and vice versa. Nevertheless, the authorities can reserve the right to carry out GMP inspections in certain cases despite the agreement.
This extends the sectoral annex for pharmaceutical GMP inspections under the Mutual Recognition Agreement (MRA) to veterinary medicinal products.
The US Food and Drug Administration (FDA) has already recognised the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal 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 Member State Competent Authorities will continue according to a timetable agreed with the US. The target date for completion of the assessment of all EU authorities has been set at July 2024.
More details can be found on the website of the EMA.