EMA: Revised Q&A MRA EU-USA
The EMA has updated its Questions and Answers on the EU-US Mutual Recognition Agreement (MRA). The update follows the completion of the FDA's assessment of all EU authorities responsible for GMP inspections of veterinary medicinal products on 29 May 2026. As a result, mutual recognition is now fully operational for veterinary medicinal products.
For eligible veterinary medicinal products manufactured and tested in the United States, import testing in the EU may now be waived, provided that the products have been manufactured and tested in the United States and are accompanied by a batch certificate. The corresponding provisions for human medicinal products have been in place since 11 July 2019.
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