The requirement of a EU batch release site established in the EU is a fundamental pillar of the EU system of ensuring quality of medicinal products. Following Brexit, UK will be a third country for the EU. This third-country status will apply under all Brexit scenarios and therefore all batch release activities must be moved from the United Kingdom to the European Union. UK companies will have to comply with this requirement by the withdrawal date, meaning by 01 January 2021 at the latest.
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