BioCentury
ARTICLE | Politics & Policy

Some drugs with U.K. sponsors may miss Brexit cut

July 10, 2018 9:48 PM UTC

EMA found that 16% of centrally approved medicines with manufacturing sites located in the U.K. only are at risk of losing marketing authorization in the EU when the U.K. leaves the union next March. These at-risk products include 88 human products and 20 veterinary products.

EMA said its survey of 694 centrally authorized products whose market authorization holder is located in the U.K. raised "serious concerns" that marketing authorization holders of the 108 at-risk products are not on track with regulatory planning to ensure their marketing authorization will remain valid after Brexit...