2:48 PM
Jul 10, 2018
 |  BC Extra  |  Politics & Policy

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

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.

Under EU law, a company can only market a medicine in the EU if the marketing authorization holder, the qualified person for pharmacovigilance (QPPV), the pharmacovigilance system master file (PSMF) and certain manufacturing sites are all based in the European Economic Area.

Sponsors for 58% of the surveyed products are on track with their planning, according to the survey. The agency did not receive replies from companies for 10% of authorized products.

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