FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

MHRA Issues Update on Exporting Active Substances in No-Deal Brexit

May 29, 2019

In its latest Brexit update, the UK’s Medicines and Healthcare products Regulatory Agency said the EU will consider the UK to be a “third country”—the EU’s term for non-member countries—when the UK exports active substances to the European Economic Area (EEA).

The MHRA plans to post online the confirmations that will be required for all shipments of UK-manufactured active substances distributed to the EEA. These confirmations, which are valid for three years from the date of a facility’s last inspection, are used to affirm that the facility undergoes regular inspections and ensure adherence to the EU’s GMP standards.

Requirements for acquiring written confirmations for importing active substances into the UK from EU and third countries won’t change—and UK drugmakers will still need to obtain them from the relevant issuing authorities in those countries.

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