FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EMA Issues Update on Drug Shortage Prevention Strategy for Brexit

April 3, 2019
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The European Medicines Agency released another update on its efforts to avoid drug shortages in the event that the UK crashes out of the union without a formal deal.

In a “no deal” Brexit scenario, EU law will no longer apply in the UK, so companies with operations in the UK will need to make changes if they want to supply drugs to the EU, the agency said. 

Temporary exemptions may be granted for one of the required changes under certain conditions, EMA said, such as if the batch release site is supervised by a qualified person established in the EU by the Brexit withdrawal date.

EU law requires that drugmakers carry out certain “essential operations” within the European Economic Area (EEA) to market drugs inside the zone. The EU’s drug evaluation methods will not change with Brexit, but EU authorities will pick up the evaluation activities currently carried out by the UK, the agency said.

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