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FDA Export Certificates No Longer Needed for Drug Ingredient Shipments to EU

Tuesday, June 25, 2013
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration announced June 21 that the European Commission has approved a request that the FDA’s good manufacturing practices with respect to active pharmaceutical ingredients be considered at least equivalent to those in Europe. As a result, U.S. companies will not have to obtain an FDA export certificate before shipping APIs to Europe. An agency press release states that without this status all U.S. companies shipping APIs to Europe after July 1 would have had to first submit FDA documentation that the product was manufactured in accordance with Europe’s good manufacturing practices.

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