EU Exempts U.S. APIs From Export Certification Requirements
Exporters of active pharmaceutical ingredients to the EU will avoid burdensome certification requirements, after the European Commission declared the U.S. a “listed” country June 21 (here). Without the waiver, all U.S. companies shipping APIs to Europe after July 1 would have had to first submit documentation from the Food and Drug Administration that the product was manufactured in accordance with Europe’s good manufacturing practices, FDA said.
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To avoid the export certification requirement, FDA filed a request with the European Commission in January for a “listing” request that U.S. current good manufacturing practices are equivalent to EU standards. After an audit in May, the European Commission found the U.S. qualified. Without the equivalence finding, U.S. APIs would have been subject to the requirements of the EU’s 2011 Falsified Medicines Directive, including certification.