Friday, June 21, 2013

FDA Gets EC Waiver To Export APIs

Press Announcements > FDA obtains waiver from European Commission to facilitate export for U.S. pharmaceutical manufacturers:

" . . . the U.S. is now a “listed” country with the European Commission (EC) so that U.S. companies need not obtain an export certificate from the FDA before shipping certain pharmaceutical products to Europe.

Without the waiver, all U.S. companies shipping active pharmaceutical ingredients (APIs) to Europe after July 1, 2013 would have had to first submit documentation from the FDA that the product was manufactured in accordance with Europe’s good manufacturing practices."

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