Pharmacy Daily | US export EU waiver

The United States has become a “listed company” with the European Commission, meaning that American companies will not need to obtain an export certificate from the Food and Drug Administration before shipping certain pharmaceutical products to Europe. Without this waiver, all US firms shipping active pharmaceutical ingredients to Europe after 01 Jul 2013 would have first had to submit documentation from the FDA that the product was made in accordance with European good manufacturing practices. The FDA filed a formal “listing request” with the EC in Jan which was followed by an audit of the FDA’s oversight procedures in May. The European requirement falls under its Falsified Medicines Directive which was enacted in 2011 “in response to the challenges posed in keeping the pharmaceutical supply chain safe at a time when products are increasingly sourced from around the world”.

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