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Several key measures in the United States and European Union that address these issues are progressing with either implementation or further discussion slated for July 2013.
On top of the agenda is the implementation of the European Falsified Medicines Directive, which seeks to prevent falsified medicines entering the legal supply chain in the EU. The directive was adopted in July 2011, and EU member states began applying provisions in January 2013. The directive harmonizes and strengthens safety and control measures across Europe in four main areas: safety features of medicines, supply chain and good distribution practices (GDPs), active substances and excipients, and internet sales.
On the pharmaceutical ingredient side, beginning this month, all active substances manufactured outside the EU and imported into the EU must be accompanied by a written confirmation from the regulatory authority of the exporting country.
To meet the requirement for the import of active pharmaceutical ingredients (APIs) under the European Falsified Medicines Directive, FDA reported on June 21, 2013, that the U.S. is now a "listed country" within the EC so that U.S. companies need not obtain an export certificate from FDA before shipping certain pharmaceutical products to Europe. Without the waiver, all U.S. companies shipping APIs to Europe after July 1, 2013 would have had to first submit documentation from FDA that the product was manufactured in accordance with Europe's good manufacturing practices.
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