FDA Asks for Exemption From New EU API Rules

February 1, 2013

The FDA is asking for a “third country” exemption from new API import rules under the EU’s Falsified Medicines Directive.

Under the directive, API manufacturers from countries outside the EU must obtain written confirmation from local or national regulators that their good manufacturing practices are equivalent to those in the EU.

The FDA submitted its request Jan. 17, 2013, and it will take at least seven months to receive the designation, experts have estimated.

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