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Falsified Medicines Directive requires imported APIs to have written confirmation of GMP standards.
Europe’s Falsified Medicines Directive, which came into effect in January 2013, requires that all active substances imported into the European Union (EU) have written documentation from the exporting country confirming the substance meets EU GMP standards. Confirmation is required for each manufacturing site and each substance and should provide assurance that GMPs are equivalent to EU standards; the plant is subject to enforcement and inspections, and any non-compliance findings are supplied by the exporting country promptly.
According to the European Medicines Authority (EMA), this requirement provides “a clear legal basis for the concept of international cooperation on active substances (also known as active pharmaceutical ingredients or APIs) which is based on sharing responsibilities with local regulators. These new requirements reinforce the need for pharmaceutical companies to ensure that the active substance manufacturers they are working with are registered with their respective local authorities and subject to adequate regulatory oversight, no matter where in the world they are located.”
Countries with a regulatory system equivalent to that of the EU may not need written confirmations and may request to be exempt. The requirement goes into effect July 2, 2013.