
Europe Calls for Guarantee of GMP Standards
Falsified Medicines Directive requires imported APIs to have written confirmation of GMP standards.
RELATED ARTICLES
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
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.
Newsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.