Mexico: Directive Allows Sale of Pharmaceuticals Previously Approved by the U.S. FDA
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(Dec 14, 2012)
Mexico's Department of Health recently issued a Directive that allows the approval for sale of certain pharmaceuticals in Mexico, provided that they have previously been approved by the U.S. Food and Drug Administration (FDA). (Acuerdo por el que se reconocen como equivalentes los requisitos (...) y los procedimientos de evaluación técnica realizados por la (COFEPRIS) para elotorgamiento del registro sanitario de los insumos para la salud (...) a los requisitos solicitados (...) por la Administración de Alimentos y Medicamentos de los Estados Unidos de América para permitir en su país la venta, distribución y uso de dichos insumos para la salud, DIARIO OFICIAL (Oct. 5, 2012).)
The Directive indicates that the procedures followed by the FDA in the approval for sale of certain pharmaceuticals in the United States are equivalent to those provided by Mexican law. Therefore, applicants for approval of such drugs may present evidence that they have been previously approved in the United States, in order to streamline the process in Mexico. That process may take up to 60 business days if such evidence is provided. This Directive entered into force in November 2012. (Id.)
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Last updated: 12/14/2012