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Mexico: COFEPRIS Adopts International Best Practices Pharmacovigilance Standards

Wednesday, July 19, 2017: The Federal Commission for Protection against Health Risks (COFEPRIS) reports that the Official Federal Official Gazette (DOF) published the Official Mexican Standard NOM-220-SSA1-2016, for the installation and operation of Pharmacovigilance. This Standard represents an advanced regulatory framework that makes Mexico a country with regulations harmonized with international best practices in Pharmacovigilance. Pharmacovigilance is a public health activity for the detection, identification, quantification, evaluation and prevention of possible risks arising from the use of drugs and vaccines.

This Standard establishes the guidelines for the installation and operation of Pharmacovigilance in the national territory.

This ordinance is mandatory in the country for the dependencies and entities of the Federal and local Public Administration, as well as for the natural or moral persons of the social and private sectors, who are part of the National Health System, health professionals , Institutions or establishments where health research is carried out, as well as for holders of health registries or their legal representatives, distributors and marketers of medicines and vaccines.

Pharmacovigilance is considered an indispensable tool for countries to guarantee the quality, safety and efficacy of the medicines and vaccines that are dispensed, and, therefore, to protect and prevent the possible risks derived from the use of these inputs.

It is an activity of shared responsibility among all agents related to medicines and vaccines, and requires the collaboration of the countries that make up the International Program for Monitoring Medicines, of which Mexico is a member.

This standard represents an advanced regulatory framework that makes Mexico a country with regulations that are harmonized with best practices at the international level.

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