Proyecto de Norma Oficial Mexicana PROY-NOM-220-SSA1-2024 instalación y operación de la Farmacovigilancia (Draft Mexican Official Standard PROY-NOM-220-SSA1-2024: Introduction and operation of pharmacovigilance) (24 pages, in Spanish)

Protection of human health or safety (TBT)

Applicable to pharmacovigilance to prevent and assess potential risks arising from the use of medicines and vaccines.

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Human health

Purpose The notified draft Standard will establish guidelines for the introduction and operation of pharmacovigilance throughout the national territory. Scope The notified draft Standard will be binding throughout the national territory on federal and local government agencies and entities, and on natural or legal persons in the social and private sectors that are part of the National Health System, health professionals, institutions or establishments where health research is conducted or managed, holders of sanitary registration certificates or their legal representatives, storage and distribution warehouses, points of sale, caregivers, patients and consumers of medicines and vaccines.

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