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NOM-220-SSA1-2016, Installation and operation of Pharmacovigilance. Published in the DOF on July 19, 2017

LAW, REGULATION, OR NOM - what is the difference?  

NORMA OFICIAL MEXICANA NOM-220-SSA1-2016, INSTALACIÓN Y OPERACIÓN DE LA FARMACOVIGILANCIA

OFFICIAL MEXICAN STANDARD NOM-220-SSA1-2016, INSTALLATION AND OPERATION OF THE PHARMACOVIGILANCE

ÍNDICE

INDEX

0. Introducción

0. Introduction

1. Objetivo

1. Objective

2. Campo de aplicación

2. Field of application

3. Referencias Normativas

3. Legal References

4. Términos y Definiciones

4. Terms and Definitions

5. Símbolos y Términos abreviados

5. Abbreviated Symbols and terms

6. Integrantes de la Farmacovigilancia en México

6. Members of Pharmacovigilance in Mexico

7. Acciones de los integrantes de la Farmacovigilancia en México

7. Actions of the members of the Pharmacovigilance in Mexico

8. Metodología para Actividades de Farmacovigilancia

8. Methodology for Activities of Pharmacovigilance

9. Concordancia con normas internacionales

9. Concordance with International Standards.

10. Bibliografía

10. Bibliography

11. Observancia de la Norma

11. Observance of the Standard

12. Evaluación de la conformidad

12. Evaluation of conformity

13. Vigencia

13. Effective date

0. Introducción

0. Introduction

El uso terapéutico de un medicamento o vacuna se basa en criterios de eficacia, calidad y seguridad, considerados desde la perspectiva de la relación beneficio/riesgo. De manera general, los medicamentos y vacunas son seguros cuando sus riesgos se consideran aceptables con relación al beneficio profiláctico y terapéutico que aportan, es decir, cuando el patrón de reacciones adversas resulta tolerable.

The therapeutic use of a drug product or vaccine is based on criteria of efficacy, quality, and safety considered from the perspective of the risk/benefit ratio. Generally, the drug products and vaccines are safe when their risks are considered acceptable with regards to the prophylactic and therapeutic benefit that they provide, that is to say, when the pattern of adverse reactions is tolerable.

 

 

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