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NOM-220-SSA1-2012, Installation and operation of pharmacovigilance.

 

  Published in the DOF January 7, 2013

 

 

This Standard is under the oversight of the SSA = (Secretaría de Salud - Secretary of Health) Environmental Health  www.ssa.gob.mx

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

RELATED DOCUMENTS

NOM-220-SSA1-2012, Instalación y operación de la farmacovigilancia. NOM-220-SSA1-2012, Installation and operation of pharmacovigilance.

INDICE

INDEX

0. Introducción

0. Introduction

1. Objetivo y campo de aplicación

1. Objective and field of application

2. Referencias

2. References

3. Definiciones, símbolos y abreviaturas

3. Definitions, symbols and abbreviations

4. Clasificación de eventos adversos, sospechas de reacción adversa y las reacciones adversas de los medicamentos.

4. Classification of adverse events, suspicions of an adverse reaction and adverse reactions of drug products.

5. Organización

5. Organization

6. Metodología

6. Methodology

7. Notificación

7. Report

8. Funciones, responsabilidades y actividades de los integrantes del Programa Permanente de Farmacovigilancia

8. Tasks, responsibilities and activities of members of the Pharmacovigilance Permanent Program

9. Concordancia con normas internacionales y mexicanas

9. Concordance with Mexican and 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

Apéndice informativo A.

Informative Appendix A

Apéndice informativo B.

Informative Appendix B

0. Introducción

0. Introduction

El uso terapéutico de un medicamento se basa en criterios de eficacia y seguridad, considerados desde la perspectiva de la relación riesgo/beneficio. De manera general, un medicamento es seguro cuando sus riesgos se consideran aceptables con relación al beneficio terapéutico que aporta, es decir, cuando el patrón de reacciones adversas resulta tolerable.

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

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