Farmacovigilancia
1
La autenticidad y la calidad de los datos recogidos, que permitan evaluar en cada momento los riesgos atribuibles al medicamento..
2
La confidencialidad de las informaciones relativas a la identidad de las personas que hayan presentado o notificado las reacciones adversas.
3
El uso de criterios uniformes en la evaluación de las notificaciones y en la generación de señales de alerta.
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Anexo 205
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