Gaois

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  1. SOCIAL QUESTIONS|health|health policy|organisation of health care|public health

    #687632

    IATE #3636803
    riosca tromchúiseach féideartha don tsláinte phoiblí Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    potential serious risk to public health
    en
    Definition situation where there is a significant probability that a serious hazard resulting from a human medicinal product in the context of its proposed use will affect public health Reference "Guideline on the definition of a potential serious risk to public health in the context of Article 29(1) and (2) of Directive 2001/83/EC — March 2006"
    Comment ‘Serious’ in this context means a hazard that could result in death, could be life-threatening, could result in patient hospitalisation or prolongation of existing hospitalisation, could result in persistent or significant disability or incapacity, or could be a congenital anomaly/birth defect or permanent or prolonged signs in exposed humans.