Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #591603

    IATE #3572784
    tuarascáil maidir le staidéar cliniciúil Reference Rialachán (AE) Uimh. 536/2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine, agus lena n-aisghairtear Treoir 2001/20/CE, CELEX:02014R0536-20140527/GA ;Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Definition tuarascáil maidir leis an triail chliniciúil arna chur i láthair i bhformáid atá furasta le cuardach agus a ullmhaítear i gcomhréir le hIarscríbhinn I, Cuid I, Modúl 5 de Threoir 2001/83/CE agus a dhéantar a thíolacadh in iarratas ar údarú margaíochta Reference Rialachán (AE) Uimh. 536/2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine, agus lena n-aisghairtear Treoir 2001/20/CE, CELEX:02014R0536-20140527/GA
    clinical study report
    en
    Definition a report on the clinical trial presented in an easily searchable format, prepared in accordance with Annex I, Part I, Module 5 of Directive 2001/83/EC and accompanying an application for marketing authorisation Reference Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, CELEX:02014R0536-20140527