Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry · PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|research|scientific research

    #666534

    IATE #3623648
    substaint ghníomhach nua le haghaidh comhar sábháilteachta Reference "Rialachán Cur Chun Feidhme (AE) 2022/20 lena leagtar síos rialacha maidir le cur i bhfeidhm Rialachán (AE) Uimh. 536/2014 ó Pharlaimint na hEorpa agus ón gComhairle a mhéid a bhaineann le bunú na rialacha agus na nósanna imeachta um chomhar idir na Ballstáit sa mheasúnú sábháilteachta ar thrialacha cliniciúla, CELEX:32022R0020/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Definition substaint ghníomhach nár úsáideadh cheana i dtáirge íocshláinte imscrúdaitheach in aon triail chliniciúil ar bith arna húdarú san Aontas faoi Rialachán (AE) Uimh. 536/2014, agus dá bhrí sin, nach bhfuil Ballstát measúnaithe sábháilteachta sannta di Reference "Rialachán Cur Chun Feidhme (AE) 2022/20 lena leagtar síos rialacha maidir le cur i bhfeidhm Rialachán (AE) Uimh. 536/2014 ó Pharlaimint na hEorpa agus ón gComhairle a mhéid a bhaineann le bunú na rialacha agus na nósanna imeachta um chomhar idir na Ballstáit sa mheasúnú sábháilteachta ar thrialacha cliniciúla, CELEX:32022R0020/GA"
    neuer der Zusammenarbeit auf dem Gebiet der Sicherheit unterliegender Wirkstoff
    de
    Definition "Wirkstoff, der bisher nicht in einem Prüfpräparat in einer in der Union nach der Verordnung (EU) Nr. 536/2014 genehmigten klinischen Prüfung verwendet wurde und daher keinem die Sicherheit bewertenden Mitgliedstaat zugewiesen ist" Reference COM-internes Dokument: SANTE-2021-81060 (klinische Prüfungen)
    new active substance for safety cooperation
    en
    Definition "active substance which has not been previously used in an investigational medicinal product in any clinical trial authorised in the Union under Regulation (EU) No 536/2014, and therefore does not have an assigned safety assessing Member State" Reference "Commission Implementing Regulation (EU) 2022/20 laying down rules for the application of Regulation (EU) No 536/2014 as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials"