Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #683141

    IATE #3544244
    staidéar éifeachtúlachta iar-údarúcháin Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Déanfar an oibleagáid go ndéanfaí an staidéar éifeachtúlachta iar-údarúcháin a bhunú ar na gníomhartha tarmligthe a ghlactar de bhun Airteagal 10b, agus an treoraíocht eolaíoch dá dtagraítear in Airteagal 108a de Threoir 2001/83/CE á cur san áireamh.' Reference "Rialachán (AE) Uimh. 1235/2010 lena leasaítear, maidir le cógas-aireachas ar tháirgí íocshláinte lena n-úsáid ag an duine, Rialachán (CE) Uimh. 726/2004 lena leagtar síos nósanna imeachta Comhphobail maidir le húdarú agus maoirseacht táirgí íocshláinte lena n-úsáid ag an duine agus le haghaidh úsáide tréidliachta agus lena mbunaítear Gníomhaireacht Leigheasra Eorpach, agus Rialachán (CE) Uimh. 1394/2007 maidir le táirgí íocshláinte ardteiripe, CELEX:32010R1235/GA"
    post-authorisation efficacy study | post-marketing efficacy study | post-authorisation efficacy studies
    en
    Definition study conducted after a product has been placed on the market when the understanding of the disease or the clinical methodology indicate that previous efficacy evaluations might have to be revised significantly Reference "COM-Terminology Coordination, based on: Directive 2001/83/EC on the Community code relating to medicinal products for human use"
    étude d'efficacité postautorisation | étude d'efficacité post-commercialisation | PAES | étude d'efficacité post-autorisation
    fr
    Definition étude effectuée après qu'un produit a été mis sur le marché lorsque la compréhension de la maladie ou la méthodologie clinique indique que les évaluations d'efficacité antérieures pourraient devoir être revues de manière significative Reference "Conseil-FR, d'après la directive 2001/83/CE instituant un code communautaire relatif aux médicaments à usage humain"