Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #648655

    IATE #3543169
    táirge íocshláinte imscrúdaitheach ardteiripe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Prüfpräparat für neuartige Therapien
    de
    Definition Prüfpräparat, das ein Arzneimittel für neuartige Therapien im Sinne des Artikels 2 Absatz 1 der Verordnung (EG) Nr. 1394/2007 des Europäischen Parlaments und des Rates ist Reference COM-Internes Dokument SANCO-2012-80155-02-01
    advanced therapy investigational medicinal product
    en
    Definition "advanced therapy medicinal product [ IATE:2228848 ] which is also an investigational medicinal product [ IATE:2146586 ]" Reference "COM-EN, based on:Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, CELEX:52012PC0369/EN"
    médicament expérimental de thérapie innovante
    fr
    Definition "médicament expérimental correspondant à un médicament de thérapie innovante [ IATE:2228848 ]" Reference COM-Document interne: SANCO-2012-80155-00-04Règlement relatif aux essais cliniques de médicaments à usage humain