Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #648660

    IATE #3543176
    táirge íocshláinte cúntach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Hilfspräparat
    de
    auxiliary medicinal product | auxiliary medicinal products
    en
    Definition medicinal product used in the context of a clinical trial, but not as an investigational medicinal product 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:32014R0536/EN"
    Comment Auxiliary medicinal products do not include concomitant medications, i.e. medications unrelated to the clinical trial and not relevant for the design of the clinical trial.
    médicament auxiliaire
    fr
    Definition médicament utilisé dans le contexte d'un essai clinique, mais non comme médicament expérimental Reference COM-Document interne: SANCO-2012-80155-00-04Règlement relatif aux essais cliniques de médicaments à usage humain