Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product

    #617731

    IATE #1073980
    táirge íocshláinte bitheolaíoch Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    biologisches Arzneimittel | Biologikum | Biologika | Biopharmakon
    de
    Definition "Arzneimittel, dessen Wirkstoff ein biologischer Stoff ist" Reference "Richtlinie 2003/63/EG der Kommissionzur Änderung der Richtlinie 2001/83/EG zur Schaffung eines Gemeinschaftskodexes für Humanarzneimittel"
    biological medicinal product | biologic | biomedicine | biopharmaceutical
    en
    Definition "product, the active substance of which is a biological substance" Reference "Directive 2001/83/EC on the Community code relating to medicinal products for human use"
    Comment medicinal product, the active substance of which is produced by or extracted from a biological source and which due to its complexity, its characterisation and the determination of its quality may require a combination of physico-chemical-biological testing, together with its control strategy
    médicament biologique | biomédicament
    fr
    Definition produit dont la substance active est une substance biologique Reference "Directive 2003/63/CE de la Commission, CELEX:32003L0063/fr"