Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry · SOCIAL QUESTIONS|health|pharmaceutical industry|veterinary medicinal product

    #598310

    IATE #3592721
    substaint de bhunadh bitheolaíoch Reference Rialachán Tarmligthe (AE) 2021/805 lena leasaítear Iarscríbhinn II a ghabhann le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32021R0805/GA ;Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    substaint bhitheolaíochta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    substaint de thionscnamh bitheolaíoch Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Cuirfear faisnéis ar fáil i gcás gach substainte de thionscnamh bitheolaíoch a úsáideadh ag céim ar bith den nós imeachta monaraíochta.' Reference Rialachán Tarmligthe (AE) 2021/805 lena leasaítear Iarscríbhinn II a ghabhann le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32021R0805/GA
    arzneilich wirksamer Bestandteil biologischen Ursprungs | biologischer Stoff
    de
    Definition ein Stoff, der biologischen Ursprungs ist oder aus biologischem Ursprungsmaterial erzeugt wird und zu dessen Charakterisierung und Qualitätsbestimmung physikalische, chemische und biologischer Prüfungen und die Beurteilung des Produktionsprozesses und seiner Kontrolle erforderlich sind Reference Richtlinie 2003/63/EG der Kommission, CELEX:32003L0063/de
    substance of biological origin | biological active substance | active principle of biological origin | biological substance
    en
    Definition substance that is produced by or extracted from a biological source and that needs for its characterisation and the determination of its quality a combination of physico-chemical-biological testing, together with knowledge of the production process and its control Reference Regulation (EC) No 1084/2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State
    substance biologique | principe actif d'origine biologique
    fr
    Definition substance qui est produite à partir d'une source biologique ou en est extraite et dont la caractérisation et la détermination de la qualité nécessitent une combinaison d'essais physico-chimico-biologiques, ainsi que la connaissance de son procédé de fabrication et de son contrôle Reference Directiva 2003/63/CE de la Comisión, CELEX:32003L0063/fr