Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #664750

    IATE #3592721
    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"
    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
    biologischer Stoff | arzneilich wirksamer Bestandteil biologischen Ursprungs
    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 substance | biological active substance | active principle of biological origin
    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 (EU) 2019/6 on veterinary medicinal products and repealing Directive 2001/82/EC"
    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"