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  2. SOCIAL QUESTIONS|health|pharmaceutical industry

    #651737

    IATE #3555276
    táirgí atá cosúil go bunúsach Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    essentially similar product | essentially similar medicinal product
    en
    Sainmhíniú "medicinal product that satisfies the criteria of having the same qualitative and quantitative composition in terms of active substances, of having the same pharmaceutical form, and of being bioequivalent with the original product, unless it is apparent in the light of scientific knowledge that it differs from it as regards safety and efficacy" Tagairt "COM-Terminology Coordination, based on: European Medicines Agency. Committee for Proprietary Medicinal Products (CPMP). 'Note for Guidance on the Investigation of Bioavailability and Bioequivalence' (7.6.2023). London, 14 December 2000"