Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry
    táirge íocshláinte faoi bhun caighdeáin Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    minderwertiges Arzneimittel
    de
    Definition Produkt, dessen Zusammensetzung und Bestandteile nicht den korrekten wissenschaftlichen Spezifikationen entsprechen und das dadurch unwirksam und häufig auch gefährlich für den Patienten ist Reference "WHO zitiert nach EAASM (European Alliance for Access to Safe Medicines), http://www.eaasm.eu/counterfeit-medicines,de (6.10.2014)"
    substandard medicinal product | substandard medicine | substandard medicines
    en
    Definition "pharmaceutical product [ IATE:1443220 ] that does not meet the quality standards and specifications" Reference "WHO. SIXTY-FOURTH WORLD HEALTH ASSEMBLY. Provisional agenda item 13.7. Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical Products, http://apps.who.int/gb/ssffc/pdf_files/A64_16-en.pdf [4.12.2013]"
    Comment Each pharmaceutical product that a manufacturer produces has to comply with quality assurance standards and specifications, at release and throughout its shelf-life, according to the requirements of the territory of use. Normally, these standards and specifications are reviewed, assessed and approved by the applicable national or regional medicines regulatory authority before the product is authorized for marketing.
    médicament de qualité inférieure | produit médical de qualité inférieure
    fr
    Definition médicaments ne répondant pas aux normes de sécurité, d’efficacité et de qualité en vigueur Reference "COM-FR, d'après Décision WHA63(10) de l’OMS relative aux «Produits médicaux de qualité inférieure/faux/faussement étiquetés/falsifiés/contrefaits», 63e Assemblée mondiale de la santé, avril 2010, http://apps.who.int/gb/ebwha/pdf_files/WHA63/A63_DIV3-fr.pdf [12.8.2014]"
    Comment "Voir aussi: médicament [IATE:1443220 ]"