Gaois

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  2. SOCIAL QUESTIONS|health|pharmaceutical industry

    #542658

    IATE #930942
    ordú bona fide gan iarraidh Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    nach Treu und Glauben aufgegebene Bestellung, für die nicht geworben wurde
    de
    Comment XREF: Mitleidsindikation (A269074);DIV: SBH 25/06/2003
    bona fide unsolicited order
    en
    Definition request for a medicinal product by a doctor as a result of an actual examination of his patients and on the basis of purely therapeutic considerations Reference COM-Terminology Coordination, based on:Case C-185/10. European Commission v Republic of Poland. Summary of the Judgment, http://curia.europa.eu/juris/document/document.jsf?docid=147586&mode=req&pageIndex=1&dir=&occ=first&part=1&text=&doclang=EN&cid=162807 [3.3.2014]
    Comment Unsolicited means that the supplier has not sought or initiated the order, that is, the person placing it did so entirely on their own initiative.Reference: Correspondence with UK Medicines and Healthcare Products Regulatory Agency, dated 4.3.2104For more information, see also: UK Medicines and Healthcare Products Regulatory Agency, http://webarchive.nationalarchives.gov.uk/20091007144938/http://mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON007547&RevisionSelectionMethod=Latest [5.3.2014]& http://webarchive.nationalarchives.gov.uk/20091007144938/http://mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON026413&RevisionSelectionMethod=Latest [5.3.2014] (main page: http://webarchive.nationalarchives.gov.uk/20091007144938/mhra.gov.uk/howweregulate/medicines/importingandexportingmedicines/importingunlicensedmedicines/index.htm [5.3.2014])
    demande d'autorisation temporaire d'utilisation | demande d'ATU | commande loyale et non sollicitée
    fr
    Definition demande faite par un médecin à l'issue d'un examen effectif de ses patients et en se fondant sur des considérations purement thérapeutique (et non en réponse à des sollicitations, notamment de la part de laboratoires pharmaceutiques) lorsque l'état de santé desdits patients requiert l'administration d'un médicament dont il n'existe pas d'équivalent autorisé sur le marché national ou qui se trouve indisponible sur ce marché Reference Conseil-FR, d'après l'Affaire C-185/10, Commission européenne contre République de pologne, sommaire de l'arrêt, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:62010CJ0185:FR:HTML [4.3.2014]
    Comment Voir aussi "usage compassionnel", IATE:1687028