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  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #581240

    IATE #3542110
    tuarascáil neamhspléach thréimhsiúil chun dáta maidir le sábháilteacht Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    eigenständiger regelmäßig aktualisierter Sicherheitsbericht
    de
    stand-alone periodic safety update report | stand-alone PSUR | PSURs | reports
    en
    Sainmhíniú independent periodic safety update report (PSUR) [ IATE:3535677 ] prepared for a combination of active substances authorised to one marketing authorisation holder for which separate single-substance PSURs [ IATE:3542065 ] have been provided Tagairt COM-EN, based on:European Medicines Agency. Guideline on good pharmacovigilance practices (GVP). Module VII – Periodic safety update report http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/02/WC500123207.pdf [11.4.2012] and on information provided by DG SANCO [30.3.2012]
    Nóta Stand-alone PSURs should be cross-referenced to the related single-substance PSURs.