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    DIR 098

    Commercial release of a genetically modified live viral vaccine to protect against Japanese encephalitis (IMOJEV®)

    Page last updated 16 November 2012

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    Listen

    Notification of decision to issue a licence on application - posted 19 August 2010 (PDF 145 KB)
    Notification of decision to issue a licence on application - posted 19 August 2010 (Word 88 KB)

    Questions & Answers (PDF 152 KB)
    Questions & Answers (Word 21 KB)

    Risk Assessment and Risk Management Plan (RARMP) Executive Summary (PDF 239 KB)
    Risk Assessment and Risk Management Plan (RARMP) Executive Summary (Word 164 KB)

    Risk Assessment and Risk Management Plan (RARMP) Technical Summary (PDF 272 KB)
    Risk Assessment and Risk Management Plan (RARMP) Technical Summary (Word 167 KB)

    Full Risk Assessment and Risk Management Plan (RARMP) for the commercial release of a genetically modified live viral vaccine to protect against Japanese Encephalitis (IMOJEV®) (PDF 1079 KB)
    Full Risk Assessment and Risk Management Plan (RARMP) for the commercial release of a genetically modified live viral vaccine to protect against Japanese Encephalitis (IMOJEV®) (Word 847 KB)

    Licence application summary (PDF 238 KB)
    Licence application summary (Word 96 KB)

    GM Vaccine Licence Conditions (PDF 357 KB)
    GM Vaccine Licence Conditions (Word 93 KB)


    Reference Material

    Risk Analysis Framework for Licence Applications to the Office of the Gene Technology Regulator (3rd Edition) 2009
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