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DIR 098 - Commercial release of a genetically modified live viral vaccine to protect against Japanese encephalitis (IMOJEV®)



DIR 098 - Notification of decision to issue a licence on application - posted 19 August 2010 (RTF 523 KB)
DIR 098 - Notification of decision to issue a licence on application - posted 19 August 2010 (PDF 42 KB)

DIR 098 - Questions & Answers (RTF 38 KB)
DIR 098 - Questions & Answers (PDF 15 KB)

DIR 098 - Risk Assessment and Risk Management Plan (RARMP) Executive Summary (RTF 252 KB)
DIR 098 - Risk Assessment and Risk Management Plan (RARMP) Executive Summary (PDF 42 KB)

DIR 098 - Risk Assessment and Risk Management Plan (RARMP) Technical Summary (RTF 262 KB)
DIR 098 - Risk Assessment and Risk Management Plan (RARMP) Technical Summary (PDF 51 KB)

DIR 098 - 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®) (RTF 2.89 MB)
DIR 098 - 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 669 KB)

DIR 098 - Licence application summary (RTF 226 KB)
DIR 098 - Licence application summary (PDF 68 KB)

DIR 098 – GM Vaccine Licence Conditions (RTF 391 KB)
DIR 098 – GM Vaccine Licence Conditions (PDF 269 KB)

Reference Material

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

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