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Country's Decision or any other Communication (DEC)
  |  
BCH-DEC-NZ-115094-1   |   PDF   |   Print   |  
last updated: 07 Aug 2019
Amendment
No
General Information
APP202371 Decision
EN
16 Apr 2019
No
Subject of the decision, notification, communication or declaration
  • Decision on LMOs for intentional introduction into the environment (according to Article 10 or domestic regulatory framework)
LMOs for intentional introduction into the environment
No
Yes
No
Yes
Yes
Result of the decision
Approval of the import and/or use of the LMO(s) without conditions
LMO identification & risk assessment
  • BCH-LMO-SCBD-114728-1 Living Modified Organism Imojev (Japanese Encephalitis Chimeric Virus Vaccine; JE-CV)
    Sanofi-Aventis New Zealand Limited | Modified viral epitopes
  • BCH-RA-NZ-115092-1 Risk Assessment generated by a regulatory process EPA staff assessment report on application APP202371 - To import and release a genetically modified live-attenuated vaccine (IMOJEV®) to protect humans against Japanese encephalitis.
    Imojev (Japanese Encephalitis Chimeric Virus Vaccine; JE-CV) | JEV SA14-14-2, YFV 17D
Document on the decision, communication, notification or declaration