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Country's Decision or any other Communication (DEC)
  |  
BCH-DEC-NZ-111963-1   |   PDF   |   Print   |  
last updated: 31 May 2017
Amendment
Yes
  • BCH-DEC-NZ-105552-1 Country's Decision or any other Communication Proteqflu Te - equine influenza vaccine (application GMR07001)
    Proteqflu-Te - equine influenza vaccine | CNPV
The amendment was made to enable the use of the vaccine in animals for export from New Zealand, when the importing country requires vaccination against equine influenza. This amendment did not change the risk profile of the approval.
EN
General Information
Proteqflu Te - equine influenza vaccine (application GMR07001) amendment APP203144
EN
19 May 2017
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
No
No
No
Yes
Result of the decision
Approval of the import and/or use of the LMO(s) with conditions
Control 1: Any person using these vaccines must ensure that these vaccines are only administered to equine animals such as horses, donkeys, and zebras, and only by a veterinarian who has been trained, specifically on the controls placed on the use of this vaccine by MPI.
Control 2: Any registrant of the vaccine must maintain records of vaccine stocks and must make those records available to MPI for auditing.
Control 3: Any MPI-approved person storing these vaccines must ensure that the vaccines are stored in a secure location and ensure that the expired vaccines are disposed of as hazardous waste. Also, that person must ensure that a record is kept of all the vaccine stock coming into and going out of such a location and must make those records available to MPI for audit.
Control 4: Any person storing, transporting or using these vaccines must ensure that any spills including storage facility and one-off spills of the vaccine are disinfected by treating with the best available and most appropriate disinfectant (eg, 70% ethanol). In addition, any spills should be recorded and notified to MPI and to the EPA.
Control 5: Any person using these vaccines must ensure that contaminated waste from the genetically modified vaccines (including syringes, needles, disposable overalls, gloves, masks and any other material exposed to the genetically modified product) must be collected, treated and disposed of as hazardous waste. Disposal of expired vaccines must be in accord with the requirements of MAF/ERMA New Zealand Standard Facilities for Microorganisms and Cell Cultures: 2007a.
Control 6: The vaccines can only be used on equine animals for export to a country that requires vaccination for Equine influenza, or in an Equine Influenza outbreak in New Zealand as defined by MPI.
EN
To manage any risk of release of Proteqflu Te.
EN
LMO identification & risk assessment
  • BCH-LMO-SCBD-101616-7 Living Modified Organism Proteqflu-Te - equine influenza vaccine
    Merial | Production of medical or pharmaceutical compounds (human or animal) (Vaccines)
  • BCH-RA-NZ-111960-1 Risk Assessment generated by a regulatory process Application code: GMR07001 To import for release genetically modified Canarypox virus vaccines (Proteqflu and Proteqflu Te) to protect horses against equine influenza
    Proteqflu - equine influenza vaccine | CNPV, Production of medical or pharmaceutical compounds (human or animal)
Document on the decision, communication, notification or declaration
Additional Information