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Décision de pays ou tout autre communication
(DEC)
last updated: 31 mai 2017
Oui
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BCH-DEC-NZ-105551-1 Décision de pays ou tout autre communication Proteqflu - equine influenza vaccine (application GMR07001)Proteqflu - 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
Proteqflu - equine influenza vaccine (application GMR07001) amendment APP203144
EN
19 mai 2017
Non
- Décisions sur les OVM destinés à une introduction intentionnelle dans l'environnement (conformément à l'article 10 ou au cadre réglementaire national)
Non
Non
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Auckland,Personne :Ansam GanimConsultant,
, Nouvelle-ZélandeTéléphone : +64 21 1212 360,Télécopieur :E-mail : ansamganim@gmail.com,Site Web :Organisations reliéesNew Zealand Racing Board & NZ Equine Health Association ()Secteur privé (affaires et industrie)Auckland,
, Nouvelle-ZélandeTéléphone : +64 21 1212 360,Télécopieur :E-mail : ansamganim@gmail.com,Site Web :
Non
Non
Oui
Approbation de l'importation/utilisation de l'OVM avec 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
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.
To manage any risk of release of Proteqflu.
EN
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BCH-LMO-SCBD-101612-7 Organisme vivant modifié Proteqflu - equine influenza vaccineMerial | Production de composés médicaux ou pharmaceutiques (humains ou animaux) (Vaccins), Use as vaccine
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BCH-RA-NZ-111960-1 Évaluation des risques générée par un processus de réglementation Application code: GMR07001 To import for release genetically modified Canarypox virus vaccines (Proteqflu and Proteqflu Te) to protect horses against equine influenzaProteqflu - equine influenza vaccine | CNPV, Production de composés médicaux ou pharmaceutiques (humains ou animaux)