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Country's Decision or any other Communication
(DEC)
published: 21 Apr 2008
last updated: 28 Aug 2009
Approval of the import of vCP97 (a.k.a. ALVAC-FL)
EN
- Decision on LMOs for intentional introduction into the environment (according to Article 10 or domestic regulatory framework)
Yes
04 Mar 2008
10 Mar 2008
10 Mar 2008
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Organization:Merial ()29 avenue Tony GarnierLyon,
, FrancePhone: +33 4 72 72 33 89,Fax: +33 4 72 72 33 68 ,Email:Website:
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Organization:Merial Japan Limited ()2-14-2 Nagata-choChiyoda-ku, Tokyo
100-0014, JapanPhone: +81-3-5251-8182,Fax: +81-3-5251-8195,Email:Website: http://jp.merial.com/index.asp,
Approval of the import and/or use of the LMO(s) without conditions
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BCH-LMO-SCBD-45049-4 Living Modified Organism Canarypox virus ALVAC strain containing the FeLV-env, FeLV-gag and FeLV-pol genes from the feline leukemia virusResistance to diseases and pests (Viruses)
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BCH-RA-JP-42778-4 Risk Assessment generated by a regulatory process Canarypox virus ALVAC (FeLV-env, gag, pol)Canarypox virus ALVAC strain containing the FeLV-env, FeLV-gag and FeLV-pol genes from the feline leukemia virus | CNPV, Resistance to diseases and pests
- Japan Biosafety Clearing House (J-BCH) [ English ]
- vCP97enUR.pdf [ English ]
Approving the import of “Canarypox virus ALVAC to which a protective antigen protein expression gene derived from feline leukemia virus (vCP97 strain) was transferred (FeLV -env, gag, pol, Canarypox virus)” without conditions, and this decision will apply to subsequent imports of the same living modified organism.
【Additional information】
" Canarypox virus ALVAC to which a protective antigen protein expression gene derived from feline leukemia virus (vCP97 strain) was transferred (FeLV-env, gag, pol, Canarypox virus)" obtained approval in JAPAN on 18th January 2008 under the domestic law. The approval limits the use of the LMO in following types of use.
(1) Transportation and storage (including transportation and storage of inoculated animals with the viable, modified live vaccine)
(2) In case of a study to collect data on clinical research, which must be submitted as specified by Article 14 Paragraph 3 of the Pharmaceutical Affairs Law (hereinafter referred to as "clinical trial"), use in accordance with the notification of the clinical trial plan submitted according to Article 80-2 Paragraph 2 of the said Law and the protocol prepared according to Article 7 of the Ordinance for good clinical practice of new animal drugs (Ordinance of the Ministry of Agriculture, Forestry and Fisheries No. 75 of 1997)
(3) Use in accordance with the application for approval as specified by Article 14 Paragraph 1 of the Pharmaceutical Affairs Law [except operations relevant to (4)]
(4) Vaccination (excluding those involving human food)
(5) Disposal of devices and residues after inoculation in accordance with the standard for disposal of infectious industrial waste provided in Article 12-2 of the Waste Disposal and Public Cleansing Law (Law No.137 of 1970)
(6) Disposal excluding those in (5) (including cases that accompany the disposal of inoculated animals carrying the viable modified live vaccine)
(7) Acts incidental to (1) to (6)
EN
【Additional information】
" Canarypox virus ALVAC to which a protective antigen protein expression gene derived from feline leukemia virus (vCP97 strain) was transferred (FeLV-env, gag, pol, Canarypox virus)" obtained approval in JAPAN on 18th January 2008 under the domestic law. The approval limits the use of the LMO in following types of use.
(1) Transportation and storage (including transportation and storage of inoculated animals with the viable, modified live vaccine)
(2) In case of a study to collect data on clinical research, which must be submitted as specified by Article 14 Paragraph 3 of the Pharmaceutical Affairs Law (hereinafter referred to as "clinical trial"), use in accordance with the notification of the clinical trial plan submitted according to Article 80-2 Paragraph 2 of the said Law and the protocol prepared according to Article 7 of the Ordinance for good clinical practice of new animal drugs (Ordinance of the Ministry of Agriculture, Forestry and Fisheries No. 75 of 1997)
(3) Use in accordance with the application for approval as specified by Article 14 Paragraph 1 of the Pharmaceutical Affairs Law [except operations relevant to (4)]
(4) Vaccination (excluding those involving human food)
(5) Disposal of devices and residues after inoculation in accordance with the standard for disposal of infectious industrial waste provided in Article 12-2 of the Waste Disposal and Public Cleansing Law (Law No.137 of 1970)
(6) Disposal excluding those in (5) (including cases that accompany the disposal of inoculated animals carrying the viable modified live vaccine)
(7) Acts incidental to (1) to (6)