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通报成员: Japan
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负责机构: MinistryofHealth,LabourandWelfare
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通报依据条款:2.9.2[X],2.10.1[],5.6.2[],5.7.1[],
通报依据的条款其他:
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覆盖的产品: Pharmaceuticalproducts(HS: 30)
HS编码:
ICS编码:
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可能受影响的地区或国家:
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通报标题: PartialamendmenttotheMinimumRequirementsforBiologicalProducts(1page,inEnglish)
语言: 页数: 链接网址:
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内容简述: heMinimumRequirementsforBiologicalProducts(1page,inEnglish)
Descriptionofcontent: TheMinimumRequirementsforBiologicalProductsistobepartiallyamendedtoaddthestandardfortwovaccineproductsandabloodproducttobenewlyapproved.
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目标与理由:Toestablishthestandardformanufacturingprocess,properties,quality,storageandothersofdrugstowhichspecialattentionmustbepaidfortheattainmentofpublichealthandsanitation(biologicalproducts)
Protectionofhumanhealthorsafety
保护国家免受有害生物的其它危害:
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紧急事件的性质及采取紧急措施的理由:
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是否有相关国际标准?如有,指出标准:
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可提供的相关文件及文件语种:
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相关文件:
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拟批准日期: Thesamedayastheapprovalofthesaidvaccineproductsandbloodproduct
拟公布日期:
拟生效日期:
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意见反馈截止日期: 21March2016
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负责处理反馈意见的机构:
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文本可从以下机构得到:
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