生物试剂报关清关的范围 申请条件及所需材料

　　NO.1办理范围

　　NO.1 Scope of processing

　　《中华人民共和国国境卫生检疫法实施细则》第十一条规定：“入境、出境的微生物、人体组织、生物制品、血液及其制品等特殊物品的携带人、托运人或者邮递人，必须向卫生检疫机关申报并接受卫生检疫，凭卫生检疫机关签发的特殊物品审批单办理通关手续。未经卫生检疫机关许可，不准入境、出境。”

　　The People's Republic of China Border Health and Quarantine Law Implementation Rules,Article 11:"Entry and exit of microorganisms,human tissue,biological products,blood and its products and other special items of the carrier,shipper or mail carrier,must be declared to the health and quarantine authorities and accept health quarantine,with the health and quarantine authorities issued by the approval of special items for customs clearance procedures.Without the permission of the health and quarantine authorities,are not allowed to enter or leave the country."

　　微生物是指病毒、细菌、真菌、放线菌、立克次氏体、螺旋体、衣原体、支原体等医学微生物菌（毒）种及样本以及寄生虫、环保微生物菌剂。

　　Microorganisms are viruses,bacteria,fungi,actinomycetes,rickettsia,spirochetes,chlamydia,mycoplasma and other medical microbial bacteria(toxins)and samples,as well as parasites,environmental microbial agents.

　　人体组织是指人体细胞、细胞系、胚胎、器官、组织、骨髓、分泌物、排泄物等。

　　Human tissue refers to human cells,cell lines,embryos,organs,tissues,bone marrow,secretions,excretions,etc.

　　生物制品是指用于人类医学、生命科学相关领域的疫苗、抗毒素、诊断用试剂、细胞因子、酶及其制剂以及毒素、抗原、变态反应原、抗体、抗原-抗体复合物、核酸、免疫调节剂、微生态制剂等生物活性制剂。

　　Biological products refer to vaccines,antitoxins,diagnostic reagents,cytokines,enzymes and their preparations as well as toxins,antigens,allergens,antibodies,antigen-antibody complexes,nucleic acids,immunomodulators,microecological preparations and other biologically active preparations used in human medicine and life science related fields.

　　血液是指人类的全血、血浆成分和特殊血液成分。

　　Blood refers to human whole blood,plasma components and special blood components.

　　血液制品是指各种人类血浆蛋白制品。

　　Blood products refer to various human plasma protein products.

　　NO.2申请条件

　　NO.2 application conditions

　　（一）法律法规规定须获得相关部门批准文件的，应当获得相应批准文件（见申请材料）；

　　(A)laws and regulations to obtain the relevant departmental approval documents,should obtain the appropriate approval documents(see application materials).

　　（二）具备与出入境特殊物品相适应的生物安全控制能力。

　　(B)with the entry and exit of special items to adapt to the biosafety control capabilities.

　　NO.3申请材料

　　NO.3 Application materials

　　（一）申请特殊物品审批的，货主或者其代理人应当按照以下规定提供相应材料：

　　(A)the application for approval of special articles,the owner or his agent shall provide the appropriate materials in accordance with the following provisions.

　　2.出入境特殊物品描述性材料，包括特殊物品中英文名称、类别、成分、来源、用途、主要销售渠道、输出输入的国家或者地区、生产商等；

　　2.entry and exit of special articles descriptive materials,including the name of special articles in English and Chinese,categories,ingredients,sources,uses,major sales channels,export and import of countries or regions,manufacturers,etc..

　　3.入境用于预防、诊断、治疗人类疾病的生物制品、人体血液制品，应当提供国务院药品监督管理部门发给的进口药品注册证书；

　　3.entry for the prevention,diagnosis,treatment of human diseases of biological products,human blood products,should provide the State Council drug supervision and management departments issued by the registration certificate of imported drugs.

　　4.入境、出境特殊物品含有或者可能含有病原微生物的，应当提供病原微生物的学名（中文和拉丁文）、生物学特性的说明性文件（中英文对照件）以及生产经营者或者使用者具备相应生物安全防控水平的证明文件；

　　4.entry,exit special items containing or may contain pathogenic microorganisms,should provide the scientific name of the pathogenic microorganisms(Chinese and Latin),biological characteristics of descriptive documents(in English and Chinese)and the production and operators or users with the appropriate level of biosecurity control documents.

　　5.出境用于预防、诊断、治疗的人类疾病的生物制品、人体血液制品，应当提供药品监督管理部门出具的销售证明；

　　5.outbound for the prevention,diagnosis and treatment of human diseases of biological products,human blood products,should provide a certificate of sale issued by the Drug Administration.

　　6.应当取得人类遗传资源管理部门出具的批准文件，海关对有关批准文件电子数据进行系统自动比对验核；

　　6.should obtain the approval documents issued by the human genetic resources management department,the customs of the relevant approval documents electronic data for automatic system matching verification.

　　7.使用含有或者可能含有病原微生物的出入境特殊物品的单位，应当提供与生物安全风险等级相适应的生物安全实验室资质证明，BSL-3级以上实验室必须获得国家认可机构的认可；

　　7.The use of special entry and exit units containing or may contain pathogenic microorganisms,should provide a biosafety laboratory qualification certificate appropriate to the level of biosafety risk,BSL-3 level laboratory must be accredited by the national accreditation body.

　　8.出入境高致病性病原微生物菌（毒）种或者样本的，应当提供省级以上人民政府卫生主管部门的批准文件。

　　8.Entry and exit of highly pathogenic pathogenic microorganisms bacteria(viruses)or samples,should provide the approval documents of the competent health departments of the provincial government or above.

　　（二）申请人为单位的，首次申请特殊物品审批时，除提供本指南第（一）项所规定的材料以外，还应当提供单位基本情况，如单位管理体系认证情况、单位地址、生产场所、实验室设置、仓储设施设备、产品加工情况、生产过程或者工艺流程、平面图等；实验室生物安全资质证明文件。

　　(B)the applicant is a unit,the first application for approval of special items,in addition to providing the materials specified in paragraph(a)of this guide,should also provide basic information about the unit,such as the unit management system certification,unit address,production sites,laboratory settings,storage facilities and equipment,product processing,production processes or processes,floor plans,etc.;laboratory biosafety qualification documents.

　　申请人为自然人的，应当提供身份证复印件。出入境病原微生物或者可能含有病原微生物的特殊物品，其申请人不得为自然人。

　　The applicant is a natural person,should provide a copy of the ID card.Entry and exit of pathogenic microorganisms or special items that may contain pathogenic microorganisms,the applicant shall not be a natural person.