NO.1辦理范圍

　　NO.1 Scope of processing

　　《中華人民共和國(guó)國(guó)境衛(wèi)生檢疫法實(shí)施細(xì)則》第十一條規(guī)定：“入境、出境的微生物、人體組織、生物制品、血液及其制品等特殊物品的攜帶人、托運(yùn)人或者郵遞人，必須向衛(wèi)生檢疫機(jī)關(guān)申報(bào)并接受衛(wèi)生檢疫，憑衛(wèi)生檢疫機(jī)關(guān)簽發(fā)的特殊物品審批單辦理通關(guān)手續(xù)。未經(jīng)衛(wèi)生檢疫機(jī)關(guān)許可，不準(zhǔn)入境、出境?！?/span>

　　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、細(xì)菌、真菌、放線(xiàn)菌、立克次氏體、螺旋體、衣原體、支原體等醫(yī)學(xué)微生物菌（毒）種及樣本以及寄生蟲(chóng)、環(huán)保微生物菌劑。

　　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.

　　人體組織是指人體細(xì)胞、細(xì)胞系、胚胎、器官、組織、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類(lèi)醫(yī)學(xué)、生命科學(xué)相關(guān)領(lǐng)域的疫苗、抗毒素、診斷用試劑、細(xì)胞因子、酶及其制劑以及毒素、抗原、變態(tài)反應(yīng)原、抗體、抗原-抗體復(fù)合物、核酸、免疫調(diào)節(jié)劑、微生態(tài)制劑等生物活性制劑。

　　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.

　　血液是指人類(lèi)的全血、血漿成分和特殊血液成分。

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

　　血液制品是指各種人類(lèi)血漿蛋白制品。

　　Blood products refer to various human plasma protein products.

　　NO.2申請(qǐng)條件

　　NO.2 application conditions

　?。ㄒ唬┓煞ㄒ?guī)規(guī)定須獲得相關(guān)部門(mén)批準(zhǔn)文件的，應(yīng)當(dāng)獲得相應(yīng)批準(zhǔn)文件（見(jiàn)申請(qǐng)材料）；

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

　?。ǘ┚邆渑c出入境特殊物品相適應(yīng)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申請(qǐng)材料

　　NO.3 Application materials

　?。ㄒ唬┥暾?qǐng)?zhí)厥馕锲穼徟?，貨主或者其代理人?yīng)當(dāng)按照以下規(guī)定提供相應(yīng)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稱(chēng)、類(lèi)別、成分、來(lái)源、用途、主要銷(xiāo)售渠道、輸出輸入的國(guó)家或者地區(qū)、生產(chǎn)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.入境用于預(yù)防、診斷、治療人類(lèi)疾病的生物制品、人體血液制品，應(yīng)當(dāng)提供國(guó)務(wù)院藥品監(jiān)督管理部門(mén)發(fā)給的進(jìn)口藥品注冊(cè)證書(shū)；

　　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，應(yīng)當(dāng)提供病原微生物的學(xué)名（中文和拉丁文）、生物學(xué)特性的說(shuō)明性文件（中英文對(duì)照件）以及生產(chǎn)經(jīng)營(yíng)者或者使用者具備相應(yīng)生物安全防控水平的證明文件；

　　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.出境用于預(yù)防、診斷、治療的人類(lèi)疾病的生物制品、人體血液制品，應(yīng)當(dāng)提供藥品監(jiān)督管理部門(mén)出具的銷(xiāo)售證明；

　　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.應(yīng)當(dāng)取得人類(lèi)遺傳資源管理部門(mén)出具的批準(zhǔn)文件，海關(guān)對(duì)有關(guān)批準(zhǔn)文件電子數(shù)據(jù)進(jìn)行系統(tǒng)自動(dòng)比對(duì)驗(yàn)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單位，應(yīng)當(dāng)提供與生物安全風(fēng)險(xiǎn)等級(jí)相適應(yīng)的生物安全實(shí)驗(yàn)室資質(zhì)證明，BSL-3級(jí)以上實(shí)驗(yàn)室必須獲得國(guó)家認(rèn)可機(jī)構(gòu)的認(rèn)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）種或者樣本的，應(yīng)當(dāng)提供省級(jí)以上人民政府衛(wèi)生主管部門(mén)的批準(zhǔn)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）申請(qǐng)人為單位的，首次申請(qǐng)?zhí)厥馕锲穼徟鷷r(shí)，除提供本指南第（一）項(xiàng)所規(guī)定的材料以外，還應(yīng)當(dāng)提供單位基本情況，如單位管理體系認(rèn)證情況、單位地址、生產(chǎn)場(chǎng)所、實(shí)驗(yàn)室設(shè)置、倉(cāng)儲(chǔ)設(shè)施設(shè)備、產(chǎn)品加工情況、生產(chǎn)過(guò)程或者工藝流程、平面圖等；實(shí)驗(yàn)室生物安全資質(zhì)證明文件。

　　(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.

　　申請(qǐng)人為自然人的，應(yīng)當(dāng)提供身份證復(fù)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，其申請(qǐng)人不得為自然人。

　　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.