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出入境特殊物品衛(wèi)生檢疫管理規(guī)定-中英對照法律英語

青島希尼爾翻譯公司 2016年8月3日整理發(fā)布

　《出入境特殊物品衛(wèi)生檢疫管理規(guī)定》已經(jīng)2005年5月16日國家質(zhì)量監(jiān)督檢驗檢疫總局局務(wù)會議審議通過，現(xiàn)予公布，自2006年1月1日起施行。

　　局　長
　　二〇〇五年十月十七日

出入境特殊物品衛(wèi)生檢疫管理規(guī)定

　　第一章　總則

　　第一條　為規(guī)范出入境特殊物品的衛(wèi)生檢疫監(jiān)督管理，根據(jù)《中華人民共和國國境衛(wèi)生檢疫法》及其實施細(xì)則的有關(guān)規(guī)定，制定本規(guī)定。

　　第二條　本規(guī)定適用于入境、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衛(wèi)生檢疫監(jiān)督管理。

　　第三條　國家質(zhì)量監(jiān)督檢驗檢疫總局（以下簡稱國家質(zhì)檢總局）統(tǒng)一管理全國出入境特殊物品的衛(wèi)生檢疫監(jiān)督管理工作；國家質(zhì)檢總局設(shè)在各地的出入境檢驗檢疫機構(gòu)（以下簡稱檢驗檢疫機構(gòu)）對轄區(qū)內(nèi)出入境特殊物品實施衛(wèi)生檢疫監(jiān)督管理。

　　第四條　出入境特殊物品的衛(wèi)生檢疫管理實行衛(wèi)生檢疫審批、現(xiàn)場查驗和后續(xù)監(jiān)督管理制度。

　　第五條　取得《入/出境特殊物品衛(wèi)生檢疫審批單》（以下簡稱《衛(wèi)生檢疫審批單》），并經(jīng)衛(wèi)生檢疫合格的出入境特殊物品，方準(zhǔn)入境、出境。

　　第六條　出入境特殊物品由國家質(zhì)檢總局指定并公布的口岸入境、出境。

　　第二章　衛(wèi)生檢疫審批

　　第七條　直屬檢驗檢疫局負(fù)責(zé)所轄區(qū)域內(nèi)出入境特殊物品的衛(wèi)生檢疫審批。

　　第八條　入境、出境特殊物品的貨主或者其代理人應(yīng)當(dāng)在交運前向入出境口岸直屬檢驗檢疫局提交《入/出境特殊物品衛(wèi)生檢疫審批申請單》（下簡稱《審批申請單》）。

　　貨主或者其代理人應(yīng)當(dāng)根據(jù)出入境特殊物品的分類填寫《審批申請單》，每一類別填寫一份。

　　第九條　申請辦理出入境微生物、人體組織、血液的衛(wèi)生檢疫審批手續(xù)的，應(yīng)當(dāng)提供以下材料：

　?。ㄒ唬┫嚓P(guān)主管部門出具的準(zhǔn)許出入境證明（原件和復(fù)印件）；

　?。ǘ┨厥馕锲匪≡⑸锏膶W(xué)名（中文和拉丁文）和生物學(xué)特性（中英文對照件）的說明性文件；

　?。ㄈ┖谢蛘呖赡芎?至4級病原微生物的入境特殊物品，及含有或者可能含有尚未分級病原微生物的入境特殊物品，使用單位應(yīng)當(dāng)具備BSL-3級（p3級）實驗室，并提供相應(yīng)資質(zhì)的證明；

　?。ㄋ模┛蒲杏锰厥馕锲窇?yīng)當(dāng)提供科研項目批準(zhǔn)文件原件或者科研項目申請人與國內(nèi)外合作機構(gòu)協(xié)議（原件和復(fù)印件，中、英文對照件）；

　?。ㄎ澹┕┮浦灿闷鞴賾?yīng)當(dāng)提供有資質(zhì)醫(yī)院出具的供體健康證明和相關(guān)檢驗報告。

　　第十條申請辦理生物制品、血液制品的衛(wèi)生檢疫審批手續(xù)的，貨主或者其代理人應(yīng)當(dāng)提供以下材料：

　　（一）用于治療、預(yù)防、診斷的入境生物制品、血液制品，應(yīng)當(dāng)提供國家藥品監(jiān)督管理部門出具的進口注冊證明；

　?。ǘ┯糜谥委?、預(yù)防、診斷的出境生物制品、血液制品，應(yīng)當(dāng)提供藥品監(jiān)督管理部門出具的《藥品銷售證明》；

　?。ㄈ┯糜谄渌I(lǐng)域的出入境生物制品、血液制品，應(yīng)當(dāng)提供相關(guān)主管部門出具的進口批件。

　　第十一條　直屬檢驗檢疫局對申請材料齊全，符合法定形式的申請，應(yīng)當(dāng)予以受理。

　　第十二條　受理申請的直屬檢驗檢疫局對申請材料進行實質(zhì)性審查，并在20個工作日內(nèi)作出準(zhǔn)予許可或者不準(zhǔn)予許可的決定，20個工作日內(nèi)不能作出決定的，經(jīng)負(fù)責(zé)人批準(zhǔn)可以延長10個工作日，并應(yīng)當(dāng)將延長期限的理由告知申請人。

　　準(zhǔn)予許可的，應(yīng)當(dāng)簽發(fā)《衛(wèi)生檢疫審批單》，不準(zhǔn)予許可的，應(yīng)當(dāng)書面說明理由。

　　對于尚未認(rèn)知其傳染性的特殊物品，直屬檢驗檢疫局應(yīng)當(dāng)報請國家質(zhì)檢總局開展技術(shù)分析。技術(shù)分析所需時間不計入審批期限，但應(yīng)當(dāng)書面告知貨主或者其代理人。

　　第十三條　出入境的特殊物品衛(wèi)生檢疫審批單只能使用一次，有效期限為90天。

　　第十四條　供移植用器官因特殊原因未辦理衛(wèi)生檢疫審批手續(xù)的，入境、出境時檢驗檢疫機構(gòu)可以先予放行，貨主或者其代理人應(yīng)當(dāng)在放行后10日內(nèi)申請補辦衛(wèi)生檢疫審批手續(xù)。

　　第三章　衛(wèi)生檢疫

　　第十五條　入境、出境特殊物品到達(dá)口岸后或者離開口岸前，貨主或者其代理人應(yīng)當(dāng)依法向口岸檢驗檢疫機構(gòu)報檢。有下列情形之一的，檢驗檢疫機構(gòu)不予受理報檢：

　　（一）不能提供《衛(wèi)生檢疫審批單》的；

　?。ǘ缎l(wèi)生檢疫審批單》超過有效期的；

　?。ㄈ﹤卧臁⑼扛挠嘘P(guān)文件或單證的；

　?。ㄋ模┢渌环蠙z驗檢疫要求的。

　　第十六條　受理報檢的口岸檢驗檢疫機構(gòu)按照下列要求對出入境特殊物品實施現(xiàn)場查驗，并填寫《入／出境特殊物品衛(wèi)生檢疫現(xiàn)場查驗記錄》：

　?。ㄒ唬z查出入境特殊物品名稱、批號、規(guī)格、數(shù)量、輸出／輸入國和生產(chǎn)廠家等項目是否與審批單列明的內(nèi)容相符；

　?。ǘz查出入境特殊物品包裝是否安全無破損，不滲、不漏；

　?。ㄈΤ鼍车奶厥馕锲窇?yīng)核查出廠檢驗合格報告，檢查生產(chǎn)記錄、原材料來源，以及生產(chǎn)流程是否符合衛(wèi)生要求。

　　第十七條　對需抽樣檢驗的入境特殊物品，經(jīng)口岸檢驗檢疫機構(gòu)許可，貨主或者其代理人可先運至有儲存條件的場所，待檢驗合格后方可移運或使用?？诎稒z驗檢疫機構(gòu)不具有檢驗?zāi)芰Φ?，?yīng)當(dāng)委托國家質(zhì)檢總局指定的實驗室進行檢驗。

　　第十八條　郵寄、攜帶的出入境特殊物品，因特殊情況未辦理衛(wèi)生檢疫審批手續(xù)的，檢驗檢疫機構(gòu)應(yīng)當(dāng)予以截留，要求按照規(guī)定辦理衛(wèi)生檢疫審批手續(xù)，并按照第十六條進行查驗，經(jīng)檢疫合格后方可放行。

　　第十九條　口岸檢驗檢疫機構(gòu)對經(jīng)衛(wèi)生檢疫符合要求的出入境特殊物品予以放行。發(fā)現(xiàn)有下列情況之一的，簽發(fā)《檢驗檢疫處理通知書》，并予以封存、退回或者銷毀：

　?。ㄒ唬┟Q、批號、規(guī)格、數(shù)量等與審批內(nèi)容不相符的；

　?。ǘ┌b或者保存條件不符合要求的；

　?。ㄈ┏^有效使用期限的；

　　（四）經(jīng)檢驗不符合衛(wèi)生檢疫要求的；

　?。ㄎ澹┍唤亓粑锲纷越亓糁掌?0日內(nèi)未獲準(zhǔn)許可的。

　　口岸檢驗檢疫機構(gòu)對處理結(jié)果應(yīng)當(dāng)做好記錄、歸檔，并上報國家質(zhì)檢總局。

　　第四章　后續(xù)監(jiān)管

　　第二十條　檢驗檢疫機構(gòu)對轄區(qū)內(nèi)含有或可能含有病原微生物的入境特殊物品實施后續(xù)監(jiān)管。

　　需要后續(xù)監(jiān)管的入境特殊物品，未經(jīng)檢驗檢疫機構(gòu)的同意，不得擅自使用。

　　第二十一條　對需要實施異地后續(xù)監(jiān)管的入境特殊物品，口岸檢驗檢疫機構(gòu)應(yīng)當(dāng)出具《入境貨物調(diào)離單》，并及時電子轉(zhuǎn)單給目的地檢驗檢疫機構(gòu)。使用單位應(yīng)當(dāng)在特殊物品入境后30日內(nèi)，持《入境貨物調(diào)離單》到目的地檢驗檢疫機構(gòu)申報，并接受后續(xù)監(jiān)管。

　　第二十二條　檢驗檢疫機構(gòu)對入境特殊物品實施后續(xù)監(jiān)管的內(nèi)容包括：

　?。ㄒ唬┖谢蛘呖赡芎胁≡⑸锶刖程厥馕锲返氖褂脝挝皇欠窬哂邢鄳?yīng)等級的生物安全實驗室，P3級以上實驗室必須獲得國家認(rèn)可機構(gòu)的認(rèn)可；

　?。ǘ┦褂脝挝粚嶒炇也僮魅藛T是否具備相應(yīng)的資質(zhì)；

　?。ㄈ┤刖程厥馕锲肥褂们闆r記錄，是否按照審批用途使用。

　　使用單位應(yīng)當(dāng)及時向檢驗檢疫機構(gòu)提供使用情況說明。

　　第二十三條　檢驗檢疫機構(gòu)在后續(xù)監(jiān)管過程中發(fā)現(xiàn)有不符合要求的，應(yīng)當(dāng)責(zé)令限期整改，并對已入境的特殊物品進行封存，直至整改符合要求。如經(jīng)整改仍不符合要求的，責(zé)令其退運或者銷毀。

　　第二十四條　檢驗檢疫機構(gòu)對后續(xù)監(jiān)管過程中發(fā)現(xiàn)的問題，應(yīng)當(dāng)立即報告國家質(zhì)檢總局，并通報原審批的直屬檢驗檢疫局。

　　第五章　附則

　　第二十五條　違反本規(guī)定，有下列行為之一的，檢驗檢疫機構(gòu)可以給予警告或者處以5000元以下的罰款：

　?。ㄒ唬┎m報或者漏報禁止進口的微生物、人體組織、生物制品、血液及其制品等特殊物品的；

　　（二）未經(jīng)檢驗檢疫機構(gòu)許可，擅自移運、銷售和使用特殊物品的；

　　（三）在規(guī)定時限內(nèi)未向檢驗檢疫機構(gòu)申報或者拒絕接受特殊物品衛(wèi)生檢疫后續(xù)監(jiān)管的；

　?。ㄋ模﹤卧旎蛘咄扛臋z疫單、證的。

　　第二十六條　對違反本規(guī)定，引起檢疫傳染病傳播或者有引起檢疫傳染病傳播嚴(yán)重危險的，依照《中華人民共和國刑法》的有關(guān)規(guī)定追究刑事責(zé)任。

　　第二十七條　本規(guī)定下列用語的含義：

　?。ㄒ唬┪⑸锸侵覆《?、細(xì)菌、真菌、放線菌、立克次氏體、螺旋體、衣原體、支原體等醫(yī)學(xué)微生物；

　?。ǘ┤梭w組織是指人體胚胎、器官、組織、細(xì)胞、人體分泌物、排泄物；

　?。ㄈ┥镏破肥侵福杭?xì)菌類疫苗、病毒類疫苗、抗毒素、各種診斷用試劑、干擾素、激素、酶及其制劑以及其他活性制劑（毒素、抗原、變態(tài)反應(yīng)原、單克隆抗體、重組DNA產(chǎn)品、抗原-抗體復(fù)合物、免疫調(diào)節(jié)劑、微生態(tài)制劑、核酸制劑等），以及其他生物材料制備的有關(guān)制品；

　?。ㄋ模┭杭捌渲破肥侵溉⒀獫{、血清、血細(xì)胞以及由血液分離、提純或者應(yīng)用生物技術(shù)制成的血漿蛋白組分或者血細(xì)胞組分制品。

　　第二十八條　進出保稅區(qū)、出口加工區(qū)的出入境特殊物品的衛(wèi)生檢疫管理，按照本規(guī)定執(zhí)行。

　　第二十九條　本規(guī)定由國家質(zhì)檢總局負(fù)責(zé)解釋。

　　第三十條　本規(guī)定自2006年1月1日起施行。

Regulations for Administration of Entry and Exit Health Quarantine on Special Goods
October 17,2005

Regulations for Administration of Entry and Exit Health Quarantine on Special Goods

　　Chapter I General Principles

　　Article 1 For the purposes of regulating the administration of entry and exit health quarantine on special goods, these regulations are formulated in accordance with relative provisions of Health Quarantine Law of the People's Republic of China and their detailed implementation rules.

　　Article 2 These regulations apply to the supervision and administration of entry and exit health quarantine on microorganism, human body tissue, biological products, blood and its products and other special goods.

　　Article 3 General Administration of Quality Supervision, Inspection and Quarantine of China （AQSIQ） uniformly manages national supervision and administration of entry and exit health quarantine on special goods. The entry and exit inspection and quarantine organs established by AQSIQ in all local areas （inspection and quarantine organs in short below） carry out the supervision and administration of entry and exit health quarantine on special goods within the areas under their jurisdiction.

　　Article 4 Rules for health quarantine approval, examination on the spot and follow-up supervision and administration are carried out in the administration of entry and exit health quarantine on special goods.

　　Article 5 Entry and exit Special goods could enter or leave the country only when obtaining the Approval Certificate for Entry and Exit Health Quarantine on Special Goods （Health Quarantine Approval Certificate） and pass the health quarantine.

　　Article 6 Entry and exit special goods should enter and leave the country from the ports appointed and published by AQSIQ.

　　Chapter II Examination and Approval of Health Quarantine

　　Article 7 Directly affiliated Inspection and Quarantine Bureaus are responsible for the examination and approval of entry and exit health quarantine on special goods in the areas under their jurisdiction.

　　Article 8 The owners of entry and exit special goods or their agent should submit Application Form for Examination and Approval of Entry and Exit Health Quarantine on Special Goods （Application Form for Approval）.

　　The owners or their agent should fill in Application Form for Approval according to the classifications of entry and exit special goods, one form for one classification.

　　Article 9 Whoever applies for approval of entry and exit health quarantine on microorganism, human body tissues, biological products, blood should provide following materials:

　　1. Approval certificate for entry and exit issued by corresponding competent authority （original one and a copy）;

　　2. Directions of special goods, including scientific name of disease-causing microorganism （both in Chinese and Latin） and biology characteristic （bilingual Chinese-English version） contained in the special goods.

　　3. For the entry and exit special goods containing or may containing Grade 3 to 4 disease-causing microorganism, and containing or may containing disease-causing microorganism that has not been divided into grades, the unit using the goods should have Grade BSL-3 （Grade P3） Laboratory and provide corresponding qualification certificate.

　　4. For the special goods for scientific research, the original document for approving the scientific research or the agreement between the applicant for the scientific research project and internal or external cooperation organs （original one and copy in bilingual Chinese-English version） should be provided;

　　5. For the tissue used for transplanting, health certificate of the supplier and corresponding examination report issued by a hospital with qualifications should be provided.

　　Article 10 To apply for going through health quarantine approval formalities for biological products and blood products, the owner of the goods or his agent should submit following materials:

　　1. To the entry biological products and blood products used for treatment, prevention and diagnosis, import registration certificate issued by national pharmaceutical supervision and management departments should be provided;

　　2. To the exit biological products and blood products used for treatment, prevention and diagnosis, Certificate of Pharmacy Sales issued by pharmaceutical supervision and administration department should be provided;

　　3. To the entry and exit biological products and blood products used in other field, the certificate for approval of import issued by corresponding competent department should be provided.

　　Article 11 Directly affiliated inspection and quarantine bureau should accept and handle the application that the materials are completed and being up to the legal form.

　　Article 12 Directly affiliated inspection and quarantine bureau accepting and handling the application should make substantive review on the application materials and make the decision whether or not to grant the permission within 20 working days. If they could not make the decision within 20 working days, they may prolong 10 working days with the approval of the person in charge of it, and inform the applicants of the reason why to prolong the term.

　　To the special goods getting the permission, the Approval Paper for Health Quarantine should be issued, and to the special goods failing to the permission, reasons should be given in writing.

　　The direct affiliated inspection and quarantine bureau should report the special goods that have not been known to AQSIQ for technical analysis. The time needed for technical analysis should not be included into the approval term but the owner of the goods or his agent should be informed of it in writing.

　　Article 13 The approval paper for entry and exit health quarantine on special goods can be used only once, and valid for 90 days.

　　Article 14 If the tissue used for transplanting has not gone through the formalities of health quarantine approval because of special reasons, the inspection and quarantine organ may let it pass first, then the owner or his agent should apply for health quarantine approval within 10 days after the tissue got the clearance.

　　Chapter III Health Quarantine

　　Article 15 After the entry and exit special goods arrive at the port or before leaving the port, the owner or his agent should report to the inspection and quarantine organ of the port in accordance with laws. The inspection and quarantine organ should not accept and handle the quarantine in one of following circumstances:

　　1. can not provide Approval Paper for Health Quarantine;

　　2. approval Paper for Health Quarantine has lost efficacy;

　　3. forge or alter relative documents or papers;

　　4. other circumstances that do not meet the requirements of the inspection and quarantine.

　　Article 16 The inspection and quarantine organ of the port handling the quarantine report should make examination on the spot to the entry and exit special goods according to the requirements, and fill in On-the-spot Examination Record for Entry / Exit Health Quarantine on Special Goods:

　　1. Examine whether the name, batch number, specification, quantity, entry / exit country and production factory of the entry and exit special goods conform with the content listed in the approval paper;

　　2. Examine whether the pack of entry and exit special goods is safety without damage, leaking and oozing;

　　3. Examine whether the ex-factory quality inspection report, production record, origin of the raw materials and production process of exit special goods meet the requirements of health.

　　Article 17 To the entry special goods that need to be examined by selecting samples, the owner or his agent may transport the goods to a place meeting the requirements of storing with the permission of the inspection and quarantine organ of the port, and transfer or use them after passing the examination. If the inspection and quarantine organ have no ability to make the examination, it should authorize the laboratory appointed by AQSIQ to make the examination.

　　Article 18 If the entry and exit special goods that are posted or brought with do not go through health quarantine approval formalities because of special reasons, the inspection and quarantine organ should hold them back and ask to handle health quarantine approval formalities according to the rules, and examine them in accordance with Article 16. The goods can get clearance only when they pass the quarantine.

　　Article 19 The inspection and quarantine organ of the port should let the entry and exit special goods that meet the requirements of health quarantine leave the port. Notice on Inspection and Quarantine Treatment should be issued and the goods should be sealed up, returned back or destroyed if one of following cases is found:

　　1. name, batch number, specification, quantity and etc. do not conform with the approved content;

　　2. pack or storage condition do not meet the requirements;

　　3. pass the expiry date;

　　4. do not pass the health quarantine examination;

　　5. the goods that have been hold back do not obtain the approval within 60 days at the date of holding back.

　　To the treatment result, the inspection and quarantine organ of the port should take notes, put into files and report to AQSIQ.

　　Chapter IV Follow-up Supervision and Administration

　　Article 20 Inspection and quarantine organ should carry out follow-up supervision and administration on the entry special goods that contain or may contain disease-causing microorganism in the area under its jurisdiction.

　　The entry special goods that need follow-up supervision and administration should not be used without the permission of inspection and quarantine organ.

　　Article 21 To the entry special goods that need follow-up supervision in alien land, inspection and quarantine organ of the port should issue Transferring Paper for Entry Goods, and send the electronic paper to the destination inspection and quarantine organ. The unit that use the goods should declare the goods to the destination inspection and quarantine organ with the Transferring Paper for Entry Goods and accept follow-up supervision and administration within 30 days after the entry of the special goods.

　　Article 22 The content that Inspection and quarantine organ carry out follow-up administration on entry and exit special goods includes:

　　1. Whether the unit using entry special goods including or may including disease-causing microorganism has corresponding grade of biological safety laboratory, the laboratory higher than Grade P3 must obtain the approval of national approval organ.

　　2. whether the operators in the laboratory of the unit using the special goods have corresponding qualifications;

　　3. whether the record how to use the entry special goods is used according to the approved uses;

　　The unit of using the special goods should tell the inspection and quarantine organ how they use the goods.

　　Article 23 If the inspection and quarantine organ find any circumstances that does not meet the requirements during follow-up supervision and administration, they should order them to make correction and seal up the special goods that have already entered the country until they meets the requirements. If the goods do not meet the requirements after the correction, they should be returned back or destroyed.

　　Article 24 Inspection and quarantine organ should report AQSIQ immediately the problems found in the follow-up supervision and administration, and circulate a notice to the affiliated inspection and quarantine bureau that made the original approval.

　　Chapter V Supplementary Articles

　　Article 25 Inspection and quarantine organ may give a warming or fine less than 5000 yuan to one of following behaviors violating these regulations:

　　1. cancel or fail to report the microorganism, human body tissues, biological products, blood and its products and other special goods that are forbidden to be imported;

　　2. move, sell and use special goods without the permission of the inspection and quarantine organs;

　　3. do not report to the inspection and quarantine organ within the time limited or refuse to accept follow-up supervision and administration of health quarantine on special goods;

　　4. forge or alter quarantine paper or certificate.

　　Article 26 Whoever violates these regulations, causes the spread of infectious disease relating to quarantine or serious danger of spread of infectious disease relating to quarantine should be ascertained criminal responsibility in accordance with relative provisions of Criminal Law of the People's Republic of China.

　　Article 27 The meaning of the words in terms of theses regulations:

　　1. microorganism means virus, bacterium, cumycete, actinomyees, reckttsia, spirochaeta, Chlamydia, mycoplasma and other microorganism;

　　2. human body tissues means human embryo, organs, tissues, cell, human secretion, excrement;

　　3. biological products means bacterial vaccine, viral vaccine, antitoxin, all kinds of reagents for diagnosis, interferon, hormone, enzyme and its preparation and other active preparation （toxin, antigen, allegy, single clone antibody, reorganized DNA products, antigen-antibody Composites, immunologic regulator, microecology preparation, nucleic acid preparation and etc）, and relative products made of biological materials;

　　4. blood and its products means blood, plasma, serum, blood cell and the products of plasma protein component or blood cell component that are separated or purified from blood or made by application biotechnology.

　　Article 28 Health quarantine on entry and exit special goods that enter and leave the bonded area and export processing area should be administered in accordance with these regulations.

　　Article 29 The interpretation of these regulations is vested in AQSIQ.

　　Article 30 These regulations shall come into effect as of January 1, 2006.