出入境特殊物品卫生检疫管理规定

局　长
二〇〇五年十月十七日

出入境特殊物品卫生检疫管理规定

第一章　总则

第一条　为规范出入境特殊物品的卫生检疫监督管理，根据《中华人民共和国国境卫生检疫法》及其实施细则的有关规定，制定本规定。

第二条　本规定适用于入境、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卫生检疫监督管理。

第三条　国家质量监督检验检疫总局（以下简称国家质检总局）统一管理全国出入境特殊物品的卫生检疫监督管理工作；国家质检总局设在各地的出入境检验检疫机构（以下简称检验检疫机构）对辖区内出入境特殊物品实施卫生检疫监督管理。

第四条　出入境特殊物品的卫生检疫管理实行卫生检疫审批、现场查验和后续监督管理制度。

第五条　取得《入/出境特殊物品卫生检疫审批单》（以下简称《卫生检疫审批单》），并经卫生检疫合格的出入境特殊物品，方准入境、出境。

第六条　出入境特殊物品由国家质检总局指定并公布的口岸入境、出境。

第二章　卫生检疫审批

第七条　直属检验检疫局负责所辖区域内出入境特殊物品的卫生检疫审批。

第八条　入境、出境特殊物品的货主或者其代理人应当在交运前向入出境口岸直属检验检疫局提交《入/出境特殊物品卫生检疫审批申请单》（下简称《审批申请单》）。

货主或者其代理人应当根据出入境特殊物品的分类填写《审批申请单》，每一类别填写一份。

第九条　申请办理出入境微生物、人体组织、血液的卫生检疫审批手续的，应当提供以下材料：

（一）相关主管部门出具的准许出入境证明（原件和复印件）；

（二）特殊物品所含病原微生物的学名（中文和拉丁文）和生物学特性（中英文对照件）的说明性文件；

（三）含有或者可能含有3至4级病原微生物的入境特殊物品，及含有或者可能含有尚未分级病原微生物的入境特殊物品，使用单位应当具备BSL-3级（p3级）实验室，并提供相应资质的证明；

（四）科研用特殊物品应当提供科研项目批准文件原件或者科研项目申请人与国内外合作机构协议（原件和复印件，中、英文对照件）；

（五）供移植用器官应当提供有资质医院出具的供体健康证明和相关检验报告。

第十条 申请办理生物制品、血液制品的卫生检疫审批手续的，货主或者其代理人应当提供以下材料：

（一）用于治疗、预防、诊断的入境生物制品、血液制品，应当提供国家药品监督管理部门出具的进口注册证明；

（二）用于治疗、预防、诊断的出境生物制品、血液制品，应当提供药品监督管理部门出具的《药品销售证明》；

（三）用于其他领域的出入境生物制品、血液制品，应当提供相关主管部门出具的进口批件。

第十一条　直属检验检疫局对申请材料齐全，符合法定形式的申请，应当予以受理。

第十二条　受理申请的直属检验检疫局对申请材料进行实质性审查，并在20个工作日内作出准予许可或者不准予许可的决定，20个工作日内不能作出决定的，经负责人批准可以延长10个工作日，并应当将延长期限的理由告知申请人。

准予许可的，应当签发《卫生检疫审批单》，不准予许可的，应当书面说明理由。

对于尚未认知其传染性的特殊物品，直属检验检疫局应当报请国家质检总局开展技术分析。技术分析所需时间不计入审批期限，但应当书面告知货主或者其代理人。

第十三条　出入境的特殊物品卫生检疫审批单只能使用一次，有效期限为90天。

第十四条　供移植用器官因特殊原因未办理卫生检疫审批手续的，入境、出境时检验检疫机构可以先予放行，货主或者其代理人应当在放行后10日内申请补办卫生检疫审批手续。

第三章　卫生检疫

第十五条　入境、出境特殊物品到达口岸后或者离开口岸前，货主或者其代理人应当依法向口岸检验检疫机构报检。有下列情形之一的，检验检疫机构不予受理报检：

（一）不能提供《卫生检疫审批单》的；

（二）《卫生检疫审批单》超过有效期的；

（三）伪造、涂改有关文件或单证的；

（四）其他不符合检验检疫要求的。

第十六条　受理报检的口岸检验检疫机构按照下列要求对出入境特殊物品实施现场查验，并填写《入／出境特殊物品卫生检疫现场查验记录》：

（一）检查出入境特殊物品名称、批号、规格、数量、输出／输入国和生产厂家等项目是否与审批单列明的内容相符；

（二）检查出入境特殊物品包装是否安全无破损，不渗、不漏；

（三）对出境的特殊物品应核查出厂检验合格报告，检查生产记录、原材料来源，以及生产流程是否符合卫生要求。

第十七条　对需抽样检验的入境特殊物品，经口岸检验检疫机构许可，货主或者其代理人可先运至有储存条件的场所，待检验合格后方可移运或使用。口岸检验检疫机构不具有检验能力的，应当委托国家质检总局指定的实验室进行检验。

第十八条　邮寄、携带的出入境特殊物品，因特殊情况未办理卫生检疫审批手续的，检验检疫机构应当予以截留，要求按照规定办理卫生检疫审批手续，并按照第十六条进行查验，经检疫合格后方可放行。

第十九条　口岸检验检疫机构对经卫生检疫符合要求的出入境特殊物品予以放行。发现有下列情况之一的，签发《检验检疫处理通知书》，并予以封存、退回或者销毁：

（一）名称、批号、规格、数量等与审批内容不相符的；

（二）包装或者保存条件不符合要求的；

（三）超过有效使用期限的；

（四）经检验不符合卫生检疫要求的；

（五）被截留物品自截留之日起60日内未获准许可的。

口岸检验检疫机构对处理结果应当做好记录、归档，并上报国家质检总局。

第四章　后续监管

第二十条　检验检疫机构对辖区内含有或可能含有病原微生物的入境特殊物品实施后续监管。

需要后续监管的入境特殊物品，未经检验检疫机构的同意，不得擅自使用。

第二十一条　对需要实施异地后续监管的入境特殊物品，口岸检验检疫机构应当出具《入境货物调离单》，并及时电子转单给目的地检验检疫机构。使用单位应当在特殊物品入境后30日内，持《入境货物调离单》到目的地检验检疫机构申报，并接受后续监管。

第二十二条　检验检疫机构对入境特殊物品实施后续监管的内容包括：

（一）含有或者可能含有病原微生物入境特殊物品的使用单位是否具有相应等级的生物安全实验室，P3级以上实验室必须获得国家认可机构的认可；

（二）使用单位实验室操作人员是否具备相应的资质；

（三）入境特殊物品使用情况记录，是否按照审批用途使用。

使用单位应当及时向检验检疫机构提供使用情况说明。

第二十三条　检验检疫机构在后续监管过程中发现有不符合要求的，应当责令限期整改，并对已入境的特殊物品进行封存，直至整改符合要求。如经整改仍不符合要求的，责令其退运或者销毁。

第二十四条　检验检疫机构对后续监管过程中发现的问题，应当立即报告国家质检总局，并通报原审批的直属检验检疫局。

第五章　附则

第二十五条　违反本规定，有下列行为之一的，检验检疫机构可以给予警告或者处以5000元以下的罚款：

（一）瞒报或者漏报禁止进口的微生物、人体组织、生物制品、血液及其制品等特殊物品的；

（二）未经检验检疫机构许可，擅自移运、销售和使用特殊物品的；

（三）在规定时限内未向检验检疫机构申报或者拒绝接受特殊物品卫生检疫后续监管的；

（四）伪造或者涂改检疫单、证的。

第二十六条　对违反本规定，引起检疫传染病传播或者有引起检疫传染病传播严重危险的，依照《中华人民共和国刑法》的有关规定追究刑事责任。

第二十七条　本规定下列用语的含义：

（一）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；

（二）人体组织是指人体胚胎、器官、组织、细胞、人体分泌物、排泄物；

（三）生物制品是指：细菌类疫苗、病毒类疫苗、抗毒素、各种诊断用试剂、干扰素、激素、酶及其制剂以及其他活性制剂（毒素、抗原、变态反应原、单克隆抗体、重组DNA产品、抗原-抗体复合物、免疫调节剂、微生态制剂、核酸制剂等），以及其他生物材料制备的有关制品；

（四）血液及其制品是指全血、血浆、血清、血细胞以及由血液分离、提纯或者应用生物技术制成的血浆蛋白组分或者血细胞组分制品。

第二十八条　进出保税区、出口加工区的出入境特殊物品的卫生检疫管理，按照本规定执行。

第二十九条　本规定由国家质检总局负责解释。

第三十条　本规定自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