| Order of the General Administration of Quality Supervision, Inspection and Quarantine | | 中华人民共和国国家质量监督检验检疫总局令 |
| (No. 160) | | （第160号） |
| The Provisions on the Administration of the Health and Quarantine of Entry/Exit Special Articles, as deliberated and adopted at the executive meeting of the General Administration of Quality Supervision, Inspection and Quarantine, are hereby issued, and shall come into force on March 1, 2015. | | 《出入境特殊物品卫生检疫管理规定》已经2014年12月4日国家质量监督检验检疫总局局务会议审议通过，现予公布，自2015年3月1日起施行。 |
| Director: Zhi Shuping | | 局 长 支树平 |
| January 21, 2015 | | 2015年1月21日 |
| Provisions on the Administration of the Health and Quarantine of Entry/Exit Special Articles | | 出入境特殊物品卫生检疫管理规定 |
| | |
| Chapter I General Provisions | | 第一章 总 则 |
| Article 1 To regulate the supervision and administration of the health and quarantine of entry/exit special articles, prevent the introduction and spreading of infectious diseases, prevent and control bio-safety risks, and protect human health, these Provisions are developed in accordance with the Frontier Health and Quarantine Law of the People's Republic of China and the Detailed Rules for the Implementation thereof, the Regulation on the Prevention and Treatment of HIV/AIDS, the Regulation on the Bio-safety Management of Pathogenic Microorganism Laboratories, the Interim Measures for the Administration of Human Genetic Resources, and other relevant laws and regulations. | | 第一条 为了规范出入境特殊物品卫生检疫监督管理，防止传染病传入、传出，防控生物安全风险，保护人体健康，根据《中华人民共和国国境卫生检疫法》及其实施细则、《艾滋病防治条例》、《病原微生物实验室生物安全管理条例》和《人类遗传资源管理暂行办法》等法律法规规定，制定本规定。 |
| Article 2 These Provisions shall apply to the supervision and administration of health and quarantine of entry/exit microorganisms, human tissues, biological products, blood and its products, and other special articles. | | 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。 |
| Article 3 The General Administration of Quality Supervision, Inspection and Quarantine (hereinafter referred to as the “AQSIQ”) shall uniformly conduct the supervision and administration of the health and quarantine of entry/exit special articles across the country; and local entry/exit inspection and quarantine organs of the AQSIQ (hereinafter referred to as the “inspection and quarantine organs”) shall conduct the supervision and administration of the health and quarantine of entry/exit special articles within their respective jurisdictions. | | 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部门（以下简称检验检疫部门）负责所辖地区的出入境特殊物品卫生检疫监督管理工作。 |
| Article 4 The supervision and administration of the health and quarantine of entry/exit special articles shall follow the principle of risk management and the quarantine approval, quarantine inspection, and supervision and administration shall be implemented on the basis of risk assessment and according to risk levels. | | 第四条 出入境特殊物品卫生检疫监督管理遵循风险管理原则，在风险评估的基础上根据风险等级实施检疫审批、检疫查验和监督管理。 |
| The AQSIQ may assess the bio-safety control system of the export country or region. | | 国家质检总局可以对输出国家或者地区的生物安全控制体系进行评估。 |
| Article 5 The consigner of the entry/exit special articles or its agent shall, in accordance with the laws and regulations and the relevant standards, import, export, produce, operate, and use the special articles, be accountable to the society and the general public, guarantee the safety of the special articles, accept social supervision, and assume social responsibilities. | | 第五条 出入境特殊物品的货主或者其代理人，应当按照法律法规规定和相关标准的要求，输入、输出以及生产、经营、使用特殊物品，对社会和公众负责，保证特殊物品安全，接受社会监督，承担社会责任。 |
| Chapter II Quarantine Approval | | 第二章 检疫审批 |
| Article 6 The inspection and quarantine bureaus directly under the AQSIQ shall be responsible for the approval of health and quarantine of entry/exit special articles within their respective jurisdictions (hereinafter referred to as the “approval of special articles”). | | 第六条 直属检验检疫局负责辖区内出入境特殊物品的卫生检疫审批（以下简称特殊物品审批）工作。 |
| Article 7 To apply for the approval of special articles, the applicant shall meet the following conditions: | | 第七条 申请特殊物品审批应当具备下列条件： |
| (1) Where it is provided in laws and regulations that the applicant must obtain the approval documents of the relevant authorities, the applicant shall obtain corresponding approval documents. | | （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； |
| (2) The applicant shall have bio-safety control capabilities that are consistent with such entry/exit special articles. | | （二）具备与出入境特殊物品相适应的生物安全控制能力。 |
| Article 8 The consigner of the entry special articles or its agent shall file an application for the approval of special articles with the inspection and quarantine bureau directly under the AQSIQ at the destination before delivering the special articles for shipment. | | 第八条 入境特殊物品的货主或者其代理人应当在特殊物品交运前向目的地直属检验检疫局申请特殊物品审批。 |
| The consigner of the exit special articles or its agent shall file an application for the approval of special articles with the local inspection and quarantine bureau directly under the AQSIQ before delivering the special articles for shipment. | | 出境特殊物品的货主或者其代理人应当在特殊物品交运前向其所在地直属检验检疫局申请特殊物品审批。 |
| Article 9 To apply for the approval of special articles, the consigner of such special articles or its agent shall submit the following materials in accordance with the relevant provisions: | | 第九条 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： |
| (1) The Application Form for the Approval of Health and Quarantine of Entry/Exit Special Articles shall be provided. | | （一）《入/出境特殊物品卫生检疫审批申请表》； |
| (2) The descriptive documents of entry/exit special articles, including the Chinese and English names, categories, components, sources, purposes, main sale channels, export/import countries or regions, and manufacturers of such special articles, shall be provided. | | （二）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； |
| (3) For entry human blood, plasma, tissues, organs, cells, and bone marrow, the approval documents issued by competent health authorities shall be provided. | | （三）入境人体血液、血浆、组织、器官、细胞、骨髓等，应当提供卫生主管部门的批准文件； |
| (4) For entry/exit human tissues, cells, organs, and bone marrow for transplantation, the health certificates and the relevant inspection reports of the donors issued by medical institutions shall be provided. | | （四）入境、出境供移植用人体组织、细胞、器官、骨髓，应当提供医疗机构出具的供体健康证明和相关检验报告； |
| (5) For entry biological products and human blood products that are used for preventing, diagnosing, and treating human diseases, the registration certificates for imported drugs issued by the drug supervision and administration department of the State Council shall be provided. | | （五）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； |
| (6) For entry/exit special articles that contain or are likely to contain pathogenic microorganisms, the names (both in Chinese and in Latin) of such pathogenic microorganisms, the descriptive documents on the biological characters (with both Chinese and English versions), and the certificates proving that the manufacturer and operator or the user has the corresponding bio-safety prevention and control level shall be provided. | | （六）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； |
| (7) For exit biological products and human blood products that are used for preventing, diagnosing, and treating human diseases, the sale certificates issued by the drug supervision and administration departments shall be provided. | | （七）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； |
| (8) For exit special articles that are involved in the scope of administration of human genetic resources, the approval documents issued by the administrative departments of human genetic resources shall be provided. | | （八）出境特殊物品涉及人类遗传资源管理范畴的，应当提供人类遗传资源管理部门出具的批准文件； |
| (9) For entry/exit special articles that contain or are likely to contain pathogenic microorganisms, the entity using them shall provide the qualification certificate for its bio-safety laboratory that is consistent with the bio-safety risk level, and the laboratory at or above the BSL-Grade 3 shall be certified by the state certification organ. | | （九）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； |
| (10) For entry/exit highly pathogenic microorganisms (viruses) or their samples, the approval documents of the competent health departments of the people's governments at or above the provincial level shall be provided. | | （十）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。 |
| Article 10 Where the applicant is an entity, when making application for the approval of special articles for the first time, besides materials as prescribed in Article 9 of these Provisions, the applicant shall provide the following materials: | | 第十条 申请人为单位的，首次申请特殊物品审批时，除提供本规定第九条所规定的材料以外，还应当提供下列材料： |
| (1) the copies of the business license, the organization code certificate, and other certificate. At the same time, the originals shall be submitted for verification; | | （一）单位营业执照、组织机构代码证等证件复印件，同时交验原件； |
| (2) the basic information of the entity, including the management system certification of the entity, the address of the entity, the manufacturing site, the laboratory equipment, the warehousing facilities, the product processing, the manufacturing process or technical process, and the floor plan; or | | （二）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； |
| (3) the bio-safety system documents, including the management rules for the storage of special articles, the use management rules, the management rules for the disposal of wastes, the rules for the management of professionals, and the procedures for the emergency handling of contingencies. | | （三）生物安全体系文件，如特殊物品储存管理制度、使用管理制度、废弃物处置管理制度、专业人员管理制度、突发事件应急处置规程等。 |
| Where the applicant is a natural person, he or she shall provide the copy of the ID card and at the same time, submit the original I. | | 申请人为自然人的，应当提供身份证复印件，同时交验原件。 |
| The applicant of entry/exit pathogenic microorganisms or special articles that are likely to contain pathogenic microorganisms may not be a natural person. | | 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。 |
| Article 11 The inspection and quarantine bureau directly under the AQSIQ shall handle the application for the approval of special articles filed by the applicant under the following circumstances, respectively: | | 第十一条 直属检验检疫局对申请人提出的特殊物品审批申请，应当根据下列情况分别作出处理： |
| (1) Where it is unnecessary for the applicant to obtain the approval of special articles for the application item according to the law, the inspection and quarantine bureau directly under the AQSIQ shall immediately notify the applicant of its non-acceptance of the application. | | （一）申请事项依法不需要取得特殊物品审批的，应当即时告知申请人不予受理； |
| ．．．．．． | | ．．．．．． |
Dear visitor,you are attempting to view a subscription-based section of lawinfochina.com. If you are already a subscriber, please login to enjoy access to our databases . If you are not a subscriber, please subscribe . Should you have any questions, please contact us at:
+86 (10) 8268-9699 or +86 (10) 8266-8266 (ext. 153)
Mobile: +86 133-1157-0713
Fax: +86 (10) 8266-8268
database@chinalawinfo.com
| |
您好：您现在要进入的是北大法律英文网会员专区，如您是我们英文用户可直接 登录，进入会员专区查询您所需要的信息；如您还不是我们 的英文用户，请注册并交纳相应费用成为我们的英文会员 。如有问题请来电咨询；
Tel: +86 (10) 82689699, +86 (10) 82668266 ext. 153
Mobile: +86 13311570713
Fax: +86 (10) 82668268
E-mail: database@chinalawinfo.com
|
| | | |
| | | |