KYB CHINA(1996年12月30日中华人民共和国国务院令第208号发布 根据2016年2月6日《国务院关于修改部分行政法规的决定》修订)
(Promulgated by Decree No. 208 of the State Council of the People's Republic of China on December 30, 1996, and revised in accordance with the Decision of the State Council on Amending Certain Administrative Regulations on February 6, 2016)
总则
General Provisions
为了加强血液制品管理，预防和控制经血液途径传播的疾病，保证血液制品的质量，根据药品管理法和传染病防治法，制定本条例。
These Regulations are formulated in accordance with the Drug Administration Law and the Law on the Prevention and Treatment of Infectious Diseases to strengthen the administration of blood products, prevent and control the spread of diseases through blood routes, and ensure the quality of blood products.
本条例适用于在中华人民共和国境内从事原料血浆的采集、供应以及血液制品的生产、经营活动。
These Regulations apply to the collection and supply of source plasma and the production and operation of blood products within the territory of the People's Republic of China.
国务院卫生行政部门对全国的原料血浆的采集、供应和血液制品的生产、经营活动实施监督管理。
The health administrative department of the State Council shall exercise supervision and administration over the collection and supply of source plasma and the production and operation of blood products nationwide.
县级以上地方各级人民政府卫生行政部门对本行政区域内的原料血浆的采集、供应和血液制品的生产、经营活动，依照本条例第三十条规定的职责实施监督管理。
The health administrative departments of local people's governments at or above the county level shall, in accordance with the responsibilities specified in Article 30 of these Regulations, exercise supervision and administration over the collection and supply of source plasma and the production and operation of blood products within their respective administrative regions.
原料血浆的管理
Administration of Source Plasma
国家实行单采血浆站统一规划、设置的制度。
The State implements a system of unified planning and establishment of plasmapheresis stations.
国务院卫生行政部门根据核准的全国生产用原料血浆的需求，对单采血浆站的布局、数量和规模制定总体规划。省、自治区、直辖市人民政府卫生行政部门根据总体规划制定本行政区域内单采血浆站设置规划和采集血浆的区域规划，并报国务院卫生行政部门备案。
The health administrative department of the State Council shall, based on the approved national demand for source plasma for production, formulate an overall plan for the layout, number, and scale of plasmapheresis stations. The health administrative departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall, in accordance with the overall plan, formulate plans for the establishment of plasmapheresis stations and regional plans for plasma collection within their respective administrative regions, and report them to the health administrative department of the State Council for record.
单采血浆站由血液制品生产单位设置或者由县级人民政府卫生行政部门设置，专门从事单采血浆活动，具有独立法人资格。其他任何单位和个人不得从事单采血浆活动。
Plasmapheresis stations shall be established by blood product production units or by the health administrative departments of county people's governments, and shall be exclusively engaged in plasmapheresis activities with independent legal personality. No other unit or individual may engage in plasmapheresis activities.
设置单采血浆站，必须具备下列条件：
The establishment of a plasmapheresis station must meet the following conditions:
(一)符合单采血浆站布局、数量、规模的规划；
(1) Conformity with the plan for the layout, number, and scale of plasmapheresis stations;
(二)具有与所采集原料血浆相适应的卫生专业技术人员；
(2) Possession of health professionals and technicians appropriate for the collection of source plasma;
(三)具有与所采集原料血浆相适应的场所及卫生环境；
(3) Possession of premises and a sanitary environment appropriate for the collection of source plasma;
(四)具有识别供血浆者的身份识别系统；
(4) Possession of an identification system for identifying plasma donors;
(五)具有与所采集原料血浆相适应的单采血浆机械及其他设施；
(5) Possession of plasmapheresis machines and other facilities appropriate for the collection of source plasma;
(六)具有对所采集原料血浆进行质量检验的技术人员以及必要的仪器设备。
(6) Possession of technical personnel and necessary instruments and equipment for quality inspection of collected source plasma.
申请设置单采血浆站的，由县级人民政府卫生行政部门初审，经设区的市、自治州人民政府卫生行政部门或者省、自治区人民政府设立的派出机关的卫生行政机构审查同意，报省、自治区、直辖市人民政府卫生行政部门审批；经审查符合条件的，由省、自治区、直辖市人民政府卫生行政部门核发《单采血浆许可证》，并报国务院卫生行政部门备案。
An application for the establishment of a plasmapheresis station shall be initially reviewed by the health administrative department of the county people's government, examined and approved by the health administrative department of the people's government of a city divided into districts or an autonomous prefecture, or by the health administrative agency of the agency established by the people's government of a province or autonomous region, and then submitted to the health administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government for approval. If the conditions are met after examination, the health administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall issue a Plasmapheresis Station Permit and report it to the health administrative department of the State Council for record.
单采血浆站只能对省、自治区、直辖市人民政府卫生行政部门划定区域内的供血浆者进行筛查和采集血浆。
A plasmapheresis station may only screen and collect plasma from plasma donors within the area designated by the health administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government.
《单采血浆许可证》应当规定有效期。
The Plasmapheresis Station Permit shall specify a period of validity.
在一个采血浆区域内，只能设置一个单采血浆站。
Only one plasmapheresis station may be established within a plasma collection area.
严禁单采血浆站采集非划定区域内的供血浆者和其他人员的血浆。
Plasmapheresis stations are strictly prohibited from collecting plasma from plasma donors outside the designated area or from other persons.
单采血浆站必须对供血浆者进行健康检查；检查合格的，由县级人民政府卫生行政部门核发《供血浆证》。
Plasmapheresis stations must conduct health examinations on plasma donors; those who pass the examination shall be issued a Plasma Donor Certificate by the health administrative department of the county people's government.
供血浆者健康检查标准，由国务院卫生行政部门制定。
The health examination standards for plasma donors shall be formulated by the health administrative department of the State Council.
《供血浆证》由省、自治区、直辖市人民政府卫生行政部门负责设计和印制。《供血浆证》不得涂改、伪造、转让。
The Plasma Donor Certificate shall be designed and printed by the health administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government. The Plasma Donor Certificate shall not be altered, forged, or transferred.
单采血浆站在采集血浆前，必须对供血浆者进行身份识别并核实其《供血浆证》，确认无误的，方可按照规定程序进行健康检查和血液化验；对检查、化验合格的，按照有关技术操作标准及程序采集血浆，并建立供血浆者健康检查及供血浆记录档案；对检查、化验不合格的，由单采血浆站收缴《供血浆证》，并由所在地县级人民政府卫生行政部门监督销毁。
Before collecting plasma, a plasma collection station must identify the donor and verify his/her Plasma Donation Certificate. Only after confirmation may health checks and blood tests be conducted according to prescribed procedures. For those who pass the checks and tests, plasma shall be collected in accordance with relevant technical operation standards and procedures, and records of donor health checks and plasma donations shall be established. For those who fail the checks and tests, the plasma collection station shall confiscate the Plasma Donation Certificate, and the health administrative department of the local county people's government shall supervise its destruction.
严禁采集无《供血浆证》者的血浆。
It is strictly prohibited to collect plasma from persons without a Plasma Donation Certificate.
血浆采集技术操作标准及程序，由国务院卫生行政部门制定。
The technical operation standards and procedures for plasma collection shall be formulated by the health administrative department of the State Council.
单采血浆站只能向一个与其签订质量责任书的血液制品生产单位供应原料血浆，严禁向其他任何单位供应原料血浆。
A plasma collection station may only supply raw plasma to one blood product production unit with which it has signed a quality responsibility agreement, and is strictly prohibited from supplying raw plasma to any other unit.
单采血浆站必须使用单采血浆机械采集血浆，严禁手工操作采集血浆。采集的血浆必须按单人份冰冻保存，不得混浆。
A plasma collection station must use apheresis machines to collect plasma; manual collection is strictly prohibited. Collected plasma must be frozen and stored in individual donor units; pooling of plasma is prohibited.
严禁单采血浆站采集血液或者将所采集的原料血浆用于临床。
Plasma collection stations are strictly prohibited from collecting whole blood or using collected raw plasma for clinical purposes.
单采血浆站必须使用有产品批准文号并经国家药品生物制品检定机构逐批检定合格的体外诊断试剂以及合格的一次性采血浆器材。
A plasma collection station must use in vitro diagnostic reagents that have a product approval number and have been batch-tested and qualified by the National Institute for the Control of Pharmaceutical and Biological Products, as well as qualified disposable apheresis supplies.
采血浆器材等一次性消耗品使用后，必须按照国家有关规定予以销毁，并作记录。
Disposable supplies such as apheresis consumables must be destroyed after use in accordance with relevant state regulations, and records shall be kept.
单采血浆站采集的原料血浆的包装、储存、运输，必须符合国家规定的卫生标准和要求。
The packaging, storage, and transportation of raw plasma collected by a plasma collection station must comply with the hygiene standards and requirements prescribed by the state.
单采血浆站必须依照传染病防治法及其实施办法等有关规定，严格执行消毒管理及疫情上报制度。
A plasma collection station must strictly implement disinfection management and epidemic reporting systems in accordance with the Law on the Prevention and Treatment of Infectious Diseases and its implementing measures, among other relevant regulations.
单采血浆站应当每半年向所在地的县级人民政府卫生行政部门报告有关原料血浆采集情况，同时抄报设区的市、自治州人民政府卫生行政部门或者省、自治区人民政府设立的派出机关的卫生行政机构及省、自治区、直辖市人民政府卫生行政部门。省、自治区、直辖市人民政府卫生行政部门应当每年向国务院卫生行政部门汇总报告本行政区域内原料血浆的采集情况。
A plasma collection station shall report to the health administrative department of the local county people's government every six months on the collection of raw plasma, with copies to the health administrative department of the city divided into districts or autonomous prefecture people's government, or the health administrative agency of the agency established by the provincial or autonomous region people's government, and to the health administrative department of the provincial, autonomous region, or municipality directly under the Central Government people's government. The health administrative department of the provincial, autonomous region, or municipality directly under the Central Government people's government shall annually submit a summary report to the health administrative department of the State Council on the collection of raw plasma within its administrative region.
国家禁止出口原料血浆。
The state prohibits the export of raw plasma.
血液制品生产经营单位管理
Management of Blood Product Production and Operation Units
新建、改建或者扩建血液制品生产单位，经国务院卫生行政部门根据总体规划进行立项审查同意后，由省、自治区、直辖市人民政府卫生行政部门依照药品管理法的规定审核批准。
The construction, renovation, or expansion of a blood product production unit shall be subject to project review and approval by the health administrative department of the State Council based on the overall plan, and then reviewed and approved by the health administrative department of the provincial, autonomous region, or municipality directly under the Central Government people's government in accordance with the Drug Administration Law.
血液制品生产单位必须达到国务院卫生行政部门制定的《药品生产质量管理规范》规定的标准，经国务院卫生行政部门审查合格，并依法向工商行政管理部门申领营业执照后，方可从事血液制品的生产活动。
A blood product production unit must meet the standards set by the health administrative department of the State Council in the Good Manufacturing Practice for Pharmaceutical Products, pass the review by the health administrative department of the State Council, and legally obtain a business license from the administrative department for industry and commerce before engaging in blood product production activities.
血液制品生产单位应当积极开发新品种，提高血浆综合利用率。
Blood product production units shall actively develop new varieties and improve the comprehensive utilization rate of plasma.
血液制品生产单位生产国内已经生产的品种，必须依法向国务院卫生行政部门申请产品批准文号；国内尚未生产的品种，必须按照国家有关新药审批的程序和要求申报。
For varieties already produced domestically, a blood product production unit must apply to the health administrative department of the State Council for a product approval number in accordance with the law; for varieties not yet produced domestically, the application must follow the procedures and requirements for new drug approval.
严禁血液制品生产单位出让、出租、出借以及与他人共用《药品生产企业许可证》和产品批准文号。
Blood product production units are strictly prohibited from transferring, leasing, lending, or sharing with others the Pharmaceutical Production Enterprise License and product approval numbers.
血液制品生产单位不得向无《单采血浆许可证》的单采血浆站或者未与其签订质量责任书的单采血浆站及其他任何单位收集原料血浆。
A blood product production unit may not collect raw plasma from a plasma collection station that does not hold a Plasma Collection Station License, or from a plasma collection station with which it has not signed a quality responsibility agreement, or from any other unit.
血液制品生产单位不得向其他任何单位供应原料血浆。
A blood product production unit may not supply raw plasma to any other unit.
血液制品生产单位在原料血浆投料生产前，必须使用有产品批准文号并经国家药品生物制品检定机构逐批检定合格的体外诊断试剂，对每一人份血浆进行全面复检，并作检测记录。
Before putting raw plasma into production, a blood product production unit must use in vitro diagnostic reagents that have a product approval number and have been batch-tested and qualified by the National Institute for the Control of Pharmaceutical and Biological Products to conduct comprehensive retesting of each individual plasma unit, and shall keep testing records.
原料血浆经复检不合格的，不得投料生产，并必须在省级药品监督员监督下按照规定程序和方法予以销毁，并作记录。
If raw plasma fails retesting, it shall not be put into production and must be destroyed under the supervision of a provincial-level drug inspector in accordance with prescribed procedures and methods, and records shall be kept.
原料血浆经复检发现有经血液途径传播的疾病的，必须通知供应血浆的单采血浆站，并及时上报所在地省、自治区、直辖市人民政府卫生行政部门。
If raw plasma is found through retesting to carry diseases transmissible through blood routes, the plasma collection station that supplied the plasma must be notified, and the matter must be promptly reported to the health administrative department of the provincial, autonomous region, or municipality directly under the Central Government people's government.
血液制品出厂前，必须经过质量检验；经检验不符合国家标准的，严禁出厂。
Before leaving the factory, blood products must undergo quality inspection; those that do not meet national standards are strictly prohibited from leaving the factory.
开办血液制品经营单位，由省、自治区、直辖市人民政府卫生行政部门审核批准。
The establishment of a blood product operation unit shall be reviewed and approved by the health administrative department of the provincial, autonomous region, or municipality directly under the Central Government people's government.
血液制品经营单位应当具备与所经营的产品相适应的冷藏条件和熟悉所经营品种的业务人员。
Blood product business units shall have refrigeration conditions suitable for the products they operate and business personnel familiar with the varieties they operate.
血液制品生产经营单位生产、包装、储存、运输、经营血液制品，应当符合国家规定的卫生标准和要求。
Blood product production and business units shall comply with the hygiene standards and requirements prescribed by the state when producing, packaging, storing, transporting, and operating blood products.
监督管理
Supervision and Administration
县级以上地方各级人民政府卫生行政部门依照本条例的规定负责本行政区域内的单采血浆站、供血浆者、原料血浆的采集及血液制品经营单位的监督管理。
The health administrative departments of local people's governments at or above the county level shall, in accordance with these Regulations, be responsible for the supervision and administration of plasma collection stations, plasma donors, collection of source plasma, and blood product business units within their respective administrative regions.
省、自治区、直辖市人民政府卫生行政部门依照本条例的规定负责本行政区域内的血液制品生产单位的监督管理。
The health administrative departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall, in accordance with these Regulations, be responsible for the supervision and administration of blood product production units within their respective administrative regions.
县级以上地方各级人民政府卫生行政部门的监督人员执行职务时，可以按照国家有关规定抽取样品和索取有关资料，有关单位不得拒绝和隐瞒。
When performing their duties, supervisors of the health administrative departments of local people's governments at or above the county level may, in accordance with relevant state regulations, take samples and request relevant materials, and the relevant units shall not refuse or conceal them.
省、自治区、直辖市人民政府卫生行政部门每年组织1次对本行政区域内单采血浆站的监督检查并进行年度注册。
The health administrative departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall organize one supervision and inspection of plasma collection stations within their respective administrative regions each year and conduct annual registration.
设区的市、自治州人民政府卫生行政部门或者省、自治区人民政府设立的派出机关的卫生行政机构每半年对本行政区域内的单采血浆站进行1次检查。
The health administrative departments of the people's governments of cities divided into districts and autonomous prefectures, or the health administrative agencies of the dispatched organs established by the people's governments of provinces and autonomous regions, shall conduct one inspection of plasma collection stations within their respective administrative regions every six months.
国家药品生物制品检定机构及国务院卫生行政部门指定的省级药品检验机构，应当依照本条例和国家规定的标准和要求，对血液制品生产单位生产的产品定期进行检定。
The National Institute for the Control of Pharmaceutical and Biological Products and the provincial drug testing institutions designated by the health administrative department of the State Council shall, in accordance with these Regulations and the standards and requirements prescribed by the state, regularly conduct testing of products produced by blood product production units.
国务院卫生行政部门负责全国进出口血液制品的审批及监督管理。
The health administrative department of the State Council shall be responsible for the approval and supervision and administration of the import and export of blood products nationwide.
罚则
Penalties
违反本条例规定，未取得省、自治区、直辖市人民政府卫生行政部门核发的《单采血浆许可证》，非法从事组织、采集、供应、倒卖原料血浆活动的，由县级以上地方人民政府卫生行政部门予以取缔，没收违法所得和从事违法活动的器材、设备，并处违法所得5倍以上10倍以下的罚款，没有违法所得的，并处5万元以上10万元以下的罚款；造成经血液途径传播的疾病传播、人身伤害等危害，构成犯罪的，依法追究刑事责任。
Whoever, in violation of these Regulations, without obtaining the "Plasma Collection Station License" issued by the health administrative department of the people's government of a province, autonomous region, or municipality directly under the Central Government, illegally engages in organizing, collecting, supplying, or reselling source plasma activities, shall be banned by the health administrative department of the local people's government at or above the county level, have their illegal gains and the equipment and devices used for the illegal activities confiscated, and be fined not less than 5 times but not more than 10 times the illegal gains; if there are no illegal gains, a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed; if the act causes the spread of diseases through blood transmission, personal injury, or other harm, constituting a crime, criminal liability shall be pursued according to law.
单采血浆站有下列行为之一的，由县级以上地方人民政府卫生行政部门责令限期改正，处5万元以上10万元以下的罚款；有第八项所列行为的，或者有下列其他行为并且情节严重的，由省、自治区、直辖市人民政府卫生行政部门吊销《单采血浆许可证》；构成犯罪的，对负有直接责任的主管人员和其他直接责任人员依法追究刑事责任：
If a plasma collection station commits any of the following acts, the health administrative department of the local people's government at or above the county level shall order it to make corrections within a time limit and impose a fine of not less than 50,000 yuan but not more than 100,000 yuan; if it commits the act listed in item (8), or if it commits any other act listed below and the circumstances are serious, the health administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall revoke its "Plasma Collection Station License"; if a crime is constituted, the directly responsible person in charge and other directly responsible personnel shall be pursued for criminal liability according to law:
(一)采集血浆前，未按照国务院卫生行政部门颁布的健康检查标准对供血浆者进行健康检查和血液化验的；
(1) Failing to conduct health examinations and blood tests on plasma donors in accordance with the health examination standards promulgated by the health administrative department of the State Council before collecting plasma;
(二)采集非划定区域内的供血浆者或者其他人员的血浆的，或者不对供血浆者进行身份识别，采集冒名顶替者、健康检查不合格者或者无《供血浆证》者的血浆的；
(2) Collecting plasma from plasma donors outside the designated area or from other persons, or failing to identify plasma donors and collecting plasma from impersonators, persons who fail health examinations, or persons without a "Plasma Donor Certificate";
(三)违反国务院卫生行政部门制定的血浆采集技术操作标准和程序，过频过量采集血浆的；
(3) Violating the plasma collection technical operation standards and procedures formulated by the health administrative department of the State Council, collecting plasma too frequently or in excessive amounts;
(四)向医疗机构直接供应原料血浆或者擅自采集血液的；
(4) Directly supplying source plasma to medical institutions or collecting blood without authorization;
(五)未使用单采血浆机械进行血浆采集的；
(5) Failing to use apheresis machines for plasma collection;
(六)未使用有产品批准文号并经国家药品生物制品检定机构逐批检定合格的体外诊断试剂以及合格的一次性采血浆器材的；
(6) Failing to use in vitro diagnostic reagents that have a product approval number and have been batch-tested and qualified by the National Institute for the Control of Pharmaceutical and Biological Products, as well as qualified disposable plasma collection equipment;
(七)未按照国家规定的卫生标准和要求包装、储存、运输原料血浆的；
(7) Failing to package, store, and transport source plasma in accordance with the hygiene standards and requirements prescribed by the state;
(八) 对国家规定检测项目检测结果呈阳性的血浆不清除、不及时上报的；
(8) Failing to remove and promptly report plasma that tests positive for items required by state testing;
(九) 对污染的注射器、采血浆器材及不合格血浆等不经消毒处理，擅自倾倒，污染环境，造成社会危害的；
(9) Disposing of contaminated syringes, plasma collection equipment, and unqualified plasma without disinfection, dumping them without authorization, polluting the environment, and causing social harm;
(十) 重复使用一次性采血浆器材的；
(10) Reusing disposable plasma collection equipment;
(十一) 向与其签订质量责任书的血液制品生产单位以外的其他单位供应原料血浆的。
(11) Supplying source plasma to units other than the blood product production unit with which it has signed a quality responsibility agreement.
单采血浆站已知其采集的血浆检测结果呈阳性，仍向血液制品生产单位供应的，由省、自治区、直辖市人民政府卫生行政部门吊销《单采血浆许可证》，由县级以上地方人民政府卫生行政部门没收违法所得，并处10万元以上30万元以下的罚款；造成经血液途径传播的疾病传播、人身伤害等危害，构成犯罪的，对负有直接责任的主管人员和其他直接责任人员依法追究刑事责任。
If a plasma collection station, knowing that the plasma it has collected tests positive, still supplies it to a blood product production unit, the health administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall revoke its "Plasma Collection Station License", and the health administrative department of the local people's government at or above the county level shall confiscate the illegal gains and impose a fine of not less than 100,000 yuan but not more than 300,000 yuan; if the act causes the spread of diseases through blood transmission, personal injury, or other harm, constituting a crime, the directly responsible person in charge and other directly responsible personnel shall be pursued for criminal liability according to law.
涂改、伪造、转让《供血浆证》的，由县级人民政府卫生行政部门收缴《供血浆证》，没收违法所得，并处违法所得3倍以上5倍以下的罚款，没有违法所得的，并处1万元以下的罚款；构成犯罪的，依法追究刑事责任。
Whoever alters, forges, or transfers the 'Plasma Donation Certificate' shall have the certificate confiscated by the health administrative department of the county people's government, have illegal gains confiscated, and be fined not less than 3 times but not more than 5 times the illegal gains; if there are no illegal gains, a fine of not more than 10,000 yuan shall also be imposed; if a crime is constituted, criminal liability shall be pursued according to law.
血液制品生产单位有下列行为之一的，由省级以上人民政府卫生行政部门依照药品管理法及其实施办法等有关规定，按照生产假药、劣药予以处罚；构成犯罪的，对负有直接责任的主管人员和其他直接责任人员依法追究刑事责任：
If a blood product production unit commits any of the following acts, the health administrative department at or above the provincial level shall impose penalties in accordance with the Drug Administration Law and its implementing measures, treating it as producing counterfeit or substandard drugs; if a crime is constituted, the persons directly in charge and other directly responsible persons shall be pursued for criminal liability according to law:
(一)使用无《单采血浆许可证》的单采血浆站或者未与其签订质量责任书的单采血浆站及其他任何单位供应的原料血浆的，或者非法采集原料血浆的；
(1) Using a single plasma collection station without a 'Single Plasma Collection Station License' or a single plasma collection station that has not signed a quality responsibility letter with it, or any other unit supplying source plasma, or illegally collecting source plasma;
(二)投料生产前未对原料血浆进行复检的，或者使用没有产品批准文号或者未经国家药品生物制品检定机构逐批检定合格的体外诊断试剂进行复检的，或者将检测不合格的原料血浆投入生产的；
(2) Failing to retest source plasma before putting it into production, or using in vitro diagnostic reagents that do not have a product approval number or have not been batch-inspected and qualified by the national drug biological product inspection agency for retesting, or putting source plasma that fails testing into production;
(三)擅自更改生产工艺和质量标准的，或者将检验不合格的产品出厂的；
(3) Unauthorizedly changing production processes and quality standards, or releasing products that fail inspection;
(四)与他人共用产品批准文号的。
(4) Sharing product approval numbers with others.
血液制品生产单位违反本条例规定，擅自向其他单位出让、出租、出借以及与他人共用《药品生产企业许可证》、产品批准文号或者供应原料血浆的，由省级以上人民政府卫生行政部门没收违法所得，并处违法所得5倍以上10倍以下的罚款，没有违法所得的，并处5万元以上10万元以下的罚款。
If a blood product production unit violates these regulations by unauthorizedly transferring, leasing, lending, or sharing with others the 'Drug Manufacturing Enterprise License', product approval number, or supplying source plasma, the health administrative department at or above the provincial level shall confiscate illegal gains and impose a fine of not less than 5 times but not more than 10 times the illegal gains; if there are no illegal gains, a fine of not less than 50,000 yuan but not more than 100,000 yuan shall also be imposed.
违反本条例规定，血液制品生产经营单位生产、包装、储存、运输、经营血液制品不符合国家规定的卫生标准和要求的，由省、自治区、直辖市人民政府卫生行政部门责令改正，可以处1万元以下的罚款。
If a blood product production or operation unit violates these regulations by producing, packaging, storing, transporting, or dealing in blood products that do not meet the national health standards and requirements, the health administrative department of the province, autonomous region, or municipality directly under the Central Government shall order correction and may impose a fine of not more than 10,000 yuan.
在血液制品生产单位成品库待出厂的产品中，经抽检有一批次达不到国家规定的指标，经复检仍不合格的，由国务院卫生行政部门撤销该血液制品批准文号。
If, among products awaiting delivery in the finished product warehouse of a blood product production unit, one batch fails to meet the national prescribed indicators after sampling inspection and still fails after re-inspection, the health administrative department of the State Council shall revoke the approval number for that blood product.
违反本条例规定，擅自进出口血液制品或者出口原料血浆的，由省级以上人民政府卫生行政部门没收所进出口的血液制品或者所出口的原料血浆和违法所得，并处所进出口的血液制品或者所出口的原料血浆总值3倍以上5倍以下的罚款。
If anyone violates these regulations by unauthorizedly importing or exporting blood products or exporting source plasma, the health administrative department at or above the provincial level shall confiscate the imported or exported blood products or the exported source plasma and illegal gains, and impose a fine of not less than 3 times but not more than 5 times the total value of the imported or exported blood products or the exported source plasma.
血液制品检验人员虚报、瞒报、涂改、伪造检验报告及有关资料的，依法给予行政处分；构成犯罪的，依法追究刑事责任。
If a blood product inspection personnel falsely reports, conceals, alters, or forges inspection reports and related materials, administrative sanctions shall be imposed according to law; if a crime is constituted, criminal liability shall be pursued according to law.
卫生行政部门工作人员滥用职权、玩忽职守、徇私舞弊、索贿受贿，构成犯罪的，依法追究刑事责任；尚不构成犯罪的，依法给予行政处分。
If a staff member of the health administrative department abuses power, neglects duty, engages in malpractice for personal gain, or solicits or accepts bribes, if a crime is constituted, criminal liability shall be pursued according to law; if no crime is constituted, administrative sanctions shall be imposed according to law.
附则
Supplementary Provisions
本条例下列用语的含义：
The meanings of the following terms in these regulations:
血液制品，是特指各种人血浆蛋白制品。
Blood products specifically refer to various human plasma protein products.
原料血浆，是指由单采血浆站采集的专用于血液制品生产原料的血浆。
Source plasma refers to plasma collected by a single plasma collection station specifically for use as raw material in blood product production.
供血浆者，是指提供血液制品生产用原料血浆的人员。
Plasma donor refers to a person who provides source plasma for blood product production.
单采血浆站，是指根据地区血源资源，按照有关标准和要求并经严格审批设立，采集供应血液制品生产用原料血浆的单位。
Single plasma collection station refers to a unit established after strict approval based on regional blood source resources and in accordance with relevant standards and requirements, which collects and supplies source plasma for blood product production.
本条例施行前已经设立的单采血浆站和血液制品生产经营单位应当自本条例施行之日起6个月内，依照本条例的规定重新办理审批手续；凡不符合本条例规定的，一律予以关闭。
Single plasma collection stations and blood product production and operation units already established before the implementation of these regulations shall, within 6 months from the date of implementation, re-apply for approval procedures in accordance with these regulations; those that do not meet the requirements of these regulations shall be closed down.
本条例施行前已经设立的单采血浆站适用本条例第六条第五项的时间，由国务院卫生行政部门另行规定。
The time for single plasma collection stations already established before the implementation of these regulations to comply with Article 6, Item 5 of these regulations shall be separately prescribed by the health administrative department of the State Council.
本条例自发布之日起施行。
These regulations shall come into force on the date of promulgation.