Vaccine Administration Law of the People’s Republic of China
中华人民共和国疫苗管理法
Chapter I General Provisions
第一章 总则
Article 1 This Law is enacted to enhance the vaccine administration, to ensure the quality and supply of vaccines, to standardize the immunization, to promote the development of the vaccine industry, and to safeguard public health and safety.
第一条 为了加强疫苗管理，保证疫苗质量和供应，规范预防接种，促进疫苗行业发展，保障公众健康，维护公共卫生安全，制定本法。
Article 2 This Law shall govern activities involving vaccine development, manufacture, distribution, immunization and vaccine administration in the territory of the People’s Republic of China. In cases of not being stipulated in this Law, those activities shall be governed by the Drug Administration Law of the People’s Republic of China, the Law of the People’s Republic of China on the Prevention and Control of Infectious Diseases and relevant laws and administrative regulations.
第二条 在中华人民共和国境内从事疫苗研制、生产、流通和预防接种及其监督管理活动，适用本法。本法未作规定的，适用《中华人民共和国药品管理法》、《中华人民共和国传染病防治法》等法律、行政法规的规定。
For the purpose of this Law, vaccines refer to the prophylactic biological products for human immunization to prevent the occurrence and prevent, if not to be prevented, the prevalence of diseases, including immunization program vaccines and non-immunization program vaccines.
本法所称疫苗，是指为预防、控制疾病的发生、流行，用于人体免疫接种的预防性生物制品，包括免疫规划疫苗和非免疫规划疫苗。
Article 3 The State implements the most stringent regulatory system for vaccines and adheres to principles of safety first, risk management, whole process control, scientific supervision and social co-governance.
第三条 国家对疫苗实行最严格的管理制度，坚持安全第一、风险管理、全程管控、科学监管、社会共治。
Article 4 The State maintains the strategic and public welfare nature of vaccine products.
第四条 国家坚持疫苗产品的战略性和公益性。
The State supports fundamental research and application research of vaccines, promotes development and innovation of vaccines and incorporates the development, manufacture and stockpile of vaccines for the prevention and control of major diseases into the national strategy.
国家支持疫苗基础研究和应用研究，促进疫苗研制和创新，将预防、控制重大疾病的疫苗研制、生产和储备纳入国家战略。
The State formulates development planning and industry policies for the vaccine industry to support development and structural optimization of the vaccine industry, and encourages scale and intensive production and constant improvement on the production process and quality of vaccines.
国家制定疫苗行业发展规划和产业政策，支持疫苗产业发展和结构优化，鼓励疫苗生产规模化、集约化，不断提升疫苗生产工艺和质量水平。
Article 5 Vaccine marketing authorization holders (MAHs) shall enhance the vaccine life cycle quality management and be responsible for the safety, effectiveness and quality management of vaccines.
第五条 疫苗上市许可持有人应当加强疫苗全生命周期质量管理，对疫苗的安全性、有效性和质量可控性负责。
All entities and individuals engaged in vaccine development, manufacture, distribution and immunization shall comply with laws, regulations, rules, standards and norms, ensure the authenticity, accuracy, integrity and traceability of information through the whole process, take responsibilities in accordance with law and accept social supervision.(Through the whole process of vaccine development, manufacture, distribution and immunization, in which any entity or
从事疫苗研制、生产、流通和预防接种活动的单位和个人，应当遵守法律、法规、规章、标准和规范，保证全过程信息真实、准确、完整和可追溯，依法承担责任，接受社会监督。
Article 6 The State implements immunization program system.
第六条 国家实行免疫规划制度。
All citizens who reside in the territory of the People's Republic of China shall be entitled and obliged to be immunized with national immunization program vaccines according to law. The government shall provide immunization program vaccines for the citizens free of charge.
居住在中国境内的居民，依法享有接种免疫规划疫苗的权利，履行接种免疫规划疫苗的义务。政府免费向居民提供免疫规划疫苗。
People’s governments and relevant departments at or above the county level shall ensure that children at proper age are immunized with immunization program vaccines. The guardians shall ensure that children at proper age are immunized with the immunization program vaccines on schedule according to law.
县级以上人民政府及其有关部门应当保障适龄儿童接种免疫规划疫苗。监护人应当依法保证适龄儿童按时接种免疫规划疫苗。
Article 7 People's governments at or above the county level shall incorporate the vaccine safety, immunization work into the national economic and social development plans of the corresponding level, enhance the capacity building of vaccine administration, and establish and improve the work mechanism for vaccine administration.
第七条 县级以上人民政府应当将疫苗安全工作和预防接种工作纳入本级国民经济和社会发展规划，加强疫苗监督管理能力建设，建立健全疫苗监督管理工作机制。
Local people's governments at or above the county level shall be responsible for vaccine administration within their administrative regions, as well as leading, organizing and coordinating vaccine administration within their respective administrative regions in a unified manner.
县级以上地方人民政府对本行政区域疫苗监督管理工作负责，统一领导、组织、协调本行政区域疫苗监督管理工作。
Article 8 The drug regulatory department under the State Council shall be responsible for the administration of vaccines nationwide. The competent health department under the State Council shall be responsible for the administration of immunization nationwide. Other relevant departments under the State Council shall be responsible for the administration of vaccines within the scope of their respective responsibilities.
第八条 国务院药品监督管理部门负责全国疫苗监督管理工作。国务院卫生健康主管部门负责全国预防接种监督管理工作。国务院其他有关部门在各自职责范围内负责与疫苗有关的监督管理工作。
Drug regulatory departments of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the vaccine administration within their respective administrative regions. Departments undertaking responsibilities for drug administration (hereinafter referred to as drug regulatory departments) of the people’s governments of municipalities divided into districts and at county level shall undertake the administrative duties on vaccines within their respective administrative regions. The competent health departments of people's governments at or above the county level shall undertake the administration of immunization within their respective administrative regions. Other relevant departments of the people’s governments at or above the county level shall undertake the administrative duties on vaccines within the scope of their respective responsibilities.
省、自治区、直辖市人民政府药品监督管理部门负责本行政区域疫苗监督管理工作。设区的市级、县级人民政府承担药品监督管理职责的部门（以下称药品监督管理部门）负责本行政区域疫苗监督管理工作。县级以上地方人民政府卫生健康主管部门负责本行政区域预防接种监督管理工作。县级以上地方人民政府其他有关部门在各自职责范围内负责与疫苗有关的监督管理工作。
Article 9 The State Council and people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall establish a coordination mechanism to comprehensively coordinate relevant work of vaccine administration, regularly analyze the safety situations of vaccines, enhance vaccine administration and ensure vaccine supply.
第九条 国务院和省、自治区、直辖市人民政府建立部门协调机制，统筹协调疫苗监督管理有关工作，定期分析疫苗安全形势，加强疫苗监督管理，保障疫苗供应。
Article 10 The State implements the whole process electronic traceability system for vaccines.
第十条 国家实行疫苗全程电子追溯制度。
The drug regulatory department under the State Council shall, in collaboration with the competent health department under the State Council, formulate unified vaccine traceability norms and standards, establish a national coordination platform for vaccine electronic traceability, and integrate traceability information of the whole process throughout manufacture, distribution and immunization to realize the traceability of vaccines.
国务院药品监督管理部门会同国务院卫生健康主管部门制定统一的疫苗追溯标准和规范，建立全国疫苗电子追溯协同平台，整合疫苗生产、流通和预防接种全过程追溯信息，实现疫苗可追溯。
Vaccine MAHs shall establish the vaccine electronic traceability system, and connect it to the national coordination platform for vaccine electronic traceability, so as to enable the traceability and verification of the smallest package unit of vaccines through the whole process of manufacture, distribution and immunization.
疫苗上市许可持有人应当建立疫苗电子追溯系统，与全国疫苗电子追溯协同平台相衔接，实现生产、流通和预防接种全过程最小包装单位疫苗可追溯、可核查。
Disease prevention and control institutions and immunization entities shall truthfully record conditions including vaccine distribution and immunization in accordance with law, and provide traceability information to the national coordination platform for vaccine electronic traceability as required.
疾病预防控制机构、接种单位应当依法如实记录疫苗流通、预防接种等情况，并按照规定向全国疫苗电子追溯协同平台提供追溯信息。
Article 11 The biological safety management system shall be established and improved during vaccine development, manufacture and testing, to enable strict control of the biological safety risks, to enhance biological safety management of pathogenic microorganisms including bacterial and viral strains, to protect the health of operators and the public, and to ensure pathogenic microorganisms including bacterial and viral strains are used for legal and proper purposes.
第十一条 疫苗研制、生产、检验等过程中应当建立健全生物安全管理制度，严格控制生物安全风险，加强菌毒株等病原微生物的生物安全管理，保护操作人员和公众的健康，保证菌毒株等病原微生物用途合法、正当。
Bacterial and viral strains and cell strains used in the development, manufacturing and testing of vaccines shall have their track record, biological features and passage numbers specified, detailed archives established, to ensure legal, clear and traceable source; and those with unidentified source shall not be used.
疫苗研制、生产、检验等使用的菌毒株和细胞株，应当明确历史、生物学特征、代次，建立详细档案，保证来源合法、清晰、可追溯；来源不明的，不得使用。
Article 12 People’s governments at all levels and relevant departments, disease prevention and control institutions, immunization entities, vaccine MAHs and vaccine industry associations shall regularly carry out the publicity and education of laws and regulations of vaccines and knowledge of immunization in occasions such as national children's immunization day.
第十二条 各级人民政府及其有关部门、疾病预防控制机构、接种单位、疫苗上市许可持有人和疫苗行业协会等应当通过全国儿童预防接种日等活动定期开展疫苗安全法律、法规以及预防接种知识等的宣传教育、普及工作。
News media shall, for the public welfare, carry out publicity on vaccine safety laws and regulations, and knowledge of immunization, and supervise illegal behaviors related to vaccines through public opinions. Publicity reports on vaccines shall be comprehensive, scientific, objective and impartial.
新闻媒体应当开展疫苗安全法律、法规以及预防接种知识等的公益宣传，并对疫苗违法行为进行舆论监督。有关疫苗的宣传报道应当全面、科学、客观、公正。
Article 13 Vaccine industry associations shall enhance industry self-discipline, establish and improve industry norms, and promote the construction of industry integrity system, so as to guide and urge their member enterprises to manufacture and distribute vaccines in accordance with law.
第十三条 疫苗行业协会应当加强行业自律，建立健全行业规范，推动行业诚信体系建设，引导和督促会员依法开展生产经营等活动。
Chapter II Vaccine Development and Registration
第二章 疫苗研制和注册
Article 14 The State formulates relevant development plans, arranges necessary funds and supports the development of innovative vaccines such as combined and
第十四条 国家根据疾病流行情况、人群免疫状况等因素，制定相关研制规划，安排必要资金，支持多联多价等新型疫苗的研制。
The State organizes vaccine MAHs, research institutions, medical and health institutions to work jointly to develop vaccines urgently needed for disease prevention and control.
国家组织疫苗上市许可持有人、科研单位、医疗卫生机构联合攻关，研制疾病预防、控制急需的疫苗。
Article 15 To facilitate the progress of vaccine technology, the State encourages vaccine MAHs to increase capital investment on research, development and innovation, to optimize production process, and to promote quality control level.
第十五条 国家鼓励疫苗上市许可持有人加大研制和创新资金投入，优化生产工艺，提升质量控制水平，推动疫苗技术进步。
Article 16 Conduct of vaccine clinical trials shall be approved by the drug regulatory department under the State Council in accordance with law.
第十六条 开展疫苗临床试验，应当经国务院药品监督管理部门依法批准。
Vaccine clinical trials shall be carried out or organized by Class III medical institutions or disease prevention and control institutions at or above the provincial level that meet the requirements prescribed by the drug regulatory department under the State Council and the competent health department under the State Council.
疫苗临床试验应当由符合国务院药品监督管理部门和国务院卫生健康主管部门规定条件的三级医疗机构或者省级以上疾病预防控制机构实施或者组织实施。
The State encourages eligible medical institutions and disease prevention and control institutions to conduct vaccine clinical trials in accordance with law.
国家鼓励符合条件的医疗机构、疾病预防控制机构等依法开展疫苗临床试验。
Article 17 The sponsor of vaccine clinical trials shall design the clinical trial protocol, establish the safety monitoring and evaluation system for clinical trials, prudently select subjects, appropriately set up subject population and age groups, and take effective measures based on risk levels to protect legal interests of subjects.
第十七条 疫苗临床试验申办者应当制定临床试验方案，建立临床试验安全监测与评价制度，审慎选择受试者，合理设置受试者群体和年龄组，并根据风险程度采取有效措施，保护受试者合法权益。
Article 18 Written informed consent shall be obtained from subjects for vaccine clinical trials; where the subject is a person without capacity for civil conduct, the written informed consent shall be obtained from his
第十八条 开展疫苗临床试验，应当取得受试者的书面知情同意；受试者为无民事行为能力人的，应当取得其监护人的书面知情同意；受试者为限制民事行为能力人的，应当取得本人及其监护人的书面知情同意。
Article 19 Vaccines marketed in the territory of China shall be approved by the drug regulatory department under the State Council and shall be granted the drug registration certificate; to apply for vaccine registration, authentic, adequate and reliable data, dossier and samples shall be provided.
第十九条 在中国境内上市的疫苗应当经国务院药品监督管理部门批准，取得药品注册证书；申请疫苗注册，应当提供真实、充分、可靠的数据、资料和样品。
For vaccines urgently needed for disease prevention and control, and innovative vaccines, the drug regulatory department under the State Council shall give priority to evaluation, review and approval.
对疾病预防、控制急需的疫苗和创新疫苗，国务院药品监督管理部门应当予以优先审评审批。
Article 20 For vaccines which are used to respond to major public health emergencies or other vaccines which are urgently needed as identified by the competent health department under the State Council, the drug regulatory department under the State Council may grant conditional approval on registration application if benefits of those vaccines outweigh risks based on evaluation.
第二十条 应对重大突发公共卫生事件急需的疫苗或者国务院卫生健康主管部门认定急需的其他疫苗，经评估获益大于风险的，国务院药品监督管理部门可以附条件批准疫苗注册申请。
When particularly major public health emergencies or other emergencies which seriously threaten public health occur, the competent health department under the State Council shall propose recommendations on the urgent use of vaccines based on the need of disease prevention and control, and after evaluation organized by the drug regulatory department under the State Council, the permission for the urgent use within certain scope and period shall be granted by the drug regulatory department under the State Council.
出现特别重大突发公共卫生事件或者其他严重威胁公众健康的紧急事件，国务院卫生健康主管部门根据传染病预防、控制需要提出紧急使用疫苗的建议，经国务院药品监督管理部门组织论证同意后可以在一定范围和期限内紧急使用。
Article 21 The drug regulatory department under the State Council shall examine and approve the production process, quality control standards, package inserts and labels of vaccines during the approval process of the vaccine registration application.
第二十一条 国务院药品监督管理部门在批准疫苗注册申请时，对疫苗的生产工艺、质量控制标准和说明书、标签予以核准。
The drug regulatory department under the State Council shall publish the content of vaccine package inserts and labels on its websites in a timely manner.
国务院药品监督管理部门应当在其网站上及时公布疫苗说明书、标签内容。
Chapter III Vaccine Manufacture and Lot Release
第三章 疫苗生产和批签发
Article 22 The State implements strict access system for vaccine manufacturing.
第二十二条 国家对疫苗生产实行严格准入制度。
To carry out vaccine manufacturing activities, approval shall be obtained from the drug regulatory departments at or above the provincial level, and drug manufacturing certificates shall be obtained.
从事疫苗生产活动，应当经省级以上人民政府药品监督管理部门批准，取得药品生产许可证。
In addition to the conditions of drug manufacturing activities stipulated in the Drug Administration Law of the People's Republic of China, the following conditions shall also be met for vaccine manufacturing activities:
从事疫苗生产活动，除符合《中华人民共和国药品管理法》规定的从事药品生产活动的条件外，还应当具备下列条件：
(I) being equipped with appropriate scale and sufficient capacity stockpile;
（一）具备适度规模和足够的产能储备；
(II) possessing systems, facilities and equipment to ensure biological safety;
（二）具有保证生物安全的制度和设施、设备；
(III) meeting the needs of disease prevention and control.
（三）符合疾病预防、控制需要。
Vaccine MAHs shall have vaccine production capacity; and where contract production is necessary as demand exceeds the vaccine production capacity,, approval shall be obtained from the drug regulatory department under the State Council. Commissioned production shall comply with this Law and relevant regulations, ensuring the quality of vaccines.
疫苗上市许可持有人应当具备疫苗生产能力；超出疫苗生产能力确需委托生产的，应当经国务院药品监督管理部门批准。接受委托生产的，应当遵守本法规定和国家有关规定，保证疫苗质量。
Article 23 The legal representative and principal responsible person of vaccine MAHs shall have good credit records, and personnel in key positions such as the responsible person for manufacturing management, the responsible person for quality management and the quality authorized person shall have relevant professional background and work experience.
第二十三条 疫苗上市许可持有人的法定代表人、主要负责人应当具有良好的信用记录，生产管理负责人、质量管理负责人、质量受权人等关键岗位人员应当具有相关专业背景和从业经历。
Vaccine MAHs shall strengthen the training and assessment for personnel of preceding paragraph and in a timely manner report the employment and change of the aforementioned personnel to the local drug regulatory departments of people's governments of provinces, autonomous regions and municipalities directly under the Central Government.
疫苗上市许可持有人应当加强对前款规定人员的培训和考核，及时将其任职和变更情况向省、自治区、直辖市人民政府药品监督管理部门报告。
Article 24 Vaccines shall be produced and tested in accordance with the approved production process and specifications, and the entire production process shall meet the requirements prescribed by the good manufacturing practice for drugs.
第二十四条 疫苗应当按照经核准的生产工艺和质量控制标准进行生产和检验，生产全过程应当符合药品生产质量管理规范的要求。
Vaccine MAHs shall examine and test the whole process of vaccine manufacturing and vaccine quality as required.
疫苗上市许可持有人应当按照规定对疫苗生产全过程和疫苗质量进行审核、检验。
Article 25 Vaccine MAHs shall establish a complete quality management system, unceasingly enhance deviation management, and adopt information-based means to truthfully record all the data formed during manufacturing and testing, in order to ensure the whole process of manufacture persistently meets the legal requirements.
第二十五条 疫苗上市许可持有人应当建立完整的生产质量管理体系，持续加强偏差管理，采用信息化手段如实记录生产、检验过程中形成的所有数据，确保生产全过程持续符合法定要求。
Article 26 The State implements lot release system for vaccines.
第二十六条 国家实行疫苗批签发制度。
Each lot of vaccines to be sold or imported shall be examined and tested in accordance with relevant technical requirements by lot release institutions designated by the drug regulatory department under the State Council. A qualified lot shall be granted a certificate for lot release of biological product; and a disqualified lot shall be given a notice of disapproval for lot release.
每批疫苗销售前或者进口时，应当经国务院药品监督管理部门指定的批签发机构按照相关技术要求进行审核、检验。符合要求的，发给批签发证明；不符合要求的，发给不予批签发通知书。
Vaccines which are not approved for lot release are prohibited to be sold and shall be destroyed under the supervision of drug regulatory departments of the people's governments of provinces, autonomous regions or municipalities directly under the Central Government; imported vaccines which are not approved for lot release shall be destroyed or handled under the supervision of the drug regulatory department where the port locates in accordance with law.
不予批签发的疫苗不得销售，并应当由省、自治区、直辖市人民政府药品监督管理部门监督销毁；不予批签发的进口疫苗应当由口岸所在地药品监督管理部门监督销毁或者依法进行其他处理。
The drug regulatory department under the State Council and lot release institutions shall promptly publish the results of the lot release of marketed vaccines for public reference.
国务院药品监督管理部门、批签发机构应当及时公布上市疫苗批签发结果，供公众查询。
Article 27 To apply for vaccine lot release, materials such as summary protocol of manufacturing and control and samples shall be provided to the lot release institutions as required. For imported vaccines, the certificate of country of origin and certificate of lot release shall also be provided; and if the imported vaccines are exempted from lot release in the country of origin, the exemption certificate of lot release shall be provided.
第二十七条 申请疫苗批签发应当按照规定向批签发机构提供批生产及检验记录摘要等资料和同批号产品等样品。进口疫苗还应当提供原产地证明、批签发证明；在原产地免予批签发的，应当提供免予批签发证明。
Article 28 Vaccines urgently needed to prevent and control outbreaks of infectious diseases or emergencies may be exempted from lot release at the approval of the drug regulatory department under the State Council.
第二十八条 预防、控制传染病疫情或者应对突发事件急需的疫苗，经国务院药品监督管理部门批准，免予批签发。
Article 29 For lot release of vaccines, dossier review and sample testing shall be conducted lot by lot. The testing items and testing frequency for lot release of vaccines shall be dynamically adjusted according to the vaccine quality risk evaluation.
第二十九条 疫苗批签发应当逐批进行资料审核和抽样检验。疫苗批签发检验项目和检验频次应当根据疫苗质量风险评估情况进行动态调整。
If there is any doubt about the authenticity of the application dossier or samples for lot release of vaccines or any other situation which requires further verification, lot release institutions shall make the verification, and may organize on-site verifications such as sampling on-site for testing if necessary.
对疫苗批签发申请资料或者样品的真实性有疑问，或者存在其他需要进一步核实的情况的，批签发机构应当予以核实，必要时应当采用现场抽样检验等方式组织开展现场核实。
Article 30 In the case that major quality risks of vaccines are identified during the process of lot release, lot release institutions shall in a timely manner report to the drug regulatory department under the State Council and the drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government.
第三十条 批签发机构在批签发过程中发现疫苗存在重大质量风险的，应当及时向国务院药品监督管理部门和省、自治区、直辖市人民政府药品监督管理部门报告。
The departments which receive the report shall immediately carry out on-site inspection on vaccine MAHs, notify the lot release institutions to disapprove the lot release of relevant products or all products of vaccine MAHs or suspend the lot release procedure based on the inspection results, and order vaccine MAHs to make rectification. Vaccine MAHs shall immediately make rectification and in a timely manner report the rectification progress to the department which gives the order.
接到报告的部门应当立即对疫苗上市许可持有人进行现场检查，根据检查结果通知批签发机构对疫苗上市许可持有人的相关产品或者所有产品不予批签发或者暂停批签发，并责令疫苗上市许可持有人整改。疫苗上市许可持有人应当立即整改，并及时将整改情况向责令其整改的部门报告。
Article 31 Vaccine MAHs shall truthfully record production process deviations, quality deviations, failures and accidents during manufacturing as well as the corresponding measures taken and shall specify them in the document of relevant lot release application; in the case that the quality of vaccines may be affected, vaccine MAHs shall immediately take measures, and report to the drug regulatory departments of the people's governments of provinces, autonomous regions or municipalities directly under the Central Government.
第三十一条 对生产工艺偏差、质量差异、生产过程中的故障和事故以及采取的措施，疫苗上市许可持有人应当如实记录，并在相应批产品申请批签发的文件中载明；可能影响疫苗质量的，疫苗上市许可持有人应当立即采取措施，并向省、自治区、直辖市人民政府药品监督管理部门报告。
Chapter IV Vaccine Distribution
第四章 疫苗流通
Article 32 For national immunization program vaccines, the centralized bidding or unified negotiation shall be organized by the competent health department under the State Council jointly with the financial and other departments under the State Council. The winning price or transaction price shall be established and released, and each province, autonomous region and municipality directly under the Central Government shall implement unified procurement.
第三十二条 国家免疫规划疫苗由国务院卫生健康主管部门会同国务院财政部门等组织集中招标或者统一谈判，形成并公布中标价格或者成交价格，各省、自治区、直辖市实行统一采购。
For immunization program vaccines other than national immunization program vaccines and non-immunization program vaccines, each province, autonomous region and municipality directly under the Central Government shall organize the procurement through the provincial platform for the transaction of public resources.
国家免疫规划疫苗以外的其他免疫规划疫苗、非免疫规划疫苗由各省、自治区、直辖市通过省级公共资源交易平台组织采购。
Article 33 The price of a vaccine shall be established autonomously and reasonably by its MAHs in accordance with law. The price level, price difference rate and profit rate of a vaccine shall be kept within a reasonable range.
第三十三条 疫苗的价格由疫苗上市许可持有人依法自主合理制定。疫苗的价格水平、差价率、利润率应当保持在合理幅度。
Article 34 Disease prevention and control institutions at the provincial level shall, in accordance with the national immunization program and the need for disease prevention and control within their administrative regions, formulate plans for the use of immunization program vaccines within their administrative regions, report the plans to the vaccine procurement organizing departments as per relevant national regulations, and simultaneously file the record with the competent health departments under the people's governments of provinces, autonomous regions and municipalities directly under the Central Government.
第三十四条 省级疾病预防控制机构应当根据国家免疫规划和本行政区域疾病预防、控制需要，制定本行政区域免疫规划疫苗使用计划，并按照国家有关规定向组织采购疫苗的部门报告，同时报省、自治区、直辖市人民政府卫生健康主管部门备案。
Article 35 Vaccine MAHs shall supply vaccines to disease prevention and control institutions in accordance with the procurement contract.
第三十五条 疫苗上市许可持有人应当按照采购合同约定，向疾病预防控制机构供应疫苗。
Disease prevention and control institutions shall supply vaccines to immunization entities as required.
疾病预防控制机构应当按照规定向接种单位供应疫苗。
Entities or individuals other than disease prevention and control institutions shall not supply vaccines to immunization entities, and immunization entities shall not accept such vaccines.
疾病预防控制机构以外的单位和个人不得向接种单位供应疫苗，接种单位不得接收该疫苗。
Article 36 Vaccine MAHs shall deliver vaccines to disease prevention and control institutions or immunization entities designated by disease prevention and control institutions in accordance with the procurement contract.
第三十六条 疫苗上市许可持有人应当按照采购合同约定，向疾病预防控制机构或者疾病预防控制机构指定的接种单位配送疫苗。
Vaccine MAHs and disease prevention and control institutions shall operate under the vaccine cold-chain storage and transportation conditions when delivering vaccines on their own, or they may also entrust qualified vaccine distribution entities to distribute vaccines.
疫苗上市许可持有人、疾病预防控制机构自行配送疫苗应当具备疫苗冷链储存、运输条件，也可以委托符合条件的疫苗配送单位配送疫苗。
Disease prevention and control institutions may charge storage and transportation fee for distributing non-immunization program vaccines; the specific measures shall be formulated by the financial department under the State Council in conjunction with the competent pricing department under the State Council; and the charging criteria shall be formulated by the competent pricing departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government in conjunction with the financial departments at the same level.
疾病预防控制机构配送非免疫规划疫苗可以收取储存、运输费用，具体办法由国务院财政部门会同国务院价格主管部门制定，收费标准由省、自治区、直辖市人民政府价格主管部门会同财政部门制定。
Article 37 Disease prevention and control institutions, immunization entities, vaccine MAHs and vaccine distribution entities shall comply with the provision for vaccine storage and transportation to ensure vaccine quality.
第三十七条 疾病预防控制机构、接种单位、疫苗上市许可持有人、疫苗配送单位应当遵守疫苗储存、运输管理规范，保证疫苗质量。
Vaccines shall be kept under the stipulated temperature during the whole process of storage and transportation; cold-chain storage and transportation shall comply with requirements, and temperature shall be monitored and recorded on a regular basis.
疫苗在储存、运输全过程中应当处于规定的温度环境，冷链储存、运输应当符合要求，并定时监测、记录温度。
The provision for vaccine storage and transportation shall be formulated by the drug regulatory department under the State Council in conjunction with the competent health department under the State Council.
疫苗储存、运输管理规范由国务院药品监督管理部门、国务院卫生健康主管部门共同制定。
Article 38 When distributing vaccines, vaccine MAHs shall provide photocopies or electronic documents of the lot release certificates with their seal; when distributing imported vaccines, vaccine MAHs shall additionally provide photocopies or electronic documents of the Drug Import Note with their seal.
第三十八条 疫苗上市许可持有人在销售疫苗时，应当提供加盖其印章的批签发证明复印件或者电子文件；销售进口疫苗的，还应当提供加盖其印章的进口药品通关单复印件或者电子文件。
When accepting or purchasing vaccines, disease prevention and control institutions and immunization entities shall ask for the abovementioned supporting documents, and keep such documents for no less than five years upon the expiration date of vaccines for reference.
疾病预防控制机构、接种单位在接收或者购进疫苗时，应当索取前款规定的证明文件，并保存至疫苗有效期满后不少于五年备查。
Article 39 Vaccine MAHs shall establish authentic, accurate and complete sales records as required, and keep such records for no less than five years upon the expiration date of vaccines for reference.
第三十九条 疫苗上市许可持有人应当按照规定，建立真实、准确、完整的销售记录，并保存至疫苗有效期满后不少于五年备查。
Disease prevention and control institutions, immunization entities and vaccine distribution entities shall establish authentic, accurate and complete records of acceptance, purchase, storage, distribution and supply as required, and keep such records for no less than five years upon the expiration date of vaccines for reference.
疾病预防控制机构、接种单位、疫苗配送单位应当按照规定，建立真实、准确、完整的接收、购进、储存、配送、供应记录，并保存至疫苗有效期满后不少于五年备查。
When accepting or purchasing vaccines, disease prevention and control institutions and immunization entities shall ask for the temperature monitoring records during the whole process of transportation and storage, and keep such records for no less than five years upon the expiration date of vaccines for reference; where the temperature monitoring records during the whole process of transportation and storage cannot be provided or the temperature control fails to meet the requirements, disease prevention and control institutions and immunization entities shall not accept or purchase the vaccines concerned. Instead, they shall immediately report to the drug regulatory departments and the competent health departments of the people’s governments at or above the county level.
疾病预防控制机构、接种单位接收或者购进疫苗时，应当索取本次运输、储存全过程温度监测记录，并保存至疫苗有效期满后不少于五年备查；对不能提供本次运输、储存全过程温度监测记录或者温度控制不符合要求的，不得接收或者购进，并应当立即向县级以上地方人民政府药品监督管理部门、卫生健康主管部门报告。
Article 40 Disease prevention and control institutions and immunization entities shall establish routine vaccine inspection system. Vaccines that have unidentifiable packaging, fail to meet the storage temperature requirements, or have passed the expiration date, shall be isolated, labeled with warning signs, and handled in accordance with regulations of the drug regulatory department, the competent health department and competent ecological and environmental department under the State Council. Disease prevention and control institutions and immunization entities shall truthfully record the handling situation and keep the handling record for no less than five years upon the expiration date of vaccines for reference.
第四十条 疾病预防控制机构、接种单位应当建立疫苗定期检查制度，对存在包装无法识别、储存温度不符合要求、超过有效期等问题的疫苗，采取隔离存放、设置警示标志等措施，并按照国务院药品监督管理部门、卫生健康主管部门、生态环境主管部门的规定处置。疾病预防控制机构、接种单位应当如实记录处置情况，处置记录应当保存至疫苗有效期满后不少于五年备查。
Chapter V Immunization
第五章 预防接种
Article 41 The competent health department under the State Council shall formulate the national immunization program; vaccine varieties in the national immunization program shall be proposed by the competent health department under the State Council jointly with the financial department under the State Council, and released upon approval by the State Council.
第四十一条 国务院卫生健康主管部门制定国家免疫规划；国家免疫规划疫苗种类由国务院卫生健康主管部门会同国务院财政部门拟订，报国务院批准后公布。
The competent health department under the State Council shall establish an expert consultation committee on the national immunization program, and set up a dynamic adjustment mechanism for vaccines in the national immunization program jointly with the financial department under the State Council.
国务院卫生健康主管部门建立国家免疫规划专家咨询委员会，并会同国务院财政部门建立国家免疫规划疫苗种类动态调整机制。
When implementing the national immunization program, people’s governments of provinces, autonomous regions and municipalities directly under the Central Government may add vaccine varieties to their immunization program based on the need for disease prevention and control within their respective administrative regions, and release the adjustment after filing the record with the competent health department under the State Council.
省、自治区、直辖市人民政府在执行国家免疫规划时，可以根据本行政区域疾病预防、控制需要，增加免疫规划疫苗种类，报国务院卫生健康主管部门备案并公布。
Article 42 The competent health department under the State Council shall formulate and issue guidance for immunization, so as to enhance the standardized management of immunization.
第四十二条 国务院卫生健康主管部门应当制定、公布预防接种工作规范，强化预防接种规范化管理。
The competent health department under the State Council shall formulate and issue immunization procedures for the national immunization program vaccines and guidelines for the use of non-immunization program vaccines.
国务院卫生健康主管部门应当制定、公布国家免疫规划疫苗的免疫程序和非免疫规划疫苗的使用指导原则。
The competent health departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall formulate immunization plans based on the practical situation of their respective administrative regions and file the record with the competent health department under the State Council.
省、自治区、直辖市人民政府卫生健康主管部门应当结合本行政区域实际情况制定接种方案，并报国务院卫生健康主管部门备案。
Article 43 Disease prevention and control institutions at all levels shall, as per their respective duties, carry out tasks related to immunization including publicity, training, technical guidance, monitoring, assessment, epidemiology surveys, emergency response, etc..
第四十三条 各级疾病预防控制机构应当按照各自职责，开展与预防接种相关的宣传、培训、技术指导、监测、评价、流行病学调查、应急处置等工作。
Article 44 Immunization entities shall meet the following conditions:
第四十四条 接种单位应当具备下列条件：
(1) obtaining a practice license for a medical institution;
（一）取得医疗机构执业许可证；
(2) having physicians, nurses or village doctors who have received professional training on immunization organized by the competent health departments of people's governments at the county level and passed the examinations;
（二）具有经过县级人民政府卫生健康主管部门组织的预防接种专业培训并考核合格的医师、护士或者乡村医生；
(3) having cold storage facilities, equipment and cold storage system in conformity with the prescribed guidance for vaccine storage and transportation.
（三）具有符合疫苗储存、运输管理规范的冷藏设施、设备和冷藏保管制度。
The competent health departments of people's governments at or above the county level shall designate eligible medical institutions to undertake inoculation of immunization program vaccines within the responsible areas. Eligible medical institutions may undertake the inoculation of non-immunization program vaccines，and file the record with the competent health department which issued the practice license for a medical institution.
县级以上地方人民政府卫生健康主管部门指定符合条件的医疗机构承担责任区域内免疫规划疫苗接种工作。符合条件的医疗机构可以承担非免疫规划疫苗接种工作，并应当报颁发其医疗机构执业许可证的卫生健康主管部门备案。
Immunization entities shall strengthen internal management. They shall abide by the guidance for immunization, immunization procedures, guidelines for vaccine use and immunization plans.
接种单位应当加强内部管理，开展预防接种工作应当遵守预防接种工作规范、免疫程序、疫苗使用指导原则和接种方案。
Disease prevention and control institutions at all levels shall enhance technical guidance for immunization of immunization entities and management of vaccine use.
各级疾病预防控制机构应当加强对接种单位预防接种工作的技术指导和疫苗使用的管理。
Article 45 Before administering vaccines, medical and healthcare professionals shall inform vaccine recipients or their guardian of the varieties, functions, contraindications, adverse reactions, stay for observation and other precautions of the vaccines to be administered, inquire the health condition of the vaccine recipients and whether they have any immunization contraindication, and truthfully record the informing and inquiry details. The vaccine recipients or their guardian shall truthfully provide information on the vaccine recipients' health condition and contraindication etc.. Where a vaccine cannot be administered due to contraindications, the medical and healthcare professionals shall give medical advice to the vaccine recipients or their guardians and truthfully record such advice.
第四十五条 医疗卫生人员实施接种，应当告知受种者或者其监护人所接种疫苗的品种、作用、禁忌、不良反应以及现场留观等注意事项，询问受种者的健康状况以及是否有接种禁忌等情况，并如实记录告知和询问情况。受种者或者其监护人应当如实提供受种者的健康状况和接种禁忌等情况。有接种禁忌不能接种的，医疗卫生人员应当向受种者或者其监护人提出医学建议，并如实记录提出医学建议情况。
Before administering vaccines, medical and healthcare professionals shall, in accordance with the prescribed guidance for immunization, examine the vaccine recipient’s health status, immunization contraindication, check the immunization certificate, examine the appearance, lot number and expiration date of the vaccine and syringe, and verify the recipient’s name and age and the vaccine’s name, specifications, dose, injection site and route of administration. Vaccine administration shall only take place after confirmation of information on the recipient, the immunization certificate and the vaccine to be administered.
医疗卫生人员在实施接种前，应当按照预防接种工作规范的要求，检查受种者健康状况、核查接种禁忌，查对预防接种证，检查疫苗、注射器的外观、批号、有效期，核对受种者的姓名、年龄和疫苗的品名、规格、剂量、接种部位、接种途径，做到受种者、预防接种证和疫苗信息相一致，确认无误后方可实施接种。
Medical and healthcare professionals shall administer vaccines for eligible recipients. Where a recipient experiences adverse reactions during stay for observation, the medical and healthcare professionals shall follow the prescribed guidance for immunization and take prompt actions for treatment.
医疗卫生人员应当对符合接种条件的受种者实施接种。受种者在现场留观期间出现不良反应的，医疗卫生人员应当按照预防接种工作规范的要求，及时采取救治等措施。
Article 46 Medical and healthcare professionals shall, in accordance with regulations of the competent health department under the State Council, truthfully, accurately and completely record the immunization information, including vaccine variety, the MAH, identification information of the smallest package unit, the expiration date, time of immunization, the medical and healthcare professional who administered the vaccine, the recipient etc., to ensure that the immunization information is traceable and searchable. The immunization records shall be kept for no less than five years upon the vaccine’s expiration date for reference.
第四十六条 医疗卫生人员应当按照国务院卫生健康主管部门的规定，真实、准确、完整记录疫苗的品种、上市许可持有人、最小包装单位的识别信息、有效期、接种时间、实施接种的医疗卫生人员、受种者等接种信息，确保接种信息可追溯、可查询。接种记录应当保存至疫苗有效期满后不少于五年备查。
Article 47 The State implements the immunization certificate system for children. Within one month after a child is born, his
第四十七条 国家对儿童实行预防接种证制度。在儿童出生后一个月内，其监护人应当到儿童居住地承担预防接种工作的接种单位或者出生医院为其办理预防接种证。接种单位或者出生医院不得拒绝办理。监护人应当妥善保管预防接种证。
Immunization shall be managed according to the place of residence. Where a child leaves the original place of residence, the immunization entity undertaking immunization in the present residential area shall provide immunization for the child.
预防接种实行居住地管理，儿童离开原居住地期间，由现居住地承担预防接种工作的接种单位负责对其实施接种。
Format of the immunization certificate shall be stipulated by the competent health department under the State Council.
预防接种证的格式由国务院卫生健康主管部门规定。
Article 48 Where any child is admitted to a nursery or school, the nursery or school shall check the immunization certificate. Where any child is found to have not received immunization program vaccines as specified, the nursery or school shall report to the immunization entity undertaking immunization where the child lives or where the nursery or school is located and cooperate with the immunization entity to persuade the guardian of the child to have the child immunized as specified. Disease prevention and control institutions shall provide technical support to nurseries or schools in checking immunization certificates.
第四十八条 儿童入托、入学时，托幼机构、学校应当查验预防接种证，发现未按照规定接种免疫规划疫苗的，应当向儿童居住地或者托幼机构、学校所在地承担预防接种工作的接种单位报告，并配合接种单位督促其监护人按照规定补种。疾病预防控制机构应当为托幼机构、学校查验预防接种证等提供技术指导。
The measures for checking immunization certificates for the admission of children to nurseries or schools shall be formulated by the competent health department under the State Council in conjunction with the education administrative department under the State Council.
儿童入托、入学预防接种证查验办法由国务院卫生健康主管部门会同国务院教育行政部门制定。
Article 49 Immunization entities shall not charge any fees for administering immunization program vaccines.
第四十九条 接种单位接种免疫规划疫苗不得收取任何费用。
When administering non-immunization program vaccines, immunization entities may charge an immunization service fee in addition to the fee for vaccines. The criteria for immunization service fee shall be formulated by the pricing departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government jointly with the financial departments.
接种单位接种非免疫规划疫苗，除收取疫苗费用外，还可以收取接种服务费。接种服务费的收费标准由省、自治区、直辖市人民政府价格主管部门会同财政部门制定。
Article 50 In order to prevent and control the outbreak or prevalence of infectious diseases based on the monitoring and early warning information of infectious diseases, the competent health departments of the local people's governments at or above the county level may carry out cluster immunization within their respective administrative regions after reporting to the people's governments at the same level for approval and filing the record with the competent health departments of the people's governments at or above the provincial level.
第五十条 县级以上地方人民政府卫生健康主管部门根据传染病监测和预警信息，为预防、控制传染病暴发、流行，报经本级人民政府决定，并报省级以上人民政府卫生健康主管部门备案，可以在本行政区域进行群体性预防接种。
Where cluster immunization is needed nationwide or across the borders of provinces, autonomous regions and municipalities directly under the Central Government, a decision shall be made by the competent health department under the State Council.
需要在全国范围或者跨省、自治区、直辖市范围内进行群体性预防接种的，应当由国务院卫生健康主管部门决定。
The local people's governments at or above the county level or the competent health department under the State Council making the decision for carrying out cluster immunization shall organize relevant departments to carry out training, public education and resource deployment.
作出群体性预防接种决定的县级以上地方人民政府或者国务院卫生健康主管部门应当组织有关部门做好人员培训、宣传教育、物资调用等工作。
Any entity or individual is prohibited to carry out cluster immunization without approval.
任何单位和个人不得擅自进行群体性预防接种。
Article 51 Where the local people’s governments at or above the county level or their competent health departments need to take emergency immunization measures in the event of outbreak or prevalence of an infectious disease, laws and administrative regulations shall be followed.
第五十一条 传染病暴发、流行时，县级以上地方人民政府或者其卫生健康主管部门需要采取应急接种措施的，依照法律、行政法规的规定执行。
Chapter VI Adverse Reactions Monitoring and Handling
第六章 异常反应监测和处理
Article 52 An adverse reaction of immunization is an adverse drug reaction that causes damage to the vaccine recipient’s body tissue, organ and functions during or following the standard process of administering a qualified vaccine, for which no party involved is at fault.
第五十二条 预防接种异常反应，是指合格的疫苗在实施规范接种过程中或者实施规范接种后造成受种者机体组织器官、功能损害，相关各方均无过错的药品不良反应。
The following circumstances are not adverse reactions of immunization:
下列情形不属于预防接种异常反应：
(1) common reactions following immunization caused by the vaccine’s intrinsic features;
（一）因疫苗本身特性引起的接种后一般反应；
(2) injury to the vaccine recipient due to sub-standard vaccine quality;
（二）因疫苗质量问题给受种者造成的损害；
(3) injury to the vaccine recipient due to the immunization entity's incompliance with the guidance for immunization, immunization procedure, vaccine use guidelines and immunization plans;
（三）因接种单位违反预防接种工作规范、免疫程序、疫苗使用指导原则、接种方案给受种者造成的损害；
(4) coincidental events following immunization in recipients who were in the latent period or prodromal period of a certain disease at the time of immunization;
（四）受种者在接种时正处于某种疾病的潜伏期或者前驱期，接种后偶合发病；
(5) acute relapse of underlying diseases or worsening of disease conditions in vaccine recipients who have immunization contraindications prescribed on the vaccine package insert and who or whose guardian fails to provide truthful information about his/her health condition and the contraindication for the vaccine prior to immunization;
（五）受种者有疫苗说明书规定的接种禁忌，在接种前受种者或者其监护人未如实提供受种者的健康状况和接种禁忌等情况，接种后受种者原有疾病急性复发或者病情加重；
(6) individual or cluster psychogenic reaction as a result of psychological factors.
（六）因心理因素发生的个体或者群体的心因性反应。
Article 53 The State strengthens the monitoring on adverse reactions of immunization. The plan for monitoring adverse reactions of immunization shall be formulated by the competent health department under the State Council jointly with the drug regulatory department under the State Council.
第五十三条 国家加强预防接种异常反应监测。预防接种异常反应监测方案由国务院卫生健康主管部门会同国务院药品监督管理部门制定。
Article 54 Immunization entities and medical institutions shall report to disease prevention and control institutions as required when identifying suspected adverse reactions of immunization.
第五十四条 接种单位、医疗机构等发现疑似预防接种异常反应的，应当按照规定向疾病预防控制机构报告。
Vaccine MAHs shall set up special organization equipped with full-time staff to actively collect, track and analyze the suspected adverse reactions of immunization, take prompt risk control measures, report the suspected adverse events to disease prevention and control institutions and submit the quality analysis report to drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government.
疫苗上市许可持有人应当设立专门机构，配备专职人员，主动收集、跟踪分析疑似预防接种异常反应，及时采取风险控制措施，将疑似预防接种异常反应向疾病预防控制机构报告，将质量分析报告提交省、自治区、直辖市人民政府药品监督管理部门。
Article 55 Disease prevention and control institutions shall promptly report the suspected adverse reactions of immunization as required, organize the investigation and diagnosis, and inform the vaccine recipient or his/her guardian of the conclusion of the investigation and diagnosis. Where there is controversy over the conclusion of the investigation and diagnosis, an application for appraisal may be submitted according to the appraisal measures formulated by the competent health department under the State Council.
第五十五条 对疑似预防接种异常反应，疾病预防控制机构应当按照规定及时报告，组织调查、诊断，并将调查、诊断结论告知受种者或者其监护人。对调查、诊断结论有争议的，可以根据国务院卫生健康主管部门制定的鉴定办法申请鉴定。
Suspected adverse reactions of immunization that have significant influence on the society including any death or severe disability of the vaccine recipient caused by immunization and suspected cluster adverse reactions of immunization shall be investigated and handled by the competent health departments and the drug regulatory departments of the people's government of the municipalities divided into districts and above as per their respective responsibilities.
因预防接种导致受种者死亡、严重残疾，或者群体性疑似预防接种异常反应等对社会有重大影响的疑似预防接种异常反应，由设区的市级以上人民政府卫生健康主管部门、药品监督管理部门按照各自职责组织调查、处理。
The appraisal measures for adverse reactions of immunization shall be formulated by the competent health department under the State Council.
Article 56 The State implements a compensation system for adverse reactions of immunization. Where, during or after the immunization process, a vaccine recipient suffers from harm including death, severe disability, organ and tissue damage, etc., compensation shall be given thereto if these conditions are adverse reactions of immunization or the possibility cannot be ruled out. The scope of compensation is subject to catalogue management, and shall be adjusted based on the actual situations.
第五十六条 国家实行预防接种异常反应补偿制度。实施接种过程中或者实施接种后出现受种者死亡、严重残疾、器官组织损伤等损害，属于预防接种异常反应或者不能排除的，应当给予补偿。补偿范围实行目录管理，并根据实际情况进行动态调整。
Compensation needed for immunization of immunization program vaccines shall be included in the funding for immunization budgeted by the financial departments of the people’s governments of provinces, autonomous regions or municipalities directly under the Central Government; compensation needed for immunization of non-immunization program vaccines shall be paid by the vaccine MAHs involved. The State encourages compensating vaccine recipients with adverse reactions of immunization through commercial insurance and other means.
接种免疫规划疫苗所需的补偿费用，由省、自治区、直辖市人民政府财政部门在预防接种经费中安排；接种非免疫规划疫苗所需的补偿费用，由相关疫苗上市许可持有人承担。国家鼓励通过商业保险等多种形式对预防接种异常反应受种者予以补偿。
Compensation for adverse reactions of immunization shall be prompt, convenient and rational. The scope, standards and procedures of compensation for adverse reactions of immunization shall be determined by the State Council, while the specific implementation measures shall be formulated by the provinces, autonomous regions or municipalities directly under the Central Government.
预防接种异常反应补偿应当及时、便民、合理。预防接种异常反应补偿范围、标准、程序由国务院规定，省、自治区、直辖市制定具体实施办法。
Chapter VII Vaccine Post-Marketing Management
第七章 疫苗上市后管理
Article 57 Vaccine MAHs shall establish and improve quality management systems for whole life cycle of vaccines, formulate and implement vaccine post-marketing risk management plans, and conduct vaccine post-marketing studies to further verify the safety, effectiveness and quality management of vaccines.
第五十七条 疫苗上市许可持有人应当建立健全疫苗全生命周期质量管理体系，制定并实施疫苗上市后风险管理计划，开展疫苗上市后研究，对疫苗的安全性、有效性和质量可控性进行进一步确证。
Where further study is required when a vaccine's registration application is approved, the vaccine MAH shall complete the study within the prescribed time limit; where the study fails to be completed on time or fails to prove that the benefits outweigh the risks, the drug regulatory department under the State Council shall take actions in accordance with law up to revoke the vaccine's registration certificate.
对批准疫苗注册申请时提出进一步研究要求的疫苗，疫苗上市许可持有人应当在规定期限内完成研究；逾期未完成研究或者不能证明其获益大于风险的，国务院药品监督管理部门应当依法处理，直至注销该疫苗的药品注册证书。
Article 58 Vaccine MAHs shall carry out quality tracking analysis for vaccines and continuously improve quality control standards, production process and stability of the production process.
第五十八条 疫苗上市许可持有人应当对疫苗进行质量跟踪分析，持续提升质量控制标准，改进生产工艺，提高生产工艺稳定性。
Changes to the production process, production sites, critical equipment, etc., shall be assessed and validated, and shall be filed or reported in accordance with the provisions of the drug regulatory department under the State Council for change management; changes that may affect vaccine quality, effectiveness and quality management shall be subject to approval by the drug regulatory department under the State Council.
生产工艺、生产场地、关键设备等发生变更的，应当进行评估、验证，按照国务院药品监督管理部门有关变更管理的规定备案或者报告；变更可能影响疫苗安全性、有效性和质量可控性的，应当经国务院药品监督管理部门批准。
Article 59 Vaccine MAHs shall continue to update the package inserts and labels based on the post-marketing study or adverse reactions of vaccines and apply for approval or file the record as required.
第五十九条 疫苗上市许可持有人应当根据疫苗上市后研究、预防接种异常反应等情况持续更新说明书、标签，并按照规定申请核准或者备案。
The drug regulatory department under the State Council shall publish the content of vaccine package inserts and labels on its websites in a timely manner.
国务院药品监督管理部门应当在其网站上及时公布更新后的疫苗说明书、标签内容。
Article 60 Vaccine MAHs shall establish the vaccine quality retrospective analysis and risk reporting system and truthfully report information on vaccine manufacture and distribution, post-marketing studies and risk management each year as required to the drug regulatory department under the State Council.
第六十条 疫苗上市许可持有人应当建立疫苗质量回顾分析和风险报告制度，每年将疫苗生产流通、上市后研究、风险管理等情况按照规定如实向国务院药品监督管理部门报告。
Article 61 The drug regulatory department under the State Council may order vaccine MAHs to carry out post-marketing evaluation, or directly organize and carry out post-marketing evaluation.
第六十一条 国务院药品监督管理部门可以根据实际情况，责令疫苗上市许可持有人开展上市后评价或者直接组织开展上市后评价。
With respect to vaccines that have serious adverse reactions or jeopardize human health due to other reasons, the drug regulatory department under the State Council shall revoke the drug registration certificates of such vaccines.
对预防接种异常反应严重或者其他原因危害人体健康的疫苗，国务院药品监督管理部门应当注销该疫苗的药品注册证书。
Article 62 The drug regulatory department under the State Council may organize post-marketing evaluation of vaccine varieties based on the demand for disease prevention and control as well as the development of the vaccine industry. Where a vaccine variety is found to be significantly inferior to other vaccine varieties used for the prevention and control of the same disease in terms of product design, production process, safety, effectiveness or quality management, the drug registration certificates of all vaccines of the inferior variety shall be revoked and the corresponding national drug standards shall be abolished.
第六十二条 国务院药品监督管理部门可以根据疾病预防、控制需要和疫苗行业发展情况，组织对疫苗品种开展上市后评价，发现该疫苗品种的产品设计、生产工艺、安全性、有效性或者质量可控性明显劣于预防、控制同种疾病的其他疫苗品种的，应当注销该品种所有疫苗的药品注册证书并废止相应的国家药品标准。
Chapter VIII Safeguard Measures
第八章 保障措施
Article 63 To ensure the implementation of national immunization program, the people's government at or above the county level shall incorporate into the budget of the people's governments at the same level the funds needed for vaccine safety, procurement of immunization program vaccines, immunization and information-based construction.
第六十三条 县级以上人民政府应当将疫苗安全工作、购买免疫规划疫苗和预防接种工作以及信息化建设等所需经费纳入本级政府预算，保证免疫规划制度的实施。
The people's governments at county level shall grant subsidies for the village doctors and other primary immunization and healthcare personnel engaged in immunization in accordance with relevant national regulations.
县级人民政府按照国家有关规定对从事预防接种工作的乡村医生和其他基层医疗卫生人员给予补助。
The State gives support to the immunization in economically underdeveloped areas as required. People’s governments of provinces, autonomous regions and municipalities directly under the Central Government as well as people's government of municipalities divided into districts shall grant necessary financial subsidies to the work related to immunization conducted by people’s governments at county level in economically underdeveloped areas.
国家根据需要对经济欠发达地区的预防接种工作给予支持。省、自治区、直辖市人民政府和设区的市级人民政府应当对经济欠发达地区的县级人民政府开展与预防接种相关的工作给予必要的经费补助。
Article 64 Following from the epidemic tendency of infectious diseases, the people’s governments of provinces, autonomous regions or municipalities directly under the Central Government shall set up projects related to immunization in their respective administrative regions, which shall fall within the ambit of the projects for the prevention and control of infectious diseases stipulated by the health department under the State Council, and ensure the implementation of such items.
第六十四条 省、自治区、直辖市人民政府根据本行政区域传染病流行趋势，在国务院卫生健康主管部门确定的传染病预防、控制项目范围内，确定本行政区域与预防接种相关的项目，并保证项目的实施。
Article 65 The health department under the State Council shall, according to the plan of each province, autonomous region and municipality directly under the Central Government for the use of national immunization program vaccines, notify the demand information for national immunization program vaccines to vaccine MAHs, and the vaccine MAHs shall reasonably arrange their manufacture according to vaccine demand information.
第六十五条 国务院卫生健康主管部门根据各省、自治区、直辖市国家免疫规划疫苗使用计划，向疫苗上市许可持有人提供国家免疫规划疫苗需求信息，疫苗上市许可持有人根据疫苗需求信息合理安排生产。
In the case of any risk of vaccine supply shortage, the health department under the State Council and the drug regulatory department under the State Council shall propose suggestions, and the industry and information technology department and financial department under the State Council shall take effective measures to ensure the manufacture and supply of vaccines.
疫苗存在供应短缺风险时，国务院卫生健康主管部门、国务院药品监督管理部门提出建议，国务院工业和信息化主管部门、国务院财政部门应当采取有效措施，保障疫苗生产、供应。
The vaccine MAHs shall organize production and ensure the vaccine supply according to law; Vaccine MAHs stopping the manufacture of the vaccine shall promptly report to the drug regulatory department under the State Council or the drug regulatory departments of the people's government of the province, autonomous region or municipality directly under the Central Government.
疫苗上市许可持有人应当依法组织生产，保障疫苗供应；疫苗上市许可持有人停止疫苗生产的，应当及时向国务院药品监督管理部门或者省、自治区、直辖市人民政府药品监督管理部门报告。
Article 66 The State buildss vaccines into the stockpile of strategic materials, implementing the stockpile at the national and provincial levels.
第六十六条 国家将疫苗纳入战略物资储备，实行中央和省级两级储备。
The industry and information technology department and financial department under the State Council shall, in accordance with the need for disease prevention and control and public health emergency preparedness, strengthen the stockpile capacity and product management of the vaccines and establish dynamic adjustment mechanism jointly with the competent health department, public security department, market regulation department and drug regulatory department under the State Council.
国务院工业和信息化主管部门、财政部门会同国务院卫生健康主管部门、公安部门、市场监督管理部门和药品监督管理部门，根据疾病预防、控制和公共卫生应急准备的需要，加强储备疫苗的产能、产品管理，建立动态调整机制。
Article 67 The funds allocated for the immunization arranged by the financial departments at different levels shall be earmarked for dedicated purposes, and no entity or individuals may misappropriate or occupy them.
第六十七条 各级财政安排用于预防接种的经费应当专款专用，任何单位和个人不得挪用、挤占。
Relevant entities and individuals using the funds for immunization shall accept the audit supervision by the auditing administrations according to law.
有关单位和个人使用预防接种的经费应当依法接受审计机关的审计监督。
Article 68 The State implements a compulsory liability insurance system for vaccines.
第六十八条 国家实行疫苗责任强制保险制度。
Vaccine MAHs shall buy compulsory liability insurance for vaccines as required. Where the recipients’ injury is caused by quality problems, the insurance company shall pay compensation within the limits of liability insured.
疫苗上市许可持有人应当按照规定投保疫苗责任强制保险。因疫苗质量问题造成受种者损害的，保险公司在承保的责任限额内予以赔付。
Specific measure for the implementation of compulsory liability insurance system for vaccines shall be formulated by the drug regulatory department under the State Council jointly with the health department and the insurance regulatory department under the State Council.
疫苗责任强制保险制度的具体实施办法，由国务院药品监督管理部门会同国务院卫生健康主管部门、保险监督管理机构等制定。
Article 69 In the case of outbreaks or prevalence of infectious diseases, relevant vaccine MAHs shall manufacture and supply vaccines for the prevention and control of infectious diseases in a timely manner. Communication and transportation entities shall preferentially transport vaccines for the prevention and control of the infectious diseases. People's governments at or above the county level and relevant departments shall properly organization, coordination and support work.
第六十九条 传染病暴发、流行时，相关疫苗上市许可持有人应当及时生产和供应预防、控制传染病的疫苗。交通运输单位应当优先运输预防、控制传染病的疫苗。县级以上人民政府及其有关部门应当做好组织、协调、保障工作。
Chapter IX Supervision and Management
第九章 监督管理
Article 70 The drug regulatory departments and health departments shall conduct administration on the whole process of vaccine development, manufacture, distribution and immunization according to their respective responsibilities and supervise vaccine MAHs, disease prevention and control institutions, and immunization entities to fulfill their obligations according to law.
第七十条 药品监督管理部门、卫生健康主管部门按照各自职责对疫苗研制、生产、流通和预防接种全过程进行监督管理，监督疫苗上市许可持有人、疾病预防控制机构、接种单位等依法履行义务。
The drug regulatory departments shall conduct supervision and inspection on the vaccine quality during the process of the vaccine development, manufacture, storage, transportation, and immunization. The competent health departments shall conduct supervision and inspection on the implementation of the immunization planning system and immunization activities according to law.
药品监督管理部门依法对疫苗研制、生产、储存、运输以及预防接种中的疫苗质量进行监督检查。卫生健康主管部门依法对免疫规划制度的实施、预防接种活动进行监督检查。
The drug regulatory departments shall strengthen the on-site inspection on vaccine MAHs. If necessary, regulatory departments may conduct extended inspections on entities or individuals who provide products or services for vaccine development, manufacture and distribution, and relevant entities and individuals shall cooperate and not reject the inspection or conceal any information.
药品监督管理部门应当加强对疫苗上市许可持有人的现场检查；必要时，可以对为疫苗研制、生产、流通等活动提供产品或者服务的单位和个人进行延伸检查；有关单位和个人应当予以配合，不得拒绝和隐瞒。
Article 71 The State organizes professional and specialized pharmaceutical inspector teams at both national and provincial levels, and enhance supervision and inspection on vaccines.
第七十一条 国家建设中央和省级两级职业化、专业化药品检查员队伍，加强对疫苗的监督检查。
The drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall select and assign inspectors to the vaccine MAHs. The inspectors, who are accountable for their conducts during their stay in vaccine MAHs, shall be responsible for supervising and inspecting the implementation of good manufacturing practice for drugs, collecting vaccine quality risks and evidence for illegal behaviors, and reporting the conditions and proposing suggesting to the drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government.
省、自治区、直辖市人民政府药品监督管理部门选派检查员入驻疫苗上市许可持有人。检查员负责监督检查药品生产质量管理规范执行情况，收集疫苗质量风险和违法违规线索，向省、自治区、直辖市人民政府药品监督管理部门报告情况并提出建议，对派驻期间的行为负责。
Article 72 Where there exists safety risks in vaccine quality management and the vaccine MAHs have not taken measures in a timely manner to eliminate them, the relevant drug regulatory departments shall take such measures as warning meetings and orders to make rectification within a time limit etc..
第七十二条 疫苗质量管理存在安全隐患，疫苗上市许可持有人等未及时采取措施消除的，药品监督管理部门可以采取责任约谈、限期整改等措施。
In the case of serious violation against the relevant good manufacturing practice for drugs, the drug regulatory departments shall order the suspension of the production, sales and distribution of vaccines and immediate rectification; and the manufacture, sales and distribution shall be resumed only after the rectification is completed and the results meet the requirements upon the inspection by the drug regulatory departments.
严重违反药品相关质量管理规范的，药品监督管理部门应当责令暂停疫苗生产、销售、配送，立即整改；整改完成后，经药品监督管理部门检查符合要求的，方可恢复生产、销售、配送。
Drug regulatory departments shall establish a credit record system for the vaccine MAHs and their responsible persons and include them into the national credit information sharing platform, release information of their serious loss of honesty according to regulations and impose joint punishment.
药品监督管理部门应当建立疫苗上市许可持有人及其相关人员信用记录制度，纳入全国信用信息共享平台，按照规定公示其严重失信信息，实施联合惩戒。
Article 73 For vaccines with quality problems or vaccines suspected of having quality problems, vaccine MAHs, disease prevention and control institutions and immunization entities shall immediately stop the sale, distribution, and use, and if necessary, immediately stop the manufacture and report the case to drug regulatory departments and health departments of the people's governments at or above the county level according to relevant regulations. The competent health departments shall immediately organize the disease prevention and control institutions and immunization entities to take necessary emergency handling measures, and at the same time report the case to the health departments of the superior people's governments. The drug regulatory departments shall take measures including sealing and detention according to law. For vaccines having been sold, the vaccine MAHs shall in a timely manner notify relevant disease prevention and control institutions, vaccine distribution entities and immunization entities to recall such vaccines according to regulations, and truthfully record the conditions of recall and notification, and disease prevention and control institutions, vaccine distribution entities and immunization entities shall provide cooperation.
第七十三条 疫苗存在或者疑似存在质量问题的，疫苗上市许可持有人、疾病预防控制机构、接种单位应当立即停止销售、配送、使用，必要时立即停止生产，按照规定向县级以上人民政府药品监督管理部门、卫生健康主管部门报告。卫生健康主管部门应当立即组织疾病预防控制机构和接种单位采取必要的应急处置措施，同时向上级人民政府卫生健康主管部门报告。药品监督管理部门应当依法采取查封、扣押等措施。对已经销售的疫苗，疫苗上市许可持有人应当及时通知相关疾病预防控制机构、疫苗配送单位、接种单位，按照规定召回，如实记录召回和通知情况，疾病预防控制机构、疫苗配送单位、接种单位应当予以配合。
In the case of failures to stop manufacture, sales, distribution, use and recall of vaccines as the preceding paragraph, the drug regulatory departments and the health departments at or above the county level shallr to stop manufacture, sales, distribution, use and recall of such vaccines according to their respective responsibilities.
未依照前款规定停止生产、销售、配送、使用或者召回疫苗的，县级以上人民政府药品监督管理部门、卫生健康主管部门应当按照各自职责责令停止生产、销售、配送、使用或者召回疫苗。
Vaccine MAHs, disease prevention and control institutions, and immunization entities shall not conceal information, give false information, omit to report, delay the reporting, or conceal, fabricate or destroy relevant evidence when discovering vaccines with quality problems or vaccines suspected of having quality problems.
疫苗上市许可持有人、疾病预防控制机构、接种单位发现存在或者疑似存在质量问题的疫苗，不得瞒报、谎报、缓报、漏报，不得隐匿、伪造、毁灭有关证据。
Article 74 Vaccine MAHs shall establish an information publicity system and in a timely manner publish vaccine information, package inserts, labels, implementation of relevant good manufacturing practice, lot release, product recall, inspection and punishment accepted as well as compulsory vaccine liability insurance on their websites in accordance with relevant regulations.
第七十四条 疫苗上市许可持有人应当建立信息公开制度，按照规定在其网站上及时公开疫苗产品信息、说明书和标签、药品相关质量管理规范执行情况、批签发情况、召回情况、接受检查和处罚情况以及投保疫苗责任强制保险情况等信息。
Article 75 The drug regulatory department under the State Council shall liaise with the health department under the State Council to establish the information sharing mechanism for vaccine quality and immunization.
第七十五条 国务院药品监督管理部门会同国务院卫生健康主管部门等建立疫苗质量、预防接种等信息共享机制。
Drug regulatory departments and health departments of people's governments at or above the provincial level shall organize vaccine MAHs, disease prevention and control institutions, immunization entities, news media, and scientific research institutions etc. to exchange and communicate about information on vaccine quality, safety and immunizationin a scientific, objective, timely and transparent manner.
省级以上人民政府药品监督管理部门、卫生健康主管部门等应当按照科学、客观、及时、公开的原则，组织疫苗上市许可持有人、疾病预防控制机构、接种单位、新闻媒体、科研单位等，就疫苗质量和预防接种等信息进行交流沟通。
Article 76 The State implements the uniform release system for vaccine safety information.
第七十六条 国家实行疫苗安全信息统一公布制度。
Warnings against vaccine safety risks, information on major vaccine safety accidents, investigation and handling as well as other vaccine safety information subject to unified release as confirmed by the State Council shall be released by the drug regulatory department under the State Council in collaboration with relevant departments. Reports of adverse reactions during immunization across the nation shall be published in a unified manner by the health department under the State Council jointly with drug regulatory department under the State Council. The release of such information without authorization is prohibited. The release of significant vaccine quality and safety information shall be timely, accurate and comprehensive, and scientific evaluation shall be carried out as required and necessary explanations shall be made.
疫苗安全风险警示信息、重大疫苗安全事故及其调查处理信息和国务院确定需要统一公布的其他疫苗安全信息，由国务院药品监督管理部门会同有关部门公布。全国预防接种异常反应报告情况，由国务院卫生健康主管部门会同国务院药品监督管理部门统一公布。未经授权不得发布上述信息。公布重大疫苗安全信息，应当及时、准确、全面，并按照规定进行科学评估，作出必要的解释说明。
Drug regulatory departments of people's governments at or above county level discovering any vaccine quality and safety information likely to mislead the public and affect social opinions shall immediate perform verification and analysis in conjunction with the competent health departments and other relevant departments, professional institutions and relevant MAHs, and release the results in a timely manner.
县级以上人民政府药品监督管理部门发现可能误导公众和社会舆论的疫苗安全信息，应当立即会同卫生健康主管部门及其他有关部门、专业机构、相关疫苗上市许可持有人等进行核实、分析，并及时公布结果。
All entities and individuals are prohibited from fabricating or spreading any false information on vaccine safety.
任何单位和个人不得编造、散布虚假疫苗安全信息。
Article 77 All entities and individuals shall have the right to obtain vaccine information in accordance with law and put forward opinions and suggestions on vaccine administration.
第七十七条 任何单位和个人有权依法了解疫苗信息，对疫苗监督管理工作提出意见、建议。
All entities or individuals are entitled to report any vaccine illegal behaviors to the competent health departments, the drug regulatory departments etc.; if the competent health departments or the drug regulatory departments etc. fail to perform their administration duties according to law, entities or individuals may report them to the relevant departments of people’s governments at the same level or the superior level as well as relevant supervisory departments. Relevant departments shall verify and handle the report in a timely manner; if the reports are verified to be true, give rewards to the informants according to relevant regulations; and give substantial rewards to the informants who report serious illegal behaviors committed in the entities where they work if the reports are verified to be true.
任何单位和个人有权向卫生健康主管部门、药品监督管理部门等部门举报疫苗违法行为，对卫生健康主管部门、药品监督管理部门等部门及其工作人员未依法履行监督管理职责的情况有权向本级或者上级人民政府及其有关部门、监察机关举报。有关部门、机关应当及时核实、处理；对查证属实的举报，按照规定给予举报人奖励；举报人举报所在单位严重违法行为，查证属实的，给予重奖。
Article 78 People's governments at or above the county level shall formulate emergency response plans for vaccine safety incidents, stipulate the grading of vaccine safety incidents, manage organization and command systems and responsibilities, provide prevention and early warning mechanisms and manage procedures and emergency safeguarding measures.
第七十八条 县级以上人民政府应当制定疫苗安全事件应急预案，对疫苗安全事件分级、处置组织指挥体系与职责、预防预警机制、处置程序、应急保障措施等作出规定。
Vaccine MAHs shall formulate the handling procedure for vaccine safety incidents, periodically inspect the implementation of all preventive measures and eliminate potential dangers in a timely manner.
疫苗上市许可持有人应当制定疫苗安全事件处置方案，定期检查各项防范措施的落实情况，及时消除安全隐患。
In the case of vaccine safety events, vaccine MAHs shall immediately report the occurrence to the drug regulatory department under the State Council or drug regulatory departments of the people's governments of the provinces, autonomous regions or municipalities directly under the Central Government; and disease prevention and control institutions, immunization entities, and medical institutions shall immediately report the occurrence to competent health departments and drug regulatory departments of the people's governments at or above the county level. The drug regulatory departments shall establish a vaccine safety emergency response organization jointly with the competent health departments as specified in the emergency plan, conduct medical rescues, risk control, investigation and handling, information release, explanation etc., and address problems arising from the incidents such as providing supplementary immunization. The fees for supplementary immunization arising from vaccine safety incidents due to quality problems of vaccines shall be assumed by the vaccine MAHs.
发生疫苗安全事件，疫苗上市许可持有人应当立即向国务院药品监督管理部门或者省、自治区、直辖市人民政府药品监督管理部门报告；疾病预防控制机构、接种单位、医疗机构应当立即向县级以上人民政府卫生健康主管部门、药品监督管理部门报告。药品监督管理部门应当会同卫生健康主管部门按照应急预案的规定，成立疫苗安全事件处置指挥机构，开展医疗救治、风险控制、调查处理、信息发布、解释说明等工作，做好补种等善后处置工作。因质量问题造成的疫苗安全事件的补种费用由疫苗上市许可持有人承担。
Any entity or individual shall not conceal, give false information about, delay or omit reporting vaccine safety events and not conceal, forge or destroy relevant evidence.
有关单位和个人不得瞒报、谎报、缓报、漏报疫苗安全事件，不得隐匿、伪造、毁灭有关证据。
Chapter X Legal Liabilities
第十章 法律责任
Article 79 Illegal act that violates this Law and constitutes a crime shall be subject to severer criminal liabilities according to law.
第七十九条 违反本法规定，构成犯罪的，依法从重追究刑事责任。
Article 80 Where manufactured or distributed vaccines are counterfeit, the drug regulatory departments of the people's governments at or above the provincial level shall confiscate illegal gains, illegally manufactured and distributed vaccines and raw materials, excipients, packaging materials and equipment specially used for illegal production, order to stop production for rectification and stop business operation, revoke drug registration certificate and impose a fine of not less than fifteen times but not more than fifty times the value of vaccines illegally manufactured or distributed, and if the illegal values are less than RMB 500,000 yuan, it shall be counted as RMB 500,000 yuan.
第八十条 生产、销售的疫苗属于假药的，由省级以上人民政府药品监督管理部门没收违法所得和违法生产、销售的疫苗以及专门用于违法生产疫苗的原料、辅料、包装材料、设备等物品，责令停产停业整顿，吊销药品注册证书，直至吊销药品生产许可证等，并处违法生产、销售疫苗货值金额十五倍以上五十倍以下的罚款，货值金额不足五十万元的，按五十万元计算。
Where manufactured or distributed vaccines are adulterated, the drug regulatory departments of the people's governments at or above the provincial level shall confiscate illegal gains, illegally manufactured and distributed vaccines and raw materials, excipients and packaging materials and equipment and so on specially used for illegal production, order to stop production for rectification and stop business operation, and impose a fine of not less than ten times but not more than thirty times the value of vaccines illegally manufactured or distributed, and if the illegal values are less than RMB 500,000 yuan, it shall be counted as RMB 500,000 yuan; in serious circumstances, the drug regulatory departments of the people's governments at or above the provincial level shall revoke drug registration certificate, and even the drug manufacturing license.
生产、销售的疫苗属于劣药的，由省级以上人民政府药品监督管理部门没收违法所得和违法生产、销售的疫苗以及专门用于违法生产疫苗的原料、辅料、包装材料、设备等物品，责令停产停业整顿，并处违法生产、销售疫苗货值金额十倍以上三十倍以下的罚款，货值金额不足五十万元的，按五十万元计算；情节严重的，吊销药品注册证书，直至吊销药品生产许可证等。
Where manufactured or distributed vaccines are counterfeit, or adulterated with serious consequences, the legal representative, the main responsible person, the person directly in charge and personnel in key positions as well as other responsible personnel of vaccine MAHs shall be subject to a confiscation of income received from their affiliation during the occurrence of violations and a fine of not less than one time but not more than ten times the income, and shall be prohibited from engaging in drug manufacturing and operation for whole life, and detained by the public security department of not less than five days but not more than fifteen days.
生产、销售的疫苗属于假药，或者生产、销售的疫苗属于劣药且情节严重的，由省级以上人民政府药品监督管理部门对法定代表人、主要负责人、直接负责的主管人员和关键岗位人员以及其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入一倍以上十倍以下的罚款，终身禁止从事药品生产经营活动，由公安机关处五日以上十五日以下拘留。
Article 81 In any of the following circumstances, the drug regulatory departments of the people's governments at or above the provincial level shall confiscate illegal gains, illegally manufactured and distributed vaccines and raw materials, excipients, packaging materials and equipment specially used for illegal manufacture, order to stop production for rectification and stop business operation, and impose a fine of not less than fifteen times but not more than fifty times the value of vaccines illegally manufactured or distributed; if the illegal values are less than RMB 500,000 yuan, it shall be counted as RMB 500,000 yuan; in serious circumstance, the offender is subject to revocation of relevant approval documents, and up to the revocation drug manufacturing license; the legal representative, the main responsible person, director in charge and personnel in key positions as well as other responsible personnel of vaccine MAHs shall be subject to a confiscation of the income received from their organizations during the occurrence of violations, and a fine of not less than one half but not more than ten times the income, and shall be prohibited from engaging in drug manufacturing and operation for life, and be detained by the public security department for not less than five days but not more than fifteen days:
第八十一条 有下列情形之一的，由省级以上人民政府药品监督管理部门没收违法所得和违法生产、销售的疫苗以及专门用于违法生产疫苗的原料、辅料、包装材料、设备等物品，责令停产停业整顿，并处违法生产、销售疫苗货值金额十五倍以上五十倍以下的罚款，货值金额不足五十万元的，按五十万元计算；情节严重的，吊销药品相关批准证明文件，直至吊销药品生产许可证等，对法定代表人、主要负责人、直接负责的主管人员和关键岗位人员以及其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入百分之五十以上十倍以下的罚款，十年内直至终身禁止从事药品生产经营活动，由公安机关处五日以上十五日以下拘留：
(1) submitting falsified data, documents, samples or having other deceptive behaviors in application for vaccine clinical trials, registration and lot release;
（一）申请疫苗临床试验、注册、批签发提供虚假数据、资料、样品或者有其他欺骗行为；
(2) fabricating manufacturing and testing records or changing product lot number;
（二）编造生产、检验记录或者更改产品批号；
(3) distributing vaccine to immunization entities by any institution or individual other than disease prevention and control institutions;
（三）疾病预防控制机构以外的单位或者个人向接种单位供应疫苗；
(4) entrusting vaccine manufacturing without authorization;
（四）委托生产疫苗未经批准；
(5) implementing changes to production process, production site and key equipment without approval which shall have been approved as required;
（五）生产工艺、生产场地、关键设备等发生变更按照规定应当经批准而未经批准；
(6) implementing updates of vaccine package inserts and labels without approval which shall have been approved as required.
（六）更新疫苗说明书、标签按照规定应当经核准而未经核准。
Article 82 Except otherwise provided in the Law, if vaccine MAHs or other entities violate relevant drug quality management regulations, the drug regulatory departments of the people's governments at or above the county level shall order to make rectification and give a warning; and those who refuse to make rectification shall be subject to a fine of not less than RMB 200,000 yuan but not more than RMB 500,000 yuan; in serious circumstances, the offender shall be subject to a fine of not less than RMB 500,000 yuan but not more than RMB 3,000,000 yuan and an order to stop production for rectification until revocation of relevant drug approval documents and drug manufacturing license, and the legal representative, the main responsible person, executive in charge and personnel in key positions as well as other responsible personnel of vaccine MAHs shall be subject to a confiscation of the income received from their organizations during the occurrence of violations, and a fine of not less than one half but not more than five times the income, and be prohibited from engaging in drug production and operation for ten years to for life.
第八十二条 除本法另有规定的情形外，疫苗上市许可持有人或者其他单位违反药品相关质量管理规范的，由县级以上人民政府药品监督管理部门责令改正，给予警告；拒不改正的，处二十万元以上五十万元以下的罚款；情节严重的，处五十万元以上三百万元以下的罚款，责令停产停业整顿，直至吊销药品相关批准证明文件、药品生产许可证等，对法定代表人、主要负责人、直接负责的主管人员和关键岗位人员以及其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入百分之五十以上五倍以下的罚款，十年内直至终身禁止从事药品生产经营活动。
Article 83 In cases where vaccine MAHs’ violation of this Law involves any of the following circumstances, the drug regulatory departments of the people's governments at or above the provincial level shall order to make rectification and give a warning; and those who refuse to make rectification shall be subject to a fine of not less than RMB 200,000 yuan but not more than RMB 500,000 yuan; in serious circumstances, the offender shall be subject to an order to stop production for rectification and a fine of not less than RMB 500,000 yuan but not more than RMB 2,000,000 yuan:
第八十三条 违反本法规定，疫苗上市许可持有人有下列情形之一的，由省级以上人民政府药品监督管理部门责令改正，给予警告；拒不改正的，处二十万元以上五十万元以下的罚款；情节严重的，责令停产停业整顿，并处五十万元以上二百万元以下的罚款：
(1) failing to establish vaccine electronic traceability system as required;
（一）未按照规定建立疫苗电子追溯系统；
(2) persons in key positions such as legal representative, the principal, responsible person for manufacturing management, the responsible person for quality management and the quality authorized person, etc. failing to meet the prescribed conditions or failing to train and appraise these persons as required;
（二）法定代表人、主要负责人和生产管理负责人、质量管理负责人、质量受权人等关键岗位人员不符合规定条件或者未按照规定对其进行培训、考核；
(3) failing to report or file as required;
（三）未按照规定报告或者备案；
(4) failing to conduct post-marketing research, or failing to establish institutions and equip staff as required to actively collect, track and analyze adverse reactions of suspected vaccination;
（四）未按照规定开展上市后研究，或者未按照规定设立机构、配备人员主动收集、跟踪分析疑似预防接种异常反应；
(5) failing to carry compulsory vaccine liability insurance as required;
（五）未按照规定投保疫苗责任强制保险；
(6) failing to establish information disclosure system as required.
（六）未按照规定建立信息公开制度。
Article 84 Where a lot release institution has one of the following circumstances in violation of this Law, the drug regulatory department under the State Council shall order to make rectifications and give a warning to the said institution, and give warnings until downgrade as punishment to the principal, director in charge and other directly responsible personnel:
第八十四条 违反本法规定，批签发机构有下列情形之一的，由国务院药品监督管理部门责令改正，给予警告，对主要负责人、直接负责的主管人员和其他直接责任人员依法给予警告直至降级处分：
(1) failing to conduct audits and inspections as required;
（一）未按照规定进行审核和检验；
(2) failing to issue lot release results of marketed vaccine in a timely manner;
（二）未及时公布上市疫苗批签发结果；
(3) failing to verify and validate as required;
（三）未按照规定进行核实；
(4) failing to report detected significant quality risks of vaccine as required.
（四）发现疫苗存在重大质量风险未按照规定报告。
If a lot release institution fails to issue a lot release certificate or a not-release notice in violation of this Law, the drug regulatory department under the State Council shall order to make rectifications and give a warning to the said institution, and give a downgrade or dismissal as punishment to the main responsible person, executive in charge, and other directly responsible personnel according to law; and in serious circumstances, an expulsion from organization.
违反本法规定，批签发机构未按照规定发给批签发证明或者不予批签发通知书的，由国务院药品监督管理部门责令改正，给予警告，对主要负责人、直接负责的主管人员和其他直接责任人员依法给予降级或者撤职处分；情节严重的，对主要负责人、直接负责的主管人员和其他直接责任人员依法给予开除处分。
Article 85 If any disease prevention and control institution, immunization entity, vaccine MAH, or vaccine distribution entity violates cold-chain storage and transportation requirements in vaccine storage and transportation guidance, the drug regulatory department of the people's government at or above the county level shall order to make rectification and give warnings, destroy illegally stored and transported vaccines and confiscate illegal income; and for those who refuse to make rectification, it shall impose on the immunization entity, the MAH and the vaccine distribution entity a fine of more than RMB 200,000 yuan and less than RMB 1,000,000 yuan; and in serious circumstances, it shall impose on the immunization entity, vaccine MAH, and vaccine distribution entity a fine of not less than ten times and not more than thirty times of illegal values derived from illegally stored and transported vaccines; and if the illegal values are less than RMB 100,000 yuan, it shall be counted as RMB 100,000 yuan, and the vaccine MAH, vaccine distribution entity shall be subject to production and operation suspension until revocation of relevant drug approval documents, drug manufacturing certificate and so on, and their legal representative, the principal, executive in charge and key position personnel and other responsible personnel shall be subject to punishments as prescribed in Article 82 of this Law.
第八十五条 疾病预防控制机构、接种单位、疫苗上市许可持有人、疫苗配送单位违反疫苗储存、运输管理规范有关冷链储存、运输要求的，由县级以上人民政府药品监督管理部门责令改正，给予警告，对违法储存、运输的疫苗予以销毁，没收违法所得；拒不改正的，对接种单位、疫苗上市许可持有人、疫苗配送单位处二十万元以上一百万元以下的罚款；情节严重的，对接种单位、疫苗上市许可持有人、疫苗配送单位处违法储存、运输疫苗货值金额十倍以上三十倍以下的罚款，货值金额不足十万元的，按十万元计算，责令疫苗上市许可持有人、疫苗配送单位停产停业整顿，直至吊销药品相关批准证明文件、药品生产许可证等，对疫苗上市许可持有人、疫苗配送单位的法定代表人、主要负责人、直接负责的主管人员和关键岗位人员以及其他责任人员依照本法第八十二条规定给予处罚。
Where disease prevention and control institutions or immunization entity commits an illegal act as prescribed in the preceding paragraph, the competent health department of the People's government at or above the county level shall impose sanctions of a warning and up to dismissal on the main responsible person, executive in charge and other directly responsible personnel according to law, and order the responsible medical personnel to suspend the practice activities for more than one year and less than 18 months; and for serious consequences, give a dismissal according to law, and revoke immunization qualification of the immunization entity, and responsible medical and health personnel shall being revoked of business certificate by original issuing department.
疾病预防控制机构、接种单位有前款规定违法行为的，由县级以上人民政府卫生健康主管部门对主要负责人、直接负责的主管人员和其他直接责任人员依法给予警告直至撤职处分，责令负有责任的医疗卫生人员暂停一年以上十八个月以下执业活动；造成严重后果的，对主要负责人、直接负责的主管人员和其他直接责任人员依法给予开除处分，并可以吊销接种单位的接种资格，由原发证部门吊销负有责任的医疗卫生人员的执业证书。
Article 86 Where any disease prevention and control institutions, immunization entity, vaccine MAH or vaccine distribution entity violates vaccine storage and transportation guidance other than those prescribed in Article 85 of this Law, the drug regulatory departments of the people's governments at the county level shall order to make rectification, give a warning, and confiscate the illegal gains; and for those who refuse to make rectification, a fine of more than RMB 100,000 yuan and less than RMB 300,000 yuan shall be imposed on the immunization entity, vaccine MAHs, and the vaccine distribution entity; and in serious circumstances, a fine of not less than three times and not more than ten times of values derived from illegally stored and transported vaccines shall be imposed on the immunization entity, vaccine MAHs, and vaccine distribution entity. If the value of the vaccines concerned is less than RMB 100,000 yuan, it shall be counted as RMB 100,000 yuan.
第八十六条 疾病预防控制机构、接种单位、疫苗上市许可持有人、疫苗配送单位有本法第八十五条规定以外的违反疫苗储存、运输管理规范行为的，由县级以上人民政府药品监督管理部门责令改正，给予警告，没收违法所得；拒不改正的，对接种单位、疫苗上市许可持有人、疫苗配送单位处十万元以上三十万元以下的罚款；情节严重的，对接种单位、疫苗上市许可持有人、疫苗配送单位处违法储存、运输疫苗货值金额三倍以上十倍以下的罚款，货值金额不足十万元的，按十万元计算。
Where any disease prevention and control institution or immunization entity commits illegal acts as prescribed in the preceding paragraph, the competent health department of the people's government at or above the county level may impose sanctions of warning and up to the dismissal on the main responsible person, the executive in charge and other directly responsible personnel according to law, and order the responsible medical and health personnel to suspend practice activities for more than six months and less than one year; and for serious consequences, give a dismissal to the principal, the executive in charge and other directly responsible personnel according to law, and responsible medical and health personnel shall be revoked of business certificate by original issuing department.
疾病预防控制机构、接种单位有前款规定违法行为的，县级以上人民政府卫生健康主管部门可以对主要负责人、直接负责的主管人员和其他直接责任人员依法给予警告直至撤职处分，责令负有责任的医疗卫生人员暂停六个月以上一年以下执业活动；造成严重后果的，对主要负责人、直接负责的主管人员和其他直接责任人员依法给予开除处分，由原发证部门吊销负有责任的医疗卫生人员的执业证书。
Article 87 Where any disease prevention and control institution or immunization entity is under any of the following circumstances in violation of this Law, the competent health department of the people's government at or above the county level shall order to make rectification, give a warning, and confiscate the illegal income; and in serious circumstances, impose sanctions of a warning and up to dismissal on the main responsible person, directly responsible persons and other directly responsible personnel according to law, and order the responsible medical personnel to suspend practice activities for more than one year and less than eighteen months; and for serious consequence, give an expulsion to the main responsible person and executive in charge and other directly responsible personnel according to law, and responsible medical and health personnel shall be revoked of business certificate by original issuing department:
第八十七条 违反本法规定，疾病预防控制机构、接种单位有下列情形之一的，由县级以上人民政府卫生健康主管部门责令改正，给予警告，没收违法所得；情节严重的，对主要负责人、直接负责的主管人员和其他直接责任人员依法给予警告直至撤职处分，责令负有责任的医疗卫生人员暂停一年以上十八个月以下执业活动；造成严重后果的，对主要负责人、直接负责的主管人员和其他直接责任人员依法给予开除处分，由原发证部门吊销负有责任的医疗卫生人员的执业证书：
(1) failing to supply, receive, and purchase vaccines as required;
（一）未按照规定供应、接收、采购疫苗；
(2) conducting immunization activities that does not comply with the immunization work norms, immunization procedures, guidance for vaccines use and immunization plans;
（二）接种疫苗未遵守预防接种工作规范、免疫程序、疫苗使用指导原则、接种方案；
(3) conducting cluster immunization without authorization.
（三）擅自进行群体性预防接种。
Article 88 In cases where violation of this Law by disease prevention and control institution or immunization entity involves any of the following circumstances, the competent health department of the people's government at or above the county level shall order to make rectification, give a warning, and confiscate the illegal income; and in serious circumstances, impose sanctions of a warning and up to dismissal on the main responsible person, directly responsible persons and other directly responsible personnel according to law, and order the responsible medical personnel to suspend practice activities for more than six months and less than one year; for serious consequences, give an expulsion to the principal and executive in charge and other directly responsible personnel according to law, and responsible medical and health personnel shall be revoked of business certificate by original issuing department:
第八十八条 违反本法规定，疾病预防控制机构、接种单位有下列情形之一的，由县级以上人民政府卫生健康主管部门责令改正，给予警告；情节严重的，对主要负责人、直接负责的主管人员和其他直接责任人员依法给予警告直至撤职处分，责令负有责任的医疗卫生人员暂停六个月以上一年以下执业活动；造成严重后果的，对主要负责人、直接负责的主管人员和其他直接责任人员依法给予开除处分，由原发证部门吊销负有责任的医疗卫生人员的执业证书：
(1) failing to provide traceability information as required;
（一）未按照规定提供追溯信息；
(2) failing to obtain and keep relevant certification documents and temperature monitoring records when receiving or purchasing vaccines;
（二）接收或者购进疫苗时未按照规定索取并保存相关证明文件、温度监测记录；
(3) failing to establish and maintain records of vaccine reception, purchase, storage, distribution, supply, inoculation, and disposal as required;
（三）未按照规定建立并保存疫苗接收、购进、储存、配送、供应、接种、处置记录；
(4) failing to inform and inquire the recipient or his/her guardian about relevant conditions as required.
（四）未按照规定告知、询问受种者或者其监护人有关情况。
Article 89 Where any disease prevention and control institution, medical institution or immunization entity fails to report suspected immunization adverse reactions and vaccine safety incidents, or fails to organize investigation and diagnosis of suspected immunization adverse reactions as required, the competent health departments of the people's governments at or above the county level shall order to make rectification and give a warning; and in serious circumstances, it shall impose a fine of not less than RMB 50,000 yuan but not more than RMB 500,000 yuan on the immunization entities and medical institutions, and impose sanctions of a warning and up to a dismissal on the main responsible person, executive in charge and other directly responsible personnel according to law; and for serious consequence, give an expulsion to the main responsible person and executive in charge and other directly responsible personnel according to law, and the department that formerly issued the practicing license shall revoke the certificate of the responsible medical and healthcare personnel.
第八十九条 疾病预防控制机构、接种单位、医疗机构未按照规定报告疑似预防接种异常反应、疫苗安全事件等，或者未按照规定对疑似预防接种异常反应组织调查、诊断等的，由县级以上人民政府卫生健康主管部门责令改正，给予警告；情节严重的，对接种单位、医疗机构处五万元以上五十万元以下的罚款，对疾病预防控制机构、接种单位、医疗机构的主要负责人、直接负责的主管人员和其他直接责任人员依法给予警告直至撤职处分；造成严重后果的，对主要负责人、直接负责的主管人员和其他直接责任人员依法给予开除处分，由原发证部门吊销负有责任的医疗卫生人员的执业证书。
Article 90 If any disease prevention and control institutions or immunization entities violates this Law to charge fee, the competent health departments of the people's governments at or above the county level shall monitor the return of the illegally charged fee to the original paying entities or individuals, and market regulation department at or above the county level shall give corresponding sanctions thereto according to law.
第九十条 疾病预防控制机构、接种单位违反本法规定收取费用的，由县级以上人民政府卫生健康主管部门监督其将违法收取的费用退还给原缴费的单位或者个人，并由县级以上人民政府市场监督管理部门依法给予处罚。
Article 91 For any institution conducting immunization of immunization program vaccines without designation of competent health departments of the local people's government at or above the county level, or conducting immunization of non-immunization program vaccines without meeting the requirements or filing the record, the competent health departments of the people's government at or above the county level shall order to make rectification and give a warning, confiscate illegal gains and illegally possessed vaccines, order to stop operation for rectification, impose a fine of not less than RMB 100,000 yuan but not more than RMB 1,000,000 yuan and impose sanctions on the main responsible person, executive in charge and other direct responsible personnel according to law.
第九十一条 违反本法规定，未经县级以上地方人民政府卫生健康主管部门指定擅自从事免疫规划疫苗接种工作、从事非免疫规划疫苗接种工作不符合条件或者未备案的，由县级以上人民政府卫生健康主管部门责令改正，给予警告，没收违法所得和违法持有的疫苗，责令停业整顿，并处十万元以上一百万元以下的罚款，对主要负责人、直接负责的主管人员和其他直接责任人员依法给予处分。
For any entity or individual other than disease prevention and control institutions and immunization entities that engages in cluster immunization without approval in violation of this Law, the competent health departments of the people's government at or above the county level shall order to make rectification, confiscate illegal gains and illegally possessed vaccines, and impose a fine of not less than ten times and not more than thirty times ofvalues derived from illegally stored and transported vaccines, and if the values of the vaccines concerned are less than RMB 50,000 yuan, it shall be counted as RMB 50,000 yuan.
违反本法规定，疾病预防控制机构、接种单位以外的单位或者个人擅自进行群体性预防接种的，由县级以上人民政府卫生健康主管部门责令改正，没收违法所得和违法持有的疫苗，并处违法持有的疫苗货值金额十倍以上三十倍以下的罚款，货值金额不足五万元的，按五万元计算。
Article 92 If the guardian fails to ensure that the children at proper age are immunized with immunization program vaccines on schedule, the competent health departments at the county level shall give criticism and education and order to make correction.
第九十二条 监护人未依法保证适龄儿童按时接种免疫规划疫苗的，由县级人民政府卫生健康主管部门批评教育，责令改正。
Where nurseries and schools fail to check the immunization certificate as required on the admission of children, or fail to report to immunization entities after identifying any child having not been vaccinated as required, the education administrative departments of the people's government at or above the county level shall order to make correction, give a warning, and impose sanctions on the main responsible person, executive in charge and other responsible personnel.
托幼机构、学校在儿童入托、入学时未按照规定查验预防接种证，或者发现未按照规定接种的儿童后未向接种单位报告的，由县级以上地方人民政府教育行政部门责令改正，给予警告，对主要负责人、直接负责的主管人员和其他直接责任人员依法给予处分。
Article 93 Anyone who fabricates or spreads false information about vaccine safety, or picks quarrels and provokes troubles in immunization entities, thus constituting an act violating public security regulations shall be subject to public security punishment by the public security departments according to law.
第九十三条 编造、散布虚假疫苗安全信息，或者在接种单位寻衅滋事，构成违反治安管理行为的，由公安机关依法给予治安管理处罚。
Relevant competent departments shall impose sanctions according to law on a newspaper, journal, radio, television, internet website or any other media where they fabricate or disseminate anyfalse information about vaccine safety, and on the main responsible person, executive in charge and other directly responsible personnel.
报纸、期刊、广播、电视、互联网站等传播媒介编造、散布虚假疫苗安全信息的，由有关部门依法给予处罚，对主要负责人、直接负责的主管人员和其他直接责任人员依法给予处分。
Article 94 Where local people's governments at or above the county level are under any of the following circumstances in vaccine administration, the executive in charge and other directly responsible personnel shall be given a downgrade or dismissal; and in serious circumstances, the executive in charge and other directly responsible personnel shall be given an expulsion; if it causes serious consequences, the principal shall resign to assume responsibility:
第九十四条 县级以上地方人民政府在疫苗监督管理工作中有下列情形之一的，对直接负责的主管人员和其他直接责任人员依法给予降级或者撤职处分；情节严重的，依法给予开除处分；造成严重后果的，其主要负责人应当引咎辞职：
(1) performing responsibility insufficiently, resulting in serious negative effects or heavy losses;
（一）履行职责不力，造成严重不良影响或者重大损失；
(2) concealing information, giving false information, delaying reporting, giving incomplete report of vaccine safety incidents;
（二）瞒报、谎报、缓报、漏报疫苗安全事件；
(3) disturbing or obstructing vaccines-related investigation on illegal or criminal acts or safety incidents;
（三）干扰、阻碍对疫苗违法行为或者疫苗安全事件的调查；
(4) occurrence of significant vaccine safety incidents or continuous major vaccine safety incidents within the administrative region.
（四）本行政区域发生特别重大疫苗安全事故，或者连续发生重大疫苗安全事故。
Article 95 For any of the following behaviors of drug regulatory departments or competent health departments in vaccine administration, the executive in charge and other directly responsible personnel shall be given a downgrade or dismissal; and in serious circumstances, the executive in charge and other directly responsible personnel shall be given an expulsion; if it causes serious consequence, the principal shall resign to assume responsibility:
第九十五条 药品监督管理部门、卫生健康主管部门等部门在疫苗监督管理工作中有下列情形之一的，对直接负责的主管人员和其他直接责任人员依法给予降级或者撤职处分；情节严重的，依法给予开除处分；造成严重后果的，其主要负责人应当引咎辞职：
(1) failing to perform duties of supervision and inspection, or failing to promptly investigate and punish any illegal act that has been identified;
（一）未履行监督检查职责，或者发现违法行为不及时查处；
(2) carrying out cluster immunization without approval;
（二）擅自进行群体性预防接种；
(3) concealing information, giving false information, delaying reporting or giving incomplete reporting of vaccine safety incidents;
（三）瞒报、谎报、缓报、漏报疫苗安全事件；
(4) disturbing or obstructing vaccine-related investigation on illegal acts or safety incidents;
（四）干扰、阻碍对疫苗违法行为或者疫苗安全事件的调查；
(5) revealing the information of the informant;
（五）泄露举报人的信息；
(6) failing to organize investigations and handling as required when receiving reports of suspected immunization adverse reactions;
（六）接到疑似预防接种异常反应相关报告，未按照规定组织调查、处理；
(7) having any other dereliction of duty in vaccine administration, resulting in serious negative effects or heavy losses.
（七）其他未履行疫苗监督管理职责的行为，造成严重不良影响或者重大损失。
Article 96 If vaccine recipients are subject to any injury as a result of vaccine quality problem, the responsible vaccine MAH shall assume the compensation liability according to law.
第九十六条 因疫苗质量问题造成受种者损害的，疫苗上市许可持有人应当依法承担赔偿责任。
If any disease prevention and control institutions or immunization entities violate the work norms, immunization procedure, vaccine use guidance and immunization plan in immunization, and thus cause injury to vaccine recipients, they shall assume the compensation liability according to law.
疾病预防控制机构、接种单位因违反预防接种工作规范、免疫程序、疫苗使用指导原则、接种方案，造成受种者损害的，应当依法承担赔偿责任。
Chapter XI Supplementary Provisions
第十一章 附 则
Article 97 Definitions of the following terms used in this Law shall be:
第九十七条 本法下列用语的含义是：
“Immunization program vaccines” are vaccines to be inoculated in citizens as per the government provisions, including vaccines confirmed in the national immunization program, vaccines added by people’s governments of provinces, autonomous regions and municipalities directly under the Central Government while implementing the national immunization program, vaccines for emergency immunization or cluster immunization organized by the people’s governments or their competent health departments at or above the county level.
免疫规划疫苗，是指居民应当按照政府的规定接种的疫苗，包括国家免疫规划确定的疫苗，省、自治区、直辖市人民政府在执行国家免疫规划时增加的疫苗，以及县级以上人民政府或者其卫生健康主管部门组织的应急接种或者群体性预防接种所使用的疫苗。
“Non-immunization program vaccines” are other vaccines to be inoculated by citizens at their discretion.
非免疫规划疫苗，是指由居民自愿接种的其他疫苗。
Vaccine MAHs are entities that obtain drug registration certificate of vaccines and drug manufacturing certificate.
疫苗上市许可持有人，是指依法取得疫苗药品注册证书和药品生产许可证的企业。
Article 98 The State encourages vaccine manufacturers to produce and export vaccines to meet the international demand.
第九十八条 国家鼓励疫苗生产企业按照国际采购要求生产、出口疫苗。
Exported vaccines shall meet the standards of the importing country (region) or contractual requirements.
出口的疫苗应当符合进口国（地区）的标准或者合同要求。
Article 99 The immunization for exit and entry and the procurement of the vaccines needed shall be separately stipulated by border health and quarantine departments upon consultation with the financial department under the State Council.
第九十九条 出入境预防接种及所需疫苗的采购，由国境卫生检疫机关商国务院财政部门另行规定。
Article 100 This Law shall be effective as of December 1, 2019.
第一百条 本法自2019年12月1日起施行。