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Vaccine Administration Law of the People's Republic of China [Not Yet Effective]
中华人民共和国疫苗管理法 [尚未生效]
【法宝引证码】

Order of the President of the People's Republic of China 

中华人民共和国主席令

(No. 30) (第三十号)

The Vaccine Administration Law of the People's Republic of China, as adopted at the 11th Session of the Standing Committee of the Thirteenth National People's Congress of the People's Republic of China on June 29, 2019, is hereby issued and shall come into force on December 1, 2019. 《中华人民共和国疫苗管理法》已由中华人民共和国第十三届全国人民代表大会常务委员会第十一次会议于2019年6月29日通过,现予公布,自2019年12月1日起施行。
President of the People's Republic of China: Xi Jinping 中华人民共和国主席 习近平
June 29, 2019 2019年6月29日
Vaccine Administration Law of the People's Republic of China 中华人民共和国疫苗管理法
(Adopted at the 11th Session of the Standing Committee of the Thirteenth National People's Congress on June 29, 2019) (2019年6月29日第十三届全国人民代表大会常务委员会第十一次会议通过)
Table of Contents 目  录
Chapter I General Provisions 第一章 总  则
Chapter II Vaccine Development and Registration 第二章 疫苗研制和注册
Chapter III Vaccine Production and Lot Release 第三章 疫苗生产和批签发
Chapter IV Vaccine Circulation 第四章 疫苗流通
Chapter V Vaccination 第五章 预防接种
Chapter VI Monitoring and Handling of Abnormal Reactions 第六章 异常反应监测和处理
Chapter VII Management after the Marketing of Vaccines 第七章 疫苗上市后管理
Chapter VIII Safeguard Measures 第八章 保障措施
Chapter IX Supervision and Administration 第九章 监督管理
Chapter X Legal Liability 第十章 法律责任
Chapter XI Supplementary Provisions 第十一章 附  则
Chapter I General Provisions 

第一章 总  则

Article 1 This Law is developed for purposes of strengthening vaccine administration, guaranteeing vaccine quality and supply, standardizing vaccination, promoting the development of the vaccine industry, safeguarding public health, and maintaining public health security.   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 apply to vaccine development, production and circulation, vaccination and the supervision and administration thereof within the territory of the People's Republic of China. If they are not prescribed in this Law, the provisions of the Drug Administration Law of the People's Republic of China, the Law of the People's Republic of China on the Prevention and Treatment of Infectious Diseases and other laws and administrative regulations shall apply.   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” means preventive biological products for human vaccination so as to prevent and control the occurrence and prevalence of diseases, including vaccines under immunization programs and vaccines not covered by immunization programs. 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 shall implement the most stringent management rules for vaccines, and adhere to safety first, risk management, whole-process management and 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 shall adhere to 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 shall support basic research and applied research on vaccines, promote vaccine development and innovation, and integrate vaccine development, production and reserves for the prevention and control of serious diseases into national strategies. 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 shall make development plans and industry policies for the vaccine industry, support the development of the vaccine industry and optimization of structure, encourage large-scale and intensified vaccine production, and continuously improve vaccine production technology and quality. 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 license holders shall strengthen the whole life-cycle quality management of vaccines and be responsible for the safety, effectiveness and quality controllability 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。
Entities and individuals conducting vaccine development, production, circulation and vaccination activities shall comply with laws, regulations, rules and standards, ensure that the information is true, accurate, complete and traceable in the whole process, assume responsibilities in accordance with the law, and accept social supervision. 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 shall implement rules for immunization programs.   第六条 国家实行免疫规划制度。
Residents residing within China shall enjoy the right to vaccination under immunization programs in accordance with the law and fulfill their obligation to vaccination under immunization programs. Governments shall provide vaccines under immunization programs to residents 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 at or above the county level and their relevant departments shall guarantee vaccination under immunization programs for school-age children. Guardians shall, in accordance with the law, guarantee that school-age children are vaccinated on time. 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 include vaccine safety work and vaccination work in national economic and social development plans at the same level, strengthen the capability building of vaccine supervision and administration, and establish and improve the vaccine supervision and administration work mechanism.   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 the supervision and administration of vaccines in their respective administrative regions, and shall uniformly lead, organize and coordinate vaccine supervision and administration in their respective administrative regions. 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 medical products administration of the State Council shall be responsible for the supervision and administration of vaccines nationwide. The competent health department of the State Council shall be responsible for the supervision and administration of vaccination nationwide. Other relevant departments of the State Council shall be responsible for supervision and administration relating to vaccines within the scope of their respective functions.   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。
The medical products administration of the people's government of a province, autonomous region or municipality directly under the Central Government shall be responsible for the supervision and administration of vaccines in its administrative region. The department that undertakes the functions of medical products administration of the people's government at the level of a districted city or county (hereinafter referred to as the “medical products administration”) shall be responsible for the supervision and administration of vaccines in its administrative region. The competent health departments of local people's governments at or above the county level shall be responsible for the supervision and administration of vaccination in their respective administrative regions. Other relevant departments of local people's governments at or above the county level shall be responsible for the supervision and administration relating to vaccines within the scope of their respective functions. 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 departmental coordination mechanisms to make overall planning to coordinate vaccine supervision and administration, analyze vaccine safety situation on a periodical basis, strengthen vaccine supervision and administration, and guarantee 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 shall implement whole process electronic traceability rules for vaccines.   第十条 国家实行疫苗全程电子追溯制度。
The medical products administration of the State Council shall, in conjunction with the competent health department of the State Council, formulate uniform vaccine traceability standards and rules, establish a national vaccine electronic traceability collaboration platform, and integrate whole process traceability information on vaccine production, circulation and vaccination so as 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 marketing license holders shall establish vaccine electronic traceability systems, and link them with the national vaccine electronic traceability collaboration platform so as to realize traceable and verifiable vaccines of the minimum packaging unit in the whole process of production, circulation and vaccination. 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 inoculation entities shall truthfully record vaccine circulation, vaccination and other circumstances in accordance with the law, and provide traceability information to the national vaccine electronic traceability collaboration platform 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 In the process of vaccine development, production and inspection, among others, biosafety management rules shall be established and improved, biosafety risks shall be strictly controlled, the biosafety management of pathogenic microorganisms such as bacterial strains shall be strengthened, the health of operators and the public shall be protected, and it shall be guaranteed that the use of pathogenic microorganisms such as bacterial strains is legal and justified.   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。
The strains and cell strains used in the development, production and inspection of vaccines shall have specific historical and biological characteristics and generations, and detailed archives shall be established to ensure that the source is legal, clear and traceable; if the source is unknown, they 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 their relevant departments, disease prevention and control institutions, inoculation entities, vaccine marketing license holders and vaccine industry associations shall conduct the publicity and education and popularity of vaccine safety laws, regulations and vaccination knowledge through such activities as the National Child Vaccination 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 conduct the publicity of vaccine safety laws, regulations and vaccination knowledge, and conduct public opinion supervision of vaccine-related violations of law. Vaccine publicity reports shall be comprehensive, scientific, objective and fair. 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 strengthen industry self-discipline, establish and improve industry standards, promote the construction of industry credit system, and give direction to and urge members to conduct production and business operation and other activities in accordance with the 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 shall, according to the prevalence of diseases, the immune status of the population and other factors, make relevant research and development plans, allocate necessary funds, and support the development of polyvalent, multivalent and other new-type vaccines.   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 shall organize vaccine marketing license holders, scientific research entities and medical institutions to jointly tackle problems, and 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 The state encourages vaccine marketing license holders to increase investment in research and innovation, optimize production technology, improve quality control, and promote vaccine technology advancement.   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 The clinical trials of vaccines shall be subject to approval by the medical products administration of the State Council in accordance with the 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。
Clinical trials of vaccines shall be conducted or organized by tertiary medical institutions meeting the qualifications prescribed by the medical products administration of the State Council and the competent health department of the State Council or disease prevention and control institutions at or above the provincial level. 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 qualified medical institutions and disease prevention and control institutions to conduct clinical trials of vaccines in accordance with the 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 sponsors of vaccine clinical trials shall make clinical trial plans, establish clinical trial safety monitoring and evaluation rules, prudentially select trial subjects, reasonably set the subject group and age group, and take effective measures according to risk degree to protect the lawful rights and interests of trial 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 To conduct vaccine clinical trials, the written informed consent of the trial subject shall be obtained; if the subject is a person without civil capacity, the written informed consent of his or her guardian shall be obtained; if the subject is a person with limited capacity for civil conduct, the written informed consent of him or her and his or her guardian shall be obtained.   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 within China shall be subject to approval by the medical products administration of the State Council and a drug registration certificate shall be obtained; and in an application for the registration of vaccines, true, sufficient and reliable data, materials 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。
The medical products administration of the State Council shall give priority to the review and approval of vaccines urgently needed for disease prevention and control and innovative vaccines. 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 urgently needed to respond to major emergent public health incidents or other vaccines that are urgently needed as determined by the competent health department of the State Council, if benefits outweigh risks upon assessment, the medical products administration of the State Council may conditionally approve vaccine registration applications.   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。
In the case of any particularly serious public health emergency or any other serious emergency that poses a serious threat to public health, the competent health department of the State Council shall offer a proposal on the urgent use of the vaccine as required for the prevention and control of the infectious disease, and the vaccine may be put into urgent use within a certain scope and period with the approval upon organized demonstration by the medical products administration of 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 When the medical products administration of the State Council approves the vaccine registration application, it shall confirm the production technology, quality control standards, specifications and labels of the vaccine.   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 medical products administration of the State Council shall issue in a timely manner vaccine instructions and label content on its website. 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 Production and Lot Release 

第三章 疫苗生产和批签发

Article 22 The state shall implement strict access rules for vaccine production.   第二十二条 国家对疫苗生产实行严格准入制度。
Whoever conducts vaccine production activities shall obtain the pharmaceutical production permit with the approval of the medical products administration of the people's government at or above the provincial level. 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。
Whoever conducts vaccine production activities shall, in addition to meeting the conditions for conducting pharmaceutical production activities prescribed in the Pharmaceutical Administration Law of the People's Republic of China, meet the following conditions: 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:
(1) It has sufficient capacity reserves of moderate size. (一)具备适度规模和足够的产能储备;
(2) It has rules, facilities and equipment that guarantee biosafety. (二)具有保证生物安全的制度和设施、设备;
(3) It satisfies the requirements for the prevention and control of diseases. (三)符合疾病预防、控制需要。
The vaccine marketing license holder shall have the vaccine production capability; if it does need to entrust production since the production exceeds its vaccine production capability, it shall be subject to approval by the medical products administration of the State Council. Whoever accepts entrusted production shall comply with the provisions of this Law and relevant provisions of the state so as to guarantee vaccine quality. 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 person in charge of the vaccine marketing license holder shall have good credit records, and the person in charge of production management, the person in charge of quality management, the qualified person and other personnel on key positions shall have relevant professional background and practicing 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。
The vaccine marketing license holder shall strengthen the training and assessment of the personnel prescribed in the preceding paragraph, and in a timely manner, report the appointment and changes to the medical products administration 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 inspected in accordance with the confirmed production technology and quality control standards. The whole process of production shall satisfy the requirements of quality management rules for pharmaceutical production.   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。
The vaccine marketing license holder shall examine and inspect the whole process of vaccine production 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 The vaccine marketing license holder shall establish a complete production quality management system, continuously strengthen deviation management, and faithfully record all the data formed during the production and inspection process by information means so as to ensure that the entire production process continuously satisfies statutory 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 shall implement rules for the lot release of vaccines.   第二十六条 国家实行疫苗批签发制度。
Before each batch of vaccines is sold or imported, the vaccine shall be examined and inspected by the lot release institution designated by the medical products administration of the State Council in accordance with relevant technical requirements. If it satisfies the requirements, a lot release certificate shall be issued; if it fails to satisfy the requirements, a notice on disapproving the lot release shall be issued. 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 of which the lot release is disapproved shall not be sold, and shall be destroyed under the supervision of the medical products administration of the people's government of the province, autonomous region or municipality directly under the Central Government. The imported vaccines of which the lot release is disapproved shall be destroyed under the supervision of the medical products administration at the place where the port is located or otherwise handled in accordance with the 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 medical products administration of the State Council and the lot release institution shall, in a timely manner, announce the results of lot release of the marketed vaccine for public inquiry. 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 Whoever applies for the lot release of a vaccine shall provide the batch production and inspection record summary and other materials, products of the same batch number and other samples to the lot release institution as required. For the imported vaccine, the certificate of origin and the lot release certificate shall also be provided; if lot release is exempted at the place of origin, the certificate on exemption from 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 The vaccines urgently needed for the prevention and control of infectious diseases or emergency response shall be exempted from lot release with the approval of the medical products administration of 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 The lot release of vaccines shall be subject to data examination and sampling inspection by batches. Vaccine lot release inspection items and frequency shall be dynamically adjusted according to the assessment of vaccine quality risks.   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。
Where there is any doubt over the veracity of vaccine lot release application materials or samples, or if there is any other circumstance that requires further verification, the lot release institution shall conduct verification, and when necessary, organize on-site verification by such means as on-site sampling inspection. 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 Where the lot release institution finds any major quality risk of the vaccine in the course of lot release, it shall, in a timely manner, report to the medical products administration of the State Council and the medical products administration of the people's government of the province, autonomous region or municipality 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 department receiving the report shall immediately conduct on-site inspection of the vaccine marketing license holder, and according to the inspection result, notify the lot release institution that the lot release of relevant or all products of the vaccine marketing license holder is disapproved or suspended, and order the vaccine marketing license holder to make rectification. The vaccine marketing license holder shall immediately make rectification and report in a timely manner the rectification information to the department that orders the holder to make rectification. 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 For production technology deviations, quality differences, failures and incidents in the production process, and the measures taken, the vaccine marketing license holder shall faithfully record them and indicate them in the documents on application for the lot release of corresponding batch of products; if vaccine quality might be affected, the vaccine marketing license holder shall immediately take measures and report to the medical products administration of the people's government of the province, autonomous region or municipality 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 Circulation 

第四章 疫苗流通

Article 32 For vaccines under national immunization programs, the competent health department of the State Council shall, in conjunction with the public finance department of the State Council, among others, organize centralized bidding or unified negotiation, and form and release bid price or transaction price, and vaccines shall be uniformly purchased by all provinces, autonomous regions and municipalities directly under the Central Government.   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。
Vaccines under other immunization programs other than vaccines under national immunization programs and vaccines not covered by immunization programs shall be purchased as organized by all provinces, autonomous regions and municipalities directly under the Central Government through provincial public resource trading platforms. 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 Vaccine price shall be determined by the vaccine marketing license holder in a legal, independent and rational manner. The price level, spread rate and profit rate of the vaccine shall be maintained at a reasonable level.   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 The provincial disease prevention and control institution shall, in accordance with national immunization programs and the requirements for the prevention and control of diseases in its administrative region, make plans for the use of vaccines under immunization programs of its administrative region, report to the department that organizes the purchase of vaccines according to relevant provisions of the state, and at the same time, report to the competent health department of the people's government of the province, autonomous region or municipality directly under the Central Government for recordation.   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 The vaccine marketing license holder shall supply vaccines to the disease prevention and control institution as agreed upon in 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。
The disease prevention and control institution shall supply vaccines to the inoculation entity 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。
No entity or individual other than the disease prevention and control institution shall supply vaccines to the inoculation entity and the inoculation entity shall not receive 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 The vaccine marketing license holder shall distribute vaccines to the disease prevention and control institution or the inoculation entity designated by the disease prevention and control institution as agreed upon in 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。
The vaccine marketing license holder and disease prevention and control institution that distribute vaccines by themselves shall meet vaccine cold chain storage and transportation conditions, or may authorize a qualified vaccine distribution entity 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。
The disease prevention and control institution that distributes vaccines not covered by immunization programs may charge storage and transportation expenses. The specific measures shall be developed by the public finance department of the State Council in conjunction with the competent price department of the State Council. The charging standards shall be determined by the competent price department of the people's government of the province, autonomous region or municipality directly under the Central Government in conjunction with the public finance department. 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, inoculation entities, vaccine marketing license holders and vaccine distribution entities shall abide by vaccine storage and transportation management rules so as to guarantee the quality of vaccines.   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 stored and transported in the environment with the prescribed temperature during the entire process. Cold chain storage and transportation shall satisfy the requirements, and temperature shall be monitored and recorded at regular time. 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。
Vaccine storage and transportation management rules shall be jointly developed by the medical products administration of the State Council and the competent health department of 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 the vaccine marketing license holder sells the vaccine, it shall provide a photocopy of the lot release certificate to which the seal is affixed or electronic documents; if the imported vaccine is sold, it shall also provide a photocopy of the customs clearance form of the imported medicine to which the seal is affixed or electronic documents.   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 receiving or purchasing a vaccine, the disease prevention and control institution and the inoculation entity shall obtain the certification documents prescribed in the preceding paragraph and retain them for not less than five years after the expiration of validity period of the vaccine. 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 The vaccine marketing license holder shall, as required, establish true, accurate and complete sales records and retain them for not less than five years after the expiration of validity period of the vaccine.   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。
The disease prevention and control institution, inoculation entity and vaccine distribution entity shall, as required, establish true, accurate and complete receipt, purchase, storage, distribution and supply records, and retain them for not less than five years after the expiration of validity period of the vaccine. 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。
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