Vaccine Administration Law of the People's Republic of China

Vaccine Administration Law of the People's Republic of China

(Adopted at the 11th Meeting of the Standing Committee of the 13th National People's Congress on June 29, 2019)

Contents

　　Chapter 1 General Provisions
　　Chapter 2 Vaccine Research and Registration
　　Chapter 3 Vaccine Production and Batch Release
　　Chapter 4 Vaccine Circulation
　　Chapter 5 Immunization
　　Chapter 6 Adverse Reaction Monitoring and Handling
　　Chapter 7 Post-Marketing Management of Vaccines
　　Chapter 8 Safeguard Measures
　　Chapter 9 Supervision and Administration
　　Chapter 10 Legal Liability
　　Chapter 11 Supplementary Provisions
　　
　　 Chapter 1 General Provisions
　　Article 1 This law is formulated to strengthen vaccine management, ensure vaccine quality and supply, regulate immunization, promote the development of the vaccine industry, protect public health, and maintain public health security.
　　Article 2 This law applies to activities related to vaccine research, production, circulation, immunization, and supervision within the territory of the People's Republic of China. For matters not stipulated in this law, the provisions of the "Drug Administration Law of the People's Republic of China", "Law of the People's Republic of China on the Prevention and Control of Infectious Diseases" and other laws and administrative regulations shall apply.
　　The vaccines referred to in this law are preventive biological products used for human immunization to prevent and control the occurrence and spread of diseases, including immunization program vaccines and non-immunization program vaccines.
　　Article 3 The state implements the strictest management system for vaccines, adhering to the principles of safety first, risk management, full-process control, scientific supervision, and social co-governance.
　　Article 4 The state upholds the strategic and public welfare nature of vaccine products.
　　The state supports basic and applied research on vaccines, promotes vaccine research and innovation, and incorporates the research, production, and stockpiling of vaccines for the prevention and control of major diseases into the national strategy.
　　The state formulates development plans and industrial policies for the vaccine industry, supports the development and structural optimization of the vaccine industry, encourages large-scale and intensive vaccine production, and continuously improves vaccine production technology and quality levels.
　　Article 5 The holder of the vaccine marketing authorization shall strengthen quality management throughout the vaccine lifecycle and be responsible for the safety, effectiveness, and quality controllability of the vaccine.
　　Units and individuals engaged in vaccine research, production, circulation, and immunization activities shall comply with laws, regulations, rules, standards, and norms, ensure that all process information is true, accurate, complete, and traceable, bear legal responsibilities, and accept social supervision.
　　Article 6 The state implements the immunization program system.
　　Residents living within the territory of China have the right to receive immunization program vaccines according to law and the obligation to receive immunization program vaccines. The government provides immunization program vaccines to residents free of charge.
　　People's governments at or above the county level and their relevant departments shall ensure that children of appropriate age receive immunization program vaccines. Guardians shall ensure that children of appropriate age receive immunization program vaccines on time according to law.
　　Article 7 People's governments at or above the county level shall incorporate vaccine safety work and immunization work into their national economic and social development plans, strengthen vaccine supervision and management capacity building, and establish and improve vaccine supervision and management work mechanisms.
　　People's governments at or above the county level are responsible for vaccine supervision and management work within their administrative regions, and shall uniformly lead, organize, and coordinate vaccine supervision and management work within their administrative regions.
　　Article 8 The State Drug Administration Department under the State Council is responsible for nationwide vaccine supervision and management. The health administration department under the State Council is responsible for nationwide immunization supervision and management. Other relevant departments of the State Council are responsible for vaccine-related supervision and management within their respective duties.
　　The drug supervision and administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for vaccine supervision and management within their administrative regions. The departments responsible for drug supervision and administration of municipal and county-level people's governments with districts (hereinafter referred to as drug supervision and administration departments) are responsible for vaccine supervision and management within their administrative regions. The health administration departments of people's governments at or above the county level are responsible for immunization supervision and management within their administrative regions. Other relevant departments of people's governments at or above the county level are responsible for vaccine-related supervision and management within their respective duties.
　　Article 9 The State Council and the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall establish departmental coordination mechanisms to coordinate vaccine supervision and management work, regularly analyze vaccine safety situations, strengthen vaccine supervision and management, and ensure vaccine supply.
　　Article 10 The state implements a full-process electronic traceability system for vaccines.
　　The State Drug Administration Department under the State Council, together with the health administration department under the State Council, shall formulate unified vaccine traceability standards and norms, establish a national vaccine electronic traceability collaborative platform, integrate traceability information throughout the vaccine production, circulation, and immunization process, and realize vaccine traceability.
　　The holder of the vaccine marketing authorization shall establish a vaccine electronic traceability system connected with the national vaccine electronic traceability collaborative platform to achieve traceability and verifiability of vaccines at the smallest packaging unit throughout production, circulation, and immunization.
　　Disease prevention and control institutions and vaccination units shall truthfully record vaccine circulation and immunization situations according to law and provide traceability information to the national vaccine electronic traceability collaborative platform as required.
　　Article 11 A sound biosafety management system shall be established and improved during vaccine research, production, and testing processes, strictly controlling biosafety risks, strengthening biosafety management of bacterial and viral strains and other pathogenic microorganisms, protecting the health of operators and the public, and ensuring the legal and proper use of bacterial and viral strains and other pathogenic microorganisms.
　　Bacterial and viral strains and cell lines used in vaccine research, production, and testing shall have clear history, biological characteristics, and passage generations, with detailed records to ensure legal, clear, and traceable sources; those with unknown sources shall not be used.
　　Article 12 People's governments at all levels and their relevant departments, disease prevention and control institutions, vaccination units, holders of vaccine marketing authorizations, and vaccine industry associations shall regularly carry out publicity and education on vaccine safety laws, regulations, and immunization knowledge through activities such as National Childhood Immunization Day.
　　News media shall conduct public welfare publicity on vaccine safety laws, regulations, and immunization knowledge, and supervise vaccine-related illegal activities through public opinion. Vaccine-related publicity and reports shall be comprehensive, scientific, objective, and fair.
　　Article 13 Vaccine industry associations shall strengthen industry self-discipline, establish and improve industry standards, promote the construction of industry integrity systems, and guide and supervise members to carry out production and business activities in accordance with the law.

　　 Chapter 2 Vaccine Research and Registration
　　Article 14: The state shall formulate relevant development plans based on the prevalence of diseases, population immunity status, and other factors, allocate necessary funds, and support the development of new vaccines such as multivalent and polyvalent vaccines.
　　The state organizes vaccine marketing authorization holders, research institutions, and medical and health institutions to jointly tackle key issues and develop vaccines urgently needed for disease prevention and control.
　　Article 15: The state encourages vaccine marketing authorization holders to increase investment in research and innovation, optimize production processes, improve quality control levels, and promote technological progress in vaccines.
　　Article 16: Conducting vaccine clinical trials shall be approved by the drug regulatory department of the State Council in accordance with the law.
　　Vaccine clinical trials shall be conducted or organized by tertiary medical institutions or provincial-level and above disease prevention and control institutions that meet the conditions stipulated by the drug regulatory department and the health administrative department of the State Council.
　　The state encourages qualified medical institutions, disease prevention and control institutions, and others to lawfully conduct vaccine clinical trials.
　　Article 17: Applicants for vaccine clinical trials shall formulate clinical trial protocols, establish systems for safety monitoring and evaluation, carefully select subjects, reasonably set subject groups and age groups, and take effective measures according to risk levels to protect the legitimate rights and interests of subjects.
　　Article 18: Conducting vaccine clinical trials requires obtaining the written informed consent of the subjects; if the subject is a person without civil capacity, written informed consent must be obtained from their guardian; if the subject is a person with limited civil capacity, written informed consent must be obtained from both the subject and their guardian.
　　Article 19: Vaccines marketed within China must be approved by the drug regulatory department of the State Council and obtain a drug registration certificate; vaccine registration applications must provide true, sufficient, and reliable data, materials, and samples.
　　For vaccines urgently needed for disease prevention and control and innovative vaccines, the drug regulatory department of the State Council shall give priority to review and approval.
　　Article 20: For vaccines urgently needed to respond to major public health emergencies or other vaccines recognized as urgently needed by the health administrative department of the State Council, if the benefits outweigh the risks after evaluation, the drug regulatory department of the State Council may conditionally approve the vaccine registration application.
　　In the event of particularly major public health emergencies or other serious emergencies threatening public health, the health administrative department of the State Council may propose the emergency use of vaccines based on the needs for infectious disease prevention and control; after organization and agreement by the drug regulatory department of the State Council, emergency use may be permitted within a certain scope and time limit.
　　Article 21: When approving vaccine registration applications, the drug regulatory department of the State Council shall approve the vaccine's production process, quality control standards, instructions, and labels.
　　The drug regulatory department of the State Council shall promptly publish the vaccine instructions and label content on its website.
　　
　　 Chapter 3 Vaccine Production and Batch Release
　　Article 22: The state implements a strict access system for vaccine production.
　　Engaging in vaccine production activities shall be approved by the drug regulatory department of the people's government at or above the provincial level and obtain a drug production license.
　　In addition to meeting the conditions for engaging in drug production activities stipulated by the "Drug Administration Law of the People's Republic of China," those engaged in vaccine production activities shall also meet the following conditions:
　　(1) Have an appropriate scale and sufficient production capacity reserves;
　　(2) Have systems, facilities, and equipment to ensure biosafety;
　　(3) Meet the needs of disease prevention and control.
　　Vaccine marketing authorization holders shall have vaccine production capabilities; if production capacity is exceeded and outsourcing is necessary, approval must be obtained from the drug regulatory department of the State Council. Those accepting outsourced production shall comply with this law and relevant national regulations to ensure vaccine quality.
　　Article 23: The legal representative and principal responsible persons of vaccine marketing authorization holders shall have good credit records; key personnel such as production management leaders, quality management leaders, and quality authorized persons shall have relevant professional backgrounds and work experience.
　　Vaccine marketing authorization holders shall strengthen training and assessment of the personnel specified in the preceding paragraph and promptly report their appointment and changes to the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the central government.
　　Article 24: Vaccines shall be produced and inspected according to the approved production processes and quality control standards, and the entire production process shall comply with the requirements of Good Manufacturing Practice for drugs.
　　Vaccine marketing authorization holders shall audit and inspect the entire vaccine production process and vaccine quality in accordance with regulations.
　　Article 25: Vaccine marketing authorization holders shall establish a complete production quality management system, continuously strengthen deviation management, use information technology to truthfully record all data generated during production and inspection processes, and ensure continuous compliance with legal requirements throughout the production process.
　　Article 26: The state implements a vaccine batch release system.
　　Before each batch of vaccines is sold or imported, it shall be reviewed and inspected by the batch release institution designated by the drug regulatory department of the State Council according to relevant technical requirements. If it meets the requirements, a batch release certificate shall be issued; if it does not meet the requirements, a notice of non-release shall be issued.
　　Vaccines that are not batch released shall not be sold and shall be supervised for destruction by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the central government; imported vaccines not batch released shall be supervised for destruction or otherwise handled according to law by the drug regulatory department at the port of entry.
　　The drug regulatory department of the State Council and the batch release institution shall promptly publish the batch release results of marketed vaccines for public inquiry.
　　Article 27: Applications for vaccine batch release shall provide batch production and inspection record summaries and samples of products with the same batch number to the batch release institution as required. Imported vaccines shall also provide certificates of origin and batch release certificates; if batch release is exempted at the place of origin, exemption certificates shall be provided.
　　Article 28: Vaccines urgently needed for the prevention and control of infectious disease epidemics or emergency response, upon approval by the drug regulatory department of the State Council, are exempt from batch release.
　　Article 29: Vaccine batch release shall be conducted batch by batch with document review and sampling inspection. The inspection items and frequency of vaccine batch release shall be dynamically adjusted based on vaccine quality risk assessment.
　　If there are doubts about the authenticity of vaccine batch release application materials or samples, or other situations requiring further verification, the batch release institution shall verify and, if necessary, organize on-site verification through methods such as on-site sampling inspection.
　　Article 30: If the batch release institution discovers significant quality risks in vaccines during the batch release process, it shall promptly report to the drug regulatory department of the State Council and the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the central government.
　　The department receiving the report shall immediately conduct an on-site inspection of the vaccine marketing authorization holder. Based on the inspection results, it shall notify the batch release institution to refuse or suspend the batch release of the relevant products or all products of the vaccine marketing authorization holder, and order the vaccine marketing authorization holder to make corrections. The vaccine marketing authorization holder shall immediately make corrections and promptly report the correction status to the department ordering the correction.
　　Article 31: The vaccine marketing authorization holder shall truthfully record deviations in production processes, quality differences, faults and accidents during production, and the measures taken, and include them in the documents for batch release application of the corresponding batch of products; if it may affect vaccine quality, the vaccine marketing authorization holder shall immediately take measures and report to the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government.
　　
　 　Chapter 4 Vaccine Circulation
　　Article 32: National immunization program vaccines shall be centrally tendered or negotiated uniformly by the health administration department of the State Council in conjunction with the financial department of the State Council and others, forming and publishing the winning bid price or transaction price. Provinces, autonomous regions, and municipalities directly under the Central Government shall implement unified procurement.
　　Other immunization program vaccines outside the national immunization program and non-immunization program vaccines shall be procured by provinces, autonomous regions, and municipalities directly under the Central Government through provincial-level public resource trading platforms.
　　Article 33: The price of vaccines shall be independently and reasonably set by the vaccine marketing authorization holder according to law. The price level, price difference rate, and profit margin of vaccines shall be maintained within a reasonable range.
　　Article 34: Provincial-level disease prevention and control institutions shall formulate the immunization program vaccine usage plan for their administrative region based on the national immunization program and the disease prevention and control needs of the region, report to the department organizing vaccine procurement according to national regulations, and file with the health administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government.
　　Article 35: The vaccine marketing authorization holder shall supply vaccines to disease prevention and control institutions according to the procurement contract.
　　Disease prevention and control institutions shall supply vaccines to vaccination units according to regulations.
　　Units and individuals other than disease prevention and control institutions shall not supply vaccines to vaccination units, and vaccination units shall not accept such vaccines.
　　Article 36: The vaccine marketing authorization holder shall deliver vaccines to disease prevention and control institutions or vaccination units designated by disease prevention and control institutions according to the procurement contract.
　　Vaccine marketing authorization holders and disease prevention and control institutions delivering vaccines themselves shall have vaccine cold chain storage and transportation conditions, and may also entrust qualified vaccine delivery units to deliver vaccines.
　　Disease prevention and control institutions may charge storage and transportation fees for delivering non-immunization program vaccines. Specific methods shall be formulated by the financial department of the State Council in conjunction with the price administration department of the State Council, and the charging standards shall be formulated by the price administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government in conjunction with the financial department.
　　Article 37: Disease prevention and control institutions, vaccination units, vaccine marketing authorization holders, and vaccine delivery units shall comply with vaccine storage and transportation management standards to ensure vaccine quality.
　　Vaccines shall be kept at the prescribed temperature environment throughout the storage and transportation process. Cold chain storage and transportation shall meet requirements, and temperature shall be monitored and recorded regularly.
　　Vaccine storage and transportation management standards shall be jointly formulated by the drug regulatory department of the State Council and the health administration department of the State Council.
　　Article 38: When selling vaccines, the vaccine marketing authorization holder shall provide a copy or electronic file of the batch release certificate stamped with its seal; for imported vaccines, a copy or electronic file of the import drug customs clearance form stamped with its seal shall also be provided.
　　Disease prevention and control institutions and vaccination units shall request the proof documents specified in the preceding paragraph when receiving or purchasing vaccines and keep them for no less than five years after the vaccine's expiration date for inspection.
　　Article 39: The vaccine marketing authorization holder shall establish true, accurate, and complete sales records according to regulations and keep them for no less than five years after the vaccine's expiration date for inspection.
　　Disease prevention and control institutions, vaccination units, and vaccine delivery units shall establish true, accurate, and complete records of receipt, purchase, storage, delivery, and supply according to regulations and keep them for no less than five years after the vaccine's expiration date for inspection.
　　When disease prevention and control institutions and vaccination units receive or purchase vaccines, they shall request temperature monitoring records for the entire transportation and storage process and keep them for no less than five years after the vaccine's expiration date for inspection; vaccines without such records or with temperature control not meeting requirements shall not be accepted or purchased, and the county-level or above local people's government drug regulatory department and health administration department shall be immediately notified.
　　Article 40: Disease prevention and control institutions and vaccination units shall establish a regular vaccine inspection system. For vaccines with issues such as unidentifiable packaging, storage temperature not meeting requirements, or expired validity, measures such as isolated storage and warning signs shall be taken, and disposal shall be carried out according to the regulations of the drug regulatory department, health administration department, and ecological environment department of the State Council. Disease prevention and control institutions and vaccination units shall truthfully record the disposal situation, and disposal records shall be kept for no less than five years after the vaccine's expiration date for inspection.

　 　Chapter 5 Immunization
　　Article 41: The health administration department of the State Council shall formulate the national immunization program; the types of vaccines in the national immunization program shall be drafted by the health administration department of the State Council in conjunction with the financial department of the State Council, submitted to the State Council for approval, and then published.
　　The health administration department of the State Council shall establish a national immunization program expert advisory committee and, together with the financial department of the State Council, establish a dynamic adjustment mechanism for the types of vaccines in the national immunization program.
　　The people's governments of provinces, autonomous regions, and municipalities directly under the Central Government may increase the types of immunization program vaccines according to the disease prevention and control needs of their administrative regions when implementing the national immunization program, report to the health administration department of the State Council for filing, and publish.
　　Article 42: The health administration department of the State Council shall formulate and publish vaccination work standards to strengthen standardized management of vaccination.
　　The health administration department of the State Council shall formulate and publish immunization procedures for national immunization program vaccines and usage guidelines for non-immunization program vaccines.
　　The health administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall formulate vaccination plans based on the actual situation of their administrative regions and file them with the health administration department of the State Council.
　　Article 43: Disease prevention and control institutions at all levels shall carry out publicity, training, technical guidance, monitoring, evaluation, epidemiological investigation, emergency response, and other work related to vaccination according to their respective responsibilities.
　　Article 44: Vaccination units shall meet the following conditions:
　　(1) Obtain a medical institution practice license;
　　(2) Have physicians, nurses, or village doctors who have undergone vaccination professional training organized by the health administration department of the county-level people's government and passed the assessment;
　　(3) Have cold storage facilities, equipment, and cold storage management systems that comply with vaccine storage and transportation management standards.
　　The health and wellness authorities of local people's governments at or above the county level designate qualified medical institutions to undertake immunization planning vaccine inoculation work within their responsible areas. Qualified medical institutions may undertake non-immunization planning vaccine inoculation work and must file with the health and wellness authorities that issued their medical institution practice license.
　　Vaccination units shall strengthen internal management and must comply with vaccination work standards, immunization procedures, vaccine usage guidelines, and vaccination plans when carrying out vaccination work.
　　Disease prevention and control agencies at all levels shall strengthen technical guidance for vaccination units on vaccination work and management of vaccine usage.
　　Article 45: Medical and health personnel implementing vaccination shall inform the vaccine recipient or their guardian about the vaccine type, effects, contraindications, adverse reactions, and on-site observation precautions; inquire about the recipient's health status and any vaccination contraindications; and truthfully record the information provided and inquiries made. The recipient or their guardian shall truthfully provide the recipient's health status and vaccination contraindications. If vaccination is contraindicated, medical and health personnel shall provide medical advice to the recipient or their guardian and truthfully record the advice given.
　　Before administering vaccination, medical and health personnel shall, according to vaccination work standards, check the recipient's health status, verify vaccination contraindications, check the vaccination certificate, inspect the appearance, batch number, and validity of the vaccine and syringe, verify the recipient's name, age, and the vaccine's name, specification, dosage, inoculation site, and route, ensuring consistency among the recipient, vaccination certificate, and vaccine information. Vaccination may only be administered after confirmation of accuracy.
　　Medical and health personnel shall vaccinate recipients who meet the vaccination conditions. If adverse reactions occur during the on-site observation period, medical and health personnel shall promptly take treatment and other measures according to vaccination work standards.
　　Article 46: Medical and health personnel shall record vaccination information truthfully, accurately, and completely according to the regulations of the State Council's health and wellness authorities, including vaccine type, marketing authorization holder, identification information of the smallest packaging unit, validity period, vaccination time, medical personnel administering the vaccine, and the recipient, ensuring vaccination information is traceable and queryable. Vaccination records shall be kept for no less than five years after the vaccine's expiration date for reference.
　　Article 47: The state implements a vaccination certificate system for children. Within one month after a child's birth, their guardian shall go to the vaccination unit responsible for immunization work at the child's residence or the birth hospital to obtain a vaccination certificate. The vaccination unit or birth hospital shall not refuse to issue it. Guardians shall properly keep the vaccination certificate.
　　Vaccination is managed by place of residence. During the period when a child leaves their original residence, the vaccination unit responsible for immunization work at the current residence shall be responsible for vaccinating the child.
　　The format of the vaccination certificate is stipulated by the State Council's health and wellness authorities.
　　Article 48: When children enter daycare or school, daycare institutions and schools shall check the vaccination certificate. If it is found that immunization planning vaccines have not been administered as required, the vaccination unit responsible for immunization work at the child's residence or the location of the daycare institution or school shall be reported, and the vaccination unit shall cooperate to urge the guardian to complete the vaccination as required. Disease prevention and control agencies shall provide technical guidance for daycare institutions and schools in checking vaccination certificates.
　　The methods for checking vaccination certificates when children enter daycare or school shall be formulated by the State Council's health and wellness authorities in conjunction with the State Council's education administrative departments.
　　Article 49: Vaccination units shall not charge any fees for immunization planning vaccines.
　　When vaccination units administer non-immunization planning vaccines, they may charge vaccination service fees in addition to vaccine costs. The charging standards for vaccination service fees shall be formulated by the price authorities of the people's governments of provinces, autonomous regions, and municipalities directly under the central government in conjunction with the finance departments.
　　Article 50: The health and wellness authorities of local people's governments at or above the county level may, based on infectious disease monitoring and early warning information, to prevent and control outbreaks and epidemics of infectious diseases, report to the people's government at the same level for decision, and file with the health and wellness authorities of the people's government at or above the provincial level, conduct mass vaccination within their administrative region.
　　Mass vaccination that needs to be carried out nationwide or across provinces, autonomous regions, or municipalities directly under the central government shall be decided by the State Council's health and wellness authorities.
　　Local people's governments at or above the county level or the State Council's health and wellness authorities that make decisions on mass vaccination shall organize relevant departments to carry out personnel training, publicity and education, material mobilization, and other work.
　　No unit or individual shall conduct mass vaccination without authorization.
　　Article 51: When infectious diseases break out or spread, if local people's governments at or above the county level or their health and wellness authorities need to take emergency vaccination measures, they shall implement them in accordance with laws and administrative regulations.
　　
　　 Chapter 6 Adverse Reaction Monitoring and Handling
　　Article 52: Adverse reactions to vaccination refer to adverse drug reactions caused by qualified vaccines during or after standardized vaccination that result in damage to the recipient's tissues, organs, or functions, with no fault on the part of any related party.
　　The following situations are not considered adverse reactions to vaccination:
　　(1) General reactions after vaccination caused by the inherent characteristics of the vaccine;
　　(2) Damage caused to the recipient due to vaccine quality issues;
　　(3) Damage caused to the recipient due to the vaccination unit violating vaccination work standards, immunization procedures, vaccine usage guidelines, or vaccination plans;
　　(4) The recipient was in the incubation or prodromal period of a certain disease at the time of vaccination and developed the disease coincidentally after vaccination;
　　(5) The recipient had vaccination contraindications specified in the vaccine instructions, and before vaccination, the recipient or their guardian did not truthfully provide the recipient's health status and vaccination contraindications, resulting in acute relapse or worsening of the original disease after vaccination;
　　(6) Psychogenic reactions occurring individually or in groups due to psychological factors.
　　Article 53: The state strengthens monitoring of adverse reactions to vaccination. The monitoring plan for adverse reactions to vaccination shall be formulated by the State Council's health and wellness authorities in conjunction with the State Council's drug regulatory authorities.
　　Article 54: Vaccination units, medical institutions, and others discovering suspected adverse reactions to vaccination shall report to disease prevention and control agencies as required.
　　Vaccine marketing authorization holders shall establish specialized institutions, equip full-time personnel, proactively collect and track suspected adverse reactions to vaccination, promptly take risk control measures, report suspected adverse reactions to disease prevention and control agencies, and submit quality analysis reports to the drug regulatory departments of the people's governments of provinces, autonomous regions, and municipalities directly under the central government.
　　Article 55: For suspected adverse reactions to vaccination, disease prevention and control agencies shall report in a timely manner according to regulations, organize investigations and diagnoses, and inform the vaccine recipient or their guardian of the investigation and diagnosis conclusions. If there is a dispute over the investigation and diagnosis conclusions, an appraisal can be applied for according to the appraisal methods formulated by the health administration department of the State Council.
　　For suspected adverse reactions to vaccination that result in the death or severe disability of the vaccine recipient, or group suspected adverse reactions to vaccination that have a significant social impact, the health administration department and drug supervision department of the people's government at or above the municipal level shall organize investigations and handle them according to their respective responsibilities.
　　Article 56: The state implements a compensation system for adverse reactions to vaccination. If damage such as death, severe disability, or organ and tissue injury occurs during or after vaccination and is classified as an adverse reaction to vaccination or cannot be ruled out, compensation shall be provided. The scope of compensation is managed by a catalog and dynamically adjusted according to actual conditions.
　　Compensation costs required for vaccination with immunization program vaccines shall be arranged by the financial departments of the people's governments of provinces, autonomous regions, and municipalities directly under the central government within the vaccination funding; compensation costs for vaccination with non-immunization program vaccines shall be borne by the relevant vaccine marketing authorization holders. The state encourages compensation for vaccine recipients with adverse reactions through various forms such as commercial insurance.
　　Compensation for adverse reactions to vaccination shall be timely, convenient, and reasonable. The scope, standards, and procedures for compensation for adverse reactions to vaccination shall be stipulated by the State Council, and specific implementation measures shall be formulated by provinces, autonomous regions, and municipalities directly under the central government.
　　
　 　Chapter 7 Post-Marketing Management of Vaccines
　　Article 57: Vaccine marketing authorization holders shall establish and improve the vaccine quality management system throughout the entire life cycle, formulate and implement post-marketing risk management plans, conduct post-marketing studies, and further confirm the safety, efficacy, and quality controllability of vaccines.
　　For vaccines that require further research upon approval of vaccine registration applications, vaccine marketing authorization holders shall complete the research within the prescribed time limit; if the research is not completed on time or the benefit cannot be proven to outweigh the risk, the drug supervision department of the State Council shall handle it according to law, up to and including revoking the drug registration certificate of the vaccine.
　　Article 58: Vaccine marketing authorization holders shall conduct quality tracking and analysis of vaccines, continuously improve quality control standards, improve production processes, and enhance the stability of production processes.
　　If there are changes in production processes, production sites, key equipment, etc., evaluation and verification shall be conducted, and filing or reporting shall be made according to the relevant change management regulations of the drug supervision department of the State Council; if the changes may affect the safety, efficacy, and quality controllability of the vaccine, approval from the drug supervision department of the State Council shall be obtained.
　　Article 59: Vaccine marketing authorization holders shall continuously update the instructions and labels based on post-marketing studies and adverse reactions to vaccination, and apply for approval or filing according to regulations.
　　The drug supervision department of the State Council shall promptly publish the updated vaccine instructions and label content on its website.
　　Article 60: Vaccine marketing authorization holders shall establish a vaccine quality review and risk reporting system and truthfully report vaccine production, circulation, post-marketing studies, risk management, and other situations to the drug supervision department of the State Council annually according to regulations.
　　Article 61: The drug supervision department of the State Council may, based on actual conditions, order vaccine marketing authorization holders to conduct post-marketing evaluations or directly organize post-marketing evaluations.
　　For vaccines that cause severe adverse reactions to vaccination or otherwise harm human health, the drug supervision department of the State Council shall revoke the drug registration certificate of the vaccine.
　　Article 62: The drug supervision department of the State Council may, based on disease prevention and control needs and vaccine industry development, organize post-marketing evaluations of vaccine varieties. If the product design, production process, safety, efficacy, or quality controllability of a vaccine variety is significantly inferior to other vaccine varieties used for the prevention and control of the same disease, the drug registration certificates of all vaccines of that variety shall be revoked and the corresponding national drug standards abolished.
　　
　　 Chapter 8 Safeguard Measures
　　Article 63: People's governments at or above the county level shall include the funding needed for vaccine safety work, purchase of immunization program vaccines, vaccination work, and information construction in their budgets to ensure the implementation of the immunization program system.
　　County-level people's governments shall provide subsidies to village doctors and other grassroots medical and health personnel engaged in vaccination work in accordance with relevant national regulations.
　　The state provides support for vaccination work in economically underdeveloped areas as needed. People's governments of provinces, autonomous regions, municipalities directly under the central government, and municipal governments at the district level shall provide necessary financial subsidies to county-level people's governments in economically underdeveloped areas for vaccination-related work.
　　Article 64: People's governments of provinces, autonomous regions, and municipalities directly under the central government shall determine vaccination-related projects within their administrative regions based on the epidemic trends of infectious diseases and within the scope of infectious disease prevention and control projects determined by the health administration department of the State Council, and ensure the implementation of these projects.
　　Article 65: The health administration department of the State Council shall provide vaccine marketing authorization holders with national immunization program vaccine demand information based on the usage plans of provinces, autonomous regions, and municipalities directly under the central government, and vaccine marketing authorization holders shall reasonably arrange production according to vaccine demand information.
　　When there is a risk of vaccine supply shortage, the health administration department and drug supervision department of the State Council shall propose suggestions, and the industrial and information technology department and financial department of the State Council shall take effective measures to ensure vaccine production and supply.
　　Vaccine marketing authorization holders shall organize production according to law to ensure vaccine supply; if vaccine production is stopped, they shall promptly report to the drug supervision department of the State Council or the drug supervision department of the people's government of the province, autonomous region, or municipality directly under the central government.
　　Article 66: The state includes vaccines in strategic material reserves, implementing a two-level reserve system at the central and provincial levels.
　　The industrial and information technology department and financial department of the State Council, together with the health administration department, public security department, market supervision department, and drug supervision department of the State Council, shall strengthen the production capacity and product management of reserved vaccines according to the needs of disease prevention, control, and public health emergency preparedness, and establish a dynamic adjustment mechanism.
　　Article 67: Funds arranged by all levels of finance for vaccination shall be used exclusively for that purpose; no unit or individual shall misappropriate or occupy these funds.
　　Relevant units and individuals using vaccination funds shall accept audit supervision by audit authorities according to law.
　　Article 68: The state implements a compulsory vaccine liability insurance system.
　　Vaccine marketing authorization holders shall insure compulsory vaccine liability insurance according to regulations. If damage to vaccine recipients is caused by vaccine quality issues, the insurance company shall compensate within the insured liability limits.
　　The specific implementation measures of the compulsory vaccine liability insurance system shall be formulated by the drug supervision department of the State Council in conjunction with the health administration department of the State Council, insurance regulatory agencies, and others.
　　Article 69: During outbreaks or epidemics of infectious diseases, the holders of vaccine marketing authorizations shall promptly produce and supply vaccines for the prevention and control of infectious diseases. Transportation units shall prioritize the transport of vaccines for the prevention and control of infectious diseases. People's governments at or above the county level and their relevant departments shall organize, coordinate, and ensure support.
　　
　 　Chapter 9 Supervision and Administration
　　Article 70: The drug regulatory department and the health administration department shall supervise and manage the entire process of vaccine research, production, circulation, and immunization according to their respective responsibilities, overseeing that vaccine marketing authorization holders, disease prevention and control institutions, vaccination units, and others fulfill their legal obligations.
　　The drug regulatory department shall lawfully supervise and inspect the quality of vaccines during research, production, storage, transportation, and immunization. The health administration department shall lawfully supervise and inspect the implementation of the immunization program and vaccination activities.
　　The drug regulatory department shall strengthen on-site inspections of vaccine marketing authorization holders; if necessary, it may extend inspections to units and individuals providing products or services for vaccine research, production, circulation, and other activities; relevant units and individuals shall cooperate and must not refuse or conceal information.
　　Article 71: The state shall establish professional and specialized teams of drug inspectors at the central and provincial levels to strengthen supervision and inspection of vaccines.
　　The drug regulatory departments of the people's governments of provinces, autonomous regions, and municipalities directly under the central government shall assign inspectors to reside within vaccine marketing authorization holders. Inspectors are responsible for supervising and inspecting compliance with drug production quality management standards, collecting clues about vaccine quality risks and violations, reporting to the drug regulatory departments of the provincial, autonomous region, or municipal governments, and making recommendations, being accountable for their conduct during their assignment.
　　Article 72: If there are safety hazards in vaccine quality and vaccine marketing authorization holders fail to take timely measures to eliminate them, the drug regulatory department may take measures such as responsibility interviews and deadlines for rectification.
　　For serious violations of drug-related quality management standards, the drug regulatory department shall order the suspension of vaccine production, sales, and distribution, and require immediate rectification; production, sales, and distribution may only resume after the drug regulatory department inspects and confirms compliance.
　　The drug regulatory department shall establish a credit record system for vaccine marketing authorization holders and their related personnel, incorporate it into the national credit information sharing platform, publicly disclose serious dishonesty information according to regulations, and implement joint disciplinary actions.
　　Article 73: If vaccines have or are suspected to have quality problems, vaccine marketing authorization holders, disease prevention and control institutions, and vaccination units shall immediately stop sales, distribution, and use, and if necessary, immediately stop production, reporting to the drug regulatory and health administration departments of the people's government at or above the county level as prescribed. The health administration department shall immediately organize disease prevention and control institutions and vaccination units to take necessary emergency response measures and report to the higher-level health administration department. The drug regulatory department shall lawfully take measures such as sealing and seizure. For vaccines already sold, the vaccine marketing authorization holder shall promptly notify relevant disease prevention and control institutions, vaccine distribution units, and vaccination units, recall according to regulations, truthfully record recall and notification situations, and disease prevention and control institutions, vaccine distribution units, and vaccination units shall cooperate.
　　If production, sales, distribution, use, or recall of vaccines is not stopped in accordance with the preceding paragraph, the drug regulatory and health administration departments of the people's government at or above the county level shall order the cessation of production, sales, distribution, use, or recall of vaccines according to their respective responsibilities.
　　Vaccine marketing authorization holders, disease prevention and control institutions, and vaccination units discovering vaccines with or suspected to have quality problems shall not conceal, falsely report, delay report, or omit reports, nor hide, forge, or destroy relevant evidence.
　　Article 74: Vaccine marketing authorization holders shall establish an information disclosure system and timely disclose vaccine product information, instructions and labels, compliance with drug-related quality management standards, batch release status, recall status, inspection and penalty situations, and compulsory vaccine liability insurance information on their websites as prescribed.
　　Article 75: The State Council's drug regulatory department, together with the State Council's health administration department and others, shall establish information sharing mechanisms for vaccine quality, immunization, and other related information.
Drug regulatory departments, health administration departments, and others of people's governments at or above the provincial level shall organize vaccine marketing authorization holders, disease prevention and control institutions, vaccination units, news media, research institutions, and others to communicate and exchange information on vaccine quality and immunization based on principles of scientific, objective, timely, and open disclosure.
　　Article 76: The state implements a unified vaccine safety information disclosure system.
　　Vaccine safety risk warning information, major vaccine safety incidents and their investigation and handling information, and other vaccine safety information designated by the State Council for unified disclosure shall be published by the State Council's drug regulatory department in conjunction with relevant departments. Nationwide reports on abnormal immunization reactions shall be uniformly published by the State Council's health administration department together with the drug regulatory department. Unauthorized release of the above information is prohibited. Disclosure of major vaccine safety information shall be timely, accurate, comprehensive, scientifically evaluated as prescribed, and necessary explanations provided.
　　If the drug regulatory department of the people's government at or above the county level discovers vaccine safety information that may mislead the public and social opinion, it shall immediately verify and analyze it together with the health administration department, other relevant departments, professional institutions, and related vaccine marketing authorization holders, and promptly publish the results.
　　No unit or individual shall fabricate or spread false vaccine safety information.
　　Article 77: Any unit or individual has the right to lawfully access vaccine information and to provide opinions and suggestions on vaccine supervision and management work.
　　Any unit or individual has the right to report vaccine violations to the health administration department, drug regulatory department, and other departments, and to report to the people's government at the same or higher level and its relevant departments or supervisory organs if these departments and their staff fail to perform supervision and management duties according to law. Relevant departments and organs shall promptly verify and handle reports; verified reports shall reward the informants as prescribed; informants reporting serious violations by their units shall receive substantial rewards if verified.
　　Article 78: People's governments at or above the county level shall formulate emergency response plans for vaccine safety incidents, stipulating classification, organizational command systems and responsibilities for handling, prevention and early warning mechanisms, handling procedures, and emergency support measures.
　　Vaccine marketing authorization holders shall formulate vaccine safety incident handling plans, regularly inspect the implementation of preventive measures, and promptly eliminate safety hazards.
　　In the event of a vaccine safety incident, vaccine marketing authorization holders shall immediately report to the State Council's drug regulatory department or the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the central government; disease prevention and control institutions, vaccination units, and medical institutions shall immediately report to the health administration and drug regulatory departments of the people's government at or above the county level. The drug regulatory department shall, together with the health administration department, establish a vaccine safety incident handling command organization according to the emergency plan, carry out medical treatment, risk control, investigation and handling, information release, explanation, and other work, and properly handle follow-up measures such as revaccination. The cost of revaccination caused by quality problems shall be borne by the vaccine marketing authorization holder.
　　Relevant units and individuals shall not conceal, falsely report, delay report, or omit reports of vaccine safety incidents, nor hide, forge, or destroy relevant evidence.
　　
　　 Chapter 10 Legal Liability
　　Article 79: Those who violate the provisions of this law and constitute a crime shall be held criminally liable with heavier penalties according to law.
　　Article 80: Vaccines produced or sold that are counterfeit drugs shall have their illegal gains and the illegally produced and sold vaccines, as well as raw materials, excipients, packaging materials, equipment, and other items specifically used for illegal vaccine production confiscated by the drug supervision and administration department of the people's government at or above the provincial level. They shall be ordered to suspend production and business for rectification, have their drug registration certificates revoked, up to the revocation of drug production licenses, and be fined between fifteen and fifty times the value of the illegally produced and sold vaccines. If the value is less than 500,000 yuan, it shall be calculated as 500,000 yuan.
　　Vaccines produced or sold that are inferior drugs shall have their illegal gains and the illegally produced and sold vaccines, as well as raw materials, excipients, packaging materials, equipment, and other items specifically used for illegal vaccine production confiscated by the drug supervision and administration department of the people's government at or above the provincial level. They shall be ordered to suspend production and business for rectification and be fined between ten and thirty times the value of the illegally produced and sold vaccines. If the value is less than 500,000 yuan, it shall be calculated as 500,000 yuan; in serious cases, the drug registration certificate shall be revoked, up to the revocation of the drug production license.
　　If vaccines produced or sold are counterfeit drugs, or if vaccines produced or sold are inferior drugs with serious circumstances, the drug supervision and administration department of the people's government at or above the provincial level shall confiscate the income obtained by the legal representative, main responsible persons, directly responsible supervisors, key personnel, and other responsible persons during the illegal acts from their unit, impose a fine of one to ten times the income obtained, impose a lifetime ban on engaging in drug production and business activities, and the public security organs shall detain them for not less than five days and not more than fifteen days.
　　Article 81: In any of the following circumstances, the drug supervision and administration department of the people's government at or above the provincial level shall confiscate illegal gains and the illegally produced and sold vaccines, as well as raw materials, excipients, packaging materials, equipment, and other items specifically used for illegal vaccine production, order suspension of production and business for rectification, and impose a fine of fifteen to fifty times the value of the illegally produced and sold vaccines. If the value is less than 500,000 yuan, it shall be calculated as 500,000 yuan; in serious cases, revoke the relevant drug approval documents, up to the revocation of the drug production license. For the legal representative, main responsible persons, directly responsible supervisors, key personnel, and other responsible persons, confiscate the income obtained during the illegal acts from their unit, impose a fine of fifty percent to ten times the income obtained, and prohibit engaging in drug production and business activities for ten years up to a lifetime. The public security organs shall detain them for not less than five days and not more than fifteen days:
　　(1) Providing false data, materials, samples, or other deceptive acts in applying for vaccine clinical trials, registration, or batch release;
　　(2) Fabricating production or inspection records or altering product batch numbers;
　　(3) Units or individuals other than disease prevention and control institutions supplying vaccines to vaccination units;
　　(4) Entrusting vaccine production without approval;
　　(5) Changes in production processes, production sites, key equipment, etc., that should be approved according to regulations but are not approved;
　　(6) Updating vaccine instructions or labels that should be approved according to regulations but are not approved.
　　Article 82: Except as otherwise provided in this law, if the vaccine marketing authorization holder or other units violate the relevant drug quality management standards, the drug supervision and administration department of the people's government at or above the county level shall order correction and issue a warning; if correction is refused, a fine of 200,000 to 500,000 yuan shall be imposed; in serious cases, a fine of 500,000 to 3,000,000 yuan shall be imposed, production and business shall be ordered to suspend for rectification, up to revocation of relevant drug approval documents and drug production licenses. For the legal representative, main responsible persons, directly responsible supervisors, key personnel, and other responsible persons, confiscate the income obtained during the illegal acts from their unit, impose a fine of fifty percent to five times the income obtained, and prohibit engaging in drug production and business activities for ten years up to a lifetime.
　　Article 83: Those who violate the provisions of this law and the vaccine marketing authorization holder has any of the following circumstances shall be ordered to correct and warned by the drug supervision and administration department of the people's government at or above the provincial level; if correction is refused, a fine of 200,000 to 500,000 yuan shall be imposed; in serious cases, production and business shall be ordered to suspend for rectification and a fine of 500,000 to 2,000,000 yuan shall be imposed:
　　(1) Failure to establish a vaccine electronic traceability system as required;
　　(2) The legal representative, main responsible persons, production management responsible persons, quality management responsible persons, quality authorized persons, and other key personnel do not meet the required conditions or have not been trained and assessed as required;
　　(3) Failure to report or file as required;
　　(4) Failure to conduct post-marketing studies as required, or failure to establish institutions and allocate personnel to actively collect, track, and analyze suspected adverse reactions to vaccination as required;
　　(5) Failure to purchase mandatory vaccine liability insurance as required;
　　(6) Failure to establish an information disclosure system as required.
　　Article 84: If the batch release agency violates the provisions of this law and has any of the following circumstances, the State Council drug supervision and administration department shall order correction and issue a warning, and give warnings up to demotion to the main responsible persons, directly responsible supervisors, and other directly responsible personnel according to law:
　　(1) Failure to conduct review and inspection as required;
　　(2) Failure to promptly publish batch release results of marketed vaccines;
　　(3) Failure to verify as required;
　　(4) Failure to report major quality risks of vaccines as required.
　　If the batch release agency violates the provisions of this law by failing to issue batch release certificates or batch release notices as required, the State Council drug supervision and administration department shall order correction and issue a warning, and demote or dismiss the main responsible persons, directly responsible supervisors, and other directly responsible personnel according to law; in serious cases, dismiss them according to law.
　　Article 85: Disease prevention and control institutions, vaccination units, vaccine marketing authorization holders, and vaccine distribution units that violate vaccine storage and transportation management regulations related to cold chain storage and transportation requirements shall be ordered to correct and warned by the drug supervision and administration department of the people's government at or above the county level; vaccines stored or transported illegally shall be destroyed and illegal gains confiscated; if correction is refused, vaccination units, vaccine marketing authorization holders, and vaccine distribution units shall be fined between 200,000 and 1,000,000 yuan; in serious cases, a fine of ten to thirty times the value of illegally stored or transported vaccines shall be imposed, with a minimum value of 100,000 yuan calculated if the value is less than that. Vaccine marketing authorization holders and vaccine distribution units shall be ordered to suspend production and business for rectification, up to revocation of relevant drug approval documents and drug production licenses. The legal representatives, main responsible persons, directly responsible supervisors, key personnel, and other responsible persons of vaccine marketing authorization holders and vaccine distribution units shall be punished in accordance with Article 82 of this law.
　　If disease prevention and control institutions or vaccination units commit violations as stipulated in the preceding paragraph, the health administrative department of the people's government at or above the county level shall, according to law, issue warnings or even dismiss the main responsible persons, directly responsible supervisors, and other directly responsible personnel, and order the responsible medical and health personnel to suspend their practice activities for not less than one year and not more than eighteen months; if serious consequences are caused, the main responsible persons, directly responsible supervisors, and other directly responsible personnel shall be dismissed according to law, and the vaccination qualification of the vaccination unit may be revoked, and the practicing certificates of the responsible medical and health personnel shall be revoked by the original issuing department.
　　Article 86: If disease prevention and control institutions, vaccination units, vaccine marketing authorization holders, or vaccine distribution units violate vaccine storage and transportation management regulations other than those stipulated in Article 85 of this law, the drug supervision and administration department of the people's government at or above the county level shall order corrections, issue warnings, and confiscate illegal gains; if corrections are refused, a fine of not less than 100,000 yuan and not more than 300,000 yuan shall be imposed on the vaccination units, vaccine marketing authorization holders, and vaccine distribution units; if the circumstances are serious, a fine of three to ten times the value of the illegally stored or transported vaccines shall be imposed, and if the value is less than 100,000 yuan, it shall be calculated as 100,000 yuan.
　　If disease prevention and control institutions or vaccination units commit violations as stipulated in the preceding paragraph, the health administrative department of the people's government at or above the county level may, according to law, issue warnings or even dismiss the main responsible persons, directly responsible supervisors, and other directly responsible personnel, and order the responsible medical and health personnel to suspend their practice activities for not less than six months and not more than one year; if serious consequences are caused, the main responsible persons, directly responsible supervisors, and other directly responsible personnel shall be dismissed according to law, and the practicing certificates of the responsible medical and health personnel shall be revoked by the original issuing department.
　　Article 87: If disease prevention and control institutions or vaccination units violate the provisions of this law and have any of the following circumstances, the health administrative department of the people's government at or above the county level shall order corrections, issue warnings, and confiscate illegal gains; if the circumstances are serious, warnings or even dismissal shall be given to the main responsible persons, directly responsible supervisors, and other directly responsible personnel according to law, and the responsible medical and health personnel shall be ordered to suspend their practice activities for not less than one year and not more than eighteen months; if serious consequences are caused, the main responsible persons, directly responsible supervisors, and other directly responsible personnel shall be dismissed according to law, and the practicing certificates of the responsible medical and health personnel shall be revoked by the original issuing department:
　　(1) Failure to supply, receive, or purchase vaccines according to regulations;
　　(2) Failure to comply with vaccination work standards, immunization procedures, vaccine use guidelines, or vaccination plans when administering vaccines;
　　(3) Unauthorized mass vaccination.
　　Article 88: If disease prevention and control institutions or vaccination units violate the provisions of this law and have any of the following circumstances, the health administrative department of the people's government at or above the county level shall order corrections and issue warnings; if the circumstances are serious, warnings or even dismissal shall be given to the main responsible persons, directly responsible supervisors, and other directly responsible personnel according to law, and the responsible medical and health personnel shall be ordered to suspend their practice activities for not less than six months and not more than one year; if serious consequences are caused, the main responsible persons, directly responsible supervisors, and other directly responsible personnel shall be dismissed according to law, and the practicing certificates of the responsible medical and health personnel shall be revoked by the original issuing department:
　　(1) Failure to provide traceability information as required;
　　(2) Failure to request and keep relevant certification documents and temperature monitoring records when receiving or purchasing vaccines as required;
　　(3) Failure to establish and keep records of vaccine receipt, purchase, storage, distribution, supply, vaccination, and disposal as required;
　　(4) Failure to inform or inquire about relevant situations from vaccine recipients or their guardians as required.
　　Article 89: If disease prevention and control institutions, vaccination units, or medical institutions fail to report suspected adverse vaccination reactions, vaccine safety incidents, etc., as required, or fail to organize investigations and diagnoses of suspected adverse vaccination reactions as required, the health administrative department of the people's government at or above the county level shall order corrections and issue warnings; if the circumstances are serious, a fine of not less than 50,000 yuan and not more than 500,000 yuan shall be imposed on vaccination units and medical institutions, and warnings or even dismissal shall be given to the main responsible persons, directly responsible supervisors, and other directly responsible personnel of disease prevention and control institutions, vaccination units, and medical institutions according to law; if serious consequences are caused, the main responsible persons, directly responsible supervisors, and other directly responsible personnel shall be dismissed according to law, and the practicing certificates of the responsible medical and health personnel shall be revoked by the original issuing department.
　　Article 90: If disease prevention and control institutions or vaccination units collect fees in violation of the provisions of this law, the health administrative department of the people's government at or above the county level shall supervise the refund of the illegally collected fees to the original paying units or individuals, and the market supervision department of the people's government at or above the county level shall impose penalties according to law.
　　Article 91: If, in violation of the provisions of this law, vaccination work for immunization program vaccines is carried out without designation by the health administrative department of the local people's government at or above the county level, or vaccination work for non-immunization program vaccines is carried out without meeting conditions or without filing, the health administrative department of the people's government at or above the county level shall order corrections, issue warnings, confiscate illegal gains and illegally held vaccines, order suspension for rectification, and impose a fine of not less than 100,000 yuan and not more than 1,000,000 yuan, and impose penalties on the main responsible persons, directly responsible supervisors, and other directly responsible personnel according to law.
　　If units or individuals other than disease prevention and control institutions or vaccination units conduct unauthorized mass vaccination in violation of the provisions of this law, the health administrative department of the people's government at or above the county level shall order corrections, confiscate illegal gains and illegally held vaccines, and impose a fine of ten to thirty times the value of the illegally held vaccines; if the value is less than 50,000 yuan, it shall be calculated as 50,000 yuan.
　　Article 92: If guardians fail to ensure that age-appropriate children receive immunization program vaccines on time according to law, the health administrative department of the people's government at the county level shall criticize and educate them and order corrections.
　　If childcare institutions or schools fail to check vaccination certificates according to regulations when children enter care or school, or fail to report children who have not been vaccinated according to regulations to vaccination units, the education administrative department of the local people's government at or above the county level shall order corrections, issue warnings, and impose penalties on the main responsible persons, directly responsible supervisors, and other directly responsible personnel according to law.
　　Article 93: Fabricating or spreading false vaccine safety information, or causing trouble at vaccination units constituting a violation of public security management, shall be punished by the public security organs according to law.
　　Media such as newspapers, periodicals, radio, television, and internet websites that fabricate or spread false vaccine safety information shall be punished by relevant departments according to law, and penalties shall be imposed on the main responsible persons, directly responsible supervisors, and other directly responsible personnel according to law.
　　Article 94: If the local people's government at or above the county level has any of the following circumstances in vaccine supervision and management work, the directly responsible supervisors and other directly responsible personnel shall be demoted or dismissed according to law; if the circumstances are serious, they shall be dismissed according to law; if serious consequences are caused, the main responsible person shall resign to take responsibility:
　　(1) Failure to perform duties effectively, causing serious adverse effects or major losses;
　　(2) Concealing, falsifying, delaying, or omitting reports of vaccine safety incidents;
　　(3) Interfering with or obstructing investigations of vaccine violations or vaccine safety incidents;
　　(4) A particularly serious vaccine safety incident occurs in this administrative region, or multiple serious vaccine safety incidents occur consecutively.
　　Article 95: If the drug supervision and management department, health and wellness authorities, or other departments have any of the following situations in vaccine supervision and management work, the directly responsible supervisors and other directly responsible personnel shall be demoted or dismissed according to law; if the circumstances are serious, they shall be expelled according to law; if serious consequences are caused, the main responsible person shall resign in shame:
　　(1) Failure to perform supervision and inspection duties, or failure to promptly investigate and handle discovered illegal acts;
　　(2) Unauthorized mass vaccination;
　　(3) Concealing, falsely reporting, delaying reporting, or omitting reports of vaccine safety incidents;
　　(4) Interfering with or obstructing investigations into vaccine violations or vaccine safety incidents;
　　(5) Leaking whistleblower information;
　　(6) Receiving reports related to suspected abnormal vaccination reactions but failing to organize investigations and handling according to regulations;
　　(7) Other behaviors of failing to perform vaccine supervision and management duties, causing serious adverse effects or major losses.
　　Article 96: If damage to vaccine recipients is caused by vaccine quality issues, the vaccine marketing authorization holder shall bear compensation liability according to law.
　　Disease prevention and control agencies and vaccination units that cause damage to vaccine recipients due to violations of vaccination work standards, immunization procedures, vaccine use guidelines, or vaccination plans shall bear compensation liability according to law.
　　
　　 Chapter 11 Supplementary Provisions
　　Article 97: The meanings of the following terms under this law are:
　　Immunization program vaccines refer to vaccines that residents should receive according to government regulations, including vaccines determined by the national immunization program, vaccines added by provincial, autonomous region, or municipality governments when implementing the national immunization program, and vaccines used for emergency vaccination or mass vaccination organized by county-level or higher governments or their health and wellness authorities.
　　Non-immunization program vaccines refer to other vaccines voluntarily received by residents.
　　Vaccine marketing authorization holder refers to enterprises that have legally obtained vaccine drug registration certificates and drug production licenses.
　　Article 98: The state encourages vaccine manufacturers to produce and export vaccines according to international procurement requirements.
　　Exported vaccines shall meet the standards or contractual requirements of the importing country (region).
　　Article 99: The procurement of vaccines required for entry and exit vaccination shall be separately stipulated by the national border health quarantine authority in consultation with the State Council's financial department.
　　Article 100: This law shall come into effect on December 1, 2019. 月1日起施行。