Vaccine Administration Law of the People's Republic of China

Published:

2021-11-26


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)
catalogue
Chapter I General Provisions
Chapter II Vaccine Development and Registration
Chapter III Vaccine Production and Batch Issuance
Chapter IV Vaccine Circulation
Chapter V Vaccination
Chapter VI Monitoring and Handling of Abnormal Reactions
Chapter VII Post marketing Management of Vaccines
Chapter VIII Safeguard Measures
Chapter IX Supervision and Administration
Chapter X Legal Liabilities
Chapter XI Supplementary Provisions


  
Chapter I General Provisions
Article 1 This Law is formulated with a view to strengthening the administration of vaccines, ensuring the quality and supply of vaccines, standardizing preventive inoculation, promoting the development of the vaccine industry, safeguarding public health and safeguarding public health safety.
Article 2 This Law shall apply to the development, production, distribution, vaccination and its supervision and administration within the territory of the People's Republic of China. 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 to those not provided for in this Law.
The term "vaccine" as used in this Law refers to preventive biological products used for human immunization to prevent and control the occurrence and prevalence of diseases, including immunization planned vaccines and non immunization planned vaccines.
Article 3 The State implements the strictest management system for vaccines, and adheres to safety first, risk management, whole process control, scientific supervision and social co governance.
Article 4 The State adheres to the strategic and public welfare nature of vaccine products.
The state supports basic research and applied research on vaccines, promotes vaccine development and innovation, and incorporates vaccine development, production and storage 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 constantly improves the vaccine production process and quality.
Article 5 The holder of the vaccine marketing license shall strengthen the quality management of the whole life cycle of the vaccine and be responsible for the safety, effectiveness and quality controllability of the vaccine.
Units and individuals engaged in vaccine development, production, distribution and vaccination activities shall abide by laws, regulations, rules, standards and norms, ensure the authenticity, accuracy, integrity and traceability of information throughout the process, assume responsibilities according to law and accept social supervision.
Article 6 The State implements an immunization planning system.
Residents living in China shall, according to law, enjoy the right to vaccinate against planned vaccines and fulfill their obligations to vaccinate against planned 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 school-age children are vaccinated against the planned vaccines. The guardian shall, in accordance with law, ensure that school-age children are vaccinated on time according to the immunization plan.
Article 7 People's governments at or above the county level shall incorporate the work of vaccine safety and vaccination into their national economic and social development plans, strengthen the capacity building of vaccine supervision and administration, and establish and improve the working mechanism of vaccine supervision and administration.
The 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 uniformly lead, organize and coordinate the supervision and administration of vaccines in their respective administrative regions.
Article 8 The drug regulatory department under the State Council shall be responsible for the supervision and administration of vaccines throughout the country. The competent department of health under the State Council shall be responsible for the supervision and administration of vaccination throughout the country. Other relevant departments under the State Council shall be responsible for the supervision and administration related to vaccines within their respective functions and responsibilities.
The drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for the supervision and administration of vaccines in their respective administrative regions. The departments responsible for drug supervision and administration under the people's governments of cities divided into districts and counties (hereinafter referred to as drug supervision and administration departments) are responsible for the supervision and administration of vaccines in their respective administrative regions. The competent health departments of the 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 the local people's governments at or above the county level shall be responsible for the supervision and administration of vaccines within their respective functions and responsibilities.
Article 9 The State Council and the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall establish a departmental coordination mechanism to coordinate the work related to vaccine supervision and administration, regularly analyze the vaccine safety situation, strengthen vaccine supervision and administration, and ensure vaccine supply.
Article 10 The State shall implement an electronic traceability system for the whole process of vaccines.
The drug regulatory department under the State Council, together with the competent health department under the State Council, shall formulate unified vaccine traceability standards and specifications, establish a national vaccine electronic traceability collaboration platform, integrate the traceability information of the whole process of vaccine production, circulation and vaccination, and achieve vaccine traceability.
The holder of the vaccine marketing license shall establish an electronic vaccine traceability system, which shall be connected with the national vaccine electronic traceability collaboration platform to achieve the traceability and verification of the smallest packaging unit vaccine in the whole process of production, circulation and vaccination.
Disease prevention and control institutions and vaccination units shall truthfully record the circulation of vaccines, vaccination and other information according to law, and provide traceability information to the national vaccine electronic traceability collaboration platform according to regulations.
Article 11 In the process of vaccine development, production and inspection, a sound biosafety management system shall be established, biosafety risks shall be strictly controlled, biosafety management of pathogenic microorganisms such as bacteria and virus strains shall be strengthened, the health of operators and the public shall be protected, and the legitimate and legitimate use of pathogenic microorganisms such as bacteria and virus strains shall be ensured.
The history, biological characteristics and generations of bacteria, viruses and cell strains used in vaccine development, production and inspection shall be clarified, and detailed files shall be established to ensure that the sources are legal, clear and traceable; If the source is unknown, it shall not be used.
Article 12 People's governments at all levels and their relevant departments, disease prevention and control institutions, vaccination units, vaccine marketing license holders, vaccine industry associations, etc. shall regularly carry out publicity, education and popularization of vaccine safety laws, regulations and vaccination knowledge through activities such as the National Children's Vaccination Day.
The news media should carry out public publicity of vaccine safety laws, regulations and vaccination knowledge, and supervise illegal vaccine acts by public opinion. The publicity and report on vaccines should be comprehensive, scientific, objective and fair.
Article 13 The vaccine industry association shall strengthen industry self-discipline, establish and improve industry norms, promote the construction of industry integrity system, guide and urge members to carry out production and operation activities according to law.

Chapter II Vaccine Development and Registration
Article 14 The State shall, in accordance with the epidemic situation of the disease, the immune status of the population and other factors, formulate relevant research and development plans, arrange necessary funds, and support the research and development of new vaccines such as multi vaccine and multi vaccine.
The State organizes the holders of vaccine marketing licenses, scientific research institutions and medical and health institutions to jointly tackle key problems and develop vaccines urgently needed for disease prevention and control.
Article 15 The State encourages holders of vaccine marketing licenses to increase investment in research and innovation, optimize production processes, improve quality control, and promote vaccine technology progress.
Article 16 The clinical trial of vaccines shall be approved by the drug regulatory department under the State Council according to law.
The clinical trial of vaccine shall be conducted or organized by a tertiary medical institution or a disease prevention and control institution at or above the provincial level that meets the requirements specified by the drug regulatory department under the State Council and the competent health department under the State Council.
The State encourages qualified medical institutions and disease prevention and control institutions to carry out clinical trials of vaccines according to law.
Article 17 A sponsor of a vaccine clinical trial shall formulate a clinical trial plan, establish a safety monitoring and evaluation system for clinical trials, carefully select subjects, reasonably set up groups and age groups of subjects, and take effective measures according to the degree of risk to protect the legitimate rights and interests of subjects.
Article 18 The clinical trial of vaccine shall be carried out with the written informed consent of the subject; If the subject is a person without civil capacity, he/she shall obtain the written informed consent of his/her guardian; If the subject is a person with limited civil capacity, he or she shall obtain the written informed consent of himself or her guardian.
Article 19 Vaccines listed in China shall be approved by the drug regulatory department under the State Council and obtain a drug registration certificate; To apply for vaccine registration, true, sufficient and reliable data, materials and samples shall be provided.
The drug regulatory department under the State Council shall give priority to the review and approval of urgently needed vaccines and innovative vaccines for disease prevention and control.
Article 20 Where the benefits of vaccines urgently needed in response to major public health emergencies or other vaccines recognized as urgently needed by the competent health department under the State Council outweigh the risks after assessment, the drug regulatory department under the State Council may approve the application for vaccine registration with conditions attached.
In the event of a particularly serious public health emergency or any other emergency that seriously threatens public health, the competent health department under the State Council shall, according to the need for the prevention and control of infectious diseases, put forward a proposal for the emergency use of vaccines, which may be used within a certain range and period of time after the approval of the drug regulatory department under the State Council.
Article 21 When approving the application for vaccine registration, the drug regulatory department under the State Council shall approve the production process, quality control standards, instructions and labels of the vaccine.
The drug regulatory department under the State Council shall publish the vaccine instructions and labels on its website in a timely manner.
  
Chapter III Vaccine Production and Batch Issuance
Article 22 The State implements a strict access system for vaccine production.
Any vaccine production activity shall be approved by the drug regulatory department of the people's government at or above the provincial level and a drug production license shall be obtained.
To engage in vaccine production, in addition to meeting the requirements for engaging in drug production as stipulated in the Drug Administration Law of the People's Republic of China, the following conditions shall also be met:
(1) Have moderate scale and sufficient capacity reserves;
(2) Have systems, facilities and equipment to ensure biological safety;
(3) Meet the needs of disease prevention and control.
The holder of the vaccine marketing license shall have the vaccine production capacity; If it is really necessary to entrust production beyond the vaccine production capacity, it shall be approved by the drug regulatory department under the State Council. Those who accept commissioned production shall abide by the provisions of this Law and the relevant provisions of the State to ensure the quality of the vaccine.
Article 23 The legal representative and main person in charge of the holder of the vaccine marketing license shall have a good credit record, and the person in charge of production management, the person in charge of quality management, the quality authorized person and other key positions shall have relevant professional background and experience.
The holder of the vaccine marketing license shall strengthen the training and assessment of the personnel specified in the preceding paragraph, and timely report the 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 in accordance with the approved production process and quality control standards, and the whole production process shall meet the requirements of the quality control standards for drug production.
The holder of the vaccine marketing license shall review and inspect the whole process of vaccine production and vaccine quality according to the regulations.
Article 25 The holder of the vaccine marketing license shall establish a complete production quality management system, continuously strengthen the deviation management, and truthfully record all data formed in the production and inspection process by means of information technology to ensure that the entire production process continues to meet legal requirements.
Article 26 The State practices a vaccine batch issuance system.
Before each batch of vaccine is sold or imported, it shall be reviewed and inspected by the batch issuing agency designated by the drug regulatory department under the State Council according to the relevant technical requirements. If the requirements are met, a certificate of approval shall be issued; If the requirements are not met, a notice of disapproval shall be issued.
Vaccines that are not approved and issued shall not be sold, and shall be destroyed under the supervision of the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government; Imported vaccines that are not approved for issuance shall be destroyed under the supervision of the drug regulatory department in the place where the port is located or otherwise disposed of according to law.
The pharmaceutical supervisory and administrative department under the State Council and the approval and issuance institution shall publish the approval and issuance results of the marketed vaccines in a timely manner for public inquiry.
Article 27 When applying for the issuance of vaccine batches, the applicant shall provide batch production and inspection record abstract and other materials as well as samples of products of the same batch number to the batch issuing institution in accordance with regulations. The certificate of origin and the certificate of batch issuance shall also be provided for imported vaccines; In case of exemption from approval and issuance at the place of origin, the certificate of exemption from approval and issuance shall be provided.
Article 28 Vaccines needed urgently to prevent and control the epidemic situation of infectious diseases or respond to emergencies shall be exempted from approval and issuance upon approval by the drug regulatory department under the State Council.
Article 29 The information review and sampling inspection shall be carried out batch by batch for the issuance of vaccine batches. The inspection items and frequency of vaccine batch issuance shall be dynamically adjusted according to the vaccine quality risk assessment.
If there is any doubt about the authenticity of the application materials or samples for vaccine batch issuance, or there are other circumstances that need to be further verified, the batch issuing authority shall verify them, and if necessary, organize on-site verification by means of on-site sampling inspection.
Article 30 If the batch issuing institutions find that there are major quality risks in vaccines during the batch issuing process, they shall report to the drug regulatory department under the State Council and the drug regulatory department under the people's government of the province, autonomous region or municipality directly under the Central Government in a timely manner.
The department receiving the report shall immediately conduct an on-site inspection of the holder of the vaccine marketing license, notify the approval issuing institution according to the inspection results not to approve or suspend the approval issuance of the relevant products or all products of the holder of the vaccine marketing license, and order the holder of the vaccine marketing license to rectify. The holder of the vaccine marketing license shall rectify immediately and report the rectification to the department that ordered it to rectify in a timely manner.
Article 31 The holder of the vaccine marketing license shall truthfully record the production process deviation, quality difference, faults and accidents in the production process and the measures taken, and shall specify them in the documents for the issuance of the corresponding batch of products; If the quality of the vaccine may be affected, the holder of the vaccine marketing license 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 IV Vaccine CirculationArticle 32 The competent health department under the State Council, together with the financial department under the State Council, shall organize centralized bidding or unified negotiation for vaccines under the national immunization plan, form and publish bid winning prices or transaction prices, and all provinces, autonomous regions and municipalities directly under the Central Government shall implement unified procurement.
All provinces, autonomous regions, and municipalities directly under the Central Government shall organize the procurement of immunization planning vaccines and non immunization planning vaccines other than the national immunization planning vaccines through the provincial public resource trading platform.
Article 33 The price of vaccines shall be independently and reasonably determined by the holder of the vaccine marketing license according to law. The price level, price difference rate and profit margin of vaccines should be kept at a reasonable range.
Article 34 Disease prevention and control institutions at the provincial level shall, in accordance with the national immunization plan and the needs of disease prevention and control in their respective administrative regions, formulate plans for the use of vaccines in their own administrative regions, report to the departments that organize the purchase of vaccines in accordance with the relevant provisions of the State, and report to the competent health departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government for the record.
Article 35 The holder of the vaccine marketing license shall supply vaccines to the disease prevention and control institutions according to the purchase 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 receive such vaccines.
Article 36 The holder of the vaccine marketing license shall distribute the vaccine to the disease prevention and control institution or the vaccination unit designated by the disease prevention and control institution according to the purchase contract.
Vaccine marketing license holders and disease prevention and control institutions shall have the conditions for cold chain storage and transportation of vaccines when distributing vaccines by themselves, or entrust qualified vaccine distribution units to distribute vaccines.
Disease prevention and control institutions may charge storage and transportation fees for the distribution of non immunization planned vaccines. The specific measures shall be formulated by the financial department of the State Council in conjunction with the pricing department of the State Council, and the charging standards shall be formulated by the pricing 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 license holders and vaccine distribution units shall abide by the vaccine storage and transportation management standards to ensure the vaccine quality.
Vaccines should be stored and transported in a specified temperature environment. The cold chain storage and transportation should meet the requirements, and the temperature should be monitored and recorded regularly.
The drug regulatory department under the State Council and the competent health department under the State Council shall jointly formulate the rules for the administration of vaccine storage and transportation.
Article 38 When selling vaccines, vaccine marketing license holders shall provide copies or electronic documents of the approval certificate affixed with their seals; Where imported vaccines are sold, a copy or electronic document of the customs clearance form for imported drugs affixed with its seal shall also be provided.
When receiving or purchasing vaccines, disease prevention and control institutions and vaccination units shall ask for the certification documents specified in the preceding paragraph and keep them for at least five years for future reference after the expiration of the validity period of vaccines.
Article 39 The holder of the vaccine marketing license shall establish a true, accurate and complete sales record in accordance with the provisions and keep it for at least five years for future reference after the expiration of the vaccine validity period.
Disease prevention and control institutions, vaccination units and vaccine distribution units shall establish true, accurate and complete records of receipt, purchase, storage, distribution and supply according to regulations, and keep them for at least five years for future reference after the expiration of the vaccine validity period.
When disease prevention and control institutions and vaccination units receive or purchase vaccines, they should request the temperature monitoring records of the whole process of transportation and storage, and keep them for at least five years for future reference after the expiration of the vaccine validity period; Those who cannot provide the temperature monitoring records of the whole process of transportation and storage or whose temperature control does not meet the requirements shall not be accepted or purchased, and shall immediately report to the drug regulatory department and the competent health department of the local people's government at or above the county level.
Article 40 Disease prevention and control institutions and vaccination units shall establish a regular inspection system for vaccines. Vaccines with problems such as unidentifiable packaging, unqualified storage temperature, and expired vaccines shall be stored in isolation, set up warning signs, and disposed of in accordance with the provisions of the drug regulatory department, the competent health department, and the competent ecological environment department under the State Council. Disease prevention and control institutions and vaccination units shall truthfully record the disposal, and the disposal records shall be kept for at least five years for future reference after the expiration of the vaccine validity period.

Chapter V Vaccination
Article 41 The competent department of health under the State Council shall formulate the national immunization plan; The types of vaccines in the national immunization plan shall be formulated by the competent health department under the State Council in conjunction with the financial department under the State Council, and published after being submitted to the State Council for approval.
The competent health department under the State Council shall establish the National Immunization Program Expert Advisory Committee, and jointly with the financial department under the State Council, establish a dynamic adjustment mechanism for the vaccine categories of the National Immunization Program.
The people's governments of provinces, autonomous regions and municipalities directly under the Central Government may, when implementing the national immunization plan, increase the types of vaccines in the immunization plan according to the needs of disease prevention and control in their respective administrative regions, and report to the competent health department under the State Council for the record and publication.
Article 42 The competent department of health under the State Council shall formulate and promulgate norms for the work of vaccination and strengthen the standardized administration of vaccination.
The competent health department under the State Council shall formulate and publish the immunization procedures for the national immunization planned vaccines and the guidelines for the use of non immunization planned vaccines.
The competent departments of health under the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall, in light of the actual conditions of their respective administrative regions, formulate vaccination plans and submit them to the competent department of health under the State Council for the record.
Article 43 Disease prevention and control institutions at all levels shall, according to their respective duties, carry out propaganda, training, technical guidance, monitoring, evaluation, epidemiological investigation, emergency response and other work related to vaccination.
Article 44 An inoculation unit shall meet the following requirements:
(1) Obtain the practicing license of the medical institution;
(2) Have doctors, nurses or village doctors who have received professional training in vaccination organized by the competent health department of the people's government at the county level and passed the examination;
(3) It shall have refrigeration facilities, equipment and refrigeration storage system that meet the vaccine storage and transportation management specifications.
The competent health department of the local people's government at or above the county level shall designate qualified medical institutions to undertake the work of immunization planning and vaccination in their responsible areas. Eligible medical institutions may undertake the work of non immunization planned vaccination, and shall report to the competent health department that issued the practice license of their medical institutions for the record.
The vaccination unit shall strengthen its internal management, and carry out vaccination work in accordance with the norms of vaccination work, immunization procedures, guiding principles for vaccine use and vaccination programs.
Disease prevention and control institutions at all levels should strengthen the technical guidance for vaccination work of vaccination units and the management of vaccine use.
Article 45 When carrying out vaccination, medical and health personnel shall inform the recipients or their guardians of the vaccine varieties, functions, taboos, adverse reactions, on-site observation and other precautions, inquire about the health status of the recipients and whether there are vaccination taboos, and keep records of the information and inquiries. The recipient or his guardian shall truthfully provide the recipient's health status and vaccination taboos. If vaccination is forbidden and cannot be carried out, the medical and health personnel shall make medical suggestions to the recipients or their guardians, and truthfully record the medical suggestions.
Before carrying out vaccination, medical and health personnel shall, in accordance with the requirements of the vaccination work specifications, check the health status of the recipients, check the vaccination taboos, check the vaccination certificate, check the appearance, batch number and validity period of vaccines and syringes, check the name and age of the recipients, as well as the name, specification, dose, vaccination site and vaccination route of the vaccines, so as to ensure that the recipients, vaccination certificate and vaccine information are consistent, Inoculation can be carried out only after confirmation.
Medical and health personnel shall vaccinate recipients who meet the vaccination requirements. If the recipient has adverse reactions during on-site observation, the medical and health personnel shall take timely treatment and other measures in accordance with the requirements of the vaccination work specification.
Article 46 Medical and health personnel shall, in accordance with the provisions of the competent health department under the State Council, truthfully, accurately and completely record the vaccination information such as the vaccine variety, the identification information of the holder of the marketing license, the smallest packaging unit, the period of validity, the time of vaccination, the medical and health personnel implementing the vaccination, and the recipients, so as to ensure that the vaccination information is traceable and searchable. Vaccination records shall be kept for at least five years for future reference after the expiration of the vaccine validity period.
Article 47 The State applies a preventive vaccination certificate system to children. Within one month after the birth of a child, the guardian shall apply for a vaccination certificate for the child at the vaccination unit or birth hospital where the child is living. The vaccination unit or the birth hospital shall not refuse to handle it. The guardian shall properly keep the vaccination certificate.
The vaccination shall be administered in the place of residence. When children leave their original place of residence, the vaccination unit responsible for the vaccination work in their current place of residence shall be responsible for the vaccination.
The format of the vaccination certificate shall be prescribed by the competent health department under the State Council.
Article 48 When children enter kindergartens or schools, kindergartens and schools shall check their vaccination certificates. If they find that they have not been vaccinated according to the immunization plan, they shall report to the vaccination unit responsible for the vaccination work in the place where the children live or where the kindergartens and schools are located, and cooperate with the vaccination unit to urge their guardians to reseed according to the regulations. Disease prevention and control institutions shall provide technical guidance for kindergartens and schools to check vaccination certificates.
Measures for the examination of vaccination certificates for children entering kindergartens and schools shall be formulated by the competent health department under the State Council in conjunction with the education administrative department under the State Council.
Article 49 Vaccination units shall not charge any fees for vaccination of planned vaccines.
In addition to the vaccine fee, the vaccination unit may also charge the vaccination service fee for the vaccination of non immunization planned vaccines. The charging standards for vaccination service fees shall be formulated by the competent pricing departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government in conjunction with the financial departments.
Article 50 In order to prevent and control the outbreak and prevalence of infectious diseases, the competent health departments of the local people's governments at or above the county level may, on the basis of the monitoring and early warning information of infectious diseases, report to the people's governments at the corresponding levels for decision and to the competent health departments of the people's governments at or above the provincial level for the record, and carry out mass vaccination in their respective administrative areas.
The need for mass vaccination nationwide or across provinces, autonomous regions or municipalities directly under the Central Government shall be decided by the competent department of health under the State Council.
The local people's government at or above the county level or the competent department of health under the State Council that has made a decision on mass vaccination shall organize the relevant departments to do a good job in personnel training, publicity and education, material allocation, etc.
No unit or individual may carry out mass vaccination without authorization.
Article 51 When an infectious disease breaks out or prevails, the local people's government at or above the county level or its competent health department shall take emergency vaccination measures in accordance with the provisions of laws and administrative regulations.
  
Chapter VI Monitoring and Handling of Abnormal Reactions
Article 52 The term "abnormal reaction of vaccination" refers to the adverse drug reactions of qualified vaccines that cause damage to the tissues and organs and functions of the recipient during or after the implementation of standardized vaccination, and all parties concerned are not at fault.
The following situations do not belong to abnormal reaction of vaccination:
(1) The general reaction after vaccination caused by the characteristics of the vaccine itself;
(2) Damage to recipients due to vaccine quality problems;
(3) Damage to recipients caused by the vaccination unit's violation of the norms of vaccination work, immunization procedures, guiding principles for vaccine use, and vaccination programs;
(4) The recipient is in the incubation period or prodrome of a certain disease at the time of inoculation, and the disease happens by coincidence after inoculation;
(5) The recipient has the vaccination taboo specified in the vaccine specification, the recipient or its guardian fails to truthfully provide the recipient's health status and vaccination taboo before the vaccination, and the recipient's original disease relapses or worsens after the vaccination;
(6) Psychogenic reaction of individuals or groups due to psychological factors.
Article 53 The State shall strengthen the monitoring of abnormal reactions to vaccination. The monitoring plan for abnormal reactions to vaccination shall be formulated by the competent health department under the State Council in conjunction with the drug regulatory department under the State Council.
Article 54 Inoculation units and medical institutions shall report to disease prevention and control institutions in accordance with regulations if they find any abnormal reaction suspected of vaccination.
The holder of the vaccine marketing license shall set up a special organization with full-time personnel, take the initiative to collect, track and analyze the suspected abnormal vaccination reactions, take risk control measures in a timely manner, report the suspected abnormal vaccination reactions to the disease prevention and control institution, and submit the quality analysis report to the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government.
Article 55 With regard to the suspected abnormal reaction of vaccination, the disease prevention and control institution shall report in time according to the provisions, organize investigation and diagnosis, and inform the recipient or his guardian of the conclusion of the investigation and diagnosis. If there is a dispute over the conclusion of the investigation or diagnosis, an application for appraisal may be made in accordance with the appraisal methods formulated by the competent health department under the State Council.
The health department and the drug regulatory department of the people's government at or above the level of a city divided into districts shall, in accordance with their respective duties, organize the investigation and handling of the suspected abnormal vaccination reactions that have a significant impact on the society, such as the death or serious disability of the recipients due to vaccination, or the group suspected abnormal vaccination reactions.
Article 56 The State practices a system of compensation for abnormal reactions to vaccination. If the death, serious disability, organ and tissue damage and other damages of the recipient occur during or after the vaccination, which belong to the abnormal reaction of the vaccination or cannot be eliminated, compensation shall be made. The compensation scope shall be managed by directory and adjusted dynamically according to the actual situation.
The compensation expenses for vaccination of planned vaccines shall be arranged by the financial departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government from the funds for vaccination; The compensation costs for vaccination of non immunization planning vaccines shall be borne by the relevant vaccine marketing license holders. The State encourages people with abnormal reactions to vaccination to be compensated through commercial insurance and other forms.
The compensation for abnormal reaction of vaccination shall be timely, convenient and reasonable. The scope, standards and procedures of compensation for abnormal reactions in 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 VII Post marketing Management of Vaccines
Article 57 The holder of the vaccine marketing license shall establish and improve the quality management system of the whole life cycle of the vaccine, formulate and implement the post marketing risk management plan of the vaccine, carry out post marketing research of the vaccine, and further verify the safety, effectiveness and quality controllability of the vaccine.
For vaccines that require further research when approving the application for vaccine registration, the holder of the vaccine marketing license shall complete the research within the specified time limit; If the research is not completed within the time limit or it can not be proved that the benefits outweigh the risks, the drug regulatory department under the State Council shall deal with it according to law until the drug registration certificate of the vaccine is cancelled.
Article 58 The holder of the vaccine marketing license shall track and analyze the quality of the vaccine, continuously improve the quality control standards, improve the production process and enhance the stability of the production process.
In case of any change in the production process, production site, key equipment, etc., it shall be evaluated and verified, and filed or reported in accordance with the provisions of the drug regulatory department under the State Council on change management; Any change that may affect the safety, effectiveness and quality controllability of the vaccine shall be approved by the drug regulatory department under the State Council.
Article 59 The holder of the vaccine marketing license shall continuously update the instructions and labels according to the post marketing research, abnormal vaccination reactions, etc., and apply for approval or filing in accordance with regulations.
The drug regulatory department under the State Council shall publish the updated vaccine instructions and labels on its website in a timely manner.
Article 60 The holder of the vaccine marketing license shall establish a vaccine quality review and analysis and risk reporting system, and truthfully report the production and circulation of vaccines, post marketing research, risk management and other information to the drug regulatory department under the State Council in accordance with regulations every year.
Article 61 The drug regulatory department under the State Council may, according to the actual situation, order the holder of the vaccine marketing license to carry out the post marketing evaluation or directly organize the post marketing evaluation.
The drug regulatory department under the State Council shall cancel the drug registration certificate of a vaccine that has a serious adverse reaction to vaccination or is harmful to human health for other reasons.
Article 62 The drug regulatory department under the State Council may, according to the needs of disease prevention and control and the development of the vaccine industry, organize post marketing evaluation of vaccine varieties, and find that the product design, production process, safety, effectiveness or quality controllability of the vaccine varieties are obviously inferior to other vaccine varieties for the prevention and control of the same disease, The drug registration certificates of all vaccines of this variety shall be cancelled and the corresponding national drug standards shall be annulled.
  
Chapter VIII Safeguard Measures
Article 63 People's governments at or above the county level shall include the funds needed for vaccine safety, purchase of planned vaccines for immunization, vaccination work and information technology construction into the government budgets at the corresponding levels to ensure the implementation of the immunization planning system.
The people's government at the county level shall, in accordance with the relevant provisions of the State, give subsidies to village doctors and other medical and health personnel at the grass-roots level who are engaged in the work of vaccination.
The State shall, according to needs, support the vaccination work in economically underdeveloped areas. The people's governments of provinces, autonomous regions, and municipalities directly under the Central Government and the people's governments of cities divided into districts shall give necessary financial subsidies to the people's governments at the county level in economically underdeveloped areas for their work related to vaccination.
Article 64 The people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall, in accordance with the epidemic trend of infectious diseases in their respective administrative areas, determine the projects related to vaccination within the scope of the projects for prevention and control of infectious diseases determined by the competent health department under the State Council, and ensure the implementation of the projects.
Article 65 The competent health department under the State Council shall, in accordance with the national immunization planning vaccine use plan of each province, autonomous region, and municipality directly under the Central Government, provide the holder of the vaccine marketing license with the information on the vaccine demand of the national immunization planning, and the holder of the vaccine marketing license shall reasonably arrange the production according to the vaccine demand information.
When there is a risk of shortage of vaccine supply, the competent health department under the State Council and the pharmaceutical supervisory and administrative department under the State Council shall make suggestions, and the competent industry and information technology department under the State Council and the financial department under the State Council shall take effective measures to ensure vaccine production and supply.
The holder of the vaccine marketing license shall organize production according to law to ensure the supply of vaccine; If the holder of the vaccine marketing license stops the production of vaccine, it shall report to the drug regulatory department under the State Council or the drug regulatory department under the people's government of the province, autonomous region or municipality directly under the Central Government in a timely manner.
Article 66 The state shall include vaccines in the strategic material reserve and implement the reserve at the central and provincial levels.
The competent department of industry and information technology under the State Council, the financial department, together with the competent department of health under the State Council, the public security department, the market supervision and administration department and the drug supervision and administration department, shall, in accordance with the needs of disease prevention, control and public health emergency preparedness, strengthen the management of vaccine production and products and establish a dynamic adjustment mechanism.
Article 67 The funds allocated by the governments at all levels for preventive inoculation shall be used exclusively for their own purposes, and no unit or individual may misappropriate or misappropriate them.
The use of funds for vaccination by relevant units and individuals shall be subject to the supervision of audit institutions according to law.
Article 68 The State implements a compulsory insurance system for vaccine liability.
The holder of the vaccine marketing license shall purchase compulsory vaccine liability insurance in accordance with the provisions. If the vaccine quality problem causes damage to the recipient, the insurance company shall make compensation within the insured liability limit.
The specific measures for the implementation of the compulsory vaccine liability insurance system shall be formulated by the drug regulatory department under the State Council in conjunction with the competent health department under the State Council and the insurance regulatory agency.
Article 69 When an infectious disease breaks out and prevails, the holder of the relevant vaccine marketing license shall timely produce and supply vaccines for the prevention and control of infectious diseases. Transportation units shall give priority to the transportation of vaccines for the prevention and control of infectious diseases. The people's governments at or above the county level and their relevant departments shall do a good job of organization, coordination and guarantee.
  
Chapter IX Supervision and Administration
Article 70 Pharmaceutical supervisory and administrative departments and competent health departments shall, in accordance with their respective duties, supervise and administer the whole process of vaccine development, production, distribution and vaccination, and supervise vaccine marketing license holders, disease prevention and control institutions, vaccination units, etc. to perform their obligations according to law.
Pharmaceutical supervisory and administrative departments shall, according to law, supervise and inspect the vaccine quality in the development, production, storage, transportation and vaccination of vaccines. The competent health authorities shall, according to law, supervise and inspect the implementation of the immunization planning system and vaccination activities.
The drug regulatory department shall strengthen the on-site inspection of vaccine marketing license holders; When necessary, extended inspections may be conducted on the units and individuals that provide products or services for vaccine development, production, distribution and other activities; The relevant units and individuals shall cooperate and shall not refuse or conceal.
Article 71 The State shall build a team of professional and specialized drug inspectors at the central and provincial levels, and strengthen the supervision and inspection of vaccines.
The drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government appoints inspectors to be stationed in the holder of the vaccine marketing license. The inspectors are responsible for supervising and inspecting the implementation of the drug production quality management standards, collecting clues about vaccine quality risks and violations of laws and regulations, reporting the situation to the drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government and putting forward suggestions, and being responsible for their behaviors during the period of assignment.
Article 72 Where potential safety hazards exist in vaccine quality management and vaccine marketing license holders fail to take timely measures to eliminate them, the drug regulatory department may take such measures as responsibility interview and rectification within a time limit.
In case of serious violation of drug related quality management standards, the drug regulatory department shall order the suspension of vaccine production, sales and distribution and make immediate rectification; After the rectification is completed, the production, sales and distribution can be resumed only after the drug supervision and administration department checks that the requirements are met.
The drug regulatory department shall establish a credit record system for vaccine marketing license holders and their related personnel, incorporate it into the national credit information sharing platform, publicize their serious dishonesty information in accordance with regulations, and implement joint punishment.
Article 73 Where a vaccine has or is suspected to have quality problems, the holder of the vaccine marketing license, the disease prevention and control institution, and the vaccination unit shall immediately stop the sale, distribution, and use of the vaccine, and, when necessary, immediately stop production, and report to the drug regulatory department and the competent health department of the people's government at or above the county level in accordance with regulations. The competent health department shall immediately organize disease prevention and control institutions and vaccination units to take necessary emergency response measures, and report to the competent health department of the people's government at a higher level. The drug regulatory department shall take measures such as sealing up and detaining according to law. For vaccines that have been sold, the holder of the vaccine marketing license shall timely notify the relevant disease prevention and control institutions, vaccine distribution units and vaccination units, recall according to the regulations, and faithfully record the recall and notification. The disease prevention and control institutions, vaccine distribution units and vaccination units shall cooperate.
If the production, sale, distribution, use or recall of vaccines is not stopped in accordance with the provisions of the preceding paragraph, the drug regulatory department and the competent health department of the people's government at or above the county level shall, in accordance with their respective duties, order the production, sale, distribution, use or recall of vaccines to be stopped.
The holder of the vaccine marketing license, the disease prevention and control institution and the vaccination unit shall not conceal, falsely report, delay or fail to report the vaccine that has or is suspected of having quality problems, and shall not conceal, forge or destroy relevant evidence.
Article 74 The holder of the vaccine marketing license shall establish an information disclosure system, and timely disclose the vaccine product information, instructions and labels, the implementation of drug related quality management standards, the issuance of batches, the recall, the acceptance of inspection and punishment, and the insurance for compulsory vaccine liability insurance on its website in accordance with the provisions.
Article 75 The drug regulatory department under the State Council shall, together with the competent health department under the State Council, establish a mechanism for sharing information on vaccine quality and vaccination.
The drug regulatory departments and health authorities under the people's governments at or above the provincial level shall, in accordance with the principles of science, objectivity, timeliness and openness, organize vaccine marketing license holders, disease prevention and control institutions, vaccination units, news media, scientific research units, etc. to exchange and communicate information on vaccine quality and vaccination.
Article 76 The State implements a unified system for the publication of vaccine safety information.
Vaccine safety risk warning information, major vaccine safety accidents and their investigation and handling information, and other vaccine safety information determined by the State Council to be uniformly published shall be published by the drug regulatory department under the State Council in conjunction with relevant departments. The national report on abnormal reactions to vaccination shall be published by the competent health department under the State Council jointly with the drug regulatory department under the State Council. The above information shall not be released without authorization. The release of major vaccine safety information shall be timely, accurate and comprehensive, and scientific evaluation shall be carried out according to regulations, with necessary explanations.
If the drug regulatory department of the people's government at or above the county level finds vaccine safety information that may mislead the public and public opinion, it shall immediately verify and analyze it with the competent health department and other relevant departments, professional institutions, relevant vaccine marketing license holders, etc., and publish the results in a timely manner.
No unit or individual may fabricate or disseminate false vaccine safety information.
Article 77 Any unit and individual shall have the right to know about vaccine information according to law and put forward opinions and suggestions on vaccine supervision and administration.
Any unit or individual has the right to report vaccine violations to the competent health authorities, drug regulatory authorities and other departments, and to report the failure of the competent health authorities, drug regulatory authorities and other departments and their staff members to perform their duties of supervision and management according to law to the people's government at the same level or at a higher level and its relevant departments and supervisory organs. The relevant departments and organs shall verify and deal with them in a timely manner; The informer shall be rewarded in accordance with the provisions for reports verified to be true; If the informer reports a serious illegal act of his unit and it is verified that it is true, he will be given a heavy reward.
Article 78 The people's government at or above the county level shall formulate an emergency plan for vaccine safety incidents, stipulating the classification of vaccine safety incidents, the organization and command system and responsibilities for disposal, the prevention and early warning mechanism, the disposal procedures, and the emergency safeguard measures.
The holder of the vaccine marketing license shall formulate a plan for dealing with vaccine safety incidents, regularly check the implementation of various preventive measures, and timely eliminate potential safety hazards.
In case of vaccine safety incident, the holder of vaccine marketing license shall immediately report to the drug regulatory department under the State Council or the drug regulatory department under 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 competent health departments and drug regulatory departments of the people's governments at or above the county level. The drug regulatory department shall, together with the competent health department, establish a vaccine safety incident handling command organization in accordance with the provisions of the emergency plan, carry out medical treatment, risk control, investigation and handling, information release, explanation and other work, and do a good job of aftercare work such as replanting. The cost of vaccine safety incidents caused by quality problems shall be borne by the vaccine marketing license holder.
Relevant units and individuals shall not conceal, falsely report, delay or fail to report vaccine safety incidents, and shall not conceal, forge or destroy relevant evidence.
  
Chapter X Legal Liabilities​​​​​​​
Article 79 If a violation of this Law constitutes a crime, criminal responsibility shall be seriously investigated according to law.
Article 80 If the vaccines produced and sold are counterfeit drugs, the drug regulatory department of the people's government at or above the provincial level shall confiscate the illegal income and vaccines illegally produced and sold, as well as the raw materials, auxiliary materials, packaging materials, equipment and other articles specially used for the illegal production of vaccines, order them to stop production and business for rectification, revoke the drug registration certificate, or even revoke the drug production license, and concurrently impose illegal production A fine of more than 15 times but less than 50 times the value of vaccines sold shall be imposed. If the value of vaccines sold is less than 500000 yuan, it shall be calculated as 500000 yuan.
If the vaccines produced and sold are inferior drugs, the drug regulatory department of the people's government at or above the provincial level shall confiscate the illegal income and vaccines illegally produced and sold, as well as the raw materials, auxiliary materials, packaging materials, equipment and other articles specially used for the illegal production of vaccines, order them to stop production and business for rectification, and impose a fine of not less than 10 times but not more than 30 times the value of the vaccines illegally produced and sold. If the value of the vaccines is less than 500000 yuan, Calculated by 500000 yuan; If the circumstances are serious, the drug registration certificate or even the drug production license shall be revoked.
If the vaccines produced and sold are counterfeit drugs or inferior drugs and the circumstances are serious, the drug regulatory department of the people's government at or above the provincial level shall confiscate the legal representative, the principal responsible person, the directly responsible person in charge, the key post personnel and other responsible persons the income they have earned from their own units during the period of the illegal act, and impose a fine of not less than one time but not more than ten times the income they have earned, It is prohibited to engage in drug production and marketing activities for life, and the public security organ shall place a detention of not less than five days but not more than 15 days.
Article 81 Under any of the following circumstances, the pharmaceutical supervisory and administrative department of the people's government at or above the provincial level shall confiscate the illegal income, vaccines illegally produced and sold, and raw materials, auxiliary materials, packaging materials, equipment and other articles specially used for illegal vaccine production, order them to stop production and business for rectification, and impose a fine of not less than 15 times but not more than 50 times the value of vaccines illegally produced and sold, if the value of vaccines is less than 500000 yuan, Calculated by 500000 yuan; If the circumstances are serious, the approval documents related to drugs shall be revoked, even the drug production license shall be revoked. For the legal representative, the principal responsible person, the directly responsible person in charge, the key post personnel and other responsible persons, the income obtained from the unit during the period of the illegal act shall be confiscated, and a fine of not less than 50% but not more than 10 times the income obtained shall be imposed. Drug production and marketing activities shall be prohibited for ten years or even for life, The public security organ shall place a detention of not less than five days but not more than fifteen days:
(1) Providing false data, materials, samples or committing other deceptive acts when applying for clinical trial, registration, batch issuance of vaccines;
(2) Compile production and inspection records or change product batch number;
(3) Units or individuals other than disease prevention and control institutions supply vaccines to vaccination units;
(4) The entrusted production of vaccine is not approved;
(5) Changes in production process, production site and key equipment shall be approved but not approved according to regulations;
(6) The updated vaccine instructions and labels should be approved but not approved according to regulations.
Article 82 Unless otherwise provided for in this Law, the drug regulatory department of the people's government at or above the county level shall order the holder of the vaccine marketing license or any other unit to make corrections and give a warning if it violates the drug related quality control standards; If it refuses to make corrections, it shall be fined not less than 200000 yuan but not more than 500000 yuan; If the circumstances are serious, a fine of not less than 500000 yuan but not more than 3 million yuan shall be imposed, and the company shall be ordered to suspend production and business for rectifications, or even the relevant approval documents for drugs, drug production licenses, etc. shall be revoked. The legal representative, the principal responsible person, the directly responsible person in charge, the key post personnel, and other responsible persons shall be confiscated of the income obtained from the unit during the period when the violation occurred, and a fine of not less than 50% but not more than five times the income obtained shall be imposed, It is prohibited to engage in drug production and marketing activities within ten years or even for life.
Article 83 Where the holder of the vaccine marketing license, in violation of the provisions of this Law, has any of the following circumstances, the drug regulatory department of the people's government at or above the provincial level shall order him to make corrections and give him a warning; If it refuses to make corrections, it shall be fined not less than 200000 yuan but not more than 500000 yuan; If the circumstances are serious, the violator shall be ordered to suspend production and business for rectification, and shall be fined not less than 500000 yuan but not more than 2 million yuan:
(1) Failure to establish an electronic vaccine traceability system as required;
(2) The legal representative, main person in charge, person in charge of production management, person in charge of quality management, quality authorized person and other key personnel do not meet the specified conditions or fail to train and assess them as required;
(3) Failing to report or file as required;
(4) Failing to carry out post marketing research as required, or failing to set up institutions and staff as required to actively collect, track and analyze suspected abnormal vaccination reactions;
(5) Failure to purchase compulsory vaccine liability insurance as required;
(6) Failure to establish information disclosure system as required.
Article 84 In case of any of the following circumstances in violation of the provisions of this law, the drug regulatory department under the State Council shall order the approval and issuance institution to make corrections, give a warning, and give a warning or even a demotion to the main responsible person, the directly responsible person in charge and other directly responsible persons according to law:
(1) Failure to conduct audit and inspection as required;
(2) Failure to timely publish the results of issuing vaccine batches for marketing;
(3) Failure to verify as required;
(4) The vaccine was found to have major quality risks, which were not reported as required.
If, in violation of the provisions of this Law, the approval and issuance institution fails to issue the approval and issuance certificate or does not issue the notice of approval and issuance according to the provisions, the drug regulatory department under the State Council shall order it to make corrections, give a warning, and demote or dismiss the main responsible person, the directly responsible person in charge and other directly responsible persons according to law; If the circumstances are serious, the principal responsible person, the person in charge directly responsible and other persons directly responsible shall be dismissed according to law.
Article 85 If disease prevention and control institutions, vaccination units, vaccine marketing license holders, and vaccine distribution units violate the requirements of the vaccine storage and transportation management specifications for cold chain storage and transportation, the drug regulatory department of the people's government at or above the county level shall order them to make corrections, give them a warning, destroy the vaccines illegally stored and transported, and confiscate their illegal income; If it refuses to make corrections, the vaccination unit, the holder of the vaccine marketing license, and the vaccine distribution unit shall be fined not less than 200000 yuan but not more than 1 million yuan; If the circumstances are serious, the vaccination unit, vaccine marketing license holder and vaccine distribution unit shall be fined 10 to 30 times of the value of vaccines illegally stored and transported. If the value of vaccines is less than 100000 yuan, the vaccine marketing license holder and vaccine distribution unit shall be ordered to suspend production and business for rectification, until the relevant approval documents of drugs and drug production licenses are revoked The legal representative, the principal responsible person, the directly responsible person in charge, the key personnel and other responsible persons of the vaccine distribution unit shall be punished in accordance with the provisions of Article 82 of this Law.
If a disease prevention and control institution or vaccination unit commits any of the illegal acts specified in the preceding paragraph, the competent health department of the people's government at or above the county level shall give a warning or even dismiss the main responsible person, the directly responsible person in charge and other directly responsible persons according to law, and order the responsible medical and health personnel to suspend their professional activities for not less than one year but not more than 18 months; If serious consequences are caused, the main responsible person, the directly responsible person in charge and other directly responsible persons shall be dismissed according to law, and the vaccination qualification of the vaccination unit may be revoked, and the original license issuing department shall revoke the practice certificate of the responsible medical and health personnel.
Article 86 Disease prevention and control institutions, vaccination units, vaccine marketing license holders and vaccine distribution units that violate the regulations on vaccine storage and transportation management other than those specified in Article 85 of this law shall be ordered to correct, given a warning and confiscated of their illegal income by the drug regulatory department of the people's government at or above the county level; In case of refusal to make corrections, the vaccination unit, vaccine marketing license holder and vaccine distribution unit shall be fined not less than 100000 yuan but not more than 300000 yuan; If the circumstances are serious, the vaccination unit, vaccine marketing license holder, and vaccine distribution unit shall be fined not less than three times but not more than ten times the value of illegally stored and transported vaccines. If the value is less than 100000 yuan, it shall be calculated as 100000 yuan.
If a disease prevention and control institution or vaccination unit commits any of the illegal acts specified in the preceding paragraph, the competent health department of the people's government at or above the county level may, according to law, give a warning or even dismiss the main responsible person, the directly responsible person in charge and other directly responsible persons, and order the responsible medical and health personnel to suspend their professional activities for not less than six months but not more than one year; If serious consequences are caused, the main responsible person, the directly responsible person in charge and other directly responsible persons shall be dismissed according to law, and the original license issuing department shall revoke the practice certificates of the responsible medical and health personnel.
Article 87 Where any disease prevention and control institution or vaccination unit, in violation of the provisions of this Law, is under any of the following circumstances, the competent health department of the people's government at or above the county level shall order it to make corrections, give it a warning and confiscate its illegal income; If the circumstances are serious, the main responsible person, the directly responsible person in charge and other directly responsible persons shall be given a warning or even dismissed from their posts according to law, and the responsible medical and health personnel shall be ordered to suspend their professional activities for not less than one year but not more than 18 months; If serious consequences are caused, the main responsible person, the directly responsible person in charge and other directly responsible persons shall be dismissed according to law, and the original license issuing department shall revoke the practicing certificate of the responsible medical and health personnel:
(1) Fail to supply, receive and purchase vaccines as required;
(2) Vaccination did not comply with vaccination work specifications, immunization procedures, vaccine use guidelines, and vaccination programs;
(3) Unauthorized mass vaccination.
Article 88 Where any disease prevention and control institution or vaccination unit, in violation of the provisions of this Law, is under any of the following circumstances, the competent health department of the people's government at or above the county level shall order it to rectify and give it a warning; If the circumstances are serious, the main person in charge, the person in charge directly responsible and other persons directly responsible shall be given a warning or even dismissed according to law, and the medical and health personnel responsible shall be ordered to suspend their professional activities for not less than six months but not more than one year; If serious consequences are caused, the main responsible person, the directly responsible person in charge and other directly responsible persons shall be dismissed according to law, and the original license issuing department shall revoke the practicing certificate of the responsible medical and health personnel:
(1) Failure to provide traceability information as required;
(2) When receiving or purchasing vaccines, relevant certificates and temperature monitoring records were not obtained and kept as required;
(3) Failure to establish and keep records of vaccine receipt, purchase, storage, distribution, supply, vaccination and disposal as required;
(4) Failing to inform or inquire about the breeder or his guardian in accordance with the provisions.
Article 89 Where disease prevention and control institutions, vaccination units and medical institutions fail to report suspected abnormal vaccination reactions and vaccine safety incidents according to regulations, or fail to organize investigation and diagnosis of suspected abnormal vaccination reactions according to regulations, the competent health departments of the people's governments at or above the county level shall order them to make corrections and give them a warning; If the circumstances are serious, the vaccination unit or medical institution shall be fined not less than 50000 yuan but not more than 500000 yuan, and the main person in charge, the directly responsible person in charge and other directly responsible persons of the disease prevention and control institution, the vaccination unit or medical institution shall be given a warning or even dismissed according to law; If serious consequences are caused, the main responsible person, the directly responsible person in charge and other directly responsible persons shall be dismissed according to law, and the original license issuing department shall revoke the practice certificates of the responsible medical and health personnel.
Article 90 Where disease prevention and control institutions or vaccination units collect fees in violation of the provisions of this Law, the competent health departments of the people's governments at or above the county level shall supervise them to return the fees illegally collected to the units or individuals that paid the fees, and the market supervision and administration departments of the people's governments at or above the county level shall punish them according to law.
Article 91 If anyone, in violation of the provisions of this Law, engages in immunization planned vaccination or non immunization planned vaccination without being designated by the competent health department of the local people's government at or above the county level, which does not meet the requirements or fails to put on record, the competent health department of the people's government at or above the county level shall order him to make corrections, give him a warning, confiscate his illegal income and illegally held vaccine, and order him to suspend business for rectification, In addition, a fine of not less than 100000 yuan but not more than one million yuan shall be imposed, and the main person in charge, the person directly in charge and other persons directly responsible shall be punished according to law.
If, in violation of the provisions of this Law, a unit or individual other than a disease prevention and control institution or vaccination unit conducts mass vaccination without authorization, the competent health department of the people's government at or above the county level shall order it to make corrections, confiscate the illegal gains and illegally held vaccines, and impose a fine of not less than 10 times but not more than 30 times the value of the vaccines illegally held. If the value of the vaccines is less than 50000 yuan, it shall be counted as 50000 yuan.
Article 92 If a guardian fails to ensure that school-age children are vaccinated on time according to law, the competent health department of the people's government at the county level shall criticize and educate them and order them to make corrections.
Where a childcare institution or school fails to check the vaccination certificate according to regulations when a child enters kindergarten or enters school, or fails to report to the vaccination unit after finding a child who has not been vaccinated according to regulations, the education administrative department of the local people's government at or above the county level shall order it to make corrections, give it a warning, and punish the main responsible person, the person in charge directly responsible and other persons directly responsible according to law.
Article 93 If anyone fabricates or disseminates false vaccine safety information, or causes trouble in the vaccination unit, which constitutes an act against the administration of public security, the public security organ shall impose a public security administration penalty according to law.
Where newspapers, periodicals, radio, television, Internet websites and other media fabricate and disseminate false vaccine safety information, the relevant departments shall punish them according to law, and the main responsible person, the directly responsible person in charge and other directly responsible persons shall be punished according to law.
Article 94 Where the local people's government at or above the county level is under any of the following circumstances in the work of vaccine supervision and administration, the persons directly in charge and other persons directly responsible 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 take the blame and resign:
(1) Inadequate performance of duties, causing serious adverse effects or heavy losses;
(2) Concealing, misrepresenting, delaying or failing to report vaccine safety incidents;
(3) Interfering with or hindering the investigation of vaccine violations or vaccine safety incidents;
(4) Particularly serious vaccine safety accidents occur in this administrative region, or serious vaccine safety accidents occur continuously.
Article 95 If the pharmaceutical supervisory and administrative department, the competent health department and other departments have any of the following circumstances in the work of vaccine supervision and administration, the directly responsible person in charge and other directly responsible persons 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 take the blame and resign:
(1) Failing to perform the duties of supervision and inspection, or failing to investigate and deal with illegal acts in a timely manner;
(2) Unauthorized mass vaccination;
(3) Concealing, misrepresenting, delaying or failing to report vaccine safety incidents;
(4) Interfering with or hindering the investigation of vaccine violations or vaccine safety incidents;
(5) Disclose the informer's information;
(6) Receive reports on suspected abnormal vaccination reactions, and fail to organize investigation and handling as required;
(7) Other acts that fail to perform the duties of vaccine supervision and management, causing serious adverse effects or heavy losses.
Article 96 Where vaccine quality problems cause damage to the recipients, the holder of the vaccine marketing license shall be liable for compensation according to law.
Disease prevention and control institutions and vaccination units shall be liable for compensation according to law if they violate the norms of vaccination work, immunization procedures, guiding principles for the use of vaccines and vaccination programs and cause damage to recipients.
Chapter XI Supplementary ProvisionsArticle 97 For the purposes of this Law, the following terms mean:
Vaccines planned for immunization refer to the vaccines that residents should vaccinate in accordance with the provisions of the government, including the vaccines determined in the national immunization plan, the vaccines added by the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government when implementing the national immunization plan, and the vaccines used for emergency vaccination or mass vaccination organized by the people's governments at or above the county level or their competent health departments.
Non immunization planned vaccines refer to other vaccines voluntarily vaccinated by residents.
The vaccine marketing license holder refers to the enterprise that has obtained the vaccine drug registration certificate and drug production license according to law.
Article 98 The State encourages vaccine manufacturers to produce and export vaccines in accordance with international procurement requirements.
The exported vaccine shall meet the standards or contract requirements of the importing country (region).
Article 99 The entry-exit vaccination and the procurement of vaccines required shall be separately prescribed by the frontier health and quarantine office in consultation with the financial department of the State Council.
Article 100 This Law shall enter into force as of December 1, 2019.

 

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