(Adopted at the 11th meeting of the 13th the NPC Standing Committee on June 29th, 2019)
Catalogue
Chapter I General Principles
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 Reaction
Chapter VII Post-marketing Management of Vaccines
Chapter VIII Safeguard Measures
Chapter IX Supervision and Administration
Chapter X Legal Liability
Chapter XI Supplementary Provisions
Chapter I General Principles
Article 1 This Law is formulated in order to strengthen vaccine management, ensure vaccine quality and supply, standardize vaccination, promote the development of vaccine industry, safeguard public health and safeguard public health safety.
Article 2 This Law shall apply to the development, production, circulation, vaccination and supervision and management of vaccines in People’s Republic of China (PRC). Where there are no provisions in this Law, the provisions of laws and administrative regulations such as the Drug Administration Law of People’s Republic of China (PRC) and the Law of People’s Republic of China (PRC) on the Prevention and Control of Infectious Diseases shall apply.
The term "vaccine" as mentioned in this Law refers to preventive biological products used for human immunization in order to prevent and control the occurrence and epidemic 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 and applied research on vaccines, promotes vaccine research and innovation, and incorporates vaccine research, production and storage for preventing and controlling 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 the vaccine production technology and quality level.
Article 5 The holder of a vaccine marketing license shall strengthen the quality management of the vaccine throughout its life cycle and be responsible for the safety, effectiveness and quality controllability of the vaccine.
Units and individuals engaged in vaccine development, production, circulation and vaccination activities shall abide by laws, regulations, rules, standards and norms, ensure that the information in the whole process is true, accurate, complete and traceable, assume responsibilities according to law and accept social supervision.
Article 6 The State implements an immunization planning system.
Residents living in China have the right to vaccinate the EPI according to law and fulfill the obligation to vaccinate the EPI. The government provides free immunization program vaccines to residents.
The people’s governments at or above the county level and their relevant departments shall ensure that school-age children are vaccinated with immunization programs. The guardian shall ensure that school-age children are vaccinated with EPI vaccine on time according to law.
Article 7 The people’s governments at or above the county level shall incorporate vaccine safety and vaccination into the national economic and social development plan at the corresponding level, strengthen the capacity building of vaccine supervision and management, and establish and improve the working mechanism of vaccine supervision and management.
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 areas, and uniformly lead, organize and coordinate the supervision and administration of vaccines in their respective administrative areas.
Article 8 The drug supervision and administration department of the State Council is responsible for the supervision and administration of vaccines throughout the country. The competent department of health in the State Council is responsible for the supervision and management of national vaccination. Other relevant departments in the State Council are responsible for the supervision and management related to vaccines within their respective responsibilities.
The pharmaceutical supervisory and administrative departments of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the supervision and administration of vaccines in their respective administrative areas. The departments responsible for drug supervision and administration of the people’s governments at the municipal and county levels with districts (hereinafter referred to as the drug supervision and administration departments) shall be responsible for the supervision and administration of vaccines in their respective administrative areas. The competent health department of the local people’s government at or above the county level shall be responsible for the supervision and administration of vaccination in this administrative region. 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 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 the work related to vaccine supervision and management, regularly analyze the vaccine safety situation, strengthen vaccine supervision and management, and ensure vaccine supply.
Article 10 The State implements the whole-course electronic traceability system for vaccines.
The drug supervision and administration department of the State Council shall, jointly with the health authorities of the State Council, formulate unified standards and norms for vaccine traceability, establish a national collaborative platform for vaccine electronic traceability, and integrate the traceability information of the whole process of vaccine production, circulation and vaccination to realize vaccine traceability.
The holder of the vaccine marketing license shall establish a vaccine electronic traceability system, which is connected with the national vaccine electronic traceability collaborative platform, so as to realize the traceability and verifiability of the vaccine in the smallest packaging unit in the whole process of production, circulation and vaccination.
Disease prevention and control institutions and vaccination units shall truthfully record vaccine circulation and vaccination according to law, and provide traceability information to the national vaccine electronic traceability collaborative platform in accordance with regulations.
Article 11 In the process of vaccine development, production and inspection, we should establish and improve the biosafety management system, strictly control biosafety risks, strengthen biosafety management of pathogenic microorganisms such as bacterial strains, protect the health of operators and the public, and ensure that the use of pathogenic microorganisms such as bacterial strains is legal and legitimate.
The history, biological characteristics and generations of bacterial strains and cell strains used in vaccine development, production and inspection shall be clearly defined, and detailed files shall be established to ensure that the sources are legal, clear and traceable; Where 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 and vaccine industry associations shall regularly carry out publicity, education and popularization of vaccine safety laws, regulations and vaccination knowledge through activities such as National Children’s Vaccination Day.
The news media should carry out public welfare publicity on vaccine safety laws, regulations and vaccination knowledge, and supervise vaccine violations by public opinion. Publicity and reporting on vaccines should be comprehensive, scientific, objective and fair.
Thirteenth vaccine industry associations should strengthen industry self-discipline, establish and improve industry norms, promote the construction of industry credit 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, according to the epidemic situation of diseases, 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 multiple vaccines and multiple vaccines.
The state organizes vaccine marketing license holders, 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 vaccine marketing license holders to increase investment in research and innovation, optimize production technology, improve quality control level and promote vaccine technology progress.
Sixteenth to carry out clinical trials of vaccines shall be approved by the drug supervision and administration department of the State Council according to law.
Clinical trials of vaccines shall be carried out or organized by tertiary medical institutions or disease prevention and control institutions at or above the provincial level that meet the requirements set by the drug supervision and administration department of the State Council and the health authorities of 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 An applicant for a vaccine clinical trial shall formulate a clinical trial plan, establish a clinical trial safety monitoring and evaluation system, carefully select the subjects, reasonably set the subjects’ groups and age groups, and take effective measures according to the degree of risk to protect the legitimate rights and interests of the subjects.
Eighteenth to carry out clinical trials of vaccines, the written informed consent of the subjects shall be obtained; If the subject is a person without civil capacity, he shall obtain the written informed consent of his guardian; If the subject is a person with limited capacity for civil conduct, he shall obtain the written informed consent of himself and his guardian.
Nineteenth vaccines listed in China shall be approved by the drug supervision and administration department of the State Council and obtain the drug registration certificate; To apply for vaccine registration, true, sufficient and reliable data, materials and samples shall be provided.
The State Council pharmaceutical supervisory and administrative department shall give priority to the review and approval of vaccines and innovative vaccines urgently needed for disease prevention and control.
Twentieth to deal with major public health emergencies in urgent need of vaccines or other vaccines identified by the health authorities in the State Council, the benefits outweigh the risks, the drug supervision and administration department of the State Council can conditionally approve the application for vaccine registration.
In case of particularly serious public health emergencies or other emergencies that seriously threaten public health, the health authorities in the State Council put forward suggestions for emergency use of vaccines according to the needs of prevention and control of infectious diseases, which can be used urgently within a certain scope and time limit with the consent of the drug supervision and administration department in the State Council.
Twenty-first the State Council pharmaceutical supervisory and administrative departments shall, when approving the application for vaccine registration, approve the production technology, quality control standards, instructions and labels of the vaccine.
The drug supervision and administration department of the State Council shall timely publish the contents of vaccine instructions and labels on its website.
Chapter III Vaccine Production and Batch Issuance
Article 22 The State implements a strict access system for vaccine production.
To engage in vaccine production activities, it shall be approved by the pharmaceutical supervisory and administrative department of the people’s government at or above the provincial level and obtain a pharmaceutical production license.
To engage in vaccine production activities, in addition to meeting the requirements of drug production activities stipulated in the Drug Administration Law of People’s Republic of China (PRC), the following conditions shall also be met:
(1) Having a moderate scale and sufficient production capacity reserve;
(2) Having systems, facilities and equipment to ensure biological safety;
(3) meeting 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 supervision and administration department of 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 vaccines.
Article 23 The legal representative and principal responsible person of the vaccine marketing license holder shall have a good credit record, and the personnel in key positions such as the person in charge of production management, the person in charge of quality management and the person authorized by quality shall have relevant professional background and working experience.
The holder of the vaccine marketing license shall strengthen the training and assessment of the personnel specified in the preceding paragraph, and report their positions and changes to the pharmaceutical supervisory and administrative departments of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government in a timely manner.
Article 24 Vaccines shall be produced and inspected according to the approved production technology and quality control standards, and the whole production process shall meet the requirements of good manufacturing practice.
The holder of the vaccine marketing license shall, in accordance with the provisions, review and inspect the whole process of vaccine production and vaccine quality.
Article 25 The holder of vaccine marketing license shall establish a complete production quality management system, continuously strengthen deviation management, and truthfully record all data formed in the production and inspection process by means of information technology to ensure that the whole production process continues to meet the statutory requirements.
Article 26 The State implements the system of batch issuance of vaccines.
Before each batch of vaccine is sold or imported, it shall be audited and tested by the batch issuing agency designated by the drug supervision and administration department of the State Council in accordance with the relevant technical requirements. If it meets the requirements, a batch issuance certificate will be issued; Do not meet the requirements, issued a notice of disapproval.
Vaccines that are not issued in batches shall not be sold, and shall be destroyed under the supervision of the pharmaceutical supervisory and administrative departments of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government; The imported vaccines that are not issued in batches shall be destroyed under the supervision of the drug supervision and administration department at the port location or otherwise handled according to law.
The State Council pharmaceutical supervisory and administrative departments and batch issuing institutions shall publish the batch issuing results of listed vaccines in time for public inquiry.
Article 27 To apply for batch issuance of vaccines, the batch issuing institution shall be provided with the batch production and inspection records, abstracts and other materials, and samples of products with the same batch number. Imported vaccines shall also provide certificates of origin and batch issuance; In case of exemption from batch issuance in the country of origin, a certificate of exemption from batch issuance shall be provided.
Twenty-eighth to prevent and control the epidemic situation of infectious diseases or to deal with emergencies, the vaccine is approved by the drug supervision and administration department of the State Council, and is exempted from batch issuance.
Twenty-ninth batches of vaccines should be issued batch by batch for data review and sampling inspection. The inspection items and inspection frequency of vaccine batch issuance shall be dynamically adjusted according to the risk assessment of vaccine quality.
If there are doubts about the authenticity of the application materials or samples for vaccine batch issuance, or there are other situations that need further verification, the batch issuing institution shall verify them, and if necessary, organize on-site verification by means of on-site sampling inspection.
Thirtieth batch issuing institutions found that there are significant quality risks in the process of batch issuance of vaccines, it shall promptly report to the pharmaceutical supervisory and administrative departments of the State Council and the people’s governments of provinces, autonomous regions and municipalities directly under the central government.
The department that receives the report shall immediately conduct on-site inspection on the vaccine marketing license holder, notify the batch issuing institution not to approve or suspend the batch issuance of the relevant products or all products of the vaccine marketing license holder according to the inspection results, and order the vaccine marketing license holder to rectify. The holder of the vaccine marketing license shall immediately rectify and report the rectification to the department that ordered it to rectify in time.
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 specify them in the documents issued by the corresponding batch of products; If the quality of the vaccine may be affected, the holder of the vaccine marketing license shall take immediate measures and report to the pharmaceutical supervisory and administrative departments of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government.
Chapter IV Vaccine Circulation
Article 32 The national immunization program vaccine shall be subject to centralized bidding or unified negotiation by the competent health department of the State Council in conjunction with the financial department of the State Council, and the winning bid price or transaction price shall be formed and announced, and all provinces, autonomous regions and municipalities directly under the Central Government shall implement unified procurement.
Other EPI vaccines and non-EPI vaccines other than the national EPI vaccines are purchased by provinces, autonomous regions and municipalities directly under the Central Government through provincial public resource trading platforms.
Article 33 The price of vaccine shall be set by the holder of vaccine marketing license independently and reasonably according to law. The price level, price difference rate and profit rate of vaccines should be kept within a reasonable range.
Article 34 Provincial institutions for disease prevention and control shall, according to the national immunization program and the needs of disease prevention and control in their respective administrative areas, formulate plans for vaccine use in immunization programs in their respective administrative areas, and report to the departments that organize vaccine procurement in accordance with the relevant provisions of the state, and at the same time report to the health authorities of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government for the record.
Thirty-fifth vaccine marketing license holders should supply vaccines to disease prevention and control institutions in accordance with the procurement contract.
Disease prevention and control institutions shall supply vaccines to vaccination units in accordance with regulations.
Units and individuals other than disease prevention and control institutions shall not supply vaccines to vaccination units, and vaccination units shall not receive the vaccines.
Article 36 The holder of the vaccine marketing license shall distribute the vaccine to the disease prevention and control institution or the inoculation unit designated by the disease prevention and control institution in accordance with 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, and may also entrust qualified vaccine distribution units to distribute vaccines.
Disease prevention and control institutions can 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 competent price department of the State Council, and the charging standards shall be formulated by the competent price department of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government in conjunction with the financial department.
Thirty-seventh disease prevention and control institutions, vaccination units, vaccine marketing license holders and vaccine distribution units shall abide by the management norms of vaccine storage and transportation to ensure the quality of vaccines.
Vaccines should be in the specified temperature environment during the whole process of storage and transportation, and the cold chain storage and transportation should meet the requirements, and the temperature should be monitored and recorded regularly.
The management standards for vaccine storage and transportation are jointly formulated by the drug supervision and administration department of the State Council and the health department of the State Council.
Article 38 When selling vaccines, the holder of the vaccine marketing license shall provide a copy of the batch issuance certificate or an electronic document stamped with his seal; Sales of imported vaccines, should also provide a copy of the customs clearance form for imported drugs or electronic documents stamped with its seal.
Disease prevention and control institutions and vaccination units shall, when receiving or purchasing vaccines, obtain the supporting documents specified in the preceding paragraph and keep them for future reference for not less than five years after the expiration of the vaccine.
Article 39 The holder of the vaccine marketing license shall, in accordance with the regulations, establish a true, accurate and complete sales record and keep it for future reference for not less than five years after the expiration of the vaccine.
Disease prevention and control institutions, vaccination units and vaccine distribution units shall, in accordance with regulations, establish true, accurate and complete records of receipt, purchase, storage, distribution and supply, and keep them for future reference for not less than five years after the expiration of the vaccine.
When the disease prevention and control institutions and inoculation units receive or purchase vaccines, they shall obtain the temperature monitoring records of the whole process of transportation and storage, and keep them for future reference for not less than five years after the expiration of the vaccine; If the temperature monitoring records of the whole transportation and storage process cannot be provided or the temperature control does not meet the requirements, it shall not be accepted or purchased, and it shall immediately report to the pharmaceutical supervisory and administrative department and the health department of the local people’s government at or above the county level.
Article 40 Disease prevention and control institutions and inoculation entities shall establish a system of regular inspection of vaccines, and take measures such as isolated storage and setting warning signs for vaccines with unrecognizable packaging, unqualified storage temperature, and expiration date, and dispose of them in accordance with the provisions of the State Council drug supervision and administration department, health department and ecological environment department. Disease prevention and control institutions and vaccination units shall truthfully record the disposal situation, and the disposal records shall be kept for future reference for not less than five years after the expiration of the vaccine.
Chapter V Vaccination
Forty-first the State Council health authorities to develop a national immunization program; The types of vaccines under the National Immunization Program shall be drawn up by the competent health department of the State Council in conjunction with the financial department of the State Council, and published after being approved by the State Council.
The competent department of health in the State Council established the national immunization program expert advisory committee, and established the dynamic adjustment mechanism of vaccine types in the national immunization program together with the financial department of the State Council.
The people’s governments of provinces, autonomous regions and municipalities directly under the Central Government may, when implementing the national immunization program, increase the types of vaccines for immunization programs according to the needs of disease prevention and control in their respective administrative areas, and report them to the health authorities in the State Council for the record and publication.
Forty-second the State Council health authorities should formulate and publish vaccination work norms, and strengthen the standardized management of vaccination.
The competent department of health in the State Council shall formulate and publish the immunization procedures of the national immunization program vaccine and the guiding principles for the use of the non-immunization program vaccine.
The competent health authorities of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government shall formulate vaccination plans in light of the actual conditions of their respective administrative regions and report them to the competent health authorities of the State Council for the record.
Forty-third disease prevention and control institutions at all levels shall, according to their respective responsibilities, carry out publicity, training, technical guidance, monitoring, evaluation, epidemiological investigation and emergency response related to vaccination.
Article 44 An inoculation entity shall meet the following conditions:
(1) Obtaining the practice license of a medical institution;
(2) Having doctors, nurses or rural doctors who have received professional vaccination training organized by the health authorities of the people’s government at the county level and passed the examination;
(3) Having cold storage facilities, equipment and a cold storage system that meet the management standards for vaccine storage and transportation.
The competent health department of the local people’s government at or above the county level shall designate qualified medical institutions to undertake the immunization program vaccination work in the responsible area. Eligible medical institutions can undertake non-immunization vaccination work, and shall report to the competent health department that issued the practice license of their medical institutions for the record.
Vaccination units should strengthen internal management, and carry out vaccination work should abide by vaccination work norms, immunization procedures, vaccine use guidelines and vaccination programs.
Disease prevention and control institutions at all levels shall strengthen the technical guidance on 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 varieties, functions, contraindications, adverse reactions, on-site observation and other matters needing attention, inquire about the health status of the recipients and whether there are any contraindications to vaccination, and record the information truthfully. The recipient or his guardian shall truthfully provide the health status and vaccination contraindications of the recipient. If vaccination is forbidden, medical and health personnel shall give medical advice to the recipient or his guardian, and truthfully record the medical advice.
Before vaccination, medical and health personnel should check the health status of the recipients, check the vaccination contraindications, check the vaccination certificate, check the appearance, batch number and expiration date of the vaccine and syringe, check the name and age of the recipients and the name, specification, dosage, vaccination site and vaccination route of the vaccine, and ensure that the recipients, vaccination certificate and vaccine information are consistent before vaccination can be implemented.
Medical and health personnel shall vaccinate the recipients who meet the vaccination conditions. In case of adverse reactions of the seed recipients during the on-site observation, medical and health personnel shall take timely treatment and other measures in accordance with the requirements of vaccination work norms.
Article 46 Medical and health personnel shall truthfully, accurately and completely record the vaccination information such as the vaccine variety, the identification information of the marketing license holder, the smallest packaging unit, the expiration date, the vaccination time, the medical and health personnel who carried out the vaccination, the recipients, etc. in accordance with the regulations of the health authorities in the State Council, so as to ensure that the vaccination information can be traced and inquired. Vaccination records shall be kept for no less than five years after the expiration of the vaccine.
Article 47 The state practices a vaccination certificate system for children. Within one month after a child is born, his guardian shall apply for a vaccination certificate at the vaccination unit or the birth hospital where the child lives. The vaccination unit or the hospital of birth shall not refuse to handle it. The guardian shall properly keep the vaccination certificate.
Vaccination shall be administered by the place of residence. During the period when children leave their original place of residence, the vaccination unit undertaking vaccination at the current place of residence shall be responsible for vaccination.
The format of vaccination certificate shall be stipulated by the competent health department of the State Council.
Article 48 When children enter kindergartens and schools, nursery institutions and schools should check their vaccination certificates. If they find that they have not been vaccinated in accordance with the regulations, they should report to the vaccination unit where the children live or where the nursery institutions and schools are located, and cooperate with the vaccination unit to urge their guardians to replant in accordance with the regulations. Disease prevention and control institutions shall provide technical guidance for kindergartens and schools to check vaccination certificates.
Measures for the inspection of children’s nursery and school vaccination certificates shall be formulated by the competent department of health of the State Council in conjunction with the administrative department of education of the State Council.
Forty-ninth vaccination units shall not charge any fees for vaccination.
Inoculation units can charge vaccination service fees in addition to vaccine fees for non-immunization programs. The charging standards for vaccination service fees shall be formulated by the competent price 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 The competent health department of the local people’s government at or above the county level may, according to the information of infectious disease monitoring and early warning, report to the people’s government at the corresponding level for decision and report to the competent health department of the people’s government at or above the provincial level for the record, and carry out mass vaccination in the administrative area.
If it is necessary to carry out mass vaccination nationwide or across provinces, autonomous regions and municipalities directly under the Central Government, it shall be decided by the health authorities in the State Council.
The local people’s government at or above the county level or the competent department of health in the State Council, which has made the decision on mass vaccination, shall organize the relevant departments to do a good job in personnel training, publicity and education, and material mobilization.
No unit or individual may carry out mass vaccination without authorization.
Article 51 If the local people’s governments at or above the county level or their health authorities need to take emergency vaccination measures during the outbreak and epidemic of infectious diseases, it shall be implemented in accordance with the provisions of laws and administrative regulations.
Chapter VI Monitoring and Handling of Abnormal Reaction
Article 52 The term "abnormal reaction to vaccination" refers to the adverse drug reaction that a qualified vaccine causes damage to the tissues, 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 the abnormal reaction of vaccination:
(a) the general reaction after vaccination caused by the characteristics of the vaccine itself;
(2) Damage caused to the recipients due to vaccine quality problems;
(three) the damage caused to the recipients by the vaccination unit’s violation of the vaccination work norms, immunization procedures, guiding principles for vaccine use, and vaccination programs;
(four) the recipient is in the incubation period or precursor period of a disease at the time of inoculation, and the disease is coupled after inoculation;
(5) The recipient has vaccination contraindications specified in the vaccine instructions, and the recipient or his guardian failed to truthfully provide the health status and vaccination contraindications of the recipient before vaccination, and the original disease of the recipient has an acute recurrence or aggravation after vaccination;
(6) Psychogenic reactions 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 reaction of vaccination shall be formulated by the competent health department of the State Council in conjunction with the drug supervision and administration department of the State Council.
Fifty-fourth vaccination units, medical institutions and other suspected abnormal reactions to vaccination shall report to the disease prevention and control institutions in accordance with regulations.
The holder of the vaccine marketing license shall set up a special institution with full-time staff to actively collect, track and analyze the suspected abnormal vaccination reactions, take timely risk control measures, report the suspected abnormal vaccination reactions to the disease prevention and control institutions, and submit the quality analysis report to the pharmaceutical supervisory and administrative departments of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government.
Article 55 In case of suspected abnormal reaction to vaccination, the disease prevention and control institutions shall report it in time according to the regulations, organize investigation and diagnosis, and inform the recipients or their guardians of the conclusions of the investigation and diagnosis. If the conclusion of the investigation and diagnosis is controversial, you can apply for appraisal according to the appraisal method formulated by the competent department of health in the State Council.
Due to vaccination, the recipient dies, is severely disabled, or has a significant impact on the society, such as group suspected vaccination abnormal reaction. The competent health department and drug supervision and administration department of the people’s government at or above the municipal level with districts shall, according to their respective functions and duties, organize investigation and handling.
Article 56 The state practices a compensation system for abnormal reactions to vaccination. In the process of vaccination or after vaccination, the recipient’s death, serious disability, organ and tissue damage and other damages are abnormal reactions to vaccination or cannot be ruled out, and compensation should be given. The scope of compensation shall be managed by catalogue and dynamically adjusted according to the actual situation.
The compensation expenses required for immunization planning vaccine shall be arranged by the financial departments of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government in the vaccination funds; The compensation expenses required for vaccination of non-EPI vaccines shall be borne by the holders of relevant vaccine marketing licenses. The state encourages people who have received abnormal vaccination to be compensated through commercial insurance and other forms.
Compensation for abnormal reaction of vaccination should be timely, convenient and reasonable. The scope, standards and procedures of compensation for abnormal reaction of vaccination shall be stipulated by the State Council, and the provinces, autonomous regions and municipalities directly under the Central Government shall formulate specific implementation measures.
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, conduct post-marketing research of the vaccine, and further confirm the safety, effectiveness and quality controllability of the vaccine.
For vaccines that require further research when approving the application for vaccine registration, the vaccine marketing license holder shall complete the research within the prescribed time limit; If the research is not completed within the time limit or it cannot be proved that the benefits outweigh the risks, the drug supervision and administration department of the State Council shall handle it according to law until the drug registration certificate of the vaccine is cancelled.
Fifty-eighth vaccine marketing license holders should carry out quality tracking analysis of vaccines, continuously improve quality control standards, improve production processes, and improve the stability of production processes.
If the production process, production site and key equipment are changed, it shall be evaluated and verified, and filed or reported in accordance with the provisions of the drug supervision and administration department of the State Council on change management; Changes that may affect the safety, effectiveness and quality controllability of vaccines shall be approved by the drug supervision and administration department of the State Council.
Article 59 The holder of a vaccine marketing license shall continuously update the instructions and labels according to the post-marketing research and abnormal reaction of vaccination, and apply for approval or filing in accordance with regulations.
The State Council drug supervision and administration department shall publish the updated vaccine instructions and labels on its website in time.
Article 60 The holder of a vaccine marketing license shall establish a system of retrospective analysis and risk reporting of vaccine quality, and truthfully report the production and circulation of vaccine, post-marketing research and risk management to the drug supervision and administration department of the State Council every year according to regulations.
Article 61 The drug supervision and administration department of the State Council may, according to the actual situation, order the holder of vaccine marketing license to carry out post-marketing evaluation or directly organize post-marketing evaluation.
The drug supervision and administration department of the State Council shall cancel the drug registration certificate of the vaccine that has a serious abnormal reaction to vaccination or is harmful to human health for other reasons.
Article 62 The pharmaceutical supervisory and administrative department of the State Council may, according to the needs of disease prevention and control and the development of vaccine industry, organize post-marketing evaluation of vaccine varieties. If it is found that the product design, production process, safety, effectiveness or quality controllability of this vaccine variety are obviously inferior to other vaccine varieties for preventing and controlling the same disease, it shall cancel the drug registration certificates of all vaccines of this variety and abolish the corresponding national drug standards.
Chapter VIII Safeguard Measures
Sixty-third people’s governments at or above the county level shall include the funds needed for vaccine safety, purchase of planned vaccines for immunization, vaccination and information construction in the government budget at the corresponding level 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, grant subsidies to rural doctors and other primary medical and health personnel engaged in vaccination work.
The state supports vaccination work in economically underdeveloped areas according to needs. The people’s governments of provinces, autonomous regions and municipalities directly under the Central Government and the people’s governments at the municipal level divided into districts shall give necessary financial subsidies to the people’s governments at the county level in economically underdeveloped areas to carry out the work related to vaccination.
Article 64 The people’s governments of provinces, autonomous regions and municipalities directly under the Central Government shall, according to the epidemic trend of infectious diseases in their respective administrative areas, determine the projects related to vaccination within the scope of infectious disease prevention and control projects determined by the health authorities in the State Council, and ensure the implementation of the projects.
Article 65 The competent health authorities of the State Council shall provide the vaccine marketing license holders with information on the vaccine demand of the national immunization program according to the vaccine use plans of the national immunization programs of all provinces, autonomous regions and municipalities directly under the Central Government, and the vaccine marketing license holders shall make reasonable arrangements for production according to the vaccine demand information.
When there is a risk of vaccine supply shortage, the health authorities in the State Council and the drug supervision and administration departments in the State Council put forward suggestions, and the departments in charge of industry and information technology in the State Council and the finance department in the State Council should take effective measures to ensure vaccine production and supply.
The holder of vaccine marketing license shall organize production according to law to ensure vaccine supply; If the holder of the vaccine marketing license stops vaccine production, it shall report to the drug supervision and administration department of the State Council or the drug supervision and administration department of the people’s government of a province, autonomous region or municipality directly under the Central Government in time.
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 in the State Council and the financial department shall, jointly with the health authorities, public security departments, market supervision and management departments and drug supervision and management departments in the State Council, strengthen the production capacity and product management of vaccine reserves and establish a dynamic adjustment mechanism according to the needs of disease prevention, control and public health emergency preparedness.
Sixty-seventh financial arrangements at all levels for vaccination funds should be earmarked, and no unit or individual may misappropriate or occupy them.
The relevant units and individuals shall accept the audit supervision of audit institutions in accordance with the law when using the funds for vaccination.
Article 68 The State implements a compulsory vaccine liability insurance system.
The holder of the vaccine marketing license shall take out compulsory vaccine liability insurance in accordance with the regulations. If the vaccine quality problem causes damage to the recipient, the insurance company shall pay 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 supervision and administration department of the State Council in conjunction with the health authorities of the State Council and the insurance supervision and administration institutions.
Article 69 When an infectious disease breaks out and is prevalent, the holder of the relevant vaccine marketing license shall timely produce and supply vaccines for preventing and controlling infectious diseases. Transportation units should 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 in organization, coordination and guarantee.
Chapter IX Supervision and Administration
Article 70 The drug supervision and administration department and the competent health department shall, according to their respective functions and duties, supervise and manage the whole process of vaccine development, production, circulation and vaccination, and supervise the holders of vaccine marketing license, disease prevention and control institutions and vaccination units to perform their obligations according to law.
The pharmaceutical supervisory and administrative departments shall supervise and inspect the quality of vaccines in vaccine development, production, storage, transportation and vaccination according to law. Health authorities shall supervise and inspect the implementation of immunization planning system and vaccination activities according to law.
The drug supervision and administration department shall strengthen the on-site inspection of vaccine marketing license holders; When necessary, units and individuals that provide products or services for vaccine development, production, circulation and other activities may be subject to extended inspection; The relevant units and individuals shall cooperate and shall not refuse or conceal.
Article 71 The state builds a team of professional and specialized drug inspectors at the central and provincial levels, and strengthens the supervision and inspection of vaccines.
The pharmaceutical supervisory and administrative departments of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government shall send inspectors to the holders of vaccine marketing licenses. Inspectors are responsible for supervising and inspecting the implementation of good manufacturing practice, collecting clues about vaccine quality risks and violations of laws and regulations, reporting the situation to the pharmaceutical supervisory and administrative departments of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government and making suggestions, and being responsible for the behavior during their stationing.
Article 72 If there are potential safety hazards in vaccine quality management, and the holder of vaccine marketing license fails to take timely measures to eliminate them, the pharmaceutical supervisory and administrative department may take measures such as responsibility interview and rectification within a time limit.
Serious violation of drug-related quality management norms, the drug supervision and administration department shall order the suspension of vaccine production, sales and distribution, and immediately rectify; After the rectification is completed, production, sales and distribution can only be resumed if the drug supervision and administration department checks that it meets the requirements.
The drug supervision and administration 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 the regulations, and implement joint punishment.
Article 73 If there are or are suspected to be quality problems with vaccines, the vaccine marketing license holders, disease prevention and control institutions and inoculation entities shall immediately stop selling, distributing and using, and stop production if necessary, and report to the pharmaceutical supervisory and administrative departments and health authorities of the people’s governments at or above the county level in accordance with regulations. The competent health department shall immediately organize disease prevention and control institutions and inoculation units to take necessary emergency measures and report to the competent health department of the people’s government at a higher level. The pharmaceutical supervisory and administrative 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 promptly notify the relevant disease prevention and control institutions, vaccine distribution units and inoculation units, recall them in accordance with regulations, and truthfully record the recall and notification, and the disease prevention and control institutions, vaccine distribution units and inoculation units shall cooperate.
If the production, sale, distribution, use or recall of vaccines are not stopped in accordance with the provisions of the preceding paragraph, the pharmaceutical supervisory and administrative departments and health authorities of the people’s governments at or above the county level shall, according to their respective functions and duties, order them to stop production, sale, distribution, use or recall of vaccines.
Vaccine marketing license holders, disease prevention and control institutions, and vaccination units shall not conceal, falsely report, delay reporting or omit reporting vaccines that have or are suspected to have quality problems, and shall not conceal, forge or destroy relevant evidence.
Article 74 The holder of a vaccine marketing license shall establish an information disclosure system, and timely disclose information such as vaccine product information, instructions and labels, implementation of relevant quality management standards for drugs, batch issuance, recall, acceptance of inspection and punishment, and compulsory insurance for vaccine liability on its website in accordance with regulations.
Article 75 The drug supervision and administration department of the State Council shall establish an information sharing mechanism on vaccine quality and vaccination together with the health authorities of the State Council.
The pharmaceutical supervisory and administrative departments and health authorities of the people’s governments at or above the provincial level shall organize vaccine marketing license holders, disease prevention and control institutions, vaccination units, news media, scientific research units, etc. to exchange information on vaccine quality and vaccination in accordance with the principles of science, objectivity, timeliness and openness.
Article 76 The State implements a unified system for publishing 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 that needs to be published uniformly shall be published by the drug supervision and administration department of the State Council jointly with relevant departments. The national report on the abnormal reaction to vaccination shall be uniformly published by the competent health department of the State Council in conjunction with the drug supervision and administration department of the State Council. The above information shall not be released without authorization. The release of major vaccine safety information should be timely, accurate and comprehensive, and scientific evaluation should be made in accordance with the provisions, and necessary explanations should be made.
The pharmaceutical supervisory and administrative department of the people’s government at or above the county level shall immediately verify and analyze the vaccine safety information that may mislead the public and public opinion, in conjunction with the health authorities and other relevant departments, professional institutions and relevant vaccine marketing license holders, and publish the results in a timely manner.
No unit or individual may fabricate or disseminate false vaccine safety information.
Article 77 Any unit or individual has the right to know vaccine information according to law and put forward opinions and suggestions on vaccine supervision and management.
Any unit or individual has the right to report vaccine violations to the health authorities, drug supervision and administration departments and other departments, and to report to the people’s government at the same level or higher level and its relevant departments and supervisory organs if the health authorities, drug supervision and administration departments and their staff fail to perform their supervisory and administrative duties according to law. The relevant departments and organs shall promptly verify and deal with it; Reward informants for verified reports in accordance with regulations; Informants who report serious illegal acts of their units and verify them are rewarded handsomely.
Article 78 The people’s governments at or above the county level shall formulate emergency plans for vaccine safety incidents, and stipulate the classification of vaccine safety incidents, the organization and command system and responsibilities for handling, the prevention and early warning mechanism, the handling procedures and emergency safeguard measures.
The holder of the vaccine marketing license shall formulate a plan for handling vaccine safety incidents, regularly check the implementation of various preventive measures, and eliminate potential safety hazards in time.
In the event of a vaccine safety incident, the holder of the vaccine marketing license shall immediately report to the drug supervision and administration department of the State Council or the drug supervision and administration department of the people’s government of a 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 authorities and drug supervision and administration departments of the people’s governments at or above the county level. The pharmaceutical supervisory and administrative department shall, jointly with the health authorities, set up a command organization for handling vaccine safety incidents 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 in the aftermath of replanting. The cost of replanting vaccine safety incidents caused by quality problems shall be borne by the holder of vaccine marketing license.
The relevant units and individuals shall not conceal, falsely report, delay reporting or omit reporting vaccine safety incidents, and shall not conceal, forge or destroy relevant evidence.
Chapter X Legal Liability
Article 79 Whoever violates the provisions of this Law and constitutes a crime shall be severely investigated for criminal responsibility according to law.
Article 80 If the vaccines produced and sold belong to counterfeit drugs, the pharmaceutical supervisory and administrative department of the people’s government at or above the provincial level shall confiscate the illegal income, vaccines produced and sold illegally, raw materials, auxiliary materials, packaging materials, equipment and other articles specially used for illegal vaccine production, order it to stop production and business for rectification, revoke the pharmaceutical registration certificate until the pharmaceutical production license is revoked, and impose a fine of not less than 15 times but not more than 50 times the value of vaccines produced and sold illegally. If the value of vaccines is less than 500,000 yuan, it shall be calculated as 500,000 yuan.
If the vaccines produced and sold are inferior drugs, the pharmaceutical supervisory and administrative department of the people’s government at or above the provincial level shall confiscate the illegal income and vaccines produced and sold illegally, as well as raw materials, auxiliary materials, packaging materials, equipment and other items specially used for illegal vaccine production, order it 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 vaccines produced and sold illegally. If the value is less than 500,000 yuan, it shall be calculated as 500,000 yuan. If the circumstances are serious, the drug registration certificate shall be revoked until the drug production license is revoked.
If the vaccines produced and sold are fake drugs, or the vaccines produced and sold are inferior drugs and the circumstances are serious, the pharmaceutical supervisory and administrative department of the people’s government at or above the provincial level shall confiscate the income earned by the unit during the illegal act, impose a fine of more than one time and less than ten times the income earned, prohibit the pharmaceutical production and business activities for life, and be detained by the public security organ for more than five days and less than fifteen 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 and vaccines illegally produced and sold, as well as raw materials, auxiliary materials, packaging materials, equipment and other articles specially used for illegal vaccine production, order it 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 illegally produced and sold vaccines. If the value is less than 500,000 yuan, it shall be calculated as 500,000 yuan; If the circumstances are serious, the relevant drug approval documents shall be revoked until the drug production license is revoked. The legal representative, principal responsible person, directly responsible person in charge, key position personnel and other responsible personnel shall be confiscated, and they shall be fined more than 50% but less than 10 times of the income earned. They shall be prohibited from engaging in drug production and business activities for ten years until life, and shall be detained by public security organs for more than five days and less than fifteen days:
(1) Providing false data, materials, samples or committing other deceptive acts when applying for clinical trials, registration and batch issuance of vaccines;
(two) fabricating production and inspection records or changing the batch number of products;
(3) Units or individuals other than disease prevention and control institutions supply vaccines to vaccination units;
(four) commissioned the production of vaccines without approval;
(five) the production process, production site, key equipment and other changes in accordance with the provisions should be approved without approval;
(6) Updating vaccine instructions and labels shall be approved without approval according to regulations.
Article 82 Unless otherwise provided for in this Law, if the holder of vaccine marketing license or any other unit violates the relevant quality control standards of drugs, the pharmaceutical supervisory and administrative department of the people’s government at or above the county level shall order it to make corrections and give it a warning; Refuses to correct, a fine of two hundred thousand yuan and five hundred thousand yuan; If the circumstances are serious, a fine of not less than 500,000 yuan but not more than 3 million yuan shall be imposed, and the company shall be ordered to suspend production and business for rectification until the relevant drug approval documents and drug production licenses are revoked. The legal representative, principal responsible person, directly responsible person in charge, personnel in key positions and other responsible personnel shall be confiscated from their own units during the illegal act, and a fine of not less than 50% but not more than 5 times shall be imposed, and they shall be prohibited from engaging in drug production and business activities for ten years until life.
Article 83 If a holder of a vaccine marketing license violates the provisions of this Law in any of the following circumstances, the pharmaceutical supervisory and administrative department of the people’s government at or above the provincial level shall order him to make corrections and give him a warning; Refuses to correct, a fine of two hundred thousand yuan and five hundred thousand yuan; If the circumstances are serious, it shall be ordered to suspend production and business for rectification, and a fine of not less than 500,000 yuan but not more than 2 million yuan shall be imposed:
(1) Failing to establish an electronic traceability system for vaccines as required;
(two) the legal representative, the main person in charge, the person in charge of production management, the person in charge of quality management, the quality authorized person and other key positions do not meet the prescribed conditions or fail to carry out training and assessment in accordance with the provisions;
(3) Failing to report or put on record as required;
(4) Failing to carry out post-marketing research in accordance with the regulations, or failing to set up institutions and staff in accordance with the regulations to actively collect, track and analyze suspected abnormal reactions to vaccination;
(5) Failing to take out compulsory vaccine liability insurance as required;
(six) the information disclosure system is not established in accordance with the provisions.
Article 84 If a batch issuing institution violates the provisions of this Law in any of the following circumstances, the drug supervision and administration department of the State Council shall order it to make corrections and give it a warning, and the principal responsible person, the directly responsible person in charge and other directly responsible personnel shall be given a warning according to law until demotion:
(1) Failing to conduct examination and inspection in accordance with the provisions;
(2) Failing to announce the results of batch issuance of vaccines on the market in time;
(3) Failing to verify in accordance with the provisions;
(4) Failing to report the major quality risks of the vaccine as required.
If, in violation of the provisions of this Law, the batch issuing institution fails to issue a batch issuing certificate or refuses to issue a batch issuing notice in accordance with the provisions, the drug supervision and administration department of the State Council shall order it to make corrections, give it a warning, and demote or dismiss the principal responsible person, the directly responsible person in charge and other directly responsible personnel according to law; If the circumstances are serious, the principal responsible person, the directly responsible person in charge and other directly responsible personnel shall be dismissed according to law.
Article 85 If disease prevention and control institutions, inoculation units, vaccine marketing license holders and vaccine distribution units violate the requirements of cold chain storage and transportation in the management norms for vaccine storage and transportation, the pharmaceutical supervisory and administrative department of the people’s government at or above the county level shall order them to make corrections, give them a warning, destroy the illegally stored and transported vaccines and confiscate their illegal income; Refuses to correct, the vaccination units, vaccine marketing license holders, vaccine distribution units at more than two hundred thousand yuan to one million yuan fine; If the circumstances are serious, the vaccination units, vaccine marketing license holders and vaccine distribution units shall be fined for illegally storing and transporting vaccines for more than 10 times and less than 30 times. If the value is less than 100,000 yuan, the vaccine marketing license holders and vaccine distribution units shall be ordered to stop production and suspend business for rectification until the relevant approval documents and drug production licenses are revoked, and the legal representatives, principals and direct responsibilities of the vaccine marketing license holders and vaccine distribution units shall be directly responsible.
If the disease prevention and control institutions and inoculation units commit illegal acts as prescribed in the preceding paragraph, the competent health department of the people’s government at or above the county level shall give a warning to the main person in charge, the directly responsible person in charge and other directly responsible personnel according to law until they are dismissed, and order the responsible medical and health personnel to suspend their practice activities for more than one year and less than 18 months; If serious consequences are caused, the principal responsible person, the directly responsible person in charge and other directly responsible personnel shall be dismissed according to law, and the inoculation qualification of the inoculation unit may be revoked, and the practice certificate of the responsible medical and health personnel shall be revoked by the original issuing department.
Article 86 If disease prevention and control institutions, inoculation entities, vaccine marketing license holders and vaccine distribution entities violate the management norms of vaccine storage and transportation other than those specified in Article 85 of this Law, the pharmaceutical supervisory and administrative department of the people’s government at or above the county level shall order them to make corrections, give them a warning and confiscate their illegal income; Refuses to correct, the vaccination units, vaccine marketing license holders, vaccine distribution units at more than one hundred thousand yuan to three hundred thousand yuan fine; If the circumstances are serious, the vaccination unit, vaccine marketing license holder and vaccine distribution unit shall be fined for illegally storing and transporting vaccines with a value of more than three times and less than ten times. If the value is less than 100,000 yuan, it shall be calculated as 100,000 yuan.
If the disease prevention and control institutions and vaccination units commit illegal acts as prescribed in the preceding paragraph, the health department of the people’s government at or above the county level may give warning to the principal responsible person, the directly responsible person in charge and other directly responsible personnel according to law until dismissal, and order the responsible medical and health personnel to suspend their practice activities for more than six months and less than one year; If serious consequences are caused, the principal responsible person, the directly responsible person in charge and other directly responsible personnel shall be dismissed according to law, and the practice certificate of the responsible medical and health personnel shall be revoked by the original issuing department.
Article 87 If a disease prevention and control institution or vaccination unit violates the provisions of this Law in 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 principal responsible person, the directly responsible person in charge and other directly responsible personnel shall be given a warning until dismissal, and the responsible medical and health personnel shall be ordered to suspend their practice activities for more than one year and less than 18 months; If serious consequences are caused, the principal responsible person, the directly responsible person in charge and other directly responsible personnel shall be dismissed according to law, and the practice certificate of the responsible medical and health personnel shall be revoked by the original issuing department:
(1) Failing to supply, receive or purchase vaccines as required;
(two) vaccination did not comply with the vaccination work norms, immunization procedures, vaccine use guidelines, vaccination program;
(three) unauthorized mass vaccination.
Article 88 If a disease prevention and control institution or vaccination unit violates the provisions of this Law in 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 and give it a warning; If the circumstances are serious, the principal responsible person, the directly responsible person in charge and other directly responsible personnel shall be given a warning until dismissal, and the responsible medical and health personnel shall be ordered to suspend their practice activities for more than six months and less than one year; If serious consequences are caused, the principal responsible person, the directly responsible person in charge and other directly responsible personnel shall be dismissed according to law, and the practice certificate of the responsible medical and health personnel shall be revoked by the original issuing department:
(1) Failing to provide traceability information as required;
(2) Failing to obtain and keep relevant certification documents and temperature monitoring records in accordance with regulations when receiving or purchasing vaccines;
(3) Failing to establish and keep records of vaccine receipt, purchase, storage, distribution, supply, inoculation and disposal in accordance with regulations;
(4) Failing to inform or ask the recipient or his guardian about the situation in accordance with the regulations.
Article 89 If disease prevention and control institutions, vaccination units and medical institutions fail to report suspected abnormal vaccination reactions and vaccine safety incidents in accordance with regulations, or fail to organize investigation and diagnosis of suspected abnormal vaccination reactions in accordance with regulations, the competent health department of the people’s government at or above the county level shall order them to make corrections and give them a warning; If the circumstances are serious, the vaccination units and medical institutions shall be fined between 50,000 yuan and 500,000 yuan, and the principal responsible persons, directly responsible personnel in charge and other directly responsible personnel of the disease prevention and control institutions, vaccination units and medical institutions shall be given a warning according to law until dismissal; If serious consequences are caused, the principal responsible person, the directly responsible person in charge and other directly responsible personnel shall be dismissed according to law, and the practice certificate of the responsible medical and health personnel shall be revoked by the original issuing department.
Article 90 If a disease prevention and control institution or vaccination unit collects fees in violation of the provisions of this Law, the competent health department of the people’s government at or above the county level shall supervise it to return the illegally collected fees to the unit or individual who originally paid the fees, and the market supervision and management department of the people’s government at or above the county level shall punish it according to law.
Article 91 Anyone who, in violation of the provisions of this Law, engages in immunization planning vaccination without being designated by the competent health department of the local people’s government at or above the county level, or engages in non-immunization planning vaccination that does not meet the requirements or has not been put on record, shall be ordered by the competent health department of the people’s government at or above the county level to make corrections, give a warning, confiscate the illegal income and illegally held vaccines, be ordered to suspend business for rectification, and be fined not less than 100,000 yuan but not more than 1 million yuan. The principal responsible person, the directly responsible person in charge and other directly responsible personnel shall be punished according to law.
In violation of the provisions of this law, units or individuals other than disease prevention and control institutions and vaccination units carry out mass vaccination without authorization, and the health authorities of the people’s governments at or above the county level shall order them to make corrections, confiscate the illegal income and illegally held vaccines, and impose a fine of not less than 10 times but not more than 30 times the value of illegally held vaccines. If the value is less than 50,000 yuan, it shall be calculated as 50,000 yuan.
Ninety-second guardians who fail to ensure that school-age children are vaccinated on time according to law shall be criticized and educated by the health authorities of the people’s government at the county level and ordered to make corrections.
Nursery institutions and schools that fail to check vaccination certificates in accordance with the regulations when children enter kindergartens and schools, or fail to report to the vaccination unit after discovering children who have not been vaccinated in accordance with the regulations, the education administrative department of the local people’s government at or above the county level shall order them to make corrections, give them a warning, and punish the principal responsible person, the directly responsible person in charge and other directly responsible personnel according to law.
Article 93 Whoever fabricates or disseminates false vaccine safety information, or makes trouble in the inoculation unit, which constitutes a violation of public security administration, shall be punished by the public security organ according to law.
Newspapers, periodicals, radio, television, Internet sites and other media fabricate and disseminate false information about vaccine safety, and the relevant departments shall punish them according to law, and the principal responsible person, the directly responsible person in charge and other directly responsible personnel shall be punished according to law.
Article 94 If the local people’s governments at or above the county level have any of the following circumstances in vaccine supervision and management, the directly responsible person in charge and other directly responsible personnel shall be demoted or dismissed according to law; If the circumstances are serious, he shall be dismissed according to law; Causing serious consequences, the main person in charge shall resign:
(a) ineffective performance of duties, resulting in serious adverse effects or heavy losses;
(2) Concealing, misrepresenting, delaying or omitting vaccine safety incidents;
(3) Interfering with or obstructing the investigation of vaccine violations or vaccine safety incidents;
(four) a particularly serious vaccine safety accident occurred in the administrative area, or a series of major vaccine safety accidents occurred.
Article 95 If the drug supervision and administration department, health department and other departments have any of the following circumstances in vaccine supervision and management, the directly responsible person in charge and other directly responsible personnel shall be demoted or dismissed according to law; If the circumstances are serious, he shall be dismissed according to law; Causing serious consequences, the main person in charge shall resign:
(a) failing to perform the duties of supervision and inspection, or failing to investigate and deal with illegal acts in time;
(two) unauthorized mass vaccination;
(3) Concealing, misrepresenting, delaying or omitting vaccine safety incidents;
(4) Interfering with or obstructing the investigation of vaccine violations or vaccine safety incidents;
(5) divulging the information of informants;
(six) received a report on the suspected abnormal reaction to vaccination, and failed to organize the investigation and handling in accordance with the provisions;
(seven) other acts that fail to perform the duties of vaccine supervision and management, resulting in serious adverse effects or heavy losses.
Article 96 If the vaccine quality problem causes 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 that violate vaccination work norms, immunization procedures, guiding principles for the use of vaccines, and vaccination programs, causing damage to the recipients, shall be liable for compensation according to law.
Chapter XI Supplementary Provisions
Article 97 The meanings of the following terms in this Law are:
Immunization vaccines refer to vaccines that residents should be vaccinated in accordance with government regulations, including vaccines determined by the national immunization program, vaccines added by the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government when implementing the national immunization program, and vaccines used for emergency vaccination or mass vaccination organized by the people’s governments at or above the county level or their health authorities.
Non-EPI vaccines refer to other vaccines voluntarily vaccinated by residents.
The holder of vaccine marketing license refers to an enterprise that has obtained the registration certificate of vaccine drugs and the drug production license according to law.
Article 98 The State encourages vaccine production enterprises 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 Entry-exit vaccination and procurement of required vaccines shall be separately stipulated by the frontier health and quarantine organ in consultation with the financial department of the State Council.
Article 100 This Law shall come into force as of December 1, 2019.
