Vaccine Management Law of the People's Republic of China
（June 29, 2019 The 13th National People's Congress Executive Committee
Eleventh meeting passed)
Item Record
Chapter 1 General Principles
Chapter 2 Vaccine Development and Registration
Chapter III Vaccine Production and Approval
Chapter 4 Vaccine Circulation
Chapter 5 Prevention
Chapter VI Excellent Reaction Monitoring and Treatment
Chapter 7 Management after vaccine
Chapter 8 Protection Measures
Chapter 9 Supervision and Management
Chapter 10 Legal Responsibility
Chapter 11 Attachment Jeebu
Chapter 1 General Principles
Article 1 In order to strengthen vaccine management，Ensure the quality and supply of vaccine，Standardize prevention vaccination，Promoting the development of the vaccine industry，Guarantee public health，Maintain public health safety，Develop this law。
2 Entering vaccine development in the people's Republic of China、Production、Circulation and Prevention and Supervision and Management Activity，Applicable this Law。This method has not been prescribed，Applicable "The Drug Administration Law of the People's Republic of China"、"Law of the People's Republic of China Infectious Disease Prevention and Control Law" and other laws、Regulations on administrative regulations。
Vaccine referred to in this method，refers to prevention、Control the occurrence of the disease、Popular，Preventive biological products used for human immunization，Including immune planning vaccines and non -immunization planning vaccines。
Article 3 The state implements the strictest management system for the vaccine，Persist in safety first、Risk Management、Full of control、Scientific Supervision、Social co -governance。
Article 4 The State's Strategic and Charity of Vaccine Products。
National support of basic research and application research，Promote the development and innovation of vaccine，Prevention、Development of vaccines to control major diseases、Production and reserve is included in the national strategy。
The state formulates the development plan and industrial policy of the vaccine industry，Support the development and structure optimization of the vaccine industry，Encourage the scale of vaccine production、Collection，Continuously improve the vaccine production process and quality level。
Article 5 Vaccine Local Permit holder shall strengthen the quality management of the vaccine's whole life cycle，Safety of vaccine、Effectability and quality controllability is responsible。
Entering vaccine development、Production、Units and individuals for circulation and vaccination activities，It should abide by the law、Regulations、Regulations、Standards and specifications，Make sure the whole process information is true、Accurate、complete and traceable，Responsibility in accordance with the law，Accept social supervision。
6 The state implements the immunization planning system。Residents living in China，Enjoy the right to vaccinate the vaccine vaccine in accordance with the law，Performing the obligation to vaccinate immunization planning vaccines。The government provides residents with immune planning vaccines for free。
The people's governments at or above the county level and their relevant departments shall ensure that the immunization planning vaccine of children with appropriate age should be guaranteed。The guardian shall ensure that the age of child -age children is vaccinated on time in accordance with the law。
Article 7 The people's governments at or above the county level shall incorporate vaccine safety work and vaccination work into the national economic and social development plan at their own level，Strengthen the construction of vaccine supervision and management capabilities，Establish and improve the working mechanism of vaccine supervision and management。
Local people's governments at or above the county level are responsible for the supervision and management of the administrative regional vaccine，Unified Leaders、Organization、Coordinate the supervision and management of vaccine in the administrative region。
Article 8 The Drug Supervision stake sports betting appand Administration Department of the State Council is responsible for the national vaccine supervision and management。The State Council's Health and Health Administration Department is responsible for national vaccination and supervision and management。Other relevant departments of the State Council are responsible for supervision and management related to vaccine -related supervision and management within their respective duties。
Provincial、Autonomous Region、The drug supervision and management department of the people's government of the municipality directly under the Central Government is responsible。Set the city level、The department of the county -level people's government assumed the duties of drug supervision and management (hereinafter referred to as the drug supervision and management department) is responsible for the vaccine supervision and management of the administrative region。The health and health authorities of the local people's government at or above the county level are responsible for the premium supervision and management of the administrative region。Other relevant departments at the local people's government at or above the county level are responsible for supervision and management related to vaccine -related supervision and management。
Article 9 of the State Council and Provincial Council、Autonomous Region、The people's government of the municipality established a department coordination mechanism，Coordinated coordination and coordination of vaccine supervision and management related work，Regular analysis of vaccine safety situation，Strengthen vaccine supervision and management，Guarantee vaccine supply。
Article 10 The State's Electronic Retisling System of Vaccine Electronics。
The Drug Supervision and Administration of the State Council will formulate a unified vaccine traceability standard and specification with the State Council's health and health authority，Establish a national vaccine electronic traceability collaboration platform，Integrated vaccine production、Traceable information of the entire process of circulation and prevention，Realizing the vaccine traceability。
Vaccine listing permit holders shall establish a vaccine electronic traceability system，Connect with the national vaccine electronic traceability collaboration platform，Realization of production、Circulation and prevention of the smallest packaging unit vaccine traceable、can be checked。
Disease Prevention and Control Agency、The vaccination unit shall truthfully record the vaccine circulation、Prevention and other conditions，and provide traceability information to the national vaccine electronic traceability synergy in accordance with regulations。
Article 11 Vaccine Development、Production、Inspection and other processes shall be established and improved the biological safety management system，Strict control of biological safety risks，Bio -safety management of pathogenic microorganisms such as strains and other pathogens，The health of the operator and the public，Makes legal microorganisms such as strains and other pathogens、Justice。
Vaccine Development、Production、Test the strains and cells used in the test，Should be clear history、Biological features、generation，Create a detailed file，Guarantee the source of the source、Clear、traceable; unknown source，Do not use。
Article 12 The people's governments at all levels and their relevant departments、Disease Prevention and Control Agency、Inocular vacation unit、Vaccine listing permit holder and the vaccine industry association shall regularly carry out vaccine safety laws through activities such as children's vaccination days、Regulations and propaganda education for vaccination knowledge、Popularized work。
News media should carry out vaccine safety laws、Regulations and public welfare propaganda for vaccination knowledge，Public opinion supervision of vaccine illegal acts。Propaganda and reports on vaccines should be comprehensive、Science、Objective、Justice。
Article 13 The vaccine industry association shall strengthen industry self -discipline，Establish and improve industry specifications，Promoting the construction of the industry integrity system，Guide and urge members to carry out activities such as production and operation in accordance with the law。
Chapter 2 Vaccine Development and Registration
Article 14 State according to the popularity of the disease、Factors such as the immune status of the crowd，Formulate related development plan，Arrange the necessary funds，Support the development of new types of vaccines such as multi -price and multi -price vaccine。
National Organizational Vaccine Local License Holder、Scientific Research Unit、Medical and health institutions jointly related，Develop disease prevention、Control urgent vaccine。
Article 15 The state encourages the vaccine listing permit holder to increase the investment and innovative capital investment，Optimized production technology，Improve quality control level，Promoting the technical progress of vaccine。
Article 16 Cancet the clinical trial of vaccine，It should be approved by the State Council's Drug Supervision stake sports betting appand Administration Department。
The clinical trial of the vaccine shall be implemented or organized by the State Council's Drug Supervision and Management Department and the State Council's Health and Health Administrative Department or the implementation of or organized the implementation of disease prevention and control institutions at or above the provincial level。
The state encourages qualified medical institutions、Disease prevention and control institutions conduct clinical trials of vaccine in accordance with the law。
Seven vaccine clinical trial applicants shall formulate clinical trial plans，Establishing clinical trial safety monitoring and evaluation system，Choose the subject carefully，Reasonable setting the subject group and age group，and take effective measures according to the degree of risk，Protect the legitimate rights and interests of the subject。
Article 18 Carry out the clinical trial of vaccine，The written knowledge consent of the subject should be obtained;，It should obtain the written consent of the guardian;，The written knowing consent of my and their guardians should be obtained。
Article 19 The vaccine listed in China shall be approved by the State Council's drug supervision and management department，Obtain a drug registration certificate; apply for vaccine registration，Should provide real、Enough、Reliable data、Information and sample。
Prevention of disease、Control urgent vaccine and innovative vaccine，The drug supervision and management department of the State Council shall give priority to review and approval。
Article 20 Calculate vaccines in response to major emergencies or urgently needed public health incidents or other vaccines that are urgently needed by the State Council's health and health authority，Evaluation benefits are greater than risks，The Drug Supervision stake sports betting appand Administration Department of the State Council may attach conditional approved vaccine registration applications。
Special major emergencies or other emergencies that seriously threaten public health，The State Council ’s health and health authorities are based on infectious disease prevention、Control needs to propose emergency use of vaccine，After organizing and agreed by the State Council's Drug Supervision stake sports betting appand Administration Department, it can be used urgently within a certain range and period of time。
Article 21: When the State Council's Drug Supervision stake sports betting appand Administration Department is approved by the approved vaccine registration，The production process of the vaccine、Quality Control Standard and Manual、Tags are approved。
The drug supervision and management department of the State Council shall promptly publish the vaccine manual on its website、Tag content。
Chapter III Vaccine Production and Employment
22 The state implements a strict admission system for vaccine production。
Entering vaccine production activities，It should be approved by the drug supervision and management department of the people's government at or above the provincial level，Obtaining a drug production license。
Entering vaccine production activities，Except for the condition that meets the requirements of the Drug Management Law of the People's Republic of China，It should also have the following conditions:
(1) Have a moderate scale and sufficient capacity reserves;
(2) Systems and facilities with guarantee biological safety、Equipment;
(3) meets the needs of disease prevention and control.
Vaccine listing permit holders shall have the vaccine production capacity; the production capacity of the vaccine does need to be commissioned，It shall be approved by the Drug Supervision stake sports betting appand Administration Department of the State Council。Accept the commissioned production，It should abide by the provisions of this Law and the relevant state regulations，Make sure the vaccine quality。
Twenty -third of the legal representative of the holder of the vaccine listing permit、The main person in charge shall have a good credit record，The person in charge of production management、The person in charge of quality management、Personnel such as Quality Extraordinary Persons and other key positions shall have relevant professional background and experience experience。
Vaccine listing permit holders shall strengthen the training and assessment of the personnel specified in the preceding paragraph，Timely positioning and changing the situation in the province、Autonomous Region、Report on the Drug Supervision and Management Department of the People's Government of the Municipal Municipality。
Twenty -four vaccines shall be produced and inspected in accordance with the approved production technology and quality control standards，The entire production process shall meet the requirements of the quality management specifications of drug production。
Vaccine listing permit holders shall review the entire process of vaccine production and quality of vaccine in accordance with regulations、Test。
Twenty -five vaccine listing permit holders shall establish a complete production quality management system，Continuous strengthening deviation management，Using informatization means to truthfully record production、All data formed during the test，Ensure that the entire production process continues to meet legal requirements。
Article 26 The country implements a system of vaccine approval。
Before the sale or import of each batch of vaccines，The approval and issuing agencies designated by the Drug Supervision and Administration of the State Council shall be reviewed in accordance with the relevant technical requirements、Test。Meeting the requirements，Send to the approval certificate;，Issuing notification notice will be issued for not being approved。
Vaccination issued without approval shall not be sold，and should be provincial、Autonomous Region、The drug supervision and management department of the people's government directly under the Central Government is supervised and destroyed; the import vaccine issued shall not be approved shall be supervised and destroyed by the drug supervision and management department where the port is located.。
Drug Supervision stake sports betting appand Administration Department of the State Council、A batch of issuance agencies stake sports betting appshall promptly announce the results of the publication of the vaccine approval，For public inquiry。
27 The application for the application of the vaccine shall be issued in accordance with the regulations to provide the batch production and inspection record summary information and other samples of the same batch of products。Imported vaccines should also provide certificate of origin、Certificate of batch issuance;，It should provide a certificate of exemption from batch issuance。
Article 28 Prevention、Control the vaccine that is urgently needed in the infectious disease epidemic or respond to urgently needed emergencies，Approved by the State Council's Drug Supervision stake sports betting appand Administration Department，Removes for issuance。
29. 29 The approval of the vaccine shall conduct data review and sampling inspection in batches。Vaccine batch of inspection items and inspection frequency shall be dynamically adjusted according to the evaluation of the vaccine quality risk。
There are questions about the authenticity of the application information or samples for the vaccine approval，Or there are other situations that need to be further verified，A batch of issuance agencies shall verify，If necessary。
Article 30 The batch issuing agency found that there is a major quality risk during the issuance of the issuance of the issuance，shall promptly to the drug supervision and management department of the State Council and the province、Autonomous Region、Report on the Drug Supervision and Management Department of the People's Government of the Municipal Municipality。
The departments receiving the report shall immediately conduct on -site inspections of the holder of the vaccine listing permit，The relevant product or all products of the vaccine listing license holder or all products shall not be approved or suspended or issued according to the results of the inspection results，and order the vaccine listing license holder to rectify。Vaccine listing license holder shall rectify immediately，and timely report the rectification situation to the department that order it to rectify。
Article 31 of the production process deviation、Quality differences、Faults and accidents and measures taken in the production process，The holder of the vaccine listing permit shall record truthfully，and stated in the documents issued by the corresponding approved products; it may affect the quality of the vaccine，The holder of the vaccine listing permit shall immediately take measures，and province、Autonomous Region、Report on the Drug Supervision and Management Department of the People's Government of the Municipal Municipality。
Chapter 4 Vaccine Circulation
Article 32: The national immunization planning vaccine shall be concentrated in bidding or unified negotiations with the State Council's Health and Health Administration, in conjunction with the State Council Finance Department and other organizations，Form and announce the winning price or transaction price，Each province、Autonomous Region、Unified purchase of municipalities directly under the Central Government。
National immunization planning vaccine other than vaccine、Non -immune planning vaccines are provinces、Autonomous Region、Organization of the municipality through the provincial public resource trading platform is organized。
The price of the 33rd vaccine is formally formulated by the vaccine listing permit holder and the holder of the holder of the vaccine。The price level of the vaccine、difference rate、profit margins should be maintained at a reasonable amplitude。
Article 34 Provincial disease prevention and control institutions shall be in accordance with national immunization planning and prevention of diseases in their own administrative regional diseases、Control needs，Develop a plan for the use of immunization planning vaccine in this administrative region，and report to the department that purchases vaccines to purchase vaccines in accordance with relevant national regulations，Report the province at the same time、Autonomous Region、The Health and Health Administration of the People's Government of the Municipality directly under the Central Government。
Article 35 The holder of the vaccine listing permit shall be agreed in accordance with the procurement contract，Supply vaccine to disease prevention and control agencies。
Disease prevention and control institutions shall supply vaccines to the vaccination unit in accordance with regulations。
Units and individuals other than disease prevention and control institutions shall not supply vaccines to the vaccination unit，The vaccination unit shall not receive the vaccine。
Article 36 The holder of the vaccine listing permit shall be agreed in accordance with the procurement contract，Delivery vaccine specified by the disease prevention and control institution or the disease prevention and control institution。
Vaccine listing license holder、Disease prevention and control agencies should have the vaccine cold chain storage、Transportation conditions，You can also entrust eligible vaccine distribution units to distribute vaccines。
Disease prevention and control agencies Delivery non -immune planning vaccines can be stored in storage、Transportation costs，Specific measures shall be formulated by the financial department of the State Council in conjunction with the competent price department of the State Council，The charging standard is provincial、Autonomous Region、The price authority of the people's government of the municipality directly under the Central Government will formulate it with the financial department。
37. Article 37 Disease Prevention and Control Agency、Inocular vacation unit、Vaccine listing license holder、Vaccine delivery unit shall abide by the vaccine storage、Transport Management Specification，Make sure the vaccine quality。
The vaccine is storage、During the entire transportation process, it should be at the prescribed temperature environment，Cold Chain Storage、Transportation should meet the requirements，Monitor regularly、Record temperature。
Vaccine Storage、Transport Management Specifications by the State Council's Drug Supervision and Management Department、The competent department of health and health department of the State Council is jointly formulated。
Article 38: The holder of the vaccine listing license holder is when the vaccine is sold，A copy of the certificate or electronic document stamped with its seal should be provided; the sales of imported vaccines，It should also provide a copy of the imported drug clearance single or electronic file。
Disease Prevention and Control Agency、Inocularly vaccinated unit，It should be requested that the certification documents specified in the preceding paragraph，and stored until the validity period of the vaccine is not less than five years to prepare for inspection。
Article 39 The holder of the vaccine listing permit shall be in accordance with regulations，Create true、Accurate、Complete sales record，and stored until the validity period of the vaccine is not less than five years to prepare for inspection。
Disease Prevention and Control Agency、Inocular vacation unit、The vaccine distribution unit shall be in accordance with regulations，Create true、Accurate、Complete receiving、Buy、Storage、Delivery、Supply Record，and stored until the validity period of the vaccine is not less than five years to prepare for inspection。
Disease Prevention and Control Agency、When the vaccination unit is received or purchased when the vaccine，Should ask this transportation、Storage whole process temperature monitoring record，and stored until the vaccine is valid for no less than five years after the expiration;、Storage entire process temperature monitoring records or temperature control does not meet the requirements，Do not receive or buy，And should immediately immediately use the drug supervision and management department of the local people's government at or above the county level、Report on the competent department of health and health。
Article 40 Disease Prevention and Control Agency、The vaccination unit shall establish a regular inspection system for vaccine，Unable to identify the existence of packaging、Storage temperature does not meet the requirements、Vaccine that exceeds problems such as validity period，Take isolation storage、Setting warning signs and other measures，and according to the drug supervision and management department of the State Council、The competent department of health and health、Student disposal of the competent authority of the ecological environment。Disease Prevention and Control Agency、The vacation unit shall record the disposal situation truthfully，The disposal record should be stored until the validity period of the vaccine is not less than five years.。
Chapter 5 Prevention
Stake Sports Betting
Article 41 The State Council's health and health authorities formulate national immunization planning; the type of national immunization planning vaccine shall be drawn up by the State Council's Health and Health authorities in conjunction with the State Council's financial department，It was announced after being approved by the State Council。
The State Council Health and Health Administration Department establishes the National Immunization Planning Expert Consultation Committee，and together with the Finance Department of the State Council to establish a dynamic adjustment mechanism for the type of vaccine type vaccine in the State Council。
Provincial、Autonomous Region、The people's government of the municipality directly under the Central Government will be implemented by the national immunization plan，It can be prevented according to the disease prevention of diseases in this administrative area、Control needs，Increase the type of vaccine for immunization planning，The people's government of the municipality directly under the Central Government will be implemented by the national immunization plan。
Article 42 The competent department of health and health of the State Council shall formulate、Announce the specification of vaccination work，Strengthen the standardized management of vaccination。
The competent department of health and health of the State Council shall formulate、Announce the Guidance Principles of the Immunization Program and Non -Automotive Planning Vaccine of the National Immunization Planning Vaccine。
Provincial、Autonomous Region、The health and health authority of the people's government of the municipality directly under the Central Government shall formulate a vaccination plan in accordance with the actual situation of the administrative area，Reported to the competent department of health and health in the State Council for filing。
Article 43 Disease prevention and control institutions at all levels shall be in accordance with their respective responsibilities，Carry out publicity related to vaccination、Training、Technical Guidance、Monitoring、Evaluation、Epidemiological Survey、Emergency disposal and other work。
Article 44: The following conditions shall have the following conditions:
(1) Obtaining a license to obtain medical institutions;
(2) Doctors who have passed the professional training and assessment of qualified doctors organized by the health and health authority of the county -level people's government、Nurses or rural doctors;
(3) With the storage of vaccine、refrigerated facilities with standardized transportation management specifications、Equipment and refrigerator storage system。
The health and health authority of the local people's government at or above the county level designated the eligible medical institution to undertake the vaccine vaccination work in the responsible area。Eligible medical institutions can undertake non -immune planning vaccination work，and should be reported to the health and health authority of the medical institution's practice license to record the record。
The vacation unit shall strengthen internal management，Practicing the vaccination work shall comply with the specifications of vaccination work、Immune program、Guidance principles and vaccination plans for vaccine use。
Disease prevention and control institutions at all levels shall strengthen the technical guidance and management of vaccination for vaccination work in vaccination units。
Article 45 of the medical and health personnel implements vaccination，The variety of vaccines in vaccination of the seizure or the guardian shall be informed、Function、Contraindications、Note for adverse reactions and on -site views，Ask the health status of the recipient and whether there are inoculation contraindications，and record the inform and inquire about truth。The recipient or the guardian should truthfully provide the health status and inoculation taboos of the recipient。There is a taboo that cannot be vaccinated，Medical and health personnel shall make medical advice to the recipient or their guardians，and truthfully record the medical proposal。
Medical and health personnel before the implementation of vaccination，It should be in accordance with the requirements of the specifications of vaccination work，Check the health status of the recipient、Check the contraindication of vaccination，Check the proof of vaccination，Check the vaccine、The appearance of the syringe、Batch number、Validity period，Check the name of the recipient、The name of the age and the vaccine、Specification、Dose、vacation site、Verification path，Asposer、Consistency of the vaccination certificate and vaccine information，Follow the vaccination after confirming that there is no error。
Medical and health personnel shall perform vaccinations for the recipients who meet the conditions of vaccination。The recipient will have adverse reactions during the viewing period，Medical and health personnel shall be in accordance with the requirements of the standard of vaccination work，Take measures and other measures in time。
Article 46 Medical and health personnel shall be in accordance with the provisions of the State Council's health and health authority，Real、Accurate、Full record of the variety of vaccines、Located License held by holder、Identification information of the smallest packaging unit、Validity period、vaccination time、Medical and health personnel implemented in vaccination、Vacus information，Make sure the vaccination information can be traceable、Can query。The vaccination record should be stored until the validity period of the vaccine is not less than five years.。
Article 47 The state implements a vaccination certificate system for children。Within one month after child birth，Its guardians shall go to the place of child residence to undertake the vaccination unit or birth hospital for vaccination work to apply for a vaccination certificate。Inoculation unit or birth hospital must not refuse to do it。The guardian should properly keep the prevention certificate。
Prevention of vaccination implementation of residence management，Children leave the original place of residence，The vaccination unit that is responsible for vaccination work is responsible for vaccination。
The format of the vaccination certificate is stipulated by the competent health and health department of the State Council。
Article 48 Children's Trust、When school enrollment，Children's institution、The school should check the prevention certificate，It is found that the vaccine that has not been vaccinated in accordance with the regulations，It should be a place for children to live or care for children、Report on the vaccination unit where the school is located，and cooperate with the vaccination unit to urge the guardian to make up in accordance with regulations。Disease prevention and control institutions shall be childcare institutions、School inspection prevention certificate provides technical guidance。
Children's entrustment、The inspection method of the admission prevention certificate is formulated by the State Council's Health and Health Administrative Department in conjunction with the Education Administrative Department of the State Council。
Article 49: Do not charge any fees for vaccination vaccine vaccine for vaccination units。
Vaccination unit vaccination vaccine，Except for the charge of vaccine，You can also charge the vaccination service fee。The charging standard for the service fee of vaccination is provincial、Autonomous Region、The price authority of the people's government of the municipality directly under the Central Government will formulate it with the financial department。
Article 50: The health and health authorities of the local people's government at or above the county level or above shall be based on infectious disease monitoring and early warning information，For prevention、Control the outbreak of infectious diseases、Popular，It is reported by the people's government at the same level，Reported to the competent health and health department of the people's government at or above the provincial level for record，It can be carried out in this administrative area。
Need to be nationwide or cross -provincial、Autonomous Region、For mass prevention in the municipality of the municipality，It should be determined by the State Council's health and health authority。
Make a local people's government at or above the county level or the local people's government or the health and health authority of the State Council shall stake sports betting apporganize relevant departments for personnel training、Publicity Education、Material calling and other work。
No unit or individual may perform massive vaccination without authorization。
Article 51 of the infectious disease outbreak、Popularity，The local people's governments at or above the county level or their health and health authorities need to take emergency vaccination measures，According to the law、Regulations on administrative regulations。
Chapter VI Excellent Reaction Monitoring and Treatment
Article 52: Prevention abnormal reaction，refers to the qualified vaccine during the implementation specifications or after the implementation of the specification, the body tissue organs、Functional damage，Drug adverse reactions with no faults related to all parties。
The following circumstances do not belong to the abnormal response of vaccination:
(1) General reaction after vaccination caused by the characteristics of the vaccine itself;
(2) Damage caused by the quality of vaccine quality to the recipient;
(3) Violation of vaccination work due to the vaccination unit、Immune program、Guidance principle of vaccine use、The damage caused by the vaccination scheme to the recipient;
(4) The seeding person is in the incubation or front -drive period of a certain disease when vaccination，Occasionally occur after vaccination;
(5) Rescurse taboos specified in the vaccine manual，Before the vaccination, the recipient or the guardian did not truthfully provide the health status of the recipient and the contraindication of vaccination，Acute recurrence of the original disease after the vaccination or the increasing condition;
(6) The individual or group of the individual or group due to psychological factors。
Article 53 The State's State Enhance Prevention Disposal Reaction Monitor。Prevention and abnormal response monitoring plan shall be formulated by the State Council's health and health department in conjunction with the State Council's drug supervision and management department。
Article 54 of the vaccination unit、Medical institutions, etc. found suspected preventive vaccination abnormal reactions，Report to the disease prevention and control agency shall be reported。
Vaccine listing license holders shall set up a special agency，Equipment of full -time personnel，Active collection、Tracking Analysis Suspicious Prevention abnormal response，Timely risk control measures，Report the suspected prevention of vaccination abnormal response to the disease prevention and control agency，Submit the quality analysis report to the province、Autonomous Region、The Drug Supervision stake sports betting appand Administration Department of the People's Government of the Municipality directly under the Central Government。
Article 55 to the abnormal reaction of suspected prevention of vaccination，Disease prevention and control institutions shall report it in time in accordance with regulations，Organization survey、Diagnosis，and the survey、Diagnostic conclusion Inform the recipient or the guardian。Investigation、Diagnostic conclusions are controversial，You can apply for appraisal according to the appraisal method formulated by the health and health authority of the State Council。
Due to vaccination caused by vaccination、Disability，or group suspected prevention of vaccination abnormal response and other major impacts on society's suspected prevention abnormal reactions，The health and health authority of the people's government at or above the municipal level of the district、The Drug Supervision stake sports betting appand Administration Department organizes an investigation in accordance with their respective responsibilities、Treatment。
Article 56 The state implements the compensation system for preventing abnormal response in vaccination。During the vaccination process or after vaccination, the person died in the occurrence of the person、Disability、Damage of organs and tissue damage，belongs to the abnormal response of inoculation or cannot be ruled out，Compensation should be given。Compensation scope Implement directory management，and make dynamic adjustments according to the actual situation。
Calculating costs required for vaccination vaccine for vaccination，From the province、Autonomous Region、The financial department of the people's government of the municipality directly under the Central Government arranges in vaccination funds; the compensation fee required for vaccination vaccine for vaccination，Affairs of the holder of the relevant vaccine license holder。The state encourages those who respond to the occurrence of abnormal response to vaccination through various forms such as commercial insurance。
Preventive vaccination reaction compensation shall be timely、Convenience、Reasonable。Prevention and abnormal reaction compensation range、Standard、The program is stipulated by the State Council，Senior、Autonomous Region、Specific implementation measures are formulated in municipalities。
Chapter 7 After the vaccine is listed, managed
57 Vaccine listing permit holders shall establish and improve the quality management system of the entire life cycle of the vaccine，Formulate and implement the risk management plan after vaccine listing，Research after the vaccine listing，Safety of vaccine、Effectivity and quality controller further confirm。
When applying for the registration of the approval vaccine, the vaccine required for further research，The holder of the vaccine listing permit shall complete the study within the prescribed period; the failure of the overdue or fails to prove that its benefit is greater than the risk，The Drug Supervision stake sports betting appand Administration Department of the State Council shall deal with it in accordance with the law，Until canceling the drug registration certificate of the vaccine。
Article 58 The holder of the vaccine listing permit shall conduct quality tracking analysis of the vaccine，Continuous improvement of quality control standards，Improve production technology，Improve the stability of the production process。
Production process、Production venue、Key equipment such as key equipment，It should be evaluated、Verification，In accordance with the provisions of the State Council's Drug Supervision and Administration of the State Council, record or report; change may affect the safety of vaccine、Validity and quality controllability，It shall be approved by the Drug Supervision stake sports betting appand Administration Department of the State Council。
Fifty -ninth vaccine listing permit holder shall be studied according to the vaccine listing、Continuous update instructions、Tag，and apply for approval or filing in accordance with regulations。
The drug supervision and management department of the State Council stake sports betting appshall promptly announce the updated vaccine manual on its website、Tag content。
Article 60 The holder of the vaccine listing permit shall establish a system of vaccine quality retrospective analysis and risk reporting system，Ending vaccine production and circulation every year、Research after listing、Risk management and other situations reported to the State Council's drug supervision and management department in accordance with regulations。
Article 61 The drug supervision and management department of the State Council can be based on the actual situation，Order the vaccine listing permit holder to conduct evaluation after listing or directly organize the evaluation of listing。
Vaccine with severe response to abnormal vaccination or other reasons that harms human health，The Drug Supervision and Management Department of the State Council shall cancel the drug registration certificate of the vaccine。
Article 62 The drug supervision and management department of the State Council may be based on disease prevention、Control needs and development of the vaccine industry，Organizational evaluation of the vaccine variety after listing，Discover the product design of the vaccine variety、Production process、Safety、Effective or quality controllability is obviously inferior to prevention、Control other vaccine varieties of the same disease，Drug registration certificates of all vaccines of this variety should be canceled and the corresponding national drug standards should be abolished。
Chapter 8 Protection Measures
Article 63 The people's governments at or above the county level shall put the vaccine safety work、Purchase of immunization planning vaccines and vaccination work, and information construction required for incompetence into this government budget，Ensuring the implementation of the immune planning system。
The county -level people's government will subsidize rural doctors and other grass -roots medical and health personnel who are engaged in vaccination in accordance with relevant national regulations。
The state gives support to vaccination work in developed areas as needed as needed。Senior、Autonomous Region、The people's government of municipalities and municipal -level people in the municipal -level municipal level shall provide necessary funding subsidies to the county -level people's governments related to the underdeveloped regions of the economy.。
Article 64 province、Autonomous Region、The people's government of the municipality directly under the Central Government is trending in the epidemic of infectious diseases in this administrative area，Prevention prevention of infectious diseases determined by the health and health department of the State Council、Within the range of control items，Determine projects related to this administrative area and vaccination，and ensure the implementation of the project。
Article 65: The health and health authorities of the State Council according to the provinces、Autonomous Region、National immunization planning vaccine use plan，Provide the national immunization planning vaccine demand information，Vaccine listing license Hand holder arranges production reasonably according to vaccine needs。
When there is a risk of supply shortage，The State Council's Health and Health Administration Department、The Drug Supervision stake sports betting appand Administration Department of the State Council made suggestions，The competent department of industry and informatization of the State Council、The financial department of the State Council shall take effective measures，Guarantee vaccine production、Supply。
Vaccine listing permit holders shall organize production in accordance with the law，Guarantee vaccine supply; vaccine listing license holder to stop vaccine production，It should be timely to the State Council's drug supervision and management department or province、Autonomous Region、Report on the Drug Supervision and Management Department of the People's Government of the Municipal Municipality。
Article 66 State incorporate vaccine into strategic material reserves，Implement the central and provincial levels of reserves。
The competent department of industry and informatization of the State Council、The financial department is in conjunction with the health and health authority of the State Council、Public Security Department、Market Supervision and Management Department and Drug Supervision and Administration，According to disease prevention、The need for control and public health emergency preparation，Strengthen the capacity of the reserve vaccine、Product Management，Establish a dynamic adjustment mechanism。
Article 67: Financial arrangements at all levels for vaccination shall be specially dedicated，No unit or individual shall misappropriate、Squeezing。
The funds for the use of vaccinations of relevant units and individuals shall accept audit supervision of the audit organs in accordance with the law。
Article 68 The state implements the mandatory insurance system for vaccine liability。
Vaccine listing permit holders shall insure the vaccine liability for compulsory insurance。For the damage caused by the quality of the vaccine,，Insurance company pays pay within the liability limit of underwriting。
Specific implementation measures for vaccine liability for compulsory insurance system，The medical supervision and management department of the State Council is in conjunction with the State Council's health and health authority、Insurance supervision and management agency, etc.。
Article 69: Infectious disease outbreak、Popularity，Related vaccine listing permit holders shall be produced and supplied to prevent it in a timely manner、Vaccine control infectious diseases。Transportation units shall give priority to transportation prevention、Vaccine control infectious diseases。The people's government at or above the county level and their relevant departments shall make a good organization、Coordination、Guarantee work。
Chapter 9 Supervision and Management
Seventy drug supervision and management department、The competent department of health and health is developed by vaccine in accordance with their respective responsibilities、Production、Circulation and prevention of vaccination for supervision and management，Supervise the vaccine listing permit holder、Disease Prevention and Control Agency、Vacus units, etc. to fulfill their obligations in accordance with the law。
Drug Supervision stake sports betting appand Administration Department for the development of vaccines in accordance with the law、Production、Storage、Transportation and vaccination quality in vaccination and vaccination。The implementation of the competent department of health and health in accordance with the law to implement the immunization planning system、Prevention and inspection of vaccination activities。
The drug supervision and management department shall strengthen the on -site inspection of the holder of the vaccine listing permit; if necessary，can be developed for vaccine、Production、Circulation and other activities to provide products or services to provide an extension inspection; relevant units and individuals should cooperate，Do not refuse and conceal。
Article 71: National Construction of the Central and Provincial levels of professionalization、Specialized Drug Inspector Team，Strengthen the supervision and inspection of the vaccine。
Provincial、Autonomous Region、The Drug Supervision and Management Department of the People's Government of the Municipal Municipality Select inspectors to enter the vaccine listing license holder。Inspectors are responsible for supervising and inspecting the implementation of the quality management of drug production，Collect vaccine quality risks and clues of violations of laws and regulations，Xiang Province、Autonomous Region、The drug supervision and management department of the people's government of the municipality reported the situation and made suggestions，Responsible for the behavior during the staying period。
Article 72 Vaccine Quality Management has hidden safety hazards，The holder of the vaccine listing permit, which has not taken time to eliminate it in time，The drug supervision and management department can take responsibility interviews、Measures for rectification within a time limit。
serious violations of drug -related quality management specifications，The drug supervision and management department shall order the suspension of vaccine production、Sales、Delivery，Immediate rectification; after the rectification is completed，Check the requirements of the drug supervision stake sports betting appand Administration Department，Fang can resume production、Sales、Delivery。
The drug supervision and management department shall establish a vaccine listing license holder and their relevant personnel credit record system，Integrated into the national credit information sharing platform，Publicized the serious dishonest information in accordance with regulations，Implementing joint disciplinary。
Article 73 of the vaccine existence or suspected quality problems，Vaccine listing license holder、Disease Prevention and Control Agency、The vaccination unit shall stop the sales immediately、Delivery、Use，Stop production immediately if necessary，According to the regulations, the drug supervision and management department of the people's government at or above the county level、Report on the competent department of health and health。The competent department of health and health shall immediately organize the disease prevention and control institutions and vaccination units to take necessary emergency response measures，Report to the health and health department of the people's government at the same time at the same time。The drug supervision and management department shall take a seizure in accordance with the law、Search and other measures。For the vaccine that has been sold，Vaccine listing permit holder shall promptly notify the relevant disease prevention and control institutions、Vaccine delivery unit、Inocular vacation unit，Recall in accordance with regulations，Truth recording the recall and notification situation，Disease Prevention and Control Agency、Vaccine delivery unit、The vaccination unit shall cooperate。
No production is stopped in accordance with the provisions of the previous paragraph、Sales、Delivery、Use or recall the vaccine，The drug supervision and management department of the people's government at or above the county level、The competent department of health and health shall stop production in accordance with their respective responsibilities、Sales、Delivery、Use or recall vaccine。
Vaccine listing license holder、Disease Prevention and Control Agency、Vaccination of the vaccination unit found or suspected of quality problems，Do not conceal the report、Lie Bao、Slowly report、omissions，No hidden、Forgery、Destruction of relevant evidence。
Article 74 The holder of the vaccine listing permit shall establish an information disclosure system，Public vaccine product information on its website in accordance with regulations、Manual and label、Drug -related quality management specifications execution、Batch issuance、Recall situation、Information for inspection and punishment, and information such as the compulsory insurance of the vaccine liability。
Article 75. The Drug Supervision stake sports betting appand Administration Department of the State Council will establish vaccine quality with the State Council's Health and Health authorities、Prevention and other information sharing mechanisms。
Drug supervision and management department of the people's government at or above the provincial level、The competent department of health and health shall be in accordance with science、Objective、Timely、stake betting appPublic principles，Organizational vaccine Listing license holder、Disease Prevention and Control Agency、Inocular vacation unit、News media、Scientific Research Unit, etc.，AC and communication on the quality of vaccine quality and vaccination。
Article 76 The state of My stake betting appunified announcement of vaccine safety information in the state。
Vaccine safety risk warning information、Major vaccine safety accidents and their investigation processing information and other vaccine safety information that the State Council is determined to be uniformly announced，It was announced by the Drug Supervision stake sports betting appand Administration Department of the State Council with the relevant departments。National Prevention Abnormal Report Report，The competent department of health and health in the State Council will be announced uniformly with the State Council's drug supervision and management department。The above information shall not be released without authorization。Announce major vaccine safety information，Should be timely、Accurate、Comprehensive，and conduct scientific assessment in accordance with regulations，Make the necessary explanation instructions。
The drug supervision and management department of the people's government at or above the county level found that vaccine security information that might mislead the public and public opinion，It should be immediately in conjunction with the competent department of health and health、Professional institutions、Related vaccine listing permit holders to verify、Analysis，and announce the results in time。
No unit or individual may be fabricated、Dispostering false vaccine safety information。
Article 77 Any unit or individual has the right to understand the vaccine information，Make opinions on the supervision and management of vaccine、Suggestion。
Any unit or individual has the right to give the competent department of health、Drug Supervision stake sports betting appand Administration Department and other departments report vaccine violations，The competent department of health and health、Drug Supervision and Administration departments and other departments and their staff have not fulfilled supervision and management responsibilities in accordance with the law.、Report of the Supervisory Organization。Relevant departments、The agency shall verify it in time、Treatment; Report to verify the truth，Give the reporter reward in accordance with regulations; the reporter's report is serious illegal behavior，Check the true，Give reward。
Article 78 The people's governments at or above the county level shall formulate an emergency plan for vaccine safety incidents，Grade of vaccine safety events、Disposal organizational command system and responsibility、Prevention and early warning mechanism、disposal procedure、Emergency control measures, etc.。
Vaccine listing permit holders shall formulate a vaccine safety event disposal plan，Regularly check the implementation of various preventive measures，Timely eliminate hidden safety hazards。
Vaccine safety incident，The holder of the vaccine listing permit shall immediately use the drug supervision and management department of the State Council or the province、Autonomous Region、The Drug Supervision and Management Department of the People's Government of the Municipal Municipal Government;、Inocular vacation unit、Medical institutions shall immediately bring the health and health authority of the people's government at or above the county level、Report on the Drug Supervision stake sports betting appand Administration Department。The drug supervision and management department shall, in conjunction with the competent department of health and health in accordance with the provisions of the emergency plan，Establishing vaccine safety incident disposal command agency，Carry out medical treatment、Risk control、Investigation processing、Information release、Explanation instructions and other work，Do a good job of replenishment and other post -disposal work。The supplementary cost of vaccine safety incidents caused by quality problems shall be borne by the vaccine listing permit holder。
Relevant units and individuals must not hide the report、Lie Bao、Slowly report、illegal vaccine safety incident，No hidden、Forgery、Destruction of relevant evidence。
Chapter 10 Legal Responsibility
Article 79 violates the provisions of this Law，For the crime，Pressing criminal responsibility from law。
Article 80 production、The vaccine sold is a fake medicine，The drug supervision and management department of the people's government at or above the provincial level confiscated illegal income and illegal production、The vaccine sold and raw materials dedicated to illegal production of vaccines、Accessories、Packaging materials、Equipment and other items，Order to stop production and stop business and rectify，Flowing drug registration certificate，until the drug production license is revoked，Put in illegal production、Sales of fifty fifty -fold more than fifty fifty times of the sales of vaccine goods，The value of the value of the value of less than 500,000 yuan，Calculated at 500,000 yuan。
Production、The vaccine sold is a bad medicine，The drug supervision and management department of the people's government at or above the provincial level confiscated illegal income and illegal production、The vaccine sold and raw materials dedicated to illegal production of vaccines、Accessories、Packaging materials、Equipment and other items，Order to stop production and stop business and rectify，Put in illegal production、Sales of fines of more than ten times the value of vaccine value of more than ten times less than thirty times，The value of the value of the value of less than 500,000 yuan，Calculated at 500,000 yuan; if the circumstances are serious,，Flowing drug registration certificate，until the drug production license is revoked。
Production、The vaccine sold is fake medicine，or production、The vaccine sold is a bad medicine and a serious plot，Drug supervision and management department of the people's government at or above the provincial level、Main person in charge、Directly responsible for supervisors and key position personnel and other responsible personnel，The income from the unit during the occurrence of illegal acts，Power of more than ten times more than ten times the income of the office，Lifetime forbidden to engage in drug production and operation activities，Detention by the Public Security Organ Office for 5 days and less than 15 days。
Article 81 There is one of the following situations，The drug supervision and management department of the people's government at or above the provincial level confiscated illegal income and illegal production、The vaccine sold and raw materials dedicated to illegal production of vaccines、Accessories、Packaging materials、Equipment and other items，Order to stop production and stop business and rectify，Put in illegal production、Sales of fifty fifty -fold more than fifty fifty times of the sales of vaccine goods，The value of the value of the value of less than 500,000 yuan，Calculated at 500,000 yuan; if the circumstances are serious,，A revocation of the approval document of the drug，until the drug production license is revoked，For legal representatives、Main person in charge、Directly responsible for supervisors and key position personnel and other responsible personnel，The income from the unit during the occurrence of illegal acts，Power of more than 10 % of the income of more than ten percent of the income，within ten years until it is forbidden to engage in drug production and operation activities，Detention by the Public Security Organ Office of 5 days and less than 15 days:
(1) Application for clinical trials of vaccine、Registration、Employment issued to provide false data、Information、Sample or other deception;
(2) Formulating production、Inspection records or change the product batch number;
(3) Units or individuals other than disease prevention and control institutions supply vaccines to vaccination units;
(4) Entrusted production vaccine is not approved;
(5) Production process、Production venue、Change of key equipment and other changes shall be approved without approval;
(6) Update the vaccine manual、Tagged in accordance with regulations shall be approved without approval。
Article 82 Except for the situation specified in this law，Vaccine listing license holder or other units violates the drug -related quality management specifications，The drug supervision and management department of the people's government at or above the county level is ordered to make corrections，Give warning; refuse to correct，fines of more than 500,000 yuan or less than 500,000 yuan;，Fine fines of 500,000 yuan and more than 3 million yuan，Order to stop production and stop business and rectify，Until revoke the approval document of the drug、Drug production license, etc.，For legal representatives、Main person in charge、Directly responsible for supervisors and key position personnel and other responsible personnel，The income from the unit during the occurrence of illegal acts，Power of more than 50 % of the revenue of more than 50 % of the income，within ten years until it is forbidden to engage in drug production and operation activities。
Article 83 violates the provisions of this Law，Vaccine listing license holder has one of the following situations，The drug supervision and management department of the people's government at or above the provincial level is ordered to make corrections，Give warning; refuse to correct，fines of more than 500,000 yuan or less than 500,000 yuan;，Order to stop production and stop business and rectify，Fined fines of more than 500,000 yuan and more than 2 million yuan:
(1) Failure to establish a vaccine electronic traceability system in accordance with regulations;
(2) Legal representative、The principal person in charge and the person in charge of production management、The person in charge of quality management、Personnel such as Quality Extraordinary Persons do not meet the prescribed conditions or fail to train it in accordance with regulations、Assessment;
(3) No report or filing in accordance with the regulations;
(4) Research after not being carried out in accordance with regulations，or the establishment of an organization in accordance with the regulations、Equipped staff actively collect、Tracking Analysis Suspected of Prevention abnormal response;
(5) The liability insurance for vaccine is not insured in accordance with regulations;
(6) Failure to establish an information disclosure system in accordance with regulations。
Article 84 violates the provisions of this Law，A batch of issuing agencies have one of the following situations，The drug supervision and management department of the State Council is ordered to make corrections，Give warning，For the main person in charge、Direct responsible persons in charge and other directly responsible personnel give warns to a downgrade:
(1) No review and inspection in accordance with regulations;
(2) The results of the issuance of the vaccine approval were not announced in time;
(3) Failure to verify in accordance with regulations;
(4) It is found that there are major quality risks of vaccines that have not reported in accordance with regulations。
Violation of the provisions of this Law，A batch of issuance agencies fail to issue certificates to the approval certificate or not to issue notifications，The drug supervision and management department of the State Council is ordered to make corrections，Give warning，For the main person in charge、Direct responsible persons in charge and other directly responsible personnel give relegation or dismissal according to law;，For the main person in charge、Direct responsible persons in charge and other direct responsible persons give away removal in accordance with the law。
Article 85. Disease prevention and control agency、Inocular vacation unit、Vaccine listing license holder、Vaccine distribution unit violates the vaccine storage、Transportation management specifications are related to cold chain storage、Transportation requirements，The drug supervision and management department of the people's government at or above the county level is ordered to make corrections，Give warning，Storage of illegal storage、Destroyed vaccine for transportation，Confession of illegal income; refusal to correct，Inoculation unit、Vaccine listing license holder、The vaccine distribution unit is fined 200,000 yuan or less than one million yuan;，Inoculation unit、Vaccine listing license holder、Vaccine delivery units illegally stored、Finemakes of more than ten times the value of the transport vaccine value of more than ten times less than thirty times，The value of the value of less than 100,000 yuan，Calculated at 100,000 yuan，Order the vaccine listing permit holder、Vaccine distribution unit stops production and discontinued business，Until revoke the approval document of the drug、Drug production license, etc.，Permit holder of vaccine listing、Legal representative of the vaccine distribution unit、Main person in charge、Direct responsible personnel and key position personnel and other responsible personnel shall be punished in accordance with Article 82 of this Law。
Disease Prevention and Control Agency、The vaccination unit has illegal acts stipulated in the preceding paragraph，from the health and health authority of the people's government at or above the county level、Direct responsible persons in charge and other direct responsible personnel give warns to be given in accordance with the law until they are dismissed，Order responsible for responsible medical and health personnel to suspend practicing activities for more than one year or less;，For the main person in charge、Direct responsible persons in charge and other direct responsible persons give away removal in accordance with the law，and can be revoked to the vaccination qualification of the vaccination unit，A practicing certificate of the responsible medical and health personnel with the original certificate department。
Article 86 Disease Prevention and Control Agency、Inocular vacation unit、Vaccine listing license holder、Vaccine distribution units have illegal vaccine storage outside of Article 85 of this Law、Regular behavior of transportation management，The drug supervision and management department of the people's government at or above the county level is ordered to make corrections，Give warning，Confession of illegal income; refusal to correct，Inoculation unit、Vaccine listing license holder、Walls and distribution units are fined 100,000 yuan or more than 300,000 yuan;，Inoculation unit、Vaccine listing license holder、Vaccine delivery units illegally stored、Finemakes of more than three times the value of the transport vaccine value of more than ten times the value，The value of the value of less than 100,000 yuan，Calculated at 100,000 yuan。
Disease Prevention and Control Agency、The vaccination unit has illegal acts stipulated in the preceding paragraph，The health and health authority of the people's government at or above the county level may be the main person in charge、Direct responsible persons in charge and other direct responsible personnel give warns to be given in accordance with the law until they are dismissed，Order responsible for responsible medical and health personnel to suspend practicing activities for more than six months or less;，For the main person in charge、Direct responsible persons in charge and other direct responsible persons give away removal in accordance with the law，A practicing certificate of the responsible medical and health personnel with the original certificate department。
Article 87 violates the provisions of this Law，Disease Prevention and Control Agency、The inoculation unit has one of the following circumstances，The health and health authority of the people's government at or above the county level ordered correction，Give warning，Confession of illegal income; if the circumstances are serious，For the main person in charge、Direct responsible persons in charge and other direct responsible personnel give warns to be given in accordance with the law until they are dismissed，Order responsible for responsible medical and health personnel to suspend practicing activities for more than one year or less;，For the main person in charge、Direct responsible persons in charge and other direct responsible persons give away removal in accordance with the law，A practicing certificate of responsible medical and health personnel revoked by the original certificate department:
(1) No supply in accordance with regulations、Receive、Purchasing vaccine;
(2) The vaccine did not comply with the specification of vaccination work、Immune program、Guidance principle of vaccine use、vaccination plan;
(3) Unauthorized vaccination of mass prevention.
Article 88 violates the provisions of this Law，Disease Prevention and Control Agency、The inoculation unit has one of the following circumstances，The health and health authority of the people's government at or above the county level ordered correction，Give warning;，For the main person in charge、Direct responsible persons in charge and other direct responsible personnel give warns to be given in accordance with the law until they are dismissed，Order responsible for responsible medical and health personnel to suspend practicing activities for more than six months or less;，For the main person in charge、Direct responsible persons in charge and other direct responsible persons give away removal in accordance with the law，A practicing certificate of responsible medical and health personnel revoked by the original certificate department:
(1) No traceability information is not provided in accordance with regulations;9
(2) No request for obtaining and saving relevant certification documents in accordance with regulations when receiving or purchasing vaccines、temperature monitoring record;
(3) Failure to establish and save vaccine reception in accordance with regulations、Buy、Storage、Delivery、Supply、Vocating、Disposal records;
(4) No notification in accordance with regulations、Ask the recipient or the relevant situation of its guardian。
Article 89 Disease Prevention and Control Agency、Inocular vacation unit、Medical institutions have not reported in accordance with the regulations to suspect the abnormal response of vaccination、Vaccine Safety Incident, etc.，Or did not investigate the organization of suspected prevention in vaccination abnormal response in accordance with regulations、Diagnosis, etc.，The health and health authority of the people's government at or above the county level ordered correction，Give warning;，Inoculation unit、A fine of 50,000 yuan or less than 500,000 yuan for medical institutions，Disease prevention and control agency、Inocular vacation unit、The main person in charge of the medical institution、Direct responsible persons in charge and other directly responsible personnel give warns to be given in accordance with the law until they are dismissed;，For the main person in charge、Direct responsible persons in charge and other direct responsible persons give away removal in accordance with the law，A practicing certificate of the responsible medical and health personnel with the original certificate department。
Article 90 Disease Prevention and Control Agency、The vaccination unit violates the fees charged by the provisions of this Law，The health and health authorities of the people's government at or above the county level supervise that it will refund the illegal fee to the original unit or individual，and the market supervision and management department of the people's government at or above the county level is punished in accordance with the law。
Article 91 violates the provisions of this Law，Unscooing the local people's governments at or above the county level designation designated to engage in immunization planning vaccination work、If the vaccination work engaged in non -immunization planning is not eligible or unpacking，The health and health authority of the people's government at or above the county level ordered correction，Give warning，Vaccinations that confiscate illegal income and illegal holding，Order to stop business and rectify，and fined a fine of 100,000 yuan or less，For the main person in charge、Direct responsible supervisors and other directly responsible personnel give punishments in accordance with the law。
Violation of the provisions of this Law，Disease Prevention and Control Agency、Units or individuals other than vaccination units or individuals perform group prevention in vaccination without authorization，The health and health authority of the people's government at or above the county level ordered correction，Vaccinations that confiscate illegal income and illegal holding，Paper with a value of more than ten times less than ten times more than thirty times the amount of vaccine goods held in illegal illegal goods，The value of the value of less than 50,000 yuan，Calculated at 50,000 yuan。
Article 92 The guardian fails to ensure that children with appropriate age are vaccinated on time in accordance with the law，Criticive education by the health and health authority of the county -level people's government，Order to correct。
Children's institution、The school is entrusted by children、Non -checking prevention certificate in accordance with regulations，or found that the child who did not take the vaccination in accordance with the regulations，The education administrative department of the local people's government at or above the county level is ordered to make corrections，Give warning，For the main person in charge、Direct responsible supervisors and other directly responsible personnel give punishments in accordance with the law。
Article 93 Formulation、Dispostering false vaccine safety information，or provoking trouble in the vaccination unit，It constitutes a violation of public security management behaviors，Public security management punishment is given by public security organs。
Newspaper、Journal、Broadcast、TV、Internet website and other communication media composition、Disclosing the safety information of false vaccine，Penalties My stake betting appshall be punished by relevant departments in accordance with the law，For the main person in charge、Direct responsible supervisors and other directly responsible personnel give punishments in accordance with the law。
Article 94 The local people's governments at or above the county level have one of the following Stake Sports Bettingsituations in the vaccine supervision and management work，The direct responsible supervisor and other directly responsible persons give a downgrade or dismissal in accordance with the law;，Give fired sanctions in accordance with the law;，Its principal person in charge shall resign:
(1) Performing poor responsibilities，Caused serious adverse effects or major losses;
(2) Concealment、Lie Bao、Slowly report、illegal vaccine safety incident;
(3) Interference、Obstacles investigation of vaccine violations or vaccine safety incidents;
(4) Special major vaccine safety accidents occur in this administrative area，or major vaccine safety accidents occur continuously。
Article 95 Drug Supervision and Administration、The competent department and other departments of the health and health department have one of the following Stake Sports Bettingsituations in the vaccine supervision and management，The direct responsible supervisor and other directly responsible persons give a downgrade or dismissal in accordance with the law;，Give fired sanctions in accordance with the law;，Its principal person in charge shall resign:
(1) Duties of failure to perform supervision and inspection，or it is not found to be investigated and dealt with in time;
(2) Grouping for vaccination without authorization;
(3) concealment、Lie Bao、Slowly report、illegal vaccine safety incident;
(4) Interference、Obstacles investigation of vaccine violations or vaccine safety incidents;
(5) Leakage the information of the reporter;
(6) Relevant reports from suspected prevention of vaccination abnormal reactions，Failure to organize investigations in accordance with regulations、Treatment;
(7) Other behaviors that have not fulfilled vaccine supervision and administration，Caused serious adverse effects or major losses。
Article 96 It is damaged by species damage caused by vaccine quality problems，The holder of the vaccine listing permit shall bear the liability for compensation in accordance with the law。
Disease Prevention and Control Agency、The vaccination unit violates the specifications of vaccination work、Immune program、Guidance principle of vaccine use、vaccination scheme，The damage to the species，shall bear the liability for compensation in accordance with the law。
Chapter 11 Attachment Jeebu
Article 97 The meaning of the following words in this law is:
Immunization planning vaccine，Refers to the vaccine that residents should vaccinate in accordance with the government，Including vaccines determined by national immunization plan，Senior、Autonomous Region、The people's government of the municipality directly under the Central Government will increase the vaccine increased by the national immunization planning，and the emergency vaccination or mass prevention of mass prevention in the people's government at or above the county level or its health and health authority。
Non -immune planning vaccine，refers to other vaccines voluntarily vaccinated by residents。
Vaccine listing license holder，refers to an enterprise that obtains the vaccine drug registration certificate and drug production license。
Article 98 The state encourages vaccine manufacturers to produce in accordance with international procurement requirements、Export vaccine。
The vaccine exported should meet the standards or contract requirements of imported countries (regions)。
Article 99，A separate regulations of the financial department of the commercial and State Council of the State Council of the State Health and Quarantine Organization。
Article 100 of this law will be implemented from December 1, 2019。
