Article 1 This Law is enacted for the purpose of strengthening the administration of vaccines, ensuring the quality and supply of vaccines, regulating preventive vaccination, promoting the development of the vaccine industry, safeguarding public health, and maintaining public health and safety.

Article 2 This Law shall apply to the development, production, circulation and preventive inoculation of vaccines and their supervision and management activities within the territory of the People's Republic of China. Where this Law is silent, the provisions of the Drug Administration Law of the People's Republic of China, the Law of the People's Republic of China on Prevention and Control of Infectious Diseases and other laws and administrative regulations shall apply.

Vaccines referred to in this Law are preventive biological products used for human immunisation for the purpose of preventing and controlling the occurrence and prevalence of diseases, including immunisation plan vaccines and non-immunisation plan vaccines.

Article 3 The State shall implement the strictest management system for vaccines, insisting on safety first, risk management, full control, scientific supervision and social co-management.

Article 4 The State insists on the strategic and public welfare nature of vaccine products.

The State supports basic and applied research on vaccines, promotes the development and innovation of vaccines, and incorporates the development, production and stockpiling of vaccines for the prevention and control of major diseases into national strategies.

The State formulates development plans and industrial policies for the vaccine industry, supports the development and structural optimisation of the vaccine industry, encourages the scale and intensification of vaccine production, and continuously improves the vaccine production process and quality level.

Article 5 The holder of the marketing licence for vaccines shall strengthen the quality management of the whole life cycle of vaccines, and shall be responsible for the safety, efficacy and controllable quality of vaccines.

Units and individuals engaged in vaccine development, production, circulation and vaccination activities shall comply with laws, regulations, rules, standards and norms to ensure that the whole process of information is true, accurate, complete and traceable, and shall assume responsibility in accordance with the law and accept social supervision.

Article 6 The State implements a system of immunisation planning.

Residents living in China shall, in accordance with the law, enjoy the right to receive immunisation-planning vaccines and fulfil the obligation to receive immunisation-planning vaccines. The Government provides immunisation vaccines to residents free of charge.

People's governments at or above the county level and their relevant departments shall ensure that children of school age receive immunisation vaccines. Guardians shall, in accordance with the law, ensure that children of school age receive immunisation programme vaccines on time.

Article 7 The people's governments at or above the county level shall incorporate vaccine safety work and preventive vaccination work into the national economic and social development planning at their respective levels, strengthen the capacity building of vaccine supervision and management, and 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 vaccines in their own administrative areas, and unify the leadership, organisation and coordination of the supervision and management of vaccines in their own administrative areas.

Article 8 The drug supervision and administration department of the State Council is responsible for the supervision and administration of vaccines nationwide. The competent department of health under the State Council is responsible for the supervision and management of national vaccination. Other relevant departments of the State Council shall be responsible for the supervision and management of vaccine-related work within their respective areas of responsibility.

The drug supervision and administration departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for the supervision and administration of vaccines in their respective administrative regions. The departments of the people's governments at the municipal and county levels that are responsible for drug supervision and management (hereinafter referred to as drug supervision and management departments) are responsible for the supervision and management of vaccines in their respective administrative areas. The competent department of health of the local people's government at or above the county level is responsible for the supervision and management of vaccination in the administrative region. Other relevant departments of the local people's governments at or above the county level are responsible for vaccine-related supervision and management work within their respective areas of responsibility.

Article 9 The State Council and the people's governments of provinces, autonomous regions and municipalities directly under the Central Government establish a departmental coordination mechanism to coordinate the supervision and management of vaccines, regularly analyse the vaccine safety situation, strengthen the supervision and management of vaccines, and ensure the supply of vaccines.

Article 10 The State implements a full electronic traceability system for vaccines.

The drug supervision and management department under the State Council, in conjunction with the competent health department under the State Council, shall formulate unified vaccine traceability standards and specifications, establish a national electronic vaccine traceability platform, integrate vaccine production, circulation and vaccination traceability information, and realise vaccine traceability.

The holder of a listed vaccine licence shall establish an electronic vaccine traceability system, which shall be connected with the national vaccine electronic traceability coordination platform, so as to achieve the traceability and verification of the smallest packaging unit of vaccines in the whole process of production, circulation and preventive vaccination.

Disease prevention and control institutions, vaccination units shall, in accordance with the law, truthfully record the circulation of vaccines, vaccination and other circumstances, and in accordance with the provisions of the national vaccine electronic traceability platform to provide traceability information.

Article XI of the vaccine development, production, testing and other processes should establish and improve the biosafety management system, strict control of biosafety risks, strengthen the strain and other pathogenic microorganisms biosafety management, to protect the health of operators and the public, to ensure that strains of pathogenic microorganisms such as legal and legitimate use.

Vaccine development, production, testing and other use of bacteriophage and cell strains, should be clear history, biological characteristics, generation, the establishment of a detailed file, to ensure that the source is legal, clear, traceable; the source is unknown, shall not be used.

Article XII of the people's governments at all levels and their relevant departments, disease prevention and control institutions, vaccination units, vaccine marketing licence holders and vaccine industry associations should be carried out regularly through the National Children's Vaccination Day and other activities such as vaccine safety laws and regulations, as well as knowledge of preventive vaccination publicity and education, popularisation work.

The news media shall carry out public service propaganda on vaccine safety laws and regulations as well as knowledge of preventive vaccination, and shall supervise public opinion on vaccine violations. Publicity and reporting on vaccines should be comprehensive, scientific, objective and impartial.

Article XIII of the vaccine industry associations should strengthen industry self-discipline, establish and improve industry norms, promote the construction of industry integrity system, guide and supervise members of the production and management activities in accordance with the law.

Chapter II Vaccine Development and Registration

Article XIV of the state according to the prevalence of disease, population immunity status and other factors, the development of the relevant planning, arrange the necessary funds to support the development of new types of vaccines, such as multiplex polyvalent.

The State organises joint research by the holder of the marketing authorisation for vaccines, scientific research institutions and medical and health institutions to develop vaccines that are urgently needed for the prevention and control of diseases.

Article 15 The State encourages the holder of the marketing authorisation for vaccines to increase funding for research and innovation, optimise the production process, improve the level of quality control, and promote the technological progress of vaccines.

Article XVI of the vaccine clinical trials, shall be approved by the State Council Drug Administration according to law.

Vaccine clinical trials shall be implemented or organised by the State Council drug supervision and management department and the State Council department in charge of health conditions of the third level of medical institutions or disease prevention and control institutions above the provincial level.

The state encourages qualified medical institutions, disease prevention and control institutions to carry out clinical trials of vaccines according to law.

Article XVII of the vaccine clinical trial sponsors should develop clinical trial programme, the establishment of clinical trial safety monitoring and evaluation system, prudent selection of subjects, reasonable set of subjects and age groups, and according to the degree of risk to take effective measures to protect the legitimate rights and interests of the subjects.

Article 18 The clinical trials of vaccines shall obtain the written informed consent of the subjects; the subjects of persons without civil capacity, shall obtain the written informed consent of their guardians; the subjects of persons with limited civil capacity, shall obtain the written informed consent of themselves and their guardians.

Article 19 of the vaccine marketed in China shall be approved by the State Council Drug Administration, to obtain a certificate of registration of drugs; apply for vaccine registration, should provide true, adequate and reliable data, information and samples.

For disease prevention, control of vaccines and innovative vaccines in urgent need, the State Council Drug Administration shall give priority to review and approval.

Article 20 The vaccines urgently needed to deal with major public health emergencies or other vaccines that the competent health department of the State Council determines to be urgently needed, where the benefits are assessed to be greater than the risks, the drug administration department of the State Council may approve the application for registration of the vaccine with conditions.

In the event of a particularly major public health emergency or other emergency that poses a serious threat to public health, the competent department of health under the State Council shall make a proposal for the emergency use of the vaccine in accordance with the needs of prevention and control of infectious diseases, and the drug regulatory authority under the State Council may approve the emergency use of the vaccine within a certain range and period of time after the organisation of the demonstration and consent.

Article 21 The drug administration department under the State Council shall, in approving the application for registration of a vaccine, approve the production process, quality control standards, and instructions and labelling of the vaccine.

Drug supervision and administration department under the State Council shall promptly publish the content of vaccine instructions and labels on its website.

Chapter III Vaccine Production and Wholesale Issue

Article 22 The state of vaccine production to implement a strict access system.

Engaged in vaccine production activities, should be approved by the drug supervision and management department of the people's government at or above the provincial level, to obtain a drug production licence.

Engaged in vaccine production activities, in addition to meet the "Drug Administration Law of the People's Republic of China" stipulates the conditions for engaging in drug production activities, should also have the following conditions:

(a) have an appropriate scale and sufficient capacity reserves.

(ii) Have a system and facilities and equipment to ensure biological safety; and

(iii) Meet the needs of disease prevention and control.

Vaccine marketing licence holders should have vaccine production capacity; beyond the vaccine production capacity needs to be commissioned, should be approved by the State Council Drug Administration. Acceptance of commissioned production, shall comply with the provisions of this Law and the relevant provisions of the State, to ensure the quality of vaccines.

Article 23 The legal representative of the vaccine marketing licence holder, the main person in charge shall have a good credit record, production management, quality management, quality of the person in charge of the key positions such as the authorised person shall have the relevant professional background and experience.

The holder of the listed vaccine licence shall strengthen the training and assessment of the personnel stipulated in the preceding paragraph, and promptly report their positions and changes to the drug supervision and administration department of the people's government of the province, autonomous region or municipality directly under the central government.

Article 24 The vaccine shall be in accordance with the approved production process and quality control standards for production and testing, the whole process of production shall comply with the requirements of the Good Manufacturing Practice.

Vaccine marketing licence holder shall, in accordance with the provisions of the whole process of vaccine production and vaccine quality audit, inspection.

Article 25 The holder of the vaccine marketing licence shall establish a complete production quality management system, continue to strengthen the deviation management, the use of information technology means of factual records of all data formed in the production and inspection process, to ensure that the whole process of production continues to meet the statutory requirements.

Article 26 The state implements the vaccine batch issuance system.

Each batch of vaccines before sale or imported, should be designated by the State Council Drug Administration batch issue organisation in accordance with the relevant technical requirements for audit, inspection. Meet the requirements, issued by the batch issue certificate; does not meet the requirements, issued by the non-issuance notice.

Not approved and issued vaccines shall not be sold, and shall be supervised by the provincial, autonomous regions and municipalities directly under the Central People's Government drug supervision and management departments to destroy; not approved and issued imported vaccines shall be supervised by the port where the drug supervision and management departments to destroy or other treatment in accordance with the law.

Drug supervision and management department of the State Council, the approval and issuance of the agency shall promptly announce the results of listed vaccines issued for public enquiry.

Article 27 The application for the wholesale and issue of vaccines shall be in accordance with the provisions of the batch production and inspection records to provide the batch issuing agency summary information and samples of the same batch number of products. Imported vaccines should also provide proof of origin, certificate of issue; in the country of origin exempted from batch issuance, should provide proof of exemption from batch issuance.

Article 28 The prevention and control of infectious disease outbreaks or to deal with emergencies urgently needed vaccines, approved by the State Council Drug Administration, exempted from wholesale issue.

Article 29 The wholesale issuance of vaccines should be batch by batch data review and sampling. Vaccine wholesale and issue test items and test frequency should be based on the vaccine quality risk assessment for dynamic adjustment.

Application for vaccine issuance or the authenticity of the sample is in doubt, or there is a need for further verification of the situation, the agency shall be verified, if necessary, should be used to organise on-site verification of sampling and testing and other means.

Article 30 The wholesale and issue organisations in the wholesale and issue process found that there are significant quality risks of vaccines, shall promptly report to the State Council Drug Administration and the provincial, autonomous regions and municipalities directly under the Central People's Government Drug Administration.

Received the report of the department shall immediately carry out on-site inspection of the vaccine marketing licence holder, according to the results of the inspection notify the wholesale and issue agency of the vaccine marketing licence holder of the relevant products or all the products are not issued or suspended from the wholesale and issue, and order the vaccine marketing licence holder to rectify. The vaccine marketing licence holder shall immediately rectify, and promptly report the rectification situation to the department that ordered the rectification.

Article 31 of the production process deviations, quality differences, failures and accidents in the production process and the measures taken, the holder of the vaccine marketing authorisation shall be recorded truthfully, and in the corresponding batch of products in the application for batch issuance of documents; may affect the quality of the vaccine, the holder of the vaccine marketing authorisation shall take immediate measures, and to the provincial, autonomous regions and municipalities directly under the Central People's Government Drug Administration report.

Chapter IV Vaccine Circulation

Article 32 The national immunization plan vaccines by the State Council health department in conjunction with the State Council financial department and other organisations centralised bidding or unified negotiation, the formation and announcement of the winning price or transaction price, the provinces, autonomous regions and municipalities directly under the Central Government to implement unified procurement.

National Immunisation Programme vaccines other than immunisation programme vaccines, non-immunisation programme vaccines by the provinces, autonomous regions and municipalities directly under the Central Government through the provincial public resources trading platform organised procurement.

Article 33 The price of vaccines shall be independently and reasonably set by the holder of the listed vaccine licence in accordance with the law. The price level of vaccines, price differentials, profit margins should be maintained at a reasonable range.

Article 34 Provincial disease prevention and control agencies shall, in accordance with the national immunisation plan and the needs of disease prevention and control in the administrative region, formulate a plan for the use of vaccines for immunisation planning in the administrative region, and report it in accordance with the relevant provisions of the State to the department organising the procurement of vaccines, and at the same time report it to the department in charge of health of the people's government of the province, autonomous region, or municipality directly under the Central Government for the record.

Article 35 The holder of a listed licence for a vaccine shall supply the vaccine to the disease prevention and control institution in accordance with the agreement of the procurement contract.

The disease prevention and control agency shall supply vaccines to the vaccination unit in accordance with the regulations.

Units and individuals other than disease prevention and control institutions shall not supply vaccines to the vaccination unit, and the vaccination unit shall not receive the vaccine.

Article 36 The holder of the listed vaccine licence shall, in accordance with the procurement contract, to the disease prevention and control institutions or disease prevention and control institutions designated by the vaccination unit distribution of vaccines.

Vaccine marketing licence holders, disease prevention and control institutions to distribute vaccines should have the vaccine cold chain storage, transport conditions, can also be entrusted to meet the conditions of the vaccine distribution unit distribution of vaccines.

Disease prevention and control institutions to distribute non-immunisation vaccines can be charged for storage and transport costs, the specific measures developed by the State Council finance department in conjunction with the State Council department in charge of prices, charges by the provinces, autonomous regions and municipalities directly under the Central People's Government in charge of prices, in conjunction with the finance department.

Article 37 Disease prevention and control institutions, vaccination units, vaccine marketing licence holders, vaccine distribution units shall comply with the vaccine storage, transport management norms, to ensure the quality of vaccines.

Vaccines in storage, transport throughout the process should be in the specified temperature environment, cold chain storage, transport should meet the requirements, and regularly monitor and record the temperature.

Vaccine storage, transport management specifications by the State Council drug supervision and management department, the State Council department in charge of health jointly developed.

Article 38 The holder of the listed vaccine licence in the sale of vaccines, shall provide a copy of the batch issuance certificate stamped with its seal or electronic documents; sales of imported vaccines, but also shall provide a copy of the imported drug customs clearance stamped with its seal or electronic documents.

Disease prevention and control institutions, vaccination units in the receipt or purchase of vaccines, shall request the documents specified in the preceding paragraph, and save to the expiry of the vaccine not less than five years for inspection.

Article 39 The holder of the listed vaccine licence shall, in accordance with the provisions of the establishment of true, accurate and complete sales records, and save to the expiry of the vaccine not less than five years for inspection.

Disease prevention and control institutions, vaccination units, vaccine distribution units shall, in accordance with the provisions of the establishment of true, accurate and complete reception, purchase, storage, distribution, supply records, and save to the expiry of the vaccine not less than five years for inspection.

Disease prevention and control institutions, vaccination units to receive or purchase vaccines, should request the transport, storage temperature monitoring records of the whole process, and save to the expiry of the validity of the vaccine for not less than five years for inspection; can not provide the transport, storage temperature monitoring records of the whole process, or the temperature control does not meet the requirements, shall not be received or purchased, and shall immediately report to the local people's government at or above the county level, the supervision and administration of drugs, health and health authorities. , the competent department of health and health report.

Article 40 The disease prevention and control institutions, vaccination units shall establish a regular inspection system for vaccines, the existence of packaging can not be identified, the storage temperature does not meet the requirements, more than the expiry date of the vaccine, to take measures such as isolation and storage, set up warning signs, and disposed of in accordance with the State Council drug supervision and management department, the competent department of health, ecological environment, the competent department. Disease prevention and control institutions, vaccination units should be truthfully recorded disposal, disposal records should be kept until the expiration of the vaccine for no less than five years for inspection.　　Chapter V Preventive Vaccination

Article 41 The health department of the State Council to develop national immunisation plan; national immunisation plan vaccine types developed by the State Council health department in conjunction with the State Council finance department, for approval by the State Council and then announced.

The competent health department of the State Council to establish the national immunisation plan expert advisory committee, and in conjunction with the financial department of the State Council to establish the national immunisation plan vaccine types dynamic adjustment mechanism.

The people's governments of provinces, autonomous regions and municipalities directly under the Central Government may, in implementing the national immunisation programme, increase the types of vaccines for the immunisation programme in accordance with the needs for disease prevention and control in their own administrative regions, and report them to the competent health department of the State Council for the record and for publication.

Article 42 The competent health authorities under the State Council shall formulate and publish specifications for preventive vaccination work and strengthen the standardised management of preventive vaccination.

The competent health authorities under the State Council shall formulate and publish the immunisation procedures for national immunisation programme vaccines and the guiding principles for the use of non-immunisation programme vaccines.

The competent health authorities of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall formulate vaccination programmes in the light of the actual situation in their respective administrative regions and report them to the competent health authorities of the State Council for the record.

Article 43 The disease prevention and control agencies at all levels shall, in accordance with their respective responsibilities, to carry out vaccination-related publicity, training, technical guidance, monitoring, evaluation, epidemiological investigation, emergency response.

Article 44 The vaccination unit shall have the following conditions:

(a) obtain a medical practice permit.

(B) has after the county-level people's government health department organised professional training in vaccination and assessment of qualified physicians, nurses or rural doctors;.

(C) have in line with the vaccine storage, transport management norms of cold storage facilities, equipment and cold storage and storage system.

The competent health authorities of the local people's governments at or above the county level designate qualified medical institutions to assume responsibility for immunisation vaccination in the region. Qualified medical institutions may undertake non-immunisation vaccination work, and shall report to the healthcare authority that issued the licence to practise as a medical institution for the record.

Vaccination units should strengthen their internal management, and carry out vaccination work in compliance with the norms for preventive vaccination work, immunisation procedures, guiding principles for the use of vaccines and vaccination programmes.

Disease prevention and control institutions at all levels shall strengthen the technical guidance of vaccination units and the management of vaccine use.

Article 45 medical and health personnel to implement the vaccination, shall inform the vaccinee or his guardian of the vaccine varieties, role, contraindications, adverse reactions, as well as on-site observation and other precautions, and ask the vaccinee's health status and whether there are contraindications to vaccination and other circumstances, and truthfully record the information and enquiries. The vaccinee or his/her guardian should truthfully provide the vaccinee's health status and contraindications to vaccination. There are contraindications to vaccination can not be inoculated, health care personnel should be to the vaccinee or his guardian to put forward medical advice, and truthfully record the medical advice.

Medical and health personnel before the implementation of vaccination, should be in accordance with the requirements of the norms of preventive vaccination work, check the health status of the vaccinee, verification of contraindications to vaccination, check the preventive vaccination certificate, check the appearance of the vaccine, syringes, batch number, expiration date, check the name of the vaccinee, age and vaccine name, specifications, dosage, site of inoculation, route of vaccination, so as to ensure that the information on the recipient, the certificate of preventive vaccination and the vaccine information is consistent, and to confirm that there is no error before the implementation of vaccination. The vaccination shall be carried out only after it is confirmed to be correct.

Medical and health personnel shall administer the vaccination to recipients who meet the conditions for vaccination. The vaccinee in the scene during the observation of adverse reactions, medical and health personnel shall, in accordance with the requirements of the norms of preventive vaccination work, and take timely measures such as rescue and treatment.

Article 46 health care personnel shall, in accordance with the provisions of the competent health department of the State Council, true, accurate and complete records of vaccine varieties, marketing licence holders, the identification of the smallest packaging unit, the expiration date, vaccination time, implementation of vaccination of health care personnel, vaccinees and other vaccination information, to ensure that the vaccination information can be traced back and can be queried. Vaccination records shall be kept until no less than five years after the expiration date of the vaccine for inspection.

Article 47 The State shall implement a system of preventive vaccination certificates for children. Within one month after the birth of a child, his or her guardian shall go to the child's place of residence to undertake the work of preventive vaccination of the vaccination unit or birth hospital for his or her preventive vaccination certificate. The inoculation unit or hospital of birth shall not refuse to do so. The guardian shall keep the preventive vaccination certificate in a safe place.

Preventive vaccination implementation of the management of residence, the child left the original place of residence, by the current place of residence to undertake the work of preventive vaccination vaccination unit is responsible for the implementation of their vaccination.

The format of the preventive vaccination certificate shall be prescribed by the competent health authorities under the State Council.

Article 48 When a child is admitted to nursery school or school, the nursery school or school shall check the preventive vaccination certificate, and if it is found that the child has not been vaccinated with the immunisation programme vaccine in accordance with the regulations, it shall report the case to the vaccination unit responsible for preventive vaccination at the child's place of residence or where the nursery school or school is located, and cooperate with the vaccination unit in supervising the guardian to make up for the vaccination in accordance with the regulations. Disease prevention and control institutions shall provide technical guidance for childcare institutions and schools to check the preventive vaccination certificate.

Children into childcare, school preventive vaccination certificate check by the State Council department in charge of health in conjunction with the State Council administrative department of education to develop.

Article 49 The vaccination unit shall not charge any fee for immunisation vaccination.

Vaccination units to receive non-immunisation plan vaccines, in addition to charging the cost of vaccines, can also charge a vaccination service fee. The charges for vaccination service fees shall be formulated by the price department of the people's governments of the 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, based on the monitoring and early warning information on infectious diseases, and for the purpose of preventing and controlling outbreaks and epidemics of infectious diseases, report the decision of the people's government at its own level and report it to the competent health department of the people's government at or above the provincial level for the record, carry out mass vaccination in the administrative region.

Where group preventive vaccination needs to be carried out nationwide or across provinces, autonomous regions or municipalities directly under the Central Government, the decision shall be made by the competent health department of the State Council.

The local people's government at or above the county level or the competent health department under the State Council that makes the decision on group preventive vaccination shall organise the relevant departments to do a good job in personnel training, publicity and education, and material deployment.

No unit or individual shall carry out group preventive vaccination without authorisation.

Article 51 In case of an outbreak or epidemic of an infectious disease, where the local people's government at or above the county level or its competent department of health care needs to take emergency vaccination measures, it shall be implemented in accordance with the provisions of laws and administrative regulations.

Chapter VI Monitoring and Handling of Abnormal Reactions

Article 52 Abnormal reaction of preventive vaccination refers to the qualified vaccine in the implementation of standardised vaccination process or the implementation of standardised vaccination caused by the recipient organism tissue, organ, function damage, the relevant parties are not at fault of the adverse drug reaction.

The following situations are not considered abnormal reactions to preventive vaccination:

(a) general reaction after vaccination caused by the characteristics of the vaccine itself; (b) general reaction after vaccination caused by the characteristics of the vaccine itself

(ii) Damage caused to the vaccine recipient due to the quality of the vaccine; and

(c) Damage caused to the vaccinee due to the violation of the norms of preventive vaccination, immunisation procedures, guidelines for the use of vaccines, and vaccination programmes by the vaccination unit.

(d) The vaccinee is in the incubation period or the precursor period of a certain disease at the time of vaccination, and the incidental morbidity is caused by the vaccination; (e) The vaccinee is in the incubation period or the precursor period of a certain disease at the time of vaccination.

(E) vaccine recipients have vaccine instructions stipulated in the contraindications to vaccination, in the vaccination before the vaccine recipient or his or her guardian did not truthfully provide the vaccine recipient's health status and contraindications to vaccination and other circumstances, after the vaccination of the vaccine recipient's original disease acute relapse or aggravation of the disease.

(F) Individual or group psychosomatic reactions occurring due to psychological factors.

Article 53 The State shall strengthen the monitoring of abnormal reactions to preventive vaccination. The programme for monitoring abnormal reactions to preventive vaccination shall be formulated by the competent health department of the State Council in conjunction with the drug administration department of the State Council.

Article 54 The vaccination unit, medical institutions and other suspected abnormal reactions to preventive vaccination shall, in accordance with the provisions of the report to the disease prevention and control institutions.

The holder of the listed vaccine license shall set up a specialised agency, with full-time staff, take the initiative to collect, track and analyse the suspected abnormal reactions to preventive vaccination, take risk control measures in a timely manner, report the suspected abnormal reactions to preventive vaccination to the disease prevention and control institutions, and submit the quality analysis report to the drug supervision and management department of the people's government of the province, autonomous region or municipality directly under the Central Government.

Article 55 For suspected abnormal reactions to preventive vaccination, the disease prevention and control institution shall report promptly in accordance with the regulations, organise investigation and diagnosis, and inform the vaccinee or his/her guardian of the investigation and diagnosis conclusions. If there is any dispute over the investigation and diagnosis conclusion, it may apply for appraisal according to the appraisal method formulated by the competent health department of the State Council.

As a result of preventive vaccination leads to the death of the vaccinee, serious disability, or group suspected abnormal reaction of preventive vaccination and other suspected abnormal reaction of preventive vaccination that has a significant impact on the society, by the competent department of health of the people's government at or above the municipal level of the district, drug supervision and management departments in accordance with their respective responsibilities to organise the investigation and treatment.

Article 56 The State implements a compensation system for abnormal reactions to inoculation. Compensation shall be given if the death of the vaccinee, serious disability, organ and tissue damage or other damage occurs during or after the implementation of vaccination, which is an abnormal reaction to preventive vaccination or cannot be excluded. The scope of compensation is governed by a catalogue and is dynamically adjusted according to the actual situation.

Compensation for vaccination with immunisation-planning vaccines shall be arranged by the financial departments of the people's governments of the provinces, autonomous regions and municipalities directly under the central government in the funding for preventive vaccination; compensation for vaccination with non-immunisation-planning vaccines shall be borne by the holder of the listed licence for the vaccine in question. The State encourages the use of commercial insurance and other forms of compensation for recipients of abnormal reactions to preventive vaccination.

Compensation for abnormal reactions to preventive vaccination should be timely, convenient and reasonable. The scope, standards and procedures of compensation for abnormal reactions to preventive vaccination shall be regulated by the State Council, and the provinces, autonomous regions and municipalities directly under the Central Government shall formulate specific implementation measures.

Chapter VII Post-market Management of Vaccines

Article 57 The holder of a listed vaccine licence shall establish and improve the quality management system for the entire life cycle of the vaccine, develop and implement a risk management plan for post-marketing vaccines, carry out post-marketing studies of vaccines, vaccine safety, efficacy and quality controllability for further confirmation.

Approval of the vaccine registration application for further research requirements of the vaccine, the vaccine marketing permit holder shall complete the study within the specified period; overdue research or can not prove that the benefits outweigh the risks, the State Council Drug Administration shall deal with the vaccine according to law, until the cancellation of the certificate of registration of drugs.

Article 58 The holder of the listed vaccine licence shall carry out quality tracking and analysis of the vaccine, continue to improve quality control standards, improve the production process, improve the stability of the production process.

Production processes, production sites, key equipment and other changes should be assessed, verified, in accordance with the State Council drug regulatory department of the relevant provisions of the change management for the record or report; changes may affect the vaccine safety, efficacy and quality controllability, should be approved by the State Council drug regulatory department.

Article 59 The holder of the marketing licence of the vaccine shall continue to update the instructions and labels according to the post-marketing study of the vaccine, abnormal reactions to preventive vaccination, and apply for approval or record in accordance with the provisions.

Drug supervision and administration department under the state council shall publish the updated vaccine instructions, labelling content on its website in a timely manner.

Article 60 The holder of a listed vaccine licence shall establish a system of retrospective analysis of vaccine quality and risk reporting, annual vaccine production and circulation, post-market research, risk management and other situations in accordance with the provisions of the truth to the drug supervision and management department under the state council.

Article 61 The drug supervision and management department under the State Council may, according to the actual situation, order the holder of the marketing authorisation of the vaccine to carry out post-marketing evaluation or directly organise the post-marketing evaluation.

For vaccines with serious abnormal reactions to preventive vaccination or other reasons that endanger human health, the drug administration department under the State Council shall cancel the certificate of drug registration of the vaccine.

Article 62 The drug administration department under the State Council may, in accordance with the needs of disease prevention and control and the development of the vaccine industry, organise post-marketing evaluation of vaccine varieties, and find that the product design, production process, safety, efficacy, or quality controllability of such vaccine varieties are obviously inferior to those of other vaccine varieties for the prevention and control of the same kind of disease, it shall cancel the certificates of registration of all vaccines of the same kind, and shall abolish the corresponding national drug standards. The corresponding national drug standards.

Chapter VIII Safeguard Measures

Article 63 The people's governments at or above the county level shall include in the budgets of the governments at their respective levels the funds required for vaccine safety work, the purchase of vaccines for immunisation planning and preventive vaccination work, and the construction of information technology, so as to ensure the implementation of the immunisation planning system.

The people's governments at the county level shall, in accordance with the relevant provisions of the State, provide subsidies to rural doctors and other primary medical and health care personnel engaged in preventive vaccination work.

The State supports the work of preventive vaccination in economically less developed areas as needed. The people's governments of provinces, autonomous regions and municipalities directly under the Central Government and the people's governments at the city level in the districts in which they are located shall give the people's governments at the county level in economically underdeveloped areas the necessary financial subsidies to carry out work related to preventive inoculation.

Article 64 The people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall, in accordance with the trend of the prevalence of infectious diseases in their respective administrative regions, within the scope of the projects for the prevention and control of infectious diseases determined by the competent health department of the State Council, determine the projects related to preventive vaccination in their respective administrative regions and ensure their implementation.

Article 65 The competent health department under the State Council provides information on the demand for vaccines for the national immunisation programme to the holder of the listed vaccine licence in accordance with the plan for the use of vaccines for the national immunisation programme in each province, autonomous region or municipality directly under the Central Government, and the holder of the listed vaccine licence makes reasonable arrangements for production in accordance with the information on the demand for vaccines.

When there is a risk of supply shortage of vaccines, the competent health department of the State Council and the drug administration department of the State Council shall make recommendations, and the competent department of industry and information technology of the State Council and the financial department of the State Council shall take effective measures to ensure the production and supply of vaccines.

Vaccine marketing license holder shall organise production in accordance with the law, to ensure the supply of vaccines; vaccine marketing license holder to stop the production of vaccines, should be promptly reported to the State Council drug supervision and management department or provincial, autonomous regions, municipalities directly under the Central People's Government drug supervision and management department.

Article 66 of the State will be included in the strategic reserve of goods, the implementation of the central and provincial level reserves.

The State Council department in charge of industry and information technology, the financial sector, in conjunction with the State Council department in charge of health, public security departments, market supervision and management and drug supervision and management departments, according to the needs of disease prevention, control and public health emergency preparedness, to strengthen the reserve of vaccine production capacity, product management, and the establishment of a dynamic adjustment mechanism.

Article 67 The financial arrangements for preventive inoculation at all levels shall be earmarked for specific purposes, and no unit or individual shall misappropriate or squander them.

The relevant units and individuals to use the funds for vaccination shall be subject to audit supervision by the audit authorities in accordance with the law.

Article 68 The state implements a compulsory insurance system for vaccine liability.

Vaccine marketing licence holders shall, in accordance with the provisions of compulsory vaccine liability insurance. Where damage to vaccine recipients is caused by problems in the quality of vaccines, insurance companies shall pay compensation within the limits of their liability.

Compulsory vaccine liability insurance system of the specific implementation of the State Council drug supervision and management department, in conjunction with the State Council department in charge of health, insurance supervision and management agency to develop.

Article 69 In the event of an outbreak or epidemic of an infectious disease, the holder of the relevant listed licence for the vaccine shall promptly produce and supply vaccines for the prevention and control of the infectious disease. Transportation units shall give priority to transporting 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 organising, coordinating and safeguarding the work.

Chapter IX Supervision and Administration

Article 70 The drug supervision and administration department and the competent department of health in accordance with their respective duties to supervise and manage the whole process of vaccine development, production, circulation and vaccination, and supervise the holder of the marketing authorisation of the vaccine, the disease prevention and control institution, and the vaccination unit in accordance with the law to perform their obligations.

The drug supervision and administration department supervises and inspects the quality of vaccines in vaccine development, production, storage, transport and preventive vaccination in accordance with the law. The competent health authorities supervise and inspect the implementation of the immunisation planning system and preventive vaccination activities in accordance with the law.

Drug supervision and management departments shall strengthen the on-site inspection of the holder of the listed licence for vaccines; if necessary, can provide products or services for vaccine development, production, circulation and other activities of the units and individuals to extend the inspection; the relevant units and individuals shall cooperate, and shall not be refused or concealed.

Article 71 The State builds a team of professional and specialised drug inspectors at the central and provincial levels to strengthen the supervision and inspection of vaccines.

The drug supervision and management departments of the people's governments of the provinces, autonomous regions and municipalities directly under the Central Government select and assign inspectors to be stationed at the holders of marketing licences for vaccines. The inspectors are responsible for supervising and inspecting the implementation of the standards for quality management of drug production, collecting clues of vaccine quality risks and violations of laws and regulations, reporting the situation to the drug supervision and administration departments of the people's governments of the provinces, autonomous regions and municipalities directly under the central government and putting forward recommendations, and being responsible for their behaviour during the period of their stationing.

Article 72 If there are safety risks in vaccine quality management, and the holder of the listed licence of the vaccine, etc., fails to take timely measures to eliminate them, the drug supervision and administration department may take measures such as responsibility interviews and rectification within a limited period of time.

Serious violations of drug-related quality management standards, drug supervision and management department shall order the suspension of vaccine production, sales, distribution, and immediate rectification; rectification is completed, the drug supervision and management department to meet the requirements of the inspection before resuming production, sales, distribution.

Drug supervision and management department shall establish the vaccine marketing licence holders and their related personnel credit record system, into the national credit information sharing platform, in accordance with the provisions of its serious breach of trust information, the implementation of joint disciplinary action.

Article 73 Where a vaccine exists or is suspected to have quality problems, the holder of the listed permit for the vaccine, the disease prevention and control agency, the vaccination unit shall immediately stop the sale, distribution and use, and if necessary, immediately stop the production of the vaccine, in accordance with the provisions of the people's government at or above the county level of the drug supervision and management department, the competent department of health report. The competent health department shall immediately organise disease prevention and control institutions and vaccination units to take necessary emergency measures, and at the same time report to the competent health department of the people's government at a higher level. The drug supervision and administration department shall take measures such as seizure and detention in accordance with the law. For vaccines that have already been sold, the holder of the listed licence for the vaccine shall promptly notify the relevant disease prevention and control institutions, vaccine distribution units and vaccination units, recall them in accordance with the regulations, and truthfully record the recall and notification, and the disease prevention and control institutions, vaccine distribution units and vaccination units shall cooperate.

Failure to stop the production, sale, distribution, use or recall of vaccines in accordance with the provisions of the preceding paragraph, the drug supervision and management department of the people's government at or above the county level, the competent department of health shall, in accordance with their respective responsibilities, order to stop the production, sale, distribution, use or recall of vaccines.

If the holder of the listed vaccine licence, the disease prevention and control institution or the vaccination unit finds that there is or is suspected to be a quality problem of the vaccine, it shall not conceal, falsely report, delay or omit to report, and shall not conceal, falsify or destroy the relevant evidence.

Article 74 The holder of a listed vaccine licence shall establish an information disclosure system, and disclose in a timely manner on its website, in accordance with the provisions of the vaccine product information, instructions and labels, the implementation of drug-related quality management norms, batch issuance, recall, acceptance of inspections and penalties, as well as information on mandatory vaccine liability insurance.

Article 75 The drug supervision and administration department under the State Council, in conjunction with the competent health department under the State Council, shall establish a mechanism for sharing information on the quality of vaccines and preventive vaccination.

The drug supervision and administration department of the people's government at or above the provincial level and the competent department of health shall, in accordance with the principles of science, objectivity, timeliness and openness, organise exchanges and communications between the holders of marketing authorisations for vaccines, disease prevention and control organisations, inoculation units, the news media, and scientific research institutes regarding information on the quality of vaccines and preventive inoculation.

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 to be in need of uniform publication, shall be published by the Drug Administration under the State Council in conjunction with the relevant departments. The national report on abnormal reactions to vaccination shall be uniformly published by the competent health department of the State Council in conjunction with the drug administration and supervision department of the State Council. The above information shall not be published without authorisation. The publication of major vaccine safety information shall be timely, accurate and comprehensive, and scientific assessments shall be conducted in accordance with the regulations, and necessary explanatory notes shall be made.

When the drug supervision and administration department of the people's government at or above the county level discovers vaccine safety information that may mislead the public and social opinion, it shall immediately verify and analyse the information in conjunction with the competent department of health and health and other relevant departments, professional institutions, and the relevant vaccine marketing licence holders, etc., and publish the results in a timely manner.

No unit or individual shall fabricate or disseminate false vaccine safety information.

Article 77 Any unit or individual shall have the right to know vaccine information in accordance with the law, and to put forward opinions and suggestions on the supervision and management of vaccines.

Any unit or individual has the right to report vaccine violations to the competent health authorities, drug supervision and management departments and other departments, and to report to the people's government at the present or higher level and its relevant departments and supervisory organs any failure of the competent health authorities, drug supervision and management departments and their staff to perform their supervisory and management duties in accordance with the law. The relevant departments and organs shall promptly verify, deal with; the verification of reports, in accordance with the provisions of the reward given to the informer; whistleblower to report serious violations of their units, verified, given a heavy award.

Article 78 The people's governments at or above the county level shall formulate emergency response plan for vaccine safety incidents, vaccine safety incident classification, disposal organisation and command system and responsibilities, prevention and early warning mechanism, disposal procedures, emergency safeguard measures and other provisions.

Vaccine marketing licence holders shall develop vaccine safety incident disposal programme, regularly check the implementation of preventive measures, and timely elimination of potential safety hazards.

Occurrence of vaccine safety incidents, the vaccine marketing licence holder shall immediately to the State Council Drug Administration or provincial, autonomous regions, municipalities directly under the Central People's Government drug supervision and management department report; disease prevention and control institutions, vaccination units, medical institutions shall immediately to the people's government above the county level, the competent departments of health, drug supervision and management department report. Drug supervision and management departments shall, in conjunction with the competent departments of health and health in accordance with the provisions of the emergency plan, set up a vaccine safety incident disposal command organisation, to carry out medical treatment, risk control, investigation and treatment, information dissemination, explanation, etc., and to do a good job in replanting and other aftermath of the disposal work. The cost of vaccine replenishment for vaccine safety events caused by quality problems shall be borne by the holder of the listed licence of the vaccine.

The relevant units and individuals shall not conceal, falsely report, delay or omit to report vaccine safety incidents, and shall not conceal, falsify or destroy relevant evidence.

Chapter X Legal Liability

Article 79 Where violation of the provisions of this Law constitutes a crime, criminal responsibility shall be investigated severely in accordance with the law.

Article 80 If the vaccines produced or sold are counterfeit drugs, the drug supervision and management department of the people's government at or above the provincial level shall confiscate the illegal income and the vaccines illegally produced or sold, as well as the raw materials, auxiliary materials, packaging materials, equipment and other items specially used in the illegal production of the vaccines, and shall order the suspension of production and rectification of the business and revocation of the certificate of registration of the drugs until the revocation of the licence for the manufacture of the drugs, and impose a fine of fifteen times or more than fifty times of the value of the vaccine, and if the value of the vaccine is less than five hundred thousand yuan, the amount shall be calculated according to five hundred thousand yuan.

If the vaccines produced or sold are substandard drugs, the drug supervision and management department of the people's government at or above the provincial level shall confiscate the illegal proceeds and the vaccines illegally produced or sold, as well as the raw materials, auxiliary materials, packaging materials, equipment and other items specially used for the illegal production of vaccines, and shall order the suspension of production and rectification of the business, and impose a fine of more than ten times the value of ten times the value of the vaccines illegally produced or sold and more than thirty times the value of the vaccines, and the value of the vaccines is less than five hundred thousand Yuan, calculated according to The value of the goods is less than 500,000 yuan, according to 500,000 yuan; the circumstances are serious, revocation of the certificate of drug registration, until the revocation of the drug production licence.

If the vaccines produced or sold are counterfeit drugs, or if the vaccines produced or sold are substandard drugs and the circumstances are serious, the drug supervision and management department of the people's government at or above the provincial level shall confiscate the income gained from the unit during the period of the offence and impose a fine of not less than double and not more than ten times of the income gained, and shall be prohibited from engaging in drug production and operation activities for life, and shall also be prohibited by the public security bureau from engaging in drug production and operation activities. engaging in pharmaceutical production and management activities, shall be sentenced by the public security organs to detention for not less than five days and not more than fifteen days.

Article 81 Where any of the following circumstances exists, the drug supervision and management department of the people's government at or above the provincial level shall confiscate the illegal income and the vaccines illegally produced or sold, as well as the raw materials, auxiliary materials, packaging materials, equipment and other articles specially used for the illegal production of vaccines, and shall order the suspension of production and rectification of the business, and impose a fine of fifteen times or more than fifty times the amount of the value of the vaccines illegally produced or sold, and if the amount of the value of the goods is less than five hundred thousand yuan, it shall be calculated according to five hundred thousand yuan. 500,000 yuan; the circumstances are serious, revocation of drug-related approval documents, until the revocation of the drug production license, etc., the legal representative, the main person in charge, directly responsible for the competent personnel and key personnel and other responsible personnel, confiscate the illegal act from the unit during the income earned, and impose a fine of more than fifty percent of the income earned ten times the following, within ten years until the lifelong ban on engaging in the drug production and operation activities, and shall be sentenced by the public security organs to detention for not less than five days and not more than fifteen days:

(a) applying for clinical trials, registration, batch issuance of vaccines to provide false data, information, samples or other deceptive acts; and

(ii) Fabricating production or inspection records or changing product batch numbers; and

(C) units or individuals other than disease prevention and control institutions to supply vaccines to the vaccination unit; (D) entrusted the production of vaccines to the vaccination unit; (E) the vaccination of vaccines to the vaccination unit.

(D) commissioned the production of vaccines without approval.

(E) production process, production sites, key equipment and other changes in accordance with the provisions of the approval should be approved without approval.

(F) Updating vaccine instructions and labelling without approval in accordance with the regulations.

Article 82 In addition to the circumstances otherwise provided for in this Law, the holder of a listed vaccine license or other units in violation of the quality management standards related to drugs, by the people's government at or above the county level drug supervision and management department ordered to make corrections, and given a warning; refusal to make corrections, impose a fine of two hundred thousand yuan or more than five hundred thousand yuan or more than five hundred thousand yuan or more than three million yuan or more than five hundred thousand yuan, and ordered to suspend production and rectify the situation, up to revocation of drug-related approval documents, drug production license, etc., the legal representative, the main person in charge, directly responsible for the supervisors and key personnel, as well as other responsible personnel, confiscated from the unit during the period of violation of the law, and impose a fine of more than fifty per cent of the income obtained more than five times the amount of the fine, ten years up to a life-long ban on engaging in the production and operation of pharmaceutical activities.

Article 83 violation of the provisions of this law, the vaccine marketing licence holder of one of the following circumstances, by the people's government at or above the provincial level drug supervision and management department shall order correction, given a warning; refused to make corrections, shall be imposed a fine of two hundred thousand yuan or more than five hundred thousand yuan or less; the circumstances are serious, shall be ordered to suspend production and reorganisation, and impose a fine of five hundred thousand yuan or more than two million yuan or less:

(A) not in accordance with the provisions of the establishment of the vaccine electronic traceability system.

(B) the legal representative, the main person in charge and the person in charge of production management, the person in charge of quality management, the quality of the authorised person and other key position personnel do not meet the prescribed conditions or not in accordance with the provisions of the training and assessment of them;.

(D) not in accordance with the provisions of the post-marketing study, or not in accordance with the provisions of the establishment of institutions, personnel initiative to collect, track and analyse suspected abnormal reactions to preventive vaccination.

(E) not in accordance with the provisions of the mandatory vaccine liability insurance.

(F) not in accordance with the provisions of the establishment of information disclosure system.

Article 84 violation of the provisions of this Law, the batch issuing agency has one of the following circumstances, by the State Council Drug Administration shall order correction, give a warning, the principal person in charge, directly responsible for the competent personnel and other directly responsible personnel shall be given a warning until demoted according to law:

(i) Failure to carry out audits and tests in accordance with the regulations.

(ii) Failure to timely publish the results of the batch issuance of listed vaccines; (iii) Failure to publish the results of the batch issuance of listed vaccines; and

(d) Failure to report the discovery of significant quality risks in vaccines in accordance with the regulations.

Violation of the provisions of this Law, the batch issuing organisation fails to issue the batch issuing certificate or notification of non-batch issuing in accordance with the provisions of the State Council drug supervision and management department shall order rectification, give a warning to the principal person in charge, the person in charge directly responsible for the supervisory personnel and other personnel directly responsible for the person shall be given a demotion or dismissal according to the law; the circumstances are serious, the person in charge, the person in charge directly responsible for the person in charge and other personnel directly responsible for the person shall be given a dismissal. shall be given the punishment of dismissal.

Article 85 If a disease prevention and control institution, vaccination unit, listed vaccine licence holder, or vaccine distribution unit violates the vaccine storage and transport management standards regarding cold chain storage and transport requirements, the drug supervision and management department of the people's government at or above the county level shall order rectification, give a warning, and destroy the illegally stored or transported vaccines and confiscate the unlawful proceeds; and if it refuses to rectify the situation, it shall impose a fine of 200,000 yuan on the vaccination unit, the listed vaccine licence holder, or the vaccine distribution unit, and on the vaccine distribution unit. Holder, vaccine distribution unit of more than 200,000 yuan of fines of less than one million yuan; the circumstances are serious, the vaccination unit, the holder of the vaccine marketing licence, vaccine distribution unit of the illegal storage, transport of vaccines more than ten times the value of the amount of more than thirty times the amount of fines, the amount of the value of less than one hundred thousand yuan, according to the calculation of one hundred thousand yuan, the holder of the vaccine marketing licence is ordered to vaccines, vaccine distribution unit to suspend production and rectification, until the cancellation of the drug-related approval certificates, drug production licences, etc., and impose penalties on the legal representatives, principals, directly responsible supervisors and key position holders, and other responsible personnel of the vaccine marketing authorisation holders and vaccine distribution units in accordance with the provisions of Article 82 of this Law.

If a disease prevention and control institution or a vaccination unit commits any of the offences stipulated in the preceding paragraph, the competent health department of the people's government at or above the county level shall give a warning or dismissal to the principal person in charge, the person in charge directly responsible, and other persons directly responsible, and order the medical and health care personnel who are responsible to suspend the practice of medicine and health care for a period of more than one year and less than eighteen months; and if the consequences are serious, the principal person in charge, the person directly responsible, and other persons directly responsible shall be punished in accordance with the law. Supervisors and other persons directly responsible shall be given punishment of dismissal according to law, and may revoke the vaccination qualification of the vaccination unit, and revoke the practicing certificates of the responsible medical and health personnel by the original licensing department.

Article 86 Where a disease prevention and control institution, a vaccination unit, a listed vaccine license holder, or a vaccine distribution unit violates the management standards for vaccine storage and transportation other than those stipulated in Article 85 of this Law, the drug supervision and management department of the people's government at or above the county level shall order rectification, give a warning, and confiscate the unlawful proceeds; and if it refuses to rectify the situation, impose a fine of 100,000 yuan or more than 300,000 yuan on the vaccination unit, the listed vaccine license holder, or the vaccine distribution unit. 100,000 yuan or more than 300,000 yuan fine; the circumstances are serious, the vaccination unit, the vaccine marketing licence holder, the vaccine distribution unit of illegal storage, transport of vaccines more than three times the value of the amount of more than ten times the amount of fine, the value of the amount of less than 100,000 yuan, according to the calculation of 100,000 yuan.

Disease prevention and control institutions, vaccination units have the provisions of the preceding paragraph of the offence, the people's governments at or above the county level, the competent departments of health can be the main person in charge, directly responsible for the competent personnel and other personnel directly responsible for the law to give a warning until dismissal, and ordered to be responsible for the suspension of the health care personnel for six months more than one year or less of the practice of the activities; cause serious consequences, the main person in charge, directly responsible for the competent personnel and other personnel directly responsible for the law. supervisors and other persons directly responsible shall be given punishment of dismissal in accordance with law, and the original licensing department shall revoke the practice certificate of the medical and health personnel who are responsible.

Article 87 Violation of the provisions of this Law, disease prevention and control institutions, vaccination units in one of the following circumstances, by the people's governments at or above the county level, the competent departments of health ordered to make corrections, given a warning, confiscate the illegal income; the circumstances are serious, the person in charge, the person in charge directly responsible for the competent personnel and other personnel directly responsible for the person in charge of the person in accordance with the law to give a warning to dismissal, ordered the responsible health care personnel to suspend the practice activities for one year or more than eighteen months or less. More than eighteen months of the following practice; causing serious consequences, the person in charge, directly responsible for the supervisors and other personnel directly responsible for the law shall be given a dismissal, the original licensing department shall revoke the certificate of practice of the medical and health personnel responsible for:

(a) Failure to supply, receive or procure vaccines in accordance with the regulations; and

(B) vaccination without complying with the norms of preventive vaccination work, immunization procedures, guidelines for the use of vaccines, vaccination programmes;.

Article 88 violation of the provisions of this law, disease prevention and control institutions, vaccination units have one of the following circumstances, by the people's government at or above the county level, the competent department of health ordered to make corrections, and given a warning; the circumstances are serious, the main person in charge, directly responsible for the supervisory personnel and other personnel directly responsible for the person in charge according to the law to give a warning until dismissal, and ordered to bear responsibility for the suspension of the health care personnel for six months or more than one year of Practice; causing serious consequences, the person in charge, directly responsible for the supervisors and other personnel directly responsible for the law shall be given dismissal, the original licensing department shall revoke the certificate of practice of the medical and health personnel responsible:

(a) Failure to provide retrospective information in accordance with the provisions; and

(ii) Failure to request and keep relevant supporting documents and temperature monitoring records when receiving or purchasing vaccines in accordance with the regulations.

(C) Failure to establish and maintain records of vaccine receipt, purchase, storage, distribution, supply, inoculation, and disposal in accordance with the regulations; and

(D) Failure to inform and question the vaccinees or their guardians about the situation in accordance with the regulations.

Article 89 If a disease prevention and control organisation, vaccination unit or medical institution fails to report suspected abnormal reactions to vaccination and vaccine safety incidents in accordance with the regulations, or fails to organise investigations and diagnosis of suspected abnormal reactions to vaccination in accordance with the regulations, the competent health authorities of the people's governments at or above the county level shall order corrections and issue warnings; if the circumstances are serious, the vaccination unit or medical institution shall be subject to a fine of not less than 50,000 yuan and not more than 500,000 yuan, and a fine of not less than 50,000 yuan shall be imposed on the disease prevention and control unit and the medical institution. The following fine, the disease prevention and control institutions, vaccination units, medical institutions, the main person in charge, directly responsible for the supervisors and other personnel directly responsible for the law to give a warning until dismissal; serious consequences, the main person in charge, directly responsible for the supervisors and other personnel directly responsible for the law to give dismissal, by the original issuance of the certificate of the original department of the revocation of the certificate of practice of the medical and health personnel responsible for.

Article 90 Where a disease prevention and control organisation or a vaccination unit charges 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 the refund of the fees charged in violation of the law 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 be given penalties in accordance with the law.

Article 91 Where, in violation of the provisions of this Law, a person engages in vaccination for immunisation planning without being designated by the competent health department of the local people's government at or above the county level, or where the person engages in vaccination for non-immunisation planning that does not comply with the conditions or has not been prepared for the record, the competent health department of the people's government at or above the county level shall order the person to make corrections, give him a warning, confiscate the unlawful proceeds and the unlawfully possessed vaccines, and order him to suspend business and rectify the situation and impose a million yuan or less, and impose sanctions on the principal person in charge, the supervisors directly responsible and other persons directly responsible in accordance with the law.

Where, in violation of the provisions of this Law, a unit or individual other than a disease prevention and control institution or a vaccination unit carries out group preventive vaccination without authorisation, the competent health department of the people's government at or above the county level shall order rectification, confiscate the unlawful proceeds and the vaccines illegally in its possession, and impose a fine of not less than ten times and not more than thirty times the amount of the goods value of the vaccines illegally in its possession, and if the amount of the goods value is less than 50,000 yuan, then the amount shall be calculated at 50,000 yuan.

Article 92 Where a guardian fails to ensure, in accordance with the law, that a child of the appropriate age receives the immunisation plan vaccine on time, the competent health care department of the people's government at the county level shall criticize and educate the guardian and order him or her to make corrections.

Where a child-care institution or school fails to check the preventive vaccination certificate in accordance with the regulations when a child is admitted to nursery or school, or fails to report to the vaccination unit after discovering a child who has not been vaccinated in accordance with the regulations, the administrative department of education of the local people's government at or above the county level shall order rectification, give a warning, and impose sanctions on the chief person in charge, the person in charge who is directly in charge, and the other persons who are directly responsible, in accordance with the law.

Article 93 If fabricating or spreading false vaccine safety information or provoking trouble in a vaccination unit constitutes a violation of public security administration, the public security organ shall impose public security administration penalties in accordance with the law.

Where newspapers, periodicals, radio, television, Internet sites and other media fabricate or disseminate false vaccine safety information, the relevant authorities shall impose penalties in accordance with the law, and the principal person in charge, the person in charge directly responsible, and other persons directly responsible shall be given penalties in accordance with the law.

Article 94 The local people's governments at or above the county level in the supervision and management of vaccines in one of the following circumstances, the person in charge directly responsible and other persons directly responsible shall be given a demotion or dismissal in accordance with the law; the circumstances are serious, shall be given dismissal in accordance with the law; causing serious consequences, the person in charge shall take the blame and resign:

(A) the failure to fulfil their duties, resulting in serious adverse effects or major losses;.

(ii) concealment, misreporting, delayed reporting, omission to report vaccine safety incidents.

(D) The occurrence of particularly significant vaccine safety incidents in this administrative region, or the occurrence of consecutive major vaccine safety incidents.

Article 95 The drug supervision and management departments, health and health departments and other departments in the supervision and management of vaccines in one of the following circumstances, the directly responsible officer in charge and other directly responsible personnel shall be given a demotion or dismissal according to law; the circumstances are serious, shall be given dismissal according to law; the serious consequences, its main person in charge shall take the blame and resign:

(a) Failure to fulfil the duty of supervision and inspection, or found violations of the law are not investigated and dealt with in a timely manner.

(ii) unauthorised mass inoculation.

(D) Interference with or obstruction of the investigation of vaccine offences or vaccine safety incidents.

(E) disclosure of information about the informant; and

(F) receiving reports of suspected abnormal reactions to vaccination, not in accordance with the provisions of the organisation of the investigation and treatment; (G) other

(VII) other failure to perform the duties of supervision and management of vaccines, resulting in serious adverse effects or major losses.

Article 96 The vaccine quality problems caused by the vaccinee damage, the vaccine marketing licence holder shall be liable for compensation according to law.

Disease prevention and control institutions, vaccination units due to violation of the norms of preventive vaccination work, immunization procedures, guidelines for the use of vaccines, vaccination programmes, causing damage to the vaccinee, shall bear the liability for compensation according to law.

Chapter XI Bylaws

Article 97 The meanings of the following terms in this Law are:

Immunisation-planning vaccines refer to vaccines that residents shall receive in accordance with government regulations, including vaccines determined by the National Immunisation Plan, vaccines added by the people's governments of provinces, autonomous regions and municipalities directly under the Central Government in the implementation of the National Immunisation Plan, as well as vaccines used in emergency inoculations or group preventive inoculations organised by the people's governments at or above the county level or by their competent authorities in charge of health and hygiene.

Non-immunisation plan vaccines, means other vaccines voluntarily administered by residents.

Vaccine marketing permit holders refer to enterprises that have obtained vaccine drug registration certificates and drug production licences in accordance with the law.

Article 98 The State encourages vaccine manufacturers to produce and export vaccines in accordance with international procurement requirements.

Exported vaccines should meet the standards of the importing country (region) or contract requirements.

Article 99 Entry and exit preventive vaccination and the procurement of required vaccines shall be separately regulated by the state border health and quarantine authorities in consultation with the financial department of the State Council.

Article 100 This Law shall come into force on 1 December 2019.

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