Vaccine Administration Law of the People’s Republic of China
Order of the President of the People's Republic of China
No. 30
The Vaccine Administration Law of the People's Republic of China, adopted at the 11th Meeting of the Standing Committee of the Thirteenth National People's Congress on June 29, 2019, is hereby promulgated and shall go into effect as of December 1, 2019.
Xi Jinping
President of the People's Republic of China
June 29, 2019
Vaccine Administration Law of the People’s Republic of China
(Adopted at the 11th Meeting of the Standing Committee of the Thirteenth National People's Congress on June 29, 2019)
Content
Chapter I General Provisions
Chapter II Vaccine Development and Registration
Chapter III Vaccine Manufacture and Lot Release
Chapter IV Vaccine Distribution
Chapter V Immunization
Chapter VI Adverse Reactions Monitoring and Handling
Chapter VII Vaccine Post-Marketing Management
Chapter VIII Safeguard Measures
Chapter IX Supervision and Management
Chapter X Legal Liabilities
Chapter XI Supplementary Provisions
Chapter I
General Provisions
Article 1 This Law is enacted to enhance the vaccine administration, to ensure the quality and supply of vaccines, to standardize the immunization, to promote the development of the vaccine industry, and to safeguard public health and safety.
Article 2 This Law shall govern activities involving vaccine development, manufacture, distribution, immunization and vaccine administration in the territory of the People’s Republic of China. In cases of not being stipulated in this Law, those activities shall be governed by the Drug Administration Law of the People’s Republic of China, the Law of the People’s Republic of China on the Prevention and Control of Infectious Diseases and relevant laws and administrative regulations.
For the purpose of this Law, vaccines refer to the prophylactic biological products for human immunization to prevent the occurrence and prevent, if not to be prevented, the prevalence of diseases, including immunization program vaccines and non-immunization program vaccines.
Article 3 The State implements the most stringent regulatory system for vaccines and adheres to principles of safety first, risk management, whole process control, scientific supervision and social co-governance.
Article 4 The State maintains the strategic and public welfare nature of vaccine products.
The State supports fundamental research and application research of vaccines, promotes development and innovation of vaccines and incorporates the development, manufacture and stockpile of vaccines for the prevention and control of major diseases into the national strategy.
The State formulates development planning and industry policies for the vaccine industry to support development and structural optimization of the vaccine industry, and encourages scale and intensive production and constant improvement on the production process and quality of vaccines.
Article 5 Vaccine marketing authorization holders (MAHs) shall enhance the vaccine life cycle quality management and be responsible for the safety, effectiveness and quality management of vaccines.
All entities and individuals engaged in vaccine development, manufacture, distribution and immunization shall comply with laws, regulations, rules, standards and norms, ensure the authenticity, accuracy, integrity and traceability of information through the whole process, take responsibilities in accordance with law and accept social supervision.
(Through the whole process of vaccine development, manufacture, distribution and immunization, in which any entity or/and individual engaged, shall comply with laws, regulations, rules, standards and norms, ensure the authenticity, accuracy, integrity and traceability of information, take responsibilities in accordance with law and accept social supervision.)
Article 6 The State implements immunization program system.
All citizens who reside in the territory of the People's Republic of China shall be entitled and obliged to be immunized with national immunization program vaccines according to law. The government shall provide immunization program vaccines for the citizens free of charge.
People’s governments and relevant departments at or above the county level shall ensure that children at proper age are immunized with immunization program vaccines. The guardians shall ensure that children at proper age are immunized with the immunization program vaccines on schedule according to law.
Article 7 People's governments at or above the county level shall incorporate the vaccine safety, immunization work into the national economic and social development plans of the corresponding level, enhance the capacity building of vaccine administration, and establish and improve the work mechanism for vaccine administration.
Local people's governments at or above the county level shall be responsible for vaccine administration within their administrative regions, as well as leading, organizing and coordinating vaccine administration within their respective administrative regions in a unified manner.
Article 8 The drug regulatory department under the State Council shall be responsible for the administration of vaccines nationwide. The competent health department under the State Council shall be responsible for the administration of immunization nationwide. Other relevant departments under the State Council shall be responsible for the administration of vaccines within the scope of their respective responsibilities.
Drug regulatory departments of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the vaccine administration within their respective administrative regions. Departments undertaking responsibilities for drug administration (hereinafter referred to as drug regulatory departments) of the people’s governments of municipalities divided into districts and at county level shall undertake the administrative duties on vaccines within their respective administrative regions. The competent health departments of people's governments at or above the county level shall undertake the administration of immunization within their respective administrative regions. Other relevant departments of the people’s governments at or above the county level shall undertake the administrative duties on vaccines within the scope of their respective responsibilities.
Article 9 The State Council and people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall establish a coordination mechanism to comprehensively coordinate relevant work of vaccine administration, regularly analyze the safety situations of vaccines, enhance vaccine administration and ensure vaccine supply.
Article 10 The State implements the whole process electronic traceability system for vaccines.
The drug regulatory department under the State Council shall, in collaboration with the competent health department under the State Council, formulate unified vaccine traceability norms and standards, establish a national coordination platform for vaccine electronic traceability, and integrate traceability information of the whole process throughout manufacture, distribution and immunization to realize the traceability of vaccines.
Vaccine MAHs shall establish the vaccine electronic traceability system, and connect it to the national coordination platform for vaccine electronic traceability, so as to enable the traceability and verification of the smallest package unit of vaccines through the whole process of manufacture, distribution and immunization.
Disease prevention and control institutions and immunization entities shall truthfully record conditions including vaccine distribution and immunization in accordance with law, and provide traceability information to the national coordination platform for vaccine electronic traceability as required.
Article 11 The biological safety management system shall be established and improved during vaccine development, manufacture and testing, to enable strict control of the biological safety risks, to enhance biological safety management of pathogenic microorganisms including bacterial and viral strains, to protect the health of operators and the public, and to ensure pathogenic microorganisms including bacterial and viral strains are used for legal and proper purposes.
Bacterial and viral strains and cell strains used in the development, manufacturing and testing of vaccines shall have their track record, biological features and passage numbers specified, detailed archives established, to ensure legal, clear and traceable source; and those with unidentified source shall not be used.
Article 12 People’s governments at all levels and relevant departments, disease prevention and control institutions, immunization entities, vaccine MAHs and vaccine industry associations shall regularly carry out the publicity and education of laws and regulations of vaccines and knowledge of immunization in occasions such as national children's immunization day.
News media shall, for the public welfare, carry out publicity on vaccine safety laws and regulations, and knowledge of immunization, and supervise illegal behaviors related to vaccines through public opinions. Publicity reports on vaccines shall be comprehensive, scientific, objective and impartial.
Article 13 Vaccine industry associations shall enhance industry self-discipline, establish and improve industry norms, and promote the construction of industry integrity system, so as to guide and urge their member enterprises to manufacture and distribute vaccines in accordance with law.
Chapter II
Vaccine Development and Registration
Article 14 The State formulates relevant development plans, arranges necessary funds and supports the development of innovative vaccines such as combined and/or polyvalent vaccines in response to factors such as the prevalence of diseases and population immunity.
The State organizes vaccine MAHs, research institutions, medical and health institutions to work jointly to develop vaccines urgently needed for disease prevention and control.
Article 15 To facilitate the progress of vaccine technology, the State encourages vaccine MAHs to increase capital investment on research, development and innovation, to optimize production process, and to promote quality control level.
Article 16 Conduct of vaccine clinical trials shall be approved by the drug regulatory department under the State Council in accordance with law.
Vaccine clinical trials shall be carried out or organized by Class III medical institutions or disease prevention and control institutions at or above the provincial level that meet the requirements prescribed by the drug regulatory department under the State Council and the competent health department under the State Council.
The State encourages eligible medical institutions and disease prevention and control institutions to conduct vaccine clinical trials in accordance with law.
Article 17 The sponsor of vaccine clinical trials shall design the clinical trial protocol, establish the safety monitoring and evaluation system for clinical trials, prudently select subjects, appropriately set up subject population and age groups, and take effective measures based on risk levels to protect legal interests of subjects.
Article 18 Written informed consent shall be obtained from subjects for vaccine clinical trials; where the subject is a person without capacity for civil conduct, the written informed consent shall be obtained from his/her guardian; where the subject is a person with limited capacity for civil conduct, the written informed consent shall be obtained from the subject and his/her guardian.
Article 19 Vaccines marketed in the territory of China shall be approved by the drug regulatory department under the State Council and shall be granted the drug registration certificate; to apply for vaccine registration, authentic, adequate and reliable data, dossier and samples shall be provided.
For vaccines urgently needed for disease prevention and control, and innovative vaccines, the drug regulatory department under the State Council shall give priority to evaluation, review and approval.
Article 20 For vaccines which are used to respond to major public health emergencies or other vaccines which are urgently needed as identified by the competent health department under the State Council, the drug regulatory department under the State Council may grant conditional approval on registration application if benefits of those vaccines outweigh risks based on evaluation.
When particularly major public health emergencies or other emergencies which seriously threaten public health occur, the competent health department under the State Council shall propose recommendations on the urgent use of vaccines based on the need of disease prevention and control, and after evaluation organized by the drug regulatory department under the State Council, the permission for the urgent use within certain scope and period shall be granted by the drug regulatory department under the State Council.
Article 21 The drug regulatory department under the State Council shall examine and approve the production process, quality control standards, package inserts and labels of vaccines during the approval process of the vaccine registration application.
The drug regulatory department under the State Council shall publish the content of vaccine package inserts and labels on its websites in a timely manner.
Chapter III
Vaccine Manufacture and Lot Release
Article 22 The State implements strict access system for vaccine manufacturing.
To carry out vaccine manufacturing activities, approval shall be obtained from the drug regulatory departments at or above the provincial level, and drug manufacturing certificates shall be obtained.
In addition to the conditions of drug manufacturing activities stipulated in the Drug Administration Law of the People's Republic of China, the following conditions shall also be met for vaccine manufacturing activities:
(I) being equipped with appropriate scale and sufficient capacity stockpile;
(II) possessing systems, facilities and equipment to ensure biological safety;
(III) meeting the needs of disease prevention and control.
Vaccine MAHs shall have vaccine production capacity; and where contract production is necessary as demand exceeds the vaccine production capacity,, approval shall be obtained from the drug regulatory department under the State Council. Commissioned production shall comply with this Law and relevant regulations, ensuring the quality of vaccines.
Article 23 The legal representative and principal responsible person of vaccine MAHs shall have good credit records, and personnel in key positions such as the responsible person for manufacturing management, the responsible person for quality management and the quality authorized person shall have relevant professional background and work experience.
Vaccine MAHs shall strengthen the training and assessment for personnel of preceding paragraph and in a timely manner report the employment and change of the aforementioned personnel to the local drug regulatory departments of people's governments of provinces, autonomous regions and municipalities directly under the Central Government.
Article 24 Vaccines shall be produced and tested in accordance with the approved production process and specifications, and the entire production process shall meet the requirements prescribed by the good manufacturing practice for drugs.
Vaccine MAHs shall examine and test the whole process of vaccine manufacturing and vaccine quality as required.
Article 25 Vaccine MAHs shall establish a complete quality management system, unceasingly enhance deviation management, and adopt information-based means to truthfully record all the data formed during manufacturing and testing, in order to ensure the whole process of manufacture persistently meets the legal requirements.
Article 26 The State implements lot release system for vaccines.
Each lot of vaccines to be sold or imported shall be examined and tested in accordance with relevant technical requirements by lot release institutions designated by the drug regulatory department under the State Council. A qualified lot shall be granted a certificate for lot release of biological product; and a disqualified lot shall be given a notice of disapproval for lot release.
Vaccines which are not approved for lot release are prohibited to be sold and shall be destroyed under the supervision of drug regulatory departments of the people's governments of provinces, autonomous regions or municipalities directly under the Central Government; imported vaccines which are not approved for lot release shall be destroyed or handled under the supervision of the drug regulatory department where the port locates in accordance with law.
The drug regulatory department under the State Council and lot release institutions shall promptly publish the results of the lot release of marketed vaccines for public reference.
Article 27 To apply for vaccine lot release, materials such as summary protocol of manufacturing and control and samples shall be provided to the lot release institutions as required. For imported vaccines, the certificate of country of origin and certificate of lot release shall also be provided; and if the imported vaccines are exempted from lot release in the country of origin, the exemption certificate of lot release shall be provided.
Article 28 Vaccines urgently needed to prevent and control outbreaks of infectious diseases or emergencies may be exempted from lot release at the approval of the drug regulatory department under the State Council.
Article 29 For lot release of vaccines, dossier review and sample testing shall be conducted lot by lot. The testing items and testing frequency for lot release of vaccines shall be dynamically adjusted according to the vaccine quality risk evaluation.
If there is any doubt about the authenticity of the application dossier or samples for lot release of vaccines or any other situation which requires further verification, lot release institutions shall make the verification, and may organize on-site verifications such as sampling on-site for testing if necessary.
Article 30 In the case that major quality risks of vaccines are identified during the process of lot release, lot release institutions shall in a timely manner report to the drug regulatory department under the State Council and the drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government.
The departments which receive the report shall immediately carry out on-site inspection on vaccine MAHs, notify the lot release institutions to disapprove the lot release of relevant products or all products of vaccine MAHs or suspend the lot release procedure based on the inspection results, and order vaccine MAHs to make rectification. Vaccine MAHs shall immediately make rectification and in a timely manner report the rectification progress to the department which gives the order.
Article 31 Vaccine MAHs shall truthfully record production process deviations, quality deviations, failures and accidents during manufacturing as well as the corresponding measures taken and shall specify them in the document of relevant lot release application; in the case that the quality of vaccines may be affected, vaccine MAHs shall immediately take measures, and report to the drug regulatory departments of the people's governments of provinces, autonomous regions or municipalities directly under the Central Government.
Chapter IV
Vaccine Distribution
Article 32 For national immunization program vaccines, the centralized bidding or unified negotiation shall be organized by the competent health department under the State Council jointly with the financial and other departments under the State Council. The winning price or transaction price shall be established and released, and each province, autonomous region and municipality directly under the Central Government shall implement unified procurement.
For immunization program vaccines other than national immunization program vaccines and non-immunization program vaccines, each province, autonomous region and municipality directly under the Central Government shall organize the procurement through the provincial platform for the transaction of public resources.
Article 33 The price of a vaccine shall be established autonomously and reasonably by its MAHs in accordance with law. The price level, price difference rate and profit rate of a vaccine shall be kept within a reasonable range.
Article 34 Disease prevention and control institutions at the provincial level shall, in accordance with the national immunization program and the need for disease prevention and control within their administrative regions, formulate plans for the use of immunization program vaccines within their administrative regions, report the plans to the vaccine procurement organizing departments as per relevant national regulations, and simultaneously file the record with the competent health departments under the people's governments of provinces, autonomous regions and municipalities directly under the Central Government.
Article 35 Vaccine MAHs shall supply vaccines to disease prevention and control institutions in accordance with the procurement contract.
Disease prevention and control institutions shall supply vaccines to immunization entities as required.
Entities or individuals other than disease prevention and control institutions shall not supply vaccines to immunization entities, and immunization entities shall not accept such vaccines.
Article 36 Vaccine MAHs shall deliver vaccines to disease prevention and control institutions or immunization entities designated by disease prevention and control institutions in accordance with the procurement contract.
Vaccine MAHs and disease prevention and control institutions shall operate under the vaccine cold-chain storage and transportation conditions when delivering vaccines on their own, or they may also entrust qualified vaccine distribution entities to distribute vaccines.
Disease prevention and control institutions may charge storage and transportation fee for distributing non-immunization program vaccines; the specific measures shall be formulated by the financial department under the State Council in conjunction with the competent pricing department under the State Council; and the charging criteria shall be formulated by the competent pricing departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government in conjunction with the financial departments at the same level.
Article 37 Disease prevention and control institutions, immunization entities, vaccine MAHs and vaccine distribution entities shall comply with the provision for vaccine storage and transportation to ensure vaccine quality.
Vaccines shall be kept under the stipulated temperature during the whole process of storage and transportation; cold-chain storage and transportation shall comply with requirements, and temperature shall be monitored and recorded on a regular basis.
The provision for vaccine storage and transportation shall be formulated by the drug regulatory department under the State Council in conjunction with the competent health department under the State Council.
Article 38 When distributing vaccines, vaccine MAHs shall provide photocopies or electronic documents of the lot release certificates with their seal; when distributing imported vaccines, vaccine MAHs shall additionally provide photocopies or electronic documents of the Drug Import Note with their seal.
When accepting or purchasing vaccines, disease prevention and control institutions and immunization entities shall ask for the abovementioned supporting documents, and keep such documents for no less than five years upon the expiration date of vaccines for reference.
Article 39 Vaccine MAHs shall establish authentic, accurate and complete sales records as required, and keep such records for no less than five years upon the expiration date of vaccines for reference.
Disease prevention and control institutions, immunization entities and vaccine distribution entities shall establish authentic, accurate and complete records of acceptance, purchase, storage, distribution and supply as required, and keep such records for no less than five years upon the expiration date of vaccines for reference.
When accepting or purchasing vaccines, disease prevention and control institutions and immunization entities shall ask for the temperature monitoring records during the whole process of transportation and storage, and keep such records for no less than five years upon the expiration date of vaccines for reference; where the temperature monitoring records during the whole process of transportation and storage cannot be provided or the temperature control fails to meet the requirements, disease prevention and control institutions and immunization entities shall not accept or purchase the vaccines concerned. Instead, they shall immediately report to the drug regulatory departments and the competent health departments of the people’s governments at or above the county level.
Article 40 Disease prevention and control institutions and immunization entities shall establish routine vaccine inspection system. Vaccines that have unidentifiable packaging, fail to meet the storage temperature requirements, or have passed the expiration date, shall be isolated, labeled with warning signs, and handled in accordance with regulations of the drug regulatory department, the competent health department and competent ecological and environmental department under the State Council. Disease prevention and control institutions and immunization entities shall truthfully record the handling situation and keep the handling record for no less than five years upon the expiration date of vaccines for reference.
Chapter V
Immunization
Article 41 The competent health department under the State Council shall formulate the national immunization program; vaccine varieties in the national immunization program shall be proposed by the competent health department under the State Council jointly with the financial department under the State Council, and released upon approval by the State Council.
The competent health department under the State Council shall establish an expert consultation committee on the national immunization program, and set up a dynamic adjustment mechanism for vaccines in the national immunization program jointly with the financial department under the State Council.
When implementing the national immunization program, people’s governments of provinces, autonomous regions and municipalities directly under the Central Government may add vaccine varieties to their immunization program based on the need for disease prevention and control within their respective administrative regions, and release the adjustment after filing the record with the competent health department under the State Council.
Article 42 The competent health department under the State Council shall formulate and issue guidance for immunization, so as to enhance the standardized management of immunization.
The competent health department under the State Council shall formulate and issue immunization procedures for the national immunization program vaccines and guidelines for the use of non-immunization program vaccines.
The competent health departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall formulate immunization plans based on the practical situation of their respective administrative regions and file the record with the competent health department under the State Council.
Article 43 Disease prevention and control institutions at all levels shall, as per their respective duties, carry out tasks related to immunization including publicity, training, technical guidance, monitoring, assessment, epidemiology surveys, emergency response, etc..
Article 44 Immunization entities shall meet the following conditions:
(1) obtaining a practice license for a medical institution;
(2) having physicians, nurses or village doctors who have received professional training on immunization organized by the competent health departments of people's governments at the county level and passed the examinations;
(3) having cold storage facilities, equipment and cold storage system in conformity with the prescribed guidance for vaccine storage and transportation.
The competent health departments of people's governments at or above the county level shall designate eligible medical institutions to undertake inoculation of immunization program vaccines within the responsible areas. Eligible medical institutions may undertake the inoculation of non-immunization program vaccines，and file the record with the competent health department which issued the practice license for a medical institution.
Immunization entities shall strengthen internal management. They shall abide by the guidance for immunization, immunization procedures, guidelines for vaccine use and immunization plans.
Disease prevention and control institutions at all levels shall enhance technical guidance for immunization of immunization entities and management of vaccine use.
Article 45 Before administering vaccines, medical and healthcare professionals shall inform vaccine recipients or their guardian of the varieties, functions, contraindications, adverse reactions, stay for observation and other precautions of the vaccines to be administered, inquire the health condition of the vaccine recipients and whether they have any immunization contraindication, and truthfully record the informing and inquiry details. The vaccine recipients or their guardian shall truthfully provide information on the vaccine recipients' health condition and contraindication etc.. Where a vaccine cannot be administered due to contraindications, the medical and healthcare professionals shall give medical advice to the vaccine recipients or their guardians and truthfully record such advice.
Before administering vaccines, medical and healthcare professionals shall, in accordance with the prescribed guidance for immunization, examine the vaccine recipient’s health status, immunization contraindication, check the immunization certificate, examine the appearance, lot number and expiration date of the vaccine and syringe, and verify the recipient’s name and age and the vaccine’s name, specifications, dose, injection site and route of administration. Vaccine administration shall only take place after confirmation of information on the recipient, the immunization certificate and the vaccine to be administered.
Medical and healthcare professionals shall administer vaccines for eligible recipients. Where a recipient experiences adverse reactions during stay for observation, the medical and healthcare professionals shall follow the prescribed guidance for immunization and take prompt actions for treatment.
Article 46 Medical and healthcare professionals shall, in accordance with regulations of the competent health department under the State Council, truthfully, accurately and completely record the immunization information, including vaccine variety, the MAH, identification information of the smallest package unit, the expiration date, time of immunization, the medical and healthcare professional who administered the vaccine, the recipient etc., to ensure that the immunization information is traceable and searchable. The immunization records shall be kept for no less than five years upon the vaccine’s expiration date for reference.
Article 47 The State implements the immunization certificate system for children. Within one month after a child is born, his/her guardian shall go to the immunization entity undertaking immunization in the child’s area of residence or the hospital where the child was born to obtain the immunization certificate. The immunization entity or hospital of birth shall not refuse to provide the certificate. The guardians shall keep the immunization certificate properly.
Immunization shall be managed according to the place of residence. Where a child leaves the original place of residence, the immunization entity undertaking immunization in the present residential area shall provide immunization for the child.
Format of the immunization certificate shall be stipulated by the competent health department under the State Council.
Article 48 Where any child is admitted to a nursery or school, the nursery or school shall check the immunization certificate. Where any child is found to have not received immunization program vaccines as specified, the nursery or school shall report to the immunization entity undertaking immunization where the child lives or where the nursery or school is located and cooperate with the immunization entity to persuade the guardian of the child to have the child immunized as specified. Disease prevention and control institutions shall provide technical support to nurseries or schools in checking immunization certificates.
The measures for checking immunization certificates for the admission of children to nurseries or schools shall be formulated by the competent health department under the State Council in conjunction with the education administrative department under the State Council.
Article 49 Immunization entities shall not charge any fees for administering immunization program vaccines.
When administering non-immunization program vaccines, immunization entities may charge an immunization service fee in addition to the fee for vaccines. The criteria for immunization service fee shall be formulated by the pricing departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government jointly with the financial departments.
Article 50 In order to prevent and control the outbreak or prevalence of infectious diseases based on the monitoring and early warning information of infectious diseases, the competent health departments of the local people's governments at or above the county level may carry out cluster immunization within their respective administrative regions after reporting to the people's governments at the same level for approval and filing the record with the competent health departments of the people's governments at or above the provincial level.
Where cluster immunization is needed nationwide or across the borders of provinces, autonomous regions and municipalities directly under the Central Government, a decision shall be made by the competent health department under the State Council.
The local people's governments at or above the county level or the competent health department under the State Council making the decision for carrying out cluster immunization shall organize relevant departments to carry out training, public education and resource deployment.
Any entity or individual is prohibited to carry out cluster immunization without approval.
Article 51 Where the local people’s governments at or above the county level or their competent health departments need to take emergency immunization measures in the event of outbreak or prevalence of an infectious disease, laws and administrative regulations shall be followed.
Chapter VI
Adverse Reactions Monitoring and Handling
Article 52 An adverse reaction of immunization is an adverse drug reaction that causes damage to the vaccine recipient’s body tissue, organ and functions during or following the standard process of administering a qualified vaccine, for which no party involved is at fault.
The following circumstances are not adverse reactions of immunization:
(1) common reactions following immunization caused by the vaccine’s intrinsic features;
(2) injury to the vaccine recipient due to sub-standard vaccine quality;
(3) injury to the vaccine recipient due to the immunization entity's incompliance with the guidance for immunization, immunization procedure, vaccine use guidelines and immunization plans;
(4) coincidental events following immunization in recipients who were in the latent period or prodromal period of a certain disease at the time of immunization;
(5) acute relapse of underlying diseases or worsening of disease conditions in vaccine recipients who have immunization contraindications prescribed on the vaccine package insert and who or whose guardian fails to provide truthful information about his/her health condition and the contraindication for the vaccine prior to immunization;
(6) individual or cluster psychogenic reaction as a result of psychological factors.
Article 53 The State strengthens the monitoring on adverse reactions of immunization. The plan for monitoring adverse reactions of immunization shall be formulated by the competent health department under the State Council jointly with the drug regulatory department under the State Council.
Article 54 Immunization entities and medical institutions shall report to disease prevention and control institutions as required when identifying suspected adverse reactions of immunization.
Vaccine MAHs shall set up special organization equipped with full-time staff to actively collect, track and analyze the suspected adverse reactions of immunization, take prompt risk control measures, report the suspected adverse events to disease prevention and control institutions and submit the quality analysis report to drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government.
Article 55 Disease prevention and control institutions shall promptly report the suspected adverse reactions of immunization as required, organize the investigation and diagnosis, and inform the vaccine recipient or his/her guardian of the conclusion of the investigation and diagnosis. Where there is controversy over the conclusion of the investigation and diagnosis, an application for appraisal may be submitted according to the appraisal measures formulated by the competent health department under the State Council.
Suspected adverse reactions of immunization that have significant influence on the society including any death or severe disability of the vaccine recipient caused by immunization and suspected cluster adverse reactions of immunization shall be investigated and handled by the competent health departments and the drug regulatory departments of the people's government of the municipalities divided into districts and above as per their respective responsibilities.
The appraisal measures for adverse reactions of immunization shall be formulated by the competent health department under the State Council.
Article 56 The State implements a compensation system for adverse reactions of immunization. Where, during or after the immunization process, a vaccine recipient suffers from harm including death, severe disability, organ and tissue damage, etc., compensation shall be given thereto if these conditions are adverse reactions of immunization or the possibility cannot be ruled out. The scope of compensation is subject to catalogue management, and shall be adjusted based on the actual situations.
Compensation needed for immunization of immunization program vaccines shall be included in the funding for immunization budgeted by the financial departments of the people’s governments of provinces, autonomous regions or municipalities directly under the Central Government; compensation needed for immunization of non-immunization program vaccines shall be paid by the vaccine MAHs involved. The State encourages compensating vaccine recipients with adverse reactions of immunization through commercial insurance and other means.
Compensation for adverse reactions of immunization shall be prompt, convenient and rational. The scope, standards and procedures of compensation for adverse reactions of immunization shall be determined by the State Council, while the specific implementation measures shall be formulated by the provinces, autonomous regions or municipalities directly under the Central Government.
Chapter VII
Vaccine Post-Marketing Management
Article 57 Vaccine MAHs shall establish and improve quality management systems for whole life cycle of vaccines, formulate and implement vaccine post-marketing risk management plans, and conduct vaccine post-marketing studies to further verify the safety, effectiveness and quality management of vaccines.
Where further study is required when a vaccine's registration application is approved, the vaccine MAH shall complete the study within the prescribed time limit; where the study fails to be completed on time or fails to prove that the benefits outweigh the risks, the drug regulatory department under the State Council shall take actions in accordance with law up to revoke the vaccine's registration certificate.
Article 58 Vaccine MAHs shall carry out quality tracking analysis for vaccines and continuously improve quality control standards, production process and stability of the production process.
Changes to the production process, production sites, critical equipment, etc., shall be assessed and validated, and shall be filed or reported in accordance with the provisions of the drug regulatory department under the State Council for change management; changes that may affect vaccine quality, effectiveness and quality management shall be subject to approval by the drug regulatory department under the State Council.
Article 59 Vaccine MAHs shall continue to update the package inserts and labels based on the post-marketing study or adverse reactions of vaccines and apply for approval or file the record as required.
The drug regulatory department under the State Council shall publish the content of vaccine package inserts and labels on its websites in a timely manner.
Article 60 Vaccine MAHs shall establish the vaccine quality retrospective analysis and risk reporting system and truthfully report information on vaccine manufacture and distribution, post-marketing studies and risk management each year as required to the drug regulatory department under the State Council.
Article 61 The drug regulatory department under the State Council may order vaccine MAHs to carry out post-marketing evaluation, or directly organize and carry out post-marketing evaluation.
With respect to vaccines that have serious adverse reactions or jeopardize human health due to other reasons, the drug regulatory department under the State Council shall revoke the drug registration certificates of such vaccines.
Article 62 The drug regulatory department under the State Council may organize post-marketing evaluation of vaccine varieties based on the demand for disease prevention and control as well as the development of the vaccine industry. Where a vaccine variety is found to be significantly inferior to other vaccine varieties used for the prevention and control of the same disease in terms of product design, production process, safety, effectiveness or quality management, the drug registration certificates of all vaccines of the inferior variety shall be revoked and the corresponding national drug standards shall be abolished.
Chapter VIII
Safeguard Measures
Article 63 To ensure the implementation of national immunization program, the people's government at or above the county level shall incorporate into the budget of the people's governments at the same level the funds needed for vaccine safety, procurement of immunization program vaccines, immunization and information-based construction.
The people's governments at county level shall grant subsidies for the village doctors and other primary immunization and healthcare personnel engaged in immunization in accordance with relevant national regulations.
The State gives support to the immunization in economically underdeveloped areas as required. People’s governments of provinces, autonomous regions and municipalities directly under the Central Government as well as people's government of municipalities divided into districts shall grant necessary financial subsidies to the work related to immunization conducted by people’s governments at county level in economically underdeveloped areas.
Article 64 Following from the epidemic tendency of infectious diseases, the people’s governments of provinces, autonomous regions or municipalities directly under the Central Government shall set up projects related to immunization in their respective administrative regions, which shall fall within the ambit of the projects for the prevention and control of infectious diseases stipulated by the health department under the State Council, and ensure the implementation of such items.
Article 65 The health department under the State Council shall, according to the plan of each province, autonomous region and municipality directly under the Central Government for the use of national immunization program vaccines, notify the demand information for national immunization program vaccines to vaccine MAHs, and the vaccine MAHs shall reasonably arrange their manufacture according to vaccine demand information.
In the case of any risk of vaccine supply shortage, the health department under the State Council and the drug regulatory department under the State Council shall propose suggestions, and the industry and information technology department and financial department under the State Council shall take effective measures to ensure the manufacture and supply of vaccines.
The vaccine MAHs shall organize production and ensure the vaccine supply according to law; Vaccine MAHs stopping the manufacture of the vaccine shall promptly report to the drug regulatory department under the State Council or the drug regulatory departments of the people's government of the province, autonomous region or municipality directly under the Central Government.
Article 66 The State buildss vaccines into the stockpile of strategic materials, implementing the stockpile at the national and provincial levels.
The industry and information technology department and financial department under the State Council shall, in accordance with the need for disease prevention and control and public health emergency preparedness, strengthen the stockpile capacity and product management of the vaccines and establish dynamic adjustment mechanism jointly with the competent health department, public security department, market regulation department and drug regulatory department under the State Council.
Article 67 The funds allocated for the immunization arranged by the financial departments at different levels shall be earmarked for dedicated purposes, and no entity or individuals may misappropriate or occupy them.
Relevant entities and individuals using the funds for immunization shall accept the audit supervision by the auditing administrations according to law.
Article 68 The State implements a compulsory liability insurance system for vaccines.
Vaccine MAHs shall buy compulsory liability insurance for vaccines as required. Where the recipients’ injury is caused by quality problems, the insurance company shall pay compensation within the limits of liability insured.
Specific measure for the implementation of compulsory liability insurance system for vaccines shall be formulated by the drug regulatory department under the State Council jointly with the health department and the insurance regulatory department under the State Council.
Article 69 In the case of outbreaks or prevalence of infectious diseases, relevant vaccine MAHs shall manufacture and supply vaccines for the prevention and control of infectious diseases in a timely manner. Communication and transportation entities shall preferentially transport vaccines for the prevention and control of the infectious diseases. People's governments at or above the county level and relevant departments shall properly organization, coordination and support work.
Chapter IX
Supervision and Management
Article 70 The drug regulatory departments and health departments shall conduct administration on the whole process of vaccine development, manufacture, distribution and immunization according to their respective responsibilities and supervise vaccine MAHs, disease prevention and control institutions, and immunization entities to fulfill their obligations according to law.
The drug regulatory departments shall conduct supervision and inspection on the vaccine quality during the process of the vaccine development, manufacture, storage, transportation, and immunization. The competent health departments shall conduct supervision and inspection on the implementation of the immunization planning system and immunization activities according to law.
The drug regulatory departments shall strengthen the on-site inspection on vaccine MAHs. If necessary, regulatory departments may conduct extended inspections on entities or individuals who provide products or services for vaccine development, manufacture and distribution, and relevant entities and individuals shall cooperate and not reject the inspection or conceal any information.
Article 71 The State organizes professional and specialized pharmaceutical inspector teams at both national and provincial levels, and enhance supervision and inspection on vaccines.
The drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall select and assign inspectors to the vaccine MAHs. The inspectors, who are accountable for their conducts during their stay in vaccine MAHs, shall be responsible for supervising and inspecting the implementation of good manufacturing practice for drugs, collecting vaccine quality risks and evidence for illegal behaviors, and reporting the conditions and proposing suggesting to the drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government.
Article 72 Where there exists safety risks in vaccine quality management and the vaccine MAHs have not taken measures in a timely manner to eliminate them, the relevant drug regulatory departments shall take such measures as warning meetings and orders to make rectification within a time limit etc..
In the case of serious violation against the relevant good manufacturing practice for drugs, the drug regulatory departments shall order the suspension of the production, sales and distribution of vaccines and immediate rectification; and the manufacture, sales and distribution shall be resumed only after the rectification is completed and the results meet the requirements upon the inspection by the drug regulatory departments.
Drug regulatory departments shall establish a credit record system for the vaccine MAHs and their responsible persons and include them into the national credit information sharing platform, release information of their serious loss of honesty according to regulations and impose joint punishment.
Article 73 For vaccines with quality problems or vaccines suspected of having quality problems, vaccine MAHs, disease prevention and control institutions and immunization entities shall immediately stop the sale, distribution, and use, and if necessary, immediately stop the manufacture and report the case to drug regulatory departments and health departments of the people's governments at or above the county level according to relevant regulations. The competent health departments shall immediately organize the disease prevention and control institutions and immunization entities to take necessary emergency handling measures, and at the same time report the case to the health departments of the superior people's governments. The drug regulatory departments shall take measures including sealing and detention according to law. For vaccines having been sold, the vaccine MAHs shall in a timely manner notify relevant disease prevention and control institutions, vaccine distribution entities and immunization entities to recall such vaccines according to regulations, and truthfully record the conditions of recall and notification, and disease prevention and control institutions, vaccine distribution entities and immunization entities shall provide cooperation.
In the case of failures to stop manufacture, sales, distribution, use and recall of vaccines as the preceding paragraph, the drug regulatory departments and the health departments at or above the county level shallr to stop manufacture, sales, distribution, use and recall of such vaccines according to their respective responsibilities.
Vaccine MAHs, disease prevention and control institutions, and immunization entities shall not conceal information, give false information, omit to report, delay the reporting, or conceal, fabricate or destroy relevant evidence when discovering vaccines with quality problems or vaccines suspected of having quality problems.
Article 74 Vaccine MAHs shall establish an information publicity system and in a timely manner publish vaccine information, package inserts, labels, implementation of relevant good manufacturing practice, lot release, product recall, inspection and punishment accepted as well as compulsory vaccine liability insurance on their websites in accordance with relevant regulations.
Article 75 The drug regulatory department under the State Council shall liaise with the health department under the State Council to establish the information sharing mechanism for vaccine quality and immunization.
Drug regulatory departments and health departments of people's governments at or above the provincial level shall organize vaccine MAHs, disease prevention and control institutions, immunization entities, news media, and scientific research institutions etc. to exchange and communicate about information on vaccine quality, safety and immunizationin a scientific, objective, timely and transparent manner.
Article 76 The State implements the uniform release system for vaccine safety information.
Warnings against vaccine safety risks, information on major vaccine safety accidents, investigation and handling as well as other vaccine safety information subject to unified release as confirmed by the State Council shall be released by the drug regulatory department under the State Council in collaboration with relevant departments. Reports of adverse reactions during immunization across the nation shall be published in a unified manner by the health department under the State Council jointly with drug regulatory department under the State Council. The release of such information without authorization is prohibited. The release of significant vaccine quality and safety information shall be timely, accurate and comprehensive, and scientific evaluation shall be carried out as required and necessary explanations shall be made.
Drug regulatory departments of people's governments at or above county level discovering any vaccine quality and safety information likely to mislead the public and affect social opinions shall immediate perform verification and analysis in conjunction with the competent health departments and other relevant departments, professional institutions and relevant MAHs, and release the results in a timely manner.
All entities and individuals are prohibited from fabricating or spreading any false information on vaccine safety.
Article 77 All entities and individuals shall have the right to obtain vaccine information in accordance with law and put forward opinions and suggestions on vaccine administration.
All entities or individuals are entitled to report any vaccine illegal behaviors to the competent health departments, the drug regulatory departments etc.; if the competent health departments or the drug regulatory departments etc. fail to perform their administration duties according to law, entities or individuals may report them to the relevant departments of people’s governments at the same level or the superior level as well as relevant supervisory departments. Relevant departments shall verify and handle the report in a timely manner; if the reports are verified to be true, give rewards to the informants according to relevant regulations; and give substantial rewards to the informants who report serious illegal behaviors committed in the entities where they work if the reports are verified to be true.
Article 78 People's governments at or above the county level shall formulate emergency response plans for vaccine safety incidents, stipulate the grading of vaccine safety incidents, manage organization and command systems and responsibilities, provide prevention and early warning mechanisms and manage procedures and emergency safeguarding measures.
Vaccine MAHs shall formulate the handling procedure for vaccine safety incidents, periodically inspect the implementation of all preventive measures and eliminate potential dangers in a timely manner.
In the case of vaccine safety events, vaccine MAHs shall immediately report the occurrence to the drug regulatory department under the State Council or drug regulatory departments of the people's governments of the provinces, autonomous regions or municipalities directly under the Central Government; and disease prevention and control institutions, immunization entities, and medical institutions shall immediately report the occurrence to competent health departments and drug regulatory departments of the people's governments at or above the county level. The drug regulatory departments shall establish a vaccine safety emergency response organization jointly with the competent health departments as specified in the emergency plan, conduct medical rescues, risk control, investigation and handling, information release, explanation etc., and address problems arising from the incidents such as providing supplementary immunization. The fees for supplementary immunization arising from vaccine safety incidents due to quality problems of vaccines shall be assumed by the vaccine MAHs.
Any entity or individual shall not conceal, give false information about, delay or omit reporting vaccine safety events and not conceal, forge or destroy relevant evidence.
Chapter X
Legal Liabilities
Article 79 Illegal act that violates this Law and constitutes a crime shall be subject to severer criminal liabilities according to law.
Article 80 Where manufactured or distributed vaccines are counterfeit, the drug regulatory departments of the people's governments at or above the provincial level shall confiscate illegal gains, illegally manufactured and distributed vaccines and raw materials, excipients, packaging materials and equipment specially used for illegal production, order to stop production for rectification and stop business operation, revoke drug registration certificate and impose a fine of not less than fifteen times but not more than fifty times the value of vaccines illegally manufactured or distributed, and if the illegal values are less than RMB 500,000 yuan, it shall be counted as RMB 500,000 yuan.
Where manufactured or distributed vaccines are adulterated, the drug regulatory departments of the people's governments at or above the provincial level shall confiscate illegal gains, illegally manufactured and distributed vaccines and raw materials, excipients and packaging materials and equipment and so on specially used for illegal production, order to stop production for rectification and stop business operation, and impose a fine of not less than ten times but not more than thirty times the value of vaccines illegally manufactured or distributed, and if the illegal values are less than RMB 500,000 yuan, it shall be counted as RMB 500,000 yuan; in serious circumstances, the drug regulatory departments of the people's governments at or above the provincial level shall revoke drug registration certificate, and even the drug manufacturing license.
Where manufactured or distributed vaccines are counterfeit, or adulterated with serious consequences, the legal representative, the main responsible person, the person directly in charge and personnel in key positions as well as other responsible personnel of vaccine MAHs shall be subject to a confiscation of income received from their affiliation during the occurrence of violations and a fine of not less than one time but not more than ten times the income, and shall be prohibited from engaging in drug manufacturing and operation for whole life, and detained by the public security department of not less than five days but not more than fifteen days.
Article 81 In any of the following circumstances, the drug regulatory departments of the people's governments at or above the provincial level shall confiscate illegal gains, illegally manufactured and distributed vaccines and raw materials, excipients, packaging materials and equipment specially used for illegal manufacture, order to stop production for rectification and stop business operation, and impose a fine of not less than fifteen times but not more than fifty times the value of vaccines illegally manufactured or distributed; if the illegal values are less than RMB 500,000 yuan, it shall be counted as RMB 500,000 yuan; in serious circumstance, the offender is subject to revocation of relevant approval documents, and up to the revocation drug manufacturing license; the legal representative, the main responsible person, director in charge and personnel in key positions as well as other responsible personnel of vaccine MAHs shall be subject to a confiscation of the income received from their organizations during the occurrence of violations, and a fine of not less than one half but not more than ten times the income, and shall be prohibited from engaging in drug manufacturing and operation for life, and be detained by the public security department for not less than five days but not more than fifteen days:
(1) submitting falsified data, documents, samples or having other deceptive behaviors in application for vaccine clinical trials, registration and lot release;
(2) fabricating manufacturing and testing records or changing product lot number;
(3) distributing vaccine to immunization entities by any institution or individual other than disease prevention and control institutions;
(4) entrusting vaccine manufacturing without authorization;
(5) implementing changes to production process, production site and key equipment without approval which shall have been approved as required;
(6) implementing updates of vaccine package inserts and labels without approval which shall have been approved as required.
Article 82 Except otherwise provided in the Law, if vaccine MAHs or other entities violate relevant drug quality management regulations, the drug regulatory departments of the people's governments at or above the county level shall order to make rectification and give a warning; and those who refuse to make rectification shall be subject to a fine of not less than RMB 200,000 yuan but not more than RMB 500,000 yuan; in serious circumstances, the offender shall be subject to a fine of not less than RMB 500,000 yuan but not more than RMB 3,000,000 yuan and an order to stop production for rectification until revocation of relevant drug approval documents and drug manufacturing license, and the legal representative, the main responsible person, executive in charge and personnel in key positions as well as other responsible personnel of vaccine MAHs shall be subject to a confiscation of the income received from their organizations during the occurrence of violations, and a fine of not less than one half but not more than five times the income, and be prohibited from engaging in drug production and operation for ten years to for life.
Article 83 In cases where vaccine MAHs’ violation of this Law involves any of the following circumstances, the drug regulatory departments of the people's governments at or above the provincial level shall order to make rectification and give a warning; and those who refuse to make rectification shall be subject to a fine of not less than RMB 200,000 yuan but not more than RMB 500,000 yuan; in serious circumstances, the offender shall be subject to an order to stop production for rectification and a fine of not less than RMB 500,000 yuan but not more than RMB 2,000,000 yuan:
(1) failing to establish vaccine electronic traceability system as required;
(2) persons in key positions such as legal representative, the principal, responsible person for manufacturing management, the responsible person for quality management and the quality authorized person, etc. failing to meet the prescribed conditions or failing to train and appraise these persons as required;
(3) failing to report or file as required;
(4) failing to conduct post-marketing research, or failing to establish institutions and equip staff as required to actively collect, track and analyze adverse reactions of suspected vaccination;
(5) failing to carry compulsory vaccine liability insurance as required;
(6) failing to establish information disclosure system as required.
Article 84 Where a lot release institution has one of the following circumstances in violation of this Law, the drug regulatory department under the State Council shall order to make rectifications and give a warning to the said institution, and give warnings until downgrade as punishment to the principal, director in charge and other directly responsible personnel:
(1) failing to conduct audits and inspections as required;
(2) failing to issue lot release results of marketed vaccine in a timely manner;
(3) failing to verify and validate as required;
(4) failing to report detected significant quality risks of vaccine as required.
If a lot release institution fails to issue a lot release certificate or a not-release notice in violation of this Law, the drug regulatory department under the State Council shall order to make rectifications and give a warning to the said institution, and give a downgrade or dismissal as punishment to the main responsible person, executive in charge, and other directly responsible personnel according to law; and in serious circumstances, an expulsion from organization.
Article 85 If any disease prevention and control institution, immunization entity, vaccine MAH, or vaccine distribution entity violates cold-chain storage and transportation requirements in vaccine storage and transportation guidance, the drug regulatory department of the people's government at or above the county level shall order to make rectification and give warnings, destroy illegally stored and transported vaccines and confiscate illegal income; and for those who refuse to make rectification, it shall impose on the immunization entity, the MAH and the vaccine distribution entity a fine of more than RMB 200,000 yuan and less than RMB 1,000,000 yuan; and in serious circumstances, it shall impose on the immunization entity, vaccine MAH, and vaccine distribution entity a fine of not less than ten times and not more than thirty times of illegal values derived from illegally stored and transported vaccines; and if the illegal values are less than RMB 100,000 yuan, it shall be counted as RMB 100,000 yuan, and the vaccine MAH, vaccine distribution entity shall be subject to production and operation suspension until revocation of relevant drug approval documents, drug manufacturing certificate and so on, and their legal representative, the principal, executive in charge and key position personnel and other responsible personnel shall be subject to punishments as prescribed in Article 82 of this Law.
Where disease prevention and control institutions or immunization entity commits an illegal act as prescribed in the preceding paragraph, the competent health department of the People's government at or above the county level shall impose sanctions of a warning and up to dismissal on the main responsible person, executive in charge and other directly responsible personnel according to law, and order the responsible medical personnel to suspend the practice activities for more than one year and less than 18 months; and for serious consequences, give a dismissal according to law, and revoke immunization qualification of the immunization entity, and responsible medical and health personnel shall being revoked of business certificate by original issuing department.
Article 86 Where any disease prevention and control institutions, immunization entity, vaccine MAH or vaccine distribution entity violates vaccine storage and transportation guidance other than those prescribed in Article 85 of this Law, the drug regulatory departments of the people's governments at the county level shall order to make rectification, give a warning, and confiscate the illegal gains; and for those who refuse to make rectification, a fine of more than RMB 100,000 yuan and less than RMB 300,000 yuan shall be imposed on the immunization entity, vaccine MAHs, and the vaccine distribution entity; and in serious circumstances, a fine of not less than three times and not more than ten times of values derived from illegally stored and transported vaccines shall be imposed on the immunization entity, vaccine MAHs, and vaccine distribution entity. If the value of the vaccines concerned is less than RMB 100,000 yuan, it shall be counted as RMB 100,000 yuan.
Where any disease prevention and control institution or immunization entity commits illegal acts as prescribed in the preceding paragraph, the competent health department of the people's government at or above the county level may impose sanctions of warning and up to the dismissal on the main responsible person, the executive in charge and other directly responsible personnel according to law, and order the responsible medical and health personnel to suspend practice activities for more than six months and less than one year; and for serious consequences, give a dismissal to the principal, the executive in charge and other directly responsible personnel according to law, and responsible medical and health personnel shall be revoked of business certificate by original issuing department.
Article 87 Where any disease prevention and control institution or immunization entity is under any of the following circumstances in violation of this Law, the competent health department of the people's government at or above the county level shall order to make rectification, give a warning, and confiscate the illegal income; and in serious circumstances, impose sanctions of a warning and up to dismissal on the main responsible person, directly responsible persons and other directly responsible personnel according to law, and order the responsible medical personnel to suspend practice activities for more than one year and less than eighteen months; and for serious consequence, give an expulsion to the main responsible person and executive in charge and other directly responsible personnel according to law, and responsible medical and health personnel shall be revoked of business certificate by original issuing department:
(1) failing to supply, receive, and purchase vaccines as required;
(2) conducting immunization activities that does not comply with the immunization work norms, immunization procedures, guidance for vaccines use and immunization plans;
(3) conducting cluster immunization without authorization.
Article 88 In cases where violation of this Law by disease prevention and control institution or immunization entity involves any of the following circumstances, the competent health department of the people's government at or above the county level shall order to make rectification, give a warning, and confiscate the illegal income; and in serious circumstances, impose sanctions of a warning and up to dismissal on the main responsible person, directly responsible persons and other directly responsible personnel according to law, and order the responsible medical personnel to suspend practice activities for more than six months and less than one year; for serious consequences, give an expulsion to the principal and executive in charge and other directly responsible personnel according to law, and responsible medical and health personnel shall be revoked of business certificate by original issuing department:
(1) failing to provide traceability information as required;
(2) failing to obtain and keep relevant certification documents and temperature monitoring records when receiving or purchasing vaccines;
(3) failing to establish and maintain records of vaccine reception, purchase, storage, distribution, supply, inoculation, and disposal as required;
(4) failing to inform and inquire the recipient or his/her guardian about relevant conditions as required.
Article 89 Where any disease prevention and control institution, medical institution or immunization entity fails to report suspected immunization adverse reactions and vaccine safety incidents, or fails to organize investigation and diagnosis of suspected immunization adverse reactions as required, the competent health departments of the people's governments at or above the county level shall order to make rectification and give a warning; and in serious circumstances, it shall impose a fine of not less than RMB 50,000 yuan but not more than RMB 500,000 yuan on the immunization entities and medical institutions, and impose sanctions of a warning and up to a dismissal on the main responsible person, executive in charge and other directly responsible personnel according to law; and for serious consequence, give an expulsion to the main responsible person and executive in charge and other directly responsible personnel according to law, and the department that formerly issued the practicing license shall revoke the certificate of the responsible medical and healthcare personnel.
Article 90 If any disease prevention and control institutions or immunization entities violates this Law to charge fee, the competent health departments of the people's governments at or above the county level shall monitor the return of the illegally charged fee to the original paying entities or individuals, and market regulation department at or above the county level shall give corresponding sanctions thereto according to law.
Article 91 For any institution conducting immunization of immunization program vaccines without designation of competent health departments of the local people's government at or above the county level, or conducting immunization of non-immunization program vaccines without meeting the requirements or filing the record, the competent health departments of the people's government at or above the county level shall order to make rectification and give a warning, confiscate illegal gains and illegally possessed vaccines, order to stop operation for rectification, impose a fine of not less than RMB 100,000 yuan but not more than RMB 1,000,000 yuan and impose sanctions on the main responsible person, executive in charge and other direct responsible personnel according to law.
For any entity or individual other than disease prevention and control institutions and immunization entities that engages in cluster immunization without approval in violation of this Law, the competent health departments of the people's government at or above the county level shall order to make rectification, confiscate illegal gains and illegally possessed vaccines, and impose a fine of not less than ten times and not more than thirty times ofvalues derived from illegally stored and transported vaccines, and if the values of the vaccines concerned are less than RMB 50,000 yuan, it shall be counted as RMB 50,000 yuan.
Article 92 If the guardian fails to ensure that the children at proper age are immunized with immunization program vaccines on schedule, the competent health departments at the county level shall give criticism and education and order to make correction.
Where nurseries and schools fail to check the immunization certificate as required on the admission of children, or fail to report to immunization entities after identifying any child having not been vaccinated as required, the education administrative departments of the people's government at or above the county level shall order to make correction, give a warning, and impose sanctions on the main responsible person, executive in charge and other responsible personnel
Article 93 Anyone who fabricates or spreads false information about vaccine safety, or picks quarrels and provokes troubles in immunization entities, thus constituting an act violating public security regulations shall be subject to public security punishment by the public security departments according to law.
Relevant competent departments shall impose sanctions according to law on a newspaper, journal, radio, television, internet website or any other media where they fabricate or disseminate anyfalse information about vaccine safety, and on the main responsible person, executive in charge and other directly responsible personnel.
Article 94 Where local people's governments at or above the county level are under any of the following circumstances in vaccine administration, the executive in charge and other directly responsible personnel shall be given a downgrade or dismissal; and in serious circumstances, the executive in charge and other directly responsible personnel shall be given an expulsion; if it causes serious consequences, the principal shall resign to assume responsibility:
(1) performing responsibility insufficiently, resulting in serious negative effects or heavy losses;
(2) concealing information, giving false information, delaying reporting, giving incomplete report of vaccine safety incidents;
(3) disturbing or obstructing vaccines-related investigation on illegal or criminal acts or safety incidents;
(4) occurrence of significant vaccine safety incidents or continuous major vaccine safety incidents within the administrative region.
Article 95 For any of the following behaviors of drug regulatory departments or competent health departments in vaccine administration, the executive in charge and other directly responsible personnel shall be given a downgrade or dismissal; and in serious circumstances, the executive in charge and other directly responsible personnel shall be given an expulsion; if it causes serious consequence, the principal shall resign to assume responsibility:
(1) failing to perform duties of supervision and inspection, or failing to promptly investigate and punish any illegal act that has been identified;
(2) carrying out cluster immunization without approval;
(3) concealing information, giving false information, delaying reporting or giving incomplete reporting of vaccine safety incidents;
(4) disturbing or obstructing vaccine-related investigation on illegal acts or safety incidents;
(5) revealing the information of the informant;
(6) failing to organize investigations and handling as required when receiving reports of suspected immunization adverse reactions;
(7) having any other dereliction of duty in vaccine administration, resulting in serious negative effects or heavy losses.
Article 96 If vaccine recipients are subject to any injury as a result of vaccine quality problem, the responsible vaccine MAH shall assume the compensation liability according to law.
If any disease prevention and control institutions or immunization entities violate the work norms, immunization procedure, vaccine use guidance and immunization plan in immunization, and thus cause injury to vaccine recipients, they shall assume the compensation liability according to law.
Chapter XI
Supplementary Provisions
Article 97 Definitions of the following terms used in this Law shall be:
"Immunization program vaccines" are vaccines to be inoculated in citizens as per the government provisions, including vaccines confirmed in the national immunization program, vaccines added by people’s governments of provinces, autonomous regions and municipalities directly under the Central Government while implementing the national immunization program, vaccines for emergency immunization or cluster immunization organized by the people’s governments or their competent health departments at or above the county level.
"Non-immunization program vaccines" are other vaccines to be inoculated by citizens at their discretion.
Vaccine MAHs are entities that obtain drug registration certificate of vaccines and drug manufacturing certificate.
Article 98 The State encourages vaccine manufacturers to produce and export vaccines to meet the international demand.
Exported vaccines shall meet the standards of the importing country (region) or contractual requirements.
Article 99 The immunization for exit and entry and the procurement of the vaccines needed shall be separately stipulated by border health and quarantine departments upon consultation with the financial department under the State Council.
Article 100 This Law shall be effective as of December 1, 2019.
Ministry of Justice of the
People's Republic of China
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