Chinese Vaccine Law states Media must use propaganda

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The Chinese Communist Party passed Vaccine Law on June 29, 2019 which  came into effect December 1, 2019.

Consider once again the elite occult rulers love of numbers for a moment before looking at the Law

  •  June 29, 2019 . 29 gives an 11 in a 20+19=39 year
  • Dec 1 or 12/1/2019 is seen as 13/2019 or 13/39
  • It is 22 weeks from June 30 to December 1
  • As I showed in the COVID TIMELINE this plandemic started on December 31, 2019 which is seen as 13/39 also
  • Make no mistake- this whole operation is being run by occult overlords.
  • The Law was passed at the 11th session of Congress
  • The Law was passed in the 13th Congress
  • The Law has 11 chapters

Now about the Law itself

Under Article 12 the Law states : “The news media should carry out public welfare propaganda[宣传]on vaccine safety laws, regulations and vaccination knowledge, and conduct public opinion supervision on vaccine violations. Publicity reports on vaccines should be comprehensive, scientific, objective and fair.”

新闻媒体应当开展疫苗安全法律、法规以及预防接种知识等的公益宣传

Propaganda in China refers to the use of propaganda by the Chinese Communist Party (CCP) or (historically) the Kuomintang (KMT) to sway domestic and international opinion in favor of its policies.[1][2] Domestically, this includes censorship of proscribed views and an active promotion of views that favor the government. Propaganda is considered central to the operation of the CCP government.[3] The term xuanchuan (Chinese: 宣傳 “propaganda; publicity”) can have either a neutral connotation in official government contexts or a pejorative connotation in informal contexts.[4] Some xuanchuan collocations usually refer to “propaganda” (e.g., xuānchuánzhàn 宣传战 “propaganda war”), others to “publicity” (xuānchuán méijiè 宣傳媒介 “mass media; means of publicity”), and still others are ambiguous (xuānchuányuán 宣传员 “propagandist; publicist”).[5] 

The Chinese Language version is here

Vaccine Administration Law of the People’s Republic of China

(Adopted at the 11th meeting of the Standing Committee of the 13th National People’s Congress on June 29, 2019)

Release time: 2019-07-03 13:58 Source: China National People’s Congress Network

table of Contents

  • Chapter One
  • Chapter 2   Vaccine development and registration
  • Chapter III   Vaccine Production and Batch Issuance
  • Chapter 4   Vaccine Distribution
  • Chapter 5   Vaccination
  • Chapter VI   Abnormal reaction monitoring and handling
  • Chapter Seven   Post-marketing vaccine management
  • Chapter 8   Safeguard Measures
  • Chapter 9   Supervision and Management
  • Chapter Ten   Legal Liability
  • Chapter Eleven

Chapter 1  General

  •            Article 1   In order to strengthen vaccine management, ensure vaccine quality and supply, standardize vaccination, promote the development of the vaccine industry, protect public health, and maintain public health safety, this law is formulated.
  •            Article 2   This Law shall apply to vaccine development, production, circulation, vaccination and supervision and management activities within the territory of the People’s Republic of China. If there are no provisions in this law, the provisions of the “Drug Administration Law of the People’s Republic of China” and the “Law of the People’s Republic of China on the Prevention and Control of Infectious Diseases” and other laws and administrative regulations shall apply.

Vaccines as mentioned in this Law refer to preventive biological products used for human immunization to prevent and control the occurrence and prevalence of diseases, including immunization programs and non-immunization programs.

  • Article 3 The state implements the most stringent management system for vaccines, insisting on safety first, risk management, full-process control, scientific supervision, and social co-governance.
  • 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 vaccine development and innovation, and incorporates vaccine development, production and storage 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 optimization of the vaccine industry, encourages large-scale and intensified vaccine production, and continuously improves the vaccine production process and quality level.

  • Article 5: Holders of vaccine marketing authorization shall strengthen the quality management of the whole life cycle of the vaccine, and be responsible for the safety, effectiveness and quality controllability of the vaccine.

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

  • Article 6 The country implements an immunization planning system.

Residents living in China shall enjoy the right to vaccination program vaccination according to law and fulfill the obligation of vaccination vaccination program. The government provides residents with free immunization program vaccines.

The people’s government at or above the county level and its relevant departments shall ensure that school-age children are vaccinated against the immunization program. Guardians shall ensure that school-age children receive the immunization program vaccination on time according to law.

  • Article 7   People’s governments at or above the county level shall incorporate vaccine safety work and vaccination work into the national economic and social development plan at the corresponding level, strengthen vaccine supervision and management capacity building, and establish and improve vaccine supervision and management working mechanisms.

Local people’s governments at or above the county level are responsible for the supervision and management of vaccines in their administrative regions, and lead, organize and coordinate the supervision and management of vaccines in their administrative regions.

  • Article 8 The drug regulatory department of the State Council is responsible for national vaccine supervision and management. The competent health department of the State Council is responsible for the supervision and management of national vaccination. Other relevant departments of the State Council are responsible for vaccine-related supervision and management within their respective responsibilities.

The drug supervision and administration department of the people’s government of provinces, autonomous regions and municipalities directly under the Central Government is responsible for the supervision and management of vaccines in their administrative regions. Departments of people’s governments at the districted city 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 administrative regions. The health authorities of local people’s governments at or above the county level are responsible for the supervision and management of vaccination in their respective administrative regions. Other relevant departments of local people’s governments at or above the county level are responsible for vaccine-related supervision and management within their respective responsibilities.

  • Article 9   The State Council and the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government shall establish a departmental coordination mechanism to coordinate and coordinate vaccine supervision and management work, regularly analyze the vaccine safety situation, strengthen vaccine supervision and management, and ensure vaccine supply.
  • Article 10 The country implements an electronic traceability system for the entire vaccine process.

 The State Council’s drug regulatory authority, together with the State Council’s health authority, formulates unified vaccine traceability standards and specifications, establishes a national vaccine electronic traceability collaboration platform, integrates traceability information throughout the entire process of vaccine production, circulation and vaccination, and realizes vaccine traceability.

Vaccine marketing license holders shall establish a vaccine electronic traceability system, which is connected with the national vaccine electronic traceability collaborative platform to realize the traceability and verification of the smallest packaging unit vaccine in the whole process of production, circulation and vaccination.

Disease prevention and control institutions and vaccination units shall truthfully record vaccine circulation, vaccination, etc. according to law, and provide traceability information to the national vaccine electronic traceability collaboration platform in accordance with regulations.

  • Article 11 During the process of vaccine development, production, and inspection, a sound biosafety management system shall be established to strictly control biosafety risks, strengthen the biosafety management of pathogenic microorganisms such as bacterial strains, protect the health of operators and the public, and ensure the The use of pathogenic microorganisms such as strains is legal and legitimate.

The history, biological characteristics, and generation of bacterial strains and cell strains used in vaccine development, production, testing, etc. shall be clearly defined, and detailed files shall be established to ensure that the source is legal, clear and traceable; those with unknown sources shall not be used.

  • Article 12 The people’s governments at all levels and their relevant departments, disease prevention and control institutions, vaccination units, vaccine marketing license holders, vaccine industry associations, etc. shall regularly carry out vaccine safety laws, regulations and prevention through activities such as the National Child Vaccination Day. Publicity, education, and popularization of inoculation knowledge.

The news media should carry out public welfare propaganda on vaccine safety laws, regulations and vaccination knowledge, and conduct public opinion supervision on vaccine violations. Publicity reports on vaccines should be comprehensive, scientific, objective and fair.

  • Article 13  The vaccine industry association shall strengthen industry self-discipline, establish and improve industry standards, promote the construction of industry credit systems, and guide and urge members to carry out production and operation activities in accordance with the law.

Chapter 2   Vaccine Development and Registration

  • Article 14  The state shall formulate relevant research and development plans, arrange necessary funds, and support the development of new vaccines such as multi-linkage and multi-valence based on factors such as disease prevalence and population immunity.

The state organizes vaccine marketing license holders, scientific research units, and medical and health institutions to jointly tackle key problems to develop vaccines that are urgently needed for disease prevention and control.

  • Article 15 The state encourages vaccine marketing license holders to increase investment in research and innovation, optimize production processes, improve quality control levels, and promote vaccine technology progress.
  • Article 16   The development of vaccine clinical trials shall be approved by the drug regulatory department of the State Council in accordance with the law.

 Vaccine clinical trials should be implemented or organized by tertiary medical institutions or disease prevention and control institutions at or above the provincial level that meet the conditions prescribed by the drug regulatory department of the State Council and the competent health department of the State Council.

The state encourages qualified medical institutions and disease prevention and control institutions to conduct vaccine clinical trials in accordance with the law.\

  • Article 17 Vaccine clinical trial sponsors shall formulate clinical trial plans, establish a clinical trial safety monitoring and evaluation system, carefully select subjects, reasonably set subject groups and age groups, and take effective measures based on the degree of risk to protect The legitimate rights and interests of the examiner.
  • Article 18 To conduct vaccine clinical trials, the subject’s written informed consent shall be obtained; if the subject is a person without civil capacity, the written informed consent of his guardian shall be obtained; if the subject is a person with limited civil capacity, The written informed consent of the person and his guardian should be obtained.
  • Article 19   Vaccines marketed in China shall be approved by the drug regulatory department of the State Council and obtain a drug registration certificate; applying for vaccine registration shall provide true, sufficient and reliable data, materials and samples.

For vaccines and innovative vaccines urgently needed for disease prevention and control, the State Council’s drug regulatory authority shall give priority to review and approval.

  • Article 20: Vaccines that are urgently needed in response to major public health emergencies or other vaccines that are urgently needed by the health authority of the State Council are assessed that the benefits outweigh the risks, the drug regulatory authority of the State Council may approve vaccine registration applications with conditions.

In the event of a particularly major public health emergency or other emergencies that seriously threaten public health, the health authority of the State Council may make recommendations for emergency use of vaccines based on the needs of the prevention and control of infectious diseases. Emergency use within the scope and time limit.

  • Article 21   When approving vaccine registration applications, the State Council’s drug regulatory authority shall approve the production process, quality control standards, instructions and labels of the vaccine.

The drug regulatory department of the State Council shall promptly publish the contents of the vaccine insert sheet and label on its website.

Chapter III: Vaccine Production and Batch Issuance

  • Article 22 The country implements a strict access system for vaccine production.

To engage in vaccine production activities, it shall be approved by the drug regulatory department of the people’s government at or above the provincial level and obtain a drug production license.

To engage in vaccine production activities, in addition to meeting the conditions for engaging in pharmaceutical production activities stipulated in the Drug Administration Law of the People’s Republic of China, the following conditions shall also be met:

(1) Appropriate scale and sufficient capacity reserves;

(2) Have systems, facilities and equipment to ensure biosafety;

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

The holder of the vaccine marketing license shall have the vaccine production capacity; if the vaccine production capacity exceeds the vaccine production capacity, it is necessary to entrust production, it shall be approved by the drug regulatory department of the State Council. Those who accept the commissioned production shall comply with the provisions of this law and relevant state regulations to ensure the quality of vaccines.

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

Vaccine marketing license holders shall strengthen the training and assessment of the personnel specified in the preceding paragraph, and timely report their appointments and changes to the drug regulatory department of the people’s government of the province, autonomous region, and municipality directly under the Central Government.

  • Article 24   Vaccines shall be produced and inspected in accordance with approved production technology and quality control standards, and the entire production process shall comply with the requirements of drug production quality management regulations.

The holder of the vaccine marketing license shall review and inspect the entire process of vaccine production and the quality of the vaccine in accordance with regulations.

  • Article 25   Vaccine marketing license holders shall establish a complete production quality management system, continuously strengthen deviation management, and use information technology to truthfully record all data formed during the production and inspection process to ensure that the entire production process continues to meet legal requirements.
  • Article 26 The country implements a vaccine batch issuing system.

Before each batch of vaccine is sold or imported, it shall be reviewed and inspected by the batch issuing agency designated by the drug regulatory department of the State Council in accordance with relevant technical requirements. If it meets the requirements, a certificate of batch issuance will be issued; if it does not meet the requirements, a notice of not-approved is issued.

Vaccines that are not approved and issued shall not be sold, and shall be supervised and destroyed by the drug regulatory authorities of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government; imported vaccines that are not approved shall be destroyed under the supervision and destruction of the drug regulatory authorities of the port’s locality or undergo other treatment according to law.

The drug regulatory department and batch issuing agency of the State Council shall promptly announce the results of batch issuing of marketed vaccines for public inquiry.

  • Article 27   To apply for batch issuance of vaccines, the batch production and inspection record summary and other materials and samples of the same batch number shall be provided to the batch issuing agency in accordance with regulations. Imported vaccines should also provide a certificate of origin and a certificate of batch issuance; if the certificate of batch issuance is exempted in the place of origin, a certificate of exemption should be provided.
  • Article 28: Vaccines that are urgently needed to prevent and control infectious disease epidemics or respond to emergencies shall be exempted from approval and issuance after approval by the drug regulatory department of the State Council.
  • Article 29 Vaccine batch issuance shall be subject to data review and sampling inspection batch by batch. Vaccine batch issuance inspection items and inspection frequency should be dynamically adjusted based on vaccine quality risk assessment.

If there is any doubt about the authenticity of the vaccine batch issuance application materials or samples, or there are other conditions that require further verification, the batch issuing agency shall verify it, and if necessary, organize the on-site verification by means of on-site sampling inspection.

  • Article 30: If a batch issuing agency discovers that a vaccine has a major quality risk during the batch issuance process, it shall promptly report to the drug regulatory department of the State Council and the drug regulatory department of the people’s government of the province, autonomous region, or municipality.

The department receiving the report shall immediately conduct an on-site inspection of the vaccine marketing license holder, and notify the batch issuing agency based on the inspection results to not approve or suspend the batch issuance of the vaccine marketing license holder’s related products or all products, and order the vaccine Rectification by the holder of the marketing authorization. The holder of the vaccine marketing license shall make rectification immediately and report the rectification situation to the department that ordered it in a timely manner.

  • Article 31 With regard to production process deviations, quality differences, failures and accidents in the production process, and measures taken, the vaccine marketing authorization holder shall truthfully record and specify in the corresponding batch of product application and batch issuance documents; possible If the quality of the vaccine is affected, the vaccine marketing license holder shall take immediate measures and report to the drug regulatory department of the people’s government of the province, autonomous region, or municipality directly under the Central Government.

Chapter Four   Vaccine Distribution

  • Article 32   The State Council’s health authority, in conjunction with the State Council’s financial department, organizes centralized bidding or unified negotiations to form and announce the winning bid or transaction price. All provinces, autonomous regions, and municipalities implement unified procurement.

Other immunization program vaccines and non-immunization program vaccines other than the national immunization program vaccine are purchased by provinces, autonomous regions, and municipalities directly under the Central Government through the provincial public resource trading platform.

  • Article 33 The price of vaccines shall be set independently and reasonably by the holder of the vaccine marketing license according to law. The price level, price difference, and profit margin of vaccines should be maintained at a reasonable range.
  • Article 34 Provincial-level disease prevention and control institutions shall, in accordance with the national immunization plan and the needs of disease prevention and control in the administrative region, formulate a vaccine use plan for the immunization plan of the administrative region, and report to the department that organizes the procurement of vaccines in accordance with relevant national regulations. Report to the competent health authorities of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government for the record.
  • Article 35 The holder of the vaccine marketing license shall supply vaccines to the disease prevention and control agency in accordance with the purchase contract.

Disease prevention and control institutions shall supply vaccines to the inoculation units in accordance with regulations.

Units and individuals other than disease prevention and control institutions shall not supply vaccines to the inoculation units, and the inoculation units shall not receive the vaccines.

    • Article 36: The holder of the vaccine marketing license shall distribute the vaccine to the disease prevention and control agency or the inoculation unit designated by the disease prevention and control agency in accordance with the purchase contract.

Vaccine marketing license holders and disease prevention and control agencies shall have the conditions for cold chain storage and transportation of vaccines for their own distribution of vaccines, or they may entrust qualified vaccine distribution units to distribute vaccines.
The disease prevention and control agency may charge storage and transportation costs for the delivery of non-immunization planned vaccines. The specific measures shall be formulated by the financial department of the State Council in conjunction with the price department of the State Council.
Article 37   Disease prevention and control institutions, inoculation units, vaccine marketing license holders, vaccine delivery units shall comply with vaccine storage and transportation management practices to ensure vaccine quality.
Vaccines should be in a specified temperature environment during the whole process of storage and transportation. Cold chain storage and transportation should meet the requirements, and the temperature should be monitored and recorded regularly.
Vaccine storage and transportation management standards are regulated by the State Council’s drug regulatory department and the State Council’s health supervisor
Article 38 When selling vaccines, the holder of a vaccine marketing license shall provide a copy of the batch issuance certificate or an electronic document with its seal; for the sale of imported vaccines, it shall also provide a customs clearance form for imported medicines with its seal. Photocopy or electronic file.
When receiving or purchasing vaccines, disease prevention and control institutions and vaccination units shall obtain the certification documents specified in the preceding paragraph and keep them for no less than five years after the expiration of the vaccine validity period.
Article 39: Holders of vaccine marketing licenses shall establish true, accurate and complete sales records in accordance with regulations, and keep them for no less than five years after the expiration of the vaccine’s validity period for future reference.
Disease prevention and control institutions, inoculation units, and vaccine delivery units shall establish true, accurate and complete records of receipt, purchase, storage, distribution, and supply in accordance with regulations, and keep them for no less than five years after the expiration of the vaccine validity period for future reference.
When the disease prevention and control agency or inoculation unit receives or purchases the vaccine, it shall request the temperature monitoring record of the whole process of transportation and storage, and keep it for not less than five years after the expiration of the vaccine validity period; If the temperature monitoring record or temperature control in the whole process does not meet the requirements, it shall not be accepted or purchased, and shall be reported to the drug regulatory department and the health authority of the local people’s government at or above the county level.
Article 40 Disease prevention and control institutions and vaccination units shall establish a regular inspection system for vaccines, and adopt measures such as isolation storage, setting up warning signs, etc., for vaccines that have problems such as unidentifiable packaging, non-compliant storage temperature, and expiration date. Disposal as prescribed by the State Council’s drug regulatory authority, health authority, and ecological environment authority. Disease prevention and control institutions and vaccination units shall truthfully record the disposal situation, and the disposal records shall be kept for not less than five years after the expiration of the vaccine validity period for future reference.
Chapter 5 Vaccination
Article 41: The competent department of health under the State Council shall formulate a national immunization plan; the types of vaccines under the national immunization plan shall be formulated by the competent department of health and health under the State Council in conjunction with the financial department of the State Council, and be announced after being approved by the State Council.
The health department of the State Council has established the Expert Advisory Committee of the National Immunization Program and, in conjunction with the financial department of the State Council, established a dynamic adjustment mechanism for the types of vaccines in the National Immunization Program.
When implementing the national immunization plan, the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government may increase the types of vaccines in the immunization plan according to the needs of disease prevention and control in their administrative regions, and report to the health department of the State Council for record and announcement.
Article 42: The competent health department of the State Council shall formulate and publish the work norms for vaccination, and strengthen the standardized management of vaccination.
The competent health department of the State Council shall formulate and publish the immunization procedures of the national immunization program and the guidelines for the use of non-immunization programs.
The health authorities of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government shall formulate vaccination plans based on the actual conditions of their respective administrative regions and report them to the health authorities of the State Council for the record.
Article 43: Disease prevention and control institutions at all levels shall, in accordance with their respective duties, carry out publicity, training, technical guidance, monitoring, evaluation, epidemiological investigation, emergency response, etc. related to vaccination.
Article 44  The inoculation unit shall meet the following conditions:
(1) Obtain a medical institution practice license;
(2) Having doctors, nurses or village doctors who have undergone professional training on vaccination organized by the health authorities of the people’s government at the county level and qualified as assessed;
(3) Having refrigerated facilities, equipment and refrigerated storage systems that comply with vaccine storage and transportation management regulations.
The competent health department of the local people’s government at or above the county level shall designate qualified medical institutions to undertake the vaccination work of the immunization plan within the responsibility area. Eligible medical institutions can undertake non-immunization planning vaccination work, and should report to the health authority that issued their medical institution practice license for the record.
Vaccination units should strengthen internal management, and carry out preventive vaccinations in compliance with the work norms, immunization procedures, guidelines for the use of vaccines, and vaccination plans.
Disease prevention and control institutions at all levels shall strengthen the technical guidance for vaccination work and the management of vaccine use by vaccination units.
Article 45 Medical and health personnel should inform the recipients or their guardians of the types, effects, contraindications, adverse reactions, and on-site observations when performing vaccination, and ask the recipients’ health status and whether they have Vaccination contraindications, etc., and truthfully record the notification and inquiry. The recipient or his guardian shall truthfully provide the recipient’s health status and vaccination contraindications. If there are contraindications for vaccination, the medical and health personnel shall provide medical advice to the recipient or his guardian, and truthfully record the medical advice.
Before implementing vaccination, medical and health personnel should check the health status of the recipients, check vaccination contraindications, check the vaccination certificate, check the appearance, batch number, and expiration date of vaccines and syringes, and check the recipients according to the requirements of the vaccination work specification. The name, age, and product name, specification, dosage, vaccination site, and vaccination route of the vaccine must be consistent with the recipient, vaccination certificate and vaccine information, and the vaccination can be carried out after confirmation.
Medical and health personnel shall vaccinate the recipients who meet the requirements for vaccination. If the recipient has an adverse reaction during the on-site observation period, the medical and health personnel shall take timely treatment and other measures in accordance with the requirements of the vaccination work specification.
Article 46 Medical and health personnel shall, in accordance with the provisions of the competent health department of the State Council, truthfully, accurately and completely record the vaccine varieties, the identification information of the marketing license holder, the smallest packaging unit, the validity period, the time of vaccination, and the date of vaccination. Vaccination information for medical and health personnel, recipients, etc., to ensure that the vaccination information can be traced and searched. The vaccination record shall be kept for not less than five years after the expiration of the vaccine validity period for future reference.
Article 47: The State implements a vaccination certificate system for children. Within one month after the child’s birth, his guardian shall go to the vaccination unit or the birth hospital where the child lives to obtain a vaccination certificate for him. The inoculation unit or the birth hospital shall not refuse to apply. The guardian shall properly keep the vaccination certificate.
Vaccinations are managed by the place of residence. When the children leave their original place of residence, the vaccination unit undertaking the vaccination work at the current place of residence is responsible for vaccinating them.
The format of the vaccination certificate shall be prescribed by the competent health department of the State Council.
Article 48 When a child enters or enrolls in a kindergarten or school, the kindergarten institution or school shall check the vaccination certificate, and if it is found that the vaccination has not been vaccinated in accordance with the regulations, it shall undertake the vaccination work at the place where the child lives or the kindergarten institution or school is located. The vaccination unit reports and cooperates with the vaccination unit to urge its guardians to replant according to regulations. Disease prevention and control institutions shall provide technical guidance for nurseries and schools to check vaccination certificates.
The measures for the inspection of the vaccination certificate for children’s enrollment in nursery school and school shall be formulated by the competent health department of the State Council in conjunction with the educational administration department of the State Council.
Article 49: Vaccination units shall not charge any fees for vaccination in the immunization program.
Vaccination units vaccinate non-immunization program vaccines, in addition to charging vaccine fees, they can also charge vaccination service fees. The charging standard of the vaccination service fee shall be formulated by the price department of the people’s government of the province, autonomous region, and municipality directly under the Central Government in conjunction with the financial department.
Article 50 The health authority of the local people’s government at or above the county level shall, based on the monitoring and early warning information of infectious diseases, report to the people’s government at the same level for the decision to prevent and control the outbreak and prevalence of infectious diseases and report to the people’s government at or above the provincial level. Competent departments can file for the record, and mass vaccination can be carried out in the administrative area.
Where mass vaccination needs to be carried out nationwide or across provinces, autonomous regions, and municipalities directly under the Central Government, it shall be decided 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 of the State Council that made the mass vaccination decision shall organize relevant departments to do a good job in personnel training, publicity and education, and material transfer.
No unit or individual may conduct group vaccination without authorization.
Article 51: In the event of an outbreak or epidemic of infectious diseases, local people’s governments at or above the county level or their health authorities need to take emergency vaccination measures, in accordance with the provisions of laws and administrative regulations.
Article 52 “Abnormal response to preventive vaccination refers to an adverse drug reaction in which a qualified vaccine causes damage to the tissues, organs, and functions of the recipient during or after the implementation of standardized vaccination, and no related parties are at fault.
The following situations are not an abnormal response to vaccination:
(1) General reactions after vaccination caused by the characteristics of the vaccine itself;
(2) Damage to the recipient caused by the quality of the vaccine;
(3) Damage to the recipient caused by the inoculation unit’s violation of preventive vaccination work norms, immunization procedures, vaccine use guidelines, and vaccination plans;
(4) The recipient was in the incubation period or prodromal period of a certain disease at the time of vaccination, and the disease happened incidentally after vaccination;
(5) The recipient has the vaccination contraindications stipulated in the vaccine manual, the recipient or his guardian did not truthfully provide the recipient’s health status and vaccination contraindications before vaccination, and the recipient’s original disease recurred acutely after vaccination or Worsening
(6) Individual or group psychogenic reactions due to psychological factors.
Article 53: The State strengthens monitoring of abnormal reactions to vaccination. The monitoring plan for abnormal response to vaccination shall be formulated by the health department of the State Council in conjunction with the drug regulatory department of the State Council.
Article 54: Vaccination units, medical institutions, etc., shall report to the disease prevention and control institution in accordance with regulations if they find a suspected abnormal response to vaccination.
Vaccine marketing permit holders should set up a special agency with full-time personnel to actively collect, track and analyze suspected abnormal vaccination reactions, take timely risk control measures, report suspected vaccination abnormal reactions to disease prevention and control agencies, and report quality analysis Submit to the drug regulatory department of the people’s government of the province, autonomous region, or municipality directly under the Central Government.
Article 55: In response to a suspected abnormal response to vaccination, the disease prevention and control agency shall promptly report in accordance with regulations, organize investigation and diagnosis, and inform the recipient or his guardian of the investigation and diagnosis conclusion. If there is a dispute over the conclusion of the investigation or diagnosis, an application for identification may be made in accordance with the identification method formulated by the health authority under the State Council.
Suspected vaccination abnormal reactions that have a major impact on society, such as the death or severe disability of the recipient due to vaccination, or the group suspected abnormal vaccination reaction, shall be subject to the health authorities and drug supervision of the people’s government at or above the districted city level The management department organizes investigation and handling according to their respective responsibilities.
Article 56: The state implements a compensation system for abnormal responses to vaccination. If damages such as death, severe disability, organ tissue damage, etc. occur during or after the implementation of the vaccination, which is an abnormal response to the vaccination or cannot be eliminated, compensation shall be given. The scope of compensation is managed by catalog and adjusted dynamically according to actual conditions.
Compensation costs for immunization planning vaccines shall be arranged by the financial departments of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government in the vaccination funds; compensation costs for vaccinations of non-immunization planning vaccines shall be borne by the relevant vaccine marketing license holders. The state encourages the use of commercial insurance and other forms to compensate recipients of abnormal reactions to vaccination.
Compensation for abnormal response of vaccination shall be timely, convenient and reasonable. The scope, standards, and procedures of compensation for abnormal reactions of vaccination shall be stipulated by the State Council, and specific implementation measures shall be formulated by provinces, autonomous regions and municipalities directly under the Central Government.
Chapter 7: Post-marketing management of vaccines
Article 57 Holders of vaccine marketing permits shall establish and improve the quality management system for the whole life cycle of vaccines, formulate and implement post-marketing risk management plans for vaccines, and conduct post-marketing researches to ensure that the safety, effectiveness and quality of vaccines The control is further confirmed.
For vaccines that require further research during the approval of the vaccine registration application, the vaccine marketing permit holder shall complete the research within the prescribed time limit; if the research is not completed within the specified time period or cannot be proved that the benefits outweigh the risks, the drug regulatory department of the State Council shall handle the matter according to law , Until the drug registration certificate of the vaccine is cancelled.
Article 58: Holders of vaccine marketing licenses shall conduct quality follow-up analysis of vaccines, continuously improve quality control standards, improve production processes, and increase production process stability.
Changes in the production process, production site, key equipment, etc. shall be evaluated and verified, and filed or reported in accordance with the relevant change management regulations of the drug regulatory department of the State Council; the changes may affect the safety, effectiveness and quality controllability of the vaccine It shall be approved by the drug regulatory department of the State Council.
Article 59: Holders of vaccine marketing permits shall continuously update the instructions and labels according to the post-market research of the vaccine and prevent abnormal reactions in vaccination, and apply for approval or filing in accordance with regulations.
The drug regulatory department of the State Council shall promptly publish the updated vaccine instructions and label content on its website.
Article 60: Vaccine marketing license holders shall establish a vaccine quality review analysis and risk reporting system, and truthfully report the production and circulation of vaccines, post-marketing research, risk management, etc., to the drug regulatory authority of the State Council in accordance with regulations.
Article 61: The drug regulatory authority under the State Council may, based on actual conditions, order vaccine marketing license holders to conduct post-marketing evaluations or directly organize post-marketing evaluations.
For vaccines that have a serious abnormal response to vaccination or that endanger human health for other reasons, the drug regulatory department of the State Council shall cancel the drug registration certificate of the vaccine.
Article 62 The drug regulatory department of the State Council may organize post-market evaluation of vaccine varieties based on the needs of disease prevention and control and the development of the vaccine industry, and discover the product design, production process, safety, effectiveness, or effectiveness of the vaccine variety. If the quality controllability is obviously inferior to other vaccine varieties for the prevention and control of the same disease, the drug registration certificates of all vaccines of that variety shall be cancelled and the corresponding national drug standards shall be abolished.
Chapter 8   Safeguard Measures
Article 63: People’s governments at or above the county level shall include the necessary funds for vaccine safety work, purchase of vaccines for immunization planning, vaccination work, and information construction into the government budget at the corresponding level to ensure the implementation of the immunization planning system.
The county-level people’s government provides subsidies to village doctors and other primary medical and health personnel engaged in vaccination work in accordance with relevant state regulations.
The state provides support for vaccination in economically underdeveloped areas as needed. The people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government and the people’s governments of cities divided into districts shall provide necessary financial subsidies to the county-level people’s governments of economically underdeveloped areas to carry out work related to vaccination.
Article 64 The people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government shall, based on the epidemic trend of infectious diseases in their respective administrative regions, determine the items related to vaccination in their respective administrative regions within the scope of infectious disease prevention and control projects determined by the health authority of the State Council. And to ensure the implementation of the project.
Article 65 The health authority of the State Council shall provide vaccine marketing license holders with information on vaccine requirements of the national immunization program according to the vaccine use plans of the national immunization programs of the provinces, autonomous regions, and municipalities directly under the Central Government. The vaccine marketing license holders shall be reasonable based on the vaccine requirements information Arrange production.
When there is a risk of a shortage of vaccines, the State Council’s health authority and the State Council’s drug regulatory authority make recommendations. The State Council’s industry and information technology authority and the State Council’s financial department should take effective measures to ensure vaccine production and supply.
Vaccine marketing license holders shall organize production according to law to ensure vaccine supply; if vaccine marketing license holders stop vaccine production, they shall promptly report to the drug regulatory authority of the State Council or the drug regulatory authority of the people’s government of the province, autonomous region, or municipality.
Article 66: The state shall include vaccines in its strategic material reserves, and implement central and provincial-level reserves.
The competent department of industry and information technology and the financial department of the State Council, in conjunction with the competent health department, public security department, market supervision and management department, and drug supervision and management department of the State Council, strengthen the production capacity of vaccine stocks in accordance with the needs of disease prevention, control and public health emergency preparedness. Product management, establish a dynamic adjustment mechanism.
Article 67  The funds allocated by the finances at all levels for vaccination shall be earmarked for use only, and no unit or individual may misappropriate or misappropriate.
Relevant units and individuals shall accept the audit and supervision of audit institutions in accordance with the law for the use of funds for vaccination.
Article 68: The State implements a mandatory insurance system for vaccine liability.
Vaccine marketing license holders shall purchase compulsory vaccine liability insurance in accordance with regulations. In the event of damage to the victim due to the quality of the vaccine, the insurance company shall pay compensation within the limit of insured liability.
The specific implementation measures for the vaccine liability compulsory insurance system shall be formulated by the drug regulatory authority of the State Council in conjunction with the health authority and insurance regulatory authority of the State Council.
Article 69: In the event of an outbreak or epidemic of infectious diseases, the holder of the relevant vaccine marketing permit shall produce and supply vaccines for the prevention and control of infectious diseases in a timely manner. Transportation units shall give priority to the transportation of vaccines for the prevention and control of infectious diseases. People’s governments at or above the county level and their relevant departments shall do a good job of organization, coordination, and guarantee.
Chapter 9 Supervision and Management
Article 70 The drug supervision and administration department and the health authority shall supervise and manage the entire process of vaccine development, production, circulation and vaccination in accordance with their respective responsibilities, and supervise vaccine marketing license holders, disease prevention and control institutions, and vaccination units in accordance with the law. Fulfill obligations.
The drug supervision and administration department shall supervise and inspect the quality of vaccines in vaccine development, production, storage, transportation and vaccination according to law. The health authority shall supervise and inspect the implementation of the immunization planning system and vaccination activities in accordance with the law.
The drug supervision and administration department shall strengthen the on-site inspection of vaccine marketing license holders; when necessary, it may conduct extended inspections on units and individuals that provide products or services for vaccine development, production, and circulation; relevant units and individuals shall conduct inspections Cooperate, and must not refuse or conceal.
Article 71: The state builds a team of professional and specialized drug inspectors at the central and provincial levels to strengthen the supervision and inspection of vaccines.
The drug regulatory departments of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government select inspectors to be stationed in vaccine marketing license holders. Inspectors are responsible for supervising and inspecting the implementation of drug production quality management regulations, collecting vaccine quality risks and clues to violations of laws and regulations, reporting the situation and making recommendations to the drug regulatory departments of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government, and are responsible for the behavior during the period of assignment.
Article 72: If there are potential safety hazards in vaccine quality management, and vaccine marketing license holders, etc., fail to take timely measures to eliminate them, the drug regulatory authority may take responsibility interviews and rectification within a limited time.
For serious violations of drug-related quality management regulations, the drug supervision and administration department shall order the suspension of vaccine production, sales, and distribution, and immediate rectification; after the completion of the rectification, the drug supervision and management department can inspect and meet the requirements before resuming production, sales and distribution.
The drug supervision and administration department shall establish a credit record system for vaccine marketing license holders and their related personnel, incorporate it into the national credit information sharing platform, publicize their serious untrustworthy information in accordance with regulations, and implement joint punishments.
Article 73: Where there are or suspected quality problems with the vaccine, the vaccine marketing license holder, disease prevention and control agency, and vaccination unit shall immediately stop the sale, distribution, and use, and stop production if necessary, and send the vaccine to the county level or above in accordance with regulations. Report from the People’s Government Drug Supervision and Administration Department and the Health and Health Department The health authority shall immediately organize disease prevention and control institutions and vaccination units to take necessary emergency response measures, and at the same time report to the health authority of the people’s government at a higher level. The drug supervision and administration department shall take measures such as seizure and seizure according to law. For vaccines that have been sold, the vaccine marketing license holder shall promptly notify relevant disease prevention and control agencies, vaccine delivery units, and vaccination agencies, and recall them in accordance with regulations, and truthfully record the recall and notification information, disease prevention and control agencies, vaccine delivery units, and vaccination agencies It should be cooperated.
If the production, sale, distribution, use, or recall of vaccines is not stopped in accordance with the provisions of the preceding paragraph, the drug regulatory department and health authority of the people’s government at or above the county level shall order the suspension of production, sale, distribution, use or recall of vaccines in accordance with their respective duties.
Vaccine marketing license holders, disease prevention and control institutions, and vaccination units shall not conceal, falsely report, postpone the report, or omit vaccines that are found to have or are suspected of having quality problems, and shall not conceal, forge, or destroy relevant evidence.
Article 74: Vaccine marketing license holders shall establish an information disclosure system, and promptly disclose vaccine product information, instructions and labels, implementation of drug-related quality management practices, batch issuance, recall, and acceptance on their website in accordance with regulations. Information on inspections and penalties, and compulsory vaccine liability insurance.
Article 75: The drug regulatory department of the State Council shall, in conjunction with the competent health department of the State Council, establish information sharing mechanisms for vaccine quality and vaccination.
The drug regulatory authorities and health authorities of the people’s governments at or above the provincial level shall organize vaccine marketing license holders, disease prevention and control institutions, vaccination units, news media, scientific research units, etc., in accordance with the principles of science, objectivity, timeliness, and openness. , To exchange information on vaccine quality and vaccination.
Article 76: The state implements a unified release system for vaccine safety information.
Vaccine safety risk warning information, major vaccine safety accidents and their investigation and handling information, and other vaccine safety information determined by the State Council to be uniformly announced shall be announced by the drug regulatory department of the State Council in conjunction with relevant departments. Reports on abnormal reactions to vaccination nationwide are jointly announced by the health department of the State Council in conjunction with the drug regulatory department of the State Council. Unauthorized publication of the above information is not allowed. The release of major vaccine safety information should be timely, accurate, and comprehensive, and scientific evaluations should be made in accordance with regulations, and necessary explanations should be made.
When the drug regulatory department of the people’s government at or above the county level finds vaccine safety information that may mislead the public and public opinion, it should immediately verify and analyze it in conjunction with the health and health authorities, other relevant departments, professional institutions, and relevant vaccine marketing license holders. And announce the results in time.
No unit or individual shall fabricate or spread false vaccine safety information.
Article 77: Any unit or individual has the right to know vaccine information in accordance with the law, and to make comments and suggestions on vaccine supervision and management.
Any unit or individual has the right to report vaccine violations to the health authority, drug supervision and administration department, etc., and has the right to the health authority, drug supervision and administration department and other departments and their staff who fail to perform their supervision and management duties according to law Report to the people’s government at the corresponding or higher level and its relevant departments and supervisory organs. Relevant departments and agencies shall verify and deal with it in a timely manner; for reports that are verified to be true, rewards will be given to reporters in accordance with regulations; reporters who report serious violations of the law by their units, and if they are verified to be true, they will be rewarded heavily.
Article 78: People’s governments at or above the county level shall formulate emergency plans for vaccine safety incidents, and make provisions on the classification of vaccine safety incidents, the handling organization and command system and responsibilities, prevention and early warning mechanisms, handling procedures, and emergency safeguard measures.
Vaccine marketing license holders should formulate vaccine safety incident handling plans, regularly check the implementation of various preventive measures, and eliminate potential safety hazards in a timely manner.
In the event of a vaccine safety incident, the holder of the vaccine marketing authorization shall immediately report to the State
Article 79: Those who violate the provisions of this law and constitute a crime shall be investigated for criminal responsibility in accordance with the law.
Article 80 If the vaccines produced or sold are counterfeit drugs, the illegal income, illegally produced and sold vaccines, and the raw materials, excipients, packaging materials, Equipment and other items shall be ordered to stop production and business for rectification, the drug registration certificate shall be revoked, until the drug production license is revoked, etc., and a fine of fifteen times to fifty times the value of the illegal production and sales of vaccines, the value of which is less than 500,000 Yuan, 500,000 yuan.
If the vaccines produced and sold are inferior drugs, the illegal income, illegally produced and sold vaccines, and the raw materials, excipients, packaging materials, equipment and other items specially used for illegally produced vaccines shall be confiscated by the drug regulatory department of the people’s government at or above the provincial level. Order to suspend production and business for rectification, and impose a fine of ten to thirty times the value of the illegal production and sales of vaccines. If the value of the goods is less than 500,000 yuan, the calculation shall be calculated as 500,000 yuan; if the circumstances are serious, the drug registration certificate shall be revoked , Until the drug production license is revoked.
If the vaccines produced or sold are counterfeit drugs, or the vaccines produced or sold are inferior drugs and the circumstances are serious, the drug regulatory department of the people’s government at or above the provincial level shall provide the legal representative, main responsible person, directly responsible person in charge and key personnel Post personnel and other responsible personnel shall confiscate the income from their own unit during the period of the illegal act, and impose a fine of one to ten times the income, and lifelong prohibition of drug production and business activities shall be imposed by the public security organs for more than 15 days Detained below the day.
Article 81: In any of the following circumstances, the drug supervision and administration department of the people’s government at or above the provincial level shall confiscate illegal income, illegally produced and sold vaccines, and raw materials, excipients, packaging materials, equipment, etc. specially used for illegally produced vaccines Articles, order to suspend production and business for rectification, and impose a fine of fifteen times to fifty times the value of the illegal production and sale of vaccines. If the value of the goods is less than 500,000 yuan, it will be calculated as 500,000 yuan; if the circumstances are serious, it will be revoked Drug-related approval documents, until the revocation of the drug production license, etc., the legal representative, the main person in charge, the directly responsible person in charge, the personnel in key positions, and other responsible personnel shall confiscate the income from the unit during the period of the illegal act, and A fine of not less than 50% but not more than 10 times of the income earned on the premises, and prohibiting drug production and business activities for ten years or even life, shall be detained by the public security organ for not less than 5 days but not more than 15 days:
(1) Applying for vaccine clinical trials, registration, batch issuance, providing false data, materials, samples, or engaging in other deceptive behaviors;
(2) Fabricating production and inspection records or changing product batch numbers;
(3) Units or individuals other than disease prevention and control institutions supply vaccines to the inoculation units;
(4) Entrusted production of vaccines is not approved;
(5) Changes in the production process, production site, key equipment, etc. shall be approved according to regulations but not approved;
(6) The updated vaccine instructions and labels should be approved but not approved in accordance with regulations.
Article 82 Except as otherwise provided in this law, where vaccine marketing license holders or other entities violate drug-related quality management regulations, the drug regulatory department of the people’s government at or above the county level shall order corrections and give warnings; Those who fail to make corrections shall be fined not less than 200,000 yuan but not more than 500,000 yuan; if the circumstances are serious, a fine of not less than 500,000 yuan but not more than 3 million yuan shall be imposed, and production and business shall be suspended for rectification, until the relevant approval documents of the drugs and the drugs are revoked Production licenses, etc., for legal representatives, main responsible persons, directly responsible persons in charge, personnel in key positions, and other responsible persons, confiscate the income received from the unit during the period of the illegal act, and 50% of the income received from the premises For fines less than five times the above, it is forbidden to engage in drug production and business activities for ten years or for life.
Article 83 In violation of the provisions of this Law, the holder of the vaccine marketing license shall have one of the following circumstances, the drug regulatory department of the people’s government at or above the provincial level shall order correction and give a warning; if it refuses to correct, a penalty of 200,000 yuan shall be imposed. A fine of not less than 500,000 yuan; if the circumstances are serious, it shall be ordered to suspend production and business for rectification, and a fine of not less than 500,000 yuan but not more than 2 million yuan shall be imposed:
(1) Failure to establish an electronic vaccine traceability system in accordance with regulations;
(2) The legal representative, the main person in charge, the person in charge of production management, the person in charge of quality management, the quality authorized person and other key personnel who do not meet the prescribed conditions or fail to conduct training and assessment in accordance with the regulations;
(3) Failure to report or record in accordance with regulations;
(4) Failing to carry out post-marketing research in accordance with regulations, or failing to set up institutions and staff in accordance with regulations to actively collect, track and analyze suspected abnormal reactions of vaccination;
(5) Failure to insure compulsory vaccine liability insurance in accordance with regulations;
(6) Failure to establish an information disclosure system in accordance with regulations.
Article 84 In violation of the provisions of this law, if the batch issuing agency has one of the following circumstances, the drug regulatory department under the State Council shall order corrections, give warnings, and give the main persons in charge, directly responsible persons in charge and other persons directly responsible according to law Warning until demotion:
(1) Failure to conduct audits and inspections in accordance with regulations;
(2) Failure to promptly announce the results of the batch issuance of marketed vaccines;
(3) Failure to verify according to regulations;
(4) Failure to report in accordance with regulations when a major quality risk is found in the vaccine.
In violation of the provisions of this Law, if the batch issuance agency fails to issue a batch issuance certificate or a notice of non-approval issuance in accordance with the regulations, the drug regulatory department under the State Council shall order corrections and give warnings to the main persons in charge, directly responsible persons in charge, and other Persons who are directly responsible shall be degraded or dismissed according to law; if the circumstances are serious, the main person in charge, directly responsible persons in charge, and other directly responsible persons shall be expelled according to law.
Article 85: If disease prevention and control institutions, vaccination units, vaccine marketing license holders, vaccine delivery units violate the cold chain storage and transportation requirements of the vaccine storage and transportation management regulations, the drug regulatory department of the people’s government at or above the county level Order corrections, give warnings, destroy illegally stored and transported vaccines, and confiscate illegal gains; if they refuse to make corrections, the vaccination unit, vaccine marketing license holder, vaccine delivery unit will be placed at 200,000 yuan to 1 million yuan If the circumstances are serious, a fine of ten to thirty times the value of the vaccine shall be imposed on the inoculation unit, vaccine marketing license holder, and vaccine delivery unit. Based on the calculation of 100,000 yuan, the vaccine marketing license holder and the vaccine delivery unit are ordered to suspend production and business for rectification, until the drug-related approval documents and drug production licenses are revoked. The vaccine marketing license holder, the legal representative of the vaccine delivery unit, The main persons in charge, directly responsible persons in charge, persons in key positions and other persons in charge shall be punished in accordance with Article 82 of this Law.
If disease prevention and control institutions or vaccination units have illegal acts as prescribed in the preceding paragraph, the health authorities of the people’s government at or above the county level shall give warnings to the main persons in charge, directly responsible persons in charge, and other persons directly responsible in accordance with the law until dismissal, and shall be ordered to take responsibility. Responsible medical and health personnel suspend their practice activities for more than one year and less than 18 months; if serious consequences are caused, the main person in charge, the directly responsible person in charge and other directly responsible persons shall be expelled according to law, and the vaccination unit may be revoked Qualifications, the original certificate-issuing department revokes the medical and health personnel’s practice certificate.
Article 86 If disease prevention and control institutions, vaccination units, vaccine marketing license holders, vaccine delivery units violate the regulations on vaccine storage and transportation management other than those specified in Article 85 of this law, the people at or above the county level The government drug regulatory department shall order corrections, give warnings, and confiscate illegal gains; if they refuse to make corrections, they shall impose a fine of 100,000 yuan up to 300,000 yuan on the vaccination unit, vaccine marketing license holder, and vaccine delivery unit; if the circumstances are serious , The fines for illegally storing and transporting vaccines by the vaccination unit, vaccine marketing license holder, and vaccine delivery unit are three times or more and less than ten times the value of the vaccine. If the value is less than 100,000 yuan, it will be calculated as 100,000 yuan.
Where disease prevention and control institutions and vaccination units have illegal acts as prescribed in the preceding paragraph, the health authorities of the people’s governments at or above the county level may give warnings to the main persons in charge, directly responsible persons in charge, and other directly responsible persons in accordance with the law until they are dismissed, and they shall be ordered to be liable. Responsible medical and health personnel suspend their practice activities for more than six months and less than one year; if serious consequences are caused, the main person in charge, the directly responsible person in charge and other directly responsible persons shall be expelled according to law, and the original license issuing authority shall have the responsibility revoked Practicing certificate of responsible medical and health personnel.
Article 87 In violation of the provisions of this law, disease prevention and control institutions or vaccination units have one of the following circumstances, the health department of the people’s government at or above the county level shall order corrections, give warnings, and confiscate illegal income; if the circumstances are serious, the The main person in charge, the directly responsible person in charge and other directly responsible persons shall be given warnings until dismissal according to law, and the responsible medical and health personnel shall be ordered to suspend their practice activities for more than one year and less than 18 months; if serious consequences are caused, the main person in charge , The directly responsible person in charge and other directly responsible personnel shall be expelled according to law, and the medical and health personnel responsible for the practice certificate shall be revoked by the original issuing department:
(1) Failure to supply, receive, or purchase vaccines in accordance with regulations;
(2) The vaccination fails to comply with the preventive vaccination work specifications, immunization procedures, vaccine use guidelines, and vaccination plan;
(3) Unauthorized group vaccination.
Article 88: In violation of the provisions of this law, disease prevention and control institutions or vaccination units have one of the following circumstances, the health authorities of the people’s government at or above the county level shall order corrections and give warnings; if the circumstances are serious, the main person in charge, The directly responsible persons in charge and other directly responsible persons shall be given warnings up to dismissal in accordance with the law, and the responsible medical and health personnel shall be ordered to suspend their practice activities for more than six months but less than one year; if serious consequences are caused, the main person in charge and the directly responsible supervisor Personnel and other directly responsible personnel shall be expelled according to law, and the medical and health personnel responsible for the practice certificate shall be revoked by the original issuing department:
(1) Failure to provide traceability information in accordance with regulations;
(2) Failing to obtain and keep relevant certification documents and temperature monitoring records in accordance with regulations when receiving or purchasing vaccines;
(3) Failing to establish and keep records of vaccine receipt, purchase, storage, distribution, supply, inoculation, and disposal in accordance with regulations;
(4) Failing to inform or ask the recipient or his guardian of the relevant situation in accordance with the regulations.
Article 89: Where disease prevention and control institutions, vaccination units, and medical institutions fail to report suspected abnormal vaccination reactions, vaccine safety incidents, etc., or fail to organize investigations and diagnoses of suspected abnormal vaccination reactions in accordance with regulations, the county The health department of the people’s government at or above the level above shall order corrections and give warnings; if the circumstances are serious, a fine of 50,000 yuan to 500,000 yuan shall be imposed on the inoculation unit and medical institution, and the main The person in charge, the person in charge directly in charge, and other persons directly responsible shall be given a warning until dismissal according to law; if serious consequences are caused, the person in charge, the person in charge directly in charge, and other persons directly responsible shall be expelled according to law, and the original license issuing authority The practicing certificate of the responsible medical and health personnel shall be revoked.
Article 90: Where disease prevention and control institutions or vaccination units charge fees in violation of the provisions of this Law, the health authorities of the people’s government at or above the county level shall supervise them to return the fees collected in violation to the original paying unit or individual, and the county level The market supervision and management department of the above people’s government shall impose penalties in accordance with the law.
Article 91 In violation of the provisions of this law, those who engage in immunization planning vaccination work without the designation of the local people’s government at or above the county level, or engage in non-immunization planning vaccination work that do not meet the requirements or have not been filed, shall be subject to the county level The above-mentioned people’s government health authorities shall order corrections, give warnings, confiscate illegal gains and illegal possession of vaccines, order business suspension for rectification, and impose a fine of 100,000 yuan up to 1 million yuan, and the main responsible person and the directly responsible supervisor The personnel and other directly responsible personnel shall be punished according to law.
In violation of the provisions of this law, disease prevention and control institutions, units or individuals other than vaccination units administer mass vaccination without authorization, the health authorities of the people’s government at or above the county level shall order corrections, confiscate illegal gains and illegally held vaccines, and A fine of ten to thirty times the value of the vaccine held illegally is imposed. If the value of the vaccine is less than 50,000 yuan, it will be calculated at 50,000 yuan.
Article 92: If the guardian fails to ensure that school-age children receive the immunization plan on time, the health department of the people’s government at the county level shall criticize and educate and order corrections.
If a kindergarten or school fails to check the vaccination certificate in accordance with the regulations when the child enters the 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 education administrative department of the local people’s government at or above the county level shall order correction and give Warning, the main responsible person, directly responsible person in charge and other directly responsible persons shall be punished according to law.
Article 93: In case of fabricating or disseminating false vaccine safety information, or creating disturbances in the inoculation unit, which constitutes a violation of public security management, the public security organ shall impose public security management penalties in accordance with the law.
Newspapers, periodicals, radio, television, Internet sites and other media fabricated or disseminated false vaccine safety information shall be punished by relevant departments according to law, and the main responsible person, directly responsible person in charge and other directly responsible persons shall be punished according to law.
Article 94: Where the local people’s government at or above the county level has one of the following circumstances in the supervision and management of vaccines, the directly responsible person in charge and other directly responsible personnel shall be degraded or dismissed according to law; if the circumstances are serious, they shall be expelled according to law Punishment; if serious consequences are caused, the person in charge shall take the blame and resign:
(1) Insufficient performance of duties, causing serious adverse effects or major losses;
(2) Concealing, false reporting, delaying reporting, or under-reporting vaccine safety incidents;
(3) Interfering with or obstructing the investigation of vaccine violations or vaccine safety incidents;
(4) A particularly serious vaccine safety accident occurs in this administrative region, or a major vaccine safety accident occurs continuously.
Article 95: In case of any of the following circumstances in the supervision and management of vaccines by the drug supervision and administration department, the health authority and other departments, the directly responsible person in charge and other directly responsible persons shall be degraded or removed in accordance with the law; the circumstances are serious If it causes serious consequences, its main person in charge shall take the blame and resign:
(1) Failure to perform supervision and inspection duties, or failure to promptly investigate and deal with violations of law;
(2) Unauthorized group vaccination;
(3) Concealing, false reporting, delaying reporting, or under-reporting vaccine safety incidents;
(4) Interfering with or obstructing the investigation of vaccine violations or vaccine safety incidents;
(5) Disclosure of the informant’s information;
(6) Receiving a report of suspected abnormal response to vaccination, failing to organize investigation and handling in accordance with regulations;
(7) Other behaviors that fail to perform vaccine supervision and management duties, causing serious adverse effects or major losses.
Article 96: Inoculation due to vaccine quality problems
Chapter 11 Supplementary Provisions
Article 97 The meaning of the following terms in this law are:
Immunization program vaccines refer to vaccines that residents should receive in accordance with government regulations, including vaccines determined by the national immunization program, vaccines added by the people’s government of provinces, autonomous regions, and municipalities when implementing the national immunization program, and people’s governments at or above the county level or others Vaccines used for emergency vaccination or mass vaccination organized by the competent health authority.
Non-immunization program vaccines refer to other vaccines voluntarily vaccinated by residents.
Vaccine marketing license holders refer to enterprises that have obtained vaccine drug registration certificates and drug production licenses 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 or contract requirements of the importing country (region).
Article 99: Entry-exit vaccinations and the procurement of necessary vaccines shall be separately prescribed by the frontier health and quarantine agency in consultation with the financial department of the State Council.
Article 100: This law shall come into force on December 1, 2019.
 

This work comes from the laws of the People’s Republic of China. According to Article 5 of the Copyright Law of the People’s Republic of China, this work does not apply to this law, so it belongs to the public domain.

 This work comes from a specific law of the People’s Republic of China with an effective date. According to Article 5 of the Copyright Law of the People’s Republic of China, this work is not applicable to this law, so it belongs to the public domain.
 
classification: 2019 June 2019 June 29, 2019 Laws of the People’s Republic of China 2019 Laws of the People’s Republic of China with specific enforcement dates December 1, 2019