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.