Administrative Regulations on the Circulation of Vaccines and Vaccination (Revised in 2016)

Order of the State Council of the People's Republic of China No.668

April 23, 2016

(Promulgated on March 24, 2005 under Order of the State Council of the People's Republic of China No.434, and revised in accordance with the Decision of the State Council on Revising the Administrative Regulations on the Circulation of Vaccines and Vaccination dated April 23, 2016)

Chapter I General Provisions

Article 1 The Administrative Regulations on the Circulation of Vaccines and Vaccination (Revised in 2016) (hereinafter referred to as these "Regulations") are formulated in accordance with the Drug Administration Law of the People's Republic of China (hereinafter referred to as "Drug Administration Law") and the Law of the People's Republic of China on the Prevention and Treatment of Infectious Diseases (hereinafter referred to as the "Law on Prevention and Treatment of Infectious Diseases") so as to strengthen the administration of circulation of vaccines and vaccination, prevent and control the occurrence and spread of infectious diseases, and protect human health and public sanitation.

Article 2 For the purpose of these Regulations, vaccines refer to the preventive biotic products of the vaccine type, which are used for human vaccination for preventing and controlling the occurrence and spread of infectious diseases.
Vaccines are divided into two classes. Vaccines of Class 1 shall mean the vaccines provided by the government to citizens free of charge, which shall be vaccinated to citizens in accordance with the government provisions. Vaccines of this class include the vaccines determined in the State's immunity planning, the vaccines added by the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government in the implementation of the State's immunity planning, and the vaccines used in the emergency inoculation or mass vaccination organized by the people's governments at the county level or above or their respective competent health departments; and vaccines of Class 2 refer to other vaccines with which the citizens are voluntarily inoculated at their own expenses.

Article 3 The expenses for inoculation with vaccines of Class 1 shall be borne by the government, while the expenses for inoculation with vaccines of Class 2 shall be borne by the inoculated persons or their respective guardians.

Article 4 The circulation of vaccines and vaccination and the supervision and administration thereof shall be governed by these Regulations.

Article 5 The competent health department under the State Council shall, in light of such factors as the spread of infectious diseases within China and the crowd's immunity conditions, formulate the State's immunity planning; and shall, in concert with the department of public finance under the State Council, draft vaccine varieties which are included into the State's immunity planning, and promulgate them upon approval of the State Council.
The people's government of a province, autonomous region, or municipality directly under the Central Government may, when implementing the State's immunity planning, increase the vaccine varieties supplied to citizens free of charge in light of such factors as the spread of infectious diseases and the mass's immunity conditions within its own administrative region, and report to the competent health department under the State Council for archival purposes.

Article 6 The State applies a planned vaccination system, carries out and enlarges immunity planning.
Those who need to be inoculated with vaccines of Class 1 shall be inoculated in accordance with these Regulations. If the inoculated person is a minor, his/her guardian shall cooperate with the relevant disease prevention and control institution, medical institution, or other medical and health institution, so as to guarantee the said minor to be inoculated in time.

Article 7 The competent health department under the State Council shall be responsible for supervising and administering vaccination throughout the country. The competent health departments of local people's governments at the county level or above shall be responsible for supervising and administering vaccination within their own administrative regions.
The drug administration under the State Council shall be responsible for supervising and administering the quality and circulation of vaccines throughout the country. The drug administration s of the people's governments of provinces, autonomous regions, or municipalities directly under the Central Government shall be responsible for supervising and administering the quality and circulation of vaccines within their own administrative regions.

Article 8 The medical and health institution designated by the competent health department of a people's government at the county level in accordance with these Regulations (hereinafter referred to as the "inoculation entity") shall undertake the vaccination work. The competent health department of the people's government at the county level shall, when designating an inoculation entity, clarify the area of its responsibilities.
The people's government at the county level or above shall reward the inoculation entities and their personnel who undertake vaccination work and have made prominent achievements and contributions.

Article 9 The State supports and encourages entities and individuals to participate in vaccination. The people's government at each level shall improve relevant systems so as to facilitate the entities and individuals to take part in such activities as public promotion, education and donation concerning vaccination work.
Residents' committees and villagers' committees shall cooperate with relevant departments in carrying out the public promotion and education relating to vaccination, and assist in organizing residents and villagers to be inoculated with vaccines of Class 1.

Chapter II Circulation of Vaccines

Article 10 The procurement of vaccines shall be conducted via provincial public resource trading platforms.

Article 11 A disease prevention and control institution at the provincial level shall, in light of the State's immunity planning and the needs in preventing and controlling the occurrence and spread of infectious diseases in the local area, formulate the plan on use of vaccines of Class 1 in the local area (hereinafter referred to as "use plan"), and report it to the department responsible for procuring vaccines of Class 1 in accordance with the relevant provisions of the State, and at the same time also report it to the competent health department of the people's government at the same level for archival purposes. The use plan shall include such contents as the varieties and quantity of the vaccines and the avenue and method of supply.

Article 12 A department responsible for procuring vaccines of Class 1 in accordance with the relevant provisions of the State shall conclude a government procurement contract with a vaccine production enterprise in accordance with law, stipulating the varieties, quantity, prices and other information concerning the vaccines.

Article 13 A vaccine production enterprise shall, according to the stipulations in the government procurement contract, supply vaccines of Class 1 to the disease prevention and control institutions at the provincial level or other disease prevention and control institutions designated by the aforementioned institutions, and shall not supply vaccines of Class 1 to any other entities or individuals.
The vaccine production enterprise shall mark the words "Free of Charge" and the special mark of "Immunity Planning" set forth by the competent health department under the State Council at a prominent position on the smallest exterior packing of the vaccines that had been included into the State's immunity planning which it supplies. The specific administrative measures shall be formulated by the drug administration under the State Council in concert with the competent health department under the State Council.

Article 14 A disease prevention and control institution at the provincial level shall properly organize the distribution of vaccines of Class 1, and shall organize the distribution of vaccines of Class 1 to the disease prevention and control institutions at the level of city divided into districts or at the county level according to the use plan. Each disease prevention and control institution at the county level shall distribute the vaccines of Class 1 to the inoculation entities and the medical and health institutions at the township level according to the use plan. Each medical and health institution at the township level shall distribute the vaccines of Class 1 to the village medical and health institutions undertaking the vaccination work. No medical and health institution shall distribute vaccines of Class 1 to any other entity or individual. An institution that distributes vaccines of Class 1 may not charge any fee.
When an infectious disease breaks out or spreads and the local people's government at the county level or above or its competent health department needs to undertake emergency inoculation measures, the disease prevention and control institution at the level of city divided into districts or above may distribute vaccines of Class 1 directly to the inoculation entities.

Article 15 Vaccines of Class 2 shall be procured by disease prevention and control institutions at the provincial level at provincial public resource trading platforms in a centralized manner and supplied by disease prevention and control institutions at the county level to inoculation entities within the corresponding administrative regions after procurement from vaccine production enterprises.
Vaccine production enterprises shall directly distribute or entrust enterprises with conditions for cold chain storage and transport to distribute vaccines of Class 2 to disease prevention and control institutions at the county level. Enterprises entrusted with the distribution of vaccines of Class 2 may not entrust others with the distribution thereof.
The disease prevention and control institutions at the county level may collect vaccine, storage and transport fee from inoculation entities with respect to the supply of vaccines of Class 2. Vaccine fee will be collected at purchase price, and storage and transport fee will be collected in accordance with provisions of the corresponding provinces, autonomous regions and municipalities directly under the Central Government. The collection of fees shall be made public.

Article 16 The disease prevention and control institutions, the inoculation entities, the vaccine production enterprises, and the enterprises entrusted with the distribution of vaccines shall abide by the administrative rules on storage and transport of vaccines, so as to guarantee the quality of vaccines.
The whole process of storage and transport of vaccines shall be subject to the prescribed temperature and timely monitoring and record of temperature without separation from the cold chain. For vaccines that require prolonged cold chain transport or need to be distributed to remote regions, disease prevention and control institutions at the provincial level shall require the attaching of temperature control label.
The administrative rules on storage and transport of vaccines shall be formulated by the competent health department under the State Council in concert with the drug administration.

Article 17 A vaccine production enterprise shall, when selling vaccines, provide photocopies of the quality inspection testimonials or approval testimonials on each batch of biotic products, which are lawfully issued by the drug inspection institution, and affix its enterprise stamp; in case of sale of imported vaccines, it shall provide a photocopy of the imported medicine clearance certificate, and affix its enterprise stamp.
A disease prevention and control institution or an inoculation entity shall, when receiving or purchasing vaccines, obtain testimonials prescribed in the preceding paragraph from the vaccine production enterprise, and preserve them for inspection until two years after expiry of the vaccines.

Article 18 A vaccine production enterprise shall, in accordance with the Drug Administration Law and the provisions of the drug administration under the State Council, compile true and complete sales records, and preserve them for inspection until two years after expiry of the vaccines.
A disease prevention and control institution shall, in accordance with the provisions of the competent health department under the State Council, compile true and complete records on purchase, storage, distribution and supply, ensure consistent bills, accounts, goods and payments, and preserve them for inspection until two years after expiry of the vaccines.
The disease prevention and control institutions shall, when receiving or purchasing vaccines, ask for the records on temperature monitoring in the whole process of the storage and transport of vaccines; where such records cannot be provided or the temperature monitoring is not compliant with the requirements, the corresponding vaccines shall not be received or purchased, and reports shall be made immediately to drug administrations and competent health departments.

Chapter III Inoculation with Vaccines

Article 19 The competent health department under the State Council shall formulate and promulgate the rules on vaccination work, and shall, according to the national standards of vaccines, and the information on the surveys on epidemiology of infectious diseases, formulate and promulgate the immunization procedures for the vaccines included into the State's immunity planning, and the immunization procedures or guiding principles for use of other vaccines.
The competent health department of the people's government of a province, autonomous region, or municipality directly under the Central Government shall, according to the immunization procedures and the guiding principles for use of the vaccines, which are formulated by the competent health department under the State Council, and in light of the situation on spread of infectious diseases within its administrative region, formulate an inoculation program for its administrative region, and report it to the competent health department under the State Council for archival purposes.

Article 20 The disease prevention and control institutions at all levels shall, based on their respective duties, and according to the State's immunization planning or inoculation program, carry out public promotions, trainings, technical guidance, monitoring, appraisals, epidemiological surveys and emergency treatment related to vaccination, and compile records thereof in accordance with the provisions of the competent health department under the State Council.

Article 21 An inoculation entity shall meet the following conditions:
1. having a medical institution practicing permit;
2. having practicing doctors, assistant practicing doctors, nurses or village doctors who have completed the professional vaccination trainings organized by the competent health department of a people's government at the county level and who are assessed to be qualified; and
3. having the refrigerating facilities or equipment and refrigerating custody systems which conform to the administrative rules on storage and transport of vaccines.
An urban medical and health institution undertaking vaccination work shall set up an outpatient ward for vaccination.

Article 22 An inoculation entity shall undertake the vaccination work within its own responsible area, and accept the technical guidance provided by the local disease prevention and control institution at the county level.

Article 23 An inoculation entity shall, when receiving vaccines of Class 1 or purchasing vaccines of Class 2, ask for records on the whole process of the storage and transport of vaccines, set up and preserve true and complete records on the receipt and purchase, and ensure consistent bills, accounts, goods and payments. Where such records could not be provided or the temperature monitoring is incompliance with the requirements, the inoculation entity shall not receive or purchase them, and shall immediately report to the drug administration or the competent health department of the local people's government at the county level.
An inoculation entity shall, in light of the needs in vaccination, formulate the plans on the demands for vaccines of Class 1 and on the purchase of vaccines of Class 2, and shall report them to the competent health department of the people's government at the county level and the disease prevention and control institution at the county level.

Article 24 An inoculation entity shall, when inoculating vaccines, abide by the rules on vaccination work, the immunization procedures, the guiding principles for use of the vaccines and the inoculation program, and shall announce the varieties and inoculation methods of the vaccines of Class 1 prominently at its inoculation place.

Article 25 A medical and health staff shall, before carrying out the inoculation, inform the inoculated person or his/her guardian of the variety, function, contraindication and adverse effect of the inoculated vaccine and the points for attention, inquire about the inoculated person's health condition and whether he/she has contraindication to the inoculation, and other information, and shall truthfully record the particulars of information given and obtained. The inoculated person or his/her guardian shall understand the relevant knowledge on vaccination, and shall truthfully provide such information on the inoculated person's health and his/her contraindication to the inoculation.
The medical and health staff shall inoculate those who meet the conditions for inoculation, record the variety, production enterprise, the identification information of the smallest packing unit, expiration date, inoculation time, medical and health staff carrying out the inoculation, inoculated person and other information concerning vaccines in accordance with the provisions of the competent health department under the State Council. The inoculation records shall be kept for at least five years.
For a person who cannot be inoculated due to his/her contraindication to the inoculation, the medical and health staff shall propose medical suggestions to this person or his/her guardian.

Article 26 The State applies a vaccination certificate system to children. Within 1 month after a child is born, his/her guardian shall go to the inoculation entity undertaking vaccination work at the child's residential locality to obtain the vaccination certificate for the child. The inoculation entity shall check the child's vaccination certificate when carrying out the inoculation, and shall make records.
During the period when the child is not in his/her original residential locality, the responsibility to carry out the inoculation shall remain with the inoculation entity undertaking vaccination work at the child's present residential locality.
The format of the vaccination certificate shall be set forth by the competent health department of the people's government of the province, autonomous region, or municipality directly under the Central Government.

Article 27 When a child enters a nursery, kindergarten or school, the nursery, kindergarten or school shall check his/her vaccination certificate. If it finds that the child is not inoculated according to the State's immunity planning, it shall report to the local disease prevention and control institution at the county level or the inoculation entity undertaking vaccination work at the child's residential locality, and shall cooperate with the disease prevention and control institution or the inoculation entity in urging his/her guardian to have his/her child inoculated in time at the inoculation entity after the child enters the nursery, kindergarten or school.

Article 28 An inoculation entity shall, according to the State's immunity planning, inoculate those who live in its responsible area and need inoculation with vaccines of Class 1, and shall reach the inoculation rate as required by the State's immunity planning.
The disease prevention and control institution shall distribute vaccines of Class 1 in time to the inoculation entities.
Where the person to be inoculated or his/her guardian requests inoculation with the same variety of vaccine as that in vaccines of Class 1 at his/her own expenses, the inoculation entity providing the service shall inform him of the expenses, the remedies in case of unusual response, and the relevant contents prescribed in Article 25 of these Regulations.

Article 29 An inoculation entity shall, in accordance with the provisions of the competent health department under the State Council, register the information on inoculation, and report to the competent health department of the local people's government at the county level and the local disease prevention and control institution at the county level. The inoculation entity shall, after completing the State's immunity planning, report the quantity of remaining vaccines of Class 1, if any, to the original vaccine distribution entity, and state the reasons thereof.

Article 30 An inoculation entity shall not charge any fee for inoculation with vaccines of Class 1.
An inoculation entity may charge service fees and inoculation consumption fee for inoculation with vaccines of Class 2. The specific fee rates shall be ratified by the competent price department of the local people's government of the province, autonomous region, or municipality directly under the Central Government.

Article 31 Where the competent health department of a local people's government at the county level or above needs to carry out mass vaccination in some areas within its administrative region on the basis of information on monitoring and forewarning infectious diseases in order to prevent and control the break-out and spread of infectious diseases, it shall report to the people's government at the same level for their decision, and report to the competent health department of the people's government of the province, autonomous region, or municipality directly under the Central Government for archival purposes. If it needs to carry out mass vaccination within the whole region of the province, autonomous region, or municipality directly under the Central Government, the competent health department the people's government of the province, autonomous region, or municipality directly under the Central Government shall report to the people's government at the same level for their decision, and report to the competent health department under the State Council for archival purposes. If it needs to carry out mass vaccination throughout the country or in a large area covering different provinces, autonomous regions, or municipalities directly under the Central Government, the decision shall be made by the competent health department under the State Council. If a decision on approval is made, the people's government or the competent health department under the State Council shall organize relevant departments to carry out staff trainings, public promotion, education, transfer of goods and materials, and so on.
No entity or individual shall carry out mass vaccination based on their own discretion.

Article 32 When an infectious disease breaks out or spreads, the local people's government at the county level or above or its competent health department shall, if necessary, take emergency inoculation measures in accordance with the Law on Prevention and Treatment of Infectious Diseases and the Regulation on Urgent Response to Public Health Emergencies.

Article 33 The competent health department under the State Council or the competent health department of a people's government of the province, autonomous region, or municipality directly under the Central Government may, on the basis of the information on monitoring and forewarning infectious diseases, promulgate the information on suggesting inoculation with vaccines of Class 2, while no other entity or individual may promulgate such information.
The information on suggesting inoculation with vaccines of Class 2 shall include such contents as the knowledge on prevention and control of the targeted infectious disease, the relevant inoculation proposal, provided that it shall not involve any specific vaccine production enterprise.

Chapter IV Safeguard Measures

Article 34 The people's government at the county level or above shall include the vaccination work related to the State's immunization planning into the plans on national economy and social development for its own administrative region, guarantee the funds necessary for vaccination work, warrant the inoculation rate as required by the State's immunization planning, and ensure the implementation of the State's immunization planning.

Article 35 The people's government of a province, autonomous region, or municipality directly under the Central Government shall, in light of the spreading trend of infectious diseases within its administrative region, determine the projects related to vaccination within its administrative region within the scope of infectious disease prevention and control projects determined by the competent health department under the State Council, and ensure the implementation of such projects.

Article 36 The people's government of a province, autonomous region, or municipality directly under the Central Government shall guarantee the funds needed in purchasing and transporting vaccines of Class 1, and ensure the construction and operation of the cold chain systems of the disease prevention and control institutions and the inoculation entities within its administrative region.
The State may, if necessary, provide appropriate supports for the vaccination work in poverty-stricken areas.

Article 37 The people's government at the county level shall ensure the funds necessary for carrying out vaccination under the State's immunization planning, and shall, in accordance with the relevant provisions of the State, provide appropriate subsidies for village doctors engaging in vaccination and other grass-roots prevention and healthcare personnel.
The people's government of a province, autonomous region, or municipality directly under the Central Government and the people's governments at the level of city divided into districts shall provide necessary subsidies for the people's governments at the county level in poverty-stricken areas in carrying out the work related to vaccination.

Article 38 The people's government at the county level or above shall be responsible for reserving vaccines and other relevant goods and materials for future use.

Article 39 The funds arranged by finance departments at all levels for vaccination shall be used for this particular purpose, and may not be misappropriated or occupied by any entity or individual. The funds used by the relevant entities and individuals for vaccination shall be subject to the auditing organ's auditing and supervision in accordance with the law.

Chapter V Dealing with Adverse Events Following Immunization

Article 40 Adverse event following immunization ("AEFI") refers to the adverse drug reaction which causes damage to the inoculated person's tissues, organs or functions in the process of or after regularized inoculation of a qualified vaccine, and for which no relevant party has any fault.

Article 41 The following circumstances do not belong to AEFIs:
1. common responses after inoculation caused by the vaccine's features;
2. damage caused to the inoculated person due to the vaccine's poor quality;
3. damage caused to the inoculated person due to the inoculation entity's violation of the rules on vaccination work, immunization procedures, guiding principles for use of vaccines, or inoculation programs;
4. the inoculated person was in the delitescence or prodromal phase of a certain disease at the time of inoculation, and is attacked by the disease by coincidence after inoculation;
5. the inoculated person has the contraindication to the inoculation as stated in the vaccine directions, but the said inoculated person or his/her guardian fails to truthfully provide the information on the inoculated person's health and contraindication to the inoculation prior to inoculation, and the inoculated person's original disease recrudesces urgently or becomes worse after inoculation; and
6. individual or mass psychogenic responses due to psychological factors.

Article 42 Where a disease prevention and control institution or an inoculation entity or any of its medical and health staff finds any AEFI, suspected AEFI or receives any relevant report, the institution, entity or staff shall deal with the matter in time in accordance with the rules on vaccination work, and immediately report the same to the competent health department and the drug administration of the local people's government at the county level. The competent health department and the drug administration that receive the report shall immediately organize an investigation into and handling of the matter.

Article 43 The competent health department and the drug administration of a local people's government at the county level or above shall report information on the AEFIs which occur within their own administrative region and on dealing with such AEFIs separately and level by level to the competent health department and drug administration under the State Council.

Article 44 After a dispute over any AEFI, the inoculation entity or the inoculated person may ask the competent health department of the people's government at the county level at the inoculation entity's locality for settlement.
Where, due to vaccination, an inoculated person dies or becomes heavily disabled, or the masses suffer from any suspected AEFI, and the inoculation entity or the inoculated person asks the competent health department of the people's government at the county level for settlement, the competent health department receiving such request shall take necessary emergency measures to deal with the matter, report it to the people's government at the corresponding level in time, and transfer the matter to the competent health department of the people's government at the next higher level for settlement.

Article 45 The Regulations on Handling Medical Malpractices shall apply mutatis mutandis to the authentication of AEFIs, and the specific measures shall be formulated by the competent health department under the State Council in concert with the drug administration under the State Council.

Article 46 Where, due to any AEFI, an inoculated person dies or becomes heavily disabled, or any of his/her organs or tissues is injured, he/she shall be paid lump-sum compensation.
Where an inoculated person needs to be compensated due to an AEFI arising out of the inoculation of a vaccine of Class 1, the expenses for compensation shall be arranged by the finance department of the people's government of the province, autonomous region, or municipality directly under the Central Government from the funds for vaccination work. If an inoculated person needs to be compensated due to an AEFI arising out of the inoculation of a vaccine of Class 2, the expenses for compensation shall be borne by the relevant vaccine production enterprise. The State encourages the establishment of a mechanism of compensating the inoculated person suffering from an AEFI through commercial insurance or other forms.
The specific measures for compensation for AEFIs shall be formulated by the people's government of each province, autonomous region, or municipality directly under the Central Government.

Article 47 Where an inoculated person is harmed due to a vaccine's poor quality, the matter shall be dealt with in accordance with the relevant provisions of the Drug Administration Law. If an inoculated person is harmed due to the inoculation entity's violation of the rules on vaccination work, immunization procedures, guiding principles for use of vaccines, or inoculation programs, the matter shall be dealt with in accordance with the relevant provisions of the Regulations on Handling Medical Malpractices.

Chapter VI Supervision and Administration

Article 48 A drug administration shall, in accordance with the relevant provisions of the Drug Administration Law and the Implementing Regulations thereof, supervise and inspect the quality of vaccines in the processes of storage, transport, supply, sale, distribution and use, and inform the competent health department at the same level of the inspection result in a timely manner. If the drug administration carries out a random inspection over vaccines based on the needs in supervision and inspection, the entity or individual concerned shall cooperate in and shall not refuse such inspection.

Article 49 A drug administration may, in its supervision and inspection, seal up or detain the vaccine which is proved by any evidence as likely to harm human health and the relevant materials thereof, and shall hand down a decision within seven days. If the vaccine needs to be inspected, the drug administration shall make a decision within 15 days from the day when the inspection report was sent out.
Where a disease prevention and control institution, an inoculation entity, or a vaccine production enterprise finds any fake or inferior vaccine or any vaccine whose quality is questionable, it shall immediately cease the inoculation, distribution, supply or sale thereof, and immediately report the matter to the competent health department and the drug administration of the local people's government at the county level, and may not deal with the matter by itself. The competent health department that receives the report shall immediately organize the disease prevention and control institution and the inoculation entity to take necessary emergent measures to deal with the matter, and meanwhile report the same to the competent health department at the higher level. The drug administration that receives the report shall take such measures as sealing up or detaining the fake or inferior vaccine or the vaccine whose quality is questionable in accordance with the law.

Article 50 The competent health department of each people's government at the county level or above shall perform the following supervision and inspection duties within the scope of its own duties:
1. supervising and inspecting the information on the implementation of the State's immunization planning by medical and health institutions;
2. supervising and inspecting the public promotion, training, technical guidance and other work related to vaccination that are carried out by disease prevention and control institutions; and
3. supervising and inspecting the information on the distribution and purchase of vaccines by medical and health institutions.
The competent health department shall perform its supervision and administration duties mainly through inspecting the records made by medical and health institutions in accordance with these Regulations with regard to the distribution, storage, transport and inoculation of vaccines. When necessary, it may conduct on-site supervision and inspections. The competent health department shall record the information on supervision and inspections, and shall, when finding any illegal act, order the relevant entity to make a correction immediately.

Article 51 There shall be no less than two persons when the personnel of a competent health department or a drug administration perform their supervision and inspection duties in accordance with the law. They shall show relevant documentary proof, and keep confidential the trade secrets of the party under inspection.

Article 52 Competent health departments and drug administrations shall notify each other in time when finding any quality problem with a vaccine, any AEFI, or any other conditions, thus realizing information sharing.

Article 53 Any entity or individual shall have the right to report to the competent health department or the drug administration on any act of violating these Regulations, and report to the people's government at the corresponding level or the relevant department of the people's government at the higher level on the competent health department's or the drug administration's failure to perform its supervision and administration duties in accordance with the law. The people's government, competent health department or drug administration that receives the report shall verify and deal with the matter reported in time.

Article 54 The State shall establish a whole-process vaccine traceability system. The drug administration under the State Council shall, in concert with the competent health department under the State Council, formulate the unified technical specifications of the vaccine traceability system.
Vaccine production enterprises, disease prevention and control institutions and inoculation entities shall, in accordance with the Drug Administration Law, these Regulations and the provisions of the drug administration and competent health department under the State Council, establish a vaccine traceability system and faithfully record the information on the circulation and use of vaccines, so as to achieve the whole-process traceability of production, storage, transport and use of vaccines packed in packages.
The drug administration under the State Council shall, in concert with the competent health department under the State Council, establish a collaboration mechanism for whole-process tracing of vaccines.

Article 55 A disease prevention and control institution or an inoculation entity shall truthfully register any vaccine whose package cannot be recognized, or that is expired, is separated from the cold chain, or does not meet the relevant standards upon inspection, or whose source is unidentified and report the same to the drug administration of the local people's government at the county level, which shall, in concert with the competent health department at the same level, supervise the destruction of such vaccine as required. The disease prevention and control institution or the inoculation entity shall truthfully record the information on such destruction and keep the record for at least five years.

Chapter VII Legal Liability

Article 56 Where the competent health department or drug administration of a people's government at the county level or above violates these Regulations, and is under any of the following circumstances, it shall be ordered by the people's government at the corresponding level or the competent health department or drug administration of the people's government at the higher level to make a correction, and be criticized by way of circular; if the above violation causes any personal damage to any inoculated person, or dissemination or spread of any infectious disease or other severe consequences, its directly responsible person in charge and other persons directly liable shall be sanctioned in accordance with the law; if any especially serious consequences are caused, the person chiefly in charge shall also be held responsible and resign; if a crime is constituted, it shall be prosecuted for criminal liability in accordance with the law:
1. it fails to perform its supervision and inspection duties in accordance with these Regulations, or fails to timely investigate and deal with any illegal act it finds;
2. it fails to timely verify or deal with any report on not performing supervision and administration duties by any competent health department or drug administration at the lower level;
3. it fails to immediately organize the investigation and handling after it receives the relevant report on finding any AEFI or suspected AEFI;
4. it conducts mass vaccination without authorization; or
5. it has other neglects or derelicts of its duties in violation of these Regulations.

Article 57 Where a people's government at the county level or above fails to perform the duties of safeguarding vaccination in accordance with these Regulations, it shall be ordered by the people's government at the higher level to make a correction, and be criticized by way of circular; if the above behavior causes the dissemination or spread of any infectious disease or other severe consequences, its directly responsible person in charge and other persons directly liable shall be sanctioned in accordance with the law; for a region where any especially serious incident related to quality safety of vaccines occurs or serious incidents related to quality safety of vaccines continuously occur, the person chiefly in charge of its people's government shall be held responsible and resign; if a crime is constituted, the people's government shall be prosecuted for its criminal liability in accordance with the law.

Article 58 Where a disease prevention and control institution is under any of the following circumstances, it shall be ordered to make a correction, be criticized by way of circular, and be warned by the competent health department of the people's government at the county level or above; its illegal proceeds, if any, shall be confiscated; if it refuses to make a correction, its person chiefly in charge, directly responsible person in charge and other persons directly liable shall be imposed upon the punishments from warning to degradation in accordance with the law:
1. it fails to distribute vaccines of Class 1 according to the use plan to the disease prevention and control institutions at the lower level, the inoculation entities and the medical and health institutions at the township level;
2. it fails to compile and preserve the records on purchase, storage, distribution and supply of vaccines in accordance with the provisions; or
3. it fails to ask for the records on temperature monitoring as required when receiving or purchasing vaccines, receives or purchases the vaccines that do not meet the requirements, or fails to make a report in accordance with the provisions.
Where a medical and health institution at the township level fails to distribute vaccines of Class 1 to the village medical and health institutions undertaking vaccination under these Regulations, it shall be penalized in accordance with the foregoing provisions.

Article 59 Where an inoculation entity is under any of the following circumstances, it shall be ordered to make a correction and be warned by the competent health department of the local people's government at the county level; if it refuses to make a correction, its person chiefly in charge and directly responsible person in charge shall have imposed upon him the punishments from warning to degradation in accordance with the law, and the medical and health staff liable shall be ordered to suspend their practicing activities for a period of not less than three months but not more than six months:
1. it fails to ask for the records on temperature monitoring as required when receiving or purchasing vaccines, receives or purchases vaccines that do not meet the requirements, or fails to make a report in accordance with the provisions;
2. it fails to set up and preserve true and complete records on receipt or purchase of vaccines in accordance with the provisions;
3. it fails to publicize the varieties and inoculation methods of vaccines of Class 1 at a prominent position in its inoculation place;
4. the medical and health staff members fail to, prior to inoculation, inform or inquire of the inoculated person or his/her guardian about the relevant information in accordance with these Regulations;
5. the medical and health staff members conducting the vaccination fail to fill in and preserve the inoculation records in accordance with the provisions; or
6. it fails to register and report the information on the inoculation of vaccines in accordance with the provisions.

Article 60 Where a disease prevention and control institution or an inoculation entity is under any of the following circumstances, it shall be ordered to make a correction and be warned by the competent health department of the local people's government at the county level or above; its illegal proceeds, if any, shall be confiscated; if it refuses to make a correction, its person chiefly in charge, directly responsible person in charge and other persons directly liable shall have imposed upon him the punishments from warning to dismissal in accordance with the law; if it causes any personal damage to the inoculated person or other severe consequences, its person chiefly in charge and directly responsible person in charge shall be dismissed in accordance with the law, and the practicing certificates of the medical and health staff members liable shall be revoked by the original issuing department; if a crime is constituted, it shall be prosecuted for criminal liability in accordance with the law:
1. it, in violation of these Regulations, does not purchase vaccines via the provincial trading platform for public resources;
2. it, in violation of these Regulations, purchases vaccines of Class 2 from any entity or individual other than vaccine production enterprises and disease prevention and control institution at the county level;
3. it does not abide by the rules on vaccination work, immunization procedures, guiding principles for use of vaccines or inoculation programs when inoculating vaccines;
4. it fails to timely deal with or report any AEFI or suspected AEFI upon discovery thereof in accordance with the provisions;
5. it conducts mass vaccination without authorization; or
6. it fails to register or report any vaccine whose packaging cannot be recognized, or that is expired, is separated from the cold chain, or does not meet the relevant standards upon inspection, or whose source is unidentified in accordance with the provisions, or fails to record the information on destruction of such vaccine as required.

Article 61 Where a disease prevention and control institution or an inoculation entity, in violation of these Regulations, charge fees in the process of distribution, supply or inoculation of vaccines, it shall, under the supervision of the competent health department of the local people's government at the county level, refund the illegally charged fees to the original entity or individual that paid the fees, and shall be penalized by the competent price department of the people's government at the county level or above in accordance with the law.

Article 62 Where a pharmaceutical inspection institution issues a false vaccine inspection report, it shall be penalized in accordance with the provisions of Article 86 of the Drug Administration Law.

Article 63 Where a vaccine production enterprise fails to set up and preserve the records on the sale of vaccines as required, it shall be punished in accordance with the provisions of Article 78 of the Drug Administration Law.

Article 64 Where a vaccine production enterprise fails to mark the words of "Free of Charge" and the special mark of "Immunity Planning" as required on the smallest exterior packaging of the vaccines included into the State's immunity planning, it shall be ordered to make a correction and be warned by the drug administration; if it refuses to make a correction, it shall be fined not less than CNY5,000 but not more than CNY20,000, and its vaccines involved shall be sealed up and preserved.

Article 65 Where a vaccine production enterprise sells vaccines of Class 2 to any entity or individual other than the disease prevention and control institutions at the county level, the illegally sold vaccines shall be confiscated by the drug administration, and it shall be fined not less than two times but not more than five times the amount of the value of the illegally sold vaccines; the illegal proceeds, if any, shall be confiscated; its directly responsible person in charge and other persons directly liable are prohibited from engaging in any drug production and operation activities within five years; if the circumstance is severe, its vaccine production qualification shall be revoked in accordance with the law or the approval document on vaccine import obtained by it shall be canceled, and its directly responsible person in charge and other persons directly liable are required not to engage in any drug production and operation activities within ten years; if a crime is constituted, it shall be prosecuted for its criminal liability in accordance with the law.

Article 66 Where a disease prevention and control institution, an inoculation entity, a vaccine production enterprise or an enterprise distributing vaccines upon entrustment fails to store or transport vaccines under the prescribed refrigerating conditions, it shall be ordered to make a correction and be warned by the drug administration, and the vaccines it stores or transports shall be destroyed; the person chiefly in charge, directly responsible person in charge, and other persons directly liable of the disease prevention and control institution or the inoculation entity shall have imposed upon him the punishments from warning to dismissal by the competent health department in accordance with the law, and if any severe consequence is caused, such persons shall be dismissed in accordance with the law, and the inoculation entity's inoculation qualification shall be revoked; the vaccine production enterprise or the enterprise distributing vaccines upon entrustment shall be ordered by the drug administration in accordance with the law to cease production or operation for rectification, and be fined not less than two times but not more than five times the amount of the value of the vaccines that are not stored or transported in accordance with the provisions, and if any severe consequence is caused, its vaccine production qualification shall be revoked in accordance with the law or the approval document on vaccine import obtained by it shall be canceled, and its directly responsible person in charge and other persons directly liable are prohibited from engaging in any drug production and operation activities within ten years; if a crime is constituted, the said institution, entity or enterprise shall be prosecuted for its criminal liability in accordance with the law.

Article 67 Whichever entity, in violation of these Regulations, publishes the suggested information on inoculation of vaccines of Class 2 shall be ordered to eliminate the effect via mass media and be warned by the competent health department of the people's government at the county level at its locality or at the locality of occurrence; its illegal proceeds, if any, shall be confiscated, and this entity shall be fined not less than one time but not more than three times the amount of the illegal proceeds; if a crime is constituted, it shall be prosecuted for criminal liability in accordance with the law.

Article 68 An entity that engages in inoculation without being designated by the competent health department in accordance with the law shall be ordered to make a correction and be warned by the competent health department of the people's government at the county level at its locality or at the locality of occurrence; the illegally held vaccines or the illegal proceeds, if any, shall be confiscated; if it refuses to make a correction, its person chiefly in charge, directly responsible person in charge, and other persons directly liable shall be warned or demoted in accordance with the law.

Article 69 Where, when a child enters a nursery, kindergarten or school, the nursery, kindergarten or school fails to check his/her vaccination certificate in accordance with the provisions, or fails to report to the disease prevention and control institution or the inoculation entity after finding any child who is not inoculated in accordance with the provisions, it shall be ordered to make a correction and be warned by the competent education department of the local people's government at the county level or above; if it refuses to make a correction, its person chiefly in charge, directly responsible person in charge, and other persons directly liable shall be sanctioned in accordance with the law.

Article 70 Where, in violation of these Regulations, any entity or individual other than vaccine production enterprises and disease prevention and control institutions at the county level engages in the operation of vaccines, the entity or individual shall be penalized by the drug administration in accordance with the provisions of Article 72 of the Drug Administration Law.

Article 71 Where any entity or individual other than competent health departments, disease prevention and control institutions and inoculation entities, in violation of these Regulations, conducts mass vaccination, the entity or individual shall be ordered by the competent health department of the people's government at the county level or above to make a correction immediately, its illegally held vaccines shall be confiscated, and this entity shall be fined not less than two times but not more than five times the amount of the value of the illegally held vaccines; its illegal proceeds, if any, shall also be confiscated.

Article 72 An entity or individual shall bear civil liability in accordance with the law if the entity or individual violates these Regulations and causes any personal or property damage to an inoculated person.

Article 73 A person who provokes and disturbs, and disrupts the inoculation entity's normal medical treatment order or authentication of any AEFI on the pretext of occurrence of any AEFI shall be subject to penalties of public security administration in accordance with the law; if a crime is constituted, he/she shall be prosecuted for criminal liability in accordance with the law.

Chapter VIII Supplementary Provisions

Article 74 The following terms in these Regulations shall have their meanings as follows:
The State's immunity planning refers to the planned vaccination carried out among the masses according to the vaccine varieties, immunization procedures or inoculation programs determined by the State or the government of the province, autonomous region, or municipality directly under the Central Government, so as to prevent and control the occurrence and spread of certain infectious diseases.
Cold chain refers to the refrigerating facilities and equipment for storage and transport which are installed in order to guarantee the quality of vaccines in the process from the vaccine production enterprise to the inoculation entity.
Common response refers to the response occurring after the s inoculation and caused by the vaccine's own intrinsic feature, which will only result in transient impediment in physiological functions to the organism. Common responses mainly include becoming feverish or partially red and swollen, which may be accompanied with such comprehensive symptoms as general malaise, lethargy, loss of appetite, and weakened strength.
Vaccine production enterprises refer to the vaccine production enterprises within the territory of China and agencies in China designated by overseas vaccine manufacturers that export vaccines to China.

Article 75 The administrative measures for vaccination upon entry and exit shall be formulated separately by the entry and exit inspection and quarantine department of the State.

Article 76 These Regulations shall come into force as of June 1, 2005.