decree of the state council of the people’s republic of china
No.668
The Decision of the State Council on Amending the Regulations on the Administration of Vaccine Circulation and Vaccination has been adopted at the 129th executive meeting of the State Council in April 13, 2016, and is hereby promulgated and shall come into force as of the date of promulgation.
premier
Li Keqiang
April 23, 2016
The State Council on the revision of the "vaccine circulation and
Decision on the Regulations on the Administration of Vaccination
The State Council has decided to make the following amendments to the Regulations on the Administration of Vaccine Circulation and Vaccination:
I Article 10 shall be amended as: "The procurement of vaccines shall be conducted through the provincial public resource trading platform."
II. Article 15 is amended as: "Category II vaccines are centrally purchased by provincial disease prevention and control institutions on provincial public resource trading platforms, and are purchased by county-level disease prevention and control institutions from vaccine production enterprises and then supplied to vaccination units in their respective administrative regions.
"Vaccine production enterprises shall directly distribute the second kind of vaccines to county-level disease prevention and control institutions, or entrust enterprises with cold chain storage and transportation conditions to distribute them. Enterprises entrusted with the distribution of vaccines of Category II shall not entrust the distribution.
"County-level disease prevention and control institutions can charge vaccine fees and storage and transportation fees for supplying second-class vaccines to vaccination units. Vaccine fees are charged according to the purchase price, and storage and transportation fees are charged according to the provisions of provinces, autonomous regions and municipalities directly under the central government. The charges should be made public. "
III. Article 16 is amended as: "Disease prevention and control institutions, inoculation entities, vaccine production enterprises and enterprises entrusted to distribute vaccines shall abide by the management norms for vaccine storage and transportation and ensure the quality of vaccines. The whole process of vaccine storage and transportation should always be in the specified temperature environment, and should not be separated from the cold chain, and the temperature should be monitored and recorded regularly. For vaccines with long cold chain transportation time and need to be distributed to remote areas, provincial disease prevention and control institutions should put forward the requirement of temperature control labels.
"The relevant specifications for vaccine storage and transportation management are formulated by the health authorities and drug supervision and administration departments of the State Council."
4. Paragraph 1 of Article 17 is amended as: "When selling vaccines, vaccine production enterprises shall provide copies of each batch of biological products that have passed the inspection or been examined and approved by drug inspection institutions according to law, and affix the corporate seal; If you sell imported vaccines, you should also provide a copy of the customs clearance form for imported drugs and affix the corporate seal. "
V. Article 18 is amended as: "Vaccine production enterprises shall, in accordance with the provisions of the Drug Administration Law and the drug supervision and administration department of the State Council, establish true and complete sales records and keep them for future reference beyond the effective period of vaccines for 2 years.
"Disease prevention and control institutions shall, in accordance with the provisions of the competent department of health in the State Council, establish a true and complete record of purchase, storage, distribution and supply, so that tickets, accounts, goods and funds are consistent, and keep them for more than 2 years for future reference. When the disease prevention and control institutions receive or purchase vaccines, they should ask for the temperature monitoring records of the whole process of vaccine storage and transportation; If the whole process temperature monitoring record cannot be provided or the temperature control does not meet the requirements, it shall not be accepted or purchased, and it shall immediately report to the drug supervision and administration department and the competent health department. "
Six, the first paragraph of Article 23 is amended as: "Inoculation units receiving vaccines of Category I or purchasing vaccines of Category II shall ask for temperature monitoring records of the whole process of vaccine storage and transportation, and establish and keep true and complete records of receipt and purchase, so that tickets, accounts, goods and funds are consistent. If the whole process temperature monitoring record cannot be provided or the temperature control does not meet the requirements, the inoculation unit shall not accept or purchase it, and shall immediately report it to the drug supervision and administration department and the competent health department of the local county-level people’s government. "
7. Paragraph 2 of Article 25 is amended as: "Medical and health personnel shall inoculate the recipients who meet the inoculation conditions, and record the identification information of the vaccine variety, the manufacturer and the smallest packaging unit, the expiration date, the inoculation time, the medical and health personnel who carried out the inoculation, the recipients, etc. in accordance with the provisions of the competent health department of the State Council. The storage time of vaccination records shall not be less than 5 years. "
Eight, the second paragraph of Article 46 is amended as: "If it is necessary to compensate the recipients for the abnormal reaction of vaccination caused by vaccination of Class I vaccine, the compensation expenses 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 funds for vaccination work. If it is necessary to compensate the recipients for the abnormal reaction caused by vaccination of the second kind of vaccine, the compensation expenses shall be borne by the relevant vaccine production enterprises. The state encourages the establishment of a mechanism to compensate the recipients of abnormal vaccination reactions through commercial insurance. "
IX. Article 52 is amended as: "When health authorities and drug supervision and administration departments find vaccine quality problems, abnormal reactions to vaccination and other situations, they shall inform each other in time to realize information sharing."
10. One article is added as Article 54: "The State shall establish a whole-course traceability system for vaccines. The drug supervision and administration department of the State Council shall, jointly with the health authorities of the State Council, formulate a unified technical specification for vaccine traceability system.
"Vaccine production enterprises, disease prevention and control institutions, and inoculation entities shall establish a vaccine traceability system in accordance with the provisions of the Drug Administration Law, these Regulations, the drug supervision and administration department of the State Council, and the competent health department, truthfully record the information on the circulation and use of vaccines, and realize the traceability of the whole process of the production, storage, transportation and use of the minimum packaging unit of vaccines.
"The drug supervision and administration department of the State Council and the health authorities of the State Council will establish a full-time traceability cooperation mechanism for vaccines."
11. One article is added as Article 55: "Disease prevention and control institutions and inoculation entities shall truthfully register vaccines whose packages are unrecognizable, have expired, are out of the cold chain, fail to meet the standards after inspection, and have unknown sources, and report to the pharmaceutical supervisory and administrative department of the people’s government at the county level where they are located, and the pharmaceutical supervisory and administrative department of the people’s government at the county level shall, jointly with the competent health department at the same level, supervise the destruction according to regulations. Disease prevention and control institutions and vaccination units shall truthfully record the destruction, and the destruction records shall be kept for not less than 5 years. "
12. Article 54 is renumbered as Article 56, which is amended as: "If the health administrative department or drug supervision and administration department of the people’s government at or above the county level violates the provisions of these Regulations and has any of the following circumstances, the people’s government at the same level, the health administrative department of the people’s government at a higher level or the drug supervision and administration department shall order it to make corrections, informed criticism; If it causes personal injury to the recipient, the spread and epidemic of infectious diseases or other serious consequences, the directly responsible person in charge and other directly responsible personnel shall be punished according to law; If the consequences are particularly serious, the principal responsible person shall also take the blame and resign; If the case constitutes a crime, criminal responsibility shall be investigated according to law:
"(a) failing to perform the duties of supervision and inspection in accordance with the provisions of these regulations, or failing to investigate and deal with illegal acts in time;
"(2) Failing to timely verify and handle the report that the lower-level health authorities and drug supervision and administration departments fail to perform their duties of supervision and administration;
"(3) Failing to immediately organize the investigation and handling after receiving the relevant report of abnormal reaction or suspected abnormal reaction of vaccination;
"(four) unauthorized mass vaccination;
"(5) Other dereliction of duty and dereliction of duty in violation of these regulations."
XIII. Article 55 is renumbered as Article 57 and amended as: "If the people’s governments at or above the county level fail to perform their duties of vaccination protection in accordance with the provisions of these Regulations, the people’s governments at higher levels shall order them to make corrections, informed criticism; Causing the spread, epidemic or other serious consequences of infectious diseases, the directly responsible person in charge and other directly responsible personnel shall be punished according to law; In areas where particularly serious vaccine quality and safety incidents have occurred or where serious vaccine quality and safety incidents have occurred continuously, the main person in charge of the people’s government should also take the blame and resign; If it constitutes a crime, criminal responsibility shall be investigated according to law. "
Fourteen, change Article 56 to Article 58, and the first paragraph is amended as: "In any of the following circumstances, the competent health department of the people’s government at or above the county level shall order it to make corrections, and informed criticism shall give it a warning; Illegal income, confiscate the illegal income; Refuses to correct, the main person in charge, the directly responsible person in charge and other directly responsible personnel shall be given a warning to demotion:
"(1) Failing to distribute Class I vaccines to lower-level disease prevention and control institutions, inoculation units and township-level medical and health institutions according to the use plan;
"(2) Failing to establish and keep records of vaccine purchase, storage, distribution and supply in accordance with regulations;
"(3) Failing to ask for temperature monitoring records in accordance with regulations when receiving or purchasing vaccines, receiving or purchasing vaccines that do not meet the requirements, or failing to report in accordance with regulations."
15. Article 57 is renumbered as Article 59 and amended as: "In case of any of the following circumstances, the competent health department of the local people’s government at the county level shall order it to make corrections and give it a warning; Refuses to correct, the main person in charge, the directly responsible person in charge shall be given a warning to demotion, and the responsible medical and health personnel shall be ordered to suspend their practice activities for more than 3 months and less than 6 months:
"(1) Failing to ask for temperature monitoring records in accordance with regulations when receiving or purchasing vaccines, receiving or purchasing vaccines that do not meet the requirements, or failing to report in accordance with regulations;
"(2) Failing to establish and keep a true and complete record of vaccine receipt or purchase in accordance with regulations;
"(3) Failing to publicize the varieties and inoculation methods of the first-class vaccines in a prominent position in its inoculation place;
"(four) medical and health personnel before vaccination, not in accordance with the provisions of this Ordinance to inform and ask the recipient or his guardian about the situation;
"(five) the medical and health personnel who carry out vaccination fail to fill in and keep vaccination records in accordance with the regulations;
"(6) Failing to register and report the vaccination in accordance with regulations."
Sixteen, Article 58 is changed into Article 60, which is amended as: "In any of the following circumstances, the competent health department of the local people’s government at or above the county level shall order it to make corrections and give it a warning; Illegal income, confiscate the illegal income; Refuses to correct, the main person in charge, the directly responsible person in charge and other directly responsible personnel shall be given a warning to dismissal; If personal injury or other serious consequences are caused to the seed recipients, the main person in charge and the directly responsible person in charge shall be dismissed according to law, and the original license-issuing department shall revoke the practice certificate of the responsible medical and health personnel; If the case constitutes a crime, criminal responsibility shall be investigated according to law:
"(a) in violation of the provisions of this Ordinance, not through the provincial public resources trading platform to purchase vaccines;
"(two) in violation of the provisions of this Ordinance, from the vaccine production enterprises, county-level disease prevention and control institutions outside the units or individuals to buy the second kind of vaccine;
"(three) vaccination did not comply with the vaccination work norms, immunization procedures, vaccine use guidelines, vaccination programs;
"(4) Failing to deal with or report the abnormal reaction of vaccination or suspected abnormal reaction of vaccination in time according to the provisions;
"(five) unauthorized mass vaccination;
"(6) Failing to register and report vaccines whose packages are unrecognizable, have expired, are out of the cold chain, fail to meet the standards after inspection, and have unknown sources, or failing to record the destruction in accordance with regulations."
Article 61 is renumbered as Article 63 and amended as: "If a vaccine production enterprise fails to establish and keep vaccine sales records in accordance with regulations, it shall be punished in accordance with the provisions of Article 78 of the Drug Administration Law."
18. Article 63 is renumbered as Article 65 and amended as: "If a vaccine production enterprise sells Category II vaccines to units or individuals other than county-level disease prevention and control institutions, the drug supervision and administration department shall confiscate the illegally sold vaccines and impose a fine of more than 2 times and less than 5 times the value of the illegally sold vaccines; Illegal income, confiscate the illegal income; The directly responsible person in charge and other directly responsible personnel shall not engage in drug production and business activities within 5 years; If the circumstances are serious, the qualification for vaccine production or the certificate of approval for vaccine import shall be revoked according to law, and the directly responsible person in charge and other directly responsible personnel shall not engage in drug production and business activities within 10 years; If it constitutes a crime, criminal responsibility shall be investigated according to law. "
19. Article 64 is renumbered as Article 66 and amended as: "If disease prevention and control institutions, inoculation units, vaccine production enterprises and enterprises entrusted with the distribution of vaccines fail to store and transport vaccines under the prescribed refrigeration conditions, the pharmaceutical supervisory and administrative department shall order them to make corrections, give them a warning and destroy the vaccines stored and transported; By the competent department of health of disease prevention and control institutions, vaccination units, the main person in charge, the directly responsible person in charge and other directly responsible personnel shall be given a warning to dismissal according to law, resulting in serious consequences, shall be given the punishment of dismissal according to law, and the vaccination qualification of the vaccination unit shall be revoked; The pharmaceutical supervisory and administrative department shall, according to law, order vaccine production enterprises and enterprises entrusted to distribute vaccines to stop production and suspend business for rectification, and impose a fine of more than 2 times and less than 5 times the value of vaccines stored and transported in violation of regulations, thus causing serious consequences, the vaccine production qualification shall be revoked or the vaccine import approval documents shall be revoked according to law, and the directly responsible person in charge and other directly responsible personnel shall not engage in pharmaceutical production and business activities within 10 years; If it constitutes a crime, criminal responsibility shall be investigated according to law. "
Article 68 is renumbered as Article 70 and amended as: "In violation of the provisions of these Regulations, units or individuals other than vaccine production enterprises and county-level disease prevention and control institutions deal in vaccines, and the pharmaceutical supervisory and administrative departments shall punish them in accordance with the provisions of Article 72 of the Drug Administration Law."
XXI. Article 72 is renumbered as Article 74, and one paragraph is added as paragraph 5: "Vaccine production enterprises refer to vaccine production enterprises in China and the agencies designated by overseas vaccine manufacturers that export vaccines to China."
22. One article is added as Article 75: "Measures for the administration of entry-exit vaccination shall be formulated separately by the state entry-exit inspection and quarantine department."
Twenty-three, delete twelfth, thirteenth, seventeenth, second, thirty-third, forty-ninth, sixty-second in the "vaccine wholesale enterprises".
Twenty-four, sixtieth to sixty-second, and one of the "eighty-seventh" to "eighty-sixth".
In addition, the order of articles and individual words are adjusted and modified accordingly.
This decision shall come into force as of the date of promulgation.
The Regulations on the Administration of Vaccine Circulation and Vaccination shall be revised according to this decision and re-promulgated.
Regulations on the administration of vaccine circulation and vaccination
(Promulgated by Order No.434 of the State Council of the People’s Republic of China on March 24, 2005, revised according to the Decision of the State Council on Amending the Regulations on the Administration of Vaccine Circulation and Vaccination on April 23, 2016)
Chapter I General Principles
the first In order to strengthen the management of vaccine circulation and vaccination, prevent and control the occurrence and prevalence of infectious diseases, and safeguard human health and public health, these Regulations are formulated in accordance with the Drug Administration Law of People’s Republic of China (PRC) (hereinafter referred to as the Drug Administration Law) and the Law of People’s Republic of China (PRC) on the Prevention and Control of Infectious Diseases (hereinafter referred to as the Infectious Diseases Prevention Law).
the second The term "vaccine" as mentioned in these Regulations refers to the preventive biological products of vaccines used for human vaccination in order to prevent and control the occurrence and prevalence of infectious diseases.
Vaccines are divided into two categories. Category I vaccines refer to vaccines provided by the government to citizens free of charge, which citizens should receive in accordance with government regulations, including vaccines determined by the national immunization plan, vaccines added by the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government in the implementation of the national immunization plan, and vaccines used for emergency vaccination or mass vaccination organized by the people’s governments at or above the county level or their health authorities; The second category of vaccines refers to other vaccines that are inoculated by citizens at their own expense and voluntarily.
Article Vaccination of the first kind of vaccine is paid by the government. Vaccination of the second kind of vaccine shall be borne by the recipient or his guardian.
Article 4 These Regulations shall apply to the circulation, vaccination and supervision and management of vaccines.
Article 5 The health authorities in the State Council shall formulate the national immunization plan according to the epidemic situation of infectious diseases and the immune status of the population nationwide; In conjunction with the financial department of the State Council, we will formulate vaccine types to be included in the national immunization program, and report them to the State Council for approval before publication.
The people’s governments of provinces, autonomous regions and municipalities directly under the Central Government may, when implementing the national immunization plan, increase the types of vaccines provided to citizens free of charge according to factors such as the epidemic situation of infectious diseases and the immune status of the population in their respective administrative areas, and report them to the health authorities in the State Council for the record.
Article 6 The state implements a planned vaccination system and an expanded immunization program.
The recipients who need to be vaccinated with Class I vaccines shall be vaccinated in accordance with the provisions of these Regulations; If the recipient is a minor, his guardian shall cooperate with relevant disease prevention and control institutions, medical institutions and other medical and health institutions to ensure that the recipient receives the seed in time.
Article 7 The competent health department of the State Council is responsible for the supervision and management of national vaccination. The health authorities of local people’s governments at or above the county level shall be responsible for the supervision and administration of vaccination within their respective administrative areas.
The drug supervision and administration department of the State Council is responsible for the supervision and administration of the quality and circulation of vaccines throughout the country. The pharmaceutical supervisory and administrative departments of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the supervision and administration of the quality and circulation of vaccines within their respective administrative areas.
Article 8 Medical and health institutions (hereinafter referred to as vaccination units) designated by the competent health department of the people’s government at the county level in accordance with the provisions of these regulations shall undertake vaccination work. When the competent health department of the people’s government at the county level designates the inoculation unit, it shall specify its responsible area.
The people’s governments at or above the county level shall reward the vaccination units and their staff who have undertaken vaccination work and made remarkable achievements and contributions.
Article 9 The state supports and encourages units and individuals to participate in vaccination work. People’s governments at all levels should improve the relevant systems to facilitate units and individuals to participate in activities such as publicity, education and donation of vaccination work.
Residents’ committees and villagers’ committees shall cooperate with relevant departments to carry out publicity and education related to vaccination, and assist in organizing residents and villagers to receive the first-class vaccine.
Chapter II Vaccine Circulation
Article 10 The procurement of vaccines shall be carried out through the provincial public resource trading platform.
Article 11 Provincial disease prevention and control institutions shall, according to the national immunization program and the needs of preventing and controlling the occurrence and epidemic of infectious diseases in the region, formulate the use plan of the first class vaccine in the region (hereinafter referred to as the use plan), report to the department responsible for purchasing the first class vaccine in accordance with the relevant provisions of the state, and report to the competent health department of the people’s government at the same level for the record. The use plan shall include the variety, quantity, supply channel and supply mode of the vaccine.
Article 12 In accordance with the relevant provisions of the state, the department responsible for purchasing the first class vaccine shall sign a government procurement contract with the vaccine production enterprise according to law, and stipulate the variety, quantity and price of the vaccine.
Article 13 Vaccine production enterprises shall supply Class I vaccines to provincial disease prevention and control institutions or other disease prevention and control institutions designated by them in accordance with the provisions of government procurement contracts, and shall not supply them to other units or individuals.
Vaccine production enterprises shall mark the word "free" and the special logo of "immunization program" as stipulated by the competent health department of the State Council in a prominent position in the minimum outer packaging of vaccines that are included in the national immunization program. The specific management measures shall be formulated by the drug supervision and administration department of the State Council in conjunction with the health authorities of the State Council.
Article 14 Provincial disease prevention and control institutions shall do a good job in organizing the distribution of Class I vaccines, and distribute Class I vaccines to municipal disease prevention and control institutions with districts or county-level disease prevention and control institutions according to the use plan. County-level disease prevention and control institutions shall distribute Class I vaccines to vaccination units and township-level medical and health institutions according to the use plan. Township medical and health institutions shall distribute the first kind of vaccines to village medical and health institutions that undertake vaccination work. Medical and health institutions shall not distribute Category I vaccines to other units or individuals; No fees shall be charged for the distribution of Class I vaccines.
If the local people’s governments at or above the county level or their health authorities need to take emergency vaccination measures during the outbreak and epidemic of infectious diseases, the disease prevention and control institutions at or above the municipal level with districts can directly distribute the first-class vaccines to the vaccination units.
Article 15 The second kind of vaccines are centrally purchased by provincial disease prevention and control institutions on provincial public resource trading platforms, and are purchased by county-level disease prevention and control institutions from vaccine production enterprises and then supplied to vaccination units in their respective administrative regions.
Vaccine production enterprises shall directly distribute Category II vaccines to county-level disease prevention and control institutions, or entrust enterprises with cold chain storage and transportation conditions to distribute them. Enterprises entrusted with the distribution of vaccines of Category II shall not entrust the distribution.
County-level disease prevention and control institutions can charge vaccine fees and storage and transportation fees for supplying second-class vaccines to vaccination units. Vaccine fees are charged according to the purchase price, and storage and transportation fees are charged according to the provisions of provinces, autonomous regions and municipalities directly under the central government. Charges should be made public.
Article 16 Disease prevention and control institutions, vaccination units, vaccine production enterprises and enterprises entrusted with the distribution of vaccines shall abide by the management norms for vaccine storage and transportation and ensure the quality of vaccines. The whole process of vaccine storage and transportation should always be in the specified temperature environment, and should not be separated from the cold chain, and the temperature should be monitored and recorded regularly. For vaccines with long cold chain transportation time and need to be distributed to remote areas, provincial disease prevention and control institutions should put forward the requirement of temperature control labels.
The relevant standards for vaccine storage and transportation management shall be formulated by the health authorities and drug supervision and administration departments of the State Council.
Article 17 When selling vaccines, vaccine production enterprises shall provide copies of each batch of biological products that have passed the inspection or been approved by the drug inspection institutions according to law, and affix the seal of the enterprise; Sales of imported vaccines, should also provide a copy of the customs clearance form for imported drugs, and affix the seal of the enterprise.
Disease prevention and control institutions and vaccination units shall, when receiving or purchasing vaccines, obtain the certification documents specified in the preceding paragraph from vaccine production enterprises, and keep them for future reference beyond the validity period of vaccines for 2 years.
Article 18 Vaccine production enterprises shall, in accordance with the provisions of the Drug Administration Law and the drug supervision and administration department of the State Council, establish true and complete sales records and keep them for future reference beyond the validity period of vaccines for 2 years.
Disease prevention and control institutions shall, in accordance with the provisions of the competent department of health in the State Council, establish a true and complete record of purchase, storage, distribution and supply, so that tickets, accounts, goods and funds are consistent, and keep them for future reference beyond the validity period of vaccines for 2 years. When the disease prevention and control institutions receive or purchase vaccines, they should ask for the temperature monitoring records of the whole process of vaccine storage and transportation; If the whole process temperature monitoring record cannot be provided or the temperature control does not meet the requirements, it shall not be accepted or purchased, and it shall immediately report to the drug supervision and administration department and the competent health department.
Chapter III Vaccination
Article 19 The competent department of health in the State Council shall formulate and publish the norms for vaccination, and formulate and publish the immunization procedures of vaccines and other vaccines included in the national immunization plan or the guiding principles for their use according to the national standards for vaccines and the epidemiological investigation information of infectious diseases.
The health authorities of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government shall, according to the immunization procedures and vaccine use guidelines formulated by the health authorities in the State Council, and in combination with the epidemic situation of infectious diseases in their respective administrative areas, formulate vaccination programs in their respective administrative areas and report them to the health authorities in the State Council for the record.
Article 20 Disease prevention and control institutions at all levels shall, according to their respective functions and duties, carry out publicity, training, technical guidance, monitoring, evaluation, epidemiological investigation, emergency response and other work related to vaccination according to the national immunization plan or vaccination plan, and make records in accordance with the provisions of the competent health department of the State Council.
Article 21 The inoculation entity shall meet the following conditions:
(1) Having a medical institution’s practice license;
(2) Having medical practitioners, assistant medical practitioners, nurses or rural doctors who have passed the vaccination professional training organized by the competent health department of the people’s government at the county level and passed the examination;
(3) Having cold storage facilities, equipment and a cold storage system that meet the management standards for vaccine storage and transportation.
Urban medical and health institutions undertaking vaccination work shall set up vaccination clinics.
Article 22 The vaccination unit shall undertake the vaccination work within the responsible area and accept the technical guidance of the local county-level disease prevention and control institutions.
Article 23 When an inoculation entity receives a vaccine of Category I or purchases a vaccine of Category II, it shall ask for a temperature monitoring record of the whole process of vaccine storage and transportation, establish and keep a true and complete record of receipt and purchase, and ensure that the tickets, accounts, goods and funds are consistent. If the whole process temperature monitoring record cannot be provided or the temperature control does not meet the requirements, the inoculation entity shall not accept or purchase it, and shall immediately report to the pharmaceutical supervisory and administrative department and the competent health department of the local people’s government at the county level.
Inoculation units shall, according to the needs of vaccination work, formulate the demand plan for the first kind of vaccine and the purchase plan for the second kind of vaccine, and report to the competent health department of the people’s government at the county level and the disease prevention and control institutions at the county level.
Article 24 Vaccination units shall observe the vaccination work norms, immunization procedures, guiding principles for vaccine use and vaccination programs, and publicize the varieties and vaccination methods of the first type of vaccine in a prominent position in their vaccination sites.
Article 25 Before vaccination, medical and health personnel shall inform the recipients or their guardians of the varieties, functions, contraindications, adverse reactions and precautions of the vaccine, ask about the health status of the recipients and whether there are any contraindications to vaccination, and record the information truthfully. The recipient or his guardian should know the relevant knowledge of vaccination, and truthfully provide the health status and vaccination contraindications of the recipient.
Medical and health personnel shall inoculate the recipients who meet the inoculation conditions, and record the identification information of the vaccine variety, production enterprise and minimum packaging unit, validity period, inoculation time, medical and health personnel who carried out inoculation, recipients and other contents in accordance with the provisions of the competent health department of the State Council. Vaccination records shall be kept for not less than 5 years.
Medical and health personnel shall give medical advice to the recipients or their guardians who cannot be vaccinated because of vaccination taboos.
Article 26 The state implements a vaccination certificate system for children. Within one month after the child is born, his guardian shall go to the vaccination unit where the child lives to undertake vaccination work to apply for a vaccination certificate for him. When the vaccination unit vaccinates children, it shall examine the vaccination certificate and make records.
During the period when children leave their original place of residence, the vaccination unit that undertakes vaccination at their current place of residence is responsible for their vaccination.
The format of vaccination certificate shall be formulated by the competent health departments of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government.
Article 27 When children enter kindergartens and schools, nursery institutions and schools shall examine vaccination certificates. If children who are not vaccinated according to the national immunization plan are found, they shall report to the local county-level disease prevention and control institutions or the vaccination units that undertake vaccination work, and cooperate with the disease prevention and control institutions or vaccination units to urge their guardians to replant at the vaccination units in time after children enter kindergartens and schools.
Article 28 The vaccination unit shall, in accordance with the national immunization plan, vaccinate the recipients who need to be vaccinated with the first kind of vaccine in their responsible areas, and reach the vaccination rate required by the national immunization plan.
The disease prevention and control institutions shall timely distribute Class I vaccines to the inoculation entities.
If the recipient or his guardian requests to choose the vaccine of the same variety to be vaccinated with the first kind of vaccine at his own expense, the vaccination unit providing the service shall inform him of the expenses, the compensation method for abnormal reaction and the relevant contents stipulated in Article 25 of these regulations.
Article 29 The inoculation entity shall register the inoculation situation in accordance with the provisions of the competent health department of the State Council, and report to the local competent health department of the people’s government at the county level and the county-level disease prevention and control institutions. If the vaccination unit remains the first kind of vaccine after completing the national immunization plan, it shall report to the original vaccine distribution unit and explain the reasons.
Article 30 Inoculation units shall not charge any fees for inoculation of Class I vaccines.
Inoculation units can charge service fees and inoculation consumables fees for second-class vaccines, and the specific charging standards shall be approved by the competent price departments of the local people’s governments of provinces, autonomous regions and municipalities directly under the Central Government.
Article 31 If the competent health department of the local people’s government at or above the county level needs to carry out mass vaccination in some areas within its administrative region according to the monitoring and early warning information of infectious diseases in order to prevent and control the outbreak and epidemic of infectious diseases, it shall report to the people’s government at the corresponding level for decision and file with the competent health department of the people’s government of the province, autonomous region or municipality directly under the Central Government; If it is necessary to carry out mass vaccination within the entire administrative area of a province, autonomous region or municipality directly under the Central Government, the competent health department of the people’s government of the province, autonomous region or municipality directly under the Central Government shall report it to the people’s government at the corresponding level for decision and file it with the competent health department of the State Council. If mass vaccination is needed 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 people’s government that made the approval decision or the competent health department of the State Council shall organize the relevant departments to do a good job in personnel training, publicity and education, and material transfer.
No unit or individual may carry out mass vaccination without authorization.
Article 32 If the local people’s governments at or above the county level or their health authorities need to take emergency vaccination measures during the outbreak and epidemic of infectious diseases, it shall be implemented in accordance with the provisions of the Law on the Prevention and Control of Infectious Diseases and the Emergency Regulations on Public Health Emergencies.
Article 33 The competent health department of the State Council or the competent health department of the people’s government of a province, autonomous region or municipality directly under the Central Government may release the recommended information on vaccination of Class II vaccine according to the monitoring and early warning information of infectious diseases, and no other unit or individual may release it.
The recommended information for vaccination of the second kind of vaccine shall include the knowledge of prevention and control of infectious diseases and relevant vaccination schemes, but shall not involve specific vaccine production enterprises.
Chapter IV Safeguard Measures
Article 34 The people’s governments at or above the county level shall incorporate the vaccination work related to the national immunization program into the national economic and social development plan of their respective administrative areas, guarantee the funds needed for vaccination work, ensure the vaccination rate required by the national immunization program, and ensure the implementation of the national immunization program.
Article 35 The people’s governments of provinces, autonomous regions and municipalities directly under the Central Government shall, according to the epidemic trend of infectious diseases in their respective administrative areas, determine the projects related to vaccination in their respective administrative areas within the scope of infectious disease prevention and control projects determined by the health authorities in the State Council, and ensure the implementation of the projects.
Article 36 The people’s governments of provinces, autonomous regions and municipalities directly under the Central Government shall guarantee the funds needed for the purchase and transportation of Class I vaccines, and ensure the construction and operation of the cold chain system of disease prevention and control institutions and vaccination units within their respective administrative areas.
The state gives appropriate support to vaccination work in poverty-stricken areas according to needs.
Article 37 The people’s government at the county level shall ensure the funds needed for vaccination in the implementation of the national immunization plan, and give appropriate subsidies to rural doctors and other grassroots preventive and health care personnel engaged in vaccination in accordance with relevant state regulations.
The people’s governments of provinces, autonomous regions and municipalities directly under the Central Government and the people’s governments at the municipal level divided into districts shall give necessary financial subsidies to the people’s governments at the county level in difficult areas to carry out the work related to vaccination.
Article 38 The people’s governments at or above the county level shall be responsible for the reserve of vaccines and related materials for use.
Article 39 Financial arrangements at all levels for vaccination funds should be earmarked, and no unit or individual may misappropriate or occupy them. The relevant units and individuals shall accept the audit supervision of audit institutions in accordance with the law when using the funds for vaccination.
Chapter V Handling of Abnormal Reaction to Vaccination
Article 40 Abnormal reaction of vaccination refers to the adverse drug reaction caused by qualified vaccine in the process of implementing standardized vaccination or after implementing standardized vaccination, and all parties concerned have no fault.
Article 41 The following situations do not belong to the abnormal reaction of vaccination:
(a) the general reaction after vaccination caused by the characteristics of the vaccine itself;
(two) the damage caused by the unqualified vaccine quality to the recipients;
(three) the damage caused to the recipients by the vaccination unit’s violation of the vaccination work norms, immunization procedures, guiding principles for vaccine use, and vaccination programs;
(four) the recipient is in the incubation period or precursor period of a disease at the time of inoculation, and the disease is coupled after inoculation;
(5) The recipient has vaccination contraindications specified in the vaccine instructions, and the recipient or his guardian failed to truthfully provide the health status and vaccination contraindications of the recipient before vaccination, and the original disease of the recipient has an acute recurrence or aggravation after vaccination;
(6) Psychogenic reactions of individuals or groups due to psychological factors.
Article 42 Disease prevention and control institutions, vaccination units and their medical and health personnel who find abnormal reactions to vaccination, suspected abnormal reactions to vaccination or receive relevant reports shall deal with them in a timely manner in accordance with the norms of vaccination work, and immediately report to the health authorities and drug supervision and administration departments of the people’s governments at the county level where they are located. The competent health department and drug supervision and administration department that received the report shall immediately organize the investigation and handling.
Article 43 The competent health department and drug supervision and administration department of the local people’s government at or above the county level shall report the abnormal reaction of vaccination and its handling within their respective administrative areas to the competent health department and drug supervision and administration department of the State Council.
Article 44 After the dispute over the abnormal reaction of vaccination occurs, the inoculation entity or the recipient may request the competent health department of the people’s government at the county level where the inoculation entity is located to handle it.
If vaccination causes death, severe disability or group suspected abnormal reaction to vaccination, the inoculation unit or the recipient requests the health authorities of the people’s government at the county level to handle it, the health authorities that receive the request shall take necessary emergency measures, report to the people’s government at the same level in time, and transfer it to the health authorities of the people’s government at the next higher level for handling.
Article 45 The identification of abnormal reaction to vaccination shall be carried out with reference to the Regulations on Handling Medical Accidents, and the specific measures shall be formulated by the competent health department of the State Council in conjunction with the drug supervision and administration department of the State Council.
Article 46 If the abnormal reaction to vaccination causes the death, serious disability or organ and tissue damage of the recipient, a one-time compensation shall be given.
If it is necessary to compensate the recipients for the abnormal reaction of vaccination caused by vaccination of the first kind of vaccine, the compensation expenses 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 funds for vaccination work. If it is necessary to compensate the recipients for the abnormal reaction caused by vaccination of the second kind of vaccine, the compensation expenses shall be borne by the relevant vaccine production enterprises. The state encourages the establishment of a mechanism to compensate the recipients of abnormal vaccination reactions through commercial insurance and other forms.
Specific compensation measures for abnormal reactions to vaccination shall be formulated by the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government.
Article 47 If the unqualified vaccine quality causes damage to the recipients, it shall be handled in accordance with the relevant provisions of the Drug Administration Law; If the vaccination unit violates the vaccination work norms, immunization procedures, guiding principles for vaccine use and vaccination scheme, it shall be handled in accordance with the relevant provisions of the Regulations on Handling Medical Accidents.
Chapter VI Supervision and Administration
Article 48 The pharmaceutical supervisory and administrative department shall, in accordance with the relevant provisions of the Drug Administration Law and its implementing regulations, supervise and inspect the quality of vaccines in storage, transportation, supply, sale, distribution and use, and report the inspection results to the health authorities at the same level in a timely manner. If the pharmaceutical supervisory and administrative department conducts spot checks on vaccines according to the needs of supervision and inspection, the relevant units and individuals shall cooperate and shall not refuse.
Article 49 In the supervision and inspection, the drug supervision and administration department may take measures of sealing up and detaining vaccines and related materials that are proved to be harmful to human health, and make a decision on handling them within 7 days; If the vaccine needs to be tested, it shall make a decision within 15 days from the date of issuance of the test report.
Disease prevention and control institutions, inoculation entities and vaccine production enterprises shall immediately stop inoculation, distribution, supply and sale of fake or inferior vaccines, and immediately report to the health authorities and drug supervision and administration departments of the people’s governments at the county level where they are located, and shall not handle them by themselves. The competent health department receiving the report shall immediately organize the disease prevention and control institutions and inoculation units to take necessary emergency measures and report to the superior health department at the same time; The pharmaceutical supervisory and administrative department that receives the report shall take measures such as sealing up and detaining fake or inferior vaccines according to law.
Article 50 The competent health departments of the people’s governments at or above the county level shall perform the following duties of supervision and inspection within the scope of their respective duties:
(a) to supervise and inspect the implementation of the national immunization program in medical and health institutions;
(two) to supervise and inspect the propaganda, training and technical guidance related to vaccination carried out by the disease prevention and control institutions;
(three) to supervise and inspect the distribution and purchase of vaccines by medical and health institutions.
The competent health department shall perform the duties of supervision and management mainly by inspecting the records of vaccine distribution, storage, transportation and inoculation made by medical and health institutions in accordance with the provisions of these regulations; When necessary, on-site supervision and inspection can be carried out. The competent department of health shall record the situation of supervision and inspection, and shall order the relevant units to correct it immediately if illegal acts are found.
Article 51 When performing the duties of supervision and inspection according to law, the staff of the competent department of health and the drug supervision and administration department shall not be less than 2, and shall produce the certification documents; The business secrets of the inspected person shall be kept confidential.
Article 52 When the health authorities and drug supervision and administration departments find vaccine quality problems, abnormal reactions to vaccination and other situations, they should inform each other in time to realize information sharing.
Article 53 Any unit or individual has the right to report violations of the provisions of these Regulations to the competent health department and the pharmaceutical supervisory and administrative department, and to report to the relevant departments of the people’s government at the corresponding level and the people’s government at a higher level that the competent health department and the pharmaceutical supervisory and administrative department fail to perform their supervisory and administrative duties according to law. The relevant people’s governments, health authorities and drug supervision and administration departments that have received the report shall promptly verify and handle the report.
Article 54 The state establishes a whole-course traceability system for vaccines. The drug supervision and administration department of the State Council shall, jointly with the health authorities of the State Council, formulate a unified technical specification for vaccine traceability system.
Vaccine production enterprises, disease prevention and control institutions, and inoculation entities shall establish a vaccine traceability system in accordance with the provisions of the Drug Administration Law, these Regulations, the drug supervision and administration department of the State Council and the competent health department, truthfully record the circulation and use information of vaccines, and realize the traceability of the whole process of production, storage, transportation and use of vaccine minimum packaging units.
The drug supervision and administration department of the State Council and the health administrative department of the State Council shall establish a whole-course traceability cooperation mechanism for vaccines.
Article 55 Disease prevention and control institutions and inoculation entities shall truthfully register vaccines whose packaging is unrecognizable, beyond the validity period, out of the cold chain, unqualified after inspection, and of unknown origin, and report to the pharmaceutical supervisory and administrative department of the local people’s government at the county level, which shall, jointly with the competent health department at the same level, supervise the destruction according to regulations. Disease prevention and control institutions and vaccination units shall truthfully record the destruction, and the destruction records shall be kept for not less than 5 years.
Chapter VII Legal Liability
Article 56 The health administrative department and drug supervision and administration department of the people’s government at or above the county level, in violation of the provisions of this Ordinance, shall be ordered to make corrections by the people’s government at the corresponding level, the health administrative department of the people’s government at a higher level or the drug supervision and administration department, informed criticism; If it causes personal injury to the recipient, the spread and epidemic of infectious diseases or other serious consequences, the directly responsible person in charge and other directly responsible personnel shall be punished according to law; If the consequences are particularly serious, the principal responsible person shall also take the blame and resign; If the case constitutes a crime, criminal responsibility shall be investigated according to law:
(a) failing to perform the duties of supervision and inspection in accordance with the provisions of these regulations, or failing to investigate and deal with illegal acts in time;
(2) Failing to timely verify and handle the report that the lower-level health authorities and drug supervision and administration departments fail to perform their supervisory and administrative duties;
(3) Failing to immediately organize the investigation and handling after receiving relevant reports of abnormal reactions or suspected abnormal reactions to vaccination;
(four) unauthorized mass vaccination;
(five) other dereliction of duty in violation of these regulations.
Article 57 If the people’s governments at or above the county level fail to perform the duties of vaccination protection in accordance with the provisions of these regulations, the people’s governments at higher levels shall order them to make corrections, informed criticism; Causing the spread, epidemic or other serious consequences of infectious diseases, the directly responsible person in charge and other directly responsible personnel shall be punished according to law; In areas where particularly serious vaccine quality and safety incidents have occurred or where serious vaccine quality and safety incidents have occurred continuously, the main person in charge of the people’s government should also take the blame and resign; If a crime is constituted, criminal responsibility shall be investigated according to law.
Article 58 In any of the following circumstances, the disease prevention and control institution shall be ordered by the competent health department of the people’s government at or above the county level to make corrections, and informed criticism shall give a warning; Illegal income, confiscate the illegal income; Refuses to correct, the main person in charge, the directly responsible person in charge and other directly responsible personnel shall be given a warning to demotion:
(1) Failing to distribute Class I vaccines to lower-level disease prevention and control institutions, inoculation units and township-level medical and health institutions according to the use plan;
(2) Failing to establish and keep records of vaccine purchase, storage, distribution and supply in accordance with regulations;
(3) Failing to ask for temperature monitoring records in accordance with regulations when receiving or purchasing vaccines, receiving or purchasing vaccines that do not meet the requirements, or failing to report in accordance with regulations.
Township medical and health institutions that fail to distribute Class I vaccines to village medical and health institutions that undertake vaccination work in accordance with the provisions of these Regulations shall be punished in accordance with the provisions of the preceding paragraph.
Article 59 In any of the following circumstances, the competent health department of the local people’s government at the county level shall order it to make corrections and give a warning; Refuses to correct, the main person in charge, the directly responsible person in charge shall be given a warning to demotion, and the responsible medical and health personnel shall be ordered to suspend their practice activities for more than 3 months and less than 6 months:
(1) Failing to ask for temperature monitoring records in accordance with regulations when receiving or purchasing vaccines, receiving or purchasing vaccines that do not meet the requirements, or failing to report in accordance with regulations;
(2) Failing to establish and keep a true and complete record of vaccine receipt or purchase in accordance with regulations;
(3) Failing to publicize the varieties and inoculation methods of the first class vaccine in a prominent position in its inoculation place;
(four) before the vaccination, the medical and health personnel did not inform or ask the recipients or their guardians about the situation in accordance with the provisions of these regulations;
(five) the medical and health personnel who carried out vaccination did not fill in and keep the vaccination records in accordance with the regulations;
(six) failing to register and report the vaccination in accordance with the provisions.
Article 60 Disease prevention and control institutions and vaccination units shall be ordered to make corrections and given a warning by the competent health department of the local people’s government at or above the county level in any of the following circumstances; Illegal income, confiscate the illegal income; Refuses to correct, the main person in charge, the directly responsible person in charge and other directly responsible personnel shall be given a warning to dismissal; If personal injury or other serious consequences are caused to the seed recipients, the main person in charge and the directly responsible person in charge shall be dismissed according to law, and the original license-issuing department shall revoke the practice certificate of the responsible medical and health personnel; If the case constitutes a crime, criminal responsibility shall be investigated according to law:
(a) in violation of the provisions of this Ordinance, not through the provincial public resources trading platform to purchase vaccines;
(two) in violation of the provisions of this Ordinance, from the vaccine production enterprises, county-level disease prevention and control institutions outside the units or individuals to buy the second kind of vaccine;
(three) vaccination did not comply with the vaccination work norms, immunization procedures, vaccine use guidelines, vaccination programs;
(4) Failing to deal with or report the abnormal reaction or suspected abnormal reaction of vaccination in time according to the regulations;
(five) unauthorized mass vaccination;
(6) Failing to register and report vaccines whose packages are unrecognizable, have expired, are out of the cold chain, fail to meet the standards after inspection, and have unknown sources, or failing to record the destruction in accordance with regulations.
Article 61 Disease prevention and control institutions, vaccination units in the process of vaccine distribution, supply and vaccination in violation of the provisions of this Ordinance to collect fees, by the local health administrative department of the people’s government at the county level to supervise the illegal collection of fees returned to the original payment units or individuals, and by the price administrative department of the people’s government at or above the county level shall be punished according to law.
Article 62 If a drug inspection agency issues a false vaccine inspection report, it shall be punished in accordance with the provisions of Article 86 of the Drug Administration Law.
Article 63 Vaccine production enterprises that fail to establish and keep vaccine sales records in accordance with regulations shall be punished in accordance with the provisions of Article 78 of the Drug Administration Law.
Article 64 If the vaccine production enterprise fails to indicate the word "free" and the special logo of "immunization program" on the minimum outer packaging of vaccines included in the national immunization program in accordance with the regulations, the pharmaceutical supervisory and administrative department shall order it to make corrections and give a warning; Those who refuse to make corrections shall be fined between 5,000 yuan and 20,000 yuan, and the relevant vaccines shall be sealed.
Article 65 If a vaccine production enterprise sells the second kind of vaccine to units or individuals other than the county-level disease prevention and control institutions, the drug supervision and administration department shall confiscate the illegally sold vaccine and impose a fine of more than 2 times and less than 5 times the value of the illegally sold vaccine; Illegal income, confiscate the illegal income; The directly responsible person in charge and other directly responsible personnel shall not engage in drug production and business activities within 5 years; If the circumstances are serious, the qualification for vaccine production or the certificate of approval for vaccine import shall be revoked according to law, and the directly responsible person in charge and other directly responsible personnel shall not engage in drug production and business activities within 10 years; If a crime is constituted, criminal responsibility shall be investigated according to law.
Article 66 Disease prevention and control institutions, vaccination units, vaccine production enterprises, and enterprises entrusted with the distribution of vaccines fail to store and transport vaccines under the prescribed cold storage conditions, and the pharmaceutical supervisory and administrative department shall order them to make corrections, give them a warning, and destroy the vaccines stored and transported; By the competent department of health of disease prevention and control institutions, vaccination units, the main person in charge, the directly responsible person in charge and other directly responsible personnel shall be given a warning to dismissal according to law, resulting in serious consequences, shall be given the punishment of dismissal according to law, and the vaccination qualification of the vaccination unit shall be revoked; The pharmaceutical supervisory and administrative department shall, according to law, order vaccine production enterprises and enterprises entrusted to distribute vaccines to stop production and suspend business for rectification, and impose a fine of more than 2 times and less than 5 times the value of vaccines stored and transported in violation of regulations, thus causing serious consequences, the vaccine production qualification shall be revoked or the vaccine import approval documents shall be revoked according to law, and the directly responsible person in charge and other directly responsible personnel shall not engage in pharmaceutical production and business activities within 10 years; If a crime is constituted, criminal responsibility shall be investigated according to law.
Article 67 In violation of the provisions of these regulations, the health authorities of the people’s government at the county level in the place where it is located or where the behavior occurs shall order it to eliminate the influence through the mass media and give a warning; Illegal income, confiscate the illegal income, and impose a fine of more than 1 times and less than 3 times the illegal income; If a crime is constituted, criminal responsibility shall be investigated according to law.
Article 68 Those who engage in vaccination work without being designated by the competent health department according to law shall be ordered to make corrections and given a warning by the competent health department of the people’s government at the county level where the act occurred; Illegally held vaccines shall be confiscated; Illegal income, confiscate the illegal income; Refuses to correct, the main person in charge, the directly responsible person in charge and other directly responsible personnel shall be given a warning and demotion according to law.
Article 69 When children enter kindergartens and schools, nursery institutions and schools fail to check vaccination certificates in accordance with regulations, or fail to report to disease prevention and control institutions or vaccination units after discovering children who have not been vaccinated in accordance with regulations, the education departments of local people’s governments at or above the county level shall order them to make corrections and give them a warning; Refuses to correct, the principal responsible person, the directly responsible person in charge and other directly responsible personnel shall be punished according to law.
Article 70 In violation of the provisions of these regulations, units or individuals other than vaccine production enterprises and county-level disease prevention and control institutions engage in vaccine business shall be punished by the pharmaceutical supervisory and administrative department in accordance with the provisions of Article 72 of the Drug Administration Law.
Article 71 Units or individuals other than health authorities, disease prevention and control institutions and vaccination units who carry out mass vaccination in violation of the provisions of this Ordinance shall be ordered by the health authorities of the people’s governments at or above the county level to make immediate corrections, confiscate the illegally held vaccines and impose a fine of more than 2 times and less than 5 times the value of the illegally held vaccines; If there are illegal gains, the illegal gains shall be confiscated.
Article 72 Units and individuals who violate the provisions of these regulations and cause damage to the person and property of the seed recipients shall bear civil liability according to law.
Article 73 Whoever, on the grounds of abnormal reaction to vaccination, provokes troubles and disturbs the normal medical order of vaccination units and the identification of abnormal reaction to vaccination shall be given administrative penalties for public security according to law; If a crime is constituted, criminal responsibility shall be investigated according to law.
Chapter VIII Supplementary Provisions
Article 74 The meanings of the following terms in this Ordinance:
National immunization program refers to the planned vaccination among the population according to the vaccine varieties, immunization procedures or vaccination programs determined by the state or provinces, autonomous regions and municipalities directly under the Central Government, in order to prevent and control the occurrence and prevalence of specific infectious diseases.
Cold chain refers to the storage, transportation and refrigeration facilities and equipment equipped to ensure the quality of vaccines from vaccine production enterprises to inoculation units.
General reaction refers to the reaction that occurs after immunization and is caused by the inherent characteristics of the vaccine itself. It will only cause temporary physiological dysfunction to the body, mainly including fever and local redness, and may be accompanied by general discomfort, burnout, loss of appetite, fatigue and other comprehensive symptoms.
Vaccine production enterprises refer to the vaccine production enterprises in China and the agencies designated by overseas vaccine manufacturers that export vaccines to China.
Article 75 Measures for the administration of entry-exit vaccination shall be formulated separately by the national entry-exit inspection and quarantine department.
Article 76 These Regulations shall come into force as of June 1, 2005.
