People's Republic of China promulgated by Decree No. 434 of the vaccine circulation and inoculation regulations Executive meeting of the State Council on March 16, 2005 the 83rd through, are hereby promulgated and take effect on June 1, 2005.
March 24, 25, Prime Minister Wen Jiabao vaccine circulation and inoculation Regulations Chapter I General provisions article in order to improve the vaccine circulation and inoculation management, preventing and controlling the outbreak and prevalence of infectious diseases, protection of human health and public health, in accordance with the People's Republic of China Law on drug management (hereinafter referred to as the pharmaceutical administration law) and the People's Republic of China Law on infectious disease prevention and control (hereinafter referred to as law on prevention of infectious diseases), this Ordinance is enacted.
Second vaccine referred to in these regulations refers to in order to prevent and control the outbreak and prevalence of infectious diseases, preventive vaccines and biological products for human vaccination. Vaccines are divided into two categories.
First class vaccine, is refers to Government free to citizens provides, citizens should in accordance with Government of provides by species of vaccine, including national immune planning determine of vaccine, province, and autonomous regions, and municipalities Government in implementation national immune planning Shi increased of vaccine, and County above Government or its health competent sector organization of emergency vaccination or group prevention vaccination by using of vaccine; second class vaccine, is refers to by citizens at their own expense and voluntary by species of other vaccine. Article the first vaccine costs are borne by the Government.
A second kind of vaccine by a species or their guardians bear the cost.
Article fourth vaccine circulation and inoculation, supervision and management of the application of this regulation.
Article fifth health authorities under the State Council according to a nationwide epidemic, population immunity status and other factors, development of national immunization programmes; in conjunction with the financial sector the development types of vaccines into national immunization programmes, announced after the approval of the State Council.
People's Governments of provinces, autonomous regions and municipalities in the implementation of the national immunization plan, according to the administrative factors such as the prevalence of infectious diseases, the immune status of people, you can increase the type of vaccine to be provided free of charge to citizens, and report to the health authorities under the State Council for the record.
Sixth State practices systematic vaccination system, the implementation of the expanded programme on immunization.
Needed per species should be immunized against first class in accordance with the provisions of this Ordinance by species per species for minors, the guardian should fit in with the disease prevention and control institutions and medical institutions, medical institutions, guarantee the kinds of species in a timely manner. Article seventh health authorities under the State Council is responsible for supervision and administration of the national vaccination.
Local people's Governments at or above the county level health authorities responsible for the administration of vaccination in supervision and management. Pharmaceutical supervisory and administrative departments of the State Council in charge of the national vaccine quality and supervision and administration of circulation.
The provinces, autonomous regions and municipalities within the pharmaceutical supervisory and administrative department responsible for the administration of vaccine quality and supervision and administration of circulation. Article eighth by the County Health Department medical and health institutions in accordance with the provisions of this Ordinance specified (hereinafter referred to as vaccination), vaccination.
County health authorities specify immunization unit, must be clear about its area of responsibility.
The people's Governments above the county level shall take vaccination work and made remarkable achievements and the contribution of inoculated gives awards to units and their staff. Nineth State support, encourage units and individuals to participate in vaccination.
Governments at all levels should improve the system convenient for units and individuals involved in the vaccination of publicity, education and donation activities. 　
Neighborhood Committee, the villagers ' Committee shall cooperate with the relevant departments and vaccination-related information, education, and assist in organizing residents and villagers first vaccine. Tenth chapter vaccine circulation pharmaceutical wholesale business in accordance with the provisions of this Ordinance could run a vaccine after approval.
Pharmaceutical retail businesses may engage in the vaccine business.
Drug wholesaler applies to engage in the operation of the vaccine, shall satisfy the following conditions: (a) professional and technical personnel engaged in vaccine management and (ii) with cold storage facilities to ensure vaccine quality, equipment and refrigerated transportation; (c) consistent with vaccine storage, transport management and standardized management system.
The provinces, autonomous regions and municipalities directly under the drug regulatory agency of the Government to review the drug wholesale company meets the above conditions; conditions, raise operating in its drug supply certificate vaccines business.
Vaccines business achieved drug wholesale enterprises (hereinafter referred to as vaccine wholesale enterprises), should the cold storage facilities, equipment and refrigerated transportation of regular inspection, maintenance and updates, to ensure that they meet the requirements. 11th provincial disease prevention and control institutions shall, in accordance with the national immunization program and prevention in the region and the need to control the outbreak and prevalence of infectious diseases, developed first vaccine use, local district plan (hereinafter plan), and in accordance with the relevant provisions of the State responsibility for purchasing the first sectoral report for vaccine, and health departments at the same level.
Plans should include vaccines for use of varieties, quantities, supply channels and modes of supply, and so on.
12th first vaccine in accordance with the relevant provisions of the State purchasing departments shall signed with the vaccine manufacturer or vaccine wholesale businesses government procurement contracts, contract vaccine type, quantity, price, and so on.
13th vaccine production enterprise or vaccine wholesale business shall, in accordance with the Government procurement contract the contract, to the provincial disease prevention and control institutions or other specified diseases prevention and control offices supply the first vaccine may not be supplied to other units or individuals. Vaccine manufacturers, wholesale businesses in their supply of vaccine into their national immunization program vaccines the minimum package prominently marked "free" health authorities under the State Council of the "EPI" special identity.
Specific measures by the drug regulatory agency of the State Council in conjunction with the health authorities under the State Council. 14th Provincial disease prevention and control institutions shall distribute the first organization of such vaccines, and plans to distribute the vaccine first class organization to districts, the municipal disease control and prevention agency or county-level disease prevention and control institutions. Disease prevention and control institutions at the county level shall, in accordance with plans to distribute the first vaccine to immunization and health agencies at the township level. Medical and health institutions at the township level should first work distribute vaccines to take vaccinations of village medical institutions.
Medical and health institutions shall not be distributed to other units or individuals first vaccinations distributed the first such vaccine, shall not collect any fees.
Infectious disease outbreaks, epidemics, and above the county level people's Government or the health authorities of emergency vaccination measures need to be taken, districts of the city-level disease prevention and control institutions are directly distributed to vaccination unit first vaccine. 15th vaccine production enterprises can contribute to disease control and prevention, vaccination, vaccines wholesalers sold the production of the second type of vaccine.
Vaccines wholesalers can contribute to disease prevention and control institutions, vaccinated units, other wholesale companies sell the second type of vaccine.
Disease prevention and control institutions at the county level to vaccine-supply of type II; district of the city-level disease prevention and control institutions shall not have direct access to units supply the second vaccine inoculation.
16th CDC, vaccination, vaccine manufacturers, vaccine wholesale business shall comply with the specification for vaccine storage and transportation management, and ensure the quality of vaccines.
Vaccine storage, transportation, management practices by the Department of health under the State Council in conjunction with the pharmaceutical supervisory and administrative department under the State Council.
Article 17th vaccine production, vaccine wholesale enterprises selling vaccine, should be provided by the drug testing agency shall issue each batch of biological products inspection or approval certificate and affix corporate seal; wholesale enterprises engaged in import of vaccines vaccines should also be provided copies of import drugs tongguan Dan, and affix the corporate seal.
CDC, vaccination unit receiving or purchasing vaccines, vaccine production should be enterprise, vaccines wholesalers obtain the proof provided for in the preceding paragraph, and save more than the vaccine is valid for 2 years for reference.
18th vaccine production, vaccine wholesale enterprises shall, in accordance with the drug administration law and pharmaceutical supervisory and administrative department under the State Council, establish real and complete records, and save more than the vaccine is valid for 2 years for reference.
Disease prevention and control institutions shall, in accordance with the health authority under the State Council to establish authentic and complete record of purchasing, distribution, supply, and save more than the vaccine is valid for 2 years for reference.
19th chapter vaccination health authorities under the State Council shall formulate, vaccination published specification, and is based on national standards, according to the infectious diseases epidemiology research information, designed and published into the national programme on immunization vaccine immunization schedule vaccines and other immunization programs or using the guiding principles.
The provinces, autonomous regions, municipalities and health authorities shall, according to State Health Department immunization programs, vaccine guidelines, combined with the administration of epidemic situation of infectious diseases, vaccination programmes of their respective administrative areas, and reported to the health authorities under the State Council for the record.
20th for disease prevention and control institutions at all levels, in accordance with their respective responsibilities, according to the national programme on immunization or vaccination programmes, carry out vaccination-related advocacy, training, technical advice, monitoring, evaluation, epidemiological investigation, emergency response work, and prepare records in accordance with health authorities under the State Council.
21st vaccination units should meet the following conditions: (a) has a medical license to practice, (ii) through county health departments organize professional training and examination of inoculated qualified licensed physicians, physician assistants, nurse practitioners and rural doctors; (c) is consistent with vaccine storage, transportation, management of cold storage facilities, equipment and refrigerated storage system.
Undertake preventive inoculation of urban medical and health institutions shall set up vaccination clinics.
22nd vaccination unit shall be liable for in the region of vaccination, and accepts the seat of county-level disease prevention and control institutions of technical guidance.
Article 23rd units received the first vaccine inoculation or purchase a second type of vaccine, should establish and maintain true and complete receipt, purchase records. Vaccination unit shall work according to the vaccination needs, developed the first vaccine demand plan and a second kind of vaccine purchase plans and county health departments and disease prevention and control institutions at the county level report.

Article 24th vaccinate vaccination unit, shall comply with the specification for vaccination, immunization programs, guiding principles for use of the vaccine and vaccination programmes, and its inoculation sites prominently publicized the first vaccine and inoculation procedures. 25th medical and health care personnel in the implementation of the former shall inform vaccination by the species or their guardians, effects, contraindications, adverse reactions and precautions, ask how health status and the availability of vaccination of the kinds of taboos, and faithfully record the informed and information.
Per species or their guardians should be aware of knowledge about vaccination, and truthfully provide the kind of health and vaccination of those taboos, and so on.
Health professionals meets the conditions for vaccination should be administered by a kind of inoculation, and in accordance with the health authority under the State Council, fill out and save your vaccination records.
Species and by inoculation of taboo and cannot be vaccinated, health personnel should be the kind of person or medical advice to their guardians. 26th national vaccination certificate system of children. Within 1 month after the child is born, his guardian shall live to take the vaccination of children vaccinated for it to carry out the vaccination certificate.
Unit of child inoculation inoculation shall examine the vaccination certificate, and make records.
During the leave the primary residence of the child, borne by the current residence vaccination vaccination units are responsible for the implementation of vaccination.
Vaccination certificate geshiyousheng, autonomous region and municipality Health Department.
27th child daycare, school, kindergarten, schools shall examine the vaccination certificate found not in accordance with the kind of children in national immunization programmes, should be to the local county-level disease prevention and control institutions or places of residence of the child to take vaccination vaccination report, and in line with the CDC or vaccination Unit urged the guardians in child daycare, inoculation time after school to replant.
28th vaccination unit should be residing in its area of responsibility in accordance with the national immunization program vaccine need to be vaccinated in the first class of the kind of vaccination and to meet the requirements of the national immunization programme coverage.
Disease prevention and control agencies should be distributed to vaccination unit the first vaccine in a timely manner.
Who at their own expense or his guardian asked to select the first class of vaccines with vaccine, vaccination units that provide services should inform cost, exception response, compensation, and the contents of the article 25th of this Ordinance. 29th vaccination unit shall, in accordance with the health authority under the State Council to register the vaccination, and to the local county health departments and disease prevention and control institutions at the county level report.
Remaining units after the completion of the national immunization program for the first vaccination vaccine, should be reported to the vaccine distribution unit, and state the reasons.
30th vaccination unit the first such vaccine may not charge any fees.
Vaccination vaccinations vaccine can charge a service fee of the second kind, immunization supplies, specific standards by the seat of the provincial, autonomous regional and municipal people's Government price departments approved. 31st article County above place Government health competent sector according to infectious diseases monitoring and warning information, to prevention, and control infectious diseases of outbreak, and popular, need in this administrative within part area for group prevention vaccination of, should reported by this level Government decided, and to province, and autonomous regions, and municipalities Government health competent sector record; need in province, and autonomous regions, and municipalities administrative all range within for group prevention vaccination of, should by province, and autonomous regions, and Municipalities directly under the Department of health under the people's Governments at the corresponding level decided, and health authorities under the State Council for the record. Needs across the country or across provinces, autonomous regions and municipalities within the scope of mass vaccination, shall be determined by the health authority under the State Council.
Approved the decision of the people's Government or the health authority under the State Council shall organize relevant departments to do staff training, publicity, materials calls and so on.
No units or individuals are not allowed to conduct mass vaccinations.
Article 32nd infectious disease outbreaks, epidemics, and above the county level people's Government or the health authorities of emergency vaccination measures need to be taken, in accordance with communicable disease prevention law and the provisions of the emergency regulations on public health emergency.
33rd health authorities under the State Council, or the provinces, autonomous regions and municipalities health authorities according to the infectious diseases surveillance and early-warning information published a second kind of vaccine information, other any units and individuals shall not be published.
Information should include the recommendations of a second kind of vaccine against infectious diseases prevention knowledge, such as vaccinations and related content, but not relating to a specific vaccine production, vaccine wholesale business.
Fourth chapter safeguards 34th people's Governments above the county level shall be associated with the national immunization program's vaccination work in their respective administrative areas for national economic and social development plan, the vaccination requirements to be guaranteed to ensure vaccination rates required by the national immunization programme, ensure the implementation of the national immunization program.
35th under the people's Governments of provinces, autonomous regions and municipalities of the administrative area of epidemic trend of infectious diseases, at the Health Department to determine infectious disease prevention and control within the scope of the project, their respective administrative areas and vaccination-related projects, and ensure the implementation of the project.
36th people's Governments of provinces, autonomous regions and municipalities to purchase, the requirements for the transportation of such vaccines in their protection, and to ensure in the administrative area of disease prevention and control institutions and vaccination unit construction, operation of the cold chain system.
Countries need to give appropriate support to the vaccination work in poor areas.
37th article of county-level people's Governments shall ensure the implementation of the national programme on immunization vaccination requirements and vaccination in accordance with the relevant provisions of the State engaged in the rural doctors and other primary health care workers give appropriate subsidies.  
   Provinces, autonomous regions and municipalities and municipal people's Governments should be divided into districts for difficult areas of county-level people's Governments and vaccination-related work to give the necessary financial assistance.
38th the people's Governments above the county level shall be responsible for the vaccine and related matériel reserves for the call. 39th levels of funding should be earmarked for financial arrangements for vaccination, no units or individuals shall misappropriate, misuse.
Units and individuals using funds for vaccination shall accept auditing by the auditing departments.
The fifth chapter of preventive vaccination 40th preventive vaccination, refers to the practice for qualified vaccine vaccination process or implementation specification after inoculation caused by damage to body tissues and organs, function, adverse drug reactions of the relevant parties without fault. 41st article following case not belongs to prevention vaccination exception reaction: (a) for vaccine itself characteristics caused of vaccination Hou general reaction; (ii) for vaccine quality not qualified to by species who caused of damage; (three) for vaccination units violation prevention vaccination work specification, and immune program, and vaccine using Guide principles, and vaccination programme to by species who caused of damage; (four) by species who in vaccination Shi are in a species disease of latency or precursor period, vaccination Hou coupled onset; (five) by species who has vaccine manual provides of vaccination taboo,
In the former species or his guardian is not truthfully provide the kind of health situation and taboos of inoculation, vaccination after the original disease acute or recurrent illness; (vi) by psychological factors of individual or groups of psychogenic reactions. 42nd disease control and prevention and vaccination and medical workers found that preventive vaccination, suspected preventive vaccination or to the related reports, in accordance with the vaccination work in time, and to report immediately to the location of the county people's Governments in charge of health sector, the pharmaceutical supervisory and administrative departments.
Reported to health authorities, pharmaceutical supervisory and administrative departments shall immediately organize the investigation process.
Article 43rd local people's Governments at or above the county level health authorities, pharmaceutical supervisory and administrative departments shall occur within the administrative area of the preventive vaccination and treatment of cases, escalation, respectively to health authorities and pharmaceutical supervisory and administrative department under the State Council.
Unusual reaction of vaccination in 44th after a dispute has arisen, the vaccination units or party can request vaccination unit the seat of county health departments.
Due to lead to the kind of vaccination deaths, severe disability or suspected mass preventive vaccination, inoculation or suffering from county health authorities dealing with the kinds of requests, health authorities to deal with requests shall take the necessary emergency measures to promptly report to the people's Governments at the corresponding level, and transferred to government health authorities at a higher level.
Article 45th identification of preventive vaccination in the light of the implementation of the regulation on the handling of medical accidents, and the specific measures formulated by the State Council Department in charge of health in conjunction with the pharmaceutical supervisory and administrative department under the State Council.
Article 46th species due to preventive vaccination deaths, severe disability or organ or tissue damage, should be given lump-sum compensation. Caused by the first vaccine prevent vaccination need to be compensated, compensation paid for by provinces, autonomous regions and municipalities in vaccination funding arrangements in the financial sector.
Caused by a second kind of vaccine prevent vaccination need to be compensated, compensation for costs borne by the vaccine manufacturers.
Preventive vaccination of specific compensation measures for the provinces, autonomous regions and municipalities to develop.
47th due to substandard vaccines for the kinds of damage caused, in accordance with the relevant regulations of the pharmaceutical administration law; specification for vaccinations in violation of vaccination, immunization programs, guiding principles for use of the vaccine, vaccination programmes for the species causing damage to the user, in accordance with the relevant provisions of the regulation on the handling of medical accidents. Supervision and administration of the sixth chapter 48th drug management in drug supervision and management departments in accordance with the relevant provisions of the Act and its implementing regulations, the vaccine during storage, transport, supply, sale, distribution and use of quality supervision and inspection in the link, and check the results to inform health authorities at the same level in a timely manner. Pharmaceutical supervisory and administrative departments under supervision and inspection required to test the vaccine, relevant units and individuals shall cooperate, refuse.

49th in supervision and inspection of drug regulatory authorities, there is evidence that vaccines may harm human health and the relevant material can take seizure, seizure measures and make a decision in the 7th; vaccines require inspection, inspection report is issued shall make a decision within the 15th of. Disease control and prevention, vaccination, vaccine manufacturers wholesale, vaccine companies are finding counterfeit or of questionable quality vaccines, should immediately stop immunization, distribution, supply, sales, and immediately to the local people's Governments at the county level health authorities and pharmaceutical supervisory and Administrative Department report, not themselves.
Received a report of the health authority shall immediately organize the disease prevention and control institutions take the necessary emergency measures and vaccination unit, while reporting to the superior Department in charge of health; pharmaceutical supervisory and administrative departments shall, on receipt of the report the counterfeit or of questionable quality vaccine to take such measures as sealing up, distraining.
50th article County above government health competent sector in their duties range within perform following supervision check duties: (a) on medical health institutions implementation national immune planning of situation for supervision check; (ii) on disease prevention control institutions carried out and prevention vaccination related of publicity, and training, and technical guidance, work for supervision check; (three) on medical health institutions distribution and purchase vaccine of situation for supervision check. Health authorities should be based on medical and health institutions in accordance with the provisions of this Ordinance made by the vaccine distribution, storage, transport and vaccination records, such as inspection, carry out regulatory duties, if necessary, you can make the site supervision and examination.
Health authorities of supervision and inspection should be recorded and found violations, shall order the relevant units immediately corrected.
51st health authorities, pharmaceutical supervisory and Administrative Department staff to perform their duties of supervision and inspection, shall be not less than 2, and produce documents to the examiner's business secrets shall be kept confidential.
52nd drug regulatory agency of public health authorities, found the vaccine quality issues and preventive vaccination, as well as other information, shall promptly inform each other. 53rd any unit and individual have the right to health authorities, pharmaceutical supervision and management departments to report violations of the provisions of this Ordinance, to report to the relevant departments of the people's Government of the people's Governments at the corresponding level, superior health authorities sector, pharmaceuticals supervision and management departments of failing to perform their duties of supervision and management.  
Receives reports of Governments, health authorities, pharmaceutical supervisory and administrative departments of the relevant reports should be verified, processed in a timely manner.
Seventh chapter legal responsibility 54th article County above government health competent sector, and drug supervision management sector violation this Ordinance provides, has following case one of of, by this level Government, and superior government health competent sector, and drug supervision management sector ordered corrected, informed criticism; caused by species who personal damage, infectious diseases spread, and popular or other serious consequences of, on directly is responsible for of competent personnel and other directly responsibility personnel law give administrative sanctions; constitute crime of, law held criminal:
(A) not in accordance with this Ordinance provides perform supervision check duties, or found violations not timely investigation of; (ii) not timely verified, and processing on subordinate health competent sector, and drug supervision management sector not perform supervision management duties of reported of; (three) received found prevention vaccination exception reaction or suspected prevention vaccination exception reaction of related report, not immediately organization survey processing of; (four) unauthorized for group prevention vaccination of; (five) violation this Ordinance of other dereliction of, and malfeasance behavior.
55th the people's Governments above the county level shall not carry out vaccination protection duties in accordance with this Ordinance, by the higher people's Government ordered corrective action and informed criticism; resulting in the spread of infectious diseases, epidemic, or other serious consequences, the managers directly responsible and other persons directly responsible shall be given administrative sanctions constitutes a crime, criminal responsibility shall be investigated according to law.
56th article disease prevention control institutions has following case one of of, by County above government health competent sector ordered corrected, informed criticism, give warning; has illegal proceeds of, confiscated illegal proceeds; refused to corrected of, on main head, and directly is responsible for of competent personnel and other directly responsibility personnel law give warning, and downgraded of disposition: (a) not according to using plans will first class vaccine distribution to subordinate disease prevention control institutions, and vaccination units, and Xiang level medical health institutions of;
(B) District of the city-level disease prevention and control institutions in violation of these regulations directly to the flats of the second type of vaccine inoculation, (c) fails to comply with requirements to establish and preserve the vaccine purchase, distribution, supply records.
Township health institutions is not in accordance with the provisions of this Ordinance will first work distribute vaccines to take vaccinations of village medical institutions, in accordance with the preceding paragraph shall be punished.
57th article vaccination units has following case one of of, by location of County Government health competent sector ordered corrected, give warning; refused to corrected of, on main head, and directly is responsible for of competent personnel law give warning, and downgraded of disposition, on has responsibility of medical health personnel ordered suspended 3 months above 6 months following of practice industry activities: (a) not in accordance with provides established and save real, and full of vaccine received or purchased into records of;
(Ii) not in its vaccination places of significantly location publicity first class vaccine of varieties and vaccination method of; (three) medical health personnel in vaccination Qian, not in accordance with this Ordinance provides told, and asked by species who or its guardian about situation of; (four) implementation prevention vaccination of medical health personnel not in accordance with provides fill in and save vaccination records of; (five) not in accordance with provides on vaccination vaccine of situation for registration and report of. 58th article disease prevention control institutions, and vaccination units has following case one of of, by County above place Government health competent sector ordered corrected, give warning; has illegal proceeds of, confiscated illegal proceeds; refused to corrected of, on main head, and directly is responsible for of competent personnel and other directly responsibility personnel law give warning, and downgraded of disposition; caused by species who personal damage or other serious consequences of, on main head, and directly is responsible for of competent personnel law give dismissed, and fired of disposition,
And by original sent card sector revoked has responsibility of medical health personnel of practice industry certificate: (a) from not has vaccine business qualification of units or personal purchased into second class vaccine of; (ii) vaccination vaccine not comply with prevention vaccination work specification, and immune program, and vaccine using Guide principles, and vaccination programme of; (three) found prevention vaccination exception reaction or suspected prevention vaccination exception reaction, not in accordance with provides timely processing or report of; (four) unauthorized for group prevention vaccination of.
59th CDC, vaccination unit in vaccine distribution, supply and vaccination process, in violation of the provisions of this Ordinance are charged, the local county health departments will be returned to the original charge illegal fees charged by entities or individuals, and by Government price departments above the county level shall be subject to punishment.
60th drug Inspection Agency inspection report of false vaccines, penalty shall be imposed in accordance with the 87th of the pharmaceutical administration law.
61st vaccine production enterprise, wholesale Enterprise fails to comply with requirements to establish and preserve vaccines vaccine sales or purchase and sale records, in accordance with the 79th and 85th of the pharmaceutical administration law shall be punished.
62nd vaccine manufacturers, wholesale Enterprise fails to comply with the provisions of the vaccine into national immunization program vaccine minimum outer packaging marked "free" and "EPI" special identity, by the pharmaceutical supervisory and administrative departments shall be ordered to correct and give a warning; it refuses, and 5000 Yuan and 20,000 yuan fine, and seal the related vaccines. 63rd article vaccine production enterprise, and vaccine wholesale enterprise to disease prevention control institutions, and vaccination units, and vaccine wholesale Enterprise yiwai of units or personal sales second class vaccine, or vaccine wholesale enterprise from not has vaccine business qualification of units or personal purchased into second class vaccine of, by drug supervision management sector confiscated illegal sales of vaccine, and at illegal sales of vaccine goods value amount twice times above 5 times times following of fine; has illegal proceeds of, confiscated illegal proceeds; plot serious of, law revoked vaccine production qualification, and
Vaccine management qualifications. 64th article disease prevention control institutions, and vaccination units, and vaccine production enterprise, and vaccine wholesale enterprise not in provides of refrigerated conditions Xia store, and transport vaccine of, by drug supervision management sector ordered corrected, give warning, on by store, and transport of vaccine be destroyed; disease prevention control institutions, and vaccination units refused to corrected of, by health competent sector on main head, and directly is responsible for of competent personnel and other directly responsibility personnel law give warning, and downgraded of disposition; caused serious consequences of,
By health competent sector on main head, and directly is responsible for of competent personnel and other directly responsibility personnel law give dismissed, and fired of disposition, and revoked vaccination units of vaccination qualification; vaccine production enterprise, and vaccine wholesale Enterprise refused to corrected of, by drug supervision management sector law ordered discontinued, and closed reorganization, and at 5000 Yuan above 20,000 yuan following of fine; caused serious consequences of, law revoked vaccine production qualification, and vaccine business qualification.
65th in violation of the provisions of this Ordinance issued a second vaccine recommended information, the local or county health authorities shall order the removal through the mass media, warning has illegally obtained, confiscation of illegal income, and illegal gains more than 1 time 3 times the following penalty constitutes a crime, criminal responsibility shall be investigated according to law.
66th article without health competent sector law specified unauthorized engaged in vaccination work of, by location or behavior occurred to of County Government health competent sector ordered corrected, give warning; has illegal holds of vaccine of, confiscated illegal holds of vaccine; has illegal proceeds of, confiscated illegal proceeds; refused to corrected of, on main head, and directly is responsible for of competent personnel and other directly responsibility personnel law give warning, and downgraded of disposition. 67th article children nursery, and entrance Shi, kindergarten institutions, and school not in accordance with provides identification prevention vaccination card, or found not in accordance with provides by species of children Hou not to disease prevention control institutions or vaccination units report of, by County above place government education competent sector ordered corrected, give warning; refused to corrected of, on main head, and directly is responsible for of competent personnel and other directly responsibility personnel law give disposition.

68th does not have units or individuals engaged in vaccine vaccine management qualifications, by the pharmaceutical supervisory and administrative department in accordance with the 73rd of the pharmaceutical administration law and punished as such.
69th departments in charge of health, disease prevention and control institutions, vaccination unit outside unit for mass vaccinations or individual in violation of the provisions of this Ordinance, be ordered by the people's Governments above the county level health authorities immediately correct, confiscate the illegal holding of vaccines, and the value of the illegal possession of vaccine more than twice times the amount fined not more than 5 times; has illegally obtained, confiscation of illicit proceeds.
70th units and individuals in violation of the Ordinance, to the kind of personal or property damage, he shall bear civil liability.
71st to prevention by vaccination, to cause trouble, disturbance to normal vaccination unit of medical order and prevention of vaccination identification shall be given administrative penalties for public security constitutes a crime, criminal responsibility shall be investigated according to law.
72nd of the eighth chapter schedule in these regulations, the following terms mean: national immunization programmes, means any States or provinces, autonomous regions and municipalities to determine vaccine, immunization or vaccination programmes, systematic vaccination in the crowd, to specific incidence and prevalence of infectious disease prevention and control.
Cold chain refers to ensure vaccine from vaccine manufacturers to vaccination units running in-process quality and equipment storage, transport refrigeration facilities, and equipment.
The general reaction, refers to occur after vaccination, inherent characteristics caused by the vaccine itself, the body will only lead to a dysfunction of physiological reactions, including fever and redness, and may be accompanied by a general malaise, fatigue, loss of appetite, weakness, the syndrome. 73rd these regulations come into force on June 1, 2005.