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Management Of Vaccine Circulation And Inoculation Regulations

Original Language Title: 疫苗流通和预防接种管理条例

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People's Republic of China promulgated by Decree No. 668

                         
The State Council on the modified vaccine circulation and inoculation Management Ordinance of the decision of the Executive meeting of the State Council on April 13, 2016 129th by, are hereby promulgated and, as of the date of promulgation.
                             Prime Minister Li keqiang

On April 23, 2016, the State Council on amending the decision of the management of vaccine circulation and inoculation regulations

Decision of the State Council on vaccine circulation and inoculation regulations read as follows: First, the tenth amendment: "procurement of vaccines, should be conducted through the trading platform of public resources at the provincial level.



Second, the 15th is revised as follows: "the second vaccine, made by the provincial disease prevention and control institutions in the trading platform for centralized procurement of public resources at the provincial level, by the disease prevention and control institutions at the county level to supply the vaccine manufacturer after purchase to the inoculation of the administrative units. "Vaccine production enterprises shall have direct access to disease prevention and control institutions at county level distribution the second type of vaccine, or delegate to the cold chain storage and transport conditions of distribution.

Entrusted distribution enterprises shall not delegate of the second type of vaccine distribution. "County-level disease prevention and control organizations to vaccine-supply of type II can receive vaccine costs as well as storage and transportation costs. Vaccine fees charged according to the purchase price, storage and transportation costs in accordance with the provisions of the provinces, autonomous regions and municipalities directly under the charge. Fees should be open to the public.

” Third, 16th revised as follows: "CDC, vaccination, vaccine manufacturers, entrusted the distribution of vaccine companies shall comply with the specification for vaccine storage and transportation management, and ensure the quality of vaccines. Vaccine storage and transportation should always be at the required temperature during the whole process the environment may not be out of the cold chain, and regularly monitored, recorded temperatures.

For cold chain transport long, need vaccine distribution to remote areas, the provincial disease prevention and control institutions shall submit a label affixed temperature control requirements. "Vaccine storage, transportation, management of related specifications by the competent health authorities, pharmaceutical supervision and management departments.

” Four, the 17th article is changed to: "in sales of vaccines, the vaccine manufacturers, legally issued by the drug control institution should be provided each batch of biological products inspection or approval certificate and affix corporate seal; sales of imported vaccines, should also provide copies of customs clearance of imported drugs, and stamped with the company seal.



18th five, be modified to: "vaccine production enterprises shall, in accordance with the pharmaceutical administration law and pharmaceutical supervisory and administrative department under the State Council to establish real and complete sales 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 real and complete the purchase, storage, distribution and supply records, tickets, books, cargo, line, and save more than the vaccine is valid for 2 years for reference. CDC received or purchased vaccine should ask for vaccine storage and transportation temperature monitoring and recording of the entire process; not with the whole process temperature monitoring records or does not meet the requirements of temperature control, may not receive or purchase, and should be immediately reported to the pharmaceutical supervisory and administrative departments, health departments.

” Six article 23rd, amended to read: "vaccination against units receiving a first class or purchase a second type of vaccine should ask for vaccine storage and transportation temperature monitoring and recording of the entire process, establish and maintain true and complete receipt, purchase records, tickets, books, cargo, line. Cannot provide the whole process temperature monitoring records or does not meet the requirements of temperature control, vaccination may not receive or purchase, and should be immediately to the local people's Governments at the county level and drug supervision and administration departments, health authorities report.

” Seven, the 25th article modified as follows: "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, record vaccine type, manufacturer, the smallest packaging unit identification information, expiry date, inoculation time, implementation of vaccination of health workers, by species, and so on. Immunization record kept for not less than 5 years.

” 46th article eight, be modified to: "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. Encouraged, through commercial insurance and other forms of preventive vaccination by the mechanism for compensation.

” Article nine, the 52nd is revised as follows: "health authorities, pharmaceutical supervisory and administrative departments found the vaccine quality problems and preventive vaccination, as well as other information, shall promptly inform each other, and share information.

” Ten, add one, as the 54th: "national vaccine traceability system established.

Pharmaceutical supervisory and administrative departments of the State Council in conjunction with the Department of health vaccine tracking system of unified technical specifications.

"Vaccine production, disease control and prevention, vaccination unit shall, in accordance with the pharmaceutical administration law, this Ordinance and the pharmaceutical supervisory and administrative departments, provides for the establishment of Health Department vaccine tracking system record of vaccine distribution and use of information to achieve minimum packing units of vaccine production, storage, transport, traceability of the whole process. "The drug regulatory agency of the State Council in conjunction with the health authorities to establish vaccine back collaboration mechanisms.

” Cheung added, as the 55th: "CDC, vaccination unit of packaging is not recognized, expired, out of the cold chain, by not meeting the standard, vaccine sources, shall be registered accurately, reporting to the drug regulatory Department of people's Governments at the County, by the pharmaceutical supervisory and administrative departments of the people's Governments at the county level health authorities in accordance with the provisions for the monitoring of the destruction. CDC, vaccination should faithfully record the destruction, destruction of records kept for not less than 5 years.

” 12, and will 54th article to 56th article, modified for: "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 or 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 disposition; caused special serious consequences of,

The main person in charge should resign; constitutes a crime, criminal responsibility shall be investigated in accordance with law:

"(A) has not been checked in accordance with the provisions of this Ordinance in discharging its oversight responsibilities, or found the violations do not promptly investigated;

"(B) does not verify in a timely manner, on the lower level health authorities, pharmaceutical supervision and Management Department reported failure to perform duties of supervision and administration;

"(C) receiving found that preventive vaccination or suspected reports of preventive vaccination, no immediate investigation;

"(D) went ahead with mass vaccinations; "(E) other misfeasance, malfeasance in contravention of this Ordinance.

” 13, and will 55th article to 57th article, modified for: "County above Government not in accordance with this Ordinance provides perform prevention vaccination guarantees duties of, by superior Government ordered corrected, informed criticism; caused 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 disposition; occurred special serious of vaccine quality security event or continuous occurred serious of vaccine quality security event of area, its Government main head also should resigned Constitutes a crime, criminal responsibility shall be investigated according to law.



14, and will 56th article to 58th article, first paragraph modified for: "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 to downgraded of disposition:

"(A) is not in accordance with the plan to distribute the first vaccine to use lower-level disease prevention and control institutions, units, medical and health institutions at the township level of vaccination;

"(B) fails to comply with requirements to establish and preserve the vaccine purchase, storage, distribution and supply records; "(C) receiving or buying vaccines without ask for temperature monitoring and recording in accordance with the provisions of, receiving, purchasing vaccine that does not meet the requirements, or not in accordance with the provisions of the report.



XV, and will 57th article to 59th article, modified for: "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 to downgraded of disposition, on has responsibility of medical health personnel ordered suspended 3 months above 6 months following of practice industry activities:

"(A) receiving or buying vaccines without ask for temperature monitoring and recording in accordance with the provisions of, and receiving, purchasing vaccine that does not meet the requirements, or not in accordance with the provisions of the report;

"(Ii) not in accordance with the provisions establish and maintain true and complete record of the vaccine received or purchased;

"(C) is not in its first vaccine inoculation sites prominently publicized and inoculation procedures;

"(D) the medical and health care personnel in the former, is not in accordance with the provisions of this Regulation inform the situation, ask how kind or their guardians;

"(E) the implementation of vaccination of health personnel in accordance with the provisions to fill in and save your vaccination records; "(Vi) not in accordance with the provisions for registration and to report on the situation of vaccination.

” 16, and will 58th article to 60th article, modified for: "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 to dismissed of disposition; caused by species who personal damage or other serious consequences of, on main head, and

Managers directly responsible shall be subject to punishment by expulsion and revoked by the original licensing departments responsible for health care professionals practising certificate constitutes a crime, criminal responsibility shall be investigated in accordance with law:

"(A) in violation of the provisions of this Ordinance, no provincial public resources through the trading platform of purchasing vaccine;

"(B) violation of the provisions of this Ordinance, from vaccine manufacturers, the county-level disease prevention and control institutions of unit or individual purchases a second kind of vaccine;

"(C) vaccination specification for non-compliance with vaccination, immunization programs, vaccine, vaccination programmes using guiding principles;

"(D) found that vaccination abnormal reaction in preventive vaccination or is suspected, is not in accordance with the provisions of or reports in a timely manner;

"(E) went ahead with mass vaccinations; "(F) is not in accordance with the provisions of the packaging cannot be identified, expired, out of the cold chain, by not meeting the standard, with unidentified vaccine registration, reporting, or not in accordance with the provisions of records destruction.

” 17, the 61st to 63rd and amended as: "the vaccine production enterprise fails to comply with requirements to establish and preserve vaccines sales records, in accordance with the provisions of the drug administration law of the 78th.

” 18, and will 63rd article to 65th article, modified for: "vaccine production enterprise to County disease prevention control institutions yiwai of units or personal sales 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; its directly is responsible for of competent personnel and other directly responsibility personnel 5 years within shall not engaged in drug production business activities; plot serious of, Vaccine production qualification revoked or withdrawn import vaccines approved supporting documents directly in charge of personnel and other persons 10 years engaged in drug production and business activities constitutes a crime, criminal responsibility shall be investigated according to law.

” 19, and will 64th article to 66th article, modified for: "disease prevention control institutions, and vaccination units, and vaccine production enterprise, and accept delegate distribution vaccine of 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; by health competent sector on disease prevention control institutions, and vaccination units of main head, and directly is responsible for of competent personnel and other directly responsibility personnel law give warning to dismissed of disposition, Caused serious consequences of, law give fired of disposition, and revoked vaccination units of vaccination qualification; by drug supervision management sector law ordered vaccine production enterprise, and accept delegate distribution vaccine of enterprise discontinued, and closed reorganization, and at violation provides store, and transport of vaccine goods value amount twice times above 5 times times following of fine, caused serious consequences of, law revoked vaccine production qualification or revoked vaccine imports approved proved file, Directly in charge of personnel and other persons 10 years engaged in drug production and business activities constitutes a crime, criminal responsibility shall be investigated according to law.

” Under article 20, the 68th to 70th and amended as: "the violation of the provisions of this Ordinance, vaccine manufacturers, the county-level disease prevention and control institutions of units or individuals engaged in vaccine, by the pharmaceutical supervisory and administrative department in accordance with the provisions of the drug administration law of the 72nd penalty.

” Under article 21, the 72nd to 74th, one paragraph is added, as the fifth paragraph: "the vaccine manufacturer, is the vaccine production in China's enterprises and China export vaccines vaccine specified by the manufacturer in the country outside of the Agency.

” 22, the addition of an article, as the 75th: "immigration vaccination management measures shall be formulated separately by the State administration for entry-exit inspection and Quarantine Bureau.



23, delete, 12th, 13th, 17th, the second paragraph of article, 33rd and 49th, 62nd in the "vaccine wholesale enterprises."

Under article 24, the 60th to 62nd and "the 87th" amended to read "the 86th".

In addition, the clause order and individual adjustments and changes in the text.

This decision shall come into force as of the date of.



The vaccine circulation and inoculation regulations be revised according to this decision, republished.

Management of vaccine circulation and inoculation regulations

(March 24, 2005 People's Republic of China promulgated by Decree No. 434, released April 23, 2016, the State modified vaccine circulation and inoculation Management Ordinance revision of the decision)

Chapter I General provisions

First in order to strengthen the management of vaccine circulation and inoculation, preventive and control 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.

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. 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.

Chapter II vaccine distribution

Tenth Article procurement of vaccines, should be conducted through the trading platform of public resources at the provincial level. The 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 government procurement contracts with vaccine manufacturers, agreed the vaccine type, quantity, price, and so on.

13th vaccine production enterprises 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 should incorporate into their supply of the minimum package of the national immunization program vaccine 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 agencies should 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.

Article 15th vaccine organized by the provincial disease prevention and control institutions in the trading platform for centralized procurement of public resources at the provincial level, by the disease prevention and control institutions at the county level to supply the vaccine manufacturer after purchase to the inoculation of the administrative units. Vaccine manufacturers should have direct access to disease prevention and control institutions at county level distribution the second type of vaccine, or delegate to the cold chain storage and transport conditions of distribution.

Entrusted distribution enterprises shall not delegate of the second type of vaccine distribution. Disease prevention and control institutions at the county level to vaccine-supply of type II can receive vaccine costs as well as storage and transportation costs. Vaccine fees charged according to the purchase price, storage and transportation costs in accordance with the provisions of the provinces, autonomous regions and municipalities directly under the charge.

Fees should be open to the public. 16th CDC, vaccination, vaccine manufacturers, entrusted the distribution of vaccine companies shall comply with the specification for vaccine storage and transportation management, and ensure the quality of vaccines. Vaccine storage and transportation should always be at the required temperature during the whole process the environment may not be out of the cold chain, and regularly monitored, recorded temperatures.

For cold chain transport long, need vaccine distribution to remote areas, the provincial disease prevention and control institutions shall submit a label affixed temperature control requirements.

Vaccine storage, transportation, management of related specifications by the competent health authorities, pharmaceutical supervision and management departments.

17th vaccine production 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; sales of imported vaccines, should also provide copies of customs clearance of imported drugs, and stamped with the company seal.

CDC, vaccination unit receiving or purchasing vaccine, should be obtained from the vaccine manufacturers documents provided for in the preceding paragraph, and save more than the vaccine is valid for 2 years for reference.

18th vaccine production enterprises shall, in accordance with the pharmaceutical administration law and pharmaceutical supervisory and administrative department under the State Council to establish real and complete sales 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 real and complete the purchase, storage, distribution and supply records, tickets, books, cargo, line, and save more than the vaccine is valid for 2 years for reference.

CDC received or purchased vaccine should ask for vaccine storage and transportation temperature monitoring and recording of the entire process; not with the whole process temperature monitoring records or does not meet the requirements of temperature control, may not receive or purchase, and should be immediately reported to the pharmaceutical supervisory and administrative departments, health departments.

Chapter III vaccination

19th vaccination in health authorities under the State Council shall formulate, publish job specification, and is based on the 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;

(B) through county health departments organize professional training and examination of inoculated qualified licensed physicians, physician assistants, nurse practitioners and rural doctors;

(C) 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. 23rd units received the first vaccine inoculation or purchase a second type of vaccine should ask for vaccine storage and transportation temperature monitoring and recording of the entire process, establish and maintain true and complete receipt, purchase records, tickets, books, cargo, line.

Cannot provide the whole process temperature monitoring records or does not meet the requirements of temperature control, vaccination may not receive or purchase, and should be immediately to the local people's Governments at the county level and drug supervision and administration departments, health authorities report.

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.

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, record vaccine type, manufacturer, the smallest packaging unit identification information, expiry date, inoculation time, implementation of vaccination of health workers, by species, and so on.

Immunization record kept for not less than 5 years.

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 children's 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 related content of the 25th article of the 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.

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.

The 33rd State health departments or 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 manufacturers.

Chapter fourth safeguard

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 financial arrangements for funding should be earmarked 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

Unusual reaction of vaccination in 40th, 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 following circumstances don't belong to the preventive vaccination:

(A) the general reaction after vaccination due to vaccine characteristics;

(B) the damage caused by substandard vaccines for the species;

(C) the specification for vaccinations in violation of vaccination, immunization programs, guiding principles for use of the vaccine, vaccination programmes for the kinds of damage;

(D) who at the time of vaccination in some disease incubation period or prodromal stage, coupling onset after vaccination;

(E) specification of the who vaccine inoculation taboos, 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 exacerbations;

(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.

Encouraged, through commercial insurance and other forms of preventive vaccination by the mechanism for compensation.

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 vaccines 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.

In drug supervision and management in supervision and inspection of the 49th article, 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, shall from the date of inspection reports issued in the 15th made a decision. Disease control and prevention, vaccination, vaccine manufacturers find counterfeit or of questionable quality vaccine, 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 health authorities above the county level people's Governments shall perform the following duties of supervision and inspection within their respective mandates:

(A) for medical and health institutions supervise and inspect the implementation of the national programme on immunization;

(B) for disease prevention and control agencies to carry out vaccination-related advocacy, training, technical guidance, supervision and inspection;

(Iii) the distribution and purchase of vaccines for medical and health institutions supervision and inspection. 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, and share information. 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. 54th national vaccine traceability system established.

Pharmaceutical supervisory and administrative departments of the State Council in conjunction with the Department of health vaccine tracking system of unified technical specifications.

Vaccine production, disease control and prevention, vaccination unit shall, in accordance with the pharmaceutical administration law, this Ordinance and the pharmaceutical supervisory and administrative departments, provides for the establishment of Health Department vaccine tracking system record of vaccine distribution and use of information to achieve minimum packing units of vaccine production, storage, transport, traceability of the whole process.

Pharmaceutical supervisory and administrative departments of the State Council in conjunction with the health authorities to establish vaccine back collaboration mechanisms. 55th disease control and prevention, vaccination unit of packaging is not recognized, expired, out of the cold chain, by not meeting the standard, vaccine sources, shall be registered accurately, reporting to the drug regulatory Department of people's Governments at the County, by the pharmaceutical supervisory and administrative departments of the people's Governments at the county level health authorities in accordance with the provisions for the monitoring of the destruction.

CDC, vaccination should faithfully record the destruction, destruction of records kept for not less than 5 years.

The seventh chapter legal liability 56th 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 or 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 disposition; caused special serious consequences of, its main head also should resigned

Constitutes a crime, criminal responsibility shall be investigated in accordance with law:

(A) has not been checked in accordance with the provisions of this Ordinance in discharging its oversight responsibilities, or found the violations do not promptly investigated;

(B) fails to verify, on the lower level health authorities, pharmaceutical supervision and Management Department reported failure to perform duties of supervision and administration;

(C) receiving found that preventive vaccination or suspected reports of preventive vaccination, no immediate investigation;

(D) carrying out mass vaccination;

(E) other misfeasance, malfeasance in contravention of this Ordinance.

57th article County above Government not in accordance with this Ordinance provides perform prevention vaccination guarantees duties of, by superior Government ordered corrected, informed criticism; caused 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 disposition; occurred special serious of vaccine quality security event or continuous occurred serious of vaccine quality security event of area, its Government main head also should resigned; constitute crime of, law held criminal.

Article 58th of the disease prevention and control institutions in any of the following circumstances, the people's Governments above the county level health authorities ordered corrective action and informed criticism and give a warning; has illegally obtained, confiscation of illegal income; it refuses, directly responsible for directors, managers and other persons directly responsible shall be given a warning to downgrade penalties:

(A) is not in accordance with the plan to distribute the first vaccine to use lower-level disease prevention and control institutions, units, medical and health institutions at the township level of vaccination;

(B) fails to comply with requirements to establish and preserve the vaccine purchase, storage, distribution and supply records;

(C) receiving or buying vaccines without ask for temperature monitoring and recording in accordance with the provisions of, and receiving, purchasing vaccine that does not meet the requirements, or not in accordance with the provisions of the report.

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.

59th vaccination unit, one of the following circumstances, the local people's Governments at the county level health authorities be ordered to correct and give a warning; it refuses, principals, managers directly responsible shall be given a warning to downgrade penalties, the responsible medical officer suspended for more than 3 months to 6 months of practice:

(A) receiving or buying vaccines without ask for temperature monitoring and recording in accordance with the provisions of, and receiving, purchasing vaccine that does not meet the requirements, or not in accordance with the provisions of the report;

(B) fails to comply with regulations establish and maintain true and complete record of the vaccine received or purchased;

(C) is not in its first vaccine inoculation sites prominently publicized and inoculation procedures;

(D) the medical and health care personnel in the former, is not in accordance with the provisions of this Regulation inform the situation, ask how kind or their guardians;

(E) implementation of vaccination of health personnel in accordance with the provisions to fill in and save your vaccination records;

(Vi) not in accordance with the provisions for registration and to report on the situation of vaccination. 60th 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 to dismissed 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 fired of disposition,

And by the Department responsible for issuing certificate of practice of health professionals constitutes a crime, criminal responsibility shall be investigated in accordance with law:

(A) in violation of the provisions of this Ordinance, no provincial public resources through the trading platform of purchasing vaccine;

(B) violation of the provisions of this Ordinance, from vaccine manufacturers, the county-level disease prevention and control institutions of unit or individual purchases a second kind of vaccine;

(C) vaccination specification for non-compliance with vaccination, immunization programs, vaccine, vaccination programmes using guiding principles;

(D) preventive vaccination is found or suspected preventive vaccination, is not in accordance with the provisions of or reports in a timely manner;

(E) carrying out mass vaccination;

(Vi) not in accordance with the provisions of packaging is not recognized, expired, out of the cold chain, by not meeting the standard, with unidentified vaccine registration, reporting, or not in accordance with the provisions of records destruction.

61st 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.

62nd drug Inspection Agency inspection report of false vaccines, in accordance with the provisions of the drug administration law of the 86th.

63rd vaccine production enterprise fails to comply with requirements to establish and preserve vaccines sales records, in accordance with the provisions of the drug administration law of the 78th.

64th vaccine production enterprise fails to comply with minimum required to be incorporated into the national programme on immunization vaccine 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, fined not more than 5000 Yuan and 20,000 yuan, and seal the related vaccines. 65th article vaccine production enterprise to County disease prevention control institutions yiwai of units or personal sales 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; its directly is responsible for of competent personnel and other directly responsibility personnel 5 years within shall not engaged in drug production business activities; plot serious of, law revoked vaccine production qualification or revoked vaccine imports approved proved file,

Directly in charge of personnel and other persons 10 years engaged in drug production and business activities constitutes a crime, criminal responsibility shall be investigated according to law. 66th article disease prevention control institutions, and vaccination units, and vaccine production enterprise, and accept delegate distribution vaccine of 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; by health competent sector on disease prevention control institutions, and vaccination units of main head, and directly is responsible for of competent personnel and other directly responsibility personnel law give warning to dismissed of disposition, caused serious consequences of, law give fired of disposition

, And revoked vaccination units of vaccination qualification; by drug supervision management sector law ordered vaccine production enterprise, and accept delegate distribution vaccine of enterprise discontinued, and closed reorganization, and at violation provides store, and transport of vaccine goods value amount twice times above 5 times times following of fine, caused serious consequences of, law revoked vaccine production qualification or revoked vaccine imports approved proved file, its directly is responsible for of competent personnel and other directly responsibility personnel 10 years within shall not engaged in drug production business activities; constitute crime of, law held criminal.

67th 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 proceeds and illegal gains more than 1 time 3 times times the fine constitutes a crime, criminal responsibility shall be investigated according to law.

68th 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.

69th 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.

70th in violation of the provisions of this Ordinance, vaccine manufacturers, the county-level disease prevention and control institutions of units or individuals engaged in vaccine, by the pharmaceutical supervisory and administrative department in accordance with the provisions of the drug administration law of the 72nd penalty.

71st 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.

72nd units and individuals in violation of the Ordinance, to the kind of personal or property damage, he shall bear civil liability.

73rd 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.

The eighth chapter supplementary articles

74th in these regulations, the following terms mean:

National immunization program, 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.

Vaccine manufacturer, is the vaccine production in China's enterprises and China export vaccines vaccine specified by the manufacturer in the country outside of the Agency.

75th immigration vaccination management measures shall be formulated separately by the State administration for entry-exit inspection and Quarantine Bureau.

 The 76th article of the regulations come into force on June 1, 2005.