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TABLE OF CONTENTS CHAPTER I GENERAL PROVISIONS CHAPTER II CIRCULATION OF VACCINES CHAPTER III INOCULATION WITH VACCINES CHAPTER IV SAFEGUARDING MEASURES CHAPTER V DEALING WITH UNUSUAL RESPONSES TO VACCINATION CHAPTER VI SUPERVISION AND ADMINISTRATION CHAPTER VII LEGAL LIABILITIES CHAPTER VIII SUPPLEMENTARY PROVISIONS CHAPTER I GENERAL PROVISIONS Article 1. This Regulation is formulated in accordance with the Pharmaceutical Administration Law of the People's Republic of China (hereinafter referred to Pharmaceutical Administration Law) and the Law of the People's Republic of China on Prevention and Treatment of Infectious Diseases (hereinafter referred to the Law on Prevention and Treatment of Infectious Diseases) so as to strengthen the administration of circulation and vaccination of vaccines, prevent and control the occurrence and spread of infectious diseases, and guarantee human health and public sanitation. Article 2. Vaccines mentioned in this Regulation shall mean the preventive biotic products of the vaccine type, which are used for human vaccination for the sake of preventing and controlling the occurrence and spread of infectious diseases. Vaccines are divided into two classes. Vaccines of Class 1 shall mean the vaccines provided by the government to citizens free of charge, which shall be vaccinated to citizens in accordance with the government provisions. Vaccines of this class include the vaccines determined in the State's immunity planning, the vaccines added by the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government in the implementation of the State's immunity planning, and the vaccines used in the emergent inoculation or mass vaccination organized by the people's governments at the county level or above or their respective competent health departments. Vaccines of Class 2 shall mean other vaccines with which the citizens are voluntarily inoculated at their own expenses. Article 3. The expenses for inoculation with vaccines of Class 1 shall be borne by the government, while the expenses for inoculation with vaccines of Class 2 shall be borne by the inoculated persons or their respective guardians. Article 4. The circulation and vaccination of vaccines and the supervision and administration thereof shall be governed by this Regulation. Article 5. The competent department of health under the State Council shall, in light of factors such as the spread of infectious diseases within China, the crowd's immunity conditions, etc., formulate the State's immunity planning; and shall, jointly with the department of public finance under the State Council, draft vaccine varieties which are included into the State's immunity planning, and promulgate them upon approval of the State Council. The people's government of the province, autonomous region, or municipality directly under the Central Government may, when implementing the State's immunity planning, increase the vaccine varieties supplied to citizens free of charge in light of factors such as the spread of infectious diseases, the crowd's immunity conditions, etc. within its own administrative region, and report to the competent department of health under the State Council for archival purposes. Article 6. The State applies a planned vaccination system, carries out and enlarges the immunity planning. Those who need to be inoculated with vaccines of Class 1 shall be inoculated in accordance with this Regulation. If the inoculated person is a minor, his guardian shall cooperate with the relevant disease prevention and control institution, medical institution, or other medical and health institution, so as to guarantee the said minor to be inoculated in time. Article 7. The responsibility to supervise and administer the vaccination throughout the country shall remain with the competent department of health under the State Council. The competent health department of the local people's government at the county level or above shall be responsible for supervising and administering the vaccination within its own administrative region. The responsibility to supervise and administer the quality and circulation of vaccines throughout the country shall remain with the drug administration department under the State Council. The drug administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall be responsible for supervising and administering the quality and circulation of vaccines within its own administrative region. Article 8. The medical and health institution designated by the competent health department of a people's government at the county level in accordance with this Regulation (hereinafter referred to the inoculation entity) shall undertake the vaccination work. The competent health department of the people's government at the county level shall, when designating an inoculation entity, clarify the area of its responsibilities. The people's government at the county level or above shall reward the inoculation entities and their personnel who undertake vaccination work and have made prominent achievements and contributions. Article 9. The State supports and encourages entities and individuals to participate in vaccination. The people's government at each level shall improve relevant systems so as to facilitate the entities and individuals to take part in the activities of vaccination work including propaganda, education and donation. Residents' committees and villagers' committees shall cooperate with relevant departments in carrying out the propaganda and education relating to vaccination, and assist in organizing residents and villagers to be inoculated with vaccines of Class 1. CHAPTER II CIRCULATION OF VACCINES Article 10. A pharmaceutical wholesale enterprise may operate vaccines in accordance with this Regulation after it is approved. No pharmaceutical retail enterprise shall engage in vaccine business activities. Where a pharmaceutical wholesale enterprise applies for engaging in vaccine business activities, it shall meet the following conditions: (1) Having professionals undertaking vaccine management; (2) Having refrigerating facilities and equipment and refrigerating means of transport for guaranteeing the quality of vaccines; and (3) Having management systems conforming to the administrative rules for vaccine storage and transport. The drug administration department of the people's government of a province, autonomous region, or municipality directly under the Central Government shall examine whether the pharmaceutical wholesale enterprise meets the above mentioned conditions. If the enterprise meets the conditions, the vaccine business may be indicated in its pharmaceutical trading permit. A pharmaceutical wholesale enterprise that has obtained the vaccine operation qualification (hereinafter referred to vaccine wholesale enterprise) shall regularly inspect, maintain and renovate its refrigerating facilities and equipment and refrigerating means of transport so as to guarantee that they meet the prescribed requirements. Article 11. The disease prevention and control institution at the provincial level shall, in light of the State's immunity planning and the needs in preventing and controlling the occurrence and spread of infectious diseases in the local area, make the plan on use of vaccines of Class 1 in the local area (hereinafter referred to use plan), and report it to the department responsible for procuring vaccines of Class 1 in accordance with the relevant provisions of the State, and meanwhile report it to the competent health department of the people's government at the same level for archival purposes. The use plan shall include content such as the varieties and quantity of the vaccines, the avenue and method of supply. Article 12. The department responsible for procuring vaccines of Class 1 in accordance with the relevant provisions of the State shall conclude a government procurement contract with a vaccine production enterprise or vaccine wholesale enterprise in accordance with law, stipulating the varieties, quantity and prices, of the vaccines. Article 13. A vaccine production enterprise or vaccine wholesale enterprise shall, according to the stipulations in the government procurement contract, supply vaccines of Class 1 to the disease prevention and control institutions at the provincial level or other disease prevention and control institutions designated by the aforementioned institutions, and shall not supply vaccines of Class 1 to any other entities or individuals. The vaccine production enterprise or vaccine wholesale enterprise shall mark the words of "Free of Charge" and the special mark of "Immunity Planning" set forth by the competent department of health under the State Council at an eye-catching position of the smallest exterior packing of the vaccines included into the State's immunity planning which it supplies. The specific administrative measures shall be formulated by the drug administration department under the State Council jointly with the competent department of health under the State Council. Article 14. A disease prevention and control institution at the provincial level shall do a good job in organizing the distribution of vaccines of Class 1, and shall organize the distribution of vaccines of Class 1 to the disease prevention and control institutions at the level of city divided into districts or at the county level according to the use plan. Each disease prevention and control institution at the county level shall distribute the vaccines of Class 1 to the inoculation entities and the medical and health institutions at the township level according to the use plan. Each medical and health institution at the township level shall distribute the vaccines of Class 1 to the village medical and health institutions undertaking the vaccination work. No medical and health institution shall distribute vaccines of Class 1 to any other entity or individual. An institution that distributes vaccines of Class 1 may not charge any fee. Where, when an infectious disease breaks out or spreads, the local people's government at the county level or above or its competent health department needs to take emergent inoculation measures, the disease prevention and control institution at the level of city divided into districts or above may distribute vaccines of Class 1 directly to the inoculation entities. Article 15. A vaccine production enterprise may sell vaccines of Class 2 it produces to the disease prevention and control institutions, the inoculation entities and the vaccine wholesale enterprises. A vaccine wholesale enterprise may sell vaccines of Class 2 to the disease prevention and control institutions, the inoculation entities and other vaccine wholesale enterprises. A disease prevention and control institution at the county level may supply vaccines of Class 2 directly to inoculation entities; while a disease prevention and control institution at the level of city divided into districts or above shall not supply vaccines of Class 2 directly to inoculation entities. Article 16. The disease prevention and control institutions, the inoculation entities, the vaccine production enterprises, and the vaccine wholesale enterprises shall abide by the administrative rules on storage and transport of vaccines, so as to guarantee the quality of vaccines. The administrative rules on storage and transport of vaccines shall be formulated by the competent department of health under the State Council jointly with the drug administration department under the State Council. Article 17. A vaccine production enterprise or vaccine wholesale enterprise shall, when selling vaccines, provide the photocopies of the quality inspection testimonials or approval testimonials on each batch of biotic products, which are lawfully issued by the inspection institution, and affix its enterprise stamp. If a vaccine wholesale enterprise operates imported vaccines, it shall provide a photocopy of the imported medicine clearance list, and affix its enterprise stamp. A disease prevention and control institution or an inoculation entity shall, when receiving or purchasing vaccines, ask for the testimonials prescribed in the preceding paragraph from the vaccine production enterprise or vaccine wholesale enterprise, and preserve them for checking until 2 years after expiry of duration of validity of the vaccines. Article 18. A vaccine production enterprise or vaccine wholesale enterprise shall, in accordance with the Pharmaceutical Administration Law and the provisions of the drug administration department under the State Council, set up genuine and entire sales records, and preserve them for checking until 2 years after expiry of duration of validity of the vaccines. A disease prevention and control institution shall, in accordance with the provisions of the competent department of health under the State Council, set up genuine and entire records on purchase, distribution and supply, and preserve them for checking until 2 years after expiry of duration of validity of the vaccines. CHAPTER III INOCULATION WITH VACCINES Article 19. The competent department of health under the State Council shall formulate and promulgate the rules on vaccination work, and shall, according to the national standards of vaccines, and the information on the surveys on epidemiology of infectious diseases, formulate and promulgate the immunity procedures for the vaccines included into the State's immunity planning, and the immunity procedures or guiding principles for use of other vaccines. The competent health department of the people's government of a province, autonomous region, or municipality directly under the Central Government shall, according to the immunity procedures and the guiding principles for use of the vaccines, which are formulated by the competent department of health under the State Council, and in light of the situation on spread of infectious diseases within its administrative region, formulate the inoculation program for its region, and report it to the competent department of health under the State Council for archival purposes. Article 20. The disease prevention and control institutions at all levels shall, upon their respective duties, and according to the State's immunity planning or inoculation program, carry out propagandas, trainings, technical guidance, monitoring, appraisals, epidemiological surveys and emergent treatment, related to vaccination, and make records thereof in accordance with the provisions of the competent department of health under the State Council. Article 21. An inoculation entity shall meet the following conditions: (1) Having a medical institution practicing permit; (2) Having practicing doctors, assistant practicing doctors, nurses or village doctors who have accepted the professional vaccination trainings organized by the competent health department of a people's government at the county level and who are assessed to be qualified; and (3) Having the refrigerating facilities or equipment and refrigerating custody systems which conform to the administrative rules on storage and transport of vaccines. An urban medical and health institution undertaking vaccination work shall set up an outpatient ward for vaccination. Article 22. An inoculation entity shall undertake the vaccination work within its own responsible area, and accept the technical guidance provided by the local disease prevention and control institution at the county level. Article 23. An inoculation entity shall, when receiving vaccines of Class 1 or purchasing vaccines of Class 2, set up and preserve genuine and entire records on the receipt and purchase. An inoculation entity shall, in light of the needs in vaccination, formulate the plans on the demands for vaccines of Class 1 and on the purchase of vaccines of Class 2, and shall report them to the competent health department of the people's government at the county level and the disease prevention and control institution at the county level. Article 24. An inoculation entity shall, when inoculating vaccines, abide by the rules on vaccination work, the immunity procedures, the guiding principles for use of the vaccines and the inoculation program, and shall announce the varieties and inoculation methods of the vaccines of Class 1 at an eye-catching position of its inoculation place. Article 25. A medical and health staff member shall, before carrying out the inoculation, inform the inoculated person or his guardian of the variety, function, contraindication and ill response of the inoculated vaccine and the points for attention, inquire about the inoculated person's health and his information on whether he has contraindication to the inoculation, etc., and shall truthfully record the informed and inquired particulars. The inoculated person or his guardian shall know about the relevant knowledge on vaccination, and shall truthfully provide the information on the inoculated person's health and his contraindication to the inoculation. The medical and health staff shall inoculate those who meet the conditions for inoculation, fill out and preserve the inoculation records in accordance with the provisions of the competent department of health under the State Council. For a person who cannot be inoculated due to his contraindication to the inoculation, the medical and health staff shall propose medical suggestions to this person or his guardian. Article 26. The State applies a vaccination certificate system to children. Within 1 month after a child is born, his guardian shall go to the inoculation entity undertaking vaccination work at the child's residential locality to obtain the vaccination certificate for the child. The inoculation entity shall check the child's vaccination certificate when carrying out the inoculation, and shall make records. During the period when the child is not in his original residential locality, the responsibility to carry out the inoculation shall remain with the inoculation entity undertaking vaccination work at the child's present residential locality. The format of the vaccination certificate shall be set forth by the competent health department of the people's government of the province, autonomous region, or municipality directly under the Central Government. Article 27. When a child enters a nursery, kindergarten or school, the nursery, kindergarten or school shall check his vaccination certificate. If it finds that the child is not inoculated according to the State's immunity planning, it shall report to the local disease prevention and control institution at the county level or the inoculation entity undertaking vaccination work at the child's residential locality, and shall cooperate with the disease prevention and control institution or the inoculation entity in urging his guardian to have his child inoculated in time at the inoculation entity after the child enters the nursery, kindergarten or school. Article 28. An inoculation entity shall, according to the State's immunity planning, inoculate those who live in its responsible area and need inoculation with vaccines of Class 1, and shall reach the inoculation rate required by the State's immunity planning. The disease prevention and control institution shall distribute vaccines of Class 1 in time to the inoculation entities. Where the inoculated person or his guardian requests inoculation with the same variety of vaccine as that in vaccines of Class 1 at his own expenses, the inoculation entity providing the service shall inform him of the expenses, the method of compensating unusual response, and the relevant contents prescribed in Article 25 of this Regulation. Article 29. An inoculation entity shall, in accordance with the provisions of the competent department of health under the State Council, register the information on inoculation, and report to the competent health department of the local people's government at the county level and the local disease prevention and control institution at the county level. The inoculation entity shall, after completing the State's immunity planning, report the remaining vaccines of Class 1, if any, to the original vaccine distribution entity, and state the reasons thereof. Article 30. An inoculation entity shall not charge any fee for inoculation of vaccines of Class 1. An inoculation entity may charge service fees and inoculation consumption fee for inoculation of vaccines of Class 2. The specific fee rates shall be ratified by the competent price department of the local people's government of the province, autonomous region, or municipality directly under the Central Government. Article 31. Where the competent health department of a local people's government at the county level or above needs to carry out mass vaccination in some areas within its region on the basis of the information on monitoring and forewarning infectious diseases in order to prevent and control the break-out and spread of infectious diseases, it shall report to the people's government at the same level for decision, and report to the competent health department of the people's government of the province, autonomous region, or municipality directly under the Central Government for archival purposes. If it needs to carry out mass vaccination within the whole region of the province, autonomous region, or municipality directly under the Central Government, the competent health department the people's government of the province, autonomous region, or municipality directly under the Central Government shall report to the people's government at the same level for decision, and report to the competent department of health under the State Council for archival purposes. If it needs to carry out mass vaccination throughout the whole country or in a large area covering different provinces, autonomous regions, or municipalities directly under the Central Government, the decision shall be made by the competent department of health under the State Council. If a decision on approval is made, the people's government or the competent department of health under the State Council shall organize relevant departments to make staff trainings, propaganda, education, transfer of goods and materials, and so on. No entity or individual shall discretionarily carry out mass vaccination. Article 32. When an infectious disease breaks out or spreads, the local people's government at the county level or above or its competent health department shall, if necessary, take emergent inoculation measures in accordance with the Law on Prevention and Treatment of Infectious Diseases and the Regulation on Urgent Response to Public Health Emergencies. Article 33. The competent department of health under the State Council or the competent health department of a people's government of the province, autonomous region, or municipality directly under the Central Government may, on the basis of the information on monitoring and forewarning infectious diseases, promulgate the information on suggesting inoculation of vaccines of Class 2, while no other entity or individual may promulgate such information. The information on suggesting inoculation of vaccines of Class 2 shall include content such as the knowledge on prevention and control of the targeted infectious disease, the relevant inoculation program, etc., provided that it shall not involve any specific vaccine production enterprise or vaccine wholesale enterprise. CHAPTER IV SAFEGUARDING MEASURES Article 34. The people's government at the county level or above shall include the vaccination work related to the State's immunity planning into the plans on national economy and social development for its own region, guarantee the expenses necessary for vaccination work, warrant the inoculation rate required by the State's immunity planning, and ensure the implementation of the State's immunity planning. Article 35. The people's government of a province, autonomous region, or municipality directly under the Central Government shall, in light of the spreading trend of the infectious diseases within its region, determine the projects related to vaccination within its region within the scope of infectious disease prevention and control projects determined by the competent department of health under the State Council, and ensure the implementation of such projects. Article 36. The people's government of a province, autonomous region, or municipality directly under the Central Government shall guarantee the expenses needed in purchasing and transporting vaccines of Class 1, and ensure the construction and operation of the cold chain systems of the disease prevention and control institutions and the inoculation entities within its region. The State may, if necessary, provide adequate supports to the vaccination work in the poverty-stricken areas. Article 37. The people's government at the county level shall ensure the necessary expenses for carrying out vaccination in accordance with the State's immunity planning, and shall, in accordance with the relevant provisions of the State, provide adequate subsidies to the village doctors engaging in vaccination and to other grass-roots prevention and healthcare personnel. The people's government of a province, autonomous region, or municipality directly under the Central Government and the people's governments at the level of city divided into districts shall provide necessary subsidies to the people's governments at the county level in the poverty-stricken areas for carrying out the work related to vaccination. Article 38. The responsibility to reserve vaccines and other relevant goods and materials for the sake of transfer shall remain with the people's governments at the county level or above. Article 39. The expenses arranged by the public finance departments at all levels for vaccination shall be used for this particular purpose, and may not be misappropriated or occupied by any entity or individual. The expenses used by relevant entities and individuals for vaccination shall be lawfully subject to the auditing organ's auditing and supervision. CHAPTER V DEALING WITH UNUSUAL RESPONSES TO VACCINATION Article 40. Unusual response to vaccination shall mean the ill response of medicine which causes damage to the inoculated person's tissues, organs or functions in the process of or after regularized inoculation of a qualified vaccine, and for which no relevant party has any fault. Article 41. The following circumstances do not belong to unusual responses to vaccination: (1) common responses of post inoculation caused from the vaccine's feature; (2) damage caused to the inoculated person due to disqualification of the vaccine's quality; (3) damage caused to the inoculated person due to the inoculation entity's violation of the rules on vaccination work, immunity procedures, guiding principles for use of the vaccines, or inoculation program; (4) The inoculated person was in the delitescence or prodromal phase of a certain disease at the time of inoculation, and is attacked by the disease by coincidence after inoculation; (5) The inoculated person has the contraindication to the inoculation stated in the vaccine directions, but the said inoculated person or his guardian fails to truthfully provide the information on the inoculated person's health and contraindication to the inoculation, prior to the inoculation, and the inoculated person's original disease recrudesces urgently or becomes worse after the inoculation; and (6) individual or mass psychogenic responses due to psychological factors. Article 42. Where a disease prevention and control institution or an inoculation entity or any of its medical and health staff finds any unusual response to vaccination, suspected unusual response to vaccination or receives any relevant report, it/he shall deal with the matter in time in accordance with the rules on vaccination work, and immediately report to the competent health department and the drug administration department of the local people's government at the county level. The competent health department and the drug administration department that receive the report shall immediately organize an investigation into the matter. Article 43. The competent health department and the drug administration department of a local people's government at the county level or above shall report the information on the unusual responses to vaccination which occur within their own region and the information on dealing with the responses separately and level by level to the competent department of health under the State Council and the drug administration department under the State Council. Article 44. After a dispute over unusual response to vaccination arises, the inoculation entity or the inoculated person may ask the competent health department of the people's government at the county level at the inoculation entity's locality for settlement. Where, due to vaccination, an inoculated person died or becomes heavily disabled, or any suspected masses suffer from unusual response to vaccination, and the inoculation entity or the inoculated person asks the competent health department of the people's government at the county level for settlement, the competent health department receiving such request shall take necessary emergent measures to deal with the matter, report it to the people's government at the same level in time, and transfer the matter to the competent health department of the people's government at the next higher level for settlement. Article 45. The authentication of unusual responses to vaccination shall be conducted by referring to the Regulation on Handling Medical Malpractices, and the specific measures shall be formulated by the competent department of health under the State Council jointly with the drug administration department under the State Council. Article 46. Where, due to unusual response to vaccination, an inoculated person died or becomes heavily disabled, or any of his organs or tissues is injured, he shall be paid a lump sum of compensation. Where an inoculated person needs to be compensated due to an unusual response to vaccination arising out of the inoculation of a vaccine of Class 1, the expenses for compensation shall be arranged by the public finance department of the people's government of the province, autonomous region, or municipality directly under the Central Government from the expenses for vaccination work. If the inoculated person needs to be compensated due to an unusual response to vaccination arising out of the inoculation of a vaccine of Class 2, the expenses for compensation shall be borne by the relevant vaccine production enterprise. The specific measures for compensation for unusual responses to vaccination shall be formulated by the people's government of each province, autonomous region, or municipality directly under the Central Government. Article 47. Where an inoculated person is harmed due to disqualification of a vaccine's quality, the matter shall be dealt with in accordance with the relevant provisions of the Pharmaceutical Administration Law. If he is harmed due to the inoculation entity's violation of the rules on vaccination work, the immunity procedures, the guiding principles for use of the vaccines, or the inoculation program, the matter shall be dealt with in accordance with the relevant provisions of the Regulation on Handling Medical Malpractices. CHAPTER VI SUPERVISION AND ADMINISTRATION Article 48. The drug administration department shall, in accordance with the relevant provisions of the Pharmaceutical Administration Law and the Regulation for the Implementation thereof, supervise and inspect the quality of vaccines in the process of storage, transport, supply, sale, distribution and use, and circularize the result of inspection in time to the competent health department at the same level. If the drug administration department samples and inspects a vaccine upon the needs in supervision and inspection, the entity or individual concerned shall cooperate, and shall not refuse the sampling and inspection. Article 49. A drug administration department may, in its supervision and inspection, seal up or detain the vaccine which is proved by any evidence likely to harm human health and the relevant materials thereof, and shall make a handling decision within 7 days. If the vaccine needs to be inspected, the drug administration department shall make a handling decision within 15 days as of the day when the inspection report is sent out. Where a disease prevention and control institution, an inoculation entity, a vaccine production enterprise or a vaccine wholesale enterprise finds any fake, inferior vaccine or any vaccine whose quality is suspicious, it shall immediately cease the inoculation, distribution, supply or sale, and immediately report to the competent health department and the drug administration department of the local people's government at the county level, and may not deal with the matter by itself. The competent health department that receives the report shall immediately organize the disease prevention and control institution and the inoculation entity to take necessary emergent measures, and meanwhile report to the competent health department at the higher level. The drug administration department that receives the report shall lawfully take measures such as sealing up or detaining the fake, inferior vaccine or the vaccine whose quality is suspicious. Article 50. The competent health department of each people's government at the county level or above shall perform the following supervision and inspection duties within the scope of its own duties: (1) Supervising and inspecting the information on implementation of the State's immunity planning by the medical and health institutions; (2) Supervising and inspecting the propagandas, trainings and technical guidance related to vaccination, which are carried out by the disease prevention and control institutions; and (3) Supervising and inspecting the information on the distribution and purchase of vaccines by medical and health institutions. A competent health department shall perform its supervision and administration duties mainly through inspecting the records made by medical and health institutions in accordance with this Regulation on distribution, storage, transport and inoculation, of vaccines. When necessary, it may conduct on-site supervision and inspections. The competent health department shall record the information on supervision and inspections, and shall, when finding any illegal act, order the relevant entity to make a correction immediately. Article 51. There shall be no less than 2 persons when the personnel of a competent health department or a drug administration department perform their supervision and inspection duties in accordance with law. They shall show their testimonials, and keep confidential the commercial secrets of the inspected party. Article 52. The competent health department and the drug administration department shall notify each other in time when finding any quality problem with a vaccine, any unusual response to vaccination, or any other similar fact. Article 53. Any entity or individual shall have the right to expose to the competent health department or the drug administration department the act of violating this Regulation, and to expose to the people's government at the same level or the relevant department of the people's government at the higher level the competent health department's or the drug administration department's failure to lawfully perform its supervision and administration duties. The people's government, the competent health department or the drug administration department that receives the exposure shall verify the information and deal with the matter in time. CHAPTER VII LEGAL LIABILITIES Article 54. Where the competent health department or drug administration department of a people's government at the county level or above violates this Regulation, and is under any of the following circumstances, it shall be ordered by the people's government at the same level or the competent health department or drug administration department of the people's government at the higher level to make a correction, and be imposed upon a circularized criticism. If it causes any personal damage to any inoculated person, or causes dissemination or spread of any infectious disease or other severe consequences, its directly responsible person in charge and other persons directly held liable shall be imposed upon administrative sanctions in accordance with law. If a crime is constituted, it shall be subject to criminal liabilities in accordance with law: (1) It fails to perform its supervision and inspection duties in accordance with this Regulation, or fails to timely investigate the illegal act it finds; (2) It fails to timely verify and deal with the exposures on not performing supervision and administration duties by any competent health department or drug administration department at the lower level; (3) It fails to immediately organize the investigation after it receives the relevant report on finding any unusual response to vaccination or suspected unusual response to vaccination; (4) It conducts mass vaccination discretionarily; or (5) It has other neglects or derelicts of its duties in violation of this Regulation. Article 55. Where a people's government at the county level or above fails to perform the duties of safeguarding vaccination in accordance with this Regulation, it shall be ordered by the people's government at the higher level to make a correction, and be imposed upon a circularized criticism. If it causes dissemination or spread of any infectious disease or other severe consequences, its directly responsible person in charge and other persons directly held liable shall be imposed upon administrative sanctions in accordance with law. If a crime is constituted, it shall be subject to criminal liabilities in accordance with law. Article 56. Where a disease prevention and control institution is under any of the following circumstances, it shall be ordered to make a correction, be imposed upon a circularized criticism, and be warned by the competent health department of the people's government at the county level or above; its illegal proceeds, if any, shall be confiscated. If it refuses to make a correction, its principal responsible persons, directly responsible person in charge and other persons directly held liable shall be warned or be degraded in accordance with law: (1) It fails to distribute vaccines of Class 1 according to the use plan to the disease prevention and control institutions at the lower level, the inoculation entities and the medical and health institutions at the township level; (2) The disease prevention and control institution at the level of city divided into districts or above violates this Regulation by directly supplying vaccines of Class 2 to the inoculation entity; or (3) It fails to comply with the provisions to set up and preserve records on purchase, distribution and supply of vaccines. Where a medical and health institution at the township level fails to comply with this Regulation to distribute vaccines of Class 1 to the village medical and health institutions undertaking vaccination, it shall be penalized in accordance with the preceding paragraph. Article 57. Where an inoculation entity is under any of the following circumstances, it shall be ordered to make a correction and be warned by the competent health department of the local people's government at the county level. If it refuses to make a correction, its principal responsible persons and directly responsible person in charge shall be warned or degraded in accordance with law, and the medical and health staff held liable shall be ordered to suspend their practicing activities for a period of 3 months to 6 months: (1) It fails set up and preserve genuine and entire records on receipt or purchase of vaccines in accordance with the provisions; (2) It fails to announce the varieties and inoculation methods of vaccines of Class 1 at an eye-catching position in its inoculation place; (3) The medical and health staff members fail to, prior to inoculation, inform or inquire of the inoculated person or his guardian about the relevant information in accordance with this Regulation; (4) The medical and health staff members conducting the vaccination fail to fill in and preserve the inoculation records in accordance with the provisions; or (5) It fails to register and report the information on the inoculation of vaccines in accordance with the provisions. Article 58. Where a disease prevention and control institution or an inoculation entity is under any of the following circumstances, it shall be ordered to make a correction and be warned by the competent health department of the local people's government at the county level or above; its illegal proceeds, if any, shall be confiscated. If it refuses to make a correction, its principal responsible persons, directly responsible person in charge and other persons directly held liable shall be warned or degraded in accordance with law. if it causes personal damage or other severe consequences to the inoculated person, its principal responsible persons and directly responsible person in charge shall be discharged from office or dismissed in accordance with law, and the practicing certificates of the medical and health staff members held liable shall be revoked by the original certificate-issuance department: (1) It purchases vaccines of Class 2 from an entity or individual without the vaccine operation qualification; (2) It does not abide by the rules on vaccination work, the immunity procedures, the guiding principles for use of the vaccines or the inoculation program when inoculating vaccines; (3) It fails to, when finding any unusual response to vaccination or suspected unusual response to vaccination, deal with the matter or make a report in time in accordance with the provisions; or (4) It discretionarily conducts mass vaccination. Article 59. Where a disease prevention and control institution or an inoculation entity violates this Regulation to charge fees in the process of distributing or supplying vaccines or in the process of inoculation, it shall, under supervision of the competent health department of the local people's government at the county level, refund the illegally charged fees to the original entity or individual that paid the fees, and shall be penalized by the price competent department of the people's government at the county level or above in accordance with law. Article 60. Where a pharmaceutical inspection institution issues a false vaccine inspection report, it shall be penalized in accordance with Article 87 of the Pharmaceutical Administration Law. Article 61. Where a vaccine production enterprise or vaccine wholesale enterprise fails to follow the relevant provisions to set up and preserve the records on the sale or purchase of vaccines, it shall be punished respectively in accordance with Article 79 or Article 85 of the Pharmaceutical Administration Law in light of the situations. Article 62. Where a vaccine production enterprise or a vaccine wholesale enterprise fails to comply with the provisions to mark the words of "Free of Charge" and the special mark of "Immunity Planning" on the smallest exterior packing of the vaccines included into the State's immunity planning, it shall be ordered to make a correction and be warned by the drug administration department. If it refuses to make a correction, it shall be fined 5,000 Yuan up to 20,000 Yuan, and its vaccines involved shall be sealed up and preserved. Article 63. Where a vaccine production enterprise or a vaccine wholesale enterprise sells vaccines of Class 2 to any entity or individual other than the disease prevention and control institutions, inoculation entities and vaccine wholesale enterprises, or a vaccine wholesale enterprise purchases vaccines of Class 2 from an entity or individual without the vaccine operation qualification, the illegally sold vaccines shall be confiscated by the drug administration department, and it shall be fined twice to 5 times of the amount of the value of the illegally sold vaccines; the illegal proceeds, if any, shall be confiscated. If the circumstance is severe, its vaccine production or operation qualification shall be revoked in accordance with law. Article 64. Where a disease prevention and control institution, an inoculation entity, a vaccine production enterprise or a vaccine wholesale enterprise fails to store or transport vaccines under prescribed refrigerating conditions, it shall be ordered to make a correction and be warned by the drug administration department, and the vaccines it stores or transports shall be destroyed. If the disease prevention and control institution or the inoculation entity refuses to make a correction, its principal responsible persons, directly responsible person in charge, and other persons directly held liable shall be lawfully warned or degraded by the competent health department. If any severe consequence is caused, its principal responsible persons, directly responsible person in charge, and other persons directly held liable shall be lawfully discharged from office or dismissed by the competent health department, and the inoculation entity's inoculation qualification shall be revoked. If the vaccine production enterprise or vaccine wholesale enterprise refuses to make a correction, it shall be lawfully ordered by the drug administration department to cease production or operation for rectification, and be fined 5,000 Yuan up to 20,000 Yuan. If any severe consequence is caused, its vaccine production or operation qualification shall be revoked in accordance with law. Article 65. Whichever entity violates this Regulation by promulgating the suggested information on inoculation of vaccines of Class 2 shall be ordered to eliminate the effect via a mass media and be warned by the competent health department of the people's government at the county level at its locality or at the locality of occurrence; its illegal proceeds, if any, shall be confiscated, and this entity shall be fined one time to 3 times of the amount of the illegal proceeds. If a crime is constituted, it shall be subject to criminal liabilities in accordance with law. Article 66. Whichever entity discretionarily engages in inoculation without being lawfully designated by the competent health department shall be ordered to make a correction and be warned by the competent health department of the people's government at the county level at its locality or at the locality of occurrence; the illegally held vaccines or the illegal proceeds, if any, shall be confiscated. If it refuses to make a correction, its principal responsible persons, directly responsible person in charge, and other persons directly held liable shall be warned or degraded in accordance with law. Article 67. Where, when a child enters a nursery, kindergarten or school, the nursery, kindergarten or school fails to check his vaccination certificate in accordance with the provisions, or fails to report to the disease prevention and control institution or the inoculation entity after finding any child who is not inoculated in accordance with the provisions, it shall be ordered to make a correction and be warned by the educational administration department of the local people's government at the county level or above. If it refuses to make a correction, its principal responsible persons, directly responsible person in charge, and other persons directly held liable shall be imposed upon sanctions in accordance with law. Article 68. Where any entity or individual without the vaccine operation qualification operates vaccines, it shall be penalized by the drug administration department in accordance with Article 73 of the Pharmaceutical Administration Law. Article 69. Where a competent health department, a disease prevention and control institution, an entity or individual other than inoculation entities violates this Regulation to conduct mass vaccination, it shall be ordered by the competent health department of the people's government at the county level or above to make a correction immediately, its illegally held vaccines shall be confiscated, and this entity shall be fined twice to 5 times of the amount of the value of the illegally held vaccines; its illegal proceeds, if any, shall also be confiscated. Article 70. An entity or individual shall bear civil liabilities in accordance with law when violating this Regulation and causing any personal or property damage to an inoculated person. Article 71. Whoever provokes a quarrel and makes trouble, and disturbs the inoculation entity's normal medical treatment order or authentication of any unusual response to vaccination on the pretext of unusual response to vaccination shall be imposed upon penalties of public security administration in accordance with law. If a crime is constituted, he shall be subject to criminal liabilities in accordance with law. CHAPTER VIII SUPPLEMENTARY PROVISIONS Article 72. The following terms in this Regulation shall have their meanings as follows: The State's immunity planning shall mean the planned vaccination carried out among the masses according to the vaccine varieties, immunity procedures or inoculation programs determined by the State or the government of the province, autonomous region, or municipality directly under the Central Government, so as to prevent and control the occurrence and spread of certain infectious diseases. Cold chain shall mean the refrigerating facilities and equipment for storage and transport which are installed in order to guarantee the quality of vaccines in the process from the vaccine production enterprise to the inoculation entity. Common response shall mean the response occurring after the immunity inoculation and caused from the vaccine's own intrinsic feature, which will only result in transient impediment in physiological functions to the organism. Common responses mainly include becoming feverish or partially red and swollen, which may possibly accompanied with comprehensive symptoms such as discomfort from head to foot, tiredness, poor appetite, short of strength, etc. Article 73. This Regulation shall come into force as of June 1, 2005. |
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