The people's governments of all districts, cities and counties, the administrative committees of the pilot areas, the relevant departments of the municipal government, and the relevant units:
The Regulations on the Administration of Vaccine Circulation and Vaccination in Dalian (Trial) is reviewed and approved by the 18th Executive Meeting of the 16th People's Government of Dalian and is now issued to you. Please implement it carefully.
General Office of Dalian Municipal People's Government
August 27, 2018
Regulations on the Administration of Vaccine Circulation and Vaccination in Dalian (Trial)
Chapter I General Rules
Article 1 In order to further strengthen the management of vaccine circulation and vaccination, strengthen the standardization construction of vaccination clinics, ensure the quality and safety of vaccines, and promote the further standardization and precision of vaccination work, these regulations are formulated in accordance with relevant regulations such as the Regulations on Vaccine Circulation and Vaccination Management, Liaoning Notice of the General Office of the Provincial People's Government on Further Strengthening Vaccine Circulation and Vaccination Management Work, "Regulations on Vaccination Work (2016 Edition)", "Regulations on Vaccine Storage and Transportation Management (2017 Edition)" and "Setup Standards for Vaccination Clinics in Liaoning Province", and in the light of the actual situation in the city.
Article 2 The term "vaccine" as used in these Regulations refers to vaccine-preventive biological products used for the prevention and control of infectious diseases and for human vaccination
Vaccines fall into two categories. The first type of vaccine refers to the vaccine that the government provides to citizens free of charge and citizens should be vaccinated in accordance with government regulations, including the vaccines determined by the National Immunization Program, and vaccines used for emergency vaccination or mass vaccination organized by governments at or above the county level or their health authorities. The second type of vaccine refers to other vaccines that are planted voluntarily by citizens at their own expense.
Article 3 These Provisions apply to the circulation, vaccination and supervision and management of vaccines throughout the city.
Article 4 The administrative department of health and family planning shall be responsible for the supervision and administration of vaccination within its administrative area. The drug supervision and administration department is responsible for the supervision and management of vaccine quality and circulation within its administrative area.
Article 5 Health and family planning administrative departments and drug supervision and administration departments should establish a coordination mechanism for vaccine circulation and vaccination management in conjunction with relevant departments, strengthen policy coordination and convergence, timely report the progress of work and information, jointly study and solve outstanding problems, and jointly respond to major emergencies.
Chapter II Vaccine Circulation
Article 6 The first type of vaccine shall be supplied step by step through the vaccine cold chain operation system of the disease prevention and control institution, and the county-level disease prevention and control institution shall distribute the first type of vaccine to the inoculation unit according to the use plan. Medical and health institutions may not distribute the first type of vaccine to other units or individuals. The first type of vaccine is distributed and no fees are charged.
Article 7 The second type of vaccine shall be compiled by the county-level disease prevention and control agency for the demand plan of the vaccination unit in the area under its jurisdiction, and shall be purchased through the centralized procurement platform for pharmaceutical and medical consumables in Liaoning Province. After the county-level disease prevention and control institutions purchase from the production enterprises, they will supply the inoculation units in their respective jurisdictions according to the demand plan.
Article 8 Vaccine production enterprises, vaccine distribution enterprises, disease prevention and control institutions at all levels and inoculation units shall strictly implement the requirements of the "Code for the Administration of Quality of Pharmaceutical Products", "Regulations on the Management of Vaccine Storage and Transportation" and "Code for Vaccination Work".
Article 9 Vaccine production enterprises shall directly distribute the second type of vaccine to the county-level disease prevention and control institution, or entrust the enterprises with cold chain storage and transportation conditions to distribute. Enterprises that accept the distribution of the second type of vaccine may not entrust the delivery.
Article 10 Vaccine production enterprises, enterprises that accept entrusted distribution of vaccines, disease prevention and control institutions, and inoculation units shall abide by the regulations for vaccine storage and transportation management to ensure the quality of vaccines. The whole process of vaccine storage and transportation should always be in the specified temperature environment, and should not be separated from the cold chain, and the temperature should be monitored and recorded regularly. Vaccine transportation shall not be mixed with non-pharmaceutical vehicles. If it is mixed with other drugs, it shall be placed in the transportation vehicle to prevent confusion and cross-contamination, and ensure that the quality of the vaccine is not affected by the mixed transportation of the same vehicle. For the transportation of vaccines by air, the transportation process must adopt the refrigerating measures that meet the requirements of vaccine temperature control, record the transportation temperature data, and upload the air transportation temperature data before delivery to the county-level disease prevention and control agency.
Article 11 When receiving or purchasing vaccines, the disease prevention and control institution shall request the temperature monitoring records of the whole process of vaccine storage and transportation, as well as copies of each batch of biological products that have passed the inspection or approval certificate issued by the drug inspection institution according to law. If you purchase imported vaccines, you should also ask for a copy of the customs clearance form for imported medicines. Those who cannot provide the above-mentioned materials that meet the requirements shall not be received or purchased, and shall immediately report to the pharmaceutical supervisory and administrative department and the competent department of health. The requested materials are kept for future reference until they exceed the validity of the vaccine for 2 years.
Article 12 The disease prevention and control institutions and vaccination units shall regularly check and record the stored vaccines, and regularly report the vaccines that cannot be identified in the package, exceed the validity period and do not meet the storage temperature requirements step by step, with the first type of vaccines reported to the provincial disease prevention and control institutions and the second type of vaccines reported to the county disease prevention and control institutions. For vaccines that need to be scrapped, they should be destroyed in accordance with the relevant regulations under the supervision of the local food and drug supervision and administration department and the health and family planning administration department. Vaccination units need to scrap vaccines, which should be recycled to the county-level disease prevention and control institutions for unified destruction. Disease prevention and control institutions and vaccination units shall truthfully record the destruction and recovery of the records, and the records of destruction shall be kept for more than 5 years.
Article 13 Under special circumstances, such as power failure, storage and transportation equipment failure, resulting in abnormal temperature, vaccine production enterprises shall start a major deviation or minor deviation handling process to evaluate its potential impact on product quality and submit an evaluation report to the corresponding unit. If it has no impact on the quality of the product after evaluation, it can continue to be used. If the product quality is adversely affected by the assessment, it shall be destroyed under the supervision of the local health and family planning administrative department and the food and drug supervision and administration department.
Article 14 The pharmaceutical supervisory and administrative department shall, in conjunction with the health and family planning administrative department, push forward the construction of the whole process traceability information system for vaccines in accordance with the requirements of the relevant national and provincial departments, and gradually realize the traceability of the whole process of production, storage, transportation and use of vaccine minimum packaging units.
Chapter III Vaccination Services
Article 15 The health and family planning administrative department of the county government shall be responsible for designating medical and health institutions (hereinafter referred to as inoculation units) that meet the requirements and undertake vaccination work. When the administrative department of health and family planning of the county-level government designates an inoculation unit, it shall define its area of responsibility in combination with factors such as population density, service population and service radius.
Article 16 Inoculation units shall provide vaccination services in the form of setting up vaccination clinics. Inoculation units shall meet the following conditions:
(一) Having a practicing license for medical institutions;
(二) Having a practicing physician, assistant practicing physician or nurse who has obtained the vaccination certificate through the training examination organized by the competent department of health and family planning of the county government and who has been trained every year and passed the examination;
(三) Having cold-chain facilities, equipment and cold-chain storage systems that conform to the standards for vaccine storage and transportation management.
Article 17 Vaccination clinics shall be divided into qualified, standardized and demonstration (A, AA, AAA) grades according to different hardware facilities and service levels. The construction and assessment standards for vaccination clinics shall be formulated by the Municipal Health and Family Planning Commission.
Article 18 At least one vaccination clinic shall be established in each street of the town, and the service radius shall not exceed 5 kilometers. In rural areas, a centralized vaccination model based on townships and towns should be implemented. At least one vaccination clinic should be set up in each township in rural areas, with a service radius of no more than 10 kilometers. In areas where the service radius exceeds the above criteria, vaccination clinics should be added according to the situation.
Article 19 Streets (townships) serving more than 3,000 children aged 0-6 shall be provided with standardized vaccination clinics. Demonstration vaccination clinics should be built in streets (townships) serving more than 5,000 children aged 0-6. In areas where transportation is inconvenient, the availability of vaccination is improved by means of mobile services in township hospitals.
Article 20 All regions shall, in light of the actual conditions of their respective jurisdictions, promote the standardization and digitization of inoculation units according to law, standardize the setting of inoculation units, personnel qualifications, vaccination facilities, adequately deploy vaccination staff, and improve the vaccination outpatient service environment. Information management improves the efficiency of vaccination management.
Article 21 Vaccination clinics shall strictly carry out vaccination work in accordance with the provisions of the "Code for Vaccination Work" and ensure the safety of vaccination. Disease prevention and control institutions should strengthen technical guidance on vaccination prevention of vaccination units and organize training for vaccination workers in the region.
Article 22 When a child enters school, the child care institution and the school shall check the vaccination certificate. The vaccination unit shall provide technical support for the childcare institution and the school to carry out the vaccination certificate inspection work, and issue a “Children's vaccination review report” for the childcare. Institutions and schools check.
Article 23 Nursery institutions and schools should check and register children according to their vaccination certificates and the " children's vaccination audit report", urge their guardians to reseed the vaccine in time, and check the vaccination certificates again for the children reseeded, so as to ensure that the children reseeded will complete the reseeding of all the national immunization program vaccines according to the provisions of the National Immunization Program and Instructions for Children ( except for the contraindications to vaccines ).
Chapter IV Safeguards
Article 24 The district, city and county governments (the administrative committee of the pilot zone ) shall guarantee the funds needed for the implementation of the national immunization program, arrange for the capital construction of disease prevention and control institutions, the purchase of equipment, especially the cold chain system and information construction according to the development needs and development and construction plans of disease prevention and control. It is necessary to increase investment in the construction of vaccination clinics in its jurisdiction, and ensure that appropriate subsidies are provided to grassroots preventive health personnel engaged in vaccination work in accordance with relevant state regulations. The responsibility for expenditure shall be implemented, and factors such as changes in the management mode of Category II vaccines shall be considered as a whole. Personnel, public and business funds of disease prevention and control institutions shall be scientifically and reasonably approved and fully included in the budget, guaranteed by the finance at the same level, and service income shall be included in the budget management according to the two lines of revenue and expenditure.
The municipal government should give necessary financial subsidies to the county government in difficult areas to carry out the work related to vaccination.
Article 25 The financial arrangements for vaccination at all levels shall be earmarked for special purposes, and no unit or individual may misappropriate or occupy it. The funds used by relevant units and individuals for vaccination shall be subject to the audit supervision of the auditing organization according to law.
Article 26 The district, city and county governments ( the administrative committee of the pilot zone ) should carry out specific management regulations in light of local conditions, strengthen organization and leadership, incorporate the prevention and control of diseases such as vaccination and the implementation of financial policies of disease prevention and control institutions into the government's assessment content, intensify supervision and inspection, and do a good job in vaccine circulation and vaccination in an orderly manner according to law.
Article 27 Residents' committees and villagers' committees shall cooperate with relevant departments to carry out propaganda and education related to vaccination, and assist organizations and villagers to receive the first type of vaccine.
Article 28 Governments at or above the county level shall reward the vaccination units and their staff who undertake the vaccination work and make outstanding achievements and contributions.
Chapter V Supplementary Provisions
Article 29 Dalian Customs is responsible for the management of immigration vaccination work, and the translation of immigration personnel's vaccination records and the procurement, storage and use of required vaccines.
Article 30 These Provisions shall come into force as of the date of issuance. If the provisions conflict with the new regulations of the higher level, the relevant provisions of the above-mentioned levels shall prevail.