Vaccines are divided into two categories. Category I vaccines refer to vaccines provided by the government to citizens free of charge and accepted by citizens in accordance with government regulations, including vaccines determined by the national immunization program, vaccines added by the people's governments of provinces, autonomous regions and municipalities directly under the Central Government in the implementation of the national immunization program, and vaccines organized by people's governments at or above the county level or their health authorities for emergency vaccination or mass vaccination; The second category of vaccines refers to other vaccines that citizens voluntarily vaccinate at their own expense. Article 3 The vaccination expenses of Class I vaccines shall be borne by the government. The inoculation of the second kind of vaccine shall be undertaken by the recipient or his guardian. Article 4 These Regulations shall apply to the circulation, vaccination, supervision and administration of vaccines. Article 5 The competent health department of the State Council shall formulate a national immunization plan according to the epidemic situation of infectious diseases and the immunization status of the whole country. In conjunction with the financial department of the State Council, we will formulate vaccine types that will be included in the national immunization program, and report them to the State Council for approval before publication.
The people's governments of provinces, autonomous regions and municipalities directly under the Central Government may, when implementing the national immunization program, increase the types of vaccines provided to citizens free of charge according to factors such as the epidemic situation of infectious diseases and the immune status of the population within their respective administrative areas, and report them to the health authorities in the State Council for the record. Article 6 The State implements the system of planned immunization and expanded immunization.
The recipients who need to be vaccinated with Class I vaccines shall be vaccinated in accordance with the provisions of these Regulations; If the recipient is a minor, his guardian shall cooperate with relevant disease prevention and control institutions, medical institutions and other medical and health institutions to ensure that the recipient receives the seed in time. Seventh the State Council health authorities responsible for the supervision and management of national vaccination. The health authorities of local people's governments at or above the county level shall be responsible for the supervision and administration of vaccination within their respective administrative areas.
The State Council drug supervision and administration department is responsible for the supervision and management of vaccine quality and circulation throughout the country. The pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the supervision and administration of vaccine quality and circulation within their respective administrative areas. Article 8 Medical and health institutions designated by the health administrative department of the people's government at the county level in accordance with the provisions of these Regulations (hereinafter referred to as vaccination units) shall undertake vaccination work. When the competent health department of the people's government at the county level designates the inoculation unit, it shall specify its responsible area.
People's governments at or above the county level shall reward vaccination units and their staff who have undertaken vaccination work and made remarkable achievements and contributions. Article 9 The State supports and encourages units and individuals to participate in vaccination work. People's governments at all levels should improve relevant systems to facilitate units and individuals to participate in activities such as publicity, education and donation of vaccination work.
Residents' committees and villagers' committees shall cooperate with relevant departments to carry out publicity and education on vaccination, and assist residents and villagers to vaccinate the first kind of vaccine. Chapter II Circulation of Vaccines Article 10 Pharmaceutical wholesale enterprises may deal in vaccines after approval in accordance with the provisions of these Regulations. Drug retail enterprises shall not engage in vaccine business activities.
A pharmaceutical wholesale enterprise applying to engage in vaccine business activities shall meet the following conditions:
(a) there are professional and technical personnel engaged in vaccine management;
(2) Having cold storage facilities, equipment and cold storage transportation tools to ensure the quality of vaccines;
(3) It has a management system that conforms to the management norms for vaccine storage and transportation.
The pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall examine whether the pharmaceutical wholesale enterprises meet the above conditions; For those who meet the requirements, the business of operating vaccines will be increased in their drug business licenses.
Pharmaceutical wholesale enterprises that have obtained the qualification of vaccine business (hereinafter referred to as vaccine wholesale enterprises) shall regularly inspect, maintain and update their refrigeration facilities, equipment and refrigerated transport vehicles to ensure that they meet the specified requirements. Article 11 Provincial disease prevention and control institutions shall, according to the national immunization program and the needs of preventing and controlling the occurrence and epidemic of infectious diseases in the region, formulate a plan for the use of Class I vaccines in the region (hereinafter referred to as the plan), report it to the department responsible for purchasing Class I vaccines in accordance with relevant state regulations, and report it to the competent health department of the people's government at the same level for the record. The use plan shall include the variety, quantity, supply channel and supply mode of the vaccine. Article 12 The department responsible for purchasing Category I vaccines in accordance with relevant state regulations shall sign a government procurement contract with vaccine production enterprises or vaccine wholesale enterprises according to law, and stipulate the variety, quantity and price of vaccines. Thirteenth vaccine production enterprises or vaccine wholesale enterprises shall, in accordance with the provisions of the government procurement contract, supply Class I vaccines to provincial disease prevention and control institutions or other disease prevention and control institutions designated by them, and shall not supply them to other units or individuals.
Vaccine production enterprises and vaccine wholesale enterprises shall mark the word "free" and the special logo of "immunization program" specified by the competent health department of the State Council in a prominent position in the minimum package of vaccines they supply. The specific management measures shall be formulated by the drug supervision and administration department of the State Council in conjunction with the health authorities of the State Council.