About to implement the newly revised "regulations on the administration of circulation of vaccines and vaccination

The national health and family planning commission of the People's Republic of China

The 2016-06-15

Drug safety food medicine prison [2016] no. 74

Various provinces, autonomous regions and municipalities directly under the food and drug administration, health and family planning commission, the xinjiang production and construction corps food and drug administration bureau, health bureau:

Revision of the state council regulations on the administration of the circulation of vaccines and vaccination (hereinafter referred to as the regulations) announced on April 23, 2016. For the implementation of the regulations, standardize the management of circulation of vaccines and vaccination, to safeguard rights and interests of the broad masses of people's health, will now about that notice the following:

A, strictly regulate the vaccine sales and purchase behavior

The vaccine production enterprise in accordance with the law, the quality of the production and distribution of the vaccine is liable. Overseas vaccine manufacturers to export to China vaccine shall specify a agency in China, a unified sales all the vendor import vaccines, on behalf of the vendor to perform the provisions of the regulations the responsibility of the vaccine production enterprise. The agency shall be submitted to the local provincial food and drug supervision and administration authority for the record, the record is asking to see the attachment. Provincial food and drug supervision and administration department shall put on record information in the public affairs website.

Vaccine production enterprises can only be used to prevent the second type of vaccine sales for disease prevention and control institutions at the county level (including county of institution of disease prevention and control functions of institution of disease prevention and control of the municipal), sales activities shall strictly abide by the "drug-handling quality management norms" (hereinafter referred to as the "drug GSP), strengthen the management of the validity of the vaccines that prevent expired vaccine into use. Production of blood products and clinical research institute with a vaccine, the user may purchase directly to the vaccine production enterprise, production enterprises should strictly audit, and make the sales record.

By provincial public resources trading platform of institution of disease prevention and control purchasing vaccines. The first kind of vaccine, vaccination, distribution of supply management execution according to the vaccination work specification requirements. The second type of vaccine procurement plan put forward by the vaccination units, after the summary of institution of disease prevention and control at the county level step by step to submit to disease prevention and control institutions at the provincial level, provincial institution of disease prevention and control by the provincial public resources trading platform of centralized purchasing, determine the winning production enterprises, varieties, specifications, price. Institution of disease prevention and control at the county level to the vaccine production enterprise procurement supply contracts, clear the rights and obligations and responsibilities.

Responsible for national pharmaceutical reserve drug-handling enterprise and institution of disease prevention and control, should be in accordance with the relevant government department's instruction in reserve vaccine purchases and call.

Two vaccines circulation management, and strict transition

(a) the vaccine production enterprise shall be prepared to vaccine sales and distribution of various as soon as possible, actively cooperate with the relevant authorities to the vaccine into the provincial public resources trading platform, centralized purchasing in a timely manner to the sales of the second type of vaccine of institution of disease prevention and control at the county level.

Since the date of implementation of the regulations, the original distribution enterprises shall not purchase vaccine vaccine, the vaccine operation vaccine and vaccine production enterprises shall not sell to units and individuals outside of institution of disease prevention and control.

(2) can not be used at the provincial level public resources trading platform for procurement of provinces, the second type of vaccine with reference to the first type of vaccine procurement modes existing procurement. For the unfinished centralized purchasing but need to use the second type of vaccine, according to the actual situation, the disease prevention and control institutions at or above the county level shall order directly to the vaccine production enterprise. Since the date of dispatch, can not purchase a single component inactivated polio (IPV) can be used widely as the second type of vaccine.

During this period, if there is no qualified distribution enterprises, can refer to the first kind of vaccine distribution through disease prevention and control institutions at all levels of the cold chain system for distribution.

(3) the original vaccine business in 2016 before 25 April have purchased the second type of vaccine may continue to sell to the disease prevention and control institutions at all levels, from the supply. The original vaccine business on January 1, 2017 must stop vaccine sales activities, to the original issuance of food and drug supervision and administration department to apply for cancellation of the pharmaceutical trade license or subtract vaccine business scope.

(4) levels of institution of disease prevention and control in before 25 April 2016, has purchased the second type of vaccine, on December 31, 2016, can supply according to the supply way step by step.

Three, strictly implement the vaccine distribution management

Vaccine production enterprise directly to the institution of disease prevention and control at the county level distribution the second type of vaccine, the cold chain storage, transportation or entrust the industry distribution, shall strictly comply with the drug GSP requirements. Vaccine production enterprises and institution of disease prevention and control at the county level in the procurement contract shall specify the enterprise of the implementation of distribution, distribution, delivery time and place of receipt.

Vaccine production enterprises entrust other enterprise and distribution of the second type of vaccine, should control the number distribution, and the distribution enterprise have cold chain storage and transportation conditions and the ability to perform drug GSP to carry on the strict censorship, sign contracts on storage, transportation and distribution enterprises, responsibilities and obligations. Distribution enterprises shall be written promise at any time subject to the client and check the food and drug supervision and administration department, the drug GSP requirements, and shall not be accepted by the commissioned distribution entrusted again.

Vaccine production enterprise shall entrust the distribution respectively report production enterprise is located, vaccines, storage and distribution to the food and drug supervision and administration department at the provincial level, entrust the delivery the copy attached, review the situation of distribution enterprises and distribution enterprises undertaking copy. Provincial food and drug supervision and administration department shall distribution enterprise commissioned related information about the food and drug supervision and administration department.

At the county level of institution of disease prevention and control in the provincial public resources trading platform after purchasing the second type of vaccine, supply the vaccination units in their respective administrative areas.

Of institution of disease prevention and control, the vaccination units shall, in accordance with the provisions of the "vaccination work specification" and so on to build true, complete the purchase, storage, distribution, supply record, save for future reference of vaccine to more than 2 years relevant data.

Four, strictly implement the management requirements of the vaccine cold chain and traceability

Vaccine production enterprises and the distribution of the vaccine vaccine storage, transportation, shall, in accordance with the GSP requirements of, to ensure that the temperature and humidity automatic monitoring system for cold chain storage and transport data true, original, complete and accurate, and ensure that the vaccine storage, transportation, not out of the cold chain control. The vaccine loading and unloading, and delivery conditions such as temperature control requirements shall be based on the validation.

Of institution of disease prevention and control and the inoculation entity shall abide by the "vaccine storage and transportation management norms" and "standard of vaccination work", in the whole process of vaccine storage, transportation timing monitoring, recording temperature according to the requirement, and ensure the quality of the vaccine.

And inoculation of institution of disease prevention and control unit receives the vaccine or buying vaccines should be for sale and distribution side of storage and transportation process, temperature monitoring and recording records can be print or electronic format can be read. To or cannot provide temperature monitoring and recording the temperature control is not in conformity with the requirements, shall not receive or purchased, and shall immediately to the food and drug supervision and administration of family planning branch, health department report. To adopt or refrigerated transport package to vaccination unit cooler, to see the ice floe status and the thermometer or refrigerated cooler bags, and make records.

Vaccine production enterprises, and inoculation of institution of disease prevention and control unit shall, in accordance with the relevant national drug traceability system construction requirements, actively use information technology to establish the vaccine tracing system, faithfully record the vaccine sales, storage, transportation and use of information, from the smallest packing unit production to use the whole process of the traceability. The enterprise shall, in accordance with the requirements of production enterprises of distribution vaccine truthfully record storage and transportation information. The vaccine traceability information system before running all the way, can use the existing records meet the traceability requirements.

The use and management of five, strictly regulate the vaccine

Vaccination units of medical and health personnel shall meet the conditions for vaccination by the kinds of the implementation of vaccination, and in accordance with the vaccination work specification, record the vaccine varieties, production enterprise, the smallest packing unit identification information (or batch number), the period of validity, inoculation time, implementation of medical and health personnel, the kind of person. Vaccination record keeping time shall not be less than 5 years. The first kind of vaccine inoculation units shall not charge any fees, the second type of vaccine can charge the service fee, material fee.

Institution of disease prevention and control, the vaccination units found packing can't recognition, more than the period of validity, out of the cold chain, source, such as vaccines, report should be step by step, in which the first kind of vaccine to disease prevention and control institutions at the provincial level, the second type of vaccine to county of institution of disease prevention and control. The vaccine unified recycling to disease prevention and control institutions at or above the county level shall, in the food and drug supervision and administration departments at the same level and destroyed under the supervision of family planning department of public health and keep records for five years.

Sixth, strengthen circulation of vaccines and use of the supervision and inspection

The city, the food and drug supervision and administration departments at the county level shall regularly for vaccine production and distribution enterprise sales and distribution of vaccine to perform drug GSP inspection, unit vaccination of institution of disease prevention and control, storage, transportation to perform "vaccine storage and transportation management norms" examine, check the temperature monitoring records. Found that there may be a quality problem, you can sample, and according to the relevant provisions of the state inspection. Inspection and test results to the public in a timely manner.

Health family planning department at the county level should be vaccinated unit change to inform the food and drug supervision and administration departments at the same level, the food and drug supervision and administration department of institution of disease prevention and control, should be vaccinated unit supervision and inspection and notify the family planning department of public health at the same level problems in a timely manner.

Provincial food and drug supervision and administration department may, in accordance with the pharmaceutical medical instrument flight check way "requirements, the organization of vaccine production enterprises, the distribution of the vaccine to perform drug GSP for flight check, the institution of disease prevention and control, units vaccine storage, transportation, perform the vaccine storage and transportation management regulations on flight check. Inspection results in accordance with the provisions, public, and will find the related problems about family planning department of public health. To refuse, evade, hinder, against inspection, in accordance with the pharmaceutical medical instrument flight check method "the relevant provisions of the processing.

Local health family planning departments at various levels must make vaccine purchase, supply and use of supervision and inspection. Check whether the institution of disease prevention and control by the provincial public resources trading platform purchasing vaccines, whether for vaccine storage, transport process related data such as temperature monitoring and recording. Inspection unit of inoculated records are complete, shelf life conform to the regulations.

Seven, to strengthen the construction of vaccine inoculation and management ability

(a) the provincial family planning department of public health in December 31, 2016 will all vaccine procurement work included in the provincial public resources trading platform, set up vaccine procurement expert database, the highly effective purchasing process and specification, formed through the centralized purchasing price competition and negotiation mechanism. Family planning department of public health at all levels should be through the implementation of the regulations, to strengthen the construction of the vaccine cold chain equipment and management, to ensure that in the whole process of the vaccine cold chain operation and full traceability records. The health to family planning departments at various levels shall strengthen the circulation of vaccines and immunization information construction, the use of information technology, the realization of the sharing of information area improves the management level of the vaccination and vaccine cold chain.

(2) local food and drug supervision and administration departments at all levels shall with the revision of the regulations and implementation as an opportunity to improve the institutions and personnel, promote establish full-time inspector team, check and improve the professional level; Gradually improve the pharmaceutical inspection institutions at the provincial level to the vaccine products inspection ability, to intensify the supervision and inspection, the quality of vaccine to carry out the supervision responsibility; Take the initiative to report to the people's government at the same level, and actively strive for the support.

(3) the food and drug supervision and administration departments at all levels and the family planning department for public health shall establish information sharing and collaboration mechanism, perfect specific measures to jointly study, careful and meticulous complete each work, strengthening public opinion guidance, ready to interpret misgivings. For the problems in the implementation, it shall timely to the food and drug supervision bureau or national health and family planning commission report, ensure smooth effective enforcement of the regulations.

Attachment: vaccine manufacturers outside agencies for the record

The food and drug supervision administration of national health and family planning commission

On June 13, 2016

附件

境外疫苗厂商代理机构备案要求 
境外疫苗厂商代理机构备案表

　　　　　　受理号：备字  

　　　所附资料： 
　　　1.代理机构营业执照复印件； 
　　　2.境外疫苗厂商出具的授权委托书复印件及其公证文书、中文译本。

境外疫苗厂商代理机构变更备案表

　　　　　　受理号：变字

　　　　所附资料： 
　　　　1.代理机构营业执照复印件； 
　　　　2.如变更事项涉及原授权委托书内容，应提供新的授权委托书复印件及其公证文书、中文译本。 
　　　　3.如境外疫苗厂商将其代理机构变更为另一机构，不得使用本表。应另行重新备案，并说明情况。