(20227month8Day of the State Administration of Municipal Supervision No. 55No. announced, fromThe date of releaseStarting)
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The first article In order to strengthen the supervision and management of vaccine production circulation，Standardized vaccine production、Circulation Activity，According to the relevant laws such as the "Pharmaceutical Management Law of the People's Republic of China", "The People's Republic of China Vaccine Management Law" and the "Measures for the Management of Drug Registration" and "Measures for the Supervision and Management of Drug Production"、Regulations、Regulations，Formulate this regulation。
Two Entering vaccine production in the People's Republic of China、Circulation and its supervision and management activities apply for this regulation。
Article 3 Entering vaccine production、Circulation Activity，It should abide by the relevant laws of drugs and vaccines、Regulations、Regulations、Standard、specifications, etc.，Make sure the whole process information is true、Accurate、Complete and traceable。
Chapter 2 The responsibility of the holder's subject
Article 4 The state implements a listing license holder system for vaccines。The holder's safety of the vaccine、Effective and controllability negative liability，After the vaccine is launched in accordance with laws and regulations, production、Circulation and other management activities，and bear the corresponding responsibility。
Carry out the commissioned production，The holder's responsibility for the main body of the vaccine commissioned by commissioned production，Trimming vaccine manufacturers are responsible for the trustee production behavior。
Article 5 Main raw materials related to vaccine production、Contain materials and packaging materials for drugs and directly contact drugs and store in the process of vaccine supply、Transportation and other related entities assume the responsibility of the corresponding links in accordance with the law。
Article 6 The holder shall clarify the responsibilities of key positions.
Legal representative/Main person in charge: Responsible for establishing quality policies and quality goals，Provide resources to ensure production、Circulation and other activities continue to meet the requirements of relevant laws and regulations，Ensure that the quality management department fulfills its duties independently，Production of vaccine products、Circulation activities and quality are fully responsible。
Management Management in charge: Responsible for organizing and implementing vaccine product production activities，Make sure to organize production in accordance with the approved production technology and quality control standards，The continuous compliance of the production process is responsible。
Quality Management Responsible person: Responsible for organizing the establishment of an enterprise quality management system and ensuring that the system can continue to run well，Continuous compliance of the quality management of vaccine products。
Quality Enthusiasts: Responsible for the release of vaccine products，Make sure that the production of the products that has been released for each batch、The inspection meets the approved production technology and quality control standards，Responsible for the release of the product。
Article 7 The person in charge of the production management of the holder、The person in charge of quality management and key positions such as quality management should have medicine、Pharmacy、Biology and other related majors and undergraduates or above or have professional titles with intermediate or above，Have more than five years of production quality management experience in the vaccine field，Can be produced、Performing responsibilities in quality management，and bear the corresponding responsibility。
The person in charge responsible for vaccine flow quality management shall have medicine、Pharmacy、Biology and other related majors and undergraduates or above or have professional titles with intermediate or above，Have more than three years of experience in vaccine management or technical work experience，Can fulfill responsibility in vaccine liquid quality management，and bear the corresponding responsibility。
The legal representative of the holder、Main person in charge、The person in charge of production management、The person in charge of quality management and quality authority，It should have a good credit record，Drugs who have serious dishonesty are not allowed to hold the above positions。
Article 8 The holder shall be based on the law、Regulations、Regulations、Standard、specifications and other requirements，Create a complete vaccine quality management system，Regularly carry out self -examination of the operation of the quality management system and continuously improved。
The holder shall be in accordance with regulations，Production for vaccine、Raw materials involved in circulation、Accessories、Packaging materials for direct contact with drugs、The quality management system of suppliers such as storage and distribution services for review and supervision，Ensure that the supplier meets the vaccine production、Relevant requirements for circulation，Continuously improved vaccine production after listing、Circular Quality Management System。
Article 9 The holder shall produce vaccines、The whole process of circulation is carried out for quality risk management，Risk recognition of risks that may exist during the operation of the quality system、Evaluation、Control、Communication，Take effective prevention and control measures，Timely risk review，until the risk is effectively controlled。
Chapter 3 Vaccine Production Management
Article 10 State the state's strict access system for vaccine production，Strictly control the newly opened vaccine manufacturers。New vaccine manufacturers，Except for the opening conditions of the vaccine manufacturer，It should also meet the relevant policies of the competent authority of the national vaccine industry。
Article 11 The holder should have the vaccine production capacity。When engaged in vaccine production activities，It should be in accordance with the conditions stipulated in the "Drug Administration Law", "Vaccine Management Law" and "Measures for the Supervision and Management of Drug Production"，According to the prescribed procedure of the drug production license management，Submit application materials for drug production license to the provincial drug supervision and management department where the production site is located。Excessive production capacity of the holder's vaccine requires commissioning production，The trustees shall be a pharmaceutical manufacturer that obtains the scope Stake Sports Bettingof vaccine production。
Packaging of the vaccine、Tag、Packaging should be carried out in a pharmaceutical manufacturer that obtains the scope Stake Sports Bettingof vaccine production。
Article 12 Meet the vaccine variety of one of the following circumstances，The holder can submit a vaccine entrusted production application:
(1) The industrial and information management department of the State Council proposes the need for reserves，It is believed that the holder's existing production capacity cannot meet the needs;
(2) The health management department of the State Council proposes disease prevention、Control urgent need，It is believed that the holder's existing production capacity cannot meet the needs;
(3) Multi -price vaccine.
The scope of commissioned production should be all the processes Stake Sports Bettingof vaccine production。When necessary，Entrusted to produce multi -price vaccine，After organizing the argumentation and approval of My stake betting appThe State Drug Administration, it can be the production stage of the vaccine original liquid or the production stage of the preparation。
Article 13 Apply for the production of vaccines，The client and the trustees shall conduct research in accordance with the requirements of relevant technical guidance principles、Evaluation and necessary verification，and after completing the changes in the production scope of the corresponding "Drug Production License"，Application and Reporting Center for the State Drug Supervision and Administration Bureau of State Drug Administration，The "Application Form for Vaccine Entrusted Production" (Annex 1) shall be submitted when applying.，Submit the application information (Annex 2)，and the proof material specified in Article 12 of these regulations。
Article 14 The National Drug Administration accepts and the reporting center has received the application of the vaccine entrusted production application，In accordance with the requirements of Article 13 of these regulations, the application information is reviewed for form.，It should be accepted within 5 working days、Decision that is corrected or not accepted，issue a written "Acceptance Notice" or "Not Notice of Acceptance"，and indicate the date。
Article 15 My stake betting appThe State Drug Administration will review the production application of vaccine entrusted production applications in accordance with the requirements of these regulations，Decisions should be made within 20 working days。The time required for the applicant's supplementary information is not included in the approval time limit。
The review of the review is approved，The "Vaccine Entrusted Production Approval" (attachment3) and distributed to the client within 10 working days;，Written notification of the commissioner and explain the reason; you need to supplement the material，Written notification The client submits supplementary materials。
"Vaccine Entrusted Production Application" is also copied to the commissioner and the provincial drug supervision and management department of the trustee.。
Article 16 After the commissioner obtains the "Vaccine Commissional Production Approval"，In accordance with the relevant provisions of the "Administrative Measures for the change of the drug (trial)" relevant provisions, the change of registered management items involved in the change of production venue。
The provincial pharmaceutical supervision and management department of the commissioner and the locality of the trustee shall be in accordance with Article 52 of the Measures for the Supervision and Management of Drug Production，Code of compliance inspection of the quality management specifications of drug production to the commissioner and the trustee。
The client and the trustees complete the corresponding change in accordance with the law，Code for the quality management specifications of drug production，Self -inspection and approval of the products produced by the product，After the statutory release conditions are met，。
Article 17 The holder should establish a complete production quality management system，Strictly organize production in accordance with the approved production technology and quality control standards，Make sure the product meets the listing requirements of listing。During the production process, we should continue to strengthen the management of material suppliers、Change control、Bias Management、Product quality retrospective analysis and other work。Using informatization means to truthfully record production、All data formed during the test，Ensure that the entire production process continues to meet legal requirements。Artificial operation steps that cannot use online collection data，The data formed by this process should be entered into the relevant information system in time or converted into electronic data，Make sure the authenticity of the relevant data、Accurate、Complete and traceable，At the same time, save relevant paper original records as required。
Article 18 The holder is upgraded due to the process、Relocation and other reasons (except normal periodic production)，Plan for discontinued production for more than 3 months，It should be discontinued 3 months ago，Report to the provincial pharmaceutical supervision and management department of the local area。
The holder's annual production species due to emergencies caused by equipment failure, causing unable to produce normally，It is expected to discontinue productionMore than 1 month，Report to the provincial pharmaceutical supervision and management department of the local level within 3 working days of discontinuation。
Article 19 The holder's long -term discontinuation of production (except for normal periodic production) plans to restore production，Report to the provincial drug supervision and management department of the local level 1 month ago。Provincial drug supervision and administration department conducts risk assessment with daily supervision，If necessary, you can conduct on -site inspections on the varieties of resumed production。
Article 20 Holders are producing、During the management process of circulation，It is found that it may affect the major deviation or major quality problems that may affect the quality of vaccine products，It should be reported to the provincial drug supervision and management department of the local area immediately。Imported vaccines during circulation management，It is found that a major deviation or major quality problem that may affect the quality of vaccine products，Domestic agents designated by the overseas vaccine holder report to the provincial drug supervision and management department of the import port。The report includes at least the following:
(1) Details of major deviation or quality problems;
(2) The name of the product、batch number、Specification、Quantity、flowing and other information;
(3) The adverse effects that may have or may have;
(4) Emergency control or disposal measures that have been taken;
(5) The measures to be taken further;
(6) Other situations explained.
Article 21 The holder should establish an annual report system，The annual report of quality shall be written in accordance with relevant requirements。Quality Annual Report should include at least vaccine production and approval，Change of key personnel，Production technology and venue changes，Ingredients、Auxiliary materials change，Change of key facilities and equipment，Degrees，Stability inspection，Sales and distribution，Suspected to prevent the abnormal response of vaccination，Risk management，Receive inspection and punishment, etc.。
The holder should be every yearUpload the previous annual quality annual report through the "National Pharmaceutical Business Management System of the National Drug Smart Supervision Platform" by the end of April。Provincial drug supervision and management departments and Chinese inspection institutes、Drug Review Center of My stake betting appThe State Drug Administration、Checking Center、Evaluation Center、Information Center and other departments，Responsibility，Query separately、stake online sports bettingReview、Check、Evaluation and other related work development and important reference for risk assessment。
Chapter 4 Vaccine Circulation Management
Article 22 The holder shall follow the agreement of the procurement contract，Sell vaccine to the disease prevention and control institution。
Overseas vaccine holders should specify a drug wholesale enterprise with cold chain drug quality assurance capabilities in principle to uniformly sell the same variety vaccine，Performing the obligation of holders in the sales link，Responsibility。
Article 23 The holder is when selling vaccines，It should also provide a copy of the certificate or electronic documents stamped with its seal at the same time; the sales of imported vaccines，It should also provide a copy of the imported drug customs clearance single or electronic file。
The holder shall be in accordance with regulations，Create true、Accurate、Complete sales records，Sales record should include at least the universal name of the product、Buying unit、batch number、Specification、Validity period、Buying unit、Sales quantity、Single price、amount、Sales date and holder information，Entrusted storage、Transportation，It should also include entrusted storage、Transportation Enterprise Information，and stored until the validity period of the vaccine is not less than5 years of preparation.
Article 24 holder、Disease Prevention and Control Institutions Delivery Vaccine by themselves，It should have the vaccine cold chain storage、Transportation conditions，Relevant requirements that meet the standards of vaccine storage and transportation management，and bear responsibility for the quality of the vaccine in the delivery。
The procurement contract signed by the holder and the disease prevention and control agency shall clearly implement the unit of delivery、Delivery method、Delivery time limit and receiving location。
Article 25 The holder can entrust the quality management of drug business to standardize refrigerated frozen drug transport、Enterprise delivery of storage conditions、Regional storage vaccine。The holder shall evaluate the distribution capacity of the vaccine distribution company，Strictly control the number of distribution companies，Make sure that the delivery process continues to meet the legal requirements。The holder must not exceed 2 in principle in the same provincial administrative area.。
Disease prevention and control agencies entrust the distribution enterprise to distribute vaccines，Evaluate the distribution capacity of the vaccine distribution enterprise，Make sure the vaccine cold chain storage、Transportation conditions meet the relevant requirements of vaccine storage and transportation management specifications。
Article 26 The holder entrusted the delivery of the vaccine，It should be entrusted to distribute the information of vaccine varieties and entrusted storage、Delivery conditions for transport units、Evaluation of distribution capabilities and information traceability ability to report to the provincial drug supervision and management department where the holder is located and receiving the vaccine, respectively，Provincial drug supervision and management departments shall make announcements in a timely manner。Disease prevention and control agencies entrust the distribution enterprise to distribute vaccines，It should be reported to the drug supervision and management department of the same level and the competent health and health authority。Enterprises receiving commissioned distribution must not be commissioned again。
Article 27 holder、Disease prevention and control institutions and vaccination units、Relevant parties of the entrusted storage and transportation enterprises shall be in accordance with the requirements of the national vaccine electronic traceability system，Record vaccine sales truthfully、Storage、Transportation、Use information，Realize the whole process of the minimum packaging unit from production to use.。
The vaccine distribution unit shall be according to the requirements of the holder，True、Record storage completely、Transportation information。
Article 28 Vaccine non -clinical studies、Clinical research and blood product production, such as vaccines required for special circumstances，Related units after reporting to the provincial drug supervision and management department of the local area，Purchase can be purchased from the vaccine listing permit holder or disease prevention and control agency。holder、Disease prevention and control agencies and related use units shall strictly manage，Do a good job of related records，Make sure vaccine sales、Use traceable。
Chapter 5 Vaccine Change Management
Article 29 The holder shall continue to improve the safety of the product、Validity and Quality Control of the Principles，Make quality tracking and trend analysis of listed products，Improve production technology，Improve production process control ability，Continuous improvement of quality control standards，Improve the quality control level of intermediate products and finished products。
Article 30 The production process of the holder's vaccine has been listed、Production venue、Production workshop and production line、Key production facilities and equipment, etc.，Research and verification should be performed，Fully evaluate changes to the safety of vaccine、Effect of effectiveness and quality controllability，According to the "Administrative Measures for Change Change after the listing of drugs (trial)"、"Principles of Research Technical Guidance for Pharmaceutical Change of Biological Products (Trial)" and other relevant provisions determine the change classification，and apply for supplementary applications、File or report。
Article 31 The holder shall evaluate the relevant changes、Research、Research and necessary verification，If you need to be approved or filed，It shall be implemented after being approved by the procedure or the filing of the filing。
Article 32 The holder has a change in production venue and other circumstances，Provincial drug supervision and management departments shall conduct compliance inspections of drug production quality management specifications; other changes，The provincial drug supervision and management department determines whether to carry out the quality management of drug production quality management specifications in accordance with the principles of risk management。
Reported to the supplementary application of the Pharmaceutical Examination Center of My stake betting appThe State Drug Administration，According to the "Measures for the Supervision and Management of Drug Production" Article 52, the quality management specifications of drug production quality management specifications。
Chapter 6 Vaccine Supervision and Management
Article 33 Quality Supervision and Management of the National Drug Administration in charge of the national vaccine production circulation link。Formation of the regulations and regulations of the supervision and management of vaccine production、Specification、Standards and Guidelines and supervise and guide the implementation; organize vaccine inspections and spot checks;, Implement the commissioned production approval work; in conjunction with the State Council's health and health authority to formulate a unified vaccine traceability standard and specification，Establish a national vaccine electronic traceability system，Realizing the entire process of vaccine can be traceable。
Provincial drug supervision and management department is responsible for the supervision and management of vaccine production circulation in the administrative area。Responsible for the relevant permits and filing matters of the vaccine production and circulation link; be responsible for formulating annual vaccine production、Delivery enterprise supervision and inspection plan and carry out supervision and inspection; be responsible for sending inspectors to vaccine manufacturers; responsible for vaccination and management of the local drug inspection institutions in the administrative region; conduct the monitoring and investigation of vaccination stake online sports bettingabnormal response in vaccination in accordance with their responsibilities; Responsible for guiding the market、The department of the county undertaken the duties of drug supervision and management to carry out vaccine circulation、Vaccine quality supervision and management of vaccination links。
City、The county's department responsible for drug supervision and management responsibilities is responsible for vaccine circulation in the administrative area、Vaccine quality supervision and management of vaccination links; cooperate with the competent health department to implement vaccine abnormal response monitoring、Report; improve the quality information reporting mechanism and joint disposal mechanism。
Article 34 Provincial drug supervision and management department assumes the supervision and management duties of vaccine production and circulation activities in the administrative area，Supervision and management of trustees receiving commissioned production and receiving commissioned distribution in the administrative area。
The holder and the trustees are not in the same provincial administrative area，The provincial drug supervision and management department where the holder is located is responsible for the supervision and management of the holder，The provincial drug supervision and management department where the trustee is located is responsible for the supervision and management of the trusted production enterprise，Provincial drug supervision and management departments where the holder and the trustee are located shall cooperate with each other to carry out supervision and management，You can carry out a joint inspection if necessary。
Article 35 Drug Supervision and Administration Department established or designated professional and technical institutions in accordance with the law，Check the vaccine after the vaccine listing、Batch of issuance、Suspected of technical work such as suspected prevention of abnormal response monitoring and safety evaluation。
(1) The drug inspection agency is responsible for organizing the drafting vaccine to check the relevant regulations、Checking Guide，and carry out vaccine inspection work in accordance with the responsibility。
(2) The drug review agency is responsible for the relevant regulations and guidance principles of registered management involved after the vaccine listing，and carry out relevant technical review work according to the responsibility。
(3) Drug evaluation agencies are responsible for drafting the relevant regulations and guidance principles of monitoring and safety evaluation after the vaccine listing，and carry out the technical work of monitoring and safety evaluation after the vaccine listing is carried out in accordance with the responsibility。
(4) The agency and issuing agency of the vaccine shall report the major quality risks found during the vaccine approval process.，The department receiving the report shall start the vaccine check based on the risk、Investigation or quality and safety incident survey。
(5) Information management agency is responsible for the vaccine traceability collaborative service platform、Vaccine Safety Credit Archives Construction and Management，Uniform coding of vaccine production venues。
The above -mentioned vaccine supervision professional and technical institutions shall be in accordance with regulations、Specification、Regulations and standards to carry out related technical activities，and be responsible for the results of technical supervision。
higher -level professional and technical institutions should guide the quality system construction and business work of the next level of technical institutions。
Drug supervision and management departments and technical institutions at all levels shall establish up and down interoperability、Vaccine communication coordination and cooperation mechanisms connected around and right。Check on the vaccine site、Suspected of preventing inoculation of abnormal reaction monitoring and issuing issuance，Communicate information and report in time; find major product quality risks、Serious suspected prevention abnormal response，It should take effective measures to control risks immediately。
Article 36 The drug supervision and management department implements the supervision and inspection after the vaccine listing，In addition to following the "Measures for the Supervision and Management of Drug Production" and "Measures for Drug Inspection (Trial)" generally stipulated，It should also be checked in the following methods:
(1) My stake betting appThe State Drug Administration organizes the National Vaccine Inspection Center to conduct inspections on the production and quality management of vaccine production enterprises in production，and supervise the vaccine production supervision and management of the provincial drug supervision and management department。
(2) Provincial drug supervision and management department shall be vaccine manufacturers in the administrative area、Delivery enterprise、Pharmaceutical wholesale enterprises selling imported vaccines for supervision and inspection，and cooperate with My stake betting appThe State Drug Administration to do a good job in vaccine inspections and random inspections;、Prevention and control institutions of the same level of diseases to carry out supervision and inspection; if necessary, vaccine production、Circulation and other activities to provide products or services providing products or services for extension supervision and inspection。
(3) City、The county that undertakes the duties of drug supervision and management responsibilities to the disease prevention and control institution、Vocating units carry out quality supervision and inspection。
Article 37 The departments responsible for drug supervision and management at all levels are in duties to be the holder、Trusty production enterprise、Vaccine Delivery Enterprise、Disease prevention and control agencies and vaccination units to carry out supervision and inspection，The inspection plan shall be developed in accordance with the principle of quality risk management，Check the situation according to the previous on -site inspection、Quality Annual Report、Listing license change declaration、Quality spot check after listing、Batch issuance、Monitoring of suspected prevention abnormal reaction、Product Recall Information、Complaint reports, etc. For risk assessment，Formulate a check plan。Formulation of the inspection plan shall consider the frequency of inspection、Checking range、Key content、Checking time and professional background of the inspector。
The department responsible for drug supervision and management at all levels can be based on the inspection plan、Scheme，The production site of the holder、Business venues and vaccine distribution companies、Disease prevention and control agencies and vaccination units carry out on -site inspections，The inspection unit shall cooperate，Do not refuse、Escape or obstruct。During the on -site inspection，You can collect relevant evidence，relevant information collected according to law、physical objects, etc.，It can be used as the basis for determining the facts in administrative penalties; the sample needs to be drawn for inspection，It can be sampled in accordance with the relevant provisions of the sampling inspection or notified the local drug supervision and management department where the inspection unit is located in accordance with regulations，The extracted sample shall be tested by a qualified technology institution。
Article 38 Provincial drug supervision and management department shall send at least 2 inspectors to each vaccine manufacturer in the administrative area。Inspectors who are stationed in the following inspections shall do a good job of inspection:
(1) Complete the inspection tasks formulated by the provincial drug supervision and management department as required，Timely report to the provincial drug supervision and management department to supervise and inspect the situation，and propose supervision suggestions;
(II) Default items found in the provincial drug supervision and management department，Urges enterprises to rectify on time，A verification of rectification;
(3) Assisting the issuing agencies to conduct on -site verification and other tasks;
(4) When the corporate illegal clue is found，Immediately report to send department，and cooperate with the regulatory authorities to collect evidence;
(5) Complete other matters assigned by the provincial drug supervision and management department。
Article 39 My stake betting appThe State Drug Administration organizes the National Vaccine Inspection Center at least one vaccine inspection at least 1 vaccine inspection at the vaccine holder; the provincial drug supervision and administration department will check at least the vaccine holder and its commissioned production enterprise for inspection 2 each year. Second-rate，Among them, it contains at least one drug production quality management specification and compliance examination，At least a drug wholesale company selling imported vaccines each year、Vaccine Delivery Enterprise、1 test of the prevention and control institution of the same level; city、The county that undertakes the duties of drug supervision and management responsibilities per year to at least the disease prevention and control institution of the same level、Check the unit for checking 1 time。If it is found, a clue that may have a significant impact on the quality of the vaccine，Drug supervision and management departments at all levels can carry out inspection at any time。
Article 40 The inspection team shall propose on -site inspection conclusions in accordance with the on -site inspection.，Forming on -site inspection report，and submit it to the sending drug inspection institution in time。The drug inspection agency shall evaluate and review the on -site inspection report，Combined with corporate rectification，Forms a comprehensive assessment conclusion，and submit it to the drug supervision and management department。Drug Supervision and Administration Department based on comprehensive assessment conclusions，Make corresponding treatment。
Inspection found that the holder has defective items，The provincial pharmaceutical supervision and management department of the local area urges the holder to carry out rectification，After the rectification is completed, the rectification should be verified。
Inspection found that there are major quality hidden dangers or risks in the holder，The provincial pharmaceutical supervision and management department where the location is located shall immediately take corresponding administrative treatment measures to control risks，and report My stake betting appThe State Drug Administration in time。
Inspection found that holder、Trusty production enterprise、There are illegal and illegal acts of vaccine distribution companies，A survey of the drug supervision and management department where the local area is located，According to the "Drug Management Law" and "Vaccine Management Law", deal with it in accordance with the law。
Inspection found that holder、Vaccine Delivery Enterprise、Disease Prevention and Control Agency、The vaccination unit has violated the vaccine storage、Transportation management requirements and may affect the quality of the vaccine，The drug supervision and management department where the location is located shall order it to suspend vaccine sales、Delivery or distribution，and informed the competent health and health authority at the same level，Urges relevant units to make rectification。After the rectification is completed，Check the requirements of the drug supervision and management department where the local area is located，Fang can restore vaccine sales、Delivery or distribution。
Article 41 The holder shall be in accordance with the provisions of the "Administrative Measures for the Recall of Drugs"，Establish a complete drug recall management system，Related information about the safety of vaccine，Survey for quality problems that may endanger human health and life safety or other vaccine products with hidden safety hazards、Evaluation，Recalling the defective vaccine。
Drug Supervision and Administration Department is investigated and evaluated，It is believed that the existence of vaccines that may endanger human health and life safety or other hidden dangers，The holder should recall the vaccine without active recall，It should be ordered to recall the vaccine。
Article 42 A suspected prevention of vaccination abnormal response、Group bad events，Organizes experts by the competent department of health and health investigation and diagnosis or suspecting is related to the quality of vaccine，or the vaccine quality and safety information found in daily supervision and inspection and risk monitoring，and other vaccine quality and safety events that seriously affect public health，Should be dealt with in accordance with the relevant emergency plans of the local people's government。
Article 43 Vaccine manufacturers engaged in vaccine exports shall be produced in accordance with international procurement requirements、Export vaccine。Vaccine manufacturers shall directly sell vaccines only for exports to overseas，Don’t be sold in China。Do not import it to China after the vaccine exports。
Chapter 7 Attachment Ze
Article 44 This provision shall be implemented from the date of release.
