Attachment Regulations on the Management of the Production and Circulation of Vaccines (Draft for comments) list Chapter 1 General Chapter II The principal responsibility of the holder Chapter III Vaccine Production Management Chapter Four Vaccine Circulation Management Chapter 5 Vaccine Change Management Chapter 6 Vaccine Supervision and Management Chapter VII By-laws Chapter 1 General Article 1 In order to strengthen post-market supervision and management of vaccines and ensure the quality of vaccines, these Provisions are formulated in accordance with relevant laws, regulations and regulations, such as the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administration Law), the Vaccine Administration Law of the People's Republic of China (hereinafter referred to as the Vaccine Administration Law), the Measures for the Administration of Drug Registration, the Measures for the Supervision and Administration of Drug Production and the Measures for the Supervision and Administration of Drug Operations. Article 2 These Provisions shall apply to the production, circulation and supervision and management of vaccines within the territory of the People's Republic of China. Vaccine production activities are the general terms of all activities carried out by the vaccine market license holder (hereinafter referred to as the holder) in accordance with the requirements of the Drug Production Quality Management Code for the production of vaccines that meet the intended use and registration criteria. Vaccine circulation activities refer to the holder and related subjects, in accordance with the drug management norms, vaccine storage and transportation management norms, such as the general term of all activities carried out in the sale, storage, transportation of vaccines. Article 3 In engaging in the production and circulation of vaccines, the relevant laws, regulations, rules, standards and norms of vaccines and medicines shall be observed to ensure that the information in the whole process is true, accurate, complete and traceable. Chapter II The principal responsibility of the holder Article 4 The State shall implement a system of listing license holders for vaccines. The holder shall bear the main responsibility for the safety, effectiveness and quality control of the vaccine, carry out risk management activities in the production, circulation and drug alert after the vaccine is listed in accordance with the regulations, and bear the corresponding responsibility. Article 5 Other suppliers of raw materials, accessories and packaging materials related to vaccine production, as well as related subjects such as storage and transportation of vaccine supply processes, shall bear the responsibility for the corresponding links in accordance with the law. Article 6 Key personnel responsibilities Key personnel of the holder shall specify their responsibilities. Legal representative / principal person in charge: responsible for establishing quality guidelines and quality objectives, providing resources to ensure production, circulation, drug alert activities continue to comply with relevant regulatory requirements, to ensure that the quality management department independently performs its duties, the vaccine production activities and vaccine quality of full responsibility. Head of Production Management: Responsible for the organization and implementation of the production activities of vaccine products in the enterprise, to ensure that production is organized in accordance with the approved process. Responsible for ongoing compliance with the production process. Head of Quality Management: Responsible for organizing the establishment of enterprise quality management system and ensuring that the system can continue to run well. Responsible for the quality of vaccine products. Quality authorized person: responsible for the release of vaccine products, to ensure that each batch of released products are produced, tested in accordance with the relevant regulations, approved processes and standards. Responsible for products released from the factory. Person in charge of drug alert: responsible for the establishment, operation and maintenance of drug alert system; Article 7 "Key Personnel Requirements" The holder's head of production management, the person in charge of quality management and the person esclying for quality shall have a bachelor's degree or above in medicine, pharmacy and other related majors (or intermediate or above), and have more than 5 years of experience in production quality management in relevant fields, and be able to perform their duties and assume relevant responsibilities in production and quality management. The person in charge of vaccine circulation quality management shall have a bachelor's degree or above in medicine, pharmacy and other related majors, or have intermediate or above professional and technical title and more than 3 years of experience in vaccine management or technical work, and be able to perform his duties and assume relevant responsibilities in vaccine circulation quality management. The person in charge of drug alert shall have medical, pharmacy, epidemiological, statistical or related professional background, undergraduate or above or intermediate professional and technical titles, and have more than three years of practical experience in drug alert work, and be able to perform his duties and assume relevant responsibilities in drug alert activities. The legal representative of the holder, the principal person in charge, the person in charge of production management, the person in charge of quality management and the person es charged with quality, and the person who has seriously lost faith in medicine shall not hold the above-mentioned position. Article 8 The holder shall, in accordance with the requirements of relevant laws and regulations, regulations, technical standards and quality specifications, establish a complete vaccine quality management system, conduct regular self-examination and continuous improvement of the operation of the quality management system. In accordance with the provisions, the holder shall review and supervise the quality management system of the suppliers involved in the production and circulation of vaccines, such as raw materials, packaging materials, storage and distribution services, to ensure that suppliers meet the relevant requirements for vaccine production and circulation, and constantly improve the quality system of vaccine production and circulation after the market. Article 9 The holder shall, in accordance with relevant laws and regulations and quality management norms and other requirements, establish a drug alert system, set up specialized agencies, be staffed with full-time personnel, actively collect and follow up and analyze suspected abnormal responses to vaccination, and take timely risk control measures. Holders should conduct self-tests and continuously improve the operation of the drug alert system. Holders should develop and implement post-market risk management plans for vaccines, conduct post-market studies on vaccines, further confirm the safety, effectiveity and quality control of vaccines, and conduct annual post-market evaluations of the safety, ability and quality control of vaccines on the market. Article 10 "Quality Risk Management" The holder shall carry out quality risk management for the whole process of vaccine production and circulation, identify, assess, control and communicate the risks that may exist in the course of the operation of the quality system, take effective preventive and control measures, and carry out a risk review in a timely manner until the risks are closed. Chapter III Vaccine Production Management Article 11 The State shall implement a strict system of access to vaccine production and strictly control the establishment of new vaccine production enterprises. Newly established vaccine production enterprises shall, in addition to meeting the conditions for the start-up of vaccine production enterprises, also comply with the relevant policies of the competent departments of the national vaccine industry. Article 12 The holder of the production license shall have the vaccine production capacity himself. When engaging in vaccine production activities, the drug production supervision and administration departments of the provinces, autonomous regions and municipalities directly under the Central Government where the production site is located shall submit the application materials for drug production licenses in accordance with the conditions stipulated in the Drug Administration Law, the Vaccine Administration Law and the Measures for the Supervision and Administration of Drug Production, and in accordance with the prescribed procedures for the administration of drug production licenses. The recipient shall be the enterprise that obtains the Drug Production License for the vaccine. Article 13 For vaccine varieties that meet one of the following conditions, the holder may apply for the commissioned production of vaccines: （一）The National Ministry of Industry and Information Technology proposes to stockpile the vaccines needed; （二）The National Health Department proposes disease prevention and control of much-needed vaccines; （三）If multi-link multi-priced vaccines do need to be commissioned for production, the entrusting and trusteeing parties shall be pharmaceutical production enterprises that meet the statutory conditions, in which one party holds more than 50% of the shares or shares of the other party, or both parties are subordinate companies holding more than 50% of the same pharmaceutical production enterprises. The scope of commissioned production includes the entire production process of the vaccine, or only the production of raw liquids or preparations. Article 14 When applying for the commissioned production of vaccines, research, evaluation and necessary verification shall be carried out in accordance with the relevant technical guidelines, and after the corresponding changes to the Drug Production License have been completed, an application shall be submitted to the receiving center of the State Drug Administration, and the application shall be submitted to the Application Form for The Commissioned Production of Vaccines (see annex 1) and the supporting materials stipulated in Article 13of these Provisions. Article 15 After receiving an application for commissioned production of vaccines, the receiving center of the State Drug Administration shall, in accordance with the requirements of Article 13 of these Provisions, conduct a formal examination of the application materials, make a decision on acceptance or inadmissibility within 5 working days, issue a written Notice of Acceptance or Notice of Inadmissibility, and indicate the date. The receiving centre will transfer the information received to the Drug Regulatory Department. Article 16 The provincial drug administration department where the trustee is located shall, in accordance with the provisions of Article 52 of the Measures for the Supervision and Administration of Drug Production, carry out a compliance inspection of the quality management norms for drug production on the entrusted party and report the results of the inspection to the State Drug Administration in writing. Article 17 The State Drug Administration shall, in accordance with the results of the inspection of compliance with the quality management norms for pharmaceutical production, examine the application for commissioned production of vaccines in accordance with the requirements of these Provisions and shall make a decision within 20 working days from the date of acceptance (not including on-site inspection and the time required for the applicant's supplementary information). If the examination complies with the provisions, it shall be approved and the "Vaccine Commissioned Production Approval" shall be issued to the entrusting party within 10 working days from the date of the written approval decision(see annex 2); Article 18 "Change of site of commissioned production" Change of production site during the commissioned production process of vaccine entrustment, the entrusting party shall, in accordance with the requirements of the relevant technical guidelines, submit to the drug review center a supplementary application for vaccine change of production site, and the vaccine commissioned production may be implemented only after approval. Article 19 The holder shall establish a complete production quality management system to ensure that each batch of products can be organized and produced in accordance with the approved process, and that the products meet the quality standards and registration approval requirements. In the production process, material supplier management, change control, deviation management, product quality review and analysis should be continuously strengthened. The use of information-based means to truthfully record all the data formed in the production and inspection process, to ensure that the production process continues to meet the statutory requirements. For manual operation steps that cannot be used to collect data online, the data formed by this process should be entered into the relevant information system or converted into electronic data in a timely manner to ensure that the relevant data are true, complete and traceable. Holders who record data using an information system that collects data in real time shall do so in accordance with State Drug Administration Proclamation No. 58 of 2020. Article 20 If the holder plans to stop production for more than 3 months due to such reasons as process upgrading, relocation and transformation (except for normal periodic production), he shall report to the drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the production stops production is discontinued for 3 months; If the holder's year-on-year production variety is unable to produce normally due to unexpected circumstances such as equipment failure and is expected to stop production for more than 1 month, he shall report it to the drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government within 3 days. Article 21 When the holder resumes production after a long-term shutdown of the vaccine (except for normal periodic production), he shall report to the drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government, and the drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government shall conduct a risk assessment in the light of the daily supervision and control situation, and, if necessary, carry out on-site inspection of the varieties that have resumed production. Article 22 In the course of production and circulation management, the holder shall immediately report to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where he discovers any significant deviation or major quality problem that may affect the quality of the vaccine product. The report includes at least the following: (i) Details of significant deviations or quality problems; (2) Information concerning the name, lot number, specification, quantity and flow of the product; (iii) adverse effects that have been or may be caused; (4) Emergency control or disposal measures have been taken; (5) To take further measures; (6) Other circumstances that should be stated. Article 23 The holder shall establish an annual report system, and the writing of the annual report on quality shall be written in accordance with the Requirements for the Writing of the Annual Report on the Quality of Vaccine Listing License Holders (Trial), and shall include, at a minimum, the production and issuance of vaccines, changes in key personnel, changes in production processes and sites, changes in raw materials, changes in key facilities and equipment, sales and distribution, suspected vaccination abnormalities, annual quality review, risk management, inspection and punishment. The holder shall, by the end of April of each year, report the annual report of the previous year in writing to the Food and Drug Audit and Inspection Center of the State Drug Administration and the drug regulatory departments of the provinces, autonomous regions and municipalities directly under the Central Government. Chapter Four Vaccine Circulation Management Article 24 The holder of the vaccine shall, in accordance with the agreement of the procurement contract, sell the vaccine to the disease prevention and control agency. The overseas vaccine holder shall designate a domestic pharmaceutical wholesale enterprise with the ability to guarantee the quality of cold-chain drugs to sell the same variety of vaccines imported by the holder in a unified manner, fulfill the obligations of the holder in the sales process, and assume responsibility. Article 25 When selling a vaccine, the holder shall at the same time provide a copy or electronic document of the approval certificate stamped with his seal, and if the vaccine is sold, he shall also provide a copy or electronic document of the customs clearance document for imported drugs stamped with his seal. The holder shall, in accordance with the provisions, establish a true, accurate and complete sales record, which shall contain at least the generic name, approval number, lot number, specification, dosage form, validity period, purchaser, quantity sold, unit price, amount, date of sale and holder information, etc., and shall also include entrusted storage and transportation of enterprise information, and shall be kept for at least five years after the expiration of the vaccine for inspection. Article 26 Holders and disease prevention and control agencies shall, on their own, distribute vaccines in cold chain storage and transportation conditions, meet the relevant requirements of the regulations governing the storage and transportation of vaccines, and shall be liable for the quality of vaccines distributed in accordance with the law. The purchasing contract signed between the holder and the disease prevention and control agency shall specify the unit, mode of distribution, time limit for distribution and place of receipt. Article 27 The holder may entrust an enterprise with the conditions for the transportation and storage of refrigerated frozen drugs with the quality management norms for drug operations to distribute and store vaccines in the region. The holder shall evaluate the distribution capacity of the vaccine distribution enterprise, strictly control the number of distribution enterprises, and ensure that the distribution process continues to meet the statutory requirements. Holders in the same province, autonomous region, municipality directly under the Central Government to choose vaccine distribution enterprises in principle shall not exceed 2. An enterprise that accepts entrusted distribution may not re-commission. Article 28 Where the holder entrusts the distribution of the vaccine, he shall promptly report to the provincial drug supervision and administration department where the vaccine is located and where the vaccine is received, respectively, the information on the varieties of the vaccine entrusted for distribution and the assessment of the conditions for distribution by the entrusted storage, the distribution conditions of the transport unit, the distribution capacity and the information traceability. Where a disease prevention and control agency entrusts a distribution enterprise to distribute a vaccine, it shall report it to the drug supervision and administration department and the health department at the same level. The entrusted storage and transportation enterprises shall comply with the relevant provisions of the Drug Administration Law, the Vaccine Management Law and the Drug Management Quality Management Code, and shall have the ability of information tracing. Article 29 The holder, the disease prevention and control agency and the relevant parties to the vaccination unit shall, in accordance with the requirements of the national electronic traceability system for the whole process of vaccines, truthfully record the sale, storage (whether each transfer is scanned), transport and use information, and realize the traceability of the entire process from production to use of the minimum packaging unit. The vaccine distribution unit shall, in accordance with the requirements of the holder, record the storage and transportation links truthfully and completely. Article 30 Vaccines for Special Needs Vaccines Vaccines required for special circumstances such as non-clinical research, clinical research and the production of blood products may be purchased from the holders of the vaccine market license after the relevant user units have reported them to the drug regulatory departments of the provinces, autonomous regions and municipalities directly under the Central Government. Holders and relevant users should be strictly managed and documented to ensure that vaccine sales and use are traceable. Chapter 5 Vaccine Change Management Article 31 Basic Principles of Change Management: The holder shall, on the principle of continuously improving the safety, effectiveness and quality control of the products, carry out quality tracking and trend analysis of the listed products, improve the production process, improve the production process control capabilities, continuously improve the quality control standards, and improve the quality control level of intermediate products and finished products. Article 32 Where changes occur in the production process, production site, production workshop and production line, and equipment of key production facilities of a vaccine that have been listed, the holder shall conduct research and verification, fully assess the impact of the change on the safety, effectiveness and quality control of the vaccine, determine the classification of the changes in accordance with the relevant provisions of the post-market change research guidelines for biological products, the technical guidelines for the study of changes in the production process after the vaccine is listed, etc., and make additional applications or reports to the drug regulatory department in accordance with the procedures for drug registration management. In the event of a change in the production site of an overseas holder, a supplementary application shall be submitted to the Drug Review Center of the State Drug Administration. Article 33 The holder shall complete the evaluation, demonstration and research and, if approval is required, only after examination and approval by the State Drug Administration or the drug supervision and administration department of a province, autonomous region or municipality directly under the Central Government may the product be listed for sale after the change. Article 34 In the event of a major change in the production process, a change in the production site, a change in the workshop/production line, etc., the drug supervision and administration department of a province, autonomous region or municipality directly under the Central Government shall carry out a compliance inspection of the drug production quality management norms; To report to the Drug Review Center of the State Drug Administration for supplementary application matters, in accordance with Article 52 of the Measures for the Administration of Production Supervision and Administration, to carry out quality management norms for drug production compliance checks. Chapter 6 Vaccine Supervision and Management Article 35 The State Drug Administration shall be responsible for the supervision and management of the quality of vaccines throughout the country. Responsible for the formulation of rules and regulations and norms, standards and guidelines for the supervision and management of vaccine production and circulation and supervision and guidance of implementation, the organization of vaccine inspection and spot checks, supervision and guidance of vaccine approval management, in cooperation with the health and health departments to develop a unified vaccine traceability standards and norms, the establishment of a national electronic vaccine traceability system, the realization of the vaccine process information traceability. The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the supervision and management of vaccine production and circulation within their administrative areas. Responsible for the relevant licensing and filing matters in the production and circulation of vaccines, responsible for formulating the annual plan for supervision and inspection of vaccine production and distribution enterprises and carrying out supervision and inspection, sending inspectors to vaccine production enterprises, responsible for the administration of vaccine approval and issuance by local drug inspection institutions within their administrative areas, carrying out monitoring and investigation of abnormal reactions to vaccinations in accordance with their duties, and guiding the departments responsible for drug supervision and management in cities and counties to carry out the quality supervision and management of vaccines in the vaccination sector. The department responsible for drug supervision and management in the city or county shall be responsible for the supervision and management of vaccine circulation and vaccination in the administrative area, cooperate with the health and health departments in the monitoring and reporting of abnormal vaccine reactions, and improve the mechanism of quality communication and joint disposal. Article 36 The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall assume the supervision and management duties of the vaccine production and circulation activities within their jurisdictions, supervise and manage the trustees who accept commissioned production and commissioned distribution within their jurisdictions, and the drug supervision and administration departments of the provinces, autonomous regions and municipalities directly under the Central Government where the entrusted parties are located shall cooperate in carrying out supervision and management work, and the two parties may conduct joint inspections if necessary. Article 37 "Technical Institution Responsibility" The drug regulatory department shall, in accordance with law, establish or designation professional and technical institutions to undertake technical work such as post-market inspection of vaccines, approval of inspection and testing, monitoring of suspected vaccination abnormal reactions and safety evaluation. (1) The drug inspection agency shall be responsible for organizing the drafting of regulations and inspection guidelines for post-market inspection of vaccines, and shall carry out the work of vaccine inspection in accordance with its duties. (2) The drug review body shall be responsible for drafting the relevant provisions and guidelines for changes after the listing of vaccines, and shall carry out the technical review of changes after the listing of vaccines in accordance with its duties. (iii) The drug evaluation agency shall be responsible for drafting the relevant provisions and guidelines for post-market monitoring and safety evaluation of vaccines, and shall carry out technical work on post-market monitoring and safety evaluation of vaccines in accordance with its duties. (4) The vaccine approval authority shall promptly inform the relevant drug supervision and administration department of the major quality risks found in the process of vaccine batch issuance, and the department receiving the report shall initiate investigation of vaccine inspection, inspection or quality and safety incidents on the basis of the risk. (v) The information management agency shall be responsible for the construction and management of the vaccine traceability collaborative service platform, the vaccine safety credit file, and the unified coding of vaccine production sites. (6) The above-mentioned professional and technical institutions for vaccine supervision shall undertake to carry out relevant technical activities in accordance with regulations, norms, procedures and standards, and shall be responsible for the results of technical supervision. (7) Drug regulatory departments at all levels and their technical institutions shall establish mechanisms for coordination and cooperation in vaccine communication and cooperation that are connected from top to bottom and from left to right. In the course of on-site inspection of vaccines, monitoring of abnormal reactions and approval, timely communication of information and notification, and if significant product quality risks or serious adverse reactions are found, effective measures shall be taken immediately to control the risks. (8) Higher-level professional and technical institutions shall guide the construction of quality systems and business work of technical institutions at the next level. Article 38 The drug supervision and administration department shall, in addition to complying with the general provisions of the Measures for the Supervision and Administration of Drug Production and the Regulations on the Administration of Drug Inspection after listing, carry out the following inspections: (1) The State Drug Administration organizes the National Vaccine Inspection Center to conduct inspections of vaccine manufacturers in production and strengthen random spot checks; (2) The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall carry out supervision and inspection on vaccine production enterprises and distribution enterprises in their administrative regions, and cooperate with the State Drug Administration in conducting vaccine inspection and spot checks; (3) The departments responsible for drug supervision and management in cities and counties shall carry out quality supervision and inspection of the vaccination links. Article 39 When carrying out supervision and inspection on the holders, the drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall, in accordance with the principle of quality risk management, formulate inspection plans and make inspection plans based on the on-site inspection situation, the declaration of changes in listing permits, the quality sampling situation after listing, the issuance of vaccine products, information on suspected vaccination abnormal reactions, product recall information, etc. The inspection plan should take into account the frequency of inspection, the scope of inspection, the key content, the length of inspection and the professional background of the inspector. The departments responsible for drug supervision and management at all levels may, in accordance with the inspection plans and programmes, carry out on-site inspections of the holder's production sites, business premises and vaccine storage and distribution enterprises, disease prevention and control institutions and vaccination units, and the inspected units shall cooperate with them and shall not refuse, evade or hinder them. In the course of on-site inspection, relevant evidence may be collected, relevant information, physical objects, etc. collected in accordance with the law may be used as the basis for determining the facts in administrative punishment; if samples need to be taken for inspection, samples may be taken in accordance with the relevant provisions of sampling and inspection or notify the drug supervision and administration department of the place under inspection to sample according to the provisions, and samples taken shall be inspected by qualified technical institutions. Article 40 The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall station at least two inspectors to each vaccine production enterprise in their administrative areas. Resident inspectors should do the following checks: （一）To complete the inspection tasks formulated by the drug supervision and administration departments of the provinces, autonomous regions and municipalities directly under the Central Government as required, and promptly report the supervision and inspection to the drug supervision and administration departments of the provinces, autonomous regions and municipalities directly under the Central Government, and make recommendations for supervision; （二）To inspect the defect items found by the drug supervision and administration departments of the provinces, autonomous regions and municipalities directly under the Central Government, and urge the enterprises to make rectifications on time and verify the rectification situation; （三）When the clues of illegality and violation of the enterprise are found, they immediately report to the dispatch department and cooperate with the regulatory authorities to collect evidence; （四）Complete other matters as assoly assoly assosted by the drug regulatory departments of the provinces, autonomous regions and municipalities directly under the Central Government. Article 41 The State Drug Administration shall conduct an annual vaccine inspection of the holders; the drug supervision and administration departments of the provinces, autonomous regions and municipalities directly under the Central Government shall inspect the holders and their entrusted production enterprises twice a year, including at least once a compliance inspection of the drug quality management norms, and once a year on the vaccine distribution enterprises and the disease prevention and control agencies at the same level; and the departments responsible for drug supervision and administration in the municipalities and counties shall inspect the disease prevention and control institutions and vaccination units at the same level once a year. Drug regulatory authorities at all levels may conduct cause checks at all levels if they find clues that could have a significant impact on vaccine quality. Article 42 After the inspection is over, the institution responsible for the inspection shall evaluate the inspection results, make the inspection conclusions and form an audit report. If the inspection finds that the holder has defective items, the local drug supervision and administration department shall, in accordance with its duties, urge the holder to carry out rectification, and the rectification shall be verified after the completion of the rectification. If the inspection finds that the holder has a major quality hazard or risk, the local drug supervision and administration department shall, in accordance with its duties, immediately take appropriate administrative measures to control the risk and promptly report it to the State Drug Administration. If the inspection finds that the holder has caused any violation of the law, the local drug supervision and administration department shall conduct an investigation in accordance with its duties, punish him according to law in accordance with the Drug Administration Law and the Vaccine Administration Law, and report the results of the treatment to the State Drug Administration in accordance with the provisions. If the inspection finds that the holder, the vaccine distribution enterprise, the disease prevention and control agency and the vaccination unit have violated the regulations on vaccine storage and transportation management and may affect the quality of the vaccine, the local drug supervision and administration department shall order them to suspend the distribution or distribution of the vaccine, and inform the competent department of health and health at the same level and urge the relevant units to carry out rectification. After the rectification is completed, the vaccine distribution or distribution can only be resumed after the local drug supervision and administration department has checked that it meets the requirements. If the inspection finds that the holder or the vaccine distribution enterprise has violated the law and regulations, the local drug supervision and administration department shall conduct an investigation in accordance with its duties, punish him according to law in accordance with the Drug Administration Law and the Vaccine Administration Law, and report the results of the treatment to the State Drug Administration in accordance with the provisions. Article 43 The holder of a vaccine recall shall, in accordance with the provisions of the Measures for the Administration of Drug Recalls, establish a sound drug recall management system, collect relevant information on vaccine safety, investigate, evaluate and recall vaccine products that may have safety hazards. If the drug regulatory authority investigates and evaluates that the vaccine is in an unreasonable risk that may endanger human health and life safety , the holder should recall the vaccine and not recall it , and the holder should be ordered to recall the vaccine . Article 44 "Emergency Management" Vaccines with suspected vaccination reactions and adverse events in groups shall be disposed of in accordance with the relevant emergency plans of the drug regulatory department if they are confirmed or suspected to be related to the quality of the vaccine, or the information on vaccine quality and safety found in routine supervision, inspection and risk monitoring, or other vaccine quality and safety events that seriously affect public health. Chapter VII By-laws Article 45 These Provisions shall come into effect on the month of the year. Attached: 1. Application form for the commissioned production of vaccines 2. Approvals for the commissioned production of vaccines by the State Drug Administration are attached to 1 Application form for commissioned production of vaccines Delegate's Business Name: (Stamped) Application date: Month of year Prepared by the State Drug Administration Fill in the form description This form is the basic document of the applicant's application for vaccine commissioned production, and it is also the basis for the drug regulatory department to approve the application, and it is the focus of the drug regulatory department's examination of the application for vaccine commissioned production, which must be filled in accurately, standardized and meet the requirements of filling out the description. 1. Complete an application form for each declared variety (in vaccine approval number) and report a set of applications. 2. The application is filled in with the vaccine commissioned production or the vaccine commissioned production continuation. 3. Theproduction address and scope of production of the Pharmaceutical Production License, and the range of varieties that pass the GMP conformity check, fill in only the content corresponding to the vaccine varieties to be commissioned. 4. At the same time as the paper application is submitted, the electronic document of the Application Form for The Commissioned Production of Vaccines shall be submitted. 5. Under the principal's declaration opinion, the following contents should be filled in: to file an application for entrustment of production, detail the reasons for entrustment of production, and briefly outline the relevant situation of the entrusting party, the trustee, the proposed entrustment of the production of vaccines, the time limit for entrustment of production, the evaluation opinions of the trustee, the way of supervision of the entrusted party's production management and quality management, etc. The name of the principal's business The organization code Provinces The registered address Zip code Application matters Legal representative Major The person in charge of quality Major Quality authority Major Business contact Contact the phone Fax Mobile phone License for the production of medicines Number Valid until License for the production of medicines Production address and production Range Address and scope of the GMP compliance check It is proposed to commission production Vaccine name, prescription composition and commissioned production range Specifications Dosage form Drug approval number Drug approval number Valid until Direct contact with the packaging materials or containers of the drug The name of the trustee's business The organization code Provinces The registered address Zip code Legal representative Major The person in charge of quality Major Quality authority Major Business contact Contact the phone Fax Mobile phone Drug production license number Valid until Drug production licenses, Production address and production range Address and range of GMP compliance checks The intended production address to be entrusted The principal declares the opinion Sign and seal the legal representative or business owner: Year, month, day Attached 2 The State Drug Administration commissioned the production of vaccines Reference: WT The name of the drug Dosage form rules Drug approval number Wei To Party The name of the business The organization code The registered address affected To Party The name of the business The organization code The production address Approval conclusions To the month of the year. The production approval of this entrustment shall be valid only if the "Drug Production License" of both parties is entrusted to the production, the approval documents for the commissioned production of the drug are within the validity period, the trustee passes the GMP compliance inspection, and the change of production site is approved by registration. Expiration period Main delivery CC State Drug Administration (Official Seal) Year, month, day Note:1. Numbering requirements: "WT plus four-bit year number and four-bit sequence number", such as "WT20200001"; The production address of the trustee where the entrusted production variety is located shall be filled in under the production address ofthetrustee; The main delivery shall be to the entrusting party, the province, autonomous region or municipality directly under the Central Government, the Food and Drug Administration and the trustee.