The State Drug Administration on issuing the "Regulations on the Management of Vaccination and Circulation"

The State Drug Administration on issuing the "Regulations on the Management of Vaccine Production and Circulation"

(No. 55, 2022)

In order to implement laws and regulations such as the "Drug Administration Law of the People's Republic of China" and the "Vaccine Management Law of the People's Republic of China", the scientific and effective vaccine production and circulation supervision and management system is constructed. The production and circulation management activities are standardized, and the State Drug Administration has organized the formulation of the "Regulations on the Management of Vaccine Production and Circulation", which is now released and implemented from the date of release.

Special announcement.

State Drug Administration

July 8, 2022

Regulations for vaccine production circulation management

Chapter 1 General Principles

Article 1 In order to strengthen the supervision and management of vaccine production circulation, regulate vaccine production and circulation activities, in accordance with the "Drug Administration Law of the People's Republic of China", "The People's Republic of China Vaccine Management Law" and "Measures for the Management of Drug Production", Regarding laws, regulations, and regulations, these regulations are formulated.

Article 2 This regulation is applied to activities such as vaccine production, circulation, and its supervision and management in the People's Republic of China.

Article 3 Entering vaccine production and circulation activities shall abide by the relevant laws, regulations, regulations, standards, standards, etc. of drugs and vaccines to ensure the true, accurate, complete and traceability of the entire process of information.

Chapter 2 The responsibility of the holder's main body

Article 4 The state shall implement a system of listing permit holders on vaccines. The holder's responsibility for the safety, effectiveness, and quality controllability of the vaccine, the management activities such as production and circulation after vaccine listing in accordance with laws and regulations, and shall bear corresponding responsibilities.

If the commissioned production is carried out, the holder is responsible for the main body of the vaccine commissioned by commissioned production, and the entrusted vaccine manufacturer is responsible for the trustee production behavior.

Article 5 The main raw materials, auxiliary materials, and the packaging materials suppliers of the drugs related to the production of vaccine production, and related subjects in the process of storage and transportation during the vaccine supply are responsible for 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 guidelines and quality goals, providing resource guarantee production, circulation and other activities to continuously meet the requirements of relevant laws and regulations, ensure that the quality management department fulfills its duties independently, and is fully responsible for vaccine products production, circulation activities and quality. Essence

Person in charge of production management: Responsible for organizing and implementing vaccine product production activities to ensure that production is organized in accordance with the approved production process and quality control standards, and the continuous compliance of the production process is responsible.

The person in charge of quality management: Responsible for organizing the establishment of an enterprise quality management system and ensuring that the system can continue to operate well, and it is responsible for continuous compliance with the quality management of vaccine products.

Quality victim: Responsible for the release of vaccine products to ensure that the production and inspection of each batch of release products meet the approved production technology and quality control standards, which is 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 the quality of the quality authority shall have a bachelor's degree in medical, pharmacy, biology and other related majors, or have a professional and technical titles with intermediate or above. The above experience in production quality management in the field of vaccine can fulfill its duties in production and quality management and assume corresponding responsibilities.

The person in charge responsible for vaccine flow quality management shall have a bachelor's degree in medical, pharmacy, biology or above, or have a professional titles of or above or above, have more than three years of experience in vaccine management or technical work experience, and can be in the quality management of vaccine liquidity quality management Perform your duties and bear the corresponding responsibilities.

The legal representative, the principal person in charge, the person in charge of the production management, the person in charge of the quality management, and the quality authority of the holder shall have a good credit record, and the serious dishonesty personnel shall not hold the above position.

Article 8 The holder shall establish a complete vaccine quality management system in accordance with the requirements of laws, regulations, regulations, rules, standards, and specifications, and regularly conduct self -inspection of the operation of the quality management system and continuously improved.

The holder shall review and supervise the quality management system of suppliers such as raw materials, auxiliary materials, and direct contact with drugs involved in vaccine production and circulation in accordance with regulations. It is required to continuously improve the vaccine production and flow quality management system after listing.

Article 9 The holder shall carry out quality risk management of the entire process of vaccine production and circulation, and perform risk recognition, evaluation, control, and communication that may be risky during the operation of the quality system. Until the risk was effectively controlled.

Chapter III Vaccine Production Management

Article 10 The state implements a strict admission system for vaccine production and strictly controls new vaccine production enterprises. The newly opened vaccine manufacturers should also meet the relevant policies of the national vaccine industry authorities in addition to the running conditions of the vaccine manufacturers.

Article 11 The holder shall have the vaccine production capacity. When engaged in vaccine production activities, in accordance with the requirements stipulated in the "Drug Administration Law", "Vaccine Management Law" and "Measures for the Supervision and Management of Drug Production", in accordance with the procedures for the management of drug production permits Application materials for drug production license. If the production capacity of the holder's vaccine does need to be commissioned, the trustee shall be a pharmaceutical manufacturer that obtains the scope of vaccine production.

The packaging, labels, and packaging of vaccines shall be carried out in pharmaceutical manufacturers who obtain the scope of vaccine production. Article 12 The vaccine variety that meets one of the following circumstances, the holder may submit a vaccine to entrust production application:

(1) The industrial and information management departments of the State Council put forward the need for reserves, and believe that the holder's existing production capacity cannot meet the needs;

(2) The Health Management Department of the State Council proposes to prevent and control the disease, and it is believed that the holder's existing production capacity cannot meet the needs;

(3) Production of multi -price vaccines.

The scope of commissioning production should be all the processes of vaccine production. If necessary, if you commission the production of multi -price vaccines, after organizing and agreed by the State Drug Administration, it may be the production stage of the vaccine raw liquid or the production stage of the preparation.

Article 13 Anyone who applies for vaccine commission to produce, the entrusting party and the trustee shall conduct research, evaluation and necessary verification in accordance with the requirements of relevant technical guidance principles, and after completing the changes in the production scope of the "Drug Production License", the country will be directed in the direction of the commissioning direction The drug supervision and administration bureau's acceptance and reporting center submitted an application. When applying, the "Application Form for Vaccine" (Annex 1) shall be submitted, the application information (Annex 2) shall be submitted, and the provisions of the provisions of Article 12 are proof materials.

Article 14 After the National Drug Administration's acceptance and the reporting center receives an application for production application, the application information shall be reviewed in accordance with the requirements of Article 13 of these regulations. The decision to be accepted, the written "acceptance notice" or "not notice notice" was issued, and the date was indicated.

Article 15 The State Drug Administration shall review the application of vaccine commissioned production applications in accordance with the requirements of these regulations, and it shall make a decision within 20 working days. The time required for the applicant's supplementary information is not included in the approval time limit.

If the review meets the regulations, it will be approved by the provisions, and the "Vaccine Entrusted Production Approval" (Annex 3) will be performed by the State Drug Administration and will be issued to the commissioner within 10 working days. Reasons for explanation; if the materials need to be supplemented, the written notice is notified to submit supplementary materials within the prescribed time.

The "Vaccine Entrusted Production Approval" is also copied to the commissioner and the provincial drug supervision and management department of the trustee.

Article 16 After the entrusting party obtains the "Vaccine Entrusted Production Approval", it shall handle changes in the registered management items involved in the change of production venues in accordance with the relevant provisions of the "Administrative Measures for the change of the drug (trial)".

Provincial drug supervision and management departments of the commissioner and the locality of the trustees shall conduct compliance with the commissioner and the trustees in accordance with the provisions of Article 52 of the Measures for the Supervision and Administration of Drug Production.

The commissioner and the trustees have completed the corresponding changes according to law, and the quality management specifications of drug production are compliant inspections. The self -inspection and issuance of the production products are qualified, and they can be listed for sale after meeting the statutory release conditions.

Article 17 The holder shall establish a complete production quality management system, strictly organize production in accordance with the approved production process and quality control standards to ensure that the product meets the listing requirements of the listing. During the production process, we should continue to strengthen the management of material suppliers, change control, deviation management, and product quality retrospective analysis. All data formed in the process of production and inspection are truthfully recorded by information technology to ensure that the entire production process continues to meet statutory requirements. For artificial operation steps that cannot be collected online, data formed by this process should be entered in time into relevant information systems or transformed into electronic data to ensure the authenticity, accuracy, completeness, and traceability of the relevant data. At the same time, relevant paper is preserved as required. Original record.

Article 18 If the holder is upgraded and relocated (except for normal -cyclical production), the holder plans to discontinue production for more than 3 months, and shall report to the provincial drug supervision and management department of the local area before the production is suspended for 3 months.

The holder's annual production species due to emergencies such as equipment faults can not be produced normally. If the production is expected to be suspended for more than one month, it shall report to the provincial drug supervision and management department where the local drug supervision and management department is located within 3 working days.

Article 19 If the holder's long -term suspension of production (except for normal and periodic production) is planned to resume production, it shall report to the provincial drug supervision and management department of the local area before restoring production. Provincial drug supervision and management departments will conduct risk assessments based on daily supervision. If necessary, on -site inspections can be conducted on the resumed varieties.

Article 20 In the process of production and circulation management, the holder finds that a major deviation or major quality problem that may affect the quality of vaccine products shall immediately report to the provincial drug supervision and management department of the local provincial drug supervision and management department. In the process of circulation management, imported vaccines find that a major deviation or major quality problem that may affect the quality of vaccine products shall report to the provincial drug supervision and management department of the imported port where the foreign agency is located by the overseas vaccine holder. The report includes at least the following content:

(1) Details of major deviation or quality issues;

(2) Information involving the name, batch number, specifications, quantity, flowing direction of the product;

(3) The adverse effects that have or may have;

(4) Emergency control or disposal measures that have been taken;

(5) The measures to be taken further;

(6) Other situations that should be explained.

Article 21 The holder shall establish an annual report system, and the annual report of quality shall be written in accordance with relevant requirements. The quality annual report should include at least vaccine production and approval, key personnel changes, production processes and venue changes, changes in raw materials and auxiliary materials, changes in key facilities and equipment, deviations, stability inspection, sales and distribution, suspected suspected Preventing abnormal response, risk management, inspection and punishment situation. The holder shall upload the previous annual quality annual report through the "Pharmaceutical Business Management System of the National Drug Smart Supervision Platform" at the end of April each year. The provincial pharmaceutical supervision and management departments and the Chinese Inspection Institute, the Pharmaceutical Examination Center of the State Drug Administration, the inspection center, the evaluation center, the information center and other departments, in accordance with the duties, inquiries, review, inspect, evaluate relevant work and other related work and other related work. Important reference for risk assessment.

Chapter 4 Vaccine Circulation Management

Article 22 The holder shall sell the vaccine to the disease prevention and control institution in accordance with the agreement of the procurement contract.

In principle, overseas vaccine holders should specify a domestic drug wholesale enterprise with cold chain drug quality assurance capabilities to uniformly sell their same varieties of vaccines, fulfill the holders' obligations in the sales link, and bear responsibility.

第二十三条持有人在销售疫苗时，应当同时提供加盖其印章的批签发证明复印件或者电子文件；销售进口疫苗的，还应当提供加盖其印章的进口药品通关单复印件或者Electronic document.

The holder shall establish a real, accurate and complete sales record in accordance with the regulations. The sales record shall include at least the universal name, approval number, batch number, specifications, validity period, sales unit, sales quantity, unit price, sales date and sales date, sales date, sales date, sales date If the holder's information, etc., the entrusted storage and transportation shall also include the information of the entrusted storage and transportation corporate information, and store it until the validity period of the vaccine is not less than 5 years.

Article 24 The holder of the holder and the disease prevention and control institution shall have the relevant requirements of the vaccine cold chain storage and transportation conditions, meet the requirements of vaccine storage and transportation management specifications, and shall be responsible for the quality of the delivery vaccine in accordance with the law.

The procurement contract signed by the holder and the disease prevention and control institution shall clearly implement the unit, distribution method, distribution time limit, and place of receipt of delivery.

Article 25 The holder may entrust the quality management of drug operations to standardize the transportation and storage vaccines of refrigerated and frozen drug transportation and storage conditions. The holder shall evaluate the distribution capacity of the vaccine distribution company, strictly control the number of distribution companies, and ensure that the distribution process continues to meet its legal requirements. The holder must not exceed two in principle in the same provincial administrative area.

If the disease prevention and control agency entrusts the distribution enterprise to distribute vaccines, the distribution capacity of the vaccine distribution enterprise shall be evaluated to ensure the relevant requirements of the vaccine cold chain storage and transportation conditions meet the requirements of vaccine storage and transportation management specifications.

Article 26 If the holder entrusts the delivery vaccine, the entrusting the distribution of information on the distribution of vaccine varieties and entrusted storage, transportation conditions, distribution capabilities, and information traceability capabilities shall be entrusted to the partner's location and the location of the vaccine. The provincial drug supervision and management department reports that the provincial drug supervision and management department shall make announcements in a timely manner. If the disease prevention and control agency entrusts the distribution enterprise to send vaccines, it shall report to the drug supervision and management department of the same level and the competent health department of the health and health department. Enterprises receiving commissioned distribution shall not be commissioned again.

Article 27 The holders of the holder, the disease prevention and control institution and the vaccination unit, and the relevant parties of the entrusted storage and transportation enterprise shall truthfully record the vaccine sales, storage, transportation, and use information in accordance with the requirements of the national vaccine electronic traceability system to achieve the minimum packaging unit from the obedience of the packaging unit. The entire process of production to use can be traced.

The vaccine distribution unit shall record information in the storage and transportation links in real and completely according to the requirements of the holder.

Article 28 The vaccine required for special circumstances such as non -clinical research, clinical research, and blood product production, and reports to the provincial pharmaceutical supervision and management department of the local provincial drug supervision and management department. Institutional purchase. The holder, the disease prevention and control agencies and the relevant use units shall strictly manage it and make relevant records to ensure that the vaccine sales and use can be traced.

Chapter 5 Vaccine Change Management

Article 29 The holder shall conduct quality tracking and trend analysis of the quality of the product based on the principle of continuously improving the safety, effectiveness and quality control of the product, improving the production process, improving production process control capabilities, and continuous improvement of quality Control standards to improve the quality control level of intermediate products and finished products.

Article 30 If the production process, production site, production workshop and production line, and key production facilities and equipment of the holder have changed the vaccine, research and verification shall be conducted to fully evaluate the changes in the safety, effectiveness and quality of the vaccine. The impact of controllingness, in accordance with the relevant provisions of the "Administrative Measures for changes after the listing of drugs (trial)", "Principles of the Research Technical Guidance of Pharmaceutical Change of Biological Products (Trial)", etc. The procedure proposes supplementary applications, filing or reporting.

Article 31 The holder shall conduct evaluation, demonstration, research, and necessary verification on relevant changes. If the approval or filing shall be approved or filing, it shall be implemented after reviewing and approval by the procedure or shall be implemented. Article 32 In case of changes in the production venue of the holder, the provincial pharmaceutical supervision and management department shall conduct a compliant inspection of the quality management specifications of drug production; other changes shall be determined by the provincial drug supervision and management department to determine whether it is carried out in accordance with the principle of risk management. Drug production quality management specifications are compliant inspection.

The supplementary application of the Drug Administration of the State Drug Administration shall, in accordance with Article 52 of the "Measures for the Supervision and Management of Drug Production," conducts a compliant inspection of drug production quality management specifications.

Chapter 6 Vaccine Supervision and Management

Article 33 The quality supervision and management of the National Drug Administration is in charge of the national vaccine production circulation link. The rules and regulations, specifications, standards and guidelines for vaccine production and circulation supervision and management, and supervise and guide the implementation; organize and guide the implementation of vaccine inspections; supervise and guide vaccines to issue management work, implement commissioned production approval; Staying standards and specifications, establish a national vaccine electronic traceability system, and realize the information of the entire process of vaccine.

Provincial drug supervision and management departments are responsible for the supervision and management of vaccine production circulation in their own administrative areas. Responsible for vaccine production and circulation related permits and filing matters; responsible for formulating annual vaccine production, distribution enterprise supervision and inspection plans and conducting supervision and inspection; responsible for sending inspectors to vaccine manufacturers; Management work; conducting the monitoring and investigation of the abnormal response of vaccination in accordance with responsibilities; departments responsible for guiding the city and county to undertake the duties of drug supervision and management to carry out vaccine quality supervision and management of vaccine circulation and vaccination.

The departments that the city and counties bear the duties of drug supervision and management are responsible for vaccine circulation and vaccination quality supervision and management of vaccination and vaccination in their own administrative areas; Essence

Article 34 The provincial pharmaceutical supervision and management department shall assume the supervision and management responsibilities of vaccine production and circulation activities in the administrative area, and supervise and manage the trustees who accept the commissioned production and entrust distribution in the administrative area.

If the holder and the trustee are not in the same provincial administrative area, the provincial drug supervision and management department of the holder is responsible for the supervision and management of the holder. The supervision and management of enterprises, the provincial drug supervision and management departments where the holder and the entrusted enterprise is located shall cooperate with each other to carry out supervision and management work, and joint inspections can be carried out if necessary.

Article 35 The drug supervision and management department establishes or designated professional and technical institutions in accordance with the law to undertake technical work such as inspection, approval, and suspected prevention monitoring and safety evaluation after the vaccine listing.

(1) Drug inspection agencies are responsible for organizing relevant regulations, inspection guidelines for drafting vaccines, and conducting vaccine examinations in accordance with their duties.

(2) Drug review agencies are responsible for the relevant provisions and guidance principles of registration and management involved after the vaccine listing, and conduct relevant technical review work in accordance with their duties.

(3) Drug evaluation agencies are responsible for drafting the relevant regulations and guidance principles of monitoring and safety evaluation after the vaccine listing, and carried out the technical work of monitoring and safety evaluation after the vaccine listing.

(4) The vaccine batch issuance agency shall timely notify the relevant drug supervision and management departments discovered during the process of issuing the vaccine approval, and the departments receiving the report shall start the vaccine inspection, inspection or quality and safety incident investigation based on risk.

(5) The information management agency is responsible for the construction and management of vaccine traceability and cooperative service platforms, vaccine safety credit archives, and uniform encoding of vaccine production sites.

The above -mentioned vaccine supervision professional and technical institutions shall carry out related technical activities in accordance with regulations, specifications, regulations, and standards, and are responsible for the results of technical supervision.

Higher -level professional and technical institutions should guide the quality system and business work of the next level of technical institutions.

Drug supervision and management departments and technical institutions at all levels shall establish a coordinated cooperation mechanism for vaccine communication and coordination and coordination and cooperation between up and down, and left and right. In the process of checking on -site inspection, suspected prevention of inoculation of abnormal response and approval, timely communicate information and report; find that major product quality risks and severe suspected prevention abnormal reactions should be immediately taken, and effective measures should be taken to control the risk.

Article 36 The supervision and inspection of the drug supervision and management department shall be supervised and inspected after the vaccine listing. In addition to complying with the "Measures for the Supervision and Management of Drug Production" and the "Administrative Measures for Drug Inspection (Trial)", the following methods should also be carried out:

(1) The 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 pharmaceutical supervision and management department.

(2) Provincial pharmaceutical supervision and management departments shall carry out supervision and inspection of drug wholesale enterprises in the administrative area, distribution enterprises, and sales of imported vaccines, and cooperate with the State Drug Administration for vaccine inspections and spot checks; Enterprises and disease prevention and control institutions of the same level carry out supervision and inspection; units provided by vaccine production and circulation such as products or services provided by vaccine production and circulation if necessary.

(3) The departments of cities and counties undertake the duties of drug supervision and management to carry out quality supervision and inspection of disease prevention and control agencies and vaccination units.

Article 37 When the department responsible for drug supervision and management at all levels is responsible for the supervision and inspection of the holder, the trustee's production enterprise, the vaccine distribution enterprise, the disease prevention and control institution and the vaccination unit, the inspection shall be formulated in accordance with the principle of quality risk management The plan, according to the previous on -site inspection situation, quality annual report, listing of listing permits, after listing, quality sampling, approval situation, suspected prevention of vaccination abnormal response monitoring, product recall information, complaint reporting, etc., formulate inspections, formulate inspections plan. The formulation of inspection plans should consider inspection frequency, inspection range, key content, examination duration, and professional background of inspectors.

The departments responsible for drug supervision and management at all levels can conduct on -site inspections on the production venues, operating venues and vaccine distribution enterprises, disease prevention and control agencies and vaccination units according to the inspection plan and plan. , Escape or obstruct. During the on -site inspection process, relevant evidence can be collected, and relevant materials and physical materials collected in accordance with the law can be used as the basis for identifying the facts in administrative penalties; if the sample needs to be taken for inspection, you can sample or notify the drug in accordance with the relevant provisions of the sample inspection. The supervision and management department samples in accordance with regulations, and the samples extracted shall be tested by a qualified technical institution.

Article 38 The provincial pharmaceutical supervision and management department shall send at least two inspectors to each vaccine manufacturer in the administrative area. The inspector should do the following inspections:

(1) Complete the inspection tasks formulated by the provincial pharmaceutical supervision and management department as required, report the supervision and inspection of the provincial drug supervision and management department in a timely manner, and put forward supervision suggestions;

(2) Inspection found in the inspection of the provincial drug supervision and management department, urge enterprises to rectify on time and verify the rectification situation;

(3) Assist in the issuance agencies to conduct on -site verification;

(4) When the corporate illegal clues are found, they immediately report to the departments and cooperate with the regulatory authorities to collect evidence;

(5) Complete other matters organized by the provincial drug supervision and management department.

Article 39 The National Drug Administration organizes the National Vaccine Inspection Center each year to conduct a vaccine inspection of at least one vaccine holder at least 1 vaccine holder; Check it twice, including at least one drug production quality management specification, compliant inspection, and at least 1 time of drug wholesale enterprises, vaccine distribution enterprises, and disease prevention and control institutions of the same level of imported vaccines; cities and counties bear drug supervision and management The duties of duties are inspected at least once a year on the prevention and control agencies and vaccination of diseases at the same level. If it is found that the clues that may have a significant impact on the quality of the vaccine, the drug supervision and management departments at all levels can conduct cause inspections at any time.

Article 40 The inspection team shall propose on -site inspection conclusions in accordance with the on -site inspection situation, form on -site inspection reports, and report to the pharmaceutical inspection institution in a timely manner. The drug inspection agency shall evaluate and review the on -site inspection report, combine the corporate rectification situation, form a comprehensive assessment conclusion, and submit the drug supervision and management department. The drug supervision and management department makes corresponding treatment based on the comprehensive assessment of conclusions.

If the inspection finds that the holder has defective items, the provincial drug supervision and management department of the local area shall urge the holder to carry out rectification in accordance with his duties. After the completion of the rectification, the rectification should be verified.

If the inspection finds that there is a major hidden danger or risk of the holder, the provincial drug supervision and management department of the local area shall immediately take corresponding administrative treatment measures to control the risks according to their responsibilities, and report the State Drug Administration in a timely manner.

Inspection found that there are illegal acts and illegal acts of holders, trustee companies, and vaccine distribution companies, the local drug supervision and management department will conduct investigations in accordance with their responsibilities, and deal with it in accordance with the Law of the Drug Management Law and the Vaccine Management Law according to law.

Inspection found that the holder, vaccine distribution enterprise, disease prevention and control agencies, and vaccination units in violation of vaccine storage, transportation management requirements and may affect the quality of the vaccine, the local drug supervision and management department shall order it We will notify the competent health and health authorities at the same level to urge relevant units to carry out rectification. After the rectification is completed, the local drug supervision and management department checks the requirements before the vaccine sales, distribution or distribution can be restored.

Article 41 The holder shall establish a comprehensive drug recall management system in accordance with the provisions of the "Administrative Measures for the Recall of Drug", collect relevant information about vaccine safety, and give the existence of quality problems that may endanger human health and life safety or other potential safety hazards The vaccine products were investigated and evaluated to recall defective vaccines.

After investigation and evaluation, the drug supervision and management department believes that there is a quality problem that may endanger human health and life safety or other hidden safety hazards, and the holder shall recall the vaccine without actively recall, and shall order the holder to recall the vaccine.

Article 42 The vaccine is suspected of preventing abnormal response and adverse groups. The competent department of health organizes experts to investigate and diagnose or suspect the quality of vaccine quality found in daily supervision and inspection and risk monitoring, andOther vaccine quality and safety incidents that seriously affect public health shall 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 and exported vaccines in accordance with international procurement requirements.Vaccine manufacturers shall sell directly for vaccines only for exports and shall not be sold in China.The vaccine shall not be imported to China after exporting.

Chapter 7

Article 44 These regulations shall be implemented from the date of release.

appendix:

1. Entrust production application form for vaccine

2. Vaccine entrustment of production declaration information catalog

3. Entrusted production approval of the State Drug Administration Vaccine

Source: National Drug Administration

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