Vaccine Administration Law of the People’s Republic of China
中華人民共和國疫苗管理法
Chapter I General Provisions
第一章 總則
Article 1 This Law is enacted to enhance the vaccine administration, to ensure the quality and supply of vaccines, to standardize the immunization, to promote the development of the vaccine industry,? and to safeguard public health and safety.
第一條 為了加強(qiáng)疫苗管理，保證疫苗質(zhì)量和供應(yīng)，規(guī)范預(yù)防接種，促進(jìn)疫苗行業(yè)發(fā)展，保障公眾健康，維護(hù)公共衛(wèi)生安全，制定本法。
Article 2 This Law shall govern activities involving vaccine development, manufacture, distribution, immunization and vaccine administration in the territory of the People’s Republic of China. In cases of not being stipulated in this Law, those activities shall be governed by the Drug Administration Law of the People’s Republic of China, the Law of the People’s Republic of China on the Prevention and Control of Infectious Diseases and relevant laws and administrative regulations.
第二條 在中華人民共和國境內(nèi)從事疫苗研制、生產(chǎn)、流通和預(yù)防接種及其監(jiān)督管理活動(dòng)，適用本法。本法未作規(guī)定的，適用《中華人民共和國藥品管理法》、《中華人民共和國傳染病防治法》等法律、行政法規(guī)的規(guī)定。
For the purpose of this Law, vaccines refer to the prophylactic biological products for human immunization to prevent the occurrence and prevent, if not to be prevented, the prevalence of diseases, including immunization program vaccines and non-immunization program vaccines.
本法所稱疫苗，是指為預(yù)防、控制疾病的發(fā)生、流行，用于人體免疫接種的預(yù)防性生物制品，包括免疫規(guī)劃疫苗和非免疫規(guī)劃疫苗。
Article 3 The State implements the most stringent regulatory system for vaccines and adheres to principles of safety first, risk management, whole process control, scientific supervision and social co-governance.
第三條 國家對(duì)疫苗實(shí)行最嚴(yán)格的管理制度，堅(jiān)持安全第一、風(fēng)險(xiǎn)管理、全程管控、科學(xué)監(jiān)管、社會(huì)共治。
Article 4 The State maintains the strategic and public welfare nature of vaccine products.
第四條 國家堅(jiān)持疫苗產(chǎn)品的戰(zhàn)略性和公益性。
The State supports fundamental research and application research of vaccines, promotes development and innovation of vaccines and incorporates the development, manufacture and stockpile of vaccines for the prevention and control of major diseases into the national strategy.
國家支持疫苗基礎(chǔ)研究和應(yīng)用研究，促進(jìn)疫苗研制和創(chuàng)新，將預(yù)防、控制重大疾病的疫苗研制、生產(chǎn)和儲(chǔ)備納入國家戰(zhàn)略。
The State formulates development planning and industry policies for the vaccine industry to support development and structural optimization of the vaccine industry, and encourages scale and intensive production and constant improvement on the production process and quality of vaccines.
國家制定疫苗行業(yè)發(fā)展規(guī)劃和產(chǎn)業(yè)政策，支持疫苗產(chǎn)業(yè)發(fā)展和結(jié)構(gòu)優(yōu)化，鼓勵(lì)疫苗生產(chǎn)規(guī)?；⒓s化，不斷提升疫苗生產(chǎn)工藝和質(zhì)量水平。
Article 5 Vaccine marketing authorization holders (MAHs) shall enhance the vaccine life cycle quality management and be responsible for the safety, effectiveness and quality management of vaccines.
第五條 疫苗上市許可持有人應(yīng)當(dāng)加強(qiáng)疫苗全生命周期質(zhì)量管理，對(duì)疫苗的安全性、有效性和質(zhì)量可控性負(fù)責(zé)。
All entities and individuals engaged in vaccine development, manufacture, distribution and immunization shall comply with laws, regulations, rules, standards and norms, ensure the authenticity, accuracy, integrity and traceability of information through the whole process, take responsibilities in accordance with law and accept social supervision.(Through the whole process of vaccine development, manufacture, distribution and immunization, in which any entity or
從事疫苗研制、生產(chǎn)、流通和預(yù)防接種活動(dòng)的單位和個(gè)人，應(yīng)當(dāng)遵守法律、法規(guī)、規(guī)章、標(biāo)準(zhǔn)和規(guī)范，保證全過程信息真實(shí)、準(zhǔn)確、完整和可追溯，依法承擔(dān)責(zé)任，接受社會(huì)監(jiān)督。
Article 6 The State implements immunization program system.
第六條 國家實(shí)行免疫規(guī)劃制度。
All citizens who reside in the territory of the People's Republic of China shall be entitled and obliged to be immunized with national immunization program vaccines according to law. The government shall provide immunization program vaccines for the citizens free of charge.
居住在中國境內(nèi)的居民，依法享有接種免疫規(guī)劃疫苗的權(quán)利，履行接種免疫規(guī)劃疫苗的義務(wù)。政府免費(fèi)向居民提供免疫規(guī)劃疫苗。
People’s governments and relevant departments at or above the county level shall ensure that children at proper age are immunized with immunization program vaccines. The guardians shall ensure that children at proper age are immunized with the immunization program vaccines on schedule according to law.
縣級(jí)以上人民政府及其有關(guān)部門應(yīng)當(dāng)保障適齡兒童接種免疫規(guī)劃疫苗。監(jiān)護(hù)人應(yīng)當(dāng)依法保證適齡兒童按時(shí)接種免疫規(guī)劃疫苗。
Article 7 People's governments at or above the county level shall incorporate the vaccine safety, immunization work into the national economic and social development plans of the corresponding level, enhance the capacity building of vaccine administration, and establish and improve the work mechanism for vaccine administration.
第七條 縣級(jí)以上人民政府應(yīng)當(dāng)將疫苗安全工作和預(yù)防接種工作納入本級(jí)國民經(jīng)濟(jì)和社會(huì)發(fā)展規(guī)劃，加強(qiáng)疫苗監(jiān)督管理能力建設(shè)，建立健全疫苗監(jiān)督管理工作機(jī)制。
Local people's governments at or above the county level shall be responsible for vaccine administration within their administrative regions, as well as leading, organizing and coordinating vaccine administration within their respective administrative regions in a unified manner.
縣級(jí)以上地方人民政府對(duì)本行政區(qū)域疫苗監(jiān)督管理工作負(fù)責(zé)，統(tǒng)一領(lǐng)導(dǎo)、組織、協(xié)調(diào)本行政區(qū)域疫苗監(jiān)督管理工作。
Article 8 The drug regulatory department under the State Council shall be responsible for the administration of vaccines nationwide. The competent health department under the State Council shall be responsible for the administration of immunization nationwide. Other relevant departments under the State Council shall be responsible for the administration of vaccines within the scope of their respective responsibilities.
第八條 國務(wù)院藥品監(jiān)督管理部門負(fù)責(zé)全國疫苗監(jiān)督管理工作。國務(wù)院衛(wèi)生健康主管部門負(fù)責(zé)全國預(yù)防接種監(jiān)督管理工作。國務(wù)院其他有關(guān)部門在各自職責(zé)范圍內(nèi)負(fù)責(zé)與疫苗有關(guān)的監(jiān)督管理工作。
Drug regulatory departments of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the vaccine administration within their respective administrative regions. Departments undertaking responsibilities for drug administration (hereinafter referred to as drug regulatory departments) of the people’s governments of municipalities divided into districts and at county level shall undertake the administrative duties on vaccines within their respective administrative regions. The competent health departments of people's governments at or above the county level shall undertake the administration of immunization within their respective administrative regions. Other relevant departments of the people’s governments at or above the county level shall undertake the administrative duties on vaccines within the scope of their respective responsibilities.
省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門負(fù)責(zé)本行政區(qū)域疫苗監(jiān)督管理工作。設(shè)區(qū)的市級(jí)、縣級(jí)人民政府承擔(dān)藥品監(jiān)督管理職責(zé)的部門（以下稱藥品監(jiān)督管理部門）負(fù)責(zé)本行政區(qū)域疫苗監(jiān)督管理工作?？h級(jí)以上地方人民政府衛(wèi)生健康主管部門負(fù)責(zé)本行政區(qū)域預(yù)防接種監(jiān)督管理工作?？h級(jí)以上地方人民政府其他有關(guān)部門在各自職責(zé)范圍內(nèi)負(fù)責(zé)與疫苗有關(guān)的監(jiān)督管理工作。
Article 9 The State Council and people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall establish a coordination mechanism to comprehensively coordinate relevant work of vaccine administration, regularly analyze the safety situations of vaccines, enhance vaccine administration and ensure vaccine supply.
第九條 國務(wù)院和省、自治區(qū)、直轄市人民政府建立部門協(xié)調(diào)機(jī)制，統(tǒng)籌協(xié)調(diào)疫苗監(jiān)督管理有關(guān)工作，定期分析疫苗安全形勢，加強(qiáng)疫苗監(jiān)督管理，保障疫苗供應(yīng)。
Article 10 The State implements the whole process electronic traceability system for vaccines.
第十條 國家實(shí)行疫苗全程電子追溯制度。
The drug regulatory department under the State Council shall, in collaboration with the competent health department under the State Council, formulate unified vaccine traceability norms and standards, establish a national coordination platform for vaccine electronic traceability, and integrate traceability information of the whole process throughout manufacture, distribution and immunization to realize the traceability of vaccines.
國務(wù)院藥品監(jiān)督管理部門會(huì)同國務(wù)院衛(wèi)生健康主管部門制定統(tǒng)一的疫苗追溯標(biāo)準(zhǔn)和規(guī)范，建立全國疫苗電子追溯協(xié)同平臺(tái)，整合疫苗生產(chǎn)、流通和預(yù)防接種全過程追溯信息，實(shí)現(xiàn)疫苗可追溯。
Vaccine MAHs shall establish the vaccine electronic traceability system, and connect it to the national coordination platform for vaccine electronic traceability, so as to enable the traceability and verification of the smallest package unit of vaccines through the whole process of manufacture, distribution and immunization.
疫苗上市許可持有人應(yīng)當(dāng)建立疫苗電子追溯系統(tǒng)，與全國疫苗電子追溯協(xié)同平臺(tái)相銜接，實(shí)現(xiàn)生產(chǎn)、流通和預(yù)防接種全過程最小包裝單位疫苗可追溯、可核查。
Disease prevention and control institutions and immunization entities shall truthfully record conditions including vaccine distribution and immunization in accordance with law, and provide traceability information to the national coordination platform for vaccine electronic traceability as required.
疾病預(yù)防控制機(jī)構(gòu)、接種單位應(yīng)當(dāng)依法如實(shí)記錄疫苗流通、預(yù)防接種等情況，并按照規(guī)定向全國疫苗電子追溯協(xié)同平臺(tái)提供追溯信息。
Article 11 The biological safety management system shall be established and improved during vaccine development, manufacture and testing, to enable strict control of the biological safety risks, to enhance biological safety management of pathogenic microorganisms including bacterial and viral strains, to protect the health of operators and the public, and to ensure pathogenic microorganisms including bacterial and viral strains are used for legal and proper purposes.
第十一條 疫苗研制、生產(chǎn)、檢驗(yàn)等過程中應(yīng)當(dāng)建立健全生物安全管理制度，嚴(yán)格控制生物安全風(fēng)險(xiǎn)，加強(qiáng)菌毒株等病原微生物的生物安全管理，保護(hù)操作人員和公眾的健康，保證菌毒株等病原微生物用途合法、正當(dāng)。
Bacterial and viral strains and cell strains used in the development, manufacturing and testing of vaccines shall have their track record, biological features and passage numbers specified, detailed archives established, to ensure legal, clear and traceable source; and those with unidentified source shall not be used.
疫苗研制、生產(chǎn)、檢驗(yàn)等使用的菌毒株和細(xì)胞株，應(yīng)當(dāng)明確歷史、生物學(xué)特征、代次，建立詳細(xì)檔案，保證來源合法、清晰、可追溯；來源不明的，不得使用。
Article 12 People’s governments at all levels and relevant departments, disease prevention and control institutions, immunization entities, vaccine MAHs and vaccine industry associations shall regularly carry out the publicity and education of laws and regulations of vaccines and knowledge of immunization in occasions such as national children's immunization day.
第十二條 各級(jí)人民政府及其有關(guān)部門、疾病預(yù)防控制機(jī)構(gòu)、接種單位、疫苗上市許可持有人和疫苗行業(yè)協(xié)會(huì)等應(yīng)當(dāng)通過全國兒童預(yù)防接種日等活動(dòng)定期開展疫苗安全法律、法規(guī)以及預(yù)防接種知識(shí)等的宣傳教育、普及工作。
News media shall, for the public welfare, carry out publicity on vaccine safety laws and regulations, and knowledge of immunization, and supervise illegal behaviors related to vaccines through public opinions. Publicity reports on vaccines shall be comprehensive, scientific, objective and impartial.
新聞媒體應(yīng)當(dāng)開展疫苗安全法律、法規(guī)以及預(yù)防接種知識(shí)等的公益宣傳，并對(duì)疫苗違法行為進(jìn)行輿論監(jiān)督。有關(guān)疫苗的宣傳報(bào)道應(yīng)當(dāng)全面、科學(xué)、客觀、公正。
Article 13 Vaccine industry associations shall enhance industry self-discipline, establish and improve industry norms, and promote the construction of industry integrity system, so as to guide and urge their member enterprises to manufacture and distribute vaccines in accordance with law.
第十三條 疫苗行業(yè)協(xié)會(huì)應(yīng)當(dāng)加強(qiáng)行業(yè)自律，建立健全行業(yè)規(guī)范，推動(dòng)行業(yè)誠信體系建設(shè)，引導(dǎo)和督促會(huì)員依法開展生產(chǎn)經(jīng)營等活動(dòng)。
Chapter II Vaccine Development and Registration
第二章 疫苗研制和注冊(cè)
Article 14 The State formulates relevant development plans, arranges necessary funds and supports the development of innovative vaccines such as combined and
第十四條 國家根據(jù)疾病流行情況、人群免疫狀況等因素，制定相關(guān)研制規(guī)劃，安排必要資金，支持多聯(lián)多價(jià)等新型疫苗的研制。
The State organizes vaccine MAHs, research institutions, medical and health institutions to work jointly to develop vaccines urgently needed for disease prevention and control.
國家組織疫苗上市許可持有人、科研單位、醫(yī)療衛(wèi)生機(jī)構(gòu)聯(lián)合攻關(guān)，研制疾病預(yù)防、控制急需的疫苗。
Article 15 To facilitate the progress of vaccine technology, the State encourages vaccine MAHs to increase capital investment on research, development and innovation, to optimize production process, and to promote quality control level.
第十五條 國家鼓勵(lì)疫苗上市許可持有人加大研制和創(chuàng)新資金投入，優(yōu)化生產(chǎn)工藝，提升質(zhì)量控制水平，推動(dòng)疫苗技術(shù)進(jìn)步。
Article 16 Conduct of vaccine clinical trials shall be approved by the drug regulatory department under the State Council in accordance with law.
第十六條 開展疫苗臨床試驗(yàn)，應(yīng)當(dāng)經(jīng)國務(wù)院藥品監(jiān)督管理部門依法批準(zhǔn)。
Vaccine clinical trials shall be carried out or organized by Class III medical institutions or disease prevention and control institutions at or above the provincial level that meet the requirements prescribed by the drug regulatory department under the State Council and the competent health department under the State Council.
疫苗臨床試驗(yàn)應(yīng)當(dāng)由符合國務(wù)院藥品監(jiān)督管理部門和國務(wù)院衛(wèi)生健康主管部門規(guī)定條件的三級(jí)醫(yī)療機(jī)構(gòu)或者省級(jí)以上疾病預(yù)防控制機(jī)構(gòu)實(shí)施或者組織實(shí)施。
The State encourages eligible medical institutions and disease prevention and control institutions to conduct vaccine clinical trials in accordance with law.
國家鼓勵(lì)符合條件的醫(yī)療機(jī)構(gòu)、疾病預(yù)防控制機(jī)構(gòu)等依法開展疫苗臨床試驗(yàn)。
Article 17 The sponsor of vaccine clinical trials shall design the clinical trial protocol, establish the safety monitoring and evaluation system for clinical trials, prudently select subjects, appropriately set up subject population and age groups, and take effective measures based on risk levels to protect legal interests of subjects.
第十七條 疫苗臨床試驗(yàn)申辦者應(yīng)當(dāng)制定臨床試驗(yàn)方案，建立臨床試驗(yàn)安全監(jiān)測與評(píng)價(jià)制度，審慎選擇受試者，合理設(shè)置受試者群體和年齡組，并根據(jù)風(fēng)險(xiǎn)程度采取有效措施，保護(hù)受試者合法權(quán)益。
Article 18 Written informed consent shall be obtained from subjects for vaccine clinical trials; where the subject is a person without capacity for civil conduct, the written informed consent shall be obtained from his
第十八條 開展疫苗臨床試驗(yàn)，應(yīng)當(dāng)取得受試者的書面知情同意；受試者為無民事行為能力人的，應(yīng)當(dāng)取得其監(jiān)護(hù)人的書面知情同意；受試者為限制民事行為能力人的，應(yīng)當(dāng)取得本人及其監(jiān)護(hù)人的書面知情同意。
Article 19 Vaccines marketed in the territory of China shall be approved by the drug regulatory department under the State Council and shall be granted the drug registration certificate; to apply for vaccine registration, authentic, adequate and reliable data, dossier and samples shall be provided.
第十九條 在中國境內(nèi)上市的疫苗應(yīng)當(dāng)經(jīng)國務(wù)院藥品監(jiān)督管理部門批準(zhǔn)，取得藥品注冊(cè)證書；申請(qǐng)疫苗注冊(cè)，應(yīng)當(dāng)提供真實(shí)、充分、可靠的數(shù)據(jù)、資料和樣品。
For vaccines urgently needed for disease prevention and control, and innovative vaccines, the drug regulatory department under the State Council shall give priority to evaluation, review and approval.
對(duì)疾病預(yù)防、控制急需的疫苗和創(chuàng)新疫苗，國務(wù)院藥品監(jiān)督管理部門應(yīng)當(dāng)予以優(yōu)先審評(píng)審批。
Article 20 For vaccines which are used to respond to major public health emergencies or other vaccines which are urgently needed as identified by the competent health department under the State Council, the drug regulatory department under the State Council may grant conditional approval on registration application if benefits of those vaccines outweigh risks based on evaluation.
第二十條 應(yīng)對(duì)重大突發(fā)公共衛(wèi)生事件急需的疫苗或者國務(wù)院衛(wèi)生健康主管部門認(rèn)定急需的其他疫苗，經(jīng)評(píng)估獲益大于風(fēng)險(xiǎn)的，國務(wù)院藥品監(jiān)督管理部門可以附條件批準(zhǔn)疫苗注冊(cè)申請(qǐng)。
When particularly major public health emergencies or other emergencies which seriously threaten public health occur, the competent health department under the State Council shall propose recommendations on the urgent use of vaccines based on the need of disease prevention and control, and after evaluation organized by the drug regulatory department under the State Council, the permission for the urgent use within certain scope and period shall be granted by the drug regulatory department under the State Council.
出現(xiàn)特別重大突發(fā)公共衛(wèi)生事件或者其他嚴(yán)重威脅公眾健康的緊急事件，國務(wù)院衛(wèi)生健康主管部門根據(jù)傳染病預(yù)防、控制需要提出緊急使用疫苗的建議，經(jīng)國務(wù)院藥品監(jiān)督管理部門組織論證同意后可以在一定范圍和期限內(nèi)緊急使用。
Article 21 The drug regulatory department under the State Council shall examine and approve the production process, quality control standards, package inserts and labels of vaccines during the approval process of the vaccine registration application.
第二十一條 國務(wù)院藥品監(jiān)督管理部門在批準(zhǔn)疫苗注冊(cè)申請(qǐng)時(shí)，對(duì)疫苗的生產(chǎn)工藝、質(zhì)量控制標(biāo)準(zhǔn)和說明書、標(biāo)簽予以核準(zhǔn)。
The drug regulatory department under the State Council shall publish the content of vaccine package inserts and labels on its websites in a timely manner.
國務(wù)院藥品監(jiān)督管理部門應(yīng)當(dāng)在其網(wǎng)站上及時(shí)公布疫苗說明書、標(biāo)簽內(nèi)容。
Chapter III Vaccine Manufacture and Lot Release
第三章 疫苗生產(chǎn)和批簽發(fā)
Article 22 The State implements strict access system for vaccine manufacturing.
第二十二條 國家對(duì)疫苗生產(chǎn)實(shí)行嚴(yán)格準(zhǔn)入制度。
To carry out vaccine manufacturing activities, approval shall be obtained from the drug regulatory departments at or above the provincial level, and drug manufacturing certificates shall be obtained.
從事疫苗生產(chǎn)活動(dòng)，應(yīng)當(dāng)經(jīng)省級(jí)以上人民政府藥品監(jiān)督管理部門批準(zhǔn)，取得藥品生產(chǎn)許可證。
In addition to the conditions of drug manufacturing activities stipulated in the Drug Administration Law of the People's Republic of China, the following conditions shall also be met for vaccine manufacturing activities:
從事疫苗生產(chǎn)活動(dòng)，除符合《中華人民共和國藥品管理法》規(guī)定的從事藥品生產(chǎn)活動(dòng)的條件外，還應(yīng)當(dāng)具備下列條件：
(I) being equipped with appropriate scale and sufficient capacity stockpile;
（一）具備適度規(guī)模和足夠的產(chǎn)能儲(chǔ)備；
(II) possessing systems, facilities and equipment to ensure biological safety;
（二）具有保證生物安全的制度和設(shè)施、設(shè)備；
(III) meeting the needs of disease prevention and control.
（三）符合疾病預(yù)防、控制需要。
Vaccine MAHs shall have vaccine production capacity; and where contract production is necessary as demand exceeds the vaccine production capacity,, approval shall be obtained from the drug regulatory department under the State Council. Commissioned production shall comply with this Law and relevant regulations, ensuring the quality of vaccines.
疫苗上市許可持有人應(yīng)當(dāng)具備疫苗生產(chǎn)能力；超出疫苗生產(chǎn)能力確需委托生產(chǎn)的，應(yīng)當(dāng)經(jīng)國務(wù)院藥品監(jiān)督管理部門批準(zhǔn)。接受委托生產(chǎn)的，應(yīng)當(dāng)遵守本法規(guī)定和國家有關(guān)規(guī)定，保證疫苗質(zhì)量。
Article 23 The legal representative and principal responsible person of vaccine MAHs shall have good credit records, and personnel in key positions such as the responsible person for manufacturing management, the responsible person for quality management and the quality authorized person shall have relevant professional background and work experience.
第二十三條 疫苗上市許可持有人的法定代表人、主要負(fù)責(zé)人應(yīng)當(dāng)具有良好的信用記錄，生產(chǎn)管理負(fù)責(zé)人、質(zhì)量管理負(fù)責(zé)人、質(zhì)量受權(quán)人等關(guān)鍵崗位人員應(yīng)當(dāng)具有相關(guān)專業(yè)背景和從業(yè)經(jīng)歷。
Vaccine MAHs shall strengthen the training and assessment for personnel of preceding paragraph and in a? timely manner report the employment and change of the aforementioned personnel to the local drug regulatory departments of people's governments of provinces, autonomous regions and municipalities directly under the Central Government.
疫苗上市許可持有人應(yīng)當(dāng)加強(qiáng)對(duì)前款規(guī)定人員的培訓(xùn)和考核，及時(shí)將其任職和變更情況向省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門報(bào)告。
Article 24 Vaccines shall be produced and tested in accordance with the approved production process and specifications, and the entire production process shall meet the requirements prescribed by the good manufacturing practice for drugs.
第二十四條 疫苗應(yīng)當(dāng)按照經(jīng)核準(zhǔn)的生產(chǎn)工藝和質(zhì)量控制標(biāo)準(zhǔn)進(jìn)行生產(chǎn)和檢驗(yàn)，生產(chǎn)全過程應(yīng)當(dāng)符合藥品生產(chǎn)質(zhì)量管理規(guī)范的要求。
Vaccine MAHs shall examine and test the whole process of vaccine manufacturing and vaccine quality as required.
疫苗上市許可持有人應(yīng)當(dāng)按照規(guī)定對(duì)疫苗生產(chǎn)全過程和疫苗質(zhì)量進(jìn)行審核、檢驗(yàn)。
Article 25 Vaccine MAHs shall establish a complete quality management system, unceasingly enhance deviation management, and adopt information-based means to truthfully record all the data formed during manufacturing and testing, in order to ensure the whole process of manufacture persistently meets the legal requirements.
第二十五條 疫苗上市許可持有人應(yīng)當(dāng)建立完整的生產(chǎn)質(zhì)量管理體系，持續(xù)加強(qiáng)偏差管理，采用信息化手段如實(shí)記錄生產(chǎn)、檢驗(yàn)過程中形成的所有數(shù)據(jù)，確保生產(chǎn)全過程持續(xù)符合法定要求。
Article 26 The State implements lot release system for vaccines.
第二十六條 國家實(shí)行疫苗批簽發(fā)制度。
Each lot of vaccines to be sold or imported shall be examined and tested in accordance with relevant technical requirements by lot release institutions designated by the drug regulatory department under the State Council. A qualified lot shall be granted a certificate for lot release of biological product; and a disqualified lot shall be given a notice of disapproval for lot release.
每批疫苗銷售前或者進(jìn)口時(shí)，應(yīng)當(dāng)經(jīng)國務(wù)院藥品監(jiān)督管理部門指定的批簽發(fā)機(jī)構(gòu)按照相關(guān)技術(shù)要求進(jìn)行審核、檢驗(yàn)。符合要求的，發(fā)給批簽發(fā)證明；不符合要求的，發(fā)給不予批簽發(fā)通知書。
Vaccines which are not approved for lot release are prohibited to be sold and shall be destroyed under the supervision of drug regulatory departments of the people's governments of provinces, autonomous regions or municipalities directly under the Central Government; imported vaccines which are not approved for lot release shall be destroyed or handled under the supervision of the drug regulatory department where the port locates in accordance with law.
不予批簽發(fā)的疫苗不得銷售，并應(yīng)當(dāng)由省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門監(jiān)督銷毀；不予批簽發(fā)的進(jìn)口疫苗應(yīng)當(dāng)由口岸所在地藥品監(jiān)督管理部門監(jiān)督銷毀或者依法進(jìn)行其他處理。
The drug regulatory department under the State Council and lot release institutions shall promptly publish the results of the lot release of marketed vaccines for public reference.
國務(wù)院藥品監(jiān)督管理部門、批簽發(fā)機(jī)構(gòu)應(yīng)當(dāng)及時(shí)公布上市疫苗批簽發(fā)結(jié)果，供公眾查詢。
Article 27 To apply for vaccine lot release, materials such as summary protocol of manufacturing and control and samples shall be provided to the lot release institutions as required. For imported vaccines, the certificate of country of origin and certificate of lot release shall also be provided; and if the imported vaccines are exempted from lot release in the country of origin, the exemption certificate of lot release shall be provided.
第二十七條 申請(qǐng)疫苗批簽發(fā)應(yīng)當(dāng)按照規(guī)定向批簽發(fā)機(jī)構(gòu)提供批生產(chǎn)及檢驗(yàn)記錄摘要等資料和同批號(hào)產(chǎn)品等樣品。進(jìn)口疫苗還應(yīng)當(dāng)提供原產(chǎn)地證明、批簽發(fā)證明；在原產(chǎn)地免予批簽發(fā)的，應(yīng)當(dāng)提供免予批簽發(fā)證明。
Article 28 Vaccines urgently needed to prevent and control outbreaks of infectious diseases or emergencies may be exempted from lot release at the approval of the drug regulatory department under the State Council.
第二十八條 預(yù)防、控制傳染病疫情或者應(yīng)對(duì)突發(fā)事件急需的疫苗，經(jīng)國務(wù)院藥品監(jiān)督管理部門批準(zhǔn)，免予批簽發(fā)。
Article 29 For lot release of vaccines, dossier review and sample testing shall be conducted lot by lot. The testing items and testing frequency for lot release of vaccines shall be dynamically adjusted according to the vaccine quality risk evaluation.
第二十九條 疫苗批簽發(fā)應(yīng)當(dāng)逐批進(jìn)行資料審核和抽樣檢驗(yàn)。疫苗批簽發(fā)檢驗(yàn)項(xiàng)目和檢驗(yàn)頻次應(yīng)當(dāng)根據(jù)疫苗質(zhì)量風(fēng)險(xiǎn)評(píng)估情況進(jìn)行動(dòng)態(tài)調(diào)整。
If there is any doubt about the authenticity of the application dossier or samples for lot release of vaccines or any other situation which requires further verification, lot release institutions shall make the verification, and may organize on-site verifications such as sampling on-site for testing if necessary.
對(duì)疫苗批簽發(fā)申請(qǐng)資料或者樣品的真實(shí)性有疑問，或者存在其他需要進(jìn)一步核實(shí)的情況的，批簽發(fā)機(jī)構(gòu)應(yīng)當(dāng)予以核實(shí)，必要時(shí)應(yīng)當(dāng)采用現(xiàn)場抽樣檢驗(yàn)等方式組織開展現(xiàn)場核實(shí)。
Article 30 In the case that major quality risks of vaccines are identified during the process of lot release, lot release institutions shall in a timely manner report to the drug regulatory department under the State Council and the drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government.
第三十條 批簽發(fā)機(jī)構(gòu)在批簽發(fā)過程中發(fā)現(xiàn)疫苗存在重大質(zhì)量風(fēng)險(xiǎn)的，應(yīng)當(dāng)及時(shí)向國務(wù)院藥品監(jiān)督管理部門和省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門報(bào)告。
The departments which receive the report shall immediately carry out on-site inspection on vaccine MAHs, notify the lot release institutions to disapprove the lot release of relevant products or all products of vaccine MAHs or suspend the lot release procedure based on the inspection results, and order vaccine MAHs to make rectification. Vaccine MAHs shall immediately make rectification and in a timely manner report the rectification progress to the department which gives the order.
接到報(bào)告的部門應(yīng)當(dāng)立即對(duì)疫苗上市許可持有人進(jìn)行現(xiàn)場檢查，根據(jù)檢查結(jié)果通知批簽發(fā)機(jī)構(gòu)對(duì)疫苗上市許可持有人的相關(guān)產(chǎn)品或者所有產(chǎn)品不予批簽發(fā)或者暫停批簽發(fā)，并責(zé)令疫苗上市許可持有人整改。疫苗上市許可持有人應(yīng)當(dāng)立即整改，并及時(shí)將整改情況向責(zé)令其整改的部門報(bào)告。
Article 31 Vaccine MAHs shall truthfully record production process deviations, quality deviations, failures and accidents during manufacturing as well as the corresponding measures taken and shall specify them in the document of relevant lot release application; in the case that the quality of vaccines may be affected, vaccine MAHs shall immediately take measures, and report to the drug regulatory departments of the people's governments of provinces, autonomous regions or municipalities directly under the Central Government.
第三十一條 對(duì)生產(chǎn)工藝偏差、質(zhì)量差異、生產(chǎn)過程中的故障和事故以及采取的措施，疫苗上市許可持有人應(yīng)當(dāng)如實(shí)記錄，并在相應(yīng)批產(chǎn)品申請(qǐng)批簽發(fā)的文件中載明；可能影響疫苗質(zhì)量的，疫苗上市許可持有人應(yīng)當(dāng)立即采取措施，并向省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門報(bào)告。
Chapter IV Vaccine Distribution
第四章 疫苗流通
Article 32 For national immunization program vaccines, the centralized bidding or unified negotiation shall be organized by the competent health department under the State Council jointly with the financial and other departments under the State Council. The winning price or transaction price shall be established and released, and each province, autonomous region and municipality directly under the Central Government shall implement unified procurement.
第三十二條 國家免疫規(guī)劃疫苗由國務(wù)院衛(wèi)生健康主管部門會(huì)同國務(wù)院財(cái)政部門等組織集中招標(biāo)或者統(tǒng)一談判，形成并公布中標(biāo)價(jià)格或者成交價(jià)格，各省、自治區(qū)、直轄市實(shí)行統(tǒng)一采購。
For immunization program vaccines other than national immunization program vaccines and non-immunization program vaccines, each province, autonomous region and municipality directly under the Central Government shall organize the procurement through the provincial platform for the transaction of public resources.
國家免疫規(guī)劃疫苗以外的其他免疫規(guī)劃疫苗、非免疫規(guī)劃疫苗由各省、自治區(qū)、直轄市通過省級(jí)公共資源交易平臺(tái)組織采購。
Article 33 The price of a vaccine shall be established autonomously and reasonably by its MAHs in accordance with law. The price level, price difference rate and profit rate of a vaccine shall be kept within a reasonable range.
第三十三條 疫苗的價(jià)格由疫苗上市許可持有人依法自主合理制定。疫苗的價(jià)格水平、差價(jià)率、利潤率應(yīng)當(dāng)保持在合理幅度。
Article 34 Disease prevention and control institutions at the provincial level shall, in accordance with the national immunization program and the need for disease prevention and control within their administrative regions, formulate plans for the use of immunization program vaccines within their administrative regions, report the plans to the vaccine procurement organizing departments as per relevant national regulations, and simultaneously file the record with the competent health departments under the people's governments of provinces, autonomous regions and municipalities directly under the Central Government.
第三十四條 省級(jí)疾病預(yù)防控制機(jī)構(gòu)應(yīng)當(dāng)根據(jù)國家免疫規(guī)劃和本行政區(qū)域疾病預(yù)防、控制需要，制定本行政區(qū)域免疫規(guī)劃疫苗使用計(jì)劃，并按照國家有關(guān)規(guī)定向組織采購疫苗的部門報(bào)告，同時(shí)報(bào)省、自治區(qū)、直轄市人民政府衛(wèi)生健康主管部門備案。
Article 35 Vaccine MAHs shall supply vaccines to disease prevention and control institutions in accordance with the procurement contract.
第三十五條 疫苗上市許可持有人應(yīng)當(dāng)按照采購合同約定，向疾病預(yù)防控制機(jī)構(gòu)供應(yīng)疫苗。
Disease prevention and control institutions shall supply vaccines to immunization entities as required.
疾病預(yù)防控制機(jī)構(gòu)應(yīng)當(dāng)按照規(guī)定向接種單位供應(yīng)疫苗。
Entities or individuals other than disease prevention and control institutions shall not supply vaccines to immunization entities, and immunization entities shall not accept such vaccines.
疾病預(yù)防控制機(jī)構(gòu)以外的單位和個(gè)人不得向接種單位供應(yīng)疫苗，接種單位不得接收該疫苗。
Article 36 Vaccine MAHs shall deliver vaccines to disease prevention and control institutions or immunization entities designated by disease prevention and control institutions in accordance with the procurement contract.
第三十六條 疫苗上市許可持有人應(yīng)當(dāng)按照采購合同約定，向疾病預(yù)防控制機(jī)構(gòu)或者疾病預(yù)防控制機(jī)構(gòu)指定的接種單位配送疫苗。
Vaccine MAHs and disease prevention and control institutions shall operate under the vaccine cold-chain storage and transportation conditions when delivering vaccines on their own, or they may also entrust qualified vaccine distribution entities to distribute vaccines.
疫苗上市許可持有人、疾病預(yù)防控制機(jī)構(gòu)自行配送疫苗應(yīng)當(dāng)具備疫苗冷鏈儲(chǔ)存、運(yùn)輸條件，也可以委托符合條件的疫苗配送單位配送疫苗。
Disease prevention and control institutions may charge storage and transportation fee for distributing non-immunization program vaccines; the specific measures shall be formulated by the financial department under the State Council in conjunction with the competent pricing department under the State Council; and the charging criteria shall be formulated by the competent pricing departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government in conjunction with the financial departments at the same level.
疾病預(yù)防控制機(jī)構(gòu)配送非免疫規(guī)劃疫苗可以收取儲(chǔ)存、運(yùn)輸費(fèi)用，具體辦法由國務(wù)院財(cái)政部門會(huì)同國務(wù)院價(jià)格主管部門制定，收費(fèi)標(biāo)準(zhǔn)由省、自治區(qū)、直轄市人民政府價(jià)格主管部門會(huì)同財(cái)政部門制定。
Article 37 Disease prevention and control institutions, immunization entities, vaccine MAHs and vaccine distribution entities shall comply with the provision for vaccine storage and transportation to ensure vaccine quality.
第三十七條 疾病預(yù)防控制機(jī)構(gòu)、接種單位、疫苗上市許可持有人、疫苗配送單位應(yīng)當(dāng)遵守疫苗儲(chǔ)存、運(yùn)輸管理規(guī)范，保證疫苗質(zhì)量。
Vaccines shall be kept under the stipulated temperature during the whole process of storage and transportation; cold-chain storage and transportation shall comply with requirements, and temperature shall be monitored and recorded on a regular basis.
疫苗在儲(chǔ)存、運(yùn)輸全過程中應(yīng)當(dāng)處于規(guī)定的溫度環(huán)境，冷鏈儲(chǔ)存、運(yùn)輸應(yīng)當(dāng)符合要求，并定時(shí)監(jiān)測、記錄溫度。
The provision for vaccine storage and transportation shall be formulated by the drug regulatory department under the State Council in conjunction with the competent health department under the State Council.
疫苗儲(chǔ)存、運(yùn)輸管理規(guī)范由國務(wù)院藥品監(jiān)督管理部門、國務(wù)院衛(wèi)生健康主管部門共同制定。
Article 38 When distributing vaccines, vaccine MAHs shall provide photocopies or electronic documents of the lot release certificates with their seal; when distributing imported vaccines, vaccine MAHs shall additionally provide photocopies or electronic documents of the Drug Import Note with their seal.
第三十八條 疫苗上市許可持有人在銷售疫苗時(shí)，應(yīng)當(dāng)提供加蓋其印章的批簽發(fā)證明復(fù)印件或者電子文件；銷售進(jìn)口疫苗的，還應(yīng)當(dāng)提供加蓋其印章的進(jìn)口藥品通關(guān)單復(fù)印件或者電子文件。
When accepting or purchasing vaccines, disease prevention and control institutions and immunization entities shall ask for the abovementioned supporting documents, and keep such documents for no less than five years upon the expiration date of vaccines for reference.
疾病預(yù)防控制機(jī)構(gòu)、接種單位在接收或者購進(jìn)疫苗時(shí)，應(yīng)當(dāng)索取前款規(guī)定的證明文件，并保存至疫苗有效期滿后不少于五年備查。
Article 39 Vaccine MAHs shall establish authentic, accurate and complete sales records as required, and keep such records for no less than five years upon the expiration date of vaccines for reference.
第三十九條 疫苗上市許可持有人應(yīng)當(dāng)按照規(guī)定，建立真實(shí)、準(zhǔn)確、完整的銷售記錄，并保存至疫苗有效期滿后不少于五年備查。
Disease prevention and control institutions, immunization entities and vaccine distribution entities shall establish authentic, accurate and complete records of acceptance, purchase, storage, distribution and supply as required, and keep such records for no less than five years upon the expiration date of vaccines for reference.
疾病預(yù)防控制機(jī)構(gòu)、接種單位、疫苗配送單位應(yīng)當(dāng)按照規(guī)定，建立真實(shí)、準(zhǔn)確、完整的接收、購進(jìn)、儲(chǔ)存、配送、供應(yīng)記錄，并保存至疫苗有效期滿后不少于五年備查。
When accepting or purchasing vaccines, disease prevention and control institutions and immunization entities shall ask for the temperature monitoring records during the whole process of transportation and storage, and keep such records for no less than five years upon the expiration date of vaccines for reference; where the temperature monitoring records during the whole process of transportation and storage cannot be provided or the temperature control fails to meet the requirements, disease prevention and control institutions and immunization entities shall not accept or purchase the vaccines concerned. Instead, they shall immediately report to the drug regulatory departments and the competent health departments of the people’s governments at or above the county level.
疾病預(yù)防控制機(jī)構(gòu)、接種單位接收或者購進(jìn)疫苗時(shí)，應(yīng)當(dāng)索取本次運(yùn)輸、儲(chǔ)存全過程溫度監(jiān)測記錄，并保存至疫苗有效期滿后不少于五年備查；對(duì)不能提供本次運(yùn)輸、儲(chǔ)存全過程溫度監(jiān)測記錄或者溫度控制不符合要求的，不得接收或者購進(jìn)，并應(yīng)當(dāng)立即向縣級(jí)以上地方人民政府藥品監(jiān)督管理部門、衛(wèi)生健康主管部門報(bào)告。
Article 40 Disease prevention and control institutions and immunization entities shall establish routine vaccine inspection system. Vaccines that have unidentifiable packaging, fail to meet the storage temperature requirements, or have passed the expiration date, shall be isolated, labeled with warning signs, and handled in accordance with regulations of the drug regulatory department, the competent health department and competent ecological and environmental department under the State Council. Disease prevention and control institutions and immunization entities shall truthfully record the handling situation and keep the handling record for no less than five years upon the expiration date of vaccines for reference.
第四十條 疾病預(yù)防控制機(jī)構(gòu)、接種單位應(yīng)當(dāng)建立疫苗定期檢查制度，對(duì)存在包裝無法識(shí)別、儲(chǔ)存溫度不符合要求、超過有效期等問題的疫苗，采取隔離存放、設(shè)置警示標(biāo)志等措施，并按照國務(wù)院藥品監(jiān)督管理部門、衛(wèi)生健康主管部門、生態(tài)環(huán)境主管部門的規(guī)定處置。疾病預(yù)防控制機(jī)構(gòu)、接種單位應(yīng)當(dāng)如實(shí)記錄處置情況，處置記錄應(yīng)當(dāng)保存至疫苗有效期滿后不少于五年備查。
Chapter V Immunization
第五章 預(yù)防接種
Article 41 The competent health department under the State Council shall formulate the national immunization program; vaccine varieties in the national immunization program shall be proposed by the competent health department under the State Council jointly with the financial department under the State Council, and released upon approval by the State Council.
第四十一條 國務(wù)院衛(wèi)生健康主管部門制定國家免疫規(guī)劃；國家免疫規(guī)劃疫苗種類由國務(wù)院衛(wèi)生健康主管部門會(huì)同國務(wù)院財(cái)政部門擬訂，報(bào)國務(wù)院批準(zhǔn)后公布。
The competent health department under the State Council shall establish an expert consultation committee on the national immunization program, and set up a dynamic adjustment mechanism for vaccines in the national immunization program jointly with the financial department under the State Council.
國務(wù)院衛(wèi)生健康主管部門建立國家免疫規(guī)劃專家咨詢委員會(huì)，并會(huì)同國務(wù)院財(cái)政部門建立國家免疫規(guī)劃疫苗種類動(dòng)態(tài)調(diào)整機(jī)制。
When implementing the national immunization program, people’s governments of provinces, autonomous regions and municipalities directly under the Central Government may add vaccine varieties to their immunization program based on the need for disease prevention and control within their respective administrative regions, and release the adjustment after filing the record with the competent health department under the State Council.
省、自治區(qū)、直轄市人民政府在執(zhí)行國家免疫規(guī)劃時(shí)，可以根據(jù)本行政區(qū)域疾病預(yù)防、控制需要，增加免疫規(guī)劃疫苗種類，報(bào)國務(wù)院衛(wèi)生健康主管部門備案并公布。
Article 42 The competent health department under the State Council shall formulate and issue guidance for immunization, so as to enhance the standardized management of immunization.
第四十二條 國務(wù)院衛(wèi)生健康主管部門應(yīng)當(dāng)制定、公布預(yù)防接種工作規(guī)范，強(qiáng)化預(yù)防接種規(guī)范化管理。
The competent health department under the State Council shall formulate and issue immunization procedures for the national immunization program vaccines and guidelines for the use of non-immunization program vaccines.
國務(wù)院衛(wèi)生健康主管部門應(yīng)當(dāng)制定、公布國家免疫規(guī)劃疫苗的免疫程序和非免疫規(guī)劃疫苗的使用指導(dǎo)原則。
The competent health departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall formulate immunization plans based on the practical situation of their respective administrative regions and file the record with the competent health department under the State Council.
省、自治區(qū)、直轄市人民政府衛(wèi)生健康主管部門應(yīng)當(dāng)結(jié)合本行政區(qū)域?qū)嶋H情況制定接種方案，并報(bào)國務(wù)院衛(wèi)生健康主管部門備案。
Article 43 Disease prevention and control institutions at all levels shall, as per their respective duties, carry out tasks related to immunization including publicity, training, technical guidance, monitoring, assessment, epidemiology surveys, emergency response, etc..
第四十三條 各級(jí)疾病預(yù)防控制機(jī)構(gòu)應(yīng)當(dāng)按照各自職責(zé)，開展與預(yù)防接種相關(guān)的宣傳、培訓(xùn)、技術(shù)指導(dǎo)、監(jiān)測、評(píng)價(jià)、流行病學(xué)調(diào)查、應(yīng)急處置等工作。
Article 44 Immunization entities shall meet the following conditions:
第四十四條 接種單位應(yīng)當(dāng)具備下列條件：
(1) obtaining a practice license for a medical institution;
（一）取得醫(yī)療機(jī)構(gòu)執(zhí)業(yè)許可證；
(2) having physicians, nurses or village doctors who have received professional training on immunization organized by the competent health departments of people's governments at the county level and passed the examinations;
（二）具有經(jīng)過縣級(jí)人民政府衛(wèi)生健康主管部門組織的預(yù)防接種專業(yè)培訓(xùn)并考核合格的醫(yī)師、護(hù)士或者鄉(xiāng)村醫(yī)生；
(3) having cold storage facilities, equipment and cold storage system in conformity with the prescribed guidance for vaccine storage and transportation.
（三）具有符合疫苗儲(chǔ)存、運(yùn)輸管理規(guī)范的冷藏設(shè)施、設(shè)備和冷藏保管制度。
The competent health departments of people's governments at or above the county level shall designate eligible medical institutions to undertake inoculation of immunization program vaccines within the responsible areas. Eligible medical institutions may undertake the inoculation of non-immunization program vaccines，and file the record with the competent health department which issued the practice license for a medical institution.
縣級(jí)以上地方人民政府衛(wèi)生健康主管部門指定符合條件的醫(yī)療機(jī)構(gòu)承擔(dān)責(zé)任區(qū)域內(nèi)免疫規(guī)劃疫苗接種工作。符合條件的醫(yī)療機(jī)構(gòu)可以承擔(dān)非免疫規(guī)劃疫苗接種工作，并應(yīng)當(dāng)報(bào)頒發(fā)其醫(yī)療機(jī)構(gòu)執(zhí)業(yè)許可證的衛(wèi)生健康主管部門備案。
Immunization entities shall strengthen internal management. They shall abide by the guidance for immunization, immunization procedures, guidelines for vaccine use and immunization plans.
接種單位應(yīng)當(dāng)加強(qiáng)內(nèi)部管理，開展預(yù)防接種工作應(yīng)當(dāng)遵守預(yù)防接種工作規(guī)范、免疫程序、疫苗使用指導(dǎo)原則和接種方案。
Disease prevention and control institutions at all levels shall enhance technical guidance for immunization of immunization entities and management of vaccine use.
各級(jí)疾病預(yù)防控制機(jī)構(gòu)應(yīng)當(dāng)加強(qiáng)對(duì)接種單位預(yù)防接種工作的技術(shù)指導(dǎo)和疫苗使用的管理。
Article 45 Before administering vaccines, medical and healthcare professionals shall inform vaccine recipients or their guardian of the varieties, functions, contraindications, adverse reactions, stay for observation and other precautions of the vaccines to be administered, inquire the health condition of the vaccine recipients and whether they have any immunization contraindication, and truthfully record the informing and inquiry details. The vaccine recipients or their guardian shall truthfully provide information on the vaccine recipients' health condition and contraindication etc.. Where a vaccine cannot be administered due to contraindications, the medical and healthcare professionals shall give medical advice to the vaccine recipients or their guardians and truthfully record such advice.
第四十五條 醫(yī)療衛(wèi)生人員實(shí)施接種，應(yīng)當(dāng)告知受種者或者其監(jiān)護(hù)人所接種疫苗的品種、作用、禁忌、不良反應(yīng)以及現(xiàn)場留觀等注意事項(xiàng)，詢問受種者的健康狀況以及是否有接種禁忌等情況，并如實(shí)記錄告知和詢問情況。受種者或者其監(jiān)護(hù)人應(yīng)當(dāng)如實(shí)提供受種者的健康狀況和接種禁忌等情況。有接種禁忌不能接種的，醫(yī)療衛(wèi)生人員應(yīng)當(dāng)向受種者或者其監(jiān)護(hù)人提出醫(yī)學(xué)建議，并如實(shí)記錄提出醫(yī)學(xué)建議情況。
Before administering vaccines, medical and healthcare professionals shall, in accordance with the prescribed guidance for immunization, examine the vaccine recipient’s health status, immunization contraindication, check the immunization certificate, examine the appearance, lot number and expiration date of the vaccine and syringe, and verify the recipient’s name and age and the vaccine’s name, specifications, dose, injection site and route of administration. Vaccine administration shall only take place after confirmation of information on the recipient, the immunization certificate and the vaccine to be administered.
醫(yī)療衛(wèi)生人員在實(shí)施接種前，應(yīng)當(dāng)按照預(yù)防接種工作規(guī)范的要求，檢查受種者健康狀況、核查接種禁忌，查對(duì)預(yù)防接種證，檢查疫苗、注射器的外觀、批號(hào)、有效期，核對(duì)受種者的姓名、年齡和疫苗的品名、規(guī)格、劑量、接種部位、接種途徑，做到受種者、預(yù)防接種證和疫苗信息相一致，確認(rèn)無誤后方可實(shí)施接種。
Medical and healthcare professionals shall administer vaccines for eligible recipients. Where a recipient experiences adverse reactions during stay for observation, the medical and healthcare professionals shall follow the prescribed guidance for immunization and take prompt actions for treatment.
醫(yī)療衛(wèi)生人員應(yīng)當(dāng)對(duì)符合接種條件的受種者實(shí)施接種。受種者在現(xiàn)場留觀期間出現(xiàn)不良反應(yīng)的，醫(yī)療衛(wèi)生人員應(yīng)當(dāng)按照預(yù)防接種工作規(guī)范的要求，及時(shí)采取救治等措施。
Article 46 Medical and healthcare professionals shall, in accordance with regulations of the competent health department under the State Council, truthfully, accurately and completely record the immunization information, including vaccine variety, the MAH, identification information of the smallest package unit, the expiration date, time of immunization, the medical and healthcare professional who administered the vaccine, the recipient etc., to ensure that the immunization information is traceable and searchable. The immunization records shall be kept for no less than five years upon the vaccine’s expiration date for reference.
第四十六條 醫(yī)療衛(wèi)生人員應(yīng)當(dāng)按照國務(wù)院衛(wèi)生健康主管部門的規(guī)定，真實(shí)、準(zhǔn)確、完整記錄疫苗的品種、上市許可持有人、最小包裝單位的識(shí)別信息、有效期、接種時(shí)間、實(shí)施接種的醫(yī)療衛(wèi)生人員、受種者等接種信息，確保接種信息可追溯、可查詢。接種記錄應(yīng)當(dāng)保存至疫苗有效期滿后不少于五年備查。
Article 47 The State implements the immunization certificate system for children. Within one month after a child is born, his
第四十七條 國家對(duì)兒童實(shí)行預(yù)防接種證制度。在兒童出生后一個(gè)月內(nèi)，其監(jiān)護(hù)人應(yīng)當(dāng)?shù)絻和幼〉爻袚?dān)預(yù)防接種工作的接種單位或者出生醫(yī)院為其辦理預(yù)防接種證。接種單位或者出生醫(yī)院不得拒絕辦理。監(jiān)護(hù)人應(yīng)當(dāng)妥善保管預(yù)防接種證。
Immunization shall be managed according to the place of residence. Where a child leaves the original place of residence, the immunization entity undertaking immunization in the present residential area shall provide immunization for the child.
預(yù)防接種實(shí)行居住地管理，兒童離開原居住地期間，由現(xiàn)居住地承擔(dān)預(yù)防接種工作的接種單位負(fù)責(zé)對(duì)其實(shí)施接種。
Format of the immunization certificate shall be stipulated by the competent health department under the State Council.
預(yù)防接種證的格式由國務(wù)院衛(wèi)生健康主管部門規(guī)定。
Article 48 Where any child is admitted to a nursery or school, the nursery or school shall check the immunization certificate. Where any child is found to have not received immunization program vaccines as specified, the nursery or school shall report to the immunization entity undertaking immunization where the child lives or where the nursery or school is located and cooperate with the immunization entity to persuade the guardian of the child to have the child immunized as specified. Disease prevention and control institutions shall provide technical support to nurseries or schools in checking immunization certificates.
第四十八條 兒童入托、入學(xué)時(shí)，托幼機(jī)構(gòu)、學(xué)校應(yīng)當(dāng)查驗(yàn)預(yù)防接種證，發(fā)現(xiàn)未按照規(guī)定接種免疫規(guī)劃疫苗的，應(yīng)當(dāng)向兒童居住地或者托幼機(jī)構(gòu)、學(xué)校所在地承擔(dān)預(yù)防接種工作的接種單位報(bào)告，并配合接種單位督促其監(jiān)護(hù)人按照規(guī)定補(bǔ)種。疾病預(yù)防控制機(jī)構(gòu)應(yīng)當(dāng)為托幼機(jī)構(gòu)、學(xué)校查驗(yàn)預(yù)防接種證等提供技術(shù)指導(dǎo)。
The measures for checking immunization certificates for the admission of children to nurseries or schools shall be formulated by the competent health department under the State Council in conjunction with the education administrative department under the State Council.
兒童入托、入學(xué)預(yù)防接種證查驗(yàn)辦法由國務(wù)院衛(wèi)生健康主管部門會(huì)同國務(wù)院教育行政部門制定。
Article 49 Immunization entities shall not charge any fees for administering immunization program vaccines.
第四十九條 接種單位接種免疫規(guī)劃疫苗不得收取任何費(fèi)用。
When administering non-immunization program vaccines, immunization entities may charge an immunization service fee in addition to the fee for vaccines. The criteria for immunization service fee shall be formulated by the pricing departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government jointly with the financial departments.
接種單位接種非免疫規(guī)劃疫苗，除收取疫苗費(fèi)用外，還可以收取接種服務(wù)費(fèi)。接種服務(wù)費(fèi)的收費(fèi)標(biāo)準(zhǔn)由省、自治區(qū)、直轄市人民政府價(jià)格主管部門會(huì)同財(cái)政部門制定。
Article 50 In order to prevent and control the outbreak or prevalence of infectious diseases based on the monitoring and early warning information of infectious diseases, the competent health departments of the local people's governments at or above the county level may carry out cluster immunization within their respective administrative regions after reporting to the people's governments at the same level for approval and filing the record with the competent health departments of the people's governments at or above the provincial level.
第五十條 縣級(jí)以上地方人民政府衛(wèi)生健康主管部門根據(jù)傳染病監(jiān)測和預(yù)警信息，為預(yù)防、控制傳染病暴發(fā)、流行，報(bào)經(jīng)本級(jí)人民政府決定，并報(bào)省級(jí)以上人民政府衛(wèi)生健康主管部門備案，可以在本行政區(qū)域進(jìn)行群體性預(yù)防接種。
Where cluster immunization is needed nationwide or across the borders of provinces, autonomous regions and municipalities directly under the Central Government, a decision shall be made by the competent health department under the State Council.
需要在全國范圍或者跨省、自治區(qū)、直轄市范圍內(nèi)進(jìn)行群體性預(yù)防接種的，應(yīng)當(dāng)由國務(wù)院衛(wèi)生健康主管部門決定。
The local people's governments at or above the county level or the competent health department under the State Council making the decision for carrying out cluster immunization shall organize relevant departments to carry out training, public education and resource deployment.
作出群體性預(yù)防接種決定的縣級(jí)以上地方人民政府或者國務(wù)院衛(wèi)生健康主管部門應(yīng)當(dāng)組織有關(guān)部門做好人員培訓(xùn)、宣傳教育、物資調(diào)用等工作。
Any entity or individual is prohibited to carry out cluster immunization without approval.
任何單位和個(gè)人不得擅自進(jìn)行群體性預(yù)防接種。
Article 51 Where the local people’s governments at or above the county level or their competent health departments need to take emergency immunization measures in the event of outbreak or prevalence of an infectious disease, laws and administrative regulations shall be followed.
第五十一條 傳染病暴發(fā)、流行時(shí)，縣級(jí)以上地方人民政府或者其衛(wèi)生健康主管部門需要采取應(yīng)急接種措施的，依照法律、行政法規(guī)的規(guī)定執(zhí)行。
Chapter VI Adverse Reactions Monitoring and Handling
第六章 異常反應(yīng)監(jiān)測和處理
Article 52 An adverse reaction of immunization is an adverse drug reaction that causes damage to the vaccine recipient’s body tissue, organ and functions during or following the standard process of administering a qualified vaccine, for which no party involved is at fault.
第五十二條 預(yù)防接種異常反應(yīng)，是指合格的疫苗在實(shí)施規(guī)范接種過程中或者實(shí)施規(guī)范接種后造成受種者機(jī)體組織器官、功能損害，相關(guān)各方均無過錯(cuò)的藥品不良反應(yīng)。
The following circumstances are not adverse reactions of immunization:
下列情形不屬于預(yù)防接種異常反應(yīng)：
(1) common reactions following immunization caused by the vaccine’s intrinsic features;
（一）因疫苗本身特性引起的接種后一般反應(yīng)；
(2) injury to the vaccine recipient due to sub-standard vaccine quality;
（二）因疫苗質(zhì)量問題給受種者造成的損害；
(3) injury to the vaccine recipient due to the immunization entity's incompliance with the guidance for immunization, immunization procedure, vaccine use guidelines and immunization plans;
（三）因接種單位違反預(yù)防接種工作規(guī)范、免疫程序、疫苗使用指導(dǎo)原則、接種方案給受種者造成的損害；
(4) coincidental events following immunization in recipients who were in the latent period or prodromal period of a certain disease at the time of immunization;
（四）受種者在接種時(shí)正處于某種疾病的潛伏期或者前驅(qū)期，接種后偶合發(fā)??；
(5) acute relapse of underlying diseases or worsening of disease conditions in vaccine recipients who have immunization contraindications prescribed on the vaccine package insert and who or whose guardian fails to provide truthful information about his/her health condition and the contraindication for the vaccine prior to immunization;
（五）受種者有疫苗說明書規(guī)定的接種禁忌，在接種前受種者或者其監(jiān)護(hù)人未如實(shí)提供受種者的健康狀況和接種禁忌等情況，接種后受種者原有疾病急性復(fù)發(fā)或者病情加重；
(6) individual or cluster psychogenic reaction as a result of psychological factors.
（六）因心理因素發(fā)生的個(gè)體或者群體的心因性反應(yīng)。
Article 53 The State strengthens the monitoring on adverse reactions of immunization. The plan for monitoring adverse reactions of immunization shall be formulated by the competent health department under the State Council jointly with the drug regulatory department under the State Council.
第五十三條 國家加強(qiáng)預(yù)防接種異常反應(yīng)監(jiān)測。預(yù)防接種異常反應(yīng)監(jiān)測方案由國務(wù)院衛(wèi)生健康主管部門會(huì)同國務(wù)院藥品監(jiān)督管理部門制定。
Article 54 Immunization entities and medical institutions shall report to disease prevention and control institutions as required when identifying suspected adverse reactions of immunization.
第五十四條 接種單位、醫(yī)療機(jī)構(gòu)等發(fā)現(xiàn)疑似預(yù)防接種異常反應(yīng)的，應(yīng)當(dāng)按照規(guī)定向疾病預(yù)防控制機(jī)構(gòu)報(bào)告。
Vaccine MAHs shall set up special organization equipped with full-time staff to actively collect, track and analyze the suspected adverse reactions of immunization, take prompt risk control measures, report the suspected adverse events to disease prevention and control institutions and submit the quality analysis report to drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government.
疫苗上市許可持有人應(yīng)當(dāng)設(shè)立專門機(jī)構(gòu)，配備專職人員，主動(dòng)收集、跟蹤分析疑似預(yù)防接種異常反應(yīng)，及時(shí)采取風(fēng)險(xiǎn)控制措施，將疑似預(yù)防接種異常反應(yīng)向疾病預(yù)防控制機(jī)構(gòu)報(bào)告，將質(zhì)量分析報(bào)告提交省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門。
Article 55 Disease prevention and control institutions shall promptly report the suspected adverse reactions of immunization as required, organize the investigation and diagnosis, and inform the vaccine recipient or his/her guardian of the conclusion of the investigation and diagnosis. Where there is controversy over the conclusion of the investigation and diagnosis, an application for appraisal may be submitted according to the appraisal measures formulated by the competent health department under the State Council.
第五十五條 對(duì)疑似預(yù)防接種異常反應(yīng)，疾病預(yù)防控制機(jī)構(gòu)應(yīng)當(dāng)按照規(guī)定及時(shí)報(bào)告，組織調(diào)查、診斷，并將調(diào)查、診斷結(jié)論告知受種者或者其監(jiān)護(hù)人。對(duì)調(diào)查、診斷結(jié)論有爭議的，可以根據(jù)國務(wù)院衛(wèi)生健康主管部門制定的鑒定辦法申請(qǐng)鑒定。
Suspected adverse reactions of immunization that have significant influence on the society including any death or severe disability of the vaccine recipient caused by immunization and suspected cluster adverse reactions of immunization shall be investigated and handled by the competent health departments and the drug regulatory departments of the people's government of the municipalities divided into districts and above as per their respective responsibilities.
因預(yù)防接種導(dǎo)致受種者死亡、嚴(yán)重殘疾，或者群體性疑似預(yù)防接種異常反應(yīng)等對(duì)社會(huì)有重大影響的疑似預(yù)防接種異常反應(yīng)，由設(shè)區(qū)的市級(jí)以上人民政府衛(wèi)生健康主管部門、藥品監(jiān)督管理部門按照各自職責(zé)組織調(diào)查、處理。
The appraisal measures for adverse reactions of immunization shall be formulated by the competent health department under the State Council.
Article 56 The State implements a compensation system for adverse reactions of immunization. Where, during or after the immunization process, a vaccine recipient suffers from harm including death, severe disability, organ and tissue damage, etc., compensation shall be given thereto if these conditions are adverse reactions of immunization or the possibility cannot be ruled out. The scope of compensation is subject to catalogue management, and shall be adjusted based on the actual situations.
第五十六條 國家實(shí)行預(yù)防接種異常反應(yīng)補(bǔ)償制度。實(shí)施接種過程中或者實(shí)施接種后出現(xiàn)受種者死亡、嚴(yán)重殘疾、器官組織損傷等損害，屬于預(yù)防接種異常反應(yīng)或者不能排除的，應(yīng)當(dāng)給予補(bǔ)償。補(bǔ)償范圍實(shí)行目錄管理，并根據(jù)實(shí)際情況進(jìn)行動(dòng)態(tài)調(diào)整。
Compensation needed for immunization of immunization program vaccines shall be included in the funding for immunization budgeted by the financial departments of the people’s governments of provinces, autonomous regions or municipalities directly under the Central Government; compensation needed for immunization of non-immunization program vaccines shall be paid by the vaccine MAHs involved. The State encourages compensating vaccine recipients with adverse reactions of immunization through commercial insurance and other means.
接種免疫規(guī)劃疫苗所需的補(bǔ)償費(fèi)用，由省、自治區(qū)、直轄市人民政府財(cái)政部門在預(yù)防接種經(jīng)費(fèi)中安排；接種非免疫規(guī)劃疫苗所需的補(bǔ)償費(fèi)用，由相關(guān)疫苗上市許可持有人承擔(dān)。國家鼓勵(lì)通過商業(yè)保險(xiǎn)等多種形式對(duì)預(yù)防接種異常反應(yīng)受種者予以補(bǔ)償。
Compensation for adverse reactions of immunization shall be prompt, convenient and rational. The scope, standards and procedures of compensation for adverse reactions of immunization shall be determined by the State Council, while the specific implementation measures shall be formulated by the provinces, autonomous regions or municipalities directly under the Central Government.
預(yù)防接種異常反應(yīng)補(bǔ)償應(yīng)當(dāng)及時(shí)、便民、合理。預(yù)防接種異常反應(yīng)補(bǔ)償范圍、標(biāo)準(zhǔn)、程序由國務(wù)院規(guī)定，省、自治區(qū)、直轄市制定具體實(shí)施辦法。
Chapter VII Vaccine Post-Marketing Management
第七章 疫苗上市后管理
Article 57 Vaccine MAHs shall establish and improve quality management systems for whole life cycle of vaccines, formulate and implement vaccine post-marketing risk management plans, and conduct vaccine post-marketing studies to further verify the safety, effectiveness and quality management of vaccines.
第五十七條 疫苗上市許可持有人應(yīng)當(dāng)建立健全疫苗全生命周期質(zhì)量管理體系，制定并實(shí)施疫苗上市后風(fēng)險(xiǎn)管理計(jì)劃，開展疫苗上市后研究，對(duì)疫苗的安全性、有效性和質(zhì)量可控性進(jìn)行進(jìn)一步確證。
Where further study is required when a vaccine's registration application is approved, the vaccine MAH shall complete the study within the prescribed time limit; where the study fails to be completed on time or fails to prove that the benefits outweigh the risks, the drug regulatory department under the State Council shall take actions in accordance with law up to revoke the vaccine's registration certificate.
對(duì)批準(zhǔn)疫苗注冊(cè)申請(qǐng)時(shí)提出進(jìn)一步研究要求的疫苗，疫苗上市許可持有人應(yīng)當(dāng)在規(guī)定期限內(nèi)完成研究；逾期未完成研究或者不能證明其獲益大于風(fēng)險(xiǎn)的，國務(wù)院藥品監(jiān)督管理部門應(yīng)當(dāng)依法處理，直至注銷該疫苗的藥品注冊(cè)證書。
Article 58 Vaccine MAHs shall carry out quality tracking analysis for vaccines and continuously improve quality control standards, production process and stability of the production process.
第五十八條 疫苗上市許可持有人應(yīng)當(dāng)對(duì)疫苗進(jìn)行質(zhì)量跟蹤分析，持續(xù)提升質(zhì)量控制標(biāo)準(zhǔn)，改進(jìn)生產(chǎn)工藝，提高生產(chǎn)工藝穩(wěn)定性。
Changes to the production process, production sites, critical equipment, etc., shall be assessed and validated, and shall be filed or reported in accordance with the provisions of the drug regulatory department under the State Council for change management; changes that may affect vaccine quality, effectiveness and quality management shall be subject to approval by the drug regulatory department under the State Council.
生產(chǎn)工藝、生產(chǎn)場地、關(guān)鍵設(shè)備等發(fā)生變更的，應(yīng)當(dāng)進(jìn)行評(píng)估、驗(yàn)證，按照國務(wù)院藥品監(jiān)督管理部門有關(guān)變更管理的規(guī)定備案或者報(bào)告；變更可能影響疫苗安全性、有效性和質(zhì)量可控性的，應(yīng)當(dāng)經(jīng)國務(wù)院藥品監(jiān)督管理部門批準(zhǔn)。
Article 59 Vaccine MAHs shall continue to update the package inserts and labels based on the post-marketing study or adverse reactions of vaccines and apply for approval or file the record as required.
第五十九條 疫苗上市許可持有人應(yīng)當(dāng)根據(jù)疫苗上市后研究、預(yù)防接種異常反應(yīng)等情況持續(xù)更新說明書、標(biāo)簽，并按照規(guī)定申請(qǐng)核準(zhǔn)或者備案。
The drug regulatory department under the State Council shall publish the content of vaccine package inserts and labels on its websites in a timely manner.
國務(wù)院藥品監(jiān)督管理部門應(yīng)當(dāng)在其網(wǎng)站上及時(shí)公布更新后的疫苗說明書、標(biāo)簽內(nèi)容。
Article 60 Vaccine MAHs shall establish the vaccine quality retrospective analysis and risk reporting system and truthfully report information on vaccine manufacture and distribution, post-marketing studies and risk management each year as required to the drug regulatory department under the State Council.
第六十條 疫苗上市許可持有人應(yīng)當(dāng)建立疫苗質(zhì)量回顧分析和風(fēng)險(xiǎn)報(bào)告制度，每年將疫苗生產(chǎn)流通、上市后研究、風(fēng)險(xiǎn)管理等情況按照規(guī)定如實(shí)向國務(wù)院藥品監(jiān)督管理部門報(bào)告。
Article 61 The drug regulatory department under the State Council may order vaccine MAHs to carry out post-marketing evaluation, or directly organize and carry out post-marketing evaluation.
第六十一條 國務(wù)院藥品監(jiān)督管理部門可以根據(jù)實(shí)際情況，責(zé)令疫苗上市許可持有人開展上市后評(píng)價(jià)或者直接組織開展上市后評(píng)價(jià)。
With respect to vaccines that have serious adverse reactions or jeopardize human health due to other reasons, the drug regulatory department under the State Council shall revoke the drug registration certificates of such vaccines.
對(duì)預(yù)防接種異常反應(yīng)嚴(yán)重或者其他原因危害人體健康的疫苗，國務(wù)院藥品監(jiān)督管理部門應(yīng)當(dāng)注銷該疫苗的藥品注冊(cè)證書。
Article 62 The drug regulatory department under the State Council may organize post-marketing evaluation of vaccine varieties based on the demand for disease prevention and control as well as the development of the vaccine industry. Where a vaccine variety is found to be significantly inferior to other vaccine varieties used for the prevention and control of the same disease in terms of product design, production process, safety, effectiveness or quality management, the drug registration certificates of all vaccines of the inferior variety shall be revoked and the corresponding national drug standards shall be abolished.
第六十二條 國務(wù)院藥品監(jiān)督管理部門可以根據(jù)疾病預(yù)防、控制需要和疫苗行業(yè)發(fā)展情況，組織對(duì)疫苗品種開展上市后評(píng)價(jià)，發(fā)現(xiàn)該疫苗品種的產(chǎn)品設(shè)計(jì)、生產(chǎn)工藝、安全性、有效性或者質(zhì)量可控性明顯劣于預(yù)防、控制同種疾病的其他疫苗品種的，應(yīng)當(dāng)注銷該品種所有疫苗的藥品注冊(cè)證書并廢止相應(yīng)的國家藥品標(biāo)準(zhǔn)。
Chapter VIII Safeguard Measures
第八章 保障措施
Article 63 To ensure the implementation of national immunization program, the people's government at or above the county level shall incorporate into the budget of the people's governments at the same level the funds needed for vaccine safety, procurement of immunization program vaccines, immunization and information-based construction.
第六十三條 縣級(jí)以上人民政府應(yīng)當(dāng)將疫苗安全工作、購買免疫規(guī)劃疫苗和預(yù)防接種工作以及信息化建設(shè)等所需經(jīng)費(fèi)納入本級(jí)政府預(yù)算，保證免疫規(guī)劃制度的實(shí)施。
The people's governments at county level shall grant subsidies for the village doctors and other primary immunization and healthcare personnel engaged in immunization in accordance with relevant national regulations.
縣級(jí)人民政府按照國家有關(guān)規(guī)定對(duì)從事預(yù)防接種工作的鄉(xiāng)村醫(yī)生和其他基層醫(yī)療衛(wèi)生人員給予補(bǔ)助。
The State gives support to the immunization in economically underdeveloped areas as required. People’s governments of provinces, autonomous regions and municipalities directly under the Central Government as well as people's government of municipalities divided into districts shall grant necessary financial subsidies to the work related to immunization conducted by people’s governments at county level in economically underdeveloped areas.
國家根據(jù)需要對(duì)經(jīng)濟(jì)欠發(fā)達(dá)地區(qū)的預(yù)防接種工作給予支持。省、自治區(qū)、直轄市人民政府和設(shè)區(qū)的市級(jí)人民政府應(yīng)當(dāng)對(duì)經(jīng)濟(jì)欠發(fā)達(dá)地區(qū)的縣級(jí)人民政府開展與預(yù)防接種相關(guān)的工作給予必要的經(jīng)費(fèi)補(bǔ)助。
Article 64 Following from the epidemic tendency of infectious diseases, the people’s governments of provinces, autonomous regions or municipalities directly under the Central Government shall set up projects related to immunization in their respective administrative regions, which shall fall within the ambit of the projects for the prevention and control of infectious diseases stipulated by the health department under the State Council, and ensure the implementation of such items.
第六十四條 省、自治區(qū)、直轄市人民政府根據(jù)本行政區(qū)域傳染病流行趨勢，在國務(wù)院衛(wèi)生健康主管部門確定的傳染病預(yù)防、控制項(xiàng)目范圍內(nèi)，確定本行政區(qū)域與預(yù)防接種相關(guān)的項(xiàng)目，并保證項(xiàng)目的實(shí)施。
Article 65 The health department under the State Council shall, according to the plan of each province, autonomous region and municipality directly under the Central Government for the use of national immunization program vaccines, notify the demand information for national immunization program vaccines to vaccine MAHs, and the vaccine MAHs shall reasonably arrange their manufacture according to vaccine demand information.
第六十五條 國務(wù)院衛(wèi)生健康主管部門根據(jù)各省、自治區(qū)、直轄市國家免疫規(guī)劃疫苗使用計(jì)劃，向疫苗上市許可持有人提供國家免疫規(guī)劃疫苗需求信息，疫苗上市許可持有人根據(jù)疫苗需求信息合理安排生產(chǎn)。
In the case of any risk of vaccine supply shortage, the health department under the State Council and the drug regulatory department under the State Council shall propose suggestions, and the industry and information technology department and financial department under the State Council shall take effective measures to ensure the manufacture and supply of vaccines.
疫苗存在供應(yīng)短缺風(fēng)險(xiǎn)時(shí)，國務(wù)院衛(wèi)生健康主管部門、國務(wù)院藥品監(jiān)督管理部門提出建議，國務(wù)院工業(yè)和信息化主管部門、國務(wù)院財(cái)政部門應(yīng)當(dāng)采取有效措施，保障疫苗生產(chǎn)、供應(yīng)。
The vaccine MAHs shall organize production and ensure the vaccine supply according to law; Vaccine MAHs stopping the manufacture of the vaccine shall promptly report to the drug regulatory department under the State Council or the drug regulatory departments of the people's government of the province, autonomous region or municipality directly under the Central Government.
疫苗上市許可持有人應(yīng)當(dāng)依法組織生產(chǎn)，保障疫苗供應(yīng)；疫苗上市許可持有人停止疫苗生產(chǎn)的，應(yīng)當(dāng)及時(shí)向國務(wù)院藥品監(jiān)督管理部門或者省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門報(bào)告。
Article 66 The State buildss vaccines into the stockpile of strategic materials, implementing the stockpile at the national and provincial levels.
第六十六條 國家將疫苗納入戰(zhàn)略物資儲(chǔ)備，實(shí)行中央和省級(jí)兩級(jí)儲(chǔ)備。
The industry and information technology department and financial department under the State Council shall, in accordance with the need for disease prevention and control and public health emergency preparedness, strengthen the stockpile capacity and product management of the vaccines and establish dynamic adjustment mechanism jointly with the competent health department, public security department, market regulation department and drug regulatory department under the State Council.
國務(wù)院工業(yè)和信息化主管部門、財(cái)政部門會(huì)同國務(wù)院衛(wèi)生健康主管部門、公安部門、市場監(jiān)督管理部門和藥品監(jiān)督管理部門，根據(jù)疾病預(yù)防、控制和公共衛(wèi)生應(yīng)急準(zhǔn)備的需要，加強(qiáng)儲(chǔ)備疫苗的產(chǎn)能、產(chǎn)品管理，建立動(dòng)態(tài)調(diào)整機(jī)制。
Article 67 The funds allocated for the immunization arranged by the financial departments at different levels shall be earmarked for dedicated purposes, and no entity or individuals may misappropriate or occupy them.
第六十七條 各級(jí)財(cái)政安排用于預(yù)防接種的經(jīng)費(fèi)應(yīng)當(dāng)?？顚Ｓ茫魏螁挝缓蛡€(gè)人不得挪用、擠占。
Relevant entities and individuals using the funds for immunization shall accept the audit supervision by the auditing administrations according to law.
有關(guān)單位和個(gè)人使用預(yù)防接種的經(jīng)費(fèi)應(yīng)當(dāng)依法接受審計(jì)機(jī)關(guān)的審計(jì)監(jiān)督。
Article 68 The State implements a compulsory?liability insurance?system for vaccines.
第六十八條 國家實(shí)行疫苗責(zé)任強(qiáng)制保險(xiǎn)制度。
Vaccine MAHs shall buy compulsory liability insurance for vaccines as required. Where the recipients’ injury is caused by quality problems, the insurance company shall pay compensation within the limits of liability insured.
疫苗上市許可持有人應(yīng)當(dāng)按照規(guī)定投保疫苗責(zé)任強(qiáng)制保險(xiǎn)。因疫苗質(zhì)量問題造成受種者損害的，保險(xiǎn)公司在承保的責(zé)任限額內(nèi)予以賠付。
Specific measure for the implementation of compulsory?liability insurance?system for vaccines shall be formulated by the drug regulatory department under the State Council jointly with the health department and the insurance regulatory department under the State Council.
疫苗責(zé)任強(qiáng)制保險(xiǎn)制度的具體實(shí)施辦法，由國務(wù)院藥品監(jiān)督管理部門會(huì)同國務(wù)院衛(wèi)生健康主管部門、保險(xiǎn)監(jiān)督管理機(jī)構(gòu)等制定。
Article 69 In the case of outbreaks or prevalence of infectious diseases, relevant vaccine MAHs shall manufacture and supply vaccines for the prevention and control of infectious diseases in a timely manner. Communication and transportation entities shall preferentially transport vaccines for the prevention and control of the infectious diseases. People's governments at or above the county level and relevant departments shall properly organization, coordination and support work.
第六十九條 傳染病暴發(fā)、流行時(shí)，相關(guān)疫苗上市許可持有人應(yīng)當(dāng)及時(shí)生產(chǎn)和供應(yīng)預(yù)防、控制傳染病的疫苗。交通運(yùn)輸單位應(yīng)當(dāng)優(yōu)先運(yùn)輸預(yù)防、控制傳染病的疫苗?？h級(jí)以上人民政府及其有關(guān)部門應(yīng)當(dāng)做好組織、協(xié)調(diào)、保障工作。
Chapter IX Supervision and Management
第九章 監(jiān)督管理
Article 70 The drug regulatory departments and health departments shall conduct administration on the whole process of vaccine development, manufacture, distribution and immunization according to their respective responsibilities and supervise vaccine MAHs, disease prevention and control institutions, and immunization entities to fulfill their obligations according to law.
第七十條 藥品監(jiān)督管理部門、衛(wèi)生健康主管部門按照各自職責(zé)對(duì)疫苗研制、生產(chǎn)、流通和預(yù)防接種全過程進(jìn)行監(jiān)督管理，監(jiān)督疫苗上市許可持有人、疾病預(yù)防控制機(jī)構(gòu)、接種單位等依法履行義務(wù)。
The drug regulatory departments shall conduct supervision and inspection on the vaccine quality during the process of the vaccine development, manufacture, storage, transportation, and immunization. The competent health departments shall conduct supervision and inspection on the implementation of the immunization planning system and immunization activities according to law.
藥品監(jiān)督管理部門依法對(duì)疫苗研制、生產(chǎn)、儲(chǔ)存、運(yùn)輸以及預(yù)防接種中的疫苗質(zhì)量進(jìn)行監(jiān)督檢查。衛(wèi)生健康主管部門依法對(duì)免疫規(guī)劃制度的實(shí)施、預(yù)防接種活動(dòng)進(jìn)行監(jiān)督檢查。
The drug regulatory departments shall strengthen the on-site inspection on vaccine MAHs. If necessary, regulatory departments may conduct extended inspections on entities or individuals who provide products or services for vaccine development, manufacture and distribution, and relevant entities and individuals shall cooperate and not reject the inspection or conceal any information.
藥品監(jiān)督管理部門應(yīng)當(dāng)加強(qiáng)對(duì)疫苗上市許可持有人的現(xiàn)場檢查；必要時(shí)，可以對(duì)為疫苗研制、生產(chǎn)、流通等活動(dòng)提供產(chǎn)品或者服務(wù)的單位和個(gè)人進(jìn)行延伸檢查；有關(guān)單位和個(gè)人應(yīng)當(dāng)予以配合，不得拒絕和隱瞞。
Article 71 The State organizes professional and specialized pharmaceutical inspector teams at both national and provincial levels, and enhance supervision and inspection on vaccines.
第七十一條 國家建設(shè)中央和省級(jí)兩級(jí)職業(yè)化、專業(yè)化藥品檢查員隊(duì)伍，加強(qiáng)對(duì)疫苗的監(jiān)督檢查。
The drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall select and assign inspectors to the vaccine MAHs. The inspectors, who are accountable for their conducts during their stay in vaccine MAHs, shall be responsible for supervising and inspecting the implementation of good manufacturing practice for drugs, collecting vaccine quality risks and evidence for illegal behaviors, and reporting the conditions and proposing suggesting to the drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government.
省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門選派檢查員入駐疫苗上市許可持有人。檢查員負(fù)責(zé)監(jiān)督檢查藥品生產(chǎn)質(zhì)量管理規(guī)范執(zhí)行情況，收集疫苗質(zhì)量風(fēng)險(xiǎn)和違法違規(guī)線索，向省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門報(bào)告情況并提出建議，對(duì)派駐期間的行為負(fù)責(zé)。
Article 72 Where there exists safety risks in vaccine quality management and the vaccine MAHs have not taken measures in a timely manner to eliminate them, the relevant drug regulatory departments shall take such measures as warning meetings and orders to make rectification within a time limit etc..
第七十二條 疫苗質(zhì)量管理存在安全隱患，疫苗上市許可持有人等未及時(shí)采取措施消除的，藥品監(jiān)督管理部門可以采取責(zé)任約談、限期整改等措施。
In the case of serious violation against the relevant good manufacturing practice for drugs, the drug regulatory departments shall order the suspension of the production, sales and distribution of vaccines and immediate rectification; and the manufacture, sales and distribution shall be resumed only after the rectification is completed and the results meet the requirements upon the inspection by the drug regulatory departments.
嚴(yán)重違反藥品相關(guān)質(zhì)量管理規(guī)范的，藥品監(jiān)督管理部門應(yīng)當(dāng)責(zé)令暫停疫苗生產(chǎn)、銷售、配送，立即整改；整改完成后，經(jīng)藥品監(jiān)督管理部門檢查符合要求的，方可恢復(fù)生產(chǎn)、銷售、配送。
Drug regulatory departments shall establish a credit record system for the vaccine MAHs and their responsible persons and include them into the national credit information sharing platform, release information of their serious loss of honesty according to regulations and impose joint punishment.
藥品監(jiān)督管理部門應(yīng)當(dāng)建立疫苗上市許可持有人及其相關(guān)人員信用記錄制度，納入全國信用信息共享平臺(tái)，按照規(guī)定公示其嚴(yán)重失信信息，實(shí)施聯(lián)合懲戒。
Article 73 For vaccines with quality problems or vaccines suspected of having quality problems, vaccine MAHs, disease prevention and control institutions and immunization entities shall immediately stop the sale, distribution, and use, and if necessary, immediately stop the manufacture and report the case to drug regulatory departments and health departments of the people's governments at or above the county level according to relevant regulations. The competent health departments shall immediately organize the disease prevention and control institutions and immunization entities to take necessary emergency handling measures, and at the same time report the case to the health departments of the superior people's governments. The drug regulatory departments shall take measures including sealing and detention according to law. For vaccines having been sold, the vaccine MAHs shall in a timely manner notify relevant disease prevention and control institutions, vaccine distribution entities and immunization entities to recall such vaccines according to regulations, and truthfully record the conditions of recall and notification, and disease prevention and control institutions, vaccine distribution entities and immunization entities shall provide cooperation.
第七十三條 疫苗存在或者疑似存在質(zhì)量問題的，疫苗上市許可持有人、疾病預(yù)防控制機(jī)構(gòu)、接種單位應(yīng)當(dāng)立即停止銷售、配送、使用，必要時(shí)立即停止生產(chǎn)，按照規(guī)定向縣級(jí)以上人民政府藥品監(jiān)督管理部門、衛(wèi)生健康主管部門報(bào)告。衛(wèi)生健康主管部門應(yīng)當(dāng)立即組織疾病預(yù)防控制機(jī)構(gòu)和接種單位采取必要的應(yīng)急處置措施，同時(shí)向上級(jí)人民政府衛(wèi)生健康主管部門報(bào)告。藥品監(jiān)督管理部門應(yīng)當(dāng)依法采取查封、扣押等措施。對(duì)已經(jīng)銷售的疫苗，疫苗上市許可持有人應(yīng)當(dāng)及時(shí)通知相關(guān)疾病預(yù)防控制機(jī)構(gòu)、疫苗配送單位、接種單位，按照規(guī)定召回，如實(shí)記錄召回和通知情況，疾病預(yù)防控制機(jī)構(gòu)、疫苗配送單位、接種單位應(yīng)當(dāng)予以配合。
In the case of failures to stop manufacture, sales, distribution, use and recall of vaccines as the preceding paragraph, the drug regulatory departments and the health departments at or above the county level shallr to stop manufacture, sales, distribution, use and recall of such vaccines according to their respective responsibilities.
未依照前款規(guī)定停止生產(chǎn)、銷售、配送、使用或者召回疫苗的，縣級(jí)以上人民政府藥品監(jiān)督管理部門、衛(wèi)生健康主管部門應(yīng)當(dāng)按照各自職責(zé)責(zé)令停止生產(chǎn)、銷售、配送、使用或者召回疫苗。
Vaccine MAHs, disease prevention and control institutions, and immunization entities shall not conceal information, give false information, omit to report, delay the reporting, or conceal, fabricate or destroy relevant evidence when discovering vaccines with quality problems or vaccines suspected of having quality problems.
疫苗上市許可持有人、疾病預(yù)防控制機(jī)構(gòu)、接種單位發(fā)現(xiàn)存在或者疑似存在質(zhì)量問題的疫苗，不得瞞報(bào)、謊報(bào)、緩報(bào)、漏報(bào)，不得隱匿、偽造、毀滅有關(guān)證據(jù)。
Article 74 Vaccine MAHs shall establish an information publicity system and in a timely manner publish vaccine information, package inserts, labels, implementation of relevant good manufacturing practice, lot release, product recall, inspection and punishment accepted as well as compulsory vaccine liability insurance on their websites in accordance with relevant regulations.
第七十四條 疫苗上市許可持有人應(yīng)當(dāng)建立信息公開制度，按照規(guī)定在其網(wǎng)站上及時(shí)公開疫苗產(chǎn)品信息、說明書和標(biāo)簽、藥品相關(guān)質(zhì)量管理規(guī)范執(zhí)行情況、批簽發(fā)情況、召回情況、接受檢查和處罰情況以及投保疫苗責(zé)任強(qiáng)制保險(xiǎn)情況等信息。
Article 75 The drug regulatory department under the State Council shall liaise with the health department under the State Council to establish the information sharing mechanism for vaccine quality and immunization.
第七十五條 國務(wù)院藥品監(jiān)督管理部門會(huì)同國務(wù)院衛(wèi)生健康主管部門等建立疫苗質(zhì)量、預(yù)防接種等信息共享機(jī)制。
Drug regulatory departments and health departments of people's governments at or above the provincial level shall organize vaccine MAHs, disease prevention and control institutions, immunization entities, news media, and scientific research institutions etc. to exchange and communicate about information on vaccine quality, safety and immunizationin a scientific, objective, timely and transparent manner.
省級(jí)以上人民政府藥品監(jiān)督管理部門、衛(wèi)生健康主管部門等應(yīng)當(dāng)按照科學(xué)、客觀、及時(shí)、公開的原則，組織疫苗上市許可持有人、疾病預(yù)防控制機(jī)構(gòu)、接種單位、新聞媒體、科研單位等，就疫苗質(zhì)量和預(yù)防接種等信息進(jìn)行交流溝通。
Article 76 The State implements the uniform release system for vaccine safety information.
第七十六條 國家實(shí)行疫苗安全信息統(tǒng)一公布制度。
Warnings against vaccine safety risks, information on major vaccine safety accidents, investigation and handling as well as other vaccine safety information subject to unified release as confirmed by the State Council shall be released by the drug regulatory department under the State Council in collaboration with relevant departments. Reports of adverse reactions during immunization across the nation shall be published in a unified manner by the health department under the State Council jointly with drug regulatory department under the State Council. The release of such information without authorization is prohibited. The release of significant vaccine quality and safety information shall be timely, accurate and comprehensive, and scientific evaluation shall be carried out as required and necessary explanations shall be made.
疫苗安全風(fēng)險(xiǎn)警示信息、重大疫苗安全事故及其調(diào)查處理信息和國務(wù)院確定需要統(tǒng)一公布的其他疫苗安全信息，由國務(wù)院藥品監(jiān)督管理部門會(huì)同有關(guān)部門公布。全國預(yù)防接種異常反應(yīng)報(bào)告情況，由國務(wù)院衛(wèi)生健康主管部門會(huì)同國務(wù)院藥品監(jiān)督管理部門統(tǒng)一公布。未經(jīng)授權(quán)不得發(fā)布上述信息。公布重大疫苗安全信息，應(yīng)當(dāng)及時(shí)、準(zhǔn)確、全面，并按照規(guī)定進(jìn)行科學(xué)評(píng)估，作出必要的解釋說明。
Drug regulatory departments of people's governments at or above county level discovering any vaccine quality and safety information likely to mislead the public and affect social opinions shall immediate perform verification and analysis in conjunction with the competent health departments and other relevant departments, professional institutions and relevant MAHs, and release the results in a timely manner.
縣級(jí)以上人民政府藥品監(jiān)督管理部門發(fā)現(xiàn)可能誤導(dǎo)公眾和社會(huì)輿論的疫苗安全信息，應(yīng)當(dāng)立即會(huì)同衛(wèi)生健康主管部門及其他有關(guān)部門、專業(yè)機(jī)構(gòu)、相關(guān)疫苗上市許可持有人等進(jìn)行核實(shí)、分析，并及時(shí)公布結(jié)果。
All entities and individuals are prohibited from fabricating or spreading any false information on vaccine safety.
任何單位和個(gè)人不得編造、散布虛假疫苗安全信息。
Article 77 All entities and individuals shall have the right to obtain vaccine information in accordance with law and put forward opinions and suggestions on vaccine administration.
第七十七條 任何單位和個(gè)人有權(quán)依法了解疫苗信息，對(duì)疫苗監(jiān)督管理工作提出意見、建議。
All entities or individuals are entitled to report any vaccine illegal behaviors to the competent health departments, the drug regulatory departments etc.; if the competent health departments or the drug regulatory departments etc. fail to perform their administration duties according to law, entities or individuals may report them to the relevant departments of people’s governments at the same level or the superior level as well as relevant supervisory departments. Relevant departments shall verify and handle the report in a timely manner; if the reports are verified to be true, give rewards to the informants according to relevant regulations; and give substantial rewards to the informants who report serious illegal behaviors committed in the entities where they work if the reports are verified to be true.
任何單位和個(gè)人有權(quán)向衛(wèi)生健康主管部門、藥品監(jiān)督管理部門等部門舉報(bào)疫苗違法行為，對(duì)衛(wèi)生健康主管部門、藥品監(jiān)督管理部門等部門及其工作人員未依法履行監(jiān)督管理職責(zé)的情況有權(quán)向本級(jí)或者上級(jí)人民政府及其有關(guān)部門、監(jiān)察機(jī)關(guān)舉報(bào)。有關(guān)部門、機(jī)關(guān)應(yīng)當(dāng)及時(shí)核實(shí)、處理；對(duì)查證屬實(shí)的舉報(bào)，按照規(guī)定給予舉報(bào)人獎(jiǎng)勵(lì)；舉報(bào)人舉報(bào)所在單位嚴(yán)重違法行為，查證屬實(shí)的，給予重獎(jiǎng)。
Article 78 People's governments at or above the county level shall formulate emergency response plans for vaccine safety incidents, stipulate the grading of vaccine safety incidents, manage organization and command systems and responsibilities, provide prevention and early warning mechanisms and manage procedures and emergency safeguarding measures.
第七十八條 縣級(jí)以上人民政府應(yīng)當(dāng)制定疫苗安全事件應(yīng)急預(yù)案，對(duì)疫苗安全事件分級(jí)、處置組織指揮體系與職責(zé)、預(yù)防預(yù)警機(jī)制、處置程序、應(yīng)急保障措施等作出規(guī)定。
Vaccine MAHs shall formulate the handling procedure for vaccine safety incidents, periodically inspect the implementation of all preventive measures and eliminate potential dangers in a timely manner.
疫苗上市許可持有人應(yīng)當(dāng)制定疫苗安全事件處置方案，定期檢查各項(xiàng)防范措施的落實(shí)情況，及時(shí)消除安全隱患。
In the case of vaccine safety events, vaccine MAHs shall immediately report the occurrence to the drug regulatory department under the State Council or drug regulatory departments of the people's governments of the provinces, autonomous regions or municipalities directly under the Central Government; and disease prevention and control institutions, immunization entities, and medical institutions shall immediately report the occurrence to competent health departments and drug regulatory departments of the people's governments at or above the county level. The drug regulatory departments shall establish a vaccine safety emergency response organization jointly with the competent health departments as specified in the emergency plan, conduct medical rescues, risk control, investigation and handling, information release, explanation etc., and address problems arising from the incidents such as providing supplementary immunization. The fees for supplementary immunization arising from vaccine safety incidents due to quality problems of vaccines shall be assumed by the vaccine MAHs.
發(fā)生疫苗安全事件，疫苗上市許可持有人應(yīng)當(dāng)立即向國務(wù)院藥品監(jiān)督管理部門或者省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門報(bào)告；疾病預(yù)防控制機(jī)構(gòu)、接種單位、醫(yī)療機(jī)構(gòu)應(yīng)當(dāng)立即向縣級(jí)以上人民政府衛(wèi)生健康主管部門、藥品監(jiān)督管理部門報(bào)告。藥品監(jiān)督管理部門應(yīng)當(dāng)會(huì)同衛(wèi)生健康主管部門按照應(yīng)急預(yù)案的規(guī)定，成立疫苗安全事件處置指揮機(jī)構(gòu)，開展醫(yī)療救治、風(fēng)險(xiǎn)控制、調(diào)查處理、信息發(fā)布、解釋說明等工作，做好補(bǔ)種等善后處置工作。因質(zhì)量問題造成的疫苗安全事件的補(bǔ)種費(fèi)用由疫苗上市許可持有人承擔(dān)。
Any entity or individual shall not conceal, give false information about, delay or omit reporting vaccine safety events and not conceal, forge or destroy relevant evidence.
有關(guān)單位和個(gè)人不得瞞報(bào)、謊報(bào)、緩報(bào)、漏報(bào)疫苗安全事件，不得隱匿、偽造、毀滅有關(guān)證據(jù)。
Chapter X Legal Liabilities
第十章 法律責(zé)任
Article 79 Illegal act that violates this Law and constitutes a crime shall be subject to severer criminal liabilities according to law.
第七十九條 違反本法規(guī)定，構(gòu)成犯罪的，依法從重追究刑事責(zé)任。
Article 80 Where manufactured or distributed vaccines are counterfeit, the drug regulatory departments of the people's governments at or above the provincial level shall confiscate illegal gains, illegally manufactured and distributed vaccines and raw materials, excipients, packaging materials and equipment specially used for illegal production, order to stop production for rectification and stop business operation, revoke drug registration certificate and impose a fine of not less than fifteen times but not more than fifty times the value of vaccines illegally manufactured or distributed, and if the illegal values are less than RMB 500,000 yuan, it shall be counted as RMB 500,000 yuan.
第八十條 生產(chǎn)、銷售的疫苗屬于假藥的，由省級(jí)以上人民政府藥品監(jiān)督管理部門沒收違法所得和違法生產(chǎn)、銷售的疫苗以及專門用于違法生產(chǎn)疫苗的原料、輔料、包裝材料、設(shè)備等物品，責(zé)令停產(chǎn)停業(yè)整頓，吊銷藥品注冊(cè)證書，直至吊銷藥品生產(chǎn)許可證等，并處違法生產(chǎn)、銷售疫苗貨值金額十五倍以上五十倍以下的罰款，貨值金額不足五十萬元的，按五十萬元計(jì)算。
Where manufactured or distributed vaccines are adulterated, the drug regulatory departments of the people's governments at or above the provincial level shall confiscate illegal gains, illegally manufactured and distributed vaccines and raw materials, excipients and packaging materials and equipment and so on specially used for illegal production, order to stop production for rectification and stop business operation, and impose a fine of not less than ten times but not more than thirty times the value of vaccines illegally manufactured or distributed, and if the illegal values are less than RMB 500,000 yuan, it shall be counted as RMB 500,000 yuan; in serious circumstances, the drug regulatory departments of the people's governments at or above the provincial level shall revoke drug registration certificate, and even the? drug manufacturing license.
生產(chǎn)、銷售的疫苗屬于劣藥的，由省級(jí)以上人民政府藥品監(jiān)督管理部門沒收違法所得和違法生產(chǎn)、銷售的疫苗以及專門用于違法生產(chǎn)疫苗的原料、輔料、包裝材料、設(shè)備等物品，責(zé)令停產(chǎn)停業(yè)整頓，并處違法生產(chǎn)、銷售疫苗貨值金額十倍以上三十倍以下的罰款，貨值金額不足五十萬元的，按五十萬元計(jì)算；情節(jié)嚴(yán)重的，吊銷藥品注冊(cè)證書，直至吊銷藥品生產(chǎn)許可證等。
Where manufactured or distributed vaccines are counterfeit, or adulterated with serious consequences, the legal representative, the main responsible person, the person directly in charge and personnel in key positions as well as other responsible personnel of vaccine MAHs shall be subject to a confiscation of income received from their affiliation during the occurrence of violations and a fine of not less than one time but not more than ten times the income, and shall be prohibited from engaging in drug manufacturing and operation for whole life, and detained by the public security department of not less than five days but not more than fifteen days.
生產(chǎn)、銷售的疫苗屬于假藥，或者生產(chǎn)、銷售的疫苗屬于劣藥且情節(jié)嚴(yán)重的，由省級(jí)以上人民政府藥品監(jiān)督管理部門對(duì)法定代表人、主要負(fù)責(zé)人、直接負(fù)責(zé)的主管人員和關(guān)鍵崗位人員以及其他責(zé)任人員，沒收違法行為發(fā)生期間自本單位所獲收入，并處所獲收入一倍以上十倍以下的罰款，終身禁止從事藥品生產(chǎn)經(jīng)營活動(dòng)，由公安機(jī)關(guān)處五日以上十五日以下拘留。
Article 81 In any of the following circumstances, the drug regulatory departments of the people's governments at or above the provincial level shall confiscate illegal gains, illegally manufactured and distributed vaccines and raw materials, excipients, packaging materials and equipment specially used for illegal manufacture, order to stop production for rectification and stop business operation, and impose a fine of not less than fifteen times but not more than fifty times the value of vaccines illegally manufactured or distributed; if the illegal values are less than RMB 500,000 yuan, it shall be counted as RMB 500,000 yuan; in serious circumstance, the offender is subject to revocation of relevant approval documents, and up to the revocation drug manufacturing license; the legal representative, the main responsible person, director in charge and personnel in key positions as well as other responsible personnel of vaccine MAHs shall be subject to a confiscation of the income received from their organizations during the occurrence of violations, and a fine of not less than one half but not more than ten times the income, and shall be prohibited from engaging in drug manufacturing and operation for life, and be detained by the public security department for not less than five days but not more than fifteen days:
第八十一條 有下列情形之一的，由省級(jí)以上人民政府藥品監(jiān)督管理部門沒收違法所得和違法生產(chǎn)、銷售的疫苗以及專門用于違法生產(chǎn)疫苗的原料、輔料、包裝材料、設(shè)備等物品，責(zé)令停產(chǎn)停業(yè)整頓，并處違法生產(chǎn)、銷售疫苗貨值金額十五倍以上五十倍以下的罰款，貨值金額不足五十萬元的，按五十萬元計(jì)算；情節(jié)嚴(yán)重的，吊銷藥品相關(guān)批準(zhǔn)證明文件，直至吊銷藥品生產(chǎn)許可證等，對(duì)法定代表人、主要負(fù)責(zé)人、直接負(fù)責(zé)的主管人員和關(guān)鍵崗位人員以及其他責(zé)任人員，沒收違法行為發(fā)生期間自本單位所獲收入，并處所獲收入百分之五十以上十倍以下的罰款，十年內(nèi)直至終身禁止從事藥品生產(chǎn)經(jīng)營活動(dòng)，由公安機(jī)關(guān)處五日以上十五日以下拘留：
(1) submitting falsified data, documents, samples or having other deceptive behaviors in application for vaccine clinical trials, registration and lot release;
（一）申請(qǐng)疫苗臨床試驗(yàn)、注冊(cè)、批簽發(fā)提供虛假數(shù)據(jù)、資料、樣品或者有其他欺騙行為；
(2) fabricating manufacturing and testing records or changing product lot number;
（二）編造生產(chǎn)、檢驗(yàn)記錄或者更改產(chǎn)品批號(hào)；
(3) distributing vaccine to immunization entities by any institution or individual other than disease prevention and control institutions;
（三）疾病預(yù)防控制機(jī)構(gòu)以外的單位或者個(gè)人向接種單位供應(yīng)疫苗；
(4) entrusting vaccine manufacturing without authorization;
（四）委托生產(chǎn)疫苗未經(jīng)批準(zhǔn)；
(5) implementing changes to production process, production site and key equipment without approval which shall have been approved as required;
（五）生產(chǎn)工藝、生產(chǎn)場地、關(guān)鍵設(shè)備等發(fā)生變更按照規(guī)定應(yīng)當(dāng)經(jīng)批準(zhǔn)而未經(jīng)批準(zhǔn)；
(6) implementing updates of vaccine package inserts and labels without approval which shall have been approved as required.
（六）更新疫苗說明書、標(biāo)簽按照規(guī)定應(yīng)當(dāng)經(jīng)核準(zhǔn)而未經(jīng)核準(zhǔn)。
Article 82 Except otherwise provided in the Law, if vaccine MAHs or other entities violate relevant drug quality management regulations, the drug regulatory departments of the people's governments at or above the county level shall order to make rectification and give a warning; and those who refuse to make rectification shall be subject to a fine of not less than RMB 200,000 yuan but not more than RMB 500,000 yuan; in serious circumstances, the offender shall be subject to a fine of not less than RMB 500,000 yuan but not more than RMB 3,000,000 yuan and an order to stop production for rectification until revocation of relevant drug approval documents and drug manufacturing license, and the legal representative, the main responsible person, executive in charge and personnel in key positions as well as other responsible personnel of vaccine MAHs shall be subject to a confiscation of the income received from their organizations during the occurrence of violations, and a fine of not less than one half but not more than five times the income, and be prohibited from engaging in drug production and operation for ten years to for life.
第八十二條 除本法另有規(guī)定的情形外，疫苗上市許可持有人或者其他單位違反藥品相關(guān)質(zhì)量管理規(guī)范的，由縣級(jí)以上人民政府藥品監(jiān)督管理部門責(zé)令改正，給予警告；拒不改正的，處二十萬元以上五十萬元以下的罰款；情節(jié)嚴(yán)重的，處五十萬元以上三百萬元以下的罰款，責(zé)令停產(chǎn)停業(yè)整頓，直至吊銷藥品相關(guān)批準(zhǔn)證明文件、藥品生產(chǎn)許可證等，對(duì)法定代表人、主要負(fù)責(zé)人、直接負(fù)責(zé)的主管人員和關(guān)鍵崗位人員以及其他責(zé)任人員，沒收違法行為發(fā)生期間自本單位所獲收入，并處所獲收入百分之五十以上五倍以下的罰款，十年內(nèi)直至終身禁止從事藥品生產(chǎn)經(jīng)營活動(dòng)。
Article 83 In cases where vaccine MAHs’ violation of this Law involves any of the following circumstances, the drug regulatory departments of the people's governments at or above the provincial level shall order to make rectification and give a warning; and those who refuse to make rectification shall be subject to a fine of not less than RMB 200,000 yuan but not more than RMB 500,000 yuan; in serious circumstances, the offender shall be subject to an order to stop production for rectification and a fine of not less than RMB 500,000 yuan but not more than RMB 2,000,000 yuan:
第八十三條 違反本法規(guī)定，疫苗上市許可持有人有下列情形之一的，由省級(jí)以上人民政府藥品監(jiān)督管理部門責(zé)令改正，給予警告；拒不改正的，處二十萬元以上五十萬元以下的罰款；情節(jié)嚴(yán)重的，責(zé)令停產(chǎn)停業(yè)整頓，并處五十萬元以上二百萬元以下的罰款：
(1) failing to establish vaccine electronic traceability system as required;
（一）未按照規(guī)定建立疫苗電子追溯系統(tǒng)；
(2) persons in key positions such as legal representative, the principal, responsible person for manufacturing management, the responsible person for quality management and the quality authorized person, etc. failing to meet the prescribed conditions or failing to train and appraise these persons as required;
（二）法定代表人、主要負(fù)責(zé)人和生產(chǎn)管理負(fù)責(zé)人、質(zhì)量管理負(fù)責(zé)人、質(zhì)量受權(quán)人等關(guān)鍵崗位人員不符合規(guī)定條件或者未按照規(guī)定對(duì)其進(jìn)行培訓(xùn)、考核；
(3) failing to report or file as required;
（三）未按照規(guī)定報(bào)告或者備案；
(4) failing to conduct post-marketing research, or failing to establish institutions and equip staff as required to actively collect, track and analyze adverse reactions of suspected vaccination;
（四）未按照規(guī)定開展上市后研究，或者未按照規(guī)定設(shè)立機(jī)構(gòu)、配備人員主動(dòng)收集、跟蹤分析疑似預(yù)防接種異常反應(yīng)；
(5) failing to carry compulsory vaccine liability insurance as required;
（五）未按照規(guī)定投保疫苗責(zé)任強(qiáng)制保險(xiǎn)；
(6) failing to establish information disclosure system as required.
（六）未按照規(guī)定建立信息公開制度。
Article 84 Where a lot release institution has one of the following circumstances in violation of this Law, the drug regulatory department under the State Council shall order to make rectifications and give a warning to the said institution, and give warnings until downgrade as punishment to the principal, director in charge and other directly responsible personnel:
第八十四條 違反本法規(guī)定，批簽發(fā)機(jī)構(gòu)有下列情形之一的，由國務(wù)院藥品監(jiān)督管理部門責(zé)令改正，給予警告，對(duì)主要負(fù)責(zé)人、直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予警告直至降級(jí)處分：
(1) failing to conduct audits and inspections as required;
（一）未按照規(guī)定進(jìn)行審核和檢驗(yàn)；
(2) failing to issue lot release results of marketed vaccine in a timely manner;
（二）未及時(shí)公布上市疫苗批簽發(fā)結(jié)果；
(3) failing to verify and validate as required;
（三）未按照規(guī)定進(jìn)行核實(shí)；
(4) failing to report detected significant quality risks of vaccine as required.
（四）發(fā)現(xiàn)疫苗存在重大質(zhì)量風(fēng)險(xiǎn)未按照規(guī)定報(bào)告。
If a lot release institution fails to issue a lot release certificate or a not-release notice in violation of this Law, the drug regulatory department under the State Council shall order to make rectifications and give a warning to the said institution, and give a downgrade or dismissal as punishment to the main responsible person, executive in charge, and other directly responsible personnel according to law; and in serious circumstances, an expulsion from organization.
違反本法規(guī)定，批簽發(fā)機(jī)構(gòu)未按照規(guī)定發(fā)給批簽發(fā)證明或者不予批簽發(fā)通知書的，由國務(wù)院藥品監(jiān)督管理部門責(zé)令改正，給予警告，對(duì)主要負(fù)責(zé)人、直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予降級(jí)或者撤職處分；情節(jié)嚴(yán)重的，對(duì)主要負(fù)責(zé)人、直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予開除處分。
Article 85 If any disease prevention and control institution, immunization entity, vaccine MAH, or vaccine distribution entity violates cold-chain storage and transportation requirements in vaccine storage and transportation guidance, the drug regulatory department of the people's government at or above the county level shall order to make rectification and give warnings, destroy illegally stored and transported vaccines and confiscate illegal income; and for those who refuse to make rectification, it shall impose on the immunization entity, the MAH and the vaccine distribution entity a fine of more than RMB 200,000 yuan and less than RMB 1,000,000 yuan; and in serious circumstances, it shall impose on the immunization entity, vaccine MAH, and vaccine distribution entity a fine of not less than ten times and not more than thirty times of illegal values derived from illegally stored and transported vaccines; and if the illegal values are less than RMB 100,000 yuan, it shall be counted as RMB 100,000 yuan, and the vaccine MAH, vaccine distribution entity shall be subject to production and operation suspension until revocation of relevant drug approval documents, drug manufacturing certificate and so on, and their legal representative, the principal, executive in charge and key position personnel and other responsible personnel shall be subject to punishments as prescribed in Article 82 of this Law.
第八十五條 疾病預(yù)防控制機(jī)構(gòu)、接種單位、疫苗上市許可持有人、疫苗配送單位違反疫苗儲(chǔ)存、運(yùn)輸管理規(guī)范有關(guān)冷鏈儲(chǔ)存、運(yùn)輸要求的，由縣級(jí)以上人民政府藥品監(jiān)督管理部門責(zé)令改正，給予警告，對(duì)違法儲(chǔ)存、運(yùn)輸?shù)囊呙缬枰凿N毀，沒收違法所得；拒不改正的，對(duì)接種單位、疫苗上市許可持有人、疫苗配送單位處二十萬元以上一百萬元以下的罰款；情節(jié)嚴(yán)重的，對(duì)接種單位、疫苗上市許可持有人、疫苗配送單位處違法儲(chǔ)存、運(yùn)輸疫苗貨值金額十倍以上三十倍以下的罰款，貨值金額不足十萬元的，按十萬元計(jì)算，責(zé)令疫苗上市許可持有人、疫苗配送單位停產(chǎn)停業(yè)整頓，直至吊銷藥品相關(guān)批準(zhǔn)證明文件、藥品生產(chǎn)許可證等，對(duì)疫苗上市許可持有人、疫苗配送單位的法定代表人、主要負(fù)責(zé)人、直接負(fù)責(zé)的主管人員和關(guān)鍵崗位人員以及其他責(zé)任人員依照本法第八十二條規(guī)定給予處罰。
Where disease prevention and control institutions or immunization entity commits an illegal act as prescribed in the preceding paragraph, the competent health department of the People's government at or above the county level shall impose sanctions of a warning and up to dismissal on the main responsible person, executive in charge and other directly responsible personnel according to law, and order the responsible medical personnel to suspend the practice activities for more than one year and less than 18 months; and for serious consequences, give a dismissal according to law, and revoke immunization qualification of the immunization entity, and responsible medical and health personnel shall being revoked of business certificate by original issuing department.
疾病預(yù)防控制機(jī)構(gòu)、接種單位有前款規(guī)定違法行為的，由縣級(jí)以上人民政府衛(wèi)生健康主管部門對(duì)主要負(fù)責(zé)人、直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予警告直至撤職處分，責(zé)令負(fù)有責(zé)任的醫(yī)療衛(wèi)生人員暫停一年以上十八個(gè)月以下執(zhí)業(yè)活動(dòng)；造成嚴(yán)重后果的，對(duì)主要負(fù)責(zé)人、直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予開除處分，并可以吊銷接種單位的接種資格，由原發(fā)證部門吊銷負(fù)有責(zé)任的醫(yī)療衛(wèi)生人員的執(zhí)業(yè)證書。
Article 86 Where any disease prevention and control institutions, immunization entity, vaccine MAH or vaccine distribution entity violates vaccine storage and transportation guidance other than those prescribed in Article 85 of this Law, the drug regulatory departments of the people's governments at the county level shall order to make rectification, give a warning, and confiscate the illegal gains; and for those who refuse to make rectification, a fine of more than RMB 100,000 yuan and less than RMB 300,000 yuan shall be imposed on the immunization entity, vaccine MAHs, and the vaccine distribution entity; and in serious circumstances, a fine of not less than three times and not more than ten times of values derived from illegally stored and transported vaccines shall be imposed on the immunization entity, vaccine MAHs, and vaccine distribution entity. If the value of the vaccines concerned is less than RMB 100,000 yuan, it shall be counted as RMB 100,000 yuan.
第八十六條 疾病預(yù)防控制機(jī)構(gòu)、接種單位、疫苗上市許可持有人、疫苗配送單位有本法第八十五條規(guī)定以外的違反疫苗儲(chǔ)存、運(yùn)輸管理規(guī)范行為的，由縣級(jí)以上人民政府藥品監(jiān)督管理部門責(zé)令改正，給予警告，沒收違法所得；拒不改正的，對(duì)接種單位、疫苗上市許可持有人、疫苗配送單位處十萬元以上三十萬元以下的罰款；情節(jié)嚴(yán)重的，對(duì)接種單位、疫苗上市許可持有人、疫苗配送單位處違法儲(chǔ)存、運(yùn)輸疫苗貨值金額三倍以上十倍以下的罰款，貨值金額不足十萬元的，按十萬元計(jì)算。
Where any disease prevention and control institution or immunization entity commits illegal acts as prescribed in the preceding paragraph, the competent health department of the people's government at or above the county level may impose sanctions of? warning and up to the dismissal on the main responsible person, the executive in charge and other directly responsible personnel according to law, and order the responsible medical and health personnel to suspend practice activities for more than six months and less than one year; and for serious consequences, give a dismissal to the principal, the executive in charge and other directly responsible personnel according to law, and responsible medical and health personnel shall be revoked of business certificate by original issuing department.
疾病預(yù)防控制機(jī)構(gòu)、接種單位有前款規(guī)定違法行為的，縣級(jí)以上人民政府衛(wèi)生健康主管部門可以對(duì)主要負(fù)責(zé)人、直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予警告直至撤職處分，責(zé)令負(fù)有責(zé)任的醫(yī)療衛(wèi)生人員暫停六個(gè)月以上一年以下執(zhí)業(yè)活動(dòng)；造成嚴(yán)重后果的，對(duì)主要負(fù)責(zé)人、直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予開除處分，由原發(fā)證部門吊銷負(fù)有責(zé)任的醫(yī)療衛(wèi)生人員的執(zhí)業(yè)證書。
Article 87 Where any disease prevention and control institution or immunization entity is under any of the following circumstances in violation of this Law, the competent health department of the people's government at or above the county level shall order to make rectification, give a warning, and confiscate the illegal income; and in serious circumstances, impose sanctions of a warning and up to? dismissal on the main responsible person, directly responsible persons and other directly responsible personnel according to law, and order the responsible medical personnel to suspend practice activities for more than one year and less than eighteen months; and for serious consequence, give an expulsion to the main responsible person and executive in charge and other directly responsible personnel according to law, and responsible medical and health personnel shall be revoked of business certificate by original issuing department:
第八十七條 違反本法規(guī)定，疾病預(yù)防控制機(jī)構(gòu)、接種單位有下列情形之一的，由縣級(jí)以上人民政府衛(wèi)生健康主管部門責(zé)令改正，給予警告，沒收違法所得；情節(jié)嚴(yán)重的，對(duì)主要負(fù)責(zé)人、直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予警告直至撤職處分，責(zé)令負(fù)有責(zé)任的醫(yī)療衛(wèi)生人員暫停一年以上十八個(gè)月以下執(zhí)業(yè)活動(dòng)；造成嚴(yán)重后果的，對(duì)主要負(fù)責(zé)人、直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予開除處分，由原發(fā)證部門吊銷負(fù)有責(zé)任的醫(yī)療衛(wèi)生人員的執(zhí)業(yè)證書：
(1) failing to supply, receive, and purchase vaccines as required;
（一）未按照規(guī)定供應(yīng)、接收、采購疫苗；
(2) conducting immunization activities that does not comply with the immunization work norms, immunization procedures, guidance for vaccines use and immunization plans;
（二）接種疫苗未遵守預(yù)防接種工作規(guī)范、免疫程序、疫苗使用指導(dǎo)原則、接種方案；
(3) conducting cluster immunization without authorization.
（三）擅自進(jìn)行群體性預(yù)防接種。
Article 88 In cases where violation of this Law by disease prevention and control institution or immunization entity involves any of the following circumstances, the competent health department of the people's government at or above the county level shall order to make rectification, give a warning, and confiscate the illegal income; and in serious circumstances, impose sanctions of a warning and up to dismissal on the main responsible person, directly responsible persons and other directly responsible personnel according to law, and order the responsible medical personnel to suspend practice activities for more than six months and less than one year; for serious consequences, give an expulsion to the principal and executive in charge and other directly responsible personnel according to law, and responsible medical and health personnel shall be revoked of business certificate by original issuing department:
第八十八條 違反本法規(guī)定，疾病預(yù)防控制機(jī)構(gòu)、接種單位有下列情形之一的，由縣級(jí)以上人民政府衛(wèi)生健康主管部門責(zé)令改正，給予警告；情節(jié)嚴(yán)重的，對(duì)主要負(fù)責(zé)人、直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予警告直至撤職處分，責(zé)令負(fù)有責(zé)任的醫(yī)療衛(wèi)生人員暫停六個(gè)月以上一年以下執(zhí)業(yè)活動(dòng)；造成嚴(yán)重后果的，對(duì)主要負(fù)責(zé)人、直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予開除處分，由原發(fā)證部門吊銷負(fù)有責(zé)任的醫(yī)療衛(wèi)生人員的執(zhí)業(yè)證書：
(1) failing to provide traceability information as required;
（一）未按照規(guī)定提供追溯信息；
(2) failing to obtain and keep relevant certification documents and temperature monitoring records when receiving or purchasing vaccines;
（二）接收或者購進(jìn)疫苗時(shí)未按照規(guī)定索取并保存相關(guān)證明文件、溫度監(jiān)測記錄；
(3) failing to establish and maintain records of vaccine reception, purchase, storage, distribution, supply, inoculation, and disposal as required;
（三）未按照規(guī)定建立并保存疫苗接收、購進(jìn)、儲(chǔ)存、配送、供應(yīng)、接種、處置記錄；
(4) failing to inform and inquire the recipient or his/her guardian about relevant conditions as required.
（四）未按照規(guī)定告知、詢問受種者或者其監(jiān)護(hù)人有關(guān)情況。
Article 89 Where any disease prevention and control institution, medical institution or immunization entity fails to report suspected immunization adverse reactions and vaccine safety incidents, or fails to organize investigation and diagnosis of suspected immunization adverse reactions as required, the competent health departments of the people's governments at or above the county level shall order to make rectification and give a warning; and in serious circumstances, it shall impose a fine of not less than RMB 50,000 yuan but not more than RMB 500,000 yuan on the immunization entities and medical institutions, and impose sanctions of a warning and up to a dismissal on the main responsible person, executive in charge and other directly responsible personnel according to law; and for serious consequence, give an expulsion to the main responsible person and executive in charge and other directly responsible personnel according to law, and the department that formerly issued the practicing license shall revoke the certificate of the responsible medical and healthcare personnel.
第八十九條 疾病預(yù)防控制機(jī)構(gòu)、接種單位、醫(yī)療機(jī)構(gòu)未按照規(guī)定報(bào)告疑似預(yù)防接種異常反應(yīng)、疫苗安全事件等，或者未按照規(guī)定對(duì)疑似預(yù)防接種異常反應(yīng)組織調(diào)查、診斷等的，由縣級(jí)以上人民政府衛(wèi)生健康主管部門責(zé)令改正，給予警告；情節(jié)嚴(yán)重的，對(duì)接種單位、醫(yī)療機(jī)構(gòu)處五萬元以上五十萬元以下的罰款，對(duì)疾病預(yù)防控制機(jī)構(gòu)、接種單位、醫(yī)療機(jī)構(gòu)的主要負(fù)責(zé)人、直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予警告直至撤職處分；造成嚴(yán)重后果的，對(duì)主要負(fù)責(zé)人、直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予開除處分，由原發(fā)證部門吊銷負(fù)有責(zé)任的醫(yī)療衛(wèi)生人員的執(zhí)業(yè)證書。
Article 90 If any disease prevention and control institutions or immunization entities violates this Law to charge fee, the competent health departments of the people's governments at or above the county level shall monitor the return of the illegally charged fee to the original paying entities or individuals, and market regulation department at or above the county level shall give corresponding sanctions thereto according to law.
第九十條 疾病預(yù)防控制機(jī)構(gòu)、接種單位違反本法規(guī)定收取費(fèi)用的，由縣級(jí)以上人民政府衛(wèi)生健康主管部門監(jiān)督其將違法收取的費(fèi)用退還給原繳費(fèi)的單位或者個(gè)人，并由縣級(jí)以上人民政府市場監(jiān)督管理部門依法給予處罰。
Article 91 For any institution conducting immunization of immunization program vaccines without designation of competent health departments of the local people's government at or above the county level, or conducting immunization of non-immunization program vaccines without meeting the requirements or filing the record, the competent health departments of the people's government at or above the county level shall order to make rectification and give a warning, confiscate illegal gains and illegally possessed vaccines, order to stop operation for rectification, impose a fine of not less than RMB 100,000 yuan but not more than RMB 1,000,000 yuan and impose sanctions on the main responsible person, executive in charge and other direct responsible personnel according to law.
第九十一條 違反本法規(guī)定，未經(jīng)縣級(jí)以上地方人民政府衛(wèi)生健康主管部門指定擅自從事免疫規(guī)劃疫苗接種工作、從事非免疫規(guī)劃疫苗接種工作不符合條件或者未備案的，由縣級(jí)以上人民政府衛(wèi)生健康主管部門責(zé)令改正，給予警告，沒收違法所得和違法持有的疫苗，責(zé)令停業(yè)整頓，并處十萬元以上一百萬元以下的罰款，對(duì)主要負(fù)責(zé)人、直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予處分。
For any entity or individual other than disease prevention and control institutions and immunization entities that engages in cluster immunization without approval in violation of this Law, the competent health departments of the people's government at or above the county level shall order to make rectification, confiscate illegal gains and illegally possessed vaccines, and impose a fine of not less than ten times and not more than thirty times ofvalues derived from illegally stored and transported vaccines, and if the? values of the vaccines concerned are less than RMB 50,000 yuan, it shall be counted as RMB 50,000 yuan.
違反本法規(guī)定，疾病預(yù)防控制機(jī)構(gòu)、接種單位以外的單位或者個(gè)人擅自進(jìn)行群體性預(yù)防接種的，由縣級(jí)以上人民政府衛(wèi)生健康主管部門責(zé)令改正，沒收違法所得和違法持有的疫苗，并處違法持有的疫苗貨值金額十倍以上三十倍以下的罰款，貨值金額不足五萬元的，按五萬元計(jì)算。
Article 92 If the guardian fails to ensure that the children at proper age are immunized with immunization program vaccines on schedule, the competent health departments at the county level shall give criticism and education and order to make correction.
第九十二條 監(jiān)護(hù)人未依法保證適齡兒童按時(shí)接種免疫規(guī)劃疫苗的，由縣級(jí)人民政府衛(wèi)生健康主管部門批評(píng)教育，責(zé)令改正。
Where nurseries and schools fail to check the immunization certificate as required on the admission of children, or fail to report to immunization entities after identifying any child having not been vaccinated as required, the education administrative departments of the people's government at or above the county level shall order to make correction, give a warning, and impose sanctions on the main responsible person, executive in charge and other responsible personnel.
托幼機(jī)構(gòu)、學(xué)校在兒童入托、入學(xué)時(shí)未按照規(guī)定查驗(yàn)預(yù)防接種證，或者發(fā)現(xiàn)未按照規(guī)定接種的兒童后未向接種單位報(bào)告的，由縣級(jí)以上地方人民政府教育行政部門責(zé)令改正，給予警告，對(duì)主要負(fù)責(zé)人、直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予處分。
Article 93 Anyone who fabricates or spreads false information about vaccine safety, or picks quarrels and provokes troubles in immunization entities, thus constituting an act violating public security regulations shall be subject to public security punishment by the public security departments according to law.
第九十三條 編造、散布虛假疫苗安全信息，或者在接種單位尋釁滋事，構(gòu)成違反治安管理行為的，由公安機(jī)關(guān)依法給予治安管理處罰。
Relevant competent departments shall impose sanctions according to law on a newspaper, journal, radio, television, internet website or any other media where they fabricate or disseminate anyfalse information about vaccine safety, and on the main responsible person, executive in charge and other directly responsible personnel.
報(bào)紙、期刊、廣播、電視、互聯(lián)網(wǎng)站等傳播媒介編造、散布虛假疫苗安全信息的，由有關(guān)部門依法給予處罰，對(duì)主要負(fù)責(zé)人、直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予處分。
Article 94 Where local people's governments at or above the county level are under any of the following circumstances in vaccine administration, the executive in charge and other directly responsible personnel shall be given a downgrade or dismissal; and in serious circumstances, the executive in charge and other directly responsible personnel shall be given an expulsion; if it causes serious consequences, the principal shall resign to assume responsibility:
第九十四條 縣級(jí)以上地方人民政府在疫苗監(jiān)督管理工作中有下列情形之一的，對(duì)直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予降級(jí)或者撤職處分；情節(jié)嚴(yán)重的，依法給予開除處分；造成嚴(yán)重后果的，其主要負(fù)責(zé)人應(yīng)當(dāng)引咎辭職：
(1) performing responsibility insufficiently, resulting in serious negative effects or heavy losses;
（一）履行職責(zé)不力，造成嚴(yán)重不良影響或者重大損失；
(2) concealing information, giving false information, delaying reporting, giving incomplete report of vaccine safety incidents;
（二）瞞報(bào)、謊報(bào)、緩報(bào)、漏報(bào)疫苗安全事件；
(3) disturbing or obstructing vaccines-related investigation on illegal or criminal acts or safety incidents;
（三）干擾、阻礙對(duì)疫苗違法行為或者疫苗安全事件的調(diào)查；
(4) occurrence of significant vaccine safety incidents or continuous major vaccine safety incidents within the administrative region.
（四）本行政區(qū)域發(fā)生特別重大疫苗安全事故，或者連續(xù)發(fā)生重大疫苗安全事故。
Article 95 For any of the following behaviors of drug regulatory departments or competent health departments in vaccine administration, the executive in charge and other directly responsible personnel shall be given a downgrade or dismissal; and in serious circumstances, the executive in charge and other directly responsible personnel shall be given an expulsion; if it causes serious consequence, the principal shall resign to assume responsibility:
第九十五條 藥品監(jiān)督管理部門、衛(wèi)生健康主管部門等部門在疫苗監(jiān)督管理工作中有下列情形之一的，對(duì)直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予降級(jí)或者撤職處分；情節(jié)嚴(yán)重的，依法給予開除處分；造成嚴(yán)重后果的，其主要負(fù)責(zé)人應(yīng)當(dāng)引咎辭職：
(1) failing to perform duties of supervision and inspection, or failing to promptly investigate and punish any illegal act that has been identified;
（一）未履行監(jiān)督檢查職責(zé)，或者發(fā)現(xiàn)違法行為不及時(shí)查處；
(2) carrying out cluster immunization without approval;
（二）擅自進(jìn)行群體性預(yù)防接種；
(3) concealing information, giving false information, delaying reporting or giving incomplete reporting of vaccine safety incidents;
（三）瞞報(bào)、謊報(bào)、緩報(bào)、漏報(bào)疫苗安全事件；
(4) disturbing or obstructing vaccine-related investigation on illegal acts or safety incidents;
（四）干擾、阻礙對(duì)疫苗違法行為或者疫苗安全事件的調(diào)查；
(5) revealing the information of the informant;
（五）泄露舉報(bào)人的信息；
(6) failing to organize investigations and handling as required when receiving reports of suspected immunization adverse reactions;
（六）接到疑似預(yù)防接種異常反應(yīng)相關(guān)報(bào)告，未按照規(guī)定組織調(diào)查、處理；
(7) having any other dereliction of duty in vaccine administration, resulting in serious negative effects or heavy losses.
（七）其他未履行疫苗監(jiān)督管理職責(zé)的行為，造成嚴(yán)重不良影響或者重大損失。
Article 96 If vaccine recipients are subject to any injury as a result of vaccine quality problem, the responsible vaccine MAH shall assume the compensation liability according to law.
第九十六條 因疫苗質(zhì)量問題造成受種者損害的，疫苗上市許可持有人應(yīng)當(dāng)依法承擔(dān)賠償責(zé)任。
If any disease prevention and control institutions or immunization entities violate the work norms, immunization procedure, vaccine use guidance and immunization plan in immunization, and thus cause injury to vaccine recipients, they shall assume the compensation liability according to law.
疾病預(yù)防控制機(jī)構(gòu)、接種單位因違反預(yù)防接種工作規(guī)范、免疫程序、疫苗使用指導(dǎo)原則、接種方案，造成受種者損害的，應(yīng)當(dāng)依法承擔(dān)賠償責(zé)任。
Chapter XI Supplementary Provisions
第十一章 附 則
Article 97 Definitions of the following terms used in this Law shall be:
第九十七條 本法下列用語的含義是：
“Immunization program vaccines” are vaccines to be inoculated in citizens as per the government provisions, including vaccines confirmed in the national immunization program, vaccines added by people’s governments of provinces, autonomous regions and municipalities directly under the Central Government while implementing the national immunization program, vaccines for emergency immunization or cluster immunization organized by the people’s governments or their competent health departments at or above the county level.
免疫規(guī)劃疫苗，是指居民應(yīng)當(dāng)按照政府的規(guī)定接種的疫苗，包括國家免疫規(guī)劃確定的疫苗，省、自治區(qū)、直轄市人民政府在執(zhí)行國家免疫規(guī)劃時(shí)增加的疫苗，以及縣級(jí)以上人民政府或者其衛(wèi)生健康主管部門組織的應(yīng)急接種或者群體性預(yù)防接種所使用的疫苗。
“Non-immunization program vaccines” are other vaccines to be inoculated by citizens at their discretion.
非免疫規(guī)劃疫苗，是指由居民自愿接種的其他疫苗。
Vaccine MAHs are entities that obtain drug registration certificate of vaccines and drug manufacturing certificate.
疫苗上市許可持有人，是指依法取得疫苗藥品注冊(cè)證書和藥品生產(chǎn)許可證的企業(yè)。
Article 98 The State encourages vaccine manufacturers to produce and export vaccines to meet the international demand.
第九十八條 國家鼓勵(lì)疫苗生產(chǎn)企業(yè)按照國際采購要求生產(chǎn)、出口疫苗。
Exported vaccines shall meet the standards of the importing country (region) or contractual requirements.
出口的疫苗應(yīng)當(dāng)符合進(jìn)口國（地區(qū)）的標(biāo)準(zhǔn)或者合同要求。
Article 99 The immunization for exit and entry and the procurement of the vaccines needed shall be separately stipulated by border health and quarantine departments upon consultation with the financial department under the State Council.
第九十九條 出入境預(yù)防接種及所需疫苗的采購，由國境衛(wèi)生檢疫機(jī)關(guān)商國務(wù)院財(cái)政部門另行規(guī)定。
Article 100 This Law shall be effective as of December 1, 2019.
第一百條 本法自2019年12月1日起施行。