【中英文对照版】化妆品网络经营监督管理办法（2023）.docx

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1、国家药监局关于发布化 妆品网络经营监督管理办 法的公告(国家药品监督管理局公 告2023年第36号)为进一步强化化妆品网络 经营监管工作，规范化妆 品网络经营行为，保证化 妆品质量安全，根据化 妆品监督管理条例化 妆品生产经营监督管理办 法等，国家药监局组织 制定了化妆品网络经营 监督管理办法，现予公化妆品网络经营监督管理办法(2023)Measures for the Supervision and Administration of OnlineDistribution of Cosmetics ( 2023 )制定机关：国家药品监督管理局(已变更)发文字号：国家药品监督管理局公告2023

2、年第36号公布日期:2023. 03. 31施行日期：2023. 09. 01效力位阶：部门规范性文件法规类别：卫生综合规定Issuing Authority : State Drug Supervision & Administration Bureau (replaced)Document Number ： Announcement No. 36 2023 of the National Medical Products AdministrationDate Issued ： 03-31-2023Effective Date ： 09-01-2023Level of Authority ：

3、 Departmental Regulatory DocumentsArea of Law ： General Provisions on Health and SanitationAnnouncement of the National Medical Products Administration on Issuing the Measures for the Supervision and Administration of Online Distribution of Cosmetics (Announcement No. 36 2023 of the National Medical

4、 Products Administration)For the purposes of further strengthening the supervision and administration of online distribution of cosmetics, standardizing the online distribution behaviors of cosmetics and ensuring the quality and safety of cosmetics, in accordance with the Regulation on the Supervisi

5、on and Administration of Cosmetics and the Measures for the Supervision and Administration of Production and Distribution of Cosmetics, among others, the National Medical Products Administration has organized the development of the Measures for the Supervision andmaterials are used or substances tha

6、t may be harmful to human health are illegally added into the cosmetics distributed on the platform.(3) There are other major product quality and safety problems of cosmetics distributed on the platform.The department responsible for supervision and administration of medicinal products shall conduct

7、 investigation into and handle clues to suspected illegal distribution, and if cosmetics distributors on a platform are considered to have illegal acts upon investigation, the cosmetics distributors on a cosmetics e-commerce platform shall be notified of the investigation and handling results in a t

8、imely manner.Article 17 An operator of a cosmetics e-commerce platform shall report in writing the illegal distribution behaviors and disposal measures of cosmetics distributors on the platform found by the platform to the provincial medical products administrations at the places where the cosmetics

9、 distributors on the cosmetics e-commerce platform are located on a quarterly basis.营的化妆品中使用禁用原 料或者非法添加可能危害 人体健康物质的；（三）入网经营的化妆品 存在其他重大产品质量安 全问题。负责药品监督管理的部门 应当对涉嫌违法经营的线 索进行调查处理，经调查 认为平台内化妆品经营者 存在违法行为的，应当将 调查处理结果及时通知化 妆品电子商务平台经营 者。第十七条化妆品电 子商务平台经营者应当每 季度将本平台发现的平台 内化妆品经营者违法经营 行为以及处置措施书面报 告化妆品电子商务平台经 营者

10、住所地省级药品监督 管理部门。化妆品电子商务平台经营 者住所地省级药品监督管 理部门应当审核化妆品电 子商务平台经营者的书面 报告，发现化妆品电子商 务平台经营者未采取必要 措施及时制止违法行为或 者未按要求向省级药品监 督管理部门报告涉嫌违法 经营线索的，化妆品电子The provincial medical products administration at the place where an operator of a cosmetics e-commerce platform is located shall examine the written report of the op

11、erator of a cosmetics e-commerce platform, and if the operator of a cosmetics e-commerce platform is found to have failed to take necessary measures to stop illegal behaviors in a timely manner or report suspected illegal distribution clues to the provincial medical products administration as requir

12、ed, the provincial medical products administration at the place where the operator of a cosmetics e-commerceplatform is located shall conduct investigation and handling in accordance with the law.Article 18 An operator of a cosmetics e-commerce platform shall provide necessary technical support and

13、services for cosmetics distributors on the platform to fulfill the obligations of disclosure of cosmetics information according to the law.An operator of a cosmetics e-commerce platform shall be encouraged to establish an automatic information reporting mechanism in the form of open data interface w

14、ith the department responsible for supervision and administration of medicinal products.Article 19 An operator of a cosmetics e-commerce platform shall strengthen the publicity and training of the knowledge of cosmetics distributors on platforms on relevant regulations. The contents of publicity and

15、 training shall include the relevant laws and regulations on cosmetics, the legal obligations and liabilities of cosmetics distributors on platforms, the platform service agreements and trading rules, and the requirements for issuance of information on cosmetics.Chapter III Cosmetic Distributors on

16、Platforms商务平台经营者住所地省 级药品监督管理部门应当 依法进行调查处理。第十八条化妆品电 子商务平台经营者应当为 平台内化妆品经营者依法 履行化妆品信息披露等义 务提供必要的技术支持和 服务。鼓励化妆品电子商务平台 经营者与负责药品监督管 理的部门建立开放数据接 口等形式的自动化信息报 送机制。第十九条化妆品电 子商务平台经营者应当加 强对平台内化妆品经营者 相关法规知识的宣传培 训，宣传培训内容应当包 括化妆品相关法律法规、 平台内化妆品经营者法律 义务和法律责任、平台服 务协议和交易规则、化妆 品信息发布要求等。第三章平台内化妆品经 营者管理第二十条平台内化 妆品经营者应当建立

17、并执 行进货查验记录制度，查 验直接供货者的市场主体Article 20 A cosmetics distributor on a platform shall establish and implement a purchase inspection record system, check the direct suppliers market participant registration certificate, special cosmetics registration certificate or general cosmetics recordation登记证明、特殊化妆品注

18、 册证或者普通化妆品备案 信息、化妆品的产品质量 检验合格证明并保存相关 凭证，如实记录化妆品名 称、特殊化妆品注册证编 号或者普通化妆品备案编 号、使用期限、净含量、购进数量、供货者名称、 地址、联系方式、购进日 期等内容。经营儿童化妆 品的，还应当查验儿童化information, and cosmetics product quality inspection certificate, and keep relevant vouchers, truthfully record the name of cosmetics, number of the special cosmetics r

19、egistration certificate, or recordation number, expiration date, net content, purchased quantity, suppliers name, address, contact information, purchase date, and other contents of ordinary cosmetics. A distributor of childrens cosmetics shall also examine the marks of childrens cosmetics, and check

20、 the label information on childrens cosmetics distributed with the corresponding product information issued on the official website of the NMPA.妆品标志，并对所经营儿 童化妆品标签信息与国家 药品监督管理局官方网站 上公布的相应产品信息进 行核对。第二H一条平台内 化妆品经营者应当履行化 妆品信息披露的义务，全 面、真实、准确、清晰、 及时披露与注册或者备案 资料一致的化妆品标签等 信息。披露的化妆品标签 信息应当包含其所经营化 妆品标签的全部内容，其

21、 中产品名称、产品执行的 标准编号应当在其产品展 示页面显著位置以文字形 式展示；披露的其他有关 产品安全、功效宣称的信 息应当与其所经营化妆品 的注册或者备案资料中标 签信息和功效宣称依据摘 要的相关内容一致。Article 21 A cosmetics distributor on a platform shall fulfill the obligation of disclosing cosmetics information, and disclose cosmetics labels and other information consistent with the registr

22、ation or recordation materials in a comprehensive, authentic, accurate, clear and timely manner. The cosmetics label information disclosed shall contain all the contents of the label of cosmetics distributed, in which the product name and the number of standards implemented for the product shall be

23、displayed in text at a prominent place on the product display page; and other information on product safety and efficacy publicity disclosed shall be consistent with the relevant contents of the label information and efficacy publicity in the registration or recordation materials of the cosmetics di

24、stributed.A cosmetics distributor on a platform shall be encouraged to display the registration certificate of special cosmetics or the recordation information on ordinary cosmetics distributed by it.鼓励平台内化妆品经营者 展示其所经营化妆品的特 殊化妆品注册证或者普通 化妆品备案信息。Article 22 A cosmetics distributor on a platform shall p

25、roactively cooperate with operators of cosmetics e- commerce platforms in carrying out quality and safety management activities such as routine inspection, self-inspection of public regulatory information, provide relevant product information for distributors on cosmetics e-commerce platforms in a t

26、imely and accurate manner, and take necessary measures to control risks with operators of cosmetics e-commerce platforms.第二十二条 平台内 化妆品经营者I当积极配 合化妆品电子商务平台经 营者开展日常检查、监管 公开信息自查等质量安全 管理活动，及时、准确地 向化妆品电子商务平台经 营者提供相关产品信息， 并配合化妆品电子商务平 台经营者采取必要措施控 制风险。平台内化妆品经营者应当 关注所经营化妆品涉及产 品质量安全的监管公开信 息，对于经负责药品监督 管理的部门抽样检验

27、认定 为不符合规定的特定批次 化妆品，平台内化妆品经 营者应当立即停止经营。 抽样检验涉及检出禁用原 料或者可能危害人体健康 物质、儿童化妆品不符合 规定等情形的，平台内化 妆品经营者应当立即停止 经营不符合规定的特定批 次产品；对于同一品种的 其他批次产品，平台内化 妆品经营者仍继续经营 的，应当以显著方式对该 化妆品抽样检验不符合规 定的监管公开信息或者化A cosmetics distributor on a platform shall pay attention to the public regulatory information on quality and safety of

28、 cosmetics distributed by it, and immediately cease distribution of the specific batches of cosmetics that are determined to be non-compliant with the provisions by the department responsible for supervision and administration of medicinal products upon sampling testing. If the sampling inspection i

29、nvolves the detection of prohibited raw materials or substances that may harm human health, childrens cosmetics that do not comply with the provisions, and other circumstances, the cosmetics distributors on a platform shall immediately cease distribution of specific batches of products that do not c

30、omply with the provisions; and for other batches of products of the same variety, if the cosmetics distributors on a platform continue to distribute the products, they shall, in a significant way, publicize the public regulatory information on the non-compliance of the cosmetics with the provisions

31、upon sampling inspection or the report on the self-inspection conducted by the cosmetics registrant or the recordation partyconcerning the products* non-compliance with the provisions, and the relevant information shall be publicized continuously for one year for reference of consumers when purchasi

32、ng.妆品注册人、备案人针对 产品抽样检验不符合规定 开展自查的情况报告予以 公示，相关信息应当持续 公示一年，供消费者选购 时参考。Article 23 A cosmetics distributor on a platform finding out that there are quality defects or other problems in the cosmetics sold, which may endanger human health, shall immediately cease distribution and notify the relevant cosmet

33、ics registrant or recordation party. The relevant cosmetics registrant or recordation party shall carry out recall according to the law. Where a cosmetics registrant, recordation party, or cosmetics distributor on a platform fails to recall products or cease distribution according to the law, the de

34、partment responsible for supervision and administration of medicinal products shall order it to recall products or cease distribution.第二十三条 平台内 化妆品经营者W现所销售 化妆品存在质量缺陷或者 其他问题，可能危害人体 健康的，应当立即停止经 营，并通知相关化妆品注 册人、备案人。化妆品注 册人、备案人应当依法实 施召回。化妆品注册人、 备案人、平台内化妆品经 营者未依法实施召回或者 停止经营的，负责药品监 督管理的部门责令其实施 召回或者停止经营。Art

35、icle 24 Cosmetics distributors on a platform shall store and transport cosmetics in accordance with the provisions of the relevant laws and regulations and requirements indicated on cosmetic labels, and inspect on a regular basis and handle in a timely manner the deteriorated or expired cosmetics.第二

36、十四条平台内 化妆品经营者应当依照有 关法律法规的规定和化妆 品标签标示的要求贮存、 运输化妆品，定期检查并 及时处理变质或者超过使 用期限的化妆品。Chapter IV Supervision and Administration第四章监督管理第二十五条负责药 品监督管理的部门依法对 化妆品电子商务经营者实 施监督检查。Article 25 The departments responsible for supervision and administration of medicinal products shall supervise and inspect the cosmetics

37、e- commerce distributors according to the law.The NMPA shall organize departments responsible for supervision and administration of medicinal products at all levels to strengthen online monitoring of activities such as online distribution of cosmetics and services on cosmetics e-commerce platforms b

38、y technical means. The departments responsible for supervision and administration of medicinal products shall strengthen information sharing with operators on cosmetics e-commerce platforms and encourage them to carry out online monitoring of the distribution behaviors of cosmetics distributors on p

39、latforms.国家药品监督管理局组织 各级负责药品监督管理的 部门利用技术手段加强对 化妆品网络经营和化妆品 电子商务平台服务等活动 的网络监测。负责药品监 督管理的部门应当加强与 化妆品电子商务平台经营 者信息共享，鼓励其对本 平台内化妆品经营者的经 营行为开展网络监测QThe departments responsible for supervision and administration of medicinal products shall investigate into and handle the illegal acts found out in supervision

40、and inspection and monitoring of online distribution according to the law.Article 26 The departments responsible for supervision and administration of medicinal products shall have the right to take the following measures in accordance with law when supervising and inspecting cosmetics e-commerce di

41、stributors:负责药品监督管理的部门 对监督检查、网络经营监 测发现的违法行为，依法 进行调查处理。第二十六条负责药 品监督管理的部门对化妆 品电子商务经营者进行监 督检查时，有权依法采取 下列措施：(1) Implementing on-site inspection of the relevant places for carrying out online cosmetics distribution and services on cosmetics e-commerce platforms.（一）对开展化妆品网络 经营和化妆品电子商务平 台服务有关场所实施现场 检查；(2)

42、Conducting sampling inspection of cosmetics distributed online.（二）对网络经营的化妆 品进行抽样检验；（三）查阅、复制与涉嫌 违法的化妆品网络经营活 动有关的合同、票据、账(3) Consulting and copying contracts, bills, account books and other relevant materials related to suspected illegal online cosmetics distributionactivities.簿等有关资料;(4) Collecting, co

43、nsulting, and copying electronic data related to suspected illegal online cosmetics distribution activities.（四）收集、调取、复制 与涉嫌违法的化妆品网络 经营活动有关的电子数 据；(5) Inquiring about the parties suspected of carrying out illegal online cosmetics distribution activities, and investigating into and understanding releva

44、nt information from natural persons, legal persons and unincorporated organizations related to suspected illegal online cosmetics distribution activities.（五）询问涉嫌从事违法 化妆品网络经营活动的当 事人，向与涉嫌违法的化 妆品网络经营活动有关的 自然人、法人和非法人组 织调查了解有关情况；(6) Taking measures such as sealing up and detaining the cosmetics and their

45、 raw materials and packaging materials directly contacting cosmetics that fail to comply with compulsory national standards or technical specifications, or may endanger human health as proven by evidence, and tools and equipment that are used for illegal production and distribution as proven by evid

46、ence.（六）对不符合强制性国 家标准、技术规范或者有 证据证明可能危害人体健 康的化妆品及其原料、直 接接触化妆品的包装材 料，以及有证据证明用于 违法生产经营的工具、设 备依法采取查封、扣押措 施；(7) Sealing up places where illegal online cosmetics distribution activities are carried out.（七）对违法从事化妆品 网络经营活动的场所依法 查封；(8) Other measures that may be taken as prescribed by laws and regulations.（八）

47、法律、法规规定可 以采取的其他措施。Article 27 The illegal acts of operators of cosmetics e- commerce platforms and cosmetics e-commerce distributors distributing cosmetics through self-built websites and other online services shall be under the第二十七条化妆品 电子商务平台经营者和通 过自建网站、其他网络服 务经营化妆品的化妆品电子商务经营者的违法行为 由其住所地县级以上负责 药品监督管

48、理的部门管 辖，其中化妆品电子商务 平台经营者未依照化妆品 监督管理条例规定履行实 名登记、制止、报告、停 止提供电子商务平台服务 等管理义务的违法行为， 由其住所地省级药品监督 管理部门管辖。jurisdiction of the departments responsible for supervision and administration of medicinal products at or above the county level at the places where they are located. The illegal acts of operators of co

49、smetics e-commerce platforms that fail to perform real-name registration, curb, report, and stop providing e- commerce platform services and other management obligations in accordance with the Regulation on the Supervision and Administration of Cosmetics shall be under the jurisdiction of the provincial departments responsible for supervision and administration of medicinal products at the pl