【中英文对照版】化妆品生产经营监督管理办法（2021）.docx

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1、化妆品生产经营监督管理办法Measures for the Supervision and Administration of Production and Distribution of Cosmetics制定机关：国家市场监督管理总局发文字号：国家市场监督管理总局令第46号公布日期：施行日期：2022.01.01 效力位阶：部门规章 法规类别：化工产品与质量Issuing Authority ：State Administration for Market RegulationDocument Number ： Order No. 46 of the State Administratio

2、n for Market RegulationDate Issued ： 08-02-2021Effective Date ： 01-01-2022Level of Authority : Departmental RulesArea of Law ： Chemical Product and Its QualityOrder of the State Administration for Market Regulation(No. 46)The Measures for the Supervision and Administration of Production and Distribu

3、tion of Cosmetics, as deliberated and adopted at the 12th executive meeting of the State Administration for Market Regulation on July 26, 2021, are hereby issued and shall come into force on January L 2022.Director: Zhang GongAugust 2, 2021国家市场监督管理总局令（第46号）化妆品生产经营监督管理办 法已经2021年7月26日市场 监管总局第12次局务会议通

4、过，现予公布，自2022年1月 1日起施行。局长张工2021年8月2日Measures for the Supervision and Administration of 化妆品生产经营监督管理办法质量安全负责人、预留的联系方 式等发生变化的，化妆品生产企 业应当在变化后10个工作日内 向原发证的药品监督管理部门报 告。第二十条化妆品生产许可 证有效期届满需要延续的，申请 人应当在生产许可证有效期届满 前90个工作日至30个工作日期 间向所在地省、自治区、直辖市 药品监督管理部门提出延续许可 申请，并承诺其符合本办法规定 的化妆品生产许可条件。申请人 应当对提交资料和作出承诺的真 实性、合法性

5、负责。逾期未提出延续许可申请的，不 再受理其延续许可申请。第二十一条省、自治区、直辖市药品监督管理部门应当自 收到延续许可申请后5个工作日 内对申请资料进行形式审查，符 合要求的予以受理，并自受理之 日起10个工作日内向申请人换 发新的化妆品生产许可证。许可 证有效期自原许可证有效期届满 之日的次日起重新计算。第二十二条省、自治区、 直辖市药品监督管理部门应当对Where the person in charge of quality and safety, and the reserved contact information, among others, are changed, the

6、 cosmetics manufacturer shall report to the original license-issuing medical products administrative department within 10 working days after the change.Article 20 Where a cosmetics production license needs to be renewed upon expiry, the applicant shall apply for renewal of license to the medical pro

7、ducts administrative department of the province, autonomous region, or municipality directly under the central government at the place where it is located from 90 to 30 working days before the expiry of the production license, and pledge that it meets the conditions for a cosmetics production licens

8、e as prescribed in these Measures. An applicant shall be responsible for the authenticity and legitimacy of the materials submitted and commitments made.An application for renewal of a license shall no longer be accepted, where it is not filed within the prescribed time limit.Article 21 The medical

9、products administrative department of a province, autonomous region, or municipality directly under the Central Government shall conduct formal examination of the application materials within five working days after receiving an application for renewal of a license, accept the application where the

10、requirements are satisfied, and issue a new cosmetics production license to the applicant within 10 working days from the date of acceptance. The validity period of the license shall be recalculated from the date of expiry of the original license.Article 22 The medical products administrative depart

11、ment of a province, autonomous region, or municipality directly under the Central Governmentshall supervise the application materials and commitments of cosmetic manufacturers that have renewed their licenses, and revoke the cosmetics production licenses in accordance with the law, where they are fo

12、und not to meet the conditions for cosmetics production licenses as prescribed in Article 9 of these Measures.已延续许可的化妆品生产企业的 申报资料和承诺进行监督，发现 不符合本办法第九条规定的化妆 品生产许可条件的，应当依法撤 销化妆品生产许可。Article 23 Where a cosmetics manufacturer falls under any of the following circumstances, the original license-issuing me

13、dical products administrative department shall cancel its cosmetics production license in accordance with the law and make an announcement on the government website:(1) The enterprise proactively applies for cancellation.(一)企业主动申请注销的；(2) The eligibility status of the enterprise is (二)企业主体资格被依法终止 ter

14、minated in accordance with the law.的；(3) No application is filed for renewal upon expiry of (三)化妆品生产许可证有效期 the validity period of a cosmetics production license. 届满未申请延续的；第二十三条 化妆品生产企 业有下列情形之一的，原发证的 药品监督管理部门应当依法注销 其化妆品生产许可证，并在政府 网站上予以公布：(4) A cosmetics production license is withdrawn and annulled or

15、 revoked in accordance with the law.（四）化妆品生产许可依法被撤 回、撤销或者化妆品生产许可证 依法被吊销的；(5) Other circumstances under which a cosmetics production license shall be canceled as prescribed by the laws and regulations.（五）法律法规规定应当注销化 妆品生产许可的其他情形。化妆品生产企业申请注销生产许 可时，原发证的药品监督管理部 门发现注销可能影响案件查处 的，可以暂停办理注销手续。When a cosmetics

16、 manufacturer applies for cancellation of a production license, if the original license-issuing medical products administrative department finds that the cancellation may affect the investigation into a case, it may suspend the formalities for cancellation.第三章化妆品生产第二十四条国家药品监督 管理局制定化妆品生产质量管理 规范，明确质量管

17、理机构与人 员、质量保证与控制、厂房设施 与设备管理、物料与产品管理、 生产过程管理、产品销售管理等 要求。化妆品注册人、备案人、受托生 产企业应当按照化妆品生产质量 管理规范的要求组织生产化妆 品，建立化妆品生产质量管理体 系并保证持续有效运行。生产车 间等场所不得贮存、生产对化妆 品质量有不利影响的产品。第二十五条 化妆品注册 人、备案人、受托生产企业应当 建立并执行供应商遴选、原料验 收、生产过程及质量控制、设备 管理、产品检验及留样等保证化 妆品质量安全的管理制度。第二十六条 化妆品注册 人、备案人委托生产化妆品的， 应当委托取得相应化妆品生产许 可的生产企业生产，并对其生产 活动全过

18、程进行监督，对委托生 产的化妆品的质量安全负责。受 托生产企业应当具备相应的生产Chapter III Production of CosmeticsArticle 24 The NMPA shall develop specifications for the management of cosmetics production quality, to specify the requirements for quality management institutions and personnel, quality assurance and control, management of

19、plant facilities and equipment, management of materials and products, management of production process, and management of product sales, among others.Cosmetic registrants, recordation entities, and entrusted manufacturers shall, according to the requirements of the specifications for the management

20、of cosmetics production quality, organize production of cosmetics, and establish a cosmetics production quality management system and ensure continuous and effective operation. The production workshop and other places shall not store or produce products that have adverse effect on the quality of cos

21、metics.Article 25 Cosmetic registrants, recordation entities, and entrusted manufacturers shall establish and implement the administration rules ensuring the quality and safety of cosmetics on supplier selection, acceptance check of raw materials, production process and quality control, management o

22、f equipment, product inspection, and sample retention, among others.Article 26 Cosmetic registrants and recordation entities that entrust production of cosmetics shall entrust production to manufacturers with corresponding cosmetic production licenses, supervise their entire production process, and

23、be responsible for the quality and safety of the cosmetics produced on a commission basis. An entrusted manufacturer shall have the corresponding productionconditions, organize production in accordance with the laws, regulations, compulsory national standards, technical specifications and contractua

24、l agreements, be responsible for production activities, and be subject to the supervision by the entrusting party.Article 27 Cosmetic registrants, recordation entities, and entrusted manufacturers shall establish a cosmetics quality and safety responsibility system, and implement the primary respons

25、ibilities for quality and safety of cosmetics.Legal representatives and primary persons in charge of cosmetic registrants, recordation entities, and entrusted manufacturers shall be responsible for the quality and safety of cosmetics.Article 28 The person in charge of quality and safety shall, accor

26、ding to the requirements of the cosmetics quality and safety responsibility system, assist cosmetics registrant, recordation entity, and legal representative and primary person in charge of an entrusted manufacturer in assuming the following corresponding responsibilities for product quality and saf

27、ety management and product release:(1) Establishing and organizing the implementation of the enterprises quality management system, and implementing the quality and safety management responsibilities.(2) Examining and managing product formulas, production processes, and material suppliers, among oth

28、ers.条件，并依照法律、法规、强制性国家标准、技术规范和合同约 定组织生产，对生产活动负责， 接受委托方的监督。第二十七条化妆品注册 人、备案人、受托生产企业应当 建立化妆品质量安全责任制，落 实化妆品质量安全主体责任。化妆品注册人、备案人、受托生 产企业的法定代表人、主要负责 人对化妆品质量安全工作全面负 责。第二十八条质量安全负责 人按照化妆品质量安全责任制的 要求协助化妆品注册人、备案 人、受托生产企业法定代表人、 主要负责人承担下列相应的产品 质量安全管理和产品放行职责：（一）建立并组织实施本企业质 量管理体系，落实质量安全管理 责任；（二）产品配方、生产工艺、物 料供应商等的审核管

29、理；(3) Release management of materials and release of (三)物料放行管理和产品放products.行；(4) Monitoring and management of adverse reactions (四)化妆品不 良反应监测管of cosmetics.理；(5) Supervision and administration of production activities of entrusted production enterprises.The person in charge of quality and safety shal

30、l have professional knowledge and legal knowledge related to cosmetics quality and safety such as cosmetics, chemistry, chemical engineering, biology, medicine, pharmacy, food, public health or law, be familiar with the relevant laws, regulations, rules, mandatory national standards, and technical s

31、pecifications, and have more than five years of experience in cosmetics production or quality management.Article 29 Cosmetics registrants, recordation entities, and entrusted manufacturers shall establish and implement the health management system of practitioners, and create health records of pract

32、itioners. The health records shall be kept for three years at a minimum.Persons directly carrying out cosmetics production activities shall accept annual health examinations. Persons suffering from diseases that impede the quality and safety of cosmetics as prescribed by the health administrative de

33、partment of the State Council shall not directly carry out production of cosmetics.（五）受托生产企业生产活动的 监督管理。质量安全负责人应当具备化妆 品、化学、化工、生物、医学、 药学、食品、公共卫生或者法学 等化妆品质量安全相关专业知识 和法律知识，熟悉相关法律、法 规、规章、强制性国家标准、技 术规范，并具有5年以上化妆品 生产或者质量管理经验。第二十九条化妆品注册 人、备案人、受托生产企业应当 建立并执行从业人员健康管理制 度，建立从业人员健康档案。健 康档案至少保存3年。直接从事化妆品生产活动的人员 应

34、当每年接受健康检查。患有国 务院卫生行政主管部门规定的有 碍化妆品质量安全疾病的人员不 得直接从事化妆品生产活动。第三十条化妆品注册人、 备案人、受托生产企业应当制定 从业人员年度培训计划，开展化 妆品法律、法规、规章、强制性 国家标准、技术规范等知识培 训，并建立培训档案。生产岗位 操作人员、检验人员应当具有相 应的知识和实际操作技能。Article 30 Cosmetics registrants, recordation entities, and entrusted manufacturers shall develop annual training plans for practi

35、tioners, conduct knowledge training on laws, regulations, rules, mandatory national standards, and technical specifications, among others, on cosmetics, and create training files. Operators and inspectors at production positions shall have corresponding knowledge and practical skills.Article 31 Cosm

36、etics shall not be marketed until they have passed the ex-factory inspections.Cosmetics registrants and recordation entities shall keep samples and records of ex-factory cosmetics in accordance with the provisions. The reserved samples shall be kept in the original sales packages and the quantity sh

37、all satisfy the requirements of product quality inspection. The storage life of retained samples shall not be less than six months upon expiry of the product shelf life.Where cosmetics are produced on a commission basis, the entrusted manufacturer shall also keep samples and records in accordance wi

38、th the provisions of the preceding paragraph.Article 32 Cosmetic registrants, recordation entities, and entrusted manufacturers shall establish and implement the recording system for checking purchased cosmetic raw materials and packaging materials that directly contact cosmetics and the product sal

39、es recording system. The checking records on purchased goods and product sales records shall be true, complete and traceable, and be preserved for not less than one year after the expiry of the product shelf life; if the product shelf life is less than one year, the records shall be kept for not les

40、s than two years.Where cosmetics are produced on a commission basis, the records of the purchase inspection of raw materials and packaging materials directly in contact with the cosmetics may be kept by the commissioned manufacturer.第三十一条化妆品经出厂 检验合格后方可上市销售。化妆品注册人、备案人应当按照 规定对出厂的化妆品留样并记 录。留样应当保持原始销售包装

41、 且数量满足产品质量检验的要 求。留样保存期限不得少于产品 使用期限届满后6个月。委托生产化妆品的，受托生产企 业也应当按照前款的规定留样并记录。第三十二条化妆品注册 人、备案人、受托生产企业应当 建立并执行原料以及直接接触化 妆品的包装材料进货查验记录制 度、产品销售记录制度。进货查 验记录和产品销售记录应当真 实、完整，保证可追溯，保存期 限不得少于产品使用期限期满后 1年；产品使用期限不足1年 的，记录保存期限不得少于2 年。委托生产化妆品的，原料以及直 接接触化妆品的包装材料进货查 验等记录可以由受托生产企业保 存。第三十三条 化妆品注册Article 33 Cosmetics reg

42、istrants, recordation entities,and entrusted manufacturers shall conduct selfexamination on the implementation of the specifications for the management of cosmetics production quality every year. The self-examination reports shall include the problems found, product quality and safety evaluation, an

43、d rectification measures, among others, and be kept for not less than two years.Where, upon self-examination, it is found after selfinspection that the production conditions have changed and the requirements of the specifications for the management of cosmetics production quality are no longer satis

44、fied, the cosmetics registrants, recordation entities, and entrusted manufacturer shall immediately take corrective measures; if it is found that the quality and safety of cosmetics may be affected, the production shall be ceased immediately, and be reported to the medical products administrative de

45、partment of the province, autonomous region, or municipality directly under the Central Government at the place where it is located. Production may be resumed only after the risk factors affecting quality and safety are eliminated. The medical products administrative department of a province, autono

46、mous region, and municipality directly under the Central Government may organize on-site inspections in light of actual circumstances.人、备案人、受托生产企业应当 每年对化妆品生产质量管理规范 的执行情况进行自查。自查报告 应当包括发现的问题、产品质量 安全评价、整改措施等，保存期 限不得少于2年。经自查发现生产条件发生变化， 不再符合化妆品生产质量管理规 范要求的，化妆品注册人、备案 人、受托生产企业应当立即采取 整改措施；发现可能影响化妆品 质量安全的，应当

47、立即停止生 产，并向所在地省、自治区、直 辖市药品监督管理部门报告。影 响质量安全的风险因素消除后， 方可恢复生产。省、自治区、直 辖市药品监督管理部门可以根据 实际情况组织现场检查。第三十四条化妆品注册人、备案人、受托生产企业连续 停产1年以上，重新生产前，应 当进行全面自查，确认符合要求 后，方可恢复生产。自查和整改 情况应当在恢复生产之日起10 个工作日内向所在地省、自治 区、直辖市药品监督管理部门报 告。Article 34 Cosmetics registrants, recordation entities, and entrusted manufacturers that hav

48、e ceased production for more than one year shall, prior to reproduction, conduct comprehensive self-examination and may only resume production after they are confirmed to satisfy the requirements. The information on self-examination and rectification shall be reported to the medical products adminis

49、trative department of the province, autonomous region, or municipality directly under the Central Government where it is located within 10 working days from the date of resumption of第三十五条 化妆品的最小 销售单元应当有中文标签。标签内容应当与化妆品注册或者备案 资料中产品标签样稿一致。化妆品的名称、成分、功效等标 签标注的事项应当真实、合法， 不得含有明示或者暗示具有医疗 作用，以及虚假或者引人误解、 违背社会公序良俗等违反法律法 规的内容。化妆品名称使用商标 的，还应当符合国家有关商标管 理的法律法规规定。第三十六条供儿童使用的 化妆品应当符合法律、法规、强 制性