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Announcement of the National Medical Products Administration on Matters concerning the Nationwide Implementation of the Recordation of Imported Non-special-purpose Cosmetics [Effective]
国家药监局关于在全国范围实施进口非特殊用途化妆品备案管理有关事宜的公告 [现行有效]
【法宝引证码】

Announcement of the National Medical Products Administration on Matters concerning the Nationwide Implementation of the Recordation of Imported Non-special-purpose Cosmetics 

国家药监局关于在全国范围实施进口非特殊用途化妆品备案管理有关事宜的公告

(Announcement No. 88 [2018] of the National Medical Products Administration) (国家药监局公告2018年第88号)

For the purpose of implementing the requirements of the Notice by the State Council of Promoting the Reform of “Separating Permits from Business Licenses” Nationwide (No. 35 [2018] of the State Council), relevant matters concerning the nationwide implementation of the recordation of imported non-special-purpose cosmetics are hereby announced as follows: 为贯彻落实《国务院关于在全国推开“证照分离”改革的通知》(国发〔2018〕35号)要求,现就在全国范围实施进口非特殊用途化妆品备案管理工作有关事宜公告如下:
I. From November 10, 2018, the current approval administration of imported non-special-purpose cosmetics for the first time and the implementation of the pilot program on the recordation of such cosmetics in the free trade zones shall be adjusted to nationally unified recordation administration, and the national drug supervision and administration departments will no longer accept the applications for administrative licenses of imported non-special-purpose cosmetics.   一、自2018年11月10日起,首次进口非特殊用途化妆品由现行审批管理和自贸试验区试点实施备案管理,调整为全国统一备案管理,国家药品监督管理部门不再受理进口非特殊用途化妆品行政许可申请。
II. A producer of imported cosmetics shall, before importing the products, authorize its domestic responsible person to log on the “Online Operation” column of the portal website of the National Medical Products Administration ( HYPERLINK "http://www.nmpa.gov.cn" www.nmpa.gov.cn), and undergo the recordation formalities through the unified national network platform of “recordation system for imported non-special-purpose cosmetics”, and may not conduct import trade until it has obtained an electronic recordation certificate. Products for recordation shall be numbered according to the rule of “Guo Zhuang Wang Bei Jin (the abbreviation of the province in which the domestic responsible person is located) + 4-digit number of the year + 6-digit sequential number”.   二、进口化妆品生产企业应当在产品进口前,委托境内责任人登录国家药品监管局政务网站(www.nmpa.gov.cn)“网上办事”栏目,通过“进口非特殊用途化妆品备案管理系统”网络平台,办理备案手续,取得电子版备案凭证后方可进口。备案产品按照“国妆网备进字(境内责任人所在省份简称)+四位年份数字+六位顺序编号”的规则进行编号。
III. Where domestic responsible persons are registered within the provincial (municipal) administrative scope of Tianjin, Liaoning, Shanghai, Zhejiang, Fujian, Henan, Hubei, Guangdong, Chongqing, Sichuan or Shaanxi which have implemented the pilot program on the recordation of imported non-special-purpose cosmetics in the free trade zones, they shall undergo the recordation formalities at the provincial food and drug administrative departments of the places where they are registered after filling out and uploading the electronic materials on the recordation system. The relevant provincial food and drug administrative departments shall develop in a timely manner the guidelines for the recordation administration within their respective administrative regions and release them to the public. Where domestic responsible persons are registered within the administrative scope of other provinces (regions, municipalities), they shall undergo the recordation formalities at the national drug supervision and administration departments after filling out and uploading the electronic materials on the online recordation system.
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   三、境内责任人注册地在天津、辽宁、上海、浙江、福建、河南、湖北、广东、重庆、四川、陕西等前期已经开展自贸试验区试点实施进口非特殊用途化妆品备案管理的省(市)行政区域范围内的,在备案系统填报上传完成电子版资料后,向所在地省级食品药品监督管理部门办理备案。有关省级食品药品监管部门应当及时制定本行政区域内备案管理相关办事指南,并向社会公开。境内责任人注册地在其他省(区、市)行政区域范围内的,在网上备案系统填报上传完成电子版资料后,向国家药品监督管理部门办理备案。
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