关于发布实施化妆品注册和备案检验工作规范的
时间(TIME)：2021-04-22 15:23:20
为规范化妆品注册和备案检验工作，保证化妆品注册和备案检验工作公开、公平、公正、科学，国家药品监督管理局制定了《化妆品注册和备案检验工作规范》（以下简称《规范》），现予发布，并就实施有关问题公告如下：
一、自本公告发布之日起，符合《规范》规定要求的检验检测机构，可通过化妆品注册和备案检验信息管理系统提交检验检测机构相关信息后承担化妆品注册和备案检验工作。
二、自本公告发布之日起，新注册或备案的化妆品尚未开展检验的，应当按照《规范》规定要求开展检验并出具检验报告；已开展检验的或境外实验室已完成防晒检验并出具检验报告的，该检验报告可继续在化妆品注册或备案时使用。已完成注册或备案的产品，原有检验项目与《规范》不一致的，应在本公告发布后一年内，按照《规范》规定的检验项目要求（人体安全性检验项目除外），补充完成相应检验项目的检验。补充完成的检验报告，应当在产品行政许可有效期延续申请时提交，或者在产品备案确认继续生产时提供备查。
三、自2019年11月1日起，此前已获得原食品药品监管部门资格认定或指定的化妆品行政许可检验机构或国产非特殊用途化妆品备案检验机构的相关资格自动终止，相关检验机构不得继续以原认定或指定的资格名义受理化妆品注册或备案检验。
特此公告。
附件：化妆品注册和备案检验工作规范
国家药监局
2019年9月3日
国家药品监督管理局2019年第72号公告附件.doc
In order to standardize the registration and filing inspection of cosmetics and ensure the publicity, fairness, fairness and science of cosmetics registration and filing inspection, the Nation medical products Administration has formulated the work specification for the registration and filing of cosmetics (hereinafter referred to as the "specification"), and is hereby issued, and the relevant issues are announced as follows:
1、 Since the date of the announcement, inspection and testing institutions meeting the requirements of the specification may submit relevant information of inspection and testing institutions through the cosmetics registration and record inspection information management system to undertake the registration and filing inspection of cosmetics.
2、 Since the date of the announcement, if the newly registered or filed cosmetics have not been inspected, the inspection shall be carried out and an inspection report shall be issued in accordance with the requirements of the specification;
if the sunscreen test has been completed and the inspection report has been issued by the laboratory, the inspection report may continue to be used in the registration or filing of cosmetics.
If the original inspection items of the products that have been registered or filed are inconsistent with the specifications, the inspection of the corresponding inspection items shall be supplemented and completed within one year after the announcement is issued, in accordance with the requirements of the inspection items specified in the specification (except for the human safety inspection items). The supplementary inspection report shall be submitted when the application for extension of the validity period of the product administrative license is made, or a reference shall be provided when the product is recorded and confirmed to continue production.
3、 Since November 1, 2019, the relevant qualification of the administrative licensing inspection institution or the domestic non special purpose cosmetics filing inspection institution that has been qualified by the original food and drug regulatory department or designated by the original food and drug regulatory department will automatically terminate. The relevant inspection institutions shall not continue to accept the cosmetics registration or filing inspection in the name of the original recognized or designated qualification.
It is hereby announced.
Appendix: Work Specification for cosmetics registration and filing inspection
