關(guān)于發(fā)布實(shí)施化妝品注冊(cè)和備案檢驗(yàn)工作規(guī)范的
時(shí)間(TIME)：2021-04-22 15:23:20
為規(guī)范化妝品注冊(cè)和備案檢驗(yàn)工作，保證化妝品注冊(cè)和備案檢驗(yàn)工作公開、公平、公正、科學(xué)，國(guó)家藥品監(jiān)督管理局制定了《化妝品注冊(cè)和備案檢驗(yàn)工作規(guī)范》（以下簡(jiǎn)稱《規(guī)范》），現(xiàn)予發(fā)布，并就實(shí)施有關(guān)問題公告如下：
一、自本公告發(fā)布之日起，符合《規(guī)范》規(guī)定要求的檢驗(yàn)檢測(cè)機(jī)構(gòu)，可通過化妝品注冊(cè)和備案檢驗(yàn)信息管理系統(tǒng)提交檢驗(yàn)檢測(cè)機(jī)構(gòu)相關(guān)信息后承擔(dān)化妝品注冊(cè)和備案檢驗(yàn)工作。
二、自本公告發(fā)布之日起，新注冊(cè)或備案的化妝品尚未開展檢驗(yàn)的，應(yīng)當(dāng)按照《規(guī)范》規(guī)定要求開展檢驗(yàn)并出具檢驗(yàn)報(bào)告；已開展檢驗(yàn)的或境外實(shí)驗(yàn)室已完成防曬檢驗(yàn)并出具檢驗(yàn)報(bào)告的，該檢驗(yàn)報(bào)告可繼續(xù)在化妝品注冊(cè)或備案時(shí)使用。已完成注冊(cè)或備案的產(chǎn)品，原有檢驗(yàn)項(xiàng)目與《規(guī)范》不一致的，應(yīng)在本公告發(fā)布后一年內(nèi)，按照《規(guī)范》規(guī)定的檢驗(yàn)項(xiàng)目要求（人體安全性檢驗(yàn)項(xiàng)目除外），補(bǔ)充完成相應(yīng)檢驗(yàn)項(xiàng)目的檢驗(yàn)。補(bǔ)充完成的檢驗(yàn)報(bào)告，應(yīng)當(dāng)在產(chǎn)品行政許可有效期延續(xù)申請(qǐng)時(shí)提交，或者在產(chǎn)品備案確認(rèn)繼續(xù)生產(chǎn)時(shí)提供備查。
三、自2019年11月1日起，此前已獲得原食品藥品監(jiān)管部門資格認(rèn)定或指定的化妝品行政許可檢驗(yàn)機(jī)構(gòu)或國(guó)產(chǎn)非特殊用途化妝品備案檢驗(yàn)機(jī)構(gòu)的相關(guān)資格自動(dòng)終止，相關(guān)檢驗(yàn)機(jī)構(gòu)不得繼續(xù)以原認(rèn)定或指定的資格名義受理化妝品注冊(cè)或備案檢驗(yàn)。
特此公告。
附件：化妝品注冊(cè)和備案檢驗(yàn)工作規(guī)范
國(guó)家藥監(jiān)局
2019年9月3日
國(guó)家藥品監(jiān)督管理局2019年第72號(hào)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
