In order to regulate the production license, supervision and inspection of cosmetics, guide the cosmetic registrants, registrants and entrusted production enterprises to implement the Cosmetics Production Quality Management Standards, the State Food and Drug Administration has organized the formulation of the Inspection Points and Judgment Principles of Cosmetics Production Quality Management Standards in accordance with the Regulations on the Supervision and Administration of Cosmetics, the Measures for the Supervision and Administration of Cosmetics Production and Operation and other laws and regulations, and is hereby promulgated, It shall come into force as of December 1, 2022. The relevant matters are hereby announced as follows: 1、 The department in charge of drug supervision and administration shall inspect the cosmetic registrant, the registrant, and the entrusted manufacturing enterprise (hereinafter referred to as "the enterprise") in accordance with the Cosmetic Production Quality Management Standards, the Inspection Points and Judgment Principles of Cosmetic Production Quality Management Standards, and make a comprehensive judgment on the implementation of the Cosmetic Production Quality Management Standards by the enterprise. 2、 The department responsible for drug supervision and administration shall urge the enterprises that are judged to have "defects in the production quality management system" to complete the rectification and submit the rectification report within the specified time, and may organize on-site review if necessary. If the enterprise's illegal act is minor, causing no harmful consequences and meeting the requirements of the Cosmetics Production Quality Management Standard after rectification, no administrative penalty will be imposed according to law. 3、 For enterprises that are judged to have "serious defects in the production quality management system", the department in charge of drug supervision and administration shall, in accordance with Article 54 of the Regulations on the Supervision and Administration of Cosmetics, take emergency control measures such as ordering to suspend production and operation, and timely control product risks. The enterprise shall complete the rectification within the specified time and submit the rectification report to the department responsible for drug supervision and administration. The department in charge of drug supervision and administration shall conduct on-site reexamination of the enterprise, and may resume its production and operation only after confirming that the rectification meets the requirements. 4、 For enterprises that are judged to have "serious defects in the production quality management system", the department responsible for drug supervision and administration shall file an investigation in accordance with Article 60 (3) of the Regulations on the Supervision and Administration of Cosmetics and Article 59 of the Measures for the Supervision and Administration of the Production and Operation of Cosmetics.
It is hereby announced. Appendix: Inspection Points and Judgment Principles of Cosmetic Production Quality Management Specifications
State Food and Drug Administration October 20, 2022 |