Chapter III Cosmetic Registration and Filing Administration

Section I General Requirements

Article 28 The applicants for cosmetics registration and filing persons shall meet the following requirements:

(1) They shall be enterprises or organizations that are established according to law;

(2) They shall have a quality management system that corresponds with the cosmetics for which registration or filing is done; and

(3) They shall have the abilities to monitor and evaluate adverse reactions.

To apply for registration of special cosmetics for the first time or filing of general cosmetics for the first time, the applicant for registration or the filing person shall submit the document that meets the requirements as set forth before.

Article 29 The cosmetic registrant and filing person shall carry out cosmetic research and development, safety assessment, testing of registration and filing, etc. in accordance with laws, administrative regulations, mandatory national standards, technical specifications, and provisions for registration and filing administration etc., and submit registration and filing documents in accordance with the instructions for cosmetic registration and filing dossiers.

Article 30 Cosmetic registrants and filing persons shall select ingredients that meet the requirements of laws, administrative regulations, mandatory national standards and technical specifications for cosmetic production, and shall be responsible for the safety of cosmetic ingredients they use. When applying for registration and filing for filing, the cosmetic registrant and filing person shall clarify the source of ingredients and relevant information on ingredient safety through the information service platform.

Article 31 If cosmetic registrants and filing persons entrust cosmetic manufacturing, for domestic cosmetics, the entrustment shall be associated and confirmed by the cosmetic manufacturers through the information service platform when applying for registration or filing; for imported cosmetics, relevant documents demonstrating the entrustment shall be submitted by the cosmetic registrants or filing persons.

Article 32 Cosmetic registrants and filing persons shall clarify the product standards that are implemented, and submit it to the drug regulatory department when applying for registration or filing for filing.

Article 33 Cosmetic registrants and filing persons shall entrust a testing agency that has obtained qualification certifications and meets the needs for testing on cosmetic registration and filing to conduct testing according to mandatory national standards, technical specifications and testing requirements of registration and filing.

Section II Filing Administration

Article 34 Before a general cosmetic is marketed or imported, the filing person shall complete the filing by submitting the filing dossiers through the information service platform as required by the NMPA.

Article 35 If the general cosmetics that have been filed are to be imported at a port outside the administrative area of the province, autonomous region, or municipality where the domestic responsible person is located, the import port and the information on the contact person for handling customs clearance procedures shall be supplemented and filled on the information service platform.

Article 36 For general cosmetics that have been filed, the name of the product may not be changed at will without proper reasons; and the efficacy claim shall not be changed at will without sufficient scientific basis.

General cosmetics that have been filed are not allowed to change the product formula at will, except for minor changes in the product formula due to changes in the source of ingredients and other reasons.

If the address of the filing person or the domestic responsible person changes which causes the filing administration department changes, the filing person shall re-file.

Article 37 The filing person of general cosmetics shall report the production and import status, as well as the compliance with laws and regulations, compulsory national standards, and technical specifications to the drug regulatory department responsible for filing administration on a yearly basis.

If the products that have been filed are no longer produced or imported, the filing person shall promptly report to the drug regulatory department responsible for the filing administration for cancelling the filing.