On April 2, 2021, the NMPA (National Medical Products Administration) published a Q&A article to respond to questions of the cosmetics industry on the registration and filing procedures in China.
Q1: How to obtain the user account on the cosmetics registration and filing online platform?
A1: After the required documents are submitted to the online platform and the online account has been approved.
Q2: In what circumstances will it be required to appoint a Domestic Responsible Agent (DRA) for the registration or filing of cosmetic products?
A2: When the cosmetics registrant or filing applicant is an overseas company.
Q3: What are the differences between the Domestic Responsible Agent (DRA) and the former China Registration Agent (CRA)?
A3: The DRA needs to register or file the cosmetic products on behalf of the registrant or filer, assist in the monitoring of adverse events, carry out product recalls and fulfill corresponding responsibilities in accordance with the agreement for ensuring product quality and safety. If the CRA is incapable to fulfill the mentioned DRA obligations, the CRA is not qualified to perform the registration and filing of cosmetics.
Q4: What needs to be stated in the letter of authorization (LoA) for appointing the DRA in China?
A4: The LoA should at least include the following information:
- The names of the registrant, the filing person or the DRA
- The relationship between the authorized person and the authorizer
- The scope of granted authority
- The period of authorization
Q5: Can the former authorization letter of the CRA be used for the letter of authorization (LoA) of the DRA in China?
A5: The former authorization letter of the CRA can no longer be used for special cosmetics registration in China. The LoA of the DRA for imported general cosmetics in China can continue to be used (the scanned copy is only for the filing of imported “general” cosmetics). If an overseas applicant intends to expand the scope of LoA, a new LoA shall be issued.
Q6: How to register and file for cosmetics that use new raw materials during the product safety monitoring period?
A6: The new raw material registration or filing number should be submitted through the online platform after being confirmed by the new raw material applicant.
Q7: If the new raw materials have been suspended for use, how should the related cosmetics be handled?
A7: The applicant will be notified to suspend the production and operations related to the cosmetic product.
Q8: How to register and file for cosmetics that have been commissioned for production?
A8: The applicant or the DRA shall submit the registration application after the cosmetics manufacturer confirms the commissioned production relationship through the online platform; submit the relevant materials proving the commissioned production relationship.
Q9: How do cosmetic registrants and filing persons keep samples?
A9: The applicants shall keep samples of each batch of cosmetics for future reference. The number of retained samples should be able to meet the requirements for conducting registration inspections.
Q10: How to register the cosmetics that must be used with equipment or tools?
A10: Brushes, sponges, perming tools, etc. that only assist in applying the product are exempted. For cosmetics that must be used with instruments or tools, the product safety assessment process should evaluate the safety under the conditions of use with the instruments or tools.
In principle, the instruments or tools used in conjunction should not have cosmetic functions, should not be a part of the manufacturing process when cosmetics are being reused, and should not change the way cosmetics work with the skin or the mechanism of action.
Q11: Is the cosmetic formula allowed to be changed?
A11: Changes to the formula of registered cosmetics is not permitted. Acceptable cases include minor changes in the product formula that are inevitable due to the replacement of raw materials by the supplier. Re-application for registration and filing shall be done for changes made to the formula of registered cosmetics.
Q12: How to handle a change in the DRA for the filing of general cosmetics?
A12: If the addresses of general cosmetics applicants or DRA change across provinces, and the record management department (MPA) changes, the product needs to be re-filed because the filing number and the responsibility for supervision is being affected. Scanned copies of the original filing documents can still be used when re-filing.
By Jacky Li. Contact Cisema if you would like to learn more.