Based on the "Regulations on the Supervision and Administration of Cosmetics" (hereinafter referred to as the "Regulations"), the "Measures for the Administration of Registration and Filing of Cosmetics" (hereinafter referred to as the "Measures"), and the "Regulations on the Management of Registration and Filing Materials for Cosmetics" (hereinafter referred to as the "Regulations"), the Cosmetics Supervision Department of the National Medical Products Administration has compiled and answered questions from the cosmetics industry regarding the regulations on the registration and filing of cosmetics.

Q: How to obtain a user account on the cosmetics registration and filing information service platform?

A: According to the "Regulations", domestic registrants, filers, domestic responsible persons, and cosmetic manufacturers should obtain a cosmetics registration and filing user account through the registration and filing information service platform before they can handle cosmetics registration and filing. Overseas registrants and filers conduct cosmetics registration and filing related business through the user account of their domestic responsible person.

Article 18 of the "Regulations" has the same requirements for cosmetics registrants and filers. Enterprises or other organizations that meet the requirements can submit relevant materials to open registrant and filer accounts simultaneously, and then carry out cosmetics registration and filing work without needing to open registrant and filer permissions separately.

Q: Which cosmetics registrants and filers need to designate a domestic responsible person?

A: Cosmetics registrants and filers who are overseas should designate a domestic responsible person in China to handle cosmetics registration and filing, assist in carrying out adverse reaction monitoring, and implement product recalls.

If an overseas registrant or filer entrusts a domestic cosmetic manufacturer to produce cosmetics, the cosmetics are considered domestic cosmetics, but because the registrant or filer is overseas, a domestic responsible person needs to be designated; if a domestic registrant or filer entrusts an overseas cosmetic manufacturer to produce cosmetics, the cosmetics are considered imported cosmetics, but because the registrant or filer is domestic, there is no need to designate a domestic responsible person.

Q: What are the differences between the domestic responsible person and the original in-China reporting responsible unit?

A: Compared with the in-China reporting responsible unit stipulated in the original "Regulations on the Sanitary Supervision and Administration of Cosmetics" and related regulations, the domestic responsible person not only needs to handle registration and filing on behalf of the registrant and filer, but also needs to fulfill obligations such as assisting in adverse reaction monitoring, implementing product recalls, and assuming corresponding quality and safety responsibilities according to the agreement.

If the in-China reporting responsible unit does not have the ability to fulfill the corresponding obligations of the domestic responsible person, it cannot act as the domestic responsible person to carry out the registration and filing of cosmetics.

Q: What content should the authorization letter for the domestic responsible person specify?

A: The content of the authorization letter for the domestic responsible person should at least include the following content and information: the names of the registrant, filer, and domestic responsible person, the authorization and authorized relationship, the scope of authorization, and the authorization period.

If the authorization period is not clear, it is considered permanent authorization; regardless of whether the authorization letter includes assisting in cosmetics adverse reaction monitoring, implementing product recalls, and cooperating with supervision and inspection, the domestic responsible person should fulfill the obligations of assisting in adverse reaction monitoring, implementing product recalls, and cooperating with supervision and inspection according to the regulations.

Q: Can the original authorization letter be used for the domestic responsible person?

A: The original authorization letter for the in-China reporting responsible unit for imported special-use cosmetics cannot be used. The original authorization letter for the domestic responsible person for imported ordinary cosmetics can continue to be used (only for handling the import filing of ordinary cosmetics). If the original authorization letter for the domestic responsible person has been submitted to the accepting department and the original cannot be provided again, the domestic responsible person should upload a scanned copy of the original authorization letter through the registration and filing information service platform when opening the domestic responsible person account, and can submit a photocopy of the authorization letter when submitting paper documents.