To help you understand more about filing ordinary cosmetics we have translated the latest FAQs published by the Beijing Municipal Medical Products Administration.
Q1: What are the job requirements for cosmetic quality and safety responsible person?
A1: The responsible person must have professional knowledge related to the quality and safety of cosmetics, with more than five years of experience in cosmetics production or quality and safety management.
Q2: What kind of information should the CV of the responsible person cover?
A2: The CV of the responsible person must cover:
- Educational background;
- Work experience; and
- Other information related to the job.
The relevant professional knowledge and quality safety management experience of the person must meet the requirements of relevant laws and regulations.
Q3: Is it possible for the cosmetic quality and safety responsible person to work concurrently for different cosmetic registrants, filers, and entrusted manufacturers?
A3: As per the “one product, one license” principle, one person could not be the responsible person for two or more cosmetic products. That is to say, when applying for two or more cosmetics production licenses, different responsible persons shall be held responsible for each product. Different cosmetic registrants and filers cannot share one cosmetic quality and safety responsible person as well. When the cosmetic registrant, filer, and the entrusted production enterprise belong to the same company and implement the same quality management system, the registrant, the filer and the entrusted production enterprise can employ the same person as the cosmetic quality and safety responsible person.
Q4: Cosmetic registrants and filers have engaged in the production of cosmetics, do they need to open extra user rights as “manufacturers”?
A4: Those who have multiple identities such as domestic registrant or filer, domestic responsible person, and production enterprise, or one domestic responsible person corresponding to multiple overseas registrants and filers can submit all materials at one time, to obtain corresponding user rights. Existing users can supplement additional information to gain additional user rights. Cosmetic enterprises in China that have only engaged in entrusted production can obtain the user rights in the name of "manufacturer", so as to confirm the entrusted production
Q5: Do the documents on cosmetic user information need to be stamped page by page?
A5: Cosmetic registration and filing materials must be stamped with complete signatures and seals with legal effects as per the requirements on the use of seals in China. If the registrants or filers are overseas enterprises or other organizations that do not use official seals, the materials shall be signed by the legal representative or the person in charge of the enterprise (the other organization). Registration and filing materials of cosmetics, except for the original documents issued by the competent authorities or relevant institutions, registration and filing inspection institutions, and notaries, shall be affixed with the official seal of the domestic registrant, filer, or the domestic responsible person page by page.
Q6: What are the requirements for the power of attorney submitted by the domestic responsible persons when the domestic responsible persons need to open user rights?
A6: The power of attorney submitted by the domestic responsible person shall be the original document. The original notarization certificate must be submitted as well. The power of attorney must at least cover the following information:
- name of the registrant, filer, and the domestic responsible person,
- the authorization relations,
- the scope of authorization, and
- the period of authorization.
Q7: Is it possible for the domestic responsible person to still use the original power of attorney for the Chinese responsible unit?
A7: The power of attorney for the Chinese responsible unit on the imported special cosmetics declaration cannot be used by the domestic responsible person anymore. However, power of attorney for the domestic responsible person for imported ordinary cosmetics filing can be used (Only for the import filing of ordinary cosmetics) by the domestic responsible person. If the original power of attorney document for the domestic responsible person has been previously submitted to the acceptance department and cannot be provided again, the domestic responsible person shall upload the scanned copy of the original power of attorney via the registration and filing information service platform when opening a user account, and submit the copy of the power of attorney when submitting the paper document.
Q8: What are the requirements for the production specification certificates of overseas manufacturers when they apply for user rights?
A8: Overseas production enterprises shall submit qualification certificates, documents, and other supporting materials certifying that the production enterprises conform to the quality management system or production quality management specifications. The supporting materials shall be issued or recognized by the competent government departments of the country (region) where they are located, certification institutions, or a third party with the certification qualification of the country (region) where they are located, indicating the name and actual production address of the production enterprises. If the original certificate cannot be provided, a copy notarized by a Chinese notary office or confirmed by a Chinese embassy (consulate) shall be provided. If there is a valid period for the overseas production quality management specifications, the certificates shall be updated in a timely manner, and the longest period shall not exceed 90 days after the expiration of the valid period. If there is no expiry date, the documents shall be updated every five years.
Q9: How do you update user information when the names of overseas registrants and filers are changed?
A9: If overseas registrants and filers need to update their names, they can submit the updated name via the registration and filing information service platform, and update relevant information after they passed the review of the National Medical Products Administration. If overseas registrant or filer needs to update their name, they shall also provide the original relevant certifying documents issued by the competent government department or relevant institution of the country (region), to certify that the subject has not been changed. If the original document(s) cannot be provided, a photocopy notarized by a Chinese notary office or confirmed by a Chinese embassy (consulate) must be provided.
Q10: How do you update production site information on the cosmetic registration and filing information service platform when manufacturers increase their production sites?
A10: When a manufacturer increases its production site, it must submit updates to the production site on the cosmetic registration and filing information service platform, and revise relevant information after being reviewed by the NMPA. To make updates to the production sites, enterprises must provide the production site update information table. Where overseas production enterprises increase production sites, they must provide relevant materials for overseas production quality management specifications as required.
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