China cosmetics registrations FAQs have been issued recently from the National Institute of Food and Drug Control (NIFDC) and the Beijing Medical Products Administration.
Q: When applying for cosmetic registration, for raw materials that have not yet obtained the raw material submission code, how can the raw material safety information be submitted?
A: The following two ways are possible for the registrant/filer/domestic responsible agent (DRA) to provide the information according to their circumstances:
- The raw material manufacturer provides the raw material specifications or raw material safety-related information by completing the form in Annex 14 of the Cosmetics Registration Data Management Regulations. The raw material manufacturer must use the official company stamp, stamping each page. The registrant/filer and the DRA should also stamp each page with their official company stamp as well.
- The raw material manufacturer authorizes the registrant/filer or the DRA to provide the raw material safety-related information (via the form in Annex 14), then the registrant/filer or DRA shall provide their official company stamp on each page of the raw material safety-related information. In addition, in the section entitled “other issues that need to be clarified” it should be noted that : the registrant/filer or DRA (specifying the business name) is authorized by the raw material manufacturer (specifying the business name) to fill out the relevant content in Annex 14, and that the content is true and complete and accurate.
Q: What do I need to pay attention to when I submit a Chinese translation of the foreign language label of the imported product sales package?
A: In accordance with the “Regulations on the Administration of Cosmetics Registration and Filing” Article 31, paragraph 2, the registrant/filer of imported cosmetics, or the DRA shall submit the production country (region), product packaging (including instructions), as well as the Chinese translation of the foreign language label when registering or filing a cosmetic product.
The Chinese translation submitted should be a truthful translation of the original sales package label content. The Chinese label cannot conceal and shall not modify the original sales label by covering, altering, etc. If the sales package (including instructions) has the same foreign language content, then it need be translated only once, without repeated translation.
Q: What do I need to pay attention to when there are foreign language registered trademarks on the packaging and labels?
A: According to Article 6 of the Measures for the Administration of Cosmetics Labels, cosmetics shall have Chinese labels. Tthe Chinese label shall use standard Chinese characters. If other characters or symbols are used, the corresponding explanation in standard Chinese characters shall be used on the visible side of the product sales package, except for the website, the name and address of overseas enterprises, and any agreed professional terms.
If multiple visible surfaces of the product label have the same foreign language registered trademark, the standard Chinese characters corresponding explanation can be used on just one of the visible surfaces.
Q: What are the requirements for the power of attorney submitted by the register an account on the NMPA platform?
A: The power of attorney submitted by the DRA to open the user rights should be the original power of attorney of the DRA and its original notarized certificate.
- DRA authorization should at least clearly reflect the following content and information: the name of the registrant/filer
- the name of the DRA
- the nature of the relationship between the authorizer and authorizee
- authorization scope
- authorization period.
Q: Can the DRA (with power of attorney) use the authorizing letter of the original China registration agent?
A: According to the “cosmetic registration and filing management questions and answers (a)”:
- For imported special cosmetics the authorization letter of the unit responsible for the original China registration agent cannot be used.
- For imported general cosmetics the authorization letter of the DRA who originally imported ordinary cosmetics can continue to be used.
- If the original DRAs’s authorization letter has been previously submitted to the receiving department and the original cannot be provided, then the DRA shall upload a scanned copy of the original authorization letter through the registration and filing information service platform when opening the DRA user account or they may submit a copy of the authorization letter when submitting paper documents.
Q: When applying for user permissions, what are the documentary certification requirements of foreign manufacturers?
A: Overseas production enterprises shall submit qualification certificates, documents and other certification materials that shows that the production enterprise complies with the quality management system or production quality management specifications. The certification documents shall be issued or approved by the competent government department of the country (region), certification body or a third party with certification and accreditation qualifications of the country (region) where it is located and indicate the name of the production enterprise and the actual production address information.
If the original supporting documents cannot be provided, a copy notarized by a Chinese notary public or confirmed by the Chinese embassy (consulate) shall be provided.
If the certification documents of overseas production quality management standards have an effective period, the certification documents shall be updated in a timely manner, and the maximum period shall not exceed 90 days after the expiration of the validity period. If there is no validity period, the latest version shall be submitted every five years.
Q: How to update user information if the name of overseas registrant/filer has changed?
A: Where the name of an overseas registrant/filer changes and it is necessary to update user information, a general review and update of user information shall be conducted on the registration and filing information service platform, and the update of relevant information and materials shall be completed after review by the MPA.
If the names of overseas registrants and filers change, the original copies of relevant certificates issued by the competent government departments or relevant institutions of the host country (region) that the subject of the certification has not changed shall be provided.
Q: If a manufacturer increases its production site, how should this information be entered into the cosmetics registration and filing information service platform?
A: If a manufacturer increases its production site, it shall update the production site on the cosmetics registration and filing information service platform. Once the drug regulatory department has reviewed this information, the manufacturer shall complete the update of relevant information and documents.
If renewing a production site in the system, then the production site renewal information form shall be submitted.
If an overseas production enterprise increases its production site, it shall provide relevant documents such as the certification of overseas production quality management practices as required.
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