1. What are the requirements for the power of attorney submitted by the domestic responsible person when opening the user rights?
The power of attorney submitted by the domestic responsible person to open the user authority shall be the original power of attorney of the domestic responsible person and the original of the notarization certificate.
The power of attorney of the domestic responsible person shall at least clearly state the following contents and information: the name of the registrant, the filing person and the domestic responsible person, the authorization relations, the scope of authorization, and the duration of authorization.
2. Can the power of attorney of the domestic responsible person use the power of attorney of the responsible unit for declaration in China?
According to the "Answers to Questions on the Administration of Cosmetics Registration and Filing (I)", the power of attorney of the responsible unit for declaration for original imported special cosmetics in China cannot be used anymore. The power of attorney of the domestic responsible person for the original imported general cosmetics can be used continuously (only for the filing of imported general cosmetics). If the original version of the power of attorney of the original domestic responsible person has been submitted to the acceptance department before and cannot be provided again, the domestic responsible person shall upload the scanned copy of the original version of the power of attorney through the registration and filing information service platform when opening the domestic responsible person user rights and can submit the copy version of the power of attorney when submitting the paper document.
3. What are the requirements for the supporting materials of production specification of overseas production enterprises when applying for user rights?
Overseas production enterprises shall submit qualification certificates, documents, and other supporting materials which 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 host country (region), certification institutions, or a third party with the certification and accreditation qualifications of the host country (region), indicating the name and actual production address of the production enterprises.
If the original version of supporting materials cannot be provided, a copy notarized by the Chinese notary organ or confirmed by the Chinese embassy (consulate) shall be provided.
If there is a valid period for supporting materials of the overseas production quality management specifications, they shall be updated in time, and the longest period shall not exceed 90 days after the expiration of the valid period; If there is no valid period, the latest version shall be submitted every five years.
4. How to update user information if the name of the overseas registrant or filing person changes?
If the user information needs to be updated due to the change of the name of the overseas registrant or filing person, the general review and update of the user information shall be carried out on the Information Service Platform for Registration and Filing of Cosmetics, and the update of relevant information and materials shall be completed after the review by the drug regulatory department.
The general review and update information sheet shall be submitted when conducting the general review and update. If the name of the overseas registrant or filing person has changed, the original relevant certification documents issued by the competent government department or relevant institution of the country (region) where the subject has not changed shall be provided. If the original cannot be submitted, the copy notarized by a Chinese notary organ or confirmed by a Chinese embassy (consulate) shall be provided.
5. How can production enterprise increase their production addresses on the Information Service Platform for Registration and Filing of Cosmetics?
If the production enterprise increases the production address, it shall update the production address on the Information Service Platform for Registration and Filing of Cosmetics, and complete the update of relevant information and materials after the review of the drug regulatory department.
When the production address is updated, the information form for the production address update shall be submitted. If overseas production enterprises increase production addresses, they shall provide relevant materials for overseas production quality management specifications as required.
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