Following FAQs are all related to ordinary cosmetics filing, CIRS Group has compiled the information and translated them into English for your reference.
Q1: Why is there a discrepancy between the ingredient information in the "Full Ingredient Labeling" section under the product label module and the product formulation module in the filing management system?
After the filer inputs and saves information such as product formulation, implementation standards, and product labels in the system, if the filer later returns to the product formulation module to make modifications, the "Full Ingredient Labeling" section under the product label module will not be automatically updated. This results in inconsistencies between the full ingredient labeling and the product formulation.
In such cases, the filer may manually update the "Full Ingredient Labeling" section to ensure consistency. Please note that the "Ingredients" information publicly disclosed on the NMPA’s filing information platform is sourced from the "Full Ingredient Labeling" section under the label module. Therefore, it is essential to ensure the accuracy of this information.
Q2: How to apply for the cancellation of user permissions for registrants/notifiers and manufacturing enterprises?
Registrants/notifiers and manufacturing enterprises shall apply to the regulatory authorities for the cancellation of their corresponding user permissions. Registrants/notifiers or manufacturing enterprises located in Guangzhou who wish to cancel their user permissions may submit an application via email to ft@qmark.com.cn, and follow the instructions provided in the reply email to submit the required cancellation documents.
According to Article 25 of the Provisions on the Management of Cosmetic Registration and Filing Data, registrants/notifiers and manufacturing enterprises applying for cancellation of user permissions must first cancel or update all related products. Since user permissions associated with a specific enterprise role type cannot be re-applied for once cancelled, registrants/notifiers and manufacturing enterprises are advised to exercise caution when applying for the cancellation of user permissions.
Q3: How to address the issue of "A Quality and safety responsible person may not hold positions in two or more registrants/notifiers or manufacturing enterprises simultaneously" when applying for user account registration?
According to the FAQs on Cosmetic Production and Operation (Part I) issued by the National Medical Products Administration (NMPA), in order to ensure the quality and safety of cosmetics and to guarantee that the quality and safety responsible person fulfills their legal duties in product quality management and product release, the principle of “one certificate, one person” must be followed. Specifically:
- A single natural person may not serve as the QSRP for two or more cosmetic production license holders.
- A single natural person may not serve as the QSRP for multiple cosmetic registrants or notifiers.
Exception: This restriction does not apply if the cosmetic registrant/notifier and the entrusted manufacturing enterprise belong to the same corporate group, operate under the same quality management system, and the entrusted enterprise manufactures cosmetics on behalf of the registrant/notifier. In such cases, it is permissible for the same natural person to serve as the QSRP for both entities.
The enterprise information system includes a function to detect duplicate QSRP information. If you receive the aforementioned notification during account registration, you are advised to:
- Conduct a self-check to determine whether the QSRP's information is identical to that of another enterprise. Verify whether the QSRP information linked to the cosmetic production license of their previous employer has been updated. If the previous employer holds both registrant/notifier and manufacturing enterprise roles, ensure that the QSRP information for both roles has been updated accordingly.
- If the duplicate cannot be identified, you may contact the regulatory authority to request assistance in confirming the conflicting entity.
Once the issue of duplicate QSRP information has been resolved, the applicant enterprise may proceed with the user account registration as normal.
Q4: Can the address of a general cosmetics notifier be changed due to relocation?
According to Article 36 of the Measures for the Administration of Cosmetic Registration and Filing, if a change in the notifier’s or domestic responsible person’s address results in a change of the competent notification authority, the notifier must re-submit the product notification.
If the change of the notifier’s registered address does not involve a change in the competent notification authority (i.e., the provincial-level Medical Products Administration, hereinafter the same), the notifier may apply to change the address; If the change of the notifier’s registered address involves a change in the competent notification authority, the notified products must be canceled and re-notified.
Q5: Can the registrant of a special cosmetics product be changed?
According to Article 49 of the Measures for the Administration of Cosmetic Registration and Filing, the registration certificate for cosmetics shall not be transferred. In cases where the original registrant's legal entity is deregistered due to legal circumstances such as enterprise merger or division, the registrant may be changed to a newly established enterprise or another organization. In such cases, an application for change of registrant must be submitted in accordance with the provisions of these regulations. The new registrant must meet the requirements for registrants as stipulated in the regulations and bear the responsibility for the quality and safety of the products already on the market.
Apart from situations where the original registrant’s legal entity is deregistered due to merger, division, or other legal reasons, changing the registrant of a special cosmetics product is not allowed.
About CIRS
The CIRS cosmetic team is dedicated to ensuring that cosmetic products meet stringent global regulatory standards. It can provide one-stop services covering the whole life-cycle of a personal care product, which includes cosmetic ingredient development, physical/chemical tests, toxicological tests (in vivo & in vitro), efficacy studies (in vivo & in vitro), ingredient registration, and product registration.
Cosmetic services in China:
- China Cosmetic Registration and Filing;
- China New Cosmetic Ingredient Registration and Filing;
- China Cosmetic Ingredient Quality and Safety Information Code Application (NMPA Code);
- China Cosmetics Efficacy Evaluation;
- In-vitro Safety and Efficacy Evaluation;
- China Cosmetic Safety Assessment Report;
- China Toothpaste Filing;
- China Disinfectant Notification;
- China Cosmetic Formula/Label/Claim Review; and
- Customs Clearance
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
Further Information
https://scjgj.gz.gov.cn/zmhd/cjwt/pthzpba/content/post_10324537.html
