The transitional arrangements mainly clarify matters related to the acceptance, review, and approval of cosmetic registration and notification during the transitional period between the previous and the new cosmetics registration and notification information management platforms.
To ensure smooth and orderly progress of cosmetics registration and notification work during the transition period between the old and new cosmetic regulations, China National Medical Products Administration (NMPA) released a set of transitional arrangements on May 7, 2021. 1
Specifics are as follows:
- The new cosmetics registration and notification information management platform (“new platform”) officially put into service on May 1, 2021. Cosmetics registrants, notifiers, and domestic responsible persons can apply for special cosmetic registration and general cosmetic notification through the new platform.
- As of May 1, 2021, the original cosmetics administrative licensing and notification information management system (“original platform”) no longer accepts special cosmetics registration or general cosmetics notification.
● For special cosmetics whose registration applications have been submitted before that date, the technical review departments will continue to accept, review and approve the applications on the original platform in accordance with regulations.
● For general cosmetics whose notification dossiers have been submitted before that date, the notification management departments will continue to supervise and inspect the notification information on the original platform in accordance with regulations.
- If the notification management departments find that the notification dossiers on the original platform are non-compliant during the post-notification supervision and inspection, it shall be dealt with per article 65 of the Cosmetic Supervision and Administration Regulation. Where it is necessary to order corrections, the notifiers shall be ordered to make corrections before September 15, 2021. If the notifier fails to make corrections within the time limit or fails to meet the requirements after the rectification, the notification shall be canceled by the notification departments.
- For cosmetics companies that have obtained registration license or completed notification through the original platform, and are temporarily unable to submit relevant dossiers, such as the registrants and notifiers’ quality management system overview and adverse reaction monitoring and evaluation system overview, when applying for user permission on the new platform because that these systems are still in the process of perfection, the provincial medical products administrations may conditionally review and pass their user applications, open temporary user permissions, and allow them to carry out cosmetics registration and notification related work.
Cosmetic registrants, notifiers, and domestic responsible persons who have opened temporary user permissions on the new platform should supplement dossiers such as the quality management system overview, and adverse reaction monitoring and evaluation system overview before January 1, 2022. If they fail to supplement such dossiers within the time limit, their temporary user permissions will be automatically invalid on January 1, 2022. If relevant dossiers are completed in the future, they can still apply for opening the registration and notification user permissions.
Official Answers to Questions on the Platforms
1. Can I continue to submit the applications in the original platform for notifications requiring rectification after May 1?
A: Yes, you can.
2. Can applications of modification be submitted in the original platform?
A: No, shall be submitted in the new platform.
3. How long will it take to review the new platform account applications?
A: 10 working days.
4. What is a preliminary account?
A: It can be understood as referring to a temporary account. If the notifiers meet the requirements, after applying for the account the notifiers can only submit the information relating to the person in charge of quality and safety. The quality platform summary and the adverse reaction summary form may not be submitted temporarily but shall be supplemented before January next year.
5. For products successfully notified by entrusted companies after May 1, is there a need to associate with the manufacturing company?
A: There is no need.
6. The new platform must be associated with the ingredient submission code. If the ingredient supplier has not uploaded the code, do the processing companies need to provide related documents before submitting the notification in the new platform?
A: Yes, they need.
7. The new platform requires the submission of all ingredients in the product formula. For the content of an ingredient that needs to be adjusted due to various factors in the production, can the value range of the content be provided?
A: The content of ingredients in the formula shall be the actual value.
8. For applications submitted in the new platform before the implementation of the new cosmetic labeling regulations, does the labeling comply with the current labeling regulations? After the implementation of the new cosmetic labeling regulations, does the labeling of products notified in the new platform need to be changed?
A: Yes, comply with the current regulations. It is recommended that companies do not accumulate packaging material inventory. Information of notifiers, manufacturers and trace ingredients can be modified in accordance with the regulations, measures or provisions.
For more problems about the platform, you may contact 010-88331913/010-88331514 or send an email to email@example.com.
Original link：NMPA’S Notice