On April 28, Shanghai MPA issued a notice on matters related to the registration and filing of cosmetics and production during the period of epidemic prevention and control (No.9, 2022), the notice details are as follows:
1. Renewal of registration certificates of special cosmetics
If the application for renewal of special cosmetic registration fails to submit application materials within the specified time limit due to the impact of COVID-19 epidemic, in accordance with the NMPA Announcement on Matters Related to Further Clarify the Management of Original Special Cosmetics During the Transition Period (No.150, 2021), cosmetic registrants or domestic responsible persons in Shanghai shall submit a written statement and supporting materials to local MPA within 10 working day after the impact of the epidemic is eliminated. The local MPA shall verify and issue a written opinion within 10 working days from the date of receiving the relevant materials. Registrants or domestic responsible persons shall submit an application for renewal of registration to the service agency of NMPA within 5 working days of receiving the written opinion.
2. Temporary tolerance acceptance of general cosmetic filing
If filing dossiers of general cosmetics cannot be stamped with the official seal due to the impact of the epidemic, a written statement and supporting materials that have been confirmed by the enterprise legal representative or the main responsible person should be submitted. After the online review and approval of the filing platform, user rights can be opened, and related filing services can be handled in advance. The electronic materials with official seals should be uploaded and the original paper materials should be submitted within 15 working days after the impact of the local epidemic is eliminated. The municipal review and evaluation center for medical devices and cosmetics and administration for regulation of all districts shall be responsible for the registration account of the enterprise to open the user rights and handle the relevant filing service in advance after the electronic materials with official seals and original paper materials have been submitted, the record of pre-registration shall be cancelled.
3. Filling out and submitting supplementary information on products that have completed registration and filing on the original platform
According to the NMPA Announcement on Matters Related to Implement the Rules for Registration and Notification Dossiers of Cosmetics (No.35, 2021), cosmetics that have completed the registration or filing on the original registration and platform (hereinafter referred to as "historical products"), registrants and filing persons shall submit the implementation standards of products and other relevant materials prior to May 1, 2022. The FAQs on Supervision and Administration of Cosmetics (IV) issued by NMPA on April 8, 2022, have stipulated that the supplementary materials submitted on the new registration and filing platform are registration and filing materials originally filed by the enterprise for future reference. And there are no new requirements for registrants and filing persons. The filling out and submission of supplementary materials are the necessary conditions to prove that the relevant products comply with the Regulations on Supervision and Administration of Cosmetics and its supporting provisions. Products that fail to fill out and submit the supplementary materials as required, shall not continue to be produced or imported until the supplementary materials are submitted.
If registrants and filing persons fail to complete the filling out and submission of supplementary materials before May 1, 2022, due to the impact of the epidemic, they shall submit a written statement of the situation with attaching corresponding supporting materials to the local Department of Administration for Market Regulation, and complete supplement within 3 months after the impact of the local epidemic is eliminated. In principle, it shall be prior to December 31, 2022. If it fails to complete the supplement within the time limit of renewal, the drug regulatory department responsible for the filing administration shall order that correction be made within a specified timeline in accordance with the regulations. The filing persons who have made a correction as required can continue to produce or import cosmetics; If the products are no longer produced or imported and the filing persons fail to complete the supplement as required, the report for cancellation of filing shall be submitted to drug regulatory department responsible for the filing administration within the correction period, and the listed products can be sold until the warranty period expires. The corrections are not made within a specified timeline, the filing certificate will be cancelled in accordance with Article 59 (2) of the Provisions for Registration and Filing of Cosmetics.
4. Efficacy claim supporting documents
According to the NMPA Announcement on issuing the Standard for the Evaluation of Efficacy Claims of Cosmetics (No.50, 2021), cosmetics that have completed registration or filing during the period from May 1, 2021, to December 31, 2021, their registrants and filing persons shall evaluate the efficacy claims and upload the efficacy claim supporting documents as required prior to May 1, 2022. If registrants and filing persons fail to upload the efficacy claim supporting documents as required prior to May 1, 2022, due to the impact of the epidemic, enterprises shall submit a written description of the situation with attaching supporting materials to the local Administration for Market Regulation and shall submit the efficacy claim supporting documents within 3 months after the impact of the local epidemic is eliminated. In principle, it shall be prior to December 31, 2022.
5. Cosmetic production license
Cosmetics production enterprises in Shanghai can log in to the municipal government's "All-in-One Office" platform to apply for handling matters related to cosmetic production licenses through a legal person card or electronic business license. If the enterprise fails to log in to the platform to handle the application for such matters as a renewal of cosmetic production license, changes in the enterprise name, residence, legal representative (responsible person) due to the impact of the epidemic, a written description of the situation with attaching supporting materials shall be submitted to the Shanghai MPA. After the relevant impact is eliminated, the time limit of the application can be extended. If the relevant impact is not eliminated before the expiration of the cosmetic production license, the time limit of application can be extended to 15 working days after the impact is eliminated in Shanghai. The validity period of the extended cosmetic production license shall be recalculated from the date of issuance.
If the enterprise cannot accept the on-site inspection within the specified timeline after applying for a new cosmetic production license or change of license items, etc., it shall submit a written description of the situation with attaching supporting materials to the Shanghai MPA. After the relevant impact is eliminated, the time for on-site inspection can be postponed.
6. Resumption of work and production of cosmetic production enterprises
Cosmetic production enterprises that resume work and production during the period of epidemic prevention and control should formulate production plans and emergency plans before resuming work, and effectively do a good job of employee health monitoring, disinfection of production sites, and other related work so that all employees can be covered by epidemic prevention work. Enterprises should fully implement the main responsibility for the quality and safety of cosmetics, strictly abide by the "the Cosmetics Supervision and Administration Regulations", "the Provisions for the Supervision and Administration of Cosmetics Manufacture and Distribution" and relevant regulations on cosmetics production quality management, so as to ensure the effective operation of the production quality management system. For those who are directly engaged in cosmetics production activities, if they fail to conduct annual health inspections due to the impact of the epidemic, their health certificates that expire after March 1, 2022, are deemed to continue to be valid. The relevant practitioners should handle a health certificate within 1 month after the impact of the epidemic is eliminated. Cosmetics production enterprises should strengthen the health management of employees, and prohibit personnel suffering from diseases directly engaging in cosmetics production activities.