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NIFDC Notice on Handling Matters Related to Cosmetics Registration and Filing


NIFDC Notice

On June 2, 2022, NIFDC issued a notice on handling matters related to cosmetics registration and filing during the period of epidemic prevention and control, aiming to ensure the smooth implementation of the registration and declaration of special cosmetics and new raw materials due to the impact of COVID-19 pandemic. The notice details are as follows:


Ⅰ. Temporary "tolerance acceptance" of cosmetic registration and filing


1. Material requirements for applying for "tolerance acceptance"

In case of cosmetic registration or notification, due to the impact of the epidemic, if the registration and filing person fails to submit materials with affixing official seals or original documents and fails to send the paper documents, the method of "tolerance acceptance" can be adopted by the center for administrative services of China NMPA. The registrant and notification person can first submit electronic versions of documents or copies of original documents. The original documents shall be submitted after the impact of the epidemic is eliminated. The materials requirements for applying for "tolerance acceptance" are as follows:


1.1 Application for "tolerance acceptance": It should include a relevant written description, specific "contents tolerant to deficiency", and a promise that the content of subsequent uploading and submission is consistent with that of this time.


1.2 Relevant supporting materials: These materials should prove that the registration documents cannot affix official seals, the original copies of supporting documents cannot be obtained, and paper materials cannot be sent, are all affected by the epidemic, such as the announcement (notice) on the management and control of epidemic where the registrant or the production enterprise is located, the epidemic isolation certificate of the handling personnel issued by located street, abnormal logistics information, etc.


1.3 For the application that electronic materials have previously submitted and passed the review, while paper materials cannot be sent due to the epidemic, the relevant written description and supporting materials can be sent to hzppjzx@nifdc.org.cn.


2. Supplementary submission of the content tolerant to deficiency

Registrants and domestic responsible persons (RPs) of special cosmetics should prepare the content tolerant to deficiency in time after "tolerance acceptance" for the product registration materials, and upload and submit the original copies of relevant documents within the stipulated time after receiving the review comment of "supplementary information, postponed re-examination" issued by the center for cosmetic evaluation of NMPA.


If the registrants and domestic RPs fail to submit relevant materials according to the rules within the stipulated time, the Center for Cosmetic Evaluation of China NMPA will issue a review conclusion of "recommendation of not approving" and report it to China NMPA.


If the provincial MPA where the filing persons and domestic responsible persons of imported general cosmetics are located, has not undertaken the filing management of imported general, the filing persons and domestic RPs should prepare the content tolerant to deficiency in time according to the rules after "tolerance acceptance" for the product filing materials, and upload and submit the original copies of relevant materials within stipulated time after receiving the review conclusion of "an order for corrections" and other post-filing technical verification opinions issued by the center for cosmetic evaluation of China NMPA.


If the filing persons and domestic RPs fail to submit relevant materials according to the rules within the stipulated time, the Center for Cosmetic Evaluation of China NMPA will issue a review conclusion of "cancellation of the filing" and report it to China NMPA.


If the Center for Cosmetic Evaluation of China NMPA finds that the relevant materials submitted by the registrant, filing applicant, and domestic PR when applying for "tolerance acceptance" is inconsistent with the supplementary materials uploaded or submitted subsequently, or the relevant materials are false, it will be handled in accordance with the relevant regulations.


Ⅱ. Filling out and submitting of supplementary cosmetic information


According to the NMPA Announcement on Issues about Implementing the Rules for Registration and Notification Dossiers of Cosmetics (No. 2021), for cosmetics that have been registered or completed filing on the original registration and filing platform, the registrant and filing applicant shall submit the product implementation standards and other relevant materials prior to May 1, 2022.


If the registrant or filing applicant cannot complete the submission of product information before May 1, 2022, due to the impact of the epidemic, the written description of the situation with attaching relevant supporting materials shall be submitted to the Center for Administrative Services of China NMPA. The supplementary cosmetic information shall be submitted after the impact of the epidemic is eliminated. In principle, it shall be prior to December 31, 2022. Those who fail to submit supplementary information before January 1, 2023, shall not continue to produce and import cosmetics.


As for the application for change of cosmetic registration and filing items, the supplementary submission of product information shall be completed before the application for change. If the special cosmetic registration certificate expires and needs to be renewed, the supplementary submission of product information shall be completed before the application for a renewal of the registration certificate. If the applicant fails to submit the required application materials within the stipulated timeline due to the above reasons, the relevant provisions such as Article 3: Renewal management of the validity period of the special cosmetic registration certificate in the NMPA Announcement on Matters Related to Further Clarify the Management of the Original Special Use Cosmetics During Transition Period (No.150, 2021) shall be implemented.


Ⅲ. Registration and filing of products related to the update of the catalogue of raw materials banned for cosmetics


According to the "registration and filing management of products related to the update of the catalogue of prohibited raw materials for cosmetics" in the NMPA Announcement on Matters Related to Further Clarify the Management of the Original Special Use Cosmetics During Transition Period (No.150, 2021), if the original registration or filing number is to be retained, the registrant and filing applicant shall, before May 1, 2022, submit an application for formula change in accordance with the registration and filing change procedures stipulated in the Administrative Measures for Cosmetics Regulation and Notification, and submit inspection reports, safety assessment reports, and other related safety materials in accordance with material regulations of the new product registration and filing.


If the relevant registrant fails to submit an application for formula change before May 1, 2022, and fails to submit inspection reports, safety assessment reports, and other related safety materials in accordance with the Provisions for the Registration or Filing Dossier of Cosmetics due to the impact of the epidemic, the written description of the situation with attaching relevant supporting materials shall be submitted to the Center for Administrative Services of China NMPA. The application for change and required materials in accordance with the Provisions for the Registration or Filing Dossier of Cosmetics shall be submitted after the impact of the epidemic is eliminated. In principle, the application for change and supporting materials shall be submitted before December 31, 2022. Relevant products shall not be produced, imported, or sold before the change is completed.


Ⅳ. Digital Certificate Authority


On April 25, 2021, NMPA issued the Technical Guidelines for Submitting Registration and Notification Dossier of Cosmetics (Interim), and the requirements of paper materials are as follows:


After the domestic registrant, filing person, domestic RP, or cosmetic manufacturer submits the electronic version of the registration and filing materials through the information service platform, the original copies of paper materials, which are consistent with the electronic version of the registration and filing materials, shall be submitted to registration or filing management department in accordance with the rules of the Guidelines. In the supporting materials issued by the third-party institution, which have already been signed and sealed with a digital Certificate Authority (CA) that can be effectively obtained and verified through the information service platform, the paper materials can be exempt. As for other materials, the registrant, filing person, and domestic RP who have signed and sealed with complete CA can be exempted from submitting paper materials.


At present, the NMPA Intelligent Cosmetic Application and Evaluation Platform supports the digital CA. The registrant, filing person, and domestic RP who have already applied for a digital CA, can affix the electronic signature on the electronic versions of registration and filing materials that shall be submitted. The digital CA can be applied in accordance with the requirements of the Guidelines.

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