Affected by the global COVID-19,To ensure the smooth implementation of registration and declaration of special cosmetics and new raw materials,According to the National Bureau2020year6month16Issued on Circular on adjusting the submission form of supporting documents related to imported cosmetics during the epidemic  2020Year38number ,And refer to2022year4month27Issued by the National Bureau of Reply on matters related to the registration and filing management of cosmetics during the prevention and control of COVID-19  Comprehensive letter of Drug Administration 2022 226number ,The relevant matters are hereby notified as follows

one Temporary vacancy handling for registration and filing of cosmetics

one Data requirements

If affected by the COVID-19,The registrant at the time of cosmetic registration The filing person is unable to submit the original of the materials or supporting documents stamped with the official seal or send the paper materials,The administrative acceptance service agency of the State Food and drug administration may adopt Tolerance acceptance measures,I.e. registrant The filer may submit electronic documents or copies in advance,After the impact of the epidemic situation is eliminated, the registrant shall supplement and submit the original of relevant materials.apply Tolerance acceptance The requirements for submission of materials are as follows

1. Tolerance acceptance apply Relevant written instructions shall be included concrete Tolerance content ,Promise that the content of subsequent uploading and submission is consistent with that of this submission. Tolerance acceptance The application shall be confirmed by the legal representative or principal of the enterprise.

2.Relevant certification materials To prove that the registration and declaration materials are affected by the epidemic situation and affix the official seal Unable to obtain the original of the supporting documents and the proof that the paper materials cannot be sent,E.g. registrant Announcement on epidemic control in the place where the manufacturer is located announcement ,Epidemic isolation certificate issued by the street where the handler is located,Abnormal logistics information, etc.

3.Electronic materials have been submitted and approved before Applications for which paper materials are to be submitted but cannot be sent due to epidemic situation,Relevant written instructions and supporting materials can be sent tohzppjzx@nifdc.org.cn.

two Supplementary submission of tolerance content

Registrant of special cosmetics The product registration information of the domestic responsible person is in Tolerance acceptance after,It shall be prepared in time as required Tolerance content ,After receiving the Supplementary information,Deferred retrial Upload and submit the original of relevant materials within the specified time limit after the review comments.Registrant The domestic responsible person fails to submit the corresponding materials as required within the time limit,The cosmetics technical evaluation agency will issue Not recommended for approval And report to the National Bureau.Recorder of imported ordinary cosmetics The provincial drug regulatory department where the domestic responsible person is located has not undertaken the filing management of imported ordinary cosmetics,Filed by The product filing materials of the domestic responsible person are listed in Tolerance acceptance after,It shall be prepared in time as required Tolerance content ,After receiving the Order correction Upload and submit the originals of relevant materials within the specified time limit after the technical verification opinions of the filed materials.Filed by The domestic responsible person fails to submit the corresponding materials as required within the time limit,The cosmetics technical evaluation agency will issue Cancellation of filing The technical verification conclusion of the filed materials shall be submitted to the State Administration of taxation.

If the cosmetic technical evaluation agency finds the registrant Application of filer and domestic responsible person Tolerance acceptance The relevant materials submitted at the time of submission are inconsistent with the subsequent uploaded or submitted supplementary materials or are fraudulent,Handled according to relevant provisions on false declaration.

two Supplementary filling of cosmetics information

according to Circular of the State Food and Drug Administration on the implementation of<Provisions on management of cosmetics registration and filing materials>Announcement of relevant matters  2021Year35number ,Cosmetics that have been registered or filed on the original registration and filing platform,Registrant The recorder shall2022year5month1Submit the standards and other relevant materials implemented by the product a few days ago.

Affected by the COVID-19,Relevant registrant The filer cannot2022year5month1Completed the supplementary filling of historical product information a few days ago,It shall submit a written description of the situation to the administrative acceptance service agency of the State Food and Drug Administration and attach corresponding supporting materials,Complete supplementary filling after elimination of epidemic impact,In principle, it shall not exceed2022year12month31day,Not in2023year1month1Those who completed supplementary filling a few days ago,No further production Import.

Application for change of registration items of cosmetics,The supplementary filling of historical product information shall be completed before the change application.The registration certificate of special cosmetics needs to be renewed upon expiration,The supplementary filling of historical product information shall be completed before the application for renewal of registration certificate.If the applicant fails to submit the required application materials within the specified time limit due to the above reasons, it shall refer to Announcement of the State Food and Drug Administration on further clarifying the transitional period management of original cosmetics for special purposes  2021year Section150number in three On the extension of the validity of the registration certificate of special cosmetics Implementation of relevant provisions.

three Registration and filing of products related to updating the catalogue of prohibited raw materials for cosmetics

Announcement of the State Food and Drug Administration on further clarifying the transitional period management of original cosmetics for special purposes (2021Year150number)in On the registration and filing management of products related to updating the catalogue of prohibited raw materials for cosmetics to make clear To retain the original registration or filing number,Registrant The recorder shall2022year5month1Recently, according to way Prescribed registration and filing change procedures,Apply for formula change,And submit the corresponding inspection report according to the requirements of new product registration and filing data Safety assessment and other relevant safety data.

If affected by the COVID-19,The relevant registrant cannot2022year5month1The formula change application was submitted a few days ago,And in accordance with Provisions on management of cosmetics registration and filing materials Submit corresponding inspection report Safety assessment and other relevant safety data,It shall submit a written description of the situation to the administrative acceptance service agency of the State Food and Drug Administration and attach corresponding supporting materials,After the impact of the epidemic situation is eliminated, the change application shall be submitted and the compliance Provisions on management of cosmetics registration and filing materials Required information,In principle, the time for applying for change and submitting normative data shall not exceed2022year12month31day.Relevant products shall not be produced before the change is completed Import sale.

four Digital authentication certificate

2021year4month25day,Issued by National Bureau Technical guide for submission of cosmetic registration materials Trial Implementation  The requirements for paper materials in the are as follows

Domestic registrants Filed by After the domestic responsible person or cosmetics manufacturer submits the electronic registration and filing materials through the information service platform,In accordance with the requirements of these guidelines, the original paper registration and filing materials consistent with the electronic registration and filing materials shall be submitted to the registration administration department or the filing administration department.In the third party certification,Issuing authority has used digital authentication certificate Certificate Authority,CA Signed and can be effectively obtained and verified through the information service platform,Exemption from submission of paper materials In other materials,Registrant Filed by Used by domestic responsible personCASigned and sealed completely,Exemption from submission of paper materials.

at present,Digital certification supported by the cosmetics intelligent declaration and evaluation platform of the State Food and Drug Administration,Registrant Filed by The domestic responsible person has applied for the digital authentication certificate,According to the requirements of relevant data management regulations,Affix electronic signature and seal to the submitted electronic registration materials.Digital certificate can be based on Technical guide for submission of cosmetic registration materials Trial Implementation  To apply for https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210425160440171.html

Central Inspection Institute

2022year6month2day