Answered by Department of Cosmetics Supervision, SFDA: about record cancellation, annual report system, record supplementary information and so on
time: 2022/04/08

In order to further standardize the supervision and management of cosmetics,Protect the legitimate rights and interests of consumers,The cosmetics Supervision Department of the State Food and Drug Administration sorted out the annual report on the filing of ordinary cosmetics and other related issues that the industry pays more attention to,And in accordance with China's current cosmetics laws and regulations and relevant technical specifications,Answer them one by one


ask Why should the annual report system be set up for the filing of ordinary cosmetics


answer since2014year6month30Since the implementation of online filing of domestic non special purpose cosmetics on August,The filing platform has been formed for more than ten years22010000 recorded product information.Due to the imperfection of the original cosmetics regulatory regulations and systems and the functional limitations of the old filing platform,new Regulations on the supervision and administration of cosmetics hereinafter referred to as regulations Products filed before promulgation and Implementation,Although some are no longer in production,However, product information is still accumulating on the filing platform,Gradually formed corpse product,It has brought great inconvenience to the supervision and public inquiry.Found in supervision,Some products can't even find the filer,The main responsibility of product quality and safety cannot be implemented,These products bring hidden dangers to consumers' health and safety,It is urgent to clean up by legal means. regulations After promulgation and Implementation,It provides good legislative practice in the design of filing management system,Further clarify the main responsibility of the filer,The recorder shall be responsible for product quality and safety according to law. Administrative measures for registration and filing of cosmetics hereinafter referred to as way Article 37,The filing person of ordinary cosmetics shall report the production to the drug regulatory department responsible for the filing management every year Import situation,And compliance with laws and regulations Mandatory national standards Technical specifications.


according to regulations way regulations, Notice of the State Food and Drug Administration on the implementation of Regulations on the administration of registration and filing materials of cosmetics Announcement of relevant matters 2021Year35number Further clarify from2022year1month1From the day,Ordinary cosmetics filed through the original registration and filing platform and the new registration and filing platform,Unified implementation of annual report system.The person filing the record shall1month1Solstice3month31Between dates,Through the new registration and filing platform,Submit the annual report of ordinary cosmetics with a filing time of more than one year.The overdue products shall be filed according to the requirements of the annual report,Regulatory authorities will follow way Article 58,Order rectification within a time limit The recorder fails to make corrections within the specified time limit as required,Regulatory authorities will follow way Article 59,Cancel the filing of relevant products.


ask Why do registered products need to fill in relevant materials

answer To standardize the production and operation of cosmetics,Strengthen the supervision and management of cosmetics,Ensure the quality and safety of cosmetics, regulations way and Regulations on the administration of registration and filing materials of cosmetics Make clear provisions on the materials to be submitted for the registration and filing of cosmetics. regulations And relevant supporting regulations,The registration and filing materials submitted by enterprises through the old platform are relatively simple,Take the filing of domestic products as an example,In addition to product formula ingredient information Outside sales package,Other relevant materials shall be filed by the enterprise for future reference,Resulting in the lack of some necessary product information,Bring hidden dangers to consumers' health and safety.After the implementation of the new registration and filing management regulations,In order to improve the efficiency of registration and filing,Safeguarding the health rights and interests of consumers,It is necessary to continue production Supplement and improve the data of registered products on the old platform sold.It should be noted that,The supplementary materials submitted on the new platform are the registration materials originally filed by the enterprise for future reference,Not to the registrant New requirements added by the filer.meanwhile,Considering the need to connect the old and new regulations,State Food and Drug Administration of the people's Republic of China The filing person has set a reasonable transition period for supplementary filling materials.Supplement the information to prove that the relevant products meet the requirements regulations And the necessary conditions specified in its supporting laws and regulations,For products that fail to fill in supplementary information as required,Before completing the supplementary filling,No further production is allowed Import.


ask What is the difference between the filing person's initiative to cancel the filing and the filing management department's cancellation of the filing No longer continue production Whether the imported registered products need to be cancelled actively

answer according to regulations way And cosmetics registration and filing,No longer produce Imported products,The filing person can actively apply for cancellation on the filing platform.The recorder's initiative to cancel the product is conducive to safeguarding consumers' right to know,At the same time, it improves the efficiency of the regulatory department.Products applying for active cancellation,If there is no violation of laws and regulations,Relevant products listed before cancellation of filing information,It can be sold until the end of the warranty period.The cancellation of the record by the regulatory authorities is a punitive measure for illegal acts,according to regulations Article 65,The products cancelled by the filing department shall not be sold on the market from the date of cancellation of the filing Import,Still on sale Import of the product,The regulatory authorities will punish them in accordance with the law.


It is suggested that the general cosmetics filer The domestic responsible person shall sort out the products that have been filed as soon as possible,Planned to continue production Imported,The annual report shall be submitted as required and relevant materials shall be supplemented No longer produce For imported products, it shall take the initiative to apply for cancellation of products for filing.Considering the process of connecting the old and new platforms,Some filers The domestic responsible person has not registered the new platform account,To better serve the enterprise,These filers The domestic responsible person may submit a written application for voluntary cancellation of the record to the local provincial drug regulatory department,The filing management department shall assist to complete the active cancellation and public information update of the registered products on the new platform,So as not to affect the continued marketing and import of relevant products.



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