Takehome:
According to ChemLinked' s exclusive information, Pudong Filing Management Trial has been expanded to all of Shanghai in the past few days.
For the convenience of importers, Shanghai has set up acceptance offices in every district to accept filing documents from the domestic responsible persons registered in Shanghai, which means responsible persons can submit filing documents to the acceptance office in their registration district of Shanghai. The review of filing documents is still conducted by Shanghai FDA.
Pudong filing management implemented cross-district supervision. For example, if the domestic responsible person is registered in Pudong new area, but the actual office address is in Shanghai Jing' an District, Shanghai FDA will go to the actual office address for verification after product filing. After Pudong filing management is expanded to the whole city, it is unknown whether cross-district supervision will continue or not because it will no longer be necessary for the domestic responsible person to be registered in Pudong. The domestic persons can register in their office area as long as the address is in Shanghai.
Requirements relating to filing dossier compilation, documentation and to domestic responsible person are the same as Pudong filing management. Currently, products are only allowed to be imported through Pudong port. It is hoped that other ports in Shanghai will be opened for import later.
On Oct 10, 2018, the State Council also issued a notice expanding first-imported non-special use cosmetics filing management nationwide and amending relevant provisions in Regulations concerning the Hygiene Supervision over Cosmetics. National Medical Products Administration (subordinated to SAMR) may not accept applications for first imported non-special use cosmetics administrative licenses after implementing filing management nationwide. Specific measures will be released before November 10, 2018.
After the implementation of filing management nationwide, what advantages will Shanghai and the other 10 free trade zones have? Will restrictions on cosmetics import ports still exist?
Review of the Procedures to Complete Imported Non-special Use Cosmetics Filing
After preparing the required materials, stakeholders need to entrust the domestic responsible person to submit the electronic version of the materials online through "Imported Non-special Use Cosmetics Filing Management Online System" and then submit the stamped paper materials to the acceptance office onsite. After one week of a preliminary review of application dossiers, cosmetics can be imported if approved. Formal technical review will be conducted within 3 months after filing.
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