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Drug and Cosmetics Registration

Imported special-use cosmetics Application process diagram

   Source��   outao

Imported special-use cosmetics Application process diagram:

 Approval procedures:
(I)Acceptance :
After the application is filed to the Administrative Acceptance Service Center, and the application dossier submitted is in accordance with the list in VI of this Notice, the format examination shall be conducted by the work staff of the Center in line with the "Regulations for Application & Acceptance of Cosmetics Administrative Approval" and relevant requirements. Where the application item is not subject to administrative approval according to law, a decision of non-acceptance shall be notified to the applicant immediately. Where the application item is not within the functions of the administrative authority, a decision of non-acceptance shall be made immediately, and the applicant shall be informed to launch the application to relevant administrative authority. Where in the application dossier, there are errors that can be corrected on the spot, the applicant shall be allowed to make the corrections on the spot. Where the application dossier is incomplete or does not meet the statutory format, the applicant shall be informed of all the supplements and amendments to be made once and for all on the spot or within five days. If the applicant is not informed within the above-mentioned period, the application shall be deemed as accepted from date of receipt of application materials. Where the application dossier is within the functions of the administrative authority, the application materials are complete and comply with the statutory format, or where the applicant has submitted all supplements and amendments in accordance with the requirements of the administrative authority, the application for administrative approval shall be accepted.

(II)Technical review :
CFDA Center for Health Food Evaluation shall organize relevant experts and technical personnel to conduct technical review for the application dossier within 90 days. If the applicant applies for re-examination of the technical review decision of proposed disapproval of administrative approval (Notice on disapproval of administrative approval), Center for Health Food Evaluation (CHFE) shall extend the timeline of technical review and organize experts for re-examination; when necessary, CHFE shall review the product again and issue the decision of technical review according the results of re-examination.

(III)Decision of administrative examination and approval :
CFDA shall complete the administrative inspection within 20 days after receipt of the technical review conclusions, and make decision for approval or disapproval of administrative approval according to law; if a decision cannot be made within 20 days, CFDA shall grant an extension of 10 days, and issue a "Notice on the Extension of Administrative Approval” to inform the applicant of the grounds for extension.

(IV)Delivery :
CFDA shall, within 10 days as from the decision of administrative approval, issue and deliver the related certificates for administrative approval.