China Details Cosmetic License Renewal Requirements

China Food and Drug Administration released the amended provisions for renewal of cosmetic license for public consultation. The consultation period will end on Dec 31.

In the past, there was only one clause in the Provisions for Application and Acceptance of Administrative Licensing for Cosmetics regulating the renewal of cosmetic license which stipulated that “Applicants intending to extend the validity must apply 4 months prior to the expiry date”. The new provisions adjust the deadline to apply for renewal and detail the application procedures and requirements.

New Provisions

1. To apply for renewal of a cosmetic license (including the filing certificate for imported non-special use cosmetics), applicants shall submit the application 6 months prior to the expiration date. Where there is a need to supplement additional documents due to incompliance, applicants must also submit the documents 6 months prior to the expiration date. If they fail to submit before the deadline or the supplemented documents are still incompliant, the application for renewal will not be accepted.

2. If applicants submit an application for modification, reissuance or correction of the license less than 10 months prior to the expiration date, they can submit the renewal application simultaneously. If they don’t apply for simultaneous renewal and then fail to submit the application before the deadline due to the additional application for modification, reissuance or correction of the license, the application for renewal will not be accepted.

3. The technical review of the renewal application will be completed within 3 months of receipt of the renewal application. Where there is a need to supplement additional documents due to incompliance, the applicant shall supplement the documents within 30 days of receipt of the notice of supplementation. If they fail to supplement before the deadline or the supplemented documents are still incompliant, the application will be disapproved.

Transitional Measures

1. For applicants that have already received the notice of document supplementation before the release of the new provisions, they shall submit the documents before Mar 1 2017 (unless the license is valid for at least 6 months). If they fail to supplement before the deadline or the supplemented documents are still incompliant, the application will be disapproved.

2. If an application for modification, reissuance or correction of the license is under review and examination before the release of the new provisions, the applicant shall submit the application for renewal within 15 days after obtaining the new license. Where there is a need to supplement additional documents, the applicant shall supplement the documents within 15 days of receipt of the notice of supplementation. If they fail to supplement before the deadline or the supplemented documents are still incompliant, the application will be disapproved.

3. From Sep 1 2017, cosmetics with expired license are prohibited from import and manufacture. Cosmetics manufactured or imported before the expiration date can be sold until the end of shelf life.