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On May 29th 2019, China National Medical Products Administration (NMPA) released an announcement detailing the renewal procedures for imported/domestic special-use cosmetics administrative license [1]. The announcement will be implemented on June 30th, 2019. Please contact us at [email protected] if translations are required.
Compared with the previous draft of Provisions for Renewal of Special-use Cosmetics License [2] released on Nov. 30, 2018, the renewal procedures for special-use cosmetics administrative license is further simplified and the review process will be sped up significantly. 4 main changes are as follows:
1. The renewed administrative license will be issued after applicants conduct product self-inspection and make a commitment to product compliance
New Procedures:
☆ First step: 6 months prior to the expiry date of product license
Applicants intending to extend the validity of domestic/imported special-use cosmetic license must apply for renewal after conducting product self-inspection.
☆Second step: 30 working days prior to the expiry date of product license
If the product passes the self-inspection, the applicant shall submit the self-inspection commitment report and application documents through NMPA Special-use Cosmetics Approval Platform.
*Renewal application will not be accepted if the previous license validity period is within the 30 days before expiration.
☆Last step: License issuance
After NMPA conducts a formal examination, the license will be renewed.
2. Product self-inspection report attaches great importance on the product manufacture and sales condition within the validity period of the previous license
Self-inspection report (Chinese template) should include the following 6 documents:
| 1. Consistency of product manufacture and registration data |
| 2. Summary of product change history and whether the product meets the current regulations and standards |
| 3. Confirmation product’s packaging and labels meet the current regulations and standards |
| 4. Confirmation product was manufactured or imported within the validity period of the previous license |
| 5. Conditions of enterprises’ adverse reaction monitoring system and treatment of product adverse reactions |
| 6. Product sampling inspection, punishment and recall. If the product has ever violated cosmetic regulations and/or relevant legally liable entity has been subject to punishment, an explanation in the form of a report must be provided. If during sampling inspection by authorities the product was shown to violate national requirements, then a report indicating that rectifications have been made to make the product compliant should be submitted. |
The announcement specifically states that in the case of products that have not been manufactured or imported within the validity period of the previous license, the applicant shall also conduct product re-examination and safety assessment, and submit re-examination report and safety assessment documents together.
3. The review period of license renewal is greatly reduced. Only 15 working days from application to renewed license issuance
☆ Within 5 working days: NMPA will conduct a formal examination on whether the application documents are complete and conform to the specified forms, and whether the product self-inspection is comprehensive or not.
☆ Within another 10 working days: If the application documents are complete and qualified, the renewed license will be issued in 10 working days. The validity period for a renewed license shall be counted from the date of expiration of the previous license.
4. Post-market technical review will be conducted after license renewal
NMPA Technical Review Department will conduct a post-market technical review on application documents after the issuance of the renewed license.
Technical review results | Measures |
Incomplete application documents or need further explanation | The applicants supplement documents within a specific timeframe |
Fake documents | The product license will be revoked |
A technical review will be jointly conducted by the NMPA Technical Review Department and provincial MPA. Provincial MPA shall strengthen the supervision on products with a renewed license.
If the products were found in violation of related regulations and standards, or the products’ manufacture is not consistent with the application documents, investigations will be undertaken and punishments will be imposed.
If the products’ license needs to be revoked, provincial MPA shall report to NMPA in time
Criteria for the application being rejected/returned or the license revoked
Under 5 conditions, the application documents will be returned | 1. incomplete documents |
Under 5 conditions, the license will be revoked | 1. Unauthorized product formula change |
Products previous license expires and the applicant does not receive the renewed license, the products cannot be imported or manufactured. If they were found on the market, violators will be subject to appropriate punitive measures.
Transitional Measures
The announcement will be implemented on June 30th, 2019. The transitional measures are as follows:
Conditions | Measures |
Apply license renewal before June 30th but the application is not accepted because of a requirement to supply additional documentation | The applicant shall reapply for license renewal before Sep. 1st, 2019 |
The application is accepted before June 30th but the technical review is not conducted | The applicant can choose to follow the original procedures or withdraw their application and reapply for license renewal before Sep. 1st, 2019 |
The application is accepted before June 30th and the technical review is ongoing | Follow the original procedures and requirements to complete the license renewal |
△Click here to see the answers for 7 FAQs on how the new requirement is implemented.
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