China Details Special-Use Cosmetic License Renewal Requirements

Takehome:
The draft provisions adjust the deadline to apply for special-use cosmetic license renewal to 4 months, detail the application procedures, documents necessary and requirements.

On Nov 30, 2018, China NMPA released the amended provisions for Renewal of Special-use Cosmetic License for public consultation. The public consultation will last until Dec 21, 2018. Any advice or suggestions can be submitted to NMPA by email at [email protected].

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”. Then on Sep 1, 2017, the Notice on Adjusting Requirements for Renewal of Cosmetic License was effective, stipulating the deadline to apply for renewal to 6 months.

Now the draft provisions adjust the deadline to apply for special-use cosmetic license renewal to 4 months, detail the application procedures, documents necessary and requirements.

1. Applicants intending to extend the validity of domestic/imported special-use cosmetic license must apply 4-6 months prior to the expiry date after conducting product self-inspection. The application documents shall be submitted to Provincial Medical Products Administration where the applicant (responsible agent in China) registered.

Provincial Medical Products Administration will no longer issue the opinion of product manufacture, marketing and supervision. The applicant’s self-inspection report will be taken into consideration in NMPA’s routine inspection, and NMPA will focus more on checking the authenticity of license renewal application documents.

The application documents include:

2. NMPA Administrative Matters Acceptance Department will make a decision on whether to accept the application within 5 working days. If the application documents are incomplete, NMPA will return all the documents and inform the reasons.

If the applicant fails to submit the complete application documents 4 months before the expiry date, NMPA will not accept license renewal application.

3. NMPA Technical Review Department will make a technical review conclusion based on the applicant's self-inspection report within 20 working days. NMPA will make the decision on whether to grant license renewal within 5 working days after the technical review conclusion.