China Clarifies the Processing Measures on Cosmetic Notification and Registration

To further standardize the cosmetic notification and registration work, and push enterprises to implement their main responsibility, China National Medical Products Administration (NMPA) introduced several processing measures in August to provide cosmetic enterprises with direction.

1. Notification Management

On August 16, 2021, the NMPA's General Cosmetics Notification System (“new notification system”) issued a notice stating that from August 26, 2021, when applying for general cosmetics notification, only the legal person account has the permission to do the "notification information submission" step, while other handling person’s account do not have the authorization to submit the notification information. It means that for imported general cosmetics, only the domestic responsible person's (RP) legal person account is allowed to submit the notification information during notification.

The reason why NMPA adds this requirement is mainly in response to the phenomenon that some cosmetics companies choose to entrust third-party agencies or others as the agent to submit notification dossiers, due to the preparation and upload of cosmetic notification dossiers under the new regulations is more complicated and time-consuming than before. If errors or omissions occur in this process, there are likely to be problems of buck-passing and confused accountability.

Therefore, NMPA requires the legal person to be directly responsible for his products and restricts that only the "legal person account" has the permission to submit the notification information, which not only helps to define the responsible party accurately and reduce liability disputes, but also streamlines the government’s administrative procedures during post-market supervision. Meanwhile, this move also urges the RP and domestic notifiers to take their responsibilities, take the notification process seriously and attach importance to the submission of each notification dossier.

2. Registration Management

On August 20, 2021, NMPA administrative acceptance service hall introduced the following processing measures for special cosmetics with applications accepted by the original cosmetics administrative licensing and notification information management system (hereinafter referred to as the "original system"), without receiving a registration decision yet.

• For special cosmetics that have been accepted by the original system before May 1, 2021, but have yet to receive approval decisions, the National Institutes for Food and Drug Control (NIFDC) will continue the review per the procedures and principles stipulated in the Administrative Measures on Cosmetics Registration and Notification.

• The Smart Cosmetics Application and Review System (“new registration system”) was officially launched on May 1, 2021, and the original system will be permanently closed on November 30, 2021, with no service.

  For special cosmetics that have been accepted on the original system and have issued the review opinions of "re-review after dossiers supplementation," the applicant can continue the registration application by either of the following two ways:

  (1) Before November 30, 2021, applicants shall complete the dossiers supplementation in one time according to the specific review opinions received;

  (2) If the dossiers are not supplemented before November 30, 2021, the re-application of the special cosmetics shall be conducted in the new registration system after the original system terminates the registration application of the corresponding special cosmetics.

Stakeholders shall note that the time for registering special cosmetics on the original system is running short. It’s better to submit the supplementary dossiers as soon as possible and apply for approval before the old system closes.