1. Why should an annual report system be set up for the notification of general cosmetics? 

Since the implementation of the online filing system (now “notification system”) for Chinese domestic non-special use cosmetics on June 30, 2014, more than 2.2 million submission applications have been received through the notification platform. Due to the imperfection of the original regulatory scheme and the functional limitations on the previous platform, the product information notified before the implementation of Cosmetic Supervision and Administration Regulation (CSAR) has been accumulated to the platform.

Among the notified products, some of them are no longer in production. The accumulation of these products’ information has brought great inconvenience to the supervision work and public inquiries. During the supervision work, it is also found that the notifiers of some products cannot be identified, which results in a failure to ensure products’ quality and safety. These products pose possible danger to consumers’ health and safety, and urgently need to be cleaned up by legal means.

The promulgation of CSAR and Administrative Measures on Cosmetics Registration and Notification (Measures) provides a solution. According to CSAR, cosmetics notifiers are responsible for the quality and safety of cosmetics. As for the specific requirement for annual report submission, every year notifiers of general cosmetics shall report production and import conditions as well as the compliance with laws and regulations, mandatory national standards and technical specifications to the medical products administration departments. For notified products that fail to submit an annual report within the required time limit, the regulatory authorities will order rectification within a time limit. If the rectification fails to be made as required, the notification will be canceled.

2. Why is it necessary to supplement relevant documents for notified and registered products?

Before the implementation of CSAR and related supporting regulations, the registration and notification documents submitted by enterprises through the previous platform were relatively simple. Take Chinese domestic product’s notification as an example. Except for the product’s formula information and sales packaging, other relevant documents were archived by enterprises for future reference. As a result, some necessary information about the product is missing on the platform, which incurs potential risks to consumers’ health and safety.

With an aim to tackle this problem, the Measures and related regulations stipulate that, the information of products in production that are registered or notified on the previous platform shall be supplemented. It should be noted that the required supplementary documents on the new platform are the documents previously archived by enterprises. In another word, there is no new requirement on product documents for registrants and notifiers.

To ensure a smooth transition, NMPA has set a reasonable transitional period for registrants and notifiers to complete the supplementation. The submission of supplementary documents is deemed as an indispensable step to proving the product’s compliance with CSAR and its supporting regulations. For a product whose documents has not been supplemented as required, the production and import shall not be continued until the supplementation is completed.

3. What is the difference between the notifier’s voluntary cancellation of the notification and the notification management department’s cancellation of the notification? Is it necessary for notifiers to voluntarily cancel the notified products that are no longer produced or imported?

For products that are no longer produced or imported, the notifier can voluntarily apply for the cancellation on the notification platform. For products applying for voluntary cancellation, if there is no violation of laws and regulations, the related products that have been put on the market before the cancellation can be sold until the end of their shelf life. In contrast, the cancellation by the regulatory authority is a punitive measure for illegal acts. According to Article 65 of CSAR, the product whose notification is canceled by the regulatory authority shall not be sold or imported from the date of cancellation. Otherwise, strict penalties will be imposed in accordance with the law.

It is recommended that the notifier and Chinese domestic responsible person of general cosmetics should sort out the notified products as soon as possible. For products they plan to continue producing and importing, they shall submit an annual report and supplement relevant documents as required. For products, they no longer produce or import, they should cancel the notification voluntarily.

In the process of connecting the old and new platforms, there are notifiers and Chinese domestic responsible persons who have not yet registered their accounts on the new platform. To voluntarily cancel the notification, they can submit a written application to the local provincial medical products department. The notification management department will assist in completing the cancellation and updating the public information on the new platform, so as not to affect the continued sales and import of related products.