1. Does toothpaste need to be filed before being sold or imported?
The toothpaste needs to be filed before being sold or imported. According to the relevant regulations and rules, since December 1, 2023, domestic toothpaste should be filed with the provincial drug regulatory department where the notification person is located before it is put on the market for sale. Imported toothpaste should be filed with the National Medical Products Administration (NMPA) before being imported. For requirements of toothpaste notification in Beijing, please visit the official website of the Beijing Municipal Medical Products Administration to view the Beijing Municipal MPA Announcement on Matters Related to Toothpaste Notification (No.14, 2023).
2. For toothpaste products with simplified notification, what are the conditions that need to be met and what are the requirements for submission time?
Prior to the formal implementation of Cosmetics Supervision and Administration Regulations (hereinafter referred to as the Regulations) and the Measures for the Supervision and Management of Toothpastes (hereinafter referred to as the Measures), for marketed toothpaste products that have already had a certain history of production, sale, and use, and had not undergone any quality and safety related events and could fully prove their safety use history, given that their safety had been widely verified during product use, it is necessary to distinguish them from new products and simplify the corresponding notification requirements. From October 1, 2023, to November 30, 2023, the toothpaste notification person can submit simplified materials through the notification platform for the notification of marketed toothpaste products.
3. What information should be submitted for the simplified notification of toothpaste products?
Basic information of the toothpaste notification person. Including the notification person's name, address, contact information, etc. For entrusted production, the name, address, contact information, etc. of the actual production enterprise should also be submitted at the same time;
Basic product information. Including product name, product formula, label images of product sales package, etc.;
Relevant materials prove that the product has a safe use history. This includes but is not limited to the production and feeding records, sales invoices, inspection reports, and other relevant information since the product was launched, as well as the notification person's commitment to the safety of the product and the authenticity of the notification materials.
4. For toothpaste products with simplified notification, do I still need to submit complete product notification information?
For toothpaste products with simplified notification, the toothpaste notification person shall collect and complete the corresponding product notification information in accordance with relevant regulations and requirements before December 1, 2025. If the first batch of products is launched and sold before January 1, 2021, the product notification materials can be kept by the notification person for future reference; If the first batch of products are launched and sold after that, the notification person shall submit complete notification materials through the notification platform.
5. For toothpaste products with simplified notification, what are the requirements for label and efficacy claims in the transitional period?
For toothpaste products with simplified notification, if the content of the label complies with the requirements of the Regulations, Measures, and the Measures for the Administration of Cosmetics Labels, and only the format of the label needs to be standardized and adjusted, sales packaging labels for marketed products can be used during simplified notification, and product label updates should be completed as required by July 1, 2024. Except for toothpaste products that only claim to have cleaning effects, toothpaste products with the simplified notification should also upload and publish a summary of the basis of the product efficacy claims through the notification platform before December 1, 2025.
6. How to register and bind a toothpaste notification account?
The toothpaste notification person within Beijing should use the Toothpaste Notification Information Service Platform of NMPA. The notification person needs to log in to www.nmpa.gov.cn, register a legal person account in the "Government Service" column, and bind the "Toothpaste Notification Information Service Platform" in the "Account Settings" column; The registered person with an existing legal person account can directly log in and bind.
Note: Domestic toothpaste: Each provincial drug regulatory department can adopt an independent notification system, such as Guangdong Province; Beijing, Shanghai, Jiangsu, Zhejiang, and other provinces adopt the domestic toothpaste notification management platform of NMPA.
Imported toothpaste: all of them should be filed through the general cosmetics (imported toothpaste) notification management platform of NMPA.
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