While the new regulatory framework for cosmetics products is planned to be announced this autumn, new regulatory measures are already being implemented. One of the latest additions to the cosmetics regulation is the rather extensive list of requirements to the “responsible agent”. The responsible agent is a legal entity that carries the responsibility for the safety of the cosmetic products sold in China. No cosmetic product can be filed in China without a responsible agent and the decision of a responsible agent is thus the first step in a product filing process. Note that currently only products that are using the less restrictive filing system are required to have a responsible agent.
The extensive administrative roles and requirements to be conducted by the responsible agent have led many brands to consider providing their distributor with the role as responsible agent in China. This option may not be ideal as currently it is not possible at a later stage to transfer a product filing to another distributor, nor back to the brand owner. If the contract with a responsible agent is terminated – so is the registration. Our advice is to keep the ownership of the filings within the company (brand owner) by setting up a WFOE in China – or to use an agent who can host the filings in China on behalf of the brand owner.
RESPONSIBLE AGENT REQUIREMENTS IN MAINLAND CHINA
The filing of imported cosmetic products with the National Medical Products Administration (NMPA) requires a legal entity in China as well as a number of responsibilities and administrative tasks.
Requirements for a Responsible Entity:
- The actual office address of the company must be consistent with that of the business license and system registration information.
- The company should provide the Imported Goods Declaration Form
- The company shall be the domestic distributor of the filed products
- The company has signed a quality agreement with an overseas production company
- There is a quality management department or person in charge of the operations. The department has a “one-vote veto” on product quality and safety.
- The filed products of the operation are consistent with the details in the corresponding documents
- When the information of the filed product changes, the NMPA should be updated
- For products that have been filed, but are no longer being imported into China, all information and/or documents should be cancelled with the NMPA in good time
- When the NMPA inspects the company’s office after filing of their products, if a problem is found, the corresponding measures should be taken to rectify the issues
- The company should proactively cooperate with the supervision and inspection procedures of theregulatory authorities’ spot checks, and provide information and samples truthfully
- The company can only import cosmetics that are licensed or filed with the NMPA
- The company should always carry out their actions in compliance with the relevant laws and regulations
Responsible Entity Organisation/Structural Requirements:
- Establish a detailed job responsibility system and clarify job responsibilities for each person
- Establish an employee training system and implement it accordingly
- Establish a document management system to correctly keep relevant documents of the filed products and inspection organisations
- Establish a clear cosmetic purchase inspection system and implement it accordingly
- Establish a cosmetic purchase and sales flow account and record information truthfully
- Establish a storage system and ensure storage facilities (i.e. warehouses) are compatible with the cosmetics and store them correctly
- Establish a successful logistics system and implement it accordingly
- Ensure labels and advertisements of the company’s cosmetics comply with relevant laws and regulations of the People’s Republic of China
- Establish an internal product compliance check system that should be carried out at least once every six months. If products are found to have problems from this internal check, the company should know how to handle and take responsibility for these issues
- Establish a product safety incident handling system (quality management system) and implement it accordingly
- Establish a product traceability system
- Establish a compliant handling system and implement it accordingly
- Establish a cosmetics adverse reaction reporting system and implement it accordingly
- In the case of adverse reactions of the products, the company needs to establish an effective cosmetic risk analysis and problem recall system. The system should include of the problem product and the time limit for recall
For more information on the requirements for a responsible agent for cosmetic filing and distribution, please contact us on firstname.lastname@example.org