Takehome: Non-special use cosmetic enterprises proposing to enter China from Hainan port can file directly with Hainan MPA.
Under China’s new cosmetic filing system , imported non-special use cosmetics are subject to filing management nationwide. The domestic responsible person (RP) located in 11 pilot free trade zones shall complete filing to provincial Medical Products Administration. While the RP located outside these FTZs in China shall complete filing to National Medical Products Administration (NMPA) after online dossiers submission.
On November 26, Hainan Medical Products Administration (Hainan MPA) announced that Hainan is the next province that is liable for filing the management of imported non-special use cosmetics within the jurisdiction.
As per the notice, specific requirements for filing management are as follows:
1. Starting from Nov. 26, domestic responsible person registered within the administrative jurisdiction of Hainan province can fulfill filing of first-imported non-special use cosmetics with Hainan MPA.
Information of the acceptance offices:
- Name: MPA Accepting window of Hainan Government Affairs Service Center
- Phone Number: 0898-65203119
- Procedures of Filing Management for First Import Non-special Use Cosmetics through Shanghai Pudong New Area (Interim)
- Service Guidance for the Filing of Imported Non-Special Use Cosmetic in Hainan
2. Domestic responsible person intending to import a filed product from more ports outside Hainan are required to supplement relevant information about the new import port and the consignee through online filing system.
3. Applicants whose application of registration for first imported non-specials cosmetics has been accepted by NMPA before the introduction of new filing policy, but have not yet been approved are permitted to apply for filing as required by this announcement, except for products rejected for safety reasons.
Products that have obtained administrative licenses for non-special use cosmetics shall be handled in accordance with the new policy.
4. RP shall establish a comprehensive product quality and safety management system to strengthen product quality and safety source control, product traceability and adverse effect supervision. Cosmetic supervision departments at all levels shall enhance cooperation with relevant authorities such as the customs and strengthen in-market and post-market surveillance.
Implications for stakeholders
The filing management of imported non-special cosmetics can significantly simplify pre-market procedures and facilitate market access. Imported cosmetics only require a maximum of 5 days to conduct a preliminary review and get approval after submitting product dossiers (provided all the dossiers are compliant and complete), which might took about 3 to 5 months previously.
It’s also worth noting that filing management is not designed to reduce regulatory compliance obligations associated with substantiation of product safety and quality. Animal testing and other safety-related data such as testing reports and safety assessments are still required.
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