Zhejiang Details Provincial Implementation Regulations for Filing of First-Imported Non-Special Cosmetics

• Registration of first imported cosmetics to NMPA will be entirely replaced by filing to the provincial MPA from Nov. 13 in Zhejiang.
• Domestic responsible person located within the administrative jurisdiction of Zhoushan city shall complete filing to Zhoushan Market Supervision Administration.
• Domestic responsible person located outside Zhoushan in Zhejiang shall complete filing to provincial MPA.
• Unlike the filing system used for domestically manufactured goods “special filing” of first-imported general cosmetics does not entail any reduction in regulatory compliance requirements. Safety and efficacy data generated from animal testing is still required.

Following China National Medical Products Administration’s (NMPA) announcement to implement filing system of first imported non-specials cosmetics nationwide, on Nov. 13, Zhejiang Medical Products Administration (MPA) first released its practical provincial enforcement rules along with a detailed filing service guidance, stipulating post-reform regulatory requirements for cosmetic stakeholders.

Crucial provisions of the announcement are listed below:

1. Domestic responsible person (RP) registered within the administrative region of Zhejiang province are required to file with provincial MPA rather than apply for registration of first imported non-specials cosmetics to NMPA from Nov. 13.

ChemLinked Interpretation:

Registration of a domestic responsible person is available throughout the province, with no regional/geographical restrictions.

2. Foreign manufacturers shall designate a domestic responsible person and authorize the RP to file a record via online filing system at the administration website of NMPA prior to import. The step-by-step filing instructions are detailed in the service guidance*.

3. After online dossiers submission, RP located within the administrative jurisdiction of Zhoushan city shall complete filing to Zhoushan Market Supervision Administration; RP located outside Zhoushan in Zhejiang shall complete filing to provincial MPA. Information of the acceptance offices are:

• Accepting hall at No.27 Wenbei lane, Moganshan road, Hangzhou, 0571-88903246;
• Accepting window of Zhoushan Market Supervision Administration, 0580-2299279/0580-2283236.

ChemLinked Interpretation:

Two acceptance windows—Zhoushan Market Supervision Administration and Zhejiang MPA are available for filing management in Zhejiang province. Practical operation of the updated filing system for enterprises who have previously filed at the Zhoushan FTZ is the same.

4. RP registered outside Zhejiang intending to import filed products through ports in Zhejiang shall supplement relevant information about the new import port and the consignee through online filing system.

ChemLinked Interpretation:

There is no restriction of import port and RP’s registration location after the reform.

5. Applicants whose application of registration for first imported non-specials cosmetics has been accepted by NMPA, or who haven’t obtained registration approval prior to the announcement are permitted to apply for filing as required by this announcement, except for products rejected for safety reasons.

6. RP shoulders shall be liable for the control of product quality and safety, management of import and operation as well as post-market supervision. Market supervision departments at all level shall enhance cooperation with relevant authorities such as the customs and strengthen in-market and post-market surveillance.

ChemLinked Interpretation:

RP’s obligations in respect of product traceability, adverse effect supervision are especially emphasized after the reform. Stakeholders shall be clear on the similarities and differences of responsible agent and responsible person and be prepared for the authorization of RP for their products.

ChemLinked’s Reminders

1. First imported non-special filing management of cosmetics aims to simplify pre-market procedures and facilitate market access. It is not designed to reduce regulatory compliance obligations associated with substantiation of product safety and quality. Animal testing and other safety-related data are still required.
2. The comprehensive product quality and safety management system including quality and safety source control, product traceability, adverse effect supervision and shall be established and integrated into the supply chain inside the company.

*Service Guidance for Filing of First Imported Non-Special Use Cosmetics Filing in Zhejiang

The guidance which is applicable to import cosmetic business specifies the filing conditions, required dossiers and their criterions, process and duration of filing for first imported non-specials cosmetics, coupled with filing renewal requirements, providing step-by-step instructions for stakeholders. Please contact us at [email protected] if translations are needed.