On April 29, 2022, Zhejiang Medical Products Administration(MPA) issued an announcement on matters related to cosmetic notification management and production supervision, announcement details are as follows:
1. Supplement of product information on the original filing platform
According to the actual circumstances of prevention and control of the COVID-19 epidemic in Zhejiang province, the filing persons and domestic responsible persons who cannot submit the product implementation standards and other relevant materials of the products that have been filed on the original filing platform before May 1, 2022, can submit the materials before August 31, 2022. If the relevant materials cannot be supplemented before August 31 because of the impact of the epidemic, a situation statement should be submitted to the Provincial Drug and Cosmetics Review Center, and complete supplement in time after the impact of the epidemic is eliminated. In principle, the materials should be submitted before December 31, 2022. During this period, products can be produced, imported, and sold as normal.
If products are no longer produced or imported, the relevant filing persons and domestic responsible persons should take the initiative to cancel the filing information. The listed products before the filing information is cancelled can be sold until the end of the shelf life. Those who fail to supplement product materials on time shall be ordered to make corrections within a time limit according to the laws by local MPA, and shall not continue production or import until the supplement is completed. Those who fail to make corrections on time shall be dealt with in accordance with the laws.
2. Summary of efficacy claims basis of filed products
For cosmetics that have completed filing between May 1, 2021, and December 31, 2021, the relevant filing persons or domestic responsible persons, who fail to upload the summary of efficacy claims basis due to the impact of the epidemic, should complete the upload in time after the impact of the epidemic is eliminated. In principle, the summary should be uploaded before December 31, 2022. Those who fail to upload the summary shall be dealt with in accordance with the laws and included in the enterprise credit file.
3. Tolerance acceptance of cosmetic filing materials
If the filing person and domestic responsible person fail to provide filing materials with affixing seals, or temporarily fail to provide the domestic responsible person's authorization and its notarization, original written documents of GMP and other supporting documents of overseas cosmetics production due to the impact of the epidemic during the cosmetic filing process, the method of "Tolerance Acceptance" shall be adopted.
The filing person and domestic responsible person can first provide relevant copies or electronic versions of the documents, and attach a situation description confirmed by the legal representative (main responsible person) of the enterprise, then submit them to the filing platform. User rights will be opened in advance after the approval of the online review of the filing platform. Electronic versions of the documents with affixing seals and original written documents shall be uploaded and submitted in time after the impact of the epidemic is eliminated. Those who fail to upload and submit materials shall be dealt with in accordance with the laws and included in the enterprise credit file.
4. Qualifications of the person in charge of cosmetic quality and safety
Considering that the urgent needs of the current development of the cosmetics industry, and the principles of production or quality safety management of health-related products such as drugs, medical devices, and special foods are basically the same as those of cosmetics production or quality safety management, under the premise of the person in charge of cosmetics quality and safety with professional knowledge related to cosmetic quality and safety, its experience in the production or quality management of drugs, medical devices, and special foods can be regarded as experience in cosmetics production or quality and safety management.
5. Other matters
For special cosmetics that have previously completed registration, the information supplement or tolerance acceptance and other related matters shall be implemented in accordance with relevant regulations of China NMPA. If the renewal application of special cosmetic registration fails to submit the
application materials within the stipulated time due to the impact of the epidemic, a written description of the situation with corresponding certification materials shall be submitted to the provincial MPA, in accordance with the NMPA Announcement on Matters Related to Further Clarify the Management of the Original Special Use Cosmetics During Transition Period (No.150, 2021), and the provincial MPA will verify and issue written opinions in accordance with the relevant regulations.