Ministry of Health revokes 80 receipt numbers of Cosmetic Declaration Forms violating MK Skincare

In Decision No. 695/QD-QLD signed by Mr. Ta Manh Hung, Deputy Director of the Drug Administration Department, on the revocation of the receipt number of the Cosmetic Product Declaration Form and the suspension of circulation and recall of cosmetic products, 80 receipt numbers of the Cosmetic Product Declaration Form previously issued by the Drug Administration Department to MK Skincare Import-Export Production, Trading and Service Company Limited (address K31, Thoi An Residential Area, Le Thi Rieng Street, Thoi An Ward, Ho Chi Minh City) were officially revoked.

The reason for the recall, according to the Drug Administration of Vietnam, is that the enterprise failed to present the Product Information File (PIF) - a mandatory document according to Circular 06/2011/TT-BYT and related regulations in Decree 117/2020/ND-CP, as amended by Decree 124/2021/ND-CP.

Also in this Decision, the Drug Administration of Vietnam suspends circulation and recalls nationwide all remaining batches of 162 cosmetic products listed in Appendix 2 attached to this Decision.

Reason for suspension and revocation: Implement remedial measures as prescribed in Article 71 of Decree No. 117/2020/ND-CP dated September 28, 2020, amended and supplemented by Decree No. 124/2021/ND-CP dated December 28, 2021, to ensure safety for users.

The Drug Administration requires MK Skincare Production, Trade, Service, Import-Export Company Limited to send recall notices to distributors and users of the above product batches; receive returned products from business establishments, recall product batches, quarantine and preserve the recalled cosmetic products until there is an opinion on destruction from the competent state agency.

Report the recall of the above cosmetic product batches to the Drug Administration of Vietnam before December 15, 2025.

Cosmetic businesses and users nationwide must immediately stop selling and using the above product batches and return them to the product supplier.

Ho Chi Minh City Department of Health supervises MK Skincare Import Export Production Trading Service Company Limited in recalling the above product batches. Report the supervision results to the Drug Administration Department before December 15, 2025.

The Drug Administration of Vietnam requests the Department of Health of provinces and cities to notify cosmetic businesses and users to recall the above-mentioned cosmetic products, organize the reception of reports from production and business establishments and users of recalled cosmetic products; preside over and coordinate with competent authorities to handle violators according to their authority and current regulations, and transfer files to law enforcement agencies for handling in case of criminal violations.

This Decision takes effect from the date of signing and promulgation - November 25. The Director of MK Skincare Import Export Production Trading Service Company Limited and the Directors of the Department of Health of provinces and cities are responsible for implementation.

Source: https://suckhoedoisong.vn/bo-y-te-thu-hoi-80-so-tiep-nhan-phieu-cong-bo-my-pham-vi-pham-cua-mk-skincare-169251125213749122.htm