On November 25, Dr. Ta Manh Hung, Deputy Director of the Department of Drug Administration (Ministry of Health) signed a decision to revoke the receipt number of the Cosmetic Product Declaration Form and suspend the circulation and recall of cosmetic products.
The Department of Drug Administration (Ministry of Health) has just decided to revoke 80 receipt packages of the Declaration and suspend circulation, recalling nationwide 162 cosmetic products manufactured and exported by MK Skincare Import-Export Production and Service Company Limited to put on the market. The reason is that the enterprise does not present the Product Information Document (PIF) as prescribed, posing a potential risk to the safety of users. MK Skincare Import-Export Production, Trade and Service Company Limited, address K31, Thoi An Residential Area, Le Thi Rieng Street, Thoi An Ward, Ho Chi Minh City - a business owned by Mr. Hoang Kim Khanh, Mrs. Mailisa's husband.
The reason for the revocation is clearly stated: The enterprise did not present the Product Information Document (PIF) to the competent authority as prescribed in Clause 2, Article 12 of Circular No. 06/2011/TT-BYT dated January 25, 2011 of the Ministry of Health and Article 71 of Decree No. 117/2020/ND-CP amended and supplemented by Decree No. 124/2021/ND-CP. PIF documents are mandatory documents, showing detailed information about the safety, quality and effectiveness of cosmetic products, serving post-inspection work.
In addition, the Drug Administration of Vietnam also decided to suspend the circulation and nationwide recall all outstanding batches of 162 cosmetic products according to the List in Appendix 2 attached to the Decision. These products are produced at many facilities in China such as Guangzhou Yrm Biotechnology Co., Ltd; Hong Kong Maika Biotechnology Limited; Guangzhou ODDIS Cosmetics Co., Ltd; Guangzhou Bolin Cosmetics Co., Ltd; Beiyue Pharmaceutical ( Guangdong) Co., Ltd; Guangzhou Huiying Cosmetics Co., Ltd; Guangzhou Zhengqi Medical & Biological Technology Co., Ltd... and are responsible for being launched by MK Skincare in Vietnam.
The suspension of circulation and revocation of the above products is determined as a remedial measure under Article 71 of Decree 117/2020/ND-CP, to ensure the safety of users, in the context of businesses not being able to provide PIF documents according to regulations.
The decision of the Department of Drug Administration clearly states the responsibility of the parties involved: MK Skincare Import-Export Production and Trading Service Company Limited must send a recall notice to all places distributing and using the product lots in the recall list.
Receive the returned product, recall, store and store all violating cosmetics until there is a opinion on the destruction by the competent state agency.
Report the results of the recall of these product lots to the Department of Drug Administration before December 15, 2025.
Business and cosmetic users nationwide must immediately stop trading and using product lots on the List of suspended and recalled products.
Return the product to the supplier.
The Ho Chi Minh City Department of Health is responsible for supervising MK Skincare Company in implementing the recovery.
Report the monitoring results to the Department of Drug Administration before December 15, 2025.
Departments of Health of provinces and cities nationwide: Notify cosmetic production, trading and use establishments in the area about the recall of products stated in the Decision.
Organize the reception of information and reports from facilities and users about recalled products.
Preside over and coordinate with competent authorities to handle violators according to authority and current regulations, and at the same time transfer the file to the law enforcement agency if there are signs of criminal violations.
The Drug Administration of Vietnam also recommends that consumers: Check the product name, receipt number of the Declaration Form (CBMP-QLD number) and the information of the responsible unit on the product label, compare with the Revocation Lists attached to the Decision.
Stop using immediately if the product in use is on the list of products to be revoked; contact the buyer to return it according to the instructions of the distributor/business.
Consider choosing cosmetic products with clear origins, validly announced, and prioritize products with transparent information about ingredients, manufacturers, and units responsible for bringing to the market.
