The Drug Administration of Vietnam (Ministry of Health) has just issued a series of decisions to sanction administrative violations against many pharmaceutical enterprises nationwide for violating regulations on registration of drugs, drug ingredients and pharmaceutical business activities. The penalty level ranges from more than 100 million VND to 310 million VND.
Among the sanctioned enterprises, 2/9 Pharmaceutical Joint Stock Company (NADYPHAR), headquartered in Ho Chi Minh City, was fined 142.5 million VND. According to the Drug Administration of Vietnam, this enterprise did not carry out procedures to register changes and supplements to the circulation registration certificate with competent authorities before circulating drugs and drug ingredients for many products such as Kali chloride, Domperidon, Vigasmin 50mg, Ibuprofen, Dolnaltic and some pharmaceutical ingredients.
In addition, NADYPHAR also did not carry out procedures to notify changes for some drug ingredients that must be notified before circulation; and did not supplement or update information related to drug price declaration even if there were changes in the announced information. According to functional agencies, the company has many aggravating circumstances due to many batches of drugs and ingredients violating the same act.
In the same penalty period, SaVi Pharmaceutical Joint Stock Company was fined 175 million VND for many violations in pharmaceutical production and business activities. Violations include not registering changes and supplements to circulation registration certificates for many drugs and ingredients such as Masapon, SaVi Lansoprazole 30, SaVi Rosuvastatin 5, Paracetamol 500 and Rosuvastatin calcium ingredients.
This enterprise also did not carry out procedures to notify minor changes for some drugs and drug ingredients; and also purchased Ascorbic Acid raw materials from establishments without a certificate of eligibility for pharmaceutical business as prescribed.
Meanwhile, Hai Duong Pharmaceutical Medical Supplies Joint Stock Company was fined 185 million VND for a series of violations related to 10 types of drugs circulating on the market such as Hadulacton 25, Nacepil, Levofloxaxime, Famotidin, Skyld, Vitamin B12, Adrelido or BROMXIM.
According to the conclusion of the Drug Administration of Vietnam, this enterprise did not carry out procedures for registering changes and supplementing circulation registration certificates for major and minor changes that needed approval; did not notify management agencies for changes that must be notified before circulation; did not update information on labels and instructions for use of some drugs as required by the Ministry of Health.
In addition, the company was also determined to have sold drugs to establishments not in accordance with the licensed business scope when supplying Dimedrol 10mg/1ml to a pharmacy business household.
Another enterprise, An Thien Pharmaceutical Joint Stock Company in Ho Chi Minh City, was also fined 115 million VND for violations in the pharmaceutical sector.
Notably, the highest penalty in this phase belongs to Mediplantex Central Pharmaceutical Joint Stock Company with a fine of up to 310 million VND due to many violations related to pharmaceutical activities.
Not only sanctioning pharmaceutical enterprises, the Drug Administration of Vietnam also issued a document suspending circulation and recalling nationwide the batch of Antisun sunscreen cosmetic products of Tami Natural Home Pharmaceutical and Cosmetic Production Co., Ltd.
The recalled product is Antisun Sunscreen, batch number 0124DH, production date March 15, 2024. According to the Drug Administration of Vietnam, the reason for the recall is that the product has formula ingredients that are not consistent with the cosmetic declaration dossier that has been licensed.
The management agency requests the Departments of Health of provinces and cities to notify establishments trading and using cosmetics to immediately stop trading and using violating products; and at the same time proceed to recall, destroy and handle violating units according to current regulations.
For Tami Natural Home Pharmaceutical and Cosmetic Production Co., Ltd., the Drug Administration of Vietnam requires the enterprise to send a recall notice to the entire distribution system, receive returned products and complete the recall and destruction of substandard products. The recall result report must be sent to the Drug Administration of Vietnam before July 25, 2026.
The Drug Administration of Vietnam also requested the Tay Ninh Provincial Department of Health to strengthen supervision of the recall and destruction of enterprise products and report the results before July 30, 2026.
