The Drug Administration of Vietnam (Ministry of Health) issued a decision to sanction administrative violations against Nam Ha Pharmaceutical Joint Stock Company with a total fine of 125 million VND due to many violations related to procedures for registration of changes and notification of changes for drugs circulating on the market.
According to the decision, Nam Ha Pharmaceutical Joint Stock Company, headquartered at No. 415 Han Thuyen Street, Nam Dinh Ward, Ninh Binh Province, has committed two violations in the field of drug management.
Specifically, the enterprise did not carry out procedures to register changes and supplements to the circulation registration certificate with competent authorities and had not been approved before circulation for 5 drug products including: Codeforte, Naphacollyre, Mebendazole, Naphacogyl and Nemydexan. These are cases of large or small changes but are subject to approval by state management agencies before putting products on the market.
The company also did not carry out procedures to notify the management agency for minor changes that must be notified before circulation for 2 types of drugs, Mebendazole and Naphacogyl.
The Drug Administration of Vietnam determined that both acts had aggravating circumstances due to being related to many drug products belonging to the same violation. For the first act, there were 5 drugs violating the same content; for the second act, there were 2 drugs violating the same content. The enterprise did not have mitigating circumstances.
On that basis, the management agency applied a fine of 90 million VND for the act of not registering changes and supplements to the circulation registration certificate as prescribed and 35 million VND for the act of not notifying minor changes that need to be notified before the drug is circulated. The total fine amount is 125 million VND.
According to the Drug Administration of Vietnam, regulations on registration and notification of changes in drug dossiers are aimed at ensuring the quality, safety and effectiveness of drugs circulating on the market. The enterprise's arbitrary implementation of changes without completing procedures according to regulations may affect state management in the pharmaceutical sector.
The Drug Administration of Vietnam also issued a Decision to sanction administrative violations against Minh Dan Pharmaceutical Joint Stock Company for failing to carry out procedures to register changes and supplements to the drug circulation registration certificate according to regulations before putting the product on the market.
According to the decision, Minh Dan Pharmaceutical Joint Stock Company, headquartered in Hoa Xa Industrial Park, Thanh Nam ward, Ninh Binh province, committed violations related to the circulation of drugs when it had not been approved by competent authorities for changes subject to registration.
Specifically, the enterprise did not carry out procedures to register changes and supplements to the circulation registration certificate for three drug products including: Kali Chloride 500mg/5ml, Midantin and Levofloxacin 750mg/150ml. These are cases of large or small changes but subject to approval by state management agencies before circulation.
Based on the provisions of Decree No. 117/2020/ND-CP of the Government on sanctioning administrative violations in the field of health (amended and supplemented), the above act is identified as a violation of regulations on drug registration and circulation.
The Drug Administration of Vietnam said that the company has an aggravating circumstance due to jointly committing violations against three types of drugs. There is no mitigating circumstance applied in this case.
On that basis, functional agencies decided to fine Minh Dan Pharmaceutical Joint Stock Company 90 million VND. The penalty level was determined from the penalty frame for individuals at 45 million VND after considering aggravating circumstances; according to regulations, the penalty level for organizations is equal to two times the penalty level applied to individuals.
