The penalty decision detailed numerous violations by the company related to drug circulation procedures, business scope, and price declaration obligations.
The most serious violation involved Cuu Long Pharmaceutical circulating 10 types of drugs without completing the necessary procedures for changing or supplementing their registration certificates and without approval from competent authorities. This specific action resulted in the highest fine of 90 million dong.
Additionally, the company failed to inform regulatory bodies about minor changes requiring prior notification before circulating 8 other types of drugs, incurring an additional fine of 35 million dong.
The Ministry of Health also determined that the company sold Nootripam 800, containing 800 mg of piracetam, to establishments outside the business scope specified in its pharmaceutical business eligibility certificate. This violation led to a 35 million dong fine.
The two remaining violations included: failing to submit required reports on drug export and import activities, resulting in a 4 million dong fine; and not declaring prices for four essential drugs: Levocef 500, Cotrimxazon 960, Ovac-20, and Aecysmux Effer 200, which incurred a 25 million dong penalty.
The Ministry of Health has mandated Cuu Long Pharmaceutical to pay the full fine within 10 days of receiving the penalty decision. Should the company fail to comply voluntarily by the deadline, authorities will enforce coercive measures and impose an additional daily charge of 0,05% on the unpaid fine amount.
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One of the four drug types produced by the company for which prices were not declared. Photo: Cuu Long Pharmaceutical
Since the beginning of this year, the Ministry of Health has consistently recalled and destroyed substandard products while penalizing pharmaceutical companies for violations. This initiative reflects the regulatory body's intensified efforts to control the pharmaceutical and cosmetic markets, combating issues like counterfeit goods, low-quality products, and misleading advertisements, all aimed at protecting consumers.
Le Nga
