The Drug Administration of Vietnam, operating under the Ministry of Health, has handed down administrative sanction decrees targeting two domestic pharmaceutical enterprises for failing to comply with mandatory regulatory procedures regarding product registration variations prior to market circulation. Both corporations faced aggravating factors as a result of executing identical regulatory infractions across multiple pharmaceutical products, and are legally required to settle their respective fines within a 10-day timeframe from receipt of the mandates.
The documented profiles covering the technical infractions and individual financial penalties feature:
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Nam Ha Pharmaceutical Joint Stock Company:
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Administrative Fines: An aggregate financial penalty of 125 million VND was imposed covering two distinct infractions (zero supplementary penalties or remedial directives were issued).
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First Infraction (Fined 90 million VND): The enterprise failed to complete regulatory procedures to amend or supplement marketing authorization certificates with competent state authorities, circulating pharmaceutical goods prior to securing formal approval for major variations and minor variations requiring pre-clearance. This non-compliance impacted 5 specific drugs: Codeforte, Naphacollyre, Mebendazol, Naphacogyl, and Nemydexan.
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Second Infraction (Fined 35 million VND): The company failed to execute mandatory notification workflows with state regulators regarding minor variations that demand pre-market notification. This infraction was isolated to 2 drug lines: Mebendazol and Naphacogyl.
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Minh Dan Pharmaceutical Joint Stock Company:
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Administrative Fines: A statutory flat fine of 90 million VND was handed down to the organization (exempt from supplementary administrative constraints or mandatory remedial actions).
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The Infraction: The corporation failed to carry out formal administrative filings to adjust or supplement marketing authorization certificates, and did not obtain required regulatory clearances before commercializing major variations or pre-approved minor variations. The systemic breach occurred across 3 individual drug products: Kali Clorid 500mg/5ml, Midantin, and Levofloxacin 750mg/150ml.
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Under prevailing administrative litigation laws, both corporate entities retain the legal right to file formal appeals or launch administrative lawsuits challenging the validity of the sanctioning decrees. Failure to voluntarily comply within the designated 10-day window will result in state-enforced compulsory execution in compliance with statutory frameworks.