The Drug Administration of Vietnam, operating under the Ministry of Health, has officially handed down an administrative sanction decree targeting Minh Dan Pharmaceutical Joint Stock Company. The regulatory penalty was executed pursuant to Point c, Clause 3, Article 56 of Decree No. 117/2020/ND-CP, subsequently amended and supplemented under Point b, Clause 13, Article 2 of Government Decree No. 124/2021/ND-CP. The corporation is contractually and legally mandated to settle the financial penalty into the State Treasury within a strict 10-day timeframe upon receipt of the formal executive order.
The documented profile covering the technical registration infractions and affected pharmaceutical assets features:
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Administrative Non-Compliance: Minh Dan Pharmaceutical Joint Stock Company failed to carry out mandatory administrative filings to adjust or supplement marketing authorization certificates with competent state regulators. The enterprise commercialized and circulated the drugs and associated drug raw materials prior to securing required approvals for both major variations and pre-cleared minor variations.
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Impacted Pharmaceutical Product Registry: The systemic regulatory breach was explicitly documented across 3 localized drug assets:
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Kali Clorid 500mg/5ml: Active marketing authorization number 893110138825 (Legacy registration code: VD-23599-15).
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Midantin: Active marketing authorization number 893110391424 (Legacy registration code: VD25724-16).
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Levofloxacin 750mg/150ml: Active marketing authorization number 893115155923.
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Source: https://suckhoedoisong.vn/cuc-quan-ly-duoc-bo-y-te-xu-phat-duoc-pham-minh-dan-169260610070417777.htm