The Drug Administration of Vietnam, operating under the Ministry of Health, has officially issued an administrative sanction decree targeting Agimexpharm Pharmaceutical Joint Stock Company. The regulatory enforcement was executed pursuant to Decree No. 117/2020/ND-CP, Decree No. 124/2021/ND-CP, and aligned statutory legal frameworks. The aggregate financial penalty imposed on the enterprise stands at 160 million VND, with a rigorous mandate requiring compliance within a 10-day timeframe.
The documented profile covering the company’s 3 distinct administrative infractions includes:
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Failure to Notify Minor Variations Prior to Market Circulation: The corporation failed to execute mandatory notification procedures with competent state authorities regarding minor variations that require pre-market notification for drugs and drug raw materials. This compliance failure impacted the following registered drug products: Agicipro, Agi-VitaC, Agiosmin, Agicarvir, Agoflox, and Agitritine 200.
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Failure to Register Major and Pre-Approved Variations: Agimexpharm failed to complete regulatory procedures to amend or supplement marketing authorization certificates, circulating pharmaceutical products before securing required approvals for major variations and minor variations that demand pre-clearance. This individual offense was documented across multiple products, including Agicipro, Datpagi 10, AgiVitaC, and others.
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Distribution of Pharmaceuticals Outside Approved Commercial Scopes: The company distributed and sold Agimetpred 4, Neomiderm, and Agimycob to retail establishments operating outside the authorized commercial scope defined in their Certificates of Eligibility for Pharmacy Business. Specifically, Agimexpharm supplied prescription medications and non-essential drugs to certain pharmacy stalls whose licensed retail parameters were legally restricted to the procurement and sale of essential and over-the-counter (OTC) drugs.
Source: https://suckhoedoisong.vn/cuc-quan-ly-duoc-xu-phat-duoc-pham-agimexpharm-169260604210125982.htm