The Drug Administration of Vietnam, operating under the Ministry of Health, has officially issued an administrative sanction decree targeting Domesco Medical Import Export Joint Stock Company. The regulatory enforcement was executed pursuant to Government Decree No. 117/2020/ND-CP and Decree No. 124/2021/ND-CP. The aggregate financial penalty imposed on the enterprise stands at 145 million VND, with a statutory mandate requiring the settlement of the fine into the State Treasury within a 10-day timeframe.
The documented profile covering the company’s administrative infractions and legal parameters includes:
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Failure to Notify Minor Variations Prior to Market Circulation: The corporation failed to complete mandatory notification procedures with competent state authorities regarding minor variations that require pre-market notification for drugs and drug raw materials. This compliance failure was documented for the pharmaceutical product Amoxicillin 500 mg (marketing authorization number: 893110910524).
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Failure to Register Major and Pre-Approved Variations: Domesco failed to execute required regulatory procedures to amend or supplement marketing authorization certificates, circulating pharmaceutical goods prior to securing formal approval for major variations and minor variations that demand pre-clearance. This offense impacted the product Dosulvon 8 mg (marketing authorization number: 893100405624).
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Distribution of Pharmaceuticals Outside Approved Commercial Scopes:
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The Infraction: The enterprise engaged in the unauthorized sale of the drug Glucofine 1000mg (marketing authorization number: 893110050300 / VD-33036-19) to 6 localized pharmacy stalls. These retail venues were verified to be operating completely outside the authorized commercial scope defined in their Certificates of Eligibility for Pharmacy Business.
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Aggravating Circumstance: Regulators officially handed down an aggravating factor against Domesco, citing that the company repeatedly distributed and sold prescription medications to unqualified medical retail establishments.
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