Pharmacy Business Eligibility Certificate

The umbrella business-condition certificate required for every form of pharmacy business in Vietnam under Article 32 of the Pharmacy Law (105/2016/QH13 as amended by Law 44/2024/QH15) — manufacture, import/export, wholesale, retail, drug-storage services, drug-testing services, and bioequivalence/clinical-trial services. Each form requires its own GCN. DAV issues for the central forms; Sở Y tế issues for retail (nhà thuốc, quầy thuốc, tủ thuốc trạm y tế xã, traditional retail). Conditions are set in Article 33: matching GxP facility, qualified responsible person holding a CCHND, qualified staff, documented quality system.

• Luật Dược 105/2016/QH13 — Article 32 (forms) + Article 33 (conditions).
• Nghị định 163/2025/NĐ-CP — implementing procedure.