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 certificate. DAV issues for the central forms; provincial Department of Health issues for retail (pharmacy, drug counter, commune health-station medicine cabinet, traditional retail). Conditions are set in Article 33: matching GxP facility, qualified responsible person holding a pharmacy practising certificate, qualified staff, documented quality system.

• Pharmacy Law 105/2016/QH13 — Article 32 (forms) + Article 33 (conditions).
• Decree 163/2025/ND-CP — implementing procedure.