Distributors & wholesalers

A Vietnamese drug wholesaler needs three core authorisations:

• Enterprise registration (giấy chứng nhận đăng ký doanh nghiệp) with the pharmaceutical business line.
• Eligibility certificate for pharmacy business (giấy chứng nhận đủ điều kiện kinh doanh dược) for the wholesale scope, issued by DAV or the provincial DOH.
• GDP certificate (Good Distribution Practice) for each warehouse, with separate sections for general, cold-chain, and special-control storage.

Add a GSP certificate for the warehouse storage standard, and a CCHND for the responsible pharmacist. All three are now consolidated under the Pharmacy Law 105/2016 as amended by Law 44/2024/QH15 (in force from 2025-07-01).

GDP is the Vietnamese standard for drug distribution operations — covering personnel qualifications, premises, equipment, documentation, complaint handling, recall, and transport conditions. Mapped from WHO TRS guidelines and aligned with PIC/S where applicable.

• Apply to the provincial DOH (Sở Y tế tỉnh) for domestic wholesalers; to DAV for FIE-serviced wholesalers and those handling special-control drugs.
• Pre-inspection is now standard; the certificate is valid 5 years.
• Renewal application opens 6 months before expiry per the Pharmacy Law framework.

The annual GDP self-assessment is also required and must be available on-site.

Two-way traceability is the core requirement under GDP and the Pharmacy Law:

• Incoming side — purchase invoices and shipping records linking each batch to the FIE's import licence and the MA number.
• Outgoing side — sales records linking each batch to the receiving healthcare facility or sub-distributor.
• Storage conditions during the time the batch was in your warehouse (temperature logs).
• The FIE will list you in its DAV notification (Công văn QLD-KD) under Decree 163/2025/NĐ-CP Article 91 §12 — keep a copy and any subsequent change notifications.
• Minimum retention: 1 year past product expiry, longer for special-control drugs.

Public-hospital drug tenders split candidates into 5 technical groups by origin, GMP standard, and bioequivalence — established by Circular 15/2019/TT-BYT and currently refreshed under Circular 40/2025/TT-BYT (in force 2025-10-25).

• Group 1: brand-name (biệt dược gốc) OR SRA + EU-GMP/PIC/S-GMP.
• Group 2: Vietnam-manufactured + EU-GMP/PIC/S-GMP.
• Group 3: imported WHO-GMP + bioequivalence proven in Vietnam.
• Group 4: Vietnam WHO-GMP + bioequivalence proven.
• Group 5: WHO-GMP, no bioequivalence.

Use the Medibase Tender Simulator at /tools/?tab=tender for a guided walk-through.

Recalls are graded I (serious), II (moderate), or III (minor). The MA-holder or its Vietnam representative co-ordinates the recall; you as wholesaler must:

• Stop further distribution within 24 hours of notification.
• Quarantine remaining stock in a clearly labelled area.
• Notify all downstream customers with batch and quantity details.
• Return or destroy stock per the MA-holder's instructions; obtain destruction certificate.
• File a closure report with DAV via the MA-holder within the stated deadline.

Search active recalls at /search/drug-recalls/ on Medibase, sourced from DAV cn89.

Circular 40/2025/TT-BYT was signed and took effect the same day, 2025-10-25. It preserves the 5-group framework first set by Circular 15/2019/TT-BYT, with refined wording in two areas:

• Tighter definition of "EU-GMP/PIC/S-GMP recognition" — must be the GMP cert covering the specific dosage form and manufacturing site.
• New mid-contract drug-substitution rules: a higher-tier drug can substitute a lower-tier one only with the procuring facility's formal approval and the same unit price.
• Clarification of what counts as a Vietnamese-recognised bioequivalence study for Groups 3 and 4.

No transition period — TT 15/2019 references in pre-existing tender packs remain valid until contract expiry.