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Pharmaceutical Distribution & Retail in Vietnam

Licensing for wholesalers, community pharmacies, drug shops, commune health-station drug cabinets, and traditional-medicine retailers under the post-1 July 2025 framework — the Pharmacy Business Eligibility Certificate (GCN đủ điều kiện kinh doanh dược), Good Distribution Practice (GDP), Good Pharmacy Practice (GPP), and Good Storage Practice (GSP), as reshaped by amended Pharmacy Law 44/2024/QH15 and Decree 163/2025/NĐ-CP.

Overview

Every commercial supply chain for medicines in Vietnam — manufacturer, importer, wholesaler, community pharmacy, drug shop, hospital pharmacy, commune-station drug cabinet, traditional-medicine retailer — must sit under a single licensing umbrella: the Giấy chứng nhận đủ điều kiện kinh doanh dược (Pharmacy Business Eligibility Certificate, hereafter "GCN ĐĐKKDD"). Distribution-stage compliance is then layered on top via Good Distribution Practice (GDP) for wholesalers, Good Pharmacy Practice (GPP) for retail outlets, and Good Storage Practice (GSP) for any establishment that warehouses finished pharmaceuticals or starting materials.

On 1 July 2025 the entire ground-layer regulation of this regime was reset: the amended Pharmacy Law 44/2024/QH15 (passed 21 November 2024) came into force together with Decree 163/2025/NĐ-CP — which replaced the prior decree stack of NĐ 54/2017/NĐ-CP, NĐ 155/2018/NĐ-CP and NĐ 88/2023/NĐ-CP for the pharmacy sector — and Circular 11/2025/TT-BYT, which amended in one sweep the three GxP circulars (TT 02/2018 GPP, TT 03/2018 GDP, TT 36/2018 GSP). Circular 31/2025/TT-BYT, also effective 1 July 2025, sets the implementing detail for Decree 163/2025 — including the procedure for the Chứng chỉ hành nghề dược (Pharmacy Practice Certificate, "CCHND") that every responsible person on a GCN ĐĐKKDD must hold. Any reference written before mid-2025 that cites NĐ 54/2017 or NĐ 88/2023 as the "current" decree is now outdated.

Scope of this page:

  • The umbrella GCN ĐĐKKDD: who must hold one, who issues it, what the dossier looks like, and how it interacts with the personnel CCHND.
  • Wholesale licensing and the GDP standard.
  • The four legally recognised retail formats and the GPP standard.
  • Storage operations and the GSP standard.
  • Post-licence obligations — drug traceability, prescription handling, antibiotic stewardship, special-control drug handling — that determine whether a licensed establishment stays in good standing.
  • Administrative sanctions for non-compliance.

Seven forms of pharmacy business (Article 32, Pharmacy Law 105/2016 as amended by Law 44/2024):

  • Manufacture of drugs / drug starting materials.
  • Import and export of drugs / drug starting materials.
  • Wholesale of drugs / drug starting materials (bán buôn).
  • Retail of drugs (bán lẻ).
  • Drug-storage services (dịch vụ bảo quản thuốc).
  • Drug-testing services (dịch vụ kiểm nghiệm).
  • Bioequivalence testing and clinical-trial services.

Each form requires its own GCN ĐĐKKDD; a single legal entity operating in two forms (for example, a domestic manufacturer that also wholesales third-party products) must hold one GCN per form. Foreign-invested enterprises (FIEs) may hold GCNs only for the forms the WTO commitment list and Vietnamese law permit them — notably manufacture and import, while direct wholesale and direct retail by FIEs remain restricted in practice.

GCN ĐĐKKDD — issuing authority:

  • Bộ Y tế, acting through the Drug Administration of Vietnam (Cục Quản lý Dược — DAV), issues the GCN for: manufacture, import/export, wholesale, drug-storage services, drug-testing services, bioequivalence testing, and clinical-trial services.
  • The provincial Sở Y tế (Department of Health), or — under the 2024–2025 local-government restructuring — the equivalent specialised health authority under the provincial People's Committee, issues the GCN for every retail format: nhà thuốc, quầy thuốc, tủ thuốc trạm y tế xã, and the dedicated retail outlets for medicinal materials, medicinal-material drugs and traditional drugs.

Core conditions to be granted a GCN (Article 33, Pharmacy Law):

  • A facility (cơ sở vật chất) compliant with the relevant GxP standard (GMP, GDP, GPP, GSP, GLP, or GCP).
  • A responsible person (người chịu trách nhiệm chuyên môn) who holds a valid CCHND of the matching scope — for example, a community pharmacy ("nhà thuốc") needs a responsible person with a university-degree pharmacist CCHND.
  • Personnel with qualifications matching the business form.
  • A quality-management system documented in standard operating procedures (SOPs). A GCN ĐĐKKDD does not carry a fixed expiry date set in Pharmacy Law 105/2016 itself; instead, it remains valid as long as the conditions continue to be met, and is subject to inspection. Whether Decree 163/2025 introduces a renewal cycle for any specific form is one of the points to confirm.

Wholesale (bán buôn thuốc): A wholesaler may sell drugs only to: licensed manufacturers using them as inputs; other licensed wholesalers; pharmacies and hospitals; and licensed retailers. Direct sale to end-consumers is prohibited.

The defining standard is Good Distribution Practice (GDP), set by Circular 03/2018/TT-BYT, as amended by Circular 09/2020/TT-BYT and most recently Circular 11/2025/TT-BYT. GDP covers: incoming-goods verification against the manufacturer batch certificate, temperature-and humidity-controlled storage zones, segregation of quarantined / rejected stock, FEFO outbound picking, transport validation, and a documented recall procedure. After 1 July 2025, GDP audits also verify integration with the national drug-traceability system and IT-system requirements for e-prescription handling where applicable .

The GDP audit is performed by DAV inspectors during initial certification and on a recurring basis. Findings are graded; major or critical findings can trigger suspension of the GCN ĐĐKKDD until corrected.

Retail outlets — four legal formats (Article 32.2.d, Pharmacy Law):

  • Nhà thuốc (community pharmacy). Responsible person must be a pharmacist (Bachelor of Pharmacy or higher). Permitted to dispense both prescription (Rx) and over-the-counter (OTC) drugs, traditional drugs, and medicinal materials. Mandatory GPP compliance.
  • Quầy thuốc (drug shop). Responsible person may be a mid-level pharmacy worker (dược sĩ trung cấp or equivalent). Permitted only in communes, towns and townships outside provincial centres; the exact geographic scope is fixed in NĐ 163/2025 and may be tightened by provincial DOH guidance. Permitted to dispense OTC and a defined subset of Rx drugs. Mandatory GPP.
  • Tủ thuốc trạm y tế xã (commune health-station drug cabinet). Operated by the commune health station; permitted to dispense a list of essential medicines fixed by the Ministry of Health. Subject to a lighter GPP equivalent appropriate to commune-station scale.
  • Cơ sở chuyên bán lẻ dược liệu, thuốc dược liệu, thuốc cổ truyền (dedicated traditional retail). Limited scope of products; responsible person must hold a CCHND in traditional medicine or medicinal materials.

GPP is set by Circular 02/2018/TT-BYT, as amended by Circular 12/2020/TT-BYT (since partially repealed) and Circular 11/2025/TT-BYT. A consolidated text is published as Văn bản hợp nhất 11/VBHN-BYT (2025). GPP covers: layout and minimum floor area; temperature and humidity control; segregation of expired or recalled stock; staff qualifications; a documented patient-counselling SOP; secure storage of special-control drugs (linked to the regime in Circular 18/2026/TT-BYT and Decree 163/2025); and full electronic transaction records that connect to the national drug-management database. Since 1 July 2025 every nhà thuốc and quầy thuốc must integrate with the national e-prescription / drug-traceability system that links pharmacy, hospital and health-insurance records.

Storage (Good Storage Practice — GSP): Set by Circular 36/2018/TT-BYT as amended by Circular 11/2025/TT-BYT. GSP applies to any establishment that warehouses finished pharmaceuticals or pharmaceutical starting materials in commercial volume — including manufacturers, wholesalers, importers, drug-storage service providers, and hospital central pharmacies above a volume threshold. GSP covers: warehouse zoning (receipt, quarantine, approved stock, rejected stock, returned/recalled, special-control vault); validated temperature-mapping; backup power for cold-chain; pest control; access control; and inventory records reconcilable to a continuous electronic ledger.

Personnel — Chứng chỉ hành nghề dược (CCHND): A natural-person professional licence required for every responsible person on a GCN ĐĐKKDD and for personnel performing pharmacy practice tasks the Pharmacy Law reserves to certified persons. After 1 July 2025 the CCHND regime is governed by Decree 163/2025/NĐ-CP and Circular 31/2025/TT-BYT, replacing the earlier procedure in NĐ 54/2017 + TT 07/2018/TT-BYT. The Sở Y tế of the applicant's place of residence issues the CCHND; the scope of practice on the certificate (community pharmacy, hospital pharmacy, wholesale, manufacture, traditional medicine, testing, etc.) dictates what business forms the holder may serve as responsible person for.

Post-licence obligations:

  • Drug source traceability — every box on the shelf must trace back through wholesaler invoice and manufacturer / importer batch to a valid registration number; mandatory electronic ledger from 1 July 2025.
  • Prescription handling — Rx drugs may be dispensed only against a valid prescription, recorded for the statutory retention period. E-prescription integration is mandatory in pharmacies above a category threshold.
  • Antibiotic stewardship — antibiotic sales without prescription remain the single most common compliance failure in Vietnamese retail; provincial DOH spot-checks are the primary enforcement mechanism.
  • Special-control drugs (narcotic, psychotropic, precursor, radioactive) — separate vault, separate logbook, and reporting under Circular 18/2026/TT-BYT and Decree 163/2025/NĐ-CP. See the Medibase Special-Control Drugs reference page for the full regime.
  • Pharmacovigilance — any establishment is required to report adverse drug reactions to the national centre. See the Medibase Pharmacovigilance reference page.

Sanctions for non-compliance: Administrative fines for breaches in the pharmacy sector are set in Decree 117/2020/NĐ-CP "on administrative penalties in the healthcare field". Sanctions range from warning and fixed-amount fines to suspension of the GCN ĐĐKKDD and revocation of the CCHND of the responsible person. Repeated breaches, dispensing of unregistered drugs, or trade in counterfeit medicines can trigger criminal liability under Article 194 of the Penal Code.

Key documents

Primary law:

  • Law on Pharmacy No. 105/2016/QH13 — passed 6 April 2016, in force 1 January 2017. The foundational statute for every pharmacy business in Vietnam. Article 32 lists the seven forms of pharmacy business; Articles 33–37 govern the GCN ĐĐKKDD; Articles 24–26 govern the CCHND; Chapter VII covers traditional medicine and medicinal materials.
  • Law No. 44/2024/QH15 — Law amending and supplementing a number of articles of the Pharmacy Law; passed 21 November 2024; effective 1 July 2025 (with limited clauses effective 1 January 2025). Consolidated text: Văn bản hợp nhất 76/VBHN-VPQH (March 2026).

Implementing decree (current — replaced the prior decree stack):

  • Decree 163/2025/NĐ-CP — issued 29 June 2025, in force 1 July 2025. Replaces, for the pharmacy sector, the combined effect of Decree 54/2017/NĐ-CP, Decree 155/2018/NĐ-CP (pharmacy chapter) and Decree 88/2023/NĐ-CP. Sets the detailed GCN ĐĐKKDD procedure, CCHND procedure, special-control drug regime, and information disclosure rules.

Circulars on Good Practices (post-July-2025 baseline):

  • Circular 02/2018/TT-BYT — Good Pharmacy Practice (GPP) for retail. Amended by Circular 12/2020/TT-BYT (partially repealed) and Circular 11/2025/TT-BYT. Consolidated text: Văn bản hợp nhất 11/VBHN-BYT (2025).
  • Circular 03/2018/TT-BYT — Good Distribution Practice (GDP) for wholesale of drugs and pharmaceutical starting materials. Amended by Circular 09/2020/TT-BYT and Circular 11/2025/TT-BYT.
  • Circular 36/2018/TT-BYT — Good Storage Practice (GSP). Amended by Circular 11/2025/TT-BYT.
  • Circular 11/2025/TT-BYT — cross-cutting amendment of GPP, GDP and GSP; effective 1 July 2025; introduced the integrated IT-system / e-prescription / drug-traceability obligations for retail and wholesale.

Circular implementing Decree 163/2025:

  • Circular 31/2025/TT-BYT — detailed implementation of Decree 163/2025/NĐ-CP, including the CCHND application procedure, GCN ĐĐKKDD application forms (Phụ lục I), inspection checklists, and transitional rules for businesses operating under prior decrees.

Adjacent regimes (cross-cutting):

  • Circular 18/2026/TT-BYT — special-control drugs (narcotic, psychotropic, precursor, radioactive). Relevant for any retailer or wholesaler handling these categories; see the Medibase Special-Control Drugs page.
  • Decree 117/2020/NĐ-CP — administrative penalties in the healthcare field; governs fines and suspensions for distribution / retail breaches.
  • Penal Code, Article 194 — criminal liability for manufacture, trade and dispensing of counterfeit drugs.

Source documents

Direct links to the official text on government portals.

Primary law:

Decree:

GxP Circulars:

Implementing Circular:

Adjacent:

Recent updates

21 November 2024 — National Assembly passes Law 44/2024/QH15 amending the Pharmacy Law 105/2016/QH13.

29 June 2025 — Government issues Decree 163/2025/NĐ-CP, replacing the NĐ 54/2017 + NĐ 155/2018 + NĐ 88/2023 stack for the pharmacy sector.

1 July 2025 — Simultaneous effective date: amended Pharmacy Law (Law 44/2024), Decree 163/2025, Circular 11/2025/TT-BYT (cross-cutting amendment of GPP, GDP, GSP), and Circular 31/2025/TT-BYT (implementing Decree 163/2025). Every pharmacy and wholesaler must integrate with the national e-prescription and drug-traceability system from this date.

March 2026 — Văn bản hợp nhất 76/VBHN-VPQH consolidates the Pharmacy Law including all Law 44/2024 amendments. Văn bản hợp nhất 11/VBHN-BYT (issued in July 2025) consolidates GPP.

Resources & links

Operational portals (submission, lookup, e-services):

  • Drug Administration of Vietnam (DAV) — https://dav.gov.vn — main agency site for circulars, decisions and notices on manufacture, wholesale, import and storage GCNs.
  • DAV public services portal — https://dichvucong.dav.gov.vn — online submission for GCN ĐĐKKDD (DAV-issued forms) and CCHND lookup.
  • DAV GCN ĐĐKKDD lookup — https://dichvucong.dav.gov.vn/congbocoso/index — public search for establishments holding a DAV-issued GCN.
  • Provincial Departments of Health — application portal for retail GCN ĐĐKKDD; see for example Sở Y tế Hà Nội (https://soyte.hanoi.gov.vn) and Sở Y tế TP. HCM (https://medinet.gov.vn).

Legal text portals:

  • Cổng thông tin điện tử Chính phủ — văn bản pháp luật — https://vanban.chinhphu.vn — primary publisher of decrees and consolidated texts.
  • Công báo điện tử — https://congbao.chinhphu.vn — Official Gazette (legal-effect date of every law, decree and circular).
  • Thư viện pháp luật — https://thuvienphapluat.vn — searchable archive of Vietnamese legal documents; working English translations of selected circulars.
  • Cổng pháp luật quốc gia (Bộ Tư pháp) — https://vbpl.vn — official national legal database, including Ministry of Health-specific subset (https://vbpl.vn/boyte).

Frequently asked questions

Which businesses must hold a GCN đủ điều kiện kinh doanh dược?

Every legal entity that engages in any of the seven forms of pharmacy business listed in Article 32 of the Pharmacy Law — manufacture, import/export, wholesale, retail, storage services, testing services, and bioequivalence / clinical-trial services. Operating without a valid GCN is a sanctionable breach and, where unregistered or counterfeit drugs are involved, exposes the responsible persons to criminal liability under Article 194 of the Penal Code.

Can a foreign-invested enterprise (FIE) hold a wholesale or retail GCN directly?

FIEs may hold GCNs only for the forms permitted under Vietnam's WTO commitment list and Vietnamese law — primarily manufacture and import. Direct wholesale and direct retail by FIEs remain restricted in practice; foreign sponsors typically operate through a Vietnamese-owned wholesaler or distributor partner. The exact scope under Decree 163/2025/NĐ-CP should be reviewed alongside the FIE's investment registration certificate.

What is the difference between a nhà thuốc and a quầy thuốc?

A nhà thuốc (community pharmacy) is led by a Bachelor-of-Pharmacy or higher pharmacist and may dispense any drug for which it holds authorisation, including the full range of prescription drugs. A quầy thuốc (drug shop) may be led by a mid-level pharmacy worker, is permitted only in communes, towns and townships outside provincial centres, and may dispense over-the-counter drugs and a defined subset of prescription drugs. Both require GPP compliance and a GCN ĐĐKKDD issued by the provincial Sở Y tế.

How long is a GCN ĐĐKKDD valid?

The Pharmacy Law 105/2016 does not fix an expiry date in the statute itself — a GCN remains valid as long as the underlying conditions (facility, personnel, quality system) continue to be met and the certificate has not been suspended or revoked. Whether Decree 163/2025/NĐ-CP introduces a renewal cycle for any specific form is a point to confirm against the decree's transitional provisions. Inspections by the issuing authority are recurring.

What changed on 1 July 2025?

Four instruments came into force on the same day: the amended Pharmacy Law (Law 44/2024/QH15), Decree 163/2025/NĐ-CP (replacing the prior decree stack), Circular 11/2025/TT-BYT (cross-cutting amendment of GPP, GDP and GSP), and Circular 31/2025/TT-BYT (implementing Decree 163/2025). The most operationally significant new obligation is mandatory integration of every wholesaler and every nhà thuốc / quầy thuốc with the national e-prescription and drug-traceability system. All prior references to NĐ 54/2017 or NĐ 88/2023 as the "current" implementing decree are now outdated.

Page changelog

2026-06-28: Initial publication. Reflects amended Pharmacy Law 44/2024/QH15, Decree 163/2025/NĐ-CP, Circular 11/2025/TT-BYT (GPP/GDP/GSP amendment) and Circular 31/2025/TT-BYT.

Effective from:
2025-07-01
Last reviewed:
2026-06-28
Page updated:
2026-06-28

Reference information only; not legal or medical advice.