Pharmaceutical Distribution & Retail in Vietnam

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 Pharmacy Business Eligibility Certificate. 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/ND-CP — which replaced the prior decree stack of Decree 54/2017/ND-CP, Decree 155/2018/ND-CP and Decree 88/2023/ND-CP for the pharmacy sector — and Circular 11/2025/TT-BYT, which amended in one sweep the three GxP circulars (Circular 02/2018 GPP, Circular 03/2018 GDP, Circular 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 pharmacy practising certificate that every responsible person on a Pharmacy Business Eligibility Certificate must hold. Any reference written before mid-2025 that cites Decree 54/2017 or Decree 88/2023 as the "current" decree is now outdated.

Scope of this page:

• The umbrella Pharmacy Business Eligibility Certificate: who must hold one, who issues it, what the dossier looks like, and how it interacts with the personnel-level pharmacy practising certificate.
• 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.
• Retail of drugs.
• Drug-storage services.
• Drug-testing services.
• Bioequivalence testing and clinical-trial services.

Each form requires its own Pharmacy Business Eligibility Certificate; a single legal entity operating in two forms (for example, a domestic manufacturer that also wholesales third-party products) must hold one eligibility certificate per form. Foreign-invested enterprises (FIEs) may hold eligibility certificates 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.

Pharmacy Business Eligibility Certificate — issuing authority:

• Ministry of Health, acting through the Drug Administration of Vietnam (DAV), issues the eligibility certificate for: manufacture, import/export, wholesale, drug-storage services, drug-testing services, bioequivalence testing, and clinical-trial services.
• The provincial Department of Health, or — under the 2024–2025 local-government restructuring — the equivalent specialised health authority under the provincial People's Committee, issues the eligibility certificate for every retail format: pharmacy, drug counter, commune health-station drug cabinet, and the dedicated retail outlets for medicinal materials, medicinal-material drugs and traditional drugs.

Core conditions to be granted an eligibility certificate (Article 33, Pharmacy Law):

• A facility compliant with the relevant GxP standard (GMP, GDP, GPP, GSP, GLP, or GCP).
• A responsible person who holds a valid pharmacy practising certificate of the matching scope — for example, a community pharmacy needs a responsible person with a pharmacy practising certificate at university-degree pharmacist level.
• Personnel with qualifications matching the business form.
• A quality-management system documented in standard operating procedures (SOPs). A Pharmacy Business Eligibility Certificate 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: 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 Pharmacy Business Eligibility Certificate until corrected.

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

• 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.
• Drug counter (drug shop). Responsible person may be a mid-level pharmacy worker (pharmacy technician with an intermediate diploma, or equivalent). Permitted only in communes, towns and townships outside provincial centres; the exact geographic scope is fixed in Decree 163/2025 and may be tightened by provincial DOH guidance. Permitted to dispense OTC and a defined subset of Rx drugs. Mandatory GPP.
• 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.
• Dedicated retailers of medicinal materials, medicinal-material drugs and traditional medicines. Limited scope of products; responsible person must hold a pharmacy practising certificate 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 Consolidated Text 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 pharmacy and drug counter 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 — pharmacy practising certificate: A natural-person professional licence required for every responsible person on a Pharmacy Business Eligibility Certificate and for personnel performing pharmacy practice tasks the Pharmacy Law reserves to certified persons. After 1 July 2025 the pharmacy practising certificate regime is governed by Decree 163/2025/ND-CP and Circular 31/2025/TT-BYT, replacing the earlier procedure in Decree 54/2017 + Circular 07/2018/TT-BYT. The provincial Department of Health of the applicant's place of residence issues the pharmacy practising certificate; 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/ND-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/ND-CP "on administrative penalties in the healthcare field". Sanctions range from warning and fixed-amount fines to suspension of the Pharmacy Business Eligibility Certificate and revocation of the pharmacy practising certificate 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.

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 Pharmacy Business Eligibility Certificate; Articles 24–26 govern the pharmacy practising certificate; 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: Consolidated Text 76/VBHN-VPQH (March 2026).

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

• Decree 163/2025/ND-CP — issued 29 June 2025, in force 1 July 2025. Replaces, for the pharmacy sector, the combined effect of Decree 54/2017/ND-CP, Decree 155/2018/ND-CP (pharmacy chapter) and Decree 88/2023/ND-CP. Sets the detailed Pharmacy Business Eligibility Certificate procedure, pharmacy practising certificate 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: Consolidated Text 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/ND-CP, including the pharmacy practising certificate application procedure, Pharmacy Business Eligibility Certificate application forms, 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/ND-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.

Primary law:

• Law on Pharmacy No. 105/2016/QH13 — https://vbpl.vn/boyte/Pages/vbpq-toanvan.aspx?ItemID=121413
• Law 44/2024/QH15 (amending Law 105/2016) — https://vanban.chinhphu.vn/?pageid=27160&docid=212466
• Consolidated Pharmacy Law — Consolidated Text 76/VBHN-VPQH (2026) — https://datafiles.chinhphu.vn/cpp/files/vbpq/2026/3/76-vbhn-vpqh.pdf

Decree:

• Decree 163/2025/ND-CP — https://vanban.chinhphu.vn/?pageid=27160&docid=214322

GxP Circulars:

• Circular 02/2018/TT-BYT (GPP) — https://thuvienphapluat.vn/van-ban/The-thao-Y-te/Thong-tu-02-2018-TT-BYT-quy-dinh-ve-Thuc-hanh-tot-co-so-ban-le-thuoc-326672.aspx
• Circular 03/2018/TT-BYT (GDP) — https://thuvienphapluat.vn/van-ban/The-thao-Y-te/Thong-tu-03-2018-TT-BYT-quy-dinh-ve-Thuc-hanh-tot-phan-phoi-thuoc-nguyen-lieu-lam-thuoc-326675.aspx
• Circular 36/2018/TT-BYT (GSP) — https://thuvienphapluat.vn/van-ban/The-thao-Y-te/Thong-tu-36-2018-TT-BYT-quy-dinh-ve-Thuc-hanh-tot-bao-quan-thuoc-nguyen-lieu-lam-thuoc-403509.aspx
• Consolidated GPP — Consolidated Text 11/VBHN-BYT (2025) — https://datafiles.chinhphu.vn/cpp/files/vbpq/2025/7/11-vbhn-byt.pdf

Implementing Circular:

• Circular 31/2025/TT-BYT — https://hethongphapluat.com/thong-tu-31-2025-tt-byt-huong-dan-luat-duoc-va-nghi-dinh-163-2025-nd-cp-huong-dan-va-bien-phap-de-to-chuc-thi-hanh-luat-duoc-do-bo-truong-bo-y-te-ban-hanh.html

Adjacent:

• Circular 18/2026/TT-BYT (special-control drugs) — see Medibase news article and the upcoming Special-Control Drugs reference page.
• Decree 117/2020/ND-CP (administrative penalties — healthcare) — https://vanban.chinhphu.vn/?pageid=27160&docid=201271

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/ND-CP, replacing the Decree 54/2017 + Decree 155/2018 + Decree 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 — Consolidated Text 76/VBHN-VPQH consolidates the Pharmacy Law including all Law 44/2024 amendments. Consolidated Text 11/VBHN-BYT (issued in July 2025) consolidates GPP.