Many foreign investors ask: can a foreign-invested enterprise (FIE) open a retail pharmacy in Vietnam? The short answer is no — not directly. Vietnamese law sets out a closed list of rights for foreign-invested enterprises in the pharmaceutical sector, and retail sale of drugs is not on that list. This article explains the legal basis and the models FIEs are allowed to pursue in the pharma value chain.
1. Applicable Legal Framework (in force as of 14 October 2026)
- Pharmacy Law 105/2016/QH13 — still in force (consolidated in 76/VBHN-VPQH, 25 March 2026), amended by Law 44/2024/QH15 (effective 1 July 2025).
- Decree 163/2025/ND-CP guiding the Pharmacy Law (effective 1 July 2025) — fully replacing Decree 54/2017/ND-CP.
- Circular 31/2025/TT-BYT (effective 1 July 2025) — replacing Circular 07/2018/TT-BYT.
- Circular 02/2018/TT-BYT on Good Pharmacy Practice (GPP) — still in force, amended by Circular 11/2025/TT-BYT (consolidated 11/VBHN-BYT).
2. The Key Point: Article 53a of the Pharmacy Law — What Can FIEs Do?
Article 53a of the Pharmacy Law (added by Law 44/2024/QH15) sets out a closed list of rights for foreign-invested enterprises in pharmaceuticals:
- Acquiring drugs and drug ingredients via technology transfer;
- Importing drug ingredients for manufacturing under processing or technology-transfer contracts;
- Distributing (wholesale) drugs and ingredients imported, processed or technology-transferred by the enterprise itself;
- Importing and distributing drugs for humanitarian purposes and epidemic prevention.
Retail sale of drugs is absent from this list. Consequently, a foreign-invested enterprise may not directly open a retail pharmacy — it may only participate in manufacturing, import and wholesale distribution. This is consistent with Vietnam’s WTO commitments, under which pharmaceuticals are excluded from Vietnam’s distribution commitments.
A note of caution: the “no retail” conclusion rests on Article 53a’s closed list and WTO commitments — each specific model should be assessed with counsel before implementation.
3. Opening a GPP Pharmacy — The General (Non-Foreign) Case
For domestic investors, opening a retail pharmacy requires:
- A Certificate of Eligibility for Pharmaceutical Business issued by the Department of Health;
- A professionally responsible pharmacist: a university pharmacy graduate with 2 years of practice and a pharmacy practice certificate (Article 18(1), Pharmacy Law);
- Compliance with Good Pharmacy Practice (GPP) standards under Circular 02/2018/TT-BYT (as amended);
- Re-assessment of GPP compliance every 3 years (Article 33, Pharmacy Law).
Pharmacy Chain Model (new under Law 44/2024)
Law 44/2024 introduces the pharmacy chain model: an organization meeting Good Distribution Practice (GDP) standards for wholesalers, with at least 2 member pharmacies holding Certificates of Eligibility for Pharmaceutical Business, under a unified quality-control system.
4. How Can an FIE Participate in the Pharma Chain?
- Manufacturing: investing in a drug factory in Vietnam (meeting GMP);
- Import: importing drugs and ingredients under Article 53a rights;
- Wholesale distribution: wholesaling drugs and ingredients imported, processed or technology-transferred by the enterprise itself;
- Technology transfer and contract manufacturing: partnering with domestic pharma companies.
5. Common Pitfalls and Recommendations
- Nominee structures for retail: using a domestic entity as a front for an FIE-controlled pharmacy risks enforcement action if discovered.
- Misreading wholesale rights: the Article 53a wholesale right is limited to drugs/ingredients imported, processed or technology-transferred by the enterprise itself — not wholesale of any drugs.
- Letting GPP lapse: pharmacies (general case) are re-assessed every 3 years; failure can lead to revocation.
- Citing repealed texts: Decree 54/2017 was fully replaced by Decree 163/2025 from 1 July 2025 — dossiers and contracts must cite the new basis.
6. Frequently Asked Questions
Can a 100% foreign-owned company open a pharmacy?
Not directly. Article 53a of the Pharmacy Law (Law 44/2024) does not list retail sale among FIE rights; FIEs may participate in manufacturing, import and wholesale distribution.
How often must a GPP pharmacy be re-assessed?
Every 3 years, under Article 33 of the Pharmacy Law.
What qualifications must the responsible pharmacist have?
A university pharmacy degree, 2 years of professional practice and a pharmacy practice certificate (Article 18(1), Pharmacy Law).
Is Decree 54/2017 still in force?
No. Decree 163/2025/ND-CP fully replaced Decree 54/2017 from 1 July 2025.
7. Legal Sources
- Pharmacy Law 105/2016/QH13 (consolidated 76/VBHN-VPQH, 25 March 2026); Article 53a added by Law 44/2024/QH15 (effective 1 July 2025).
- Decree 163/2025/ND-CP guiding the Pharmacy Law (effective 1 July 2025).
- Circular 02/2018/TT-BYT on GPP (amended by Circular 11/2025/TT-BYT); Circular 31/2025/TT-BYT (effective 1 July 2025).
Validity status checked on 14 October 2026 via thuvienphapluat.vn.
Transparency Note
This article is for general reference only and does not constitute legal advice for your specific case. It has been quality-checked by FLAT’s AI Legal Council; it is not a conclusion reviewed by a licensed human lawyer.
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