Foreign investors / FIE

A pharma FIE in Vietnam may hold drug-import rights — register marketing authorisations, import the finished product, and conduct technical promotion to healthcare professionals. It cannot perform wholesale or retail distribution in its own name. The wholesale step must be contracted to a Vietnamese-owned licensed wholesaler.

• Notify DAV (Cục Quản lý Dược) on every change of wholesale partner under Decree 163/2025/NĐ-CP Article 91 §12 (formerly Decree 54/2017 §12).
• Set up a representative office or a Vietnam-incorporated FIE subsidiary; both can hold MAs.
• Pharmacovigilance, recall coordination, and technical complaints remain FIE responsibilities.

Decree 163/2025/NĐ-CP Article 91 §12 (which replaced the same provision in Decree 54/2017) requires FIEs with import-only rights to notify DAV every time they add or stop a Vietnamese wholesale partner. Each notification (Công văn QLD-KD) carries a tabular appendix listing partner name, GDP certificate number, address, and effective date.

• Source listing: dav.gov.vn → "Cơ sở bán buôn thuốc của cơ sở có quyền nhập khẩu nhưng không được quyền phân phối" (cn97).
• Medibase keeps a re-aggregated view of these notifications at /search/foreign-drug-importers/.

Yes — a foreign manufacturer can hold the MA in its own name, provided it has a registered Vietnam representative office or contracts a Vietnamese legal entity as its authorised local representative. Under Law 44/2024/QH15 the MA-holder remains responsible for pharmacovigilance, labelling compliance, recall execution, and post-approval variations.

• A Vietnam representative office cannot itself import or sell the drug.
• An FIE subsidiary can both hold the MA and exercise the import right (but not distribution).
• MAs issued before 2025-07-01 may continue under the previous framework until renewal.

The pivot date is 2025-07-01, when Law 44/2024/QH15 (Pharmacy Law amendment) and Decree 163/2025/NĐ-CP both took effect together with the operational circulars (TT 31/2025 registration, TT 28/2025 GMP, TT 11/2025 GPP). Key derivatives:

• Renewal regime restructured (TT 12/2025/TT-BYT Article 12): the legal deadline is now simply "before the expiry date" — the 12-month lead-time from the old TT 08/2022 framework is gone. The 3-month threshold is the separate auto-extension qualification: if a complete renewal dossier is on file ≥ 3 months before expiry, the MA stays valid automatically while DAV reviews. After expiry, DAV no longer accepts a renewal — must apply as a new registration.
• Reference-dossier pathway opens for SRA-cleared products (faster timelines).
• Tender framework refreshed by TT 40/2025/TT-BYT (2025-10-25 in force).
• Special-control medicines: TT 18/2026/TT-BYT signed 2026-06-01, full effect 2026-07-16.

See /regulations/calendar/ for the complete dated timeline.

Vietnam deposited its accession to the 1961 Hague Apostille Convention on 2025-12-31; the Convention enters into force for Vietnam on 2026-09-11. For documents from any other signatory country (US, EU members, Japan, UK, Australia, etc.), a single apostille from the country of origin replaces consular legalisation at the Vietnamese embassy.

• Major simplification for Pharmaceutical Product Certificate (CPP), Free Sale Certificate (FSC), GMP certificates, and medical-device technical files.
• Translation into Vietnamese (sworn translation) is still required.
• Documents from non-signatory countries still need consular legalisation.

These are two different legal constructs that often coexist:

• MA-holder (chủ giấy đăng ký lưu hành) — the legal entity named on the Vietnamese Marketing Authorisation. Responsible for pharmacovigilance, labelling, recall, and variations. Can be the foreign manufacturer (with a Vietnam representative office) or a Vietnamese-registered FIE.
• Representative office (văn phòng đại diện) — a Vietnam-registered presence of the foreign manufacturer for liaison, marketing support, and regulatory communication. It cannot directly trade or invoice.

Many foreign drug companies hold the MA via the rep office while contracting an FIE subsidiary or local partner for the import/distribution chain.