What contract structure should we use with a Local Authorised Representative?

The core contract must cover: (a) scope of authority — which products, which categories, which markets, which channels; (b) liability allocation — who bears the cost of adverse-event handling, recalls, product-liability claims, sanctions under Decree 117/2020 or Decree 38/2021; (c) data ownership — the PIF or dossier belongs to the foreign brand but the LAR holds the copy submitted to the authority; (d) termination and transition — how the registration or notification transfers back to the brand or to a successor LAR, with a defined transition period (typically 6–12 months for drugs, 30–90 days for cosmetics); (e) audit and inspection rights — the brand's right to inspect the LAR's compliance records; (f) governing law and dispute resolution. In practice, most foreign brands use a bilingual English-Vietnamese contract with Vietnamese law and a Vietnamese arbitration seat (VIAC).

What are the liability exposures of a Local Authorised Representative?

The LAR is the principal for regulatory purposes and bears direct exposure to: administrative sanctions under Decree 117/2020/NĐ-CP (health-sector violations — fines up to VND 200 million and possible business suspension), Decree 38/2021/NĐ-CP (advertising violations), Decree 96/2020/NĐ-CP (customs and trade violations); product-liability civil claims from consumers; product recalls and the cost of executing them; loss of the registration or notification for repeated violations. Because the LAR is the direct legal counter-party, sanctions attach to the LAR entity, not the foreign brand — this is why contract-level liability allocation matters.

How does the Local Authorised Representative role differ across product categories?

Drugs require a Marketing Authorisation Holder (MAH) under Circular 12/2025/TT-BYT (from 1 October 2026: Circular 32/2026/TT-BYT); the MAH must be a Vietnamese-registered pharmacy business with a Certificate of Eligibility for Pharmacy Business (GCN ĐĐKKDD) or a registered foreign manufacturer with a Vietnamese representative office. Medical devices require a Vietnamese-registered entity as the registration holder under Decree 98/2021/NĐ-CP; Class C/D require additional post-market surveillance capability. Cosmetics require a Local Responsible Company (Doanh nghiệp chịu trách nhiệm) under Circular 06/2011/TT-BYT — lightest requirements. Supplements and food require a Vietnamese-registered entity as the declaration or registration holder under Decree 15/2018/NĐ-CP. Category-specific requirements are compared in the table above.

Reference · foreign companies

Vietnam Local Authorised Representative — a complete guide for foreign companies

Comparison of Local Authorised Representative / Local Responsible Company requirements across product categories (medicine, medical device, cosmetic, supplement, food) — contract structure, statutory liability, and the practical realities of switching representatives. Medibase does not provide Local Authorised Representative services — it is a RegTech platform providing reference guides and free diagnostic tools.

The requirements differ substantially by category

There is no single "Vietnamese Local Authorised Representative" role. Each of the five product categories has an independent regulatory framework with different qualification requirements, scope of liability, switching costs, and contract structures. What foreign brands call a Vietnamese Local Authorised Representative (LAR) actually maps to one of the following:

Marketing Authorisation Holder (MAH) — for drugs: Holds the giấy đăng ký lưu hành thuốc issued by DAV; bears post-market pharmacovigilance, variations, renewals, and recall responsibility.
Medical Device Registration Holder: Holds the số lưu hành issued by IMDA (Class C/D) or Sở Y tế (Class A/B); principal for post-market quality and recall under Decree 98/2021.
Local Responsible Company — for cosmetics: Holds the phiếu công bố sản phẩm mỹ phẩm filed with DAV Cosmetics Division; responsible for consistency between the notification and actual sales under Circular 06/2011.
Declaration or Registration Holder — for supplements and food: Files the self-declaration (tự công bố) or VFA registration under Decree 15/2018/NĐ-CP, depending on audience and product classification.
Importer of Record — for cross-border e-commerce channels: Appointed by Shopee, TikTok Shop, Lazada, Tiki, etc.; the platform assumes clearance and storage obligations.

Category	Local role	Key qualification	Switching cost	Primary basis
Medicine	Marketing Authorisation Holder (MAH)	Vietnamese pharmacy business with GCN ĐĐKKDD, or foreign manufacturer with registered VN rep office	High — 6–18 months	Luật 44/2024, TT 12/2025 (→ TT 32/2026)
Medical device	Registration holder	VN-registered entity; Class C/D needs post-market surveillance capability	Medium — number is indefinite (NĐ 07/2023) but change filing required	NĐ 98/2021, NĐ 07/2023
Cosmetic	Local Responsible Company	VN-registered entity — substantive business capacity	Low — 3–5 business days for re-notification	TT 06/2011 (as amended by TT 34/2025)
Health Supplement (TPBVSK)	Registration holder	VN-registered entity; VFA registration	Medium — holder change treated as re-registration	NĐ 15/2018 (NĐ 46/2026 suspended)
Food	Self-declaration holder	VN-registered entity — self-declaration filed with provincial authority	Low — self-declaration can be re-filed	NĐ 15/2018

Contract structure — what to specify

A standard LAR contract covers six areas: scope of authority, liability allocation, data ownership, termination and transition, audit rights, and governing law. In practice these may be consolidated into a single LAR contract or split between a Distribution Agreement and a separate Regulatory Agreement, depending on the partner structure.

Scope of authority: List which products, which categories, which markets, which channels (online/offline, public-hospital/retail, B2B/B2C) the LAR handles. SKU-level enumeration preferred.
Liability allocation: Specify who bears the cost of adverse-event handling, recalls, consumer claims, and administrative sanctions under Decree 117/2020 (health), Decree 38/2021 (advertising).
Data ownership: The PIF (cosmetics) or dossier (drugs/devices) belongs to the brand, but the LAR keeps the copy submitted to the authority. Specify the data-handover obligation on termination.
Termination and transition: Specify how the registration or notification transfers to a successor LAR or back to the brand, and the transition period (drugs 6–12 months, cosmetics 30–90 days). Bind the outgoing LAR to cooperation.
Audit rights: The brand's right to inspect the LAR's compliance records, pharmacovigilance records, and post-market surveillance records. Typically every 12 months or on event.
Governing law and dispute resolution: In practice most brands choose Vietnamese law with VIAC arbitration. International arbitration (SIAC, HKIAC) is possible but carries enforcement risk at the Vietnamese execution stage.

Frequently asked questions

What is a Vietnam Local Authorised Representative and why do foreign companies need one?

A Vietnam Local Authorised Representative (LAR) — variously called MAH for drugs, Local Responsible Company for cosmetics, Registration Holder for supplements — must be a Vietnamese-registered legal entity that (1) holds the registration or notification, (2) bears post-market liability including recalls and pharmacovigilance, (3) is the regulator's counter-party for the product's lifecycle, and (4) receives regulatory correspondence. Foreign companies without a Vietnamese subsidiary or representative office need a LAR because Vietnamese regulations require the registration to be held by a domestic entity capable of bearing these obligations.

Can a Vietnamese distributor act as our LAR?

Yes — but the distributor becomes both the commercial partner and the regulatory principal. The registration or notification is held in the distributor's name, so switching distributors requires re-registration or re-notification. For cosmetics (fast, cheap) this is manageable; for drugs the switching cost is 6–18 months of processing time and the potential loss of the priority date. Many foreign brands separate the two roles: they contract a specialised regulatory-affairs firm as LAR while keeping commercial distribution independent.

Does Medibase provide Local Authorised Representative services?

No. Medibase is a Regulatory Technology (RegTech) reference and tools platform, not a Local Authorised Representative. Medibase does not hold registrations or notifications on behalf of any foreign brand, does not act as MAH, does not act as Notification Holder, and does not accept regulatory correspondence for third parties. If you need a Local Authorised Representative, the options are: contract a Vietnamese distributor who takes on the role; contract a specialised regulatory-affairs firm; register a Vietnamese subsidiary (FIE) or representative office; or use a platform-appointed importer (cross-border e-commerce only).

What happens if we switch LARs?

The registration or notification is held by the current LAR and cannot be unilaterally transferred to a new LAR. The mechanism depends on category. For cosmetics: re-notification by the new Local Responsible Company (3–5 business days plus standard fees); the old notification is administratively cancelled. For drugs: transfer requires DAV approval of the new MAH — this is neither automatic nor guaranteed. In practice, most transfers happen at renewal (marketing authorisation expiry), when the new MAH files the renewal application in their name. Medical device: similar mechanism to drugs. This is why contract-level termination and transition clauses matter — the incoming LAR needs the outgoing LAR's cooperation on documentation transfer.

Drug registration process — MAH eligibility and GCN ĐĐKKDD requirements in detail
Medical device registration — Class A/B (Sở Y tế) vs. C/D (IMDA) split under Decree 98/2021
Cosmetic market entry — Local Responsible Company detail
Supplement market entry — LAR requirements for TPBVSK registration
Legal register — Index of all cited documents
Compliance tools — Ingredient checker, regulatory impact simulator