Drugs and Pharmaceutical Product Registration in Vietnam

Vietnam is one of the fastest-growing pharmaceutical markets in Southeast Asia. The sector is expected to exceed $10 billion in 2026, with foreign companies accounting for roughly half the domestic market.

Besides the local market, many multinational manufacturers are using Vietnam as an export base under the broader China+1 supply chain strategies. However, you need to navigate requirements imposed by the Drug Administration of Vietnam (DAV) under the Ministry of Health. 

Under the amended Law on Pharmacy (Law No. 44/2024/QH15), every product needs a marketing authorization from the Drug Administration of Vietnam (DAV). Furthermore, wholesale distribution and retail pharmacy sales remain exclusive to fully Vietnamese-owned companies. 

This guide walks through Vietnam's drug regulation framework. We break down how to register pharmaceutical products with DAV. We will also cover business structures foreign companies can use to navigate manufacturing, distribution, and market entry.

How Vietnam Regulates Drugs and Pharmaceuticals

The Drug Administration of Vietnam (DAV) under the Ministry of Health controls market access for every pharmaceutical product in the country. The agency is responsible for:

• Issuing marketing authorization
• Issuing import licenses
• Granting the Certificate of Pharmaceutical Product for exports
• Maintaining the register of recognized manufacturers. If your manufacturing site is not on that register, your product cannot be imported. 

The legal framework for pharmaceutical registration underwent a major overhaul in mid-2025. The National Assembly passed Law No. 44/2024/QH15 (amending the Law on Pharmacy), which took effect on 1 July 2025. Decree 163/2025/ND-CP replaced Decree 54/2017 as the main implementing guidance on the same date.

Three circulars now form the foundation of the registration process:

• Circular 12/2025/TT-BYT governs marketing authorisation. It sets out the dossier requirements, the review process, timelines, and the conditions for abbreviated and fast-track registration. It also introduced a reference assessment pathway for drugs already approved by the EMA or a Stringent Regulatory Authority, reducing the documentation burden for those products.
• Circular 28/2025/TT-BYT sets the updated Good Manufacturing Practice (GMP) standard. Any facility producing drugs for the Vietnamese market, whether domestic or foreign-owned, must be certified against this standard.
• Circular 11/2025/TT-BYT updated the rules for Good Distribution Practice (GDP) and Good Storage Practice (GSP). This applies to warehousing and logistics operations.

What the 2024 Reform Changed for Foreign Companies

Until the 2024 amendment, there was no clear statutory definition of what a foreign-invested pharmaceutical enterprise could do in Vietnam. Regulators relied on a broad catch-all clause that barred FIEs from "other acts related to distribution.”

For example, moving your own drugs from your warehouse to a wholesaler's facility counted as distribution, which would have been a violation. Law 44/2024 replaced that ambiguity with Article 53a, which clarified the list of activities for foreign-invested enterprises:

• Repurchase drugs and APIs manufactured in Vietnam through your own technology transfer arrangements.
• Sell drugs made under contract manufacturing or technology transfer to licensed wholesalers and to defined hospitals and treatment centres.
• Import API supplies for local manufacturers that hold technology transfer agreements with your enterprise.
• Import and sell drugs for humanitarian aid, disease prevention, and clinical trials.
• Transport products from your own GSP-certified warehouse to a domestic wholesaler's warehouse. This was the grey area the previous law left open. It is now explicitly permitted and no longer treated as distribution.

Foreign Ownership Rules in Vietnam’s Pharma Sector

Vietnam's pharmaceutical sector separates manufacturing and importation from distribution. Manufacturing and import are open to full foreign ownership. Meanwhile, distribution to pharmacies and retail pharmacy operations is not.

For a pharmaceutical investor, that means you can own your company outright, with no local partner and no ownership cap. What you cannot do, however, is build a wholesale network to pharmacies or open retail drugstores. Those activities are reserved for fully Vietnamese-owned companies.

The government determines what your company is allowed to do based on the VSIC code you register. If you register the wrong code, or include an overly broad activity description, it can stall your application.

Since foreign companies cannot distribute to pharmacies directly, the domestic distribution partner becomes the most important commercial relationship in your market-entry plan. In practice, most foreign pharmaceutical companies in Vietnam control the supply side. 

They decide what gets manufactured or imported, set the pricing, and own the brand. A licensed Vietnamese distributor then carries the product through its wholesale network to pharmacies and hospitals.

The terms of that distribution agreement matter as much as the product registration itself. Exclusivity, pricing, territory, and minimum purchase commitments are all negotiated between you and the domestic distributor. Getting those terms right is crucial, because once a distributor holds the relationship with pharmacies, switching partners can be slow and disruptive to your current operations.

Prerequisites for Drug and Pharmaceutical Product Registration in Vietnam

Before your products can be registered, you need to meet the following prerequisites:

1. A licensed entity to hold the registration
2. A qualified pharmacist
3. A Pharmacy Business Eligibility Certificate

1. Appointing a Local Representative or Licence Holder

Foreign companies cannot submit a marketing authorization application to DAV directly. The application must come from a Vietnamese entity that holds a Pharmacy Business Eligibility Certificate. There are two pathways to meet this requirement: 

1. Set up your own company
2. Appoint a third-party

If you take the company setup route, you would need to invest time and capital into the process. On the other hand, if you use a third-party entity, you can enter the market faster, but you won’t directly hold all licenses related to your products. 

Most multinational pharmaceutical companies entering Vietnam for the first time use this model to test market demand before committing to a local manufacturing investment.

2. Hire a Chief Pharmacist

Every pharmaceutical establishment in Vietnam must appoint a person professionally responsible for pharmacy who holds a valid practice certificate. This person oversees compliance with GMP and Good Storage Practice, and serves as the primary liaison with DAV.

Foreign pharmacists can also fill this role. Under Circular 31/2025/TT-BYT, they must demonstrate Vietnamese language proficiency or work with a registered interpreter. The employing company is legally responsible for interpreter compliance.

If you use an importer of record, the responsible pharmacist sits with the IOR entity. You do not need to appoint one separately.

3. Obtain the Pharmacy Business Eligibility Certificate

The Pharmacy Business Eligibility Certificate (GCN DDKKDD) is the Vietnamese equivalent of a licence to operate in the pharmaceutical sector. Without it, your company cannot apply for a marketing authorization. The requirements depend on the type of activity:

How to Register Drugs and Pharmaceuticals in Vietnam

Every drug sold in Vietnam needs a marketing authorization (drug registration number) from DAV. There are no exceptions, whether the product is locally manufactured or imported. The marketing authorisation is valid for five years. In some cases, such as drugs under extended safety monitoring, a three-year validity applies.

Vietnam classifies drug registrations into three types:

The standard route is the most common for foreign companies entering Vietnam. Below is a breakdown of how this works in practice.

Step 1: Prepare the Registration Dossier

The dossier must follow either the ACTD or ICH-CTD format. This is the same standardised framework used across ASEAN member countries. Core documents include:

• Certificate of Pharmaceutical Product (CPP) from the manufacturing country. Under Circular 12/2025, only one CPP is required. It must confirm the drug is licensed and currently marketed in the issuing country.
• GMP compliance certificate for the manufacturing facility
• Certificate of Analysis covering active ingredients and finished product
• Stability data appropriate to Vietnam's climate conditions
• Product labelling and packaging materials
• Clinical data demonstrating safety and efficacy, with defined exemption criteria for certain drug categories

Bear in mind that all documents must be translated into Vietnamese. Translating and legalizing them can take time and add to your overall cost. As your compliance partner, Emerhub can manage this along with the rest of your application on your behalf.

Step 2: Submit Application to DAV

The application is then submitted through DAV's online portal. Registration and document review fees are payable upon submission. Product samples must also be submitted to one of Vietnam's recognized drug testing institutes for quality testing.

For imported drugs, DAV verifies that the foreign manufacturing site appears on its register of recognized foreign manufacturers and suppliers. If the site is not on the register, the application will not proceed.

Step 3: Validation and Technical Review

DAV performs an initial completeness check, typically within 10 to 15 working days. If the dossier passes, it moves to technical evaluation.

At this stage, expert evaluators review the quality, safety, efficacy, and GMP compliance data. Should issues arise, DAV issues a request for additional data or clarification. The process is limited to two rounds of queries. A third round is permitted only in exceptional circumstances.

You generally have up to 6 months to respond to each query. If you fail to respond within that window, you risk voiding the application. Our local team can address these follow-ups promptly as your authorized partner. 

Once the evaluators are satisfied, the dossier goes to the Drug Registration Advisory Committee for final review. The committee recommends approval or rejection, and DAV issues the marketing authorization.

Step 4: Post-Approval Obligations

Before you can start selling or distributing your products, you must register the drug's price with the relevant authority. For imported drugs, a batch-level import permit is required for each shipment, and the first batch undergoes quality testing upon arrival. 

Ongoing obligations include:

• Pharmacovigilance and adverse event monitoring
• Periodic safety updates, 
• The submission of any post-approval variations. 

Renewal applications must also be filed before the marketing authorisation expires. If renewal is filed on time, the existing authorisation remains effective until DAV issues a decision.

Alternative Pathways for Product Registration (Abbreviated and Fast-Track Registration)

Not every product goes through the standard 12-to-24-month process. Circular 12/2025 and the amended Pharmacy Law introduced two shorter pathways for specific categories.

1. Abbreviated Registration

This applies to generic drugs that have already been approved by a recognised Stringent Regulatory Authority (SRA) or the European Medicines Agency (EMA). It also covers drugs included in national health programmes or centralised procurement lists.

The dossier requirements are reduced, and DAV accepts the foreign assessment report as supporting evidence. The dossier must be submitted within five years of the original approval date in the reference country. Part of its requirements must include a comparison table showing the similarities between the foreign-registered product and the one being submitted in Vietnam.

For contract-manufactured or technology-transferred drugs, DAV targets a three-month review if the drug already holds a marketing authorisation, or nine months if it does not.

2. Fast-Track/Priority Registration

This pathway is reserved for drugs that address an urgent public health need. The review timeline is significantly shorter than the standard route, typically three to six months. 

Eligibility is determined by DAV based on the public health justification. It covers three categories:

1. Orphan drugs: Medicines developed for rare diseases that affect a small number of patients. Because the commercial market for these drugs is limited, they often lack viable distribution in countries like Vietnam without a dedicated registration pathway.
2. Emergency products: Drugs needed for disease outbreaks or public health emergencies, where waiting 12 to 24 months for standard registration is not an option.
3. National programme drugs: Products required for government-led prevention programmes, such as vaccination campaigns or communicable disease control.

Work with Emerhub Vietnam on Your Pharma Market Entry

Emerhub supports pharmaceutical market entry in Vietnam from company setup through to product registration and ongoing compliance. We act as your importer of record where that is the right structure, or register the foreign-invested entity where you want to hold the licences directly.

Whether you are registering a single product or building a portfolio, your compliance starts with expert local insights. Our advisors can walk you through the most current requirements and pathways available to ensure a smooth entry. We can help you choose the right structure and get the prerequisites in place before your first dossier goes to DAV.

Get in touch with our team in Vietnam to get started. Fill out the form below for a free consultation.