Getting a US-approved medicine in Vietnam: the legal route, documents and timing
A sourced guide for patients, families and doctors in Vietnam, checked against Ministry of Health rules on 17 October 2026.
Reviewed by the Reserve Meds clinical operations team on 17 October 2026. Sources accessed 17 October 2026.
The short answer
In Vietnam, a medicine without Vietnamese marketing authorization can be imported for 'special treatment needs' under Decree 163/2025/ND-CP. This applies when no medicine with the same active substance, strength and form is authorized, when authorized supply is insufficient, or when effect differs, in cases such as emergencies, anti-rejection treatment or orphan medicines. Hospitals with a Medicine and Treatment Council can import for their patients.
- Regulator: Ministry of Health (Drug Administration of Vietnam).
- Main route: Import licence for medicinal products to serve special treatment needs.
- Who imports: A medical examination and treatment establishment with a Medicine and Treatment Council, or a licensed importer.
- Price: Quote on request.
Who regulates medicines in Vietnam
Medicines in Vietnam are controlled by the Law on Pharmacy and its implementing decrees. Decree 163/2025/ND-CP, dated 29 June 2025, details the import of medicines that do not have marketing authorization in Vietnam.[1]
The legal route for a medicine that is not registered in Vietnam
Under Article 54, an import licence for a medicinal product (except vaccines) for special treatment needs can be issued when no product with the same active substance, concentration or strength and dosage form has Vietnamese marketing authorization, when authorized products are not supplied in sufficient quantity, or when an authorized product has a different therapeutic effect. Qualifying cases include emergency, detoxification and anti-rejection use, and medicines on the list of orphan medicinal products.[1]
A medical examination and treatment establishment that has a Medicine and Treatment Council, and meets the Law on Pharmacy's conditions, may import medicines to serve the special treatment needs of its own patients. The decree also allows such medicines to be transferred to another qualifying establishment for its patients' special treatment needs.[1]
Documents you will usually need
Article 54 sets the criteria and the dossier. Our checklist for the hospital, mapped to those criteria:[1]
- The hospital's justification of the special treatment need, endorsed by its Medicine and Treatment Council
- Details of the medicine: active substance, strength, dosage form, manufacturer and country of manufacture
- Evidence that no equivalent authorized product is available, or that supply is insufficient
- Approval documents from the country of origin, such as the US FDA approval and label
Timing, quantities and fees
The decree sets the dossier and criteria; the processing time depends on the Ministry's handling of the application. We give a written timeline estimate once we see the hospital's file.[1]
How a US-approved medicine reaches a patient in Vietnam
First, confirm the medicine is approved in the US. FDA's Drugs@FDA database lists approved prescription medicines and links to the approved label.[2]
In Vietnam the treating hospital, or a licensed importer acting for it, applies for the special-treatment import licence. We provide the US approval and product documents and ship from the US through our wholesale partner to the licensed importer.
Once the local permission is in place, the medicine is bought from the US supply chain, packed for the temperature the label requires, and shipped to the named hospital, clinic or importer with the documents customs will ask for. Cold-chain medicines need a validated shipper and a temperature record for the whole journey.
If the medicine is a cell or gene therapy, the rules are different: these are usually given only at qualified treatment centers chosen by the manufacturer, so the realistic route is often treatment at a center abroad rather than import.[3]
Practical checks before you start
- Ask the treating specialist whether a registered alternative already exists in Vietnam. Most special routes only apply when it does not.
- Check whether the medicine is a controlled drug. Controlled medicines need extra permits in almost every country.
- Ask the hospital pharmacy whether it has handled this route before and who signs the application.
- Keep copies of every document and approval. Customs and the hospital will ask for them again at delivery.
How Reserve Meds helps
Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We help families and treating doctors understand the route, prepare the documents the regulator or hospital asks for, arrange supply from the US once approval is in place, and keep everyone updated. We do not diagnose, prescribe or decide what a regulator approves.
We coordinate access to FDA-approved medicines only. Investigational medicines are only available through a manufacturer's expanded-access program requested by the treating physician; we can explain that route, but we do not supply them. Your coordination fee is quoted in writing for your case before you commit. No hidden charges. We give you a written timeline estimate for your case before you commit.
Ask us about a medicine for a patient in Vietnam
Tell us the medicine, your country and a WhatsApp or phone number. We reply within one business day. On WhatsApp we usually reply the same day.
Frequently asked questions
Can a hospital in Vietnam import a medicine that is not registered there?
Yes, for special treatment needs under Decree 163/2025/ND-CP Article 54, if no equivalent authorized product is available or supply is insufficient, in qualifying cases such as emergencies or orphan medicines.
Which hospitals can import for their patients?
Medical examination and treatment establishments that have a Medicine and Treatment Council and meet the Law on Pharmacy's conditions.
Does this route cover vaccines?
No. Article 54's special-treatment licence criteria exclude vaccines.
Does Reserve Meds apply to the regulator for us?
No. The application is made by the person or institution the rules name, usually the treating doctor or hospital. We help prepare the paperwork, confirm the US approval and arrange supply from the US once permission is granted.
How much does it cost?
Quote on request. The total depends on the medicine, the dose, shipping, import steps and coordination. Your coordination fee is quoted in writing for your case before you commit. No hidden charges.
Sources for these answers: [1]
Sources
All sources were opened and checked on 17 October 2026. Rules and labels change, so the treating hospital or regulator confirms the current position before anything is filed.
- Vietnam Decree 163/2025/ND-CP detailing the Law on Pharmacy, Article 54 (via LuatVietnam English text) (accessed 17 October 2026)
- US FDA: How do I find out if a drug is approved? (accessed 17 October 2026)
- US FDA: Approved Cellular and Gene Therapy Products (accessed 17 October 2026)
Related
- All country guides
- Named-patient access, explained
- US expanded access (compassionate use)
- Answers to common access questions
- How cold-chain medicines are shipped
This page is general information, not medical or legal advice. It does not replace advice from your own doctor or the regulator.