Importing medicines into Vietnam

The regulator

The Drug Administration of Vietnam (DAV) is the Ministry of Health department that handles drug registration, import licensing and quality. The Law on Pharmacy of 2016 was amended by Law 44/2024/QH15, and the amendments and the new implementing Decree 163/2025/ND-CP took effect on 1 July 2025, replacing Decree 54/2017. Circular 31/2025/TT-BYT followed on the same day. The Ministry published the new administrative procedures in Decision 2278/QD-BYT in July 2025.

Provincial People's Committees now play a larger role. Importers of registered drugs notify the committee at least 5 working days before the customs declaration, and some import licences for unregistered drugs move to the province under the decree's transition timetable.

Legal routes for unregistered medicines

Section 2 of Chapter 4 of Decree 163 lists the cases in which a drug without a Vietnamese marketing authorisation can be licensed for import. Article 62 sets the authority and the time for each, and the Ministry of Health publishes licensed imports on its website within 5 working days.

Special treatment needs

Article 54 is the closest fit for a hospital that needs a specific medicine. It applies where no registered drug with the same active ingredient, strength and dosage form is available, or supply is not enough, and the drug is for emergency care, an antidote, transplant rejection, a disease on the Ministry's rare disease list, or a specific patient with a Group A communicable disease, cancer, HIV, tuberculosis, malaria or another serious disease named by the Minister. The hospital writes a letter with the reason, the expected number of patients and the quantity, accepts full responsibility, and attaches stamped minutes of its Drug and Therapeutics Committee. Emergency and antidote requests can list the patients instead of the committee minutes. The Ministry of Health decides within 15 days of the receipt slip, 5 days sooner for rare, new or high-tech drugs.

Rare drugs

Article 55 covers drugs on the official rare drug list that are authorised in at least one country. The dossier is closer to a product file: a certificate of pharmaceutical product, the manufacturer's specification and test methods, foreign labels and a Vietnamese label and leaflet, and GMP evidence for every site. The review period is 60 days, or 90 days where clinical or comparability data are needed, shortened by 10 days for rare drugs.

Donations, trials and emergencies

Donated drugs and humanitarian aid (Article 57) and drugs for clinical trials, bioequivalence studies and test samples (Article 58) usually take 15 days. Urgent needs for defence, security, epidemics or disasters (Article 53) are decided in 3 or 7 working days.

Personal use

Article 60 lets a person entering Vietnam bring medicines for their own treatment in luggage, up to 30 days of use for non-controlled drugs, with a customs value of no more than 200 US dollars per receipt and 3 receipts a year, or higher limits for listed diseases. It requires the prescription and outpatient record. It does not cover a foreign supplier shipping to a patient by post or courier.

Documents a buyer usually needs

• Ministry of Health import licence, issued for the batch
• Import order forms and the importer's application
• Hospital letter, Drug and Therapeutics Committee minutes and the hospital's drug report
• Certificate of pharmaceutical product and GMP evidence (rare drug route)
• Manufacturer's specification, labels and leaflets with Vietnamese drafts
• Commercial invoice, packing list and certificate of analysis with matching names and quantities
• Air waybill

Timeline: a worked example

A provincial cancer hospital needs a medicine that has no registered equivalent in Vietnam for a group of patients.

Total: roughly 5 to 9 weeks from request to delivery. These are planning estimates, not published service times.

Shipping lanes from India

Vietnam Airlines links Hanoi and Ho Chi Minh City with Delhi, Mumbai, Bengaluru and Hyderabad, and other Vietnamese and Indian carriers fly further direct routes. Express courier service is usually 3 to 6 days for small, non-controlled parcels. Air cargo with a customs broker is usually 5 to 10 days including clearance at Noi Bai (Hanoi) or Tan Son Nhat (Ho Chi Minh City).

CIP and DAP are the usual terms, and FCA suits importers with their own forwarder. DDP is rarely practical because the licensed Vietnamese importer holds the licence and clears the goods.

Practical tips for buyers

• Check whether the medicine is on the Ministry of Health's rare drug list before choosing between Articles 54 and 55, since the dossiers and review times differ.
• Decree 163 sets remaining shelf-life rules at clearance, for example at least one third for products with a total shelf life of nine months or less, according to Tilleke and Gibbins.
• VAT on medicines for prevention and treatment is 5 percent under the VAT Law in force from 1 July 2025, according to Vietnam Briefing.
• World Bank WITS data shows MFN duty of 0 to 5 percent across HS 300490 lines in 2023. Check whether a lower rate applies under the ASEAN India trade in goods agreement with a certificate of origin.
• Keep the product name, strength and quantity identical across the licence, invoice and air waybill.