Vietnam's Decree 163/2025 replaces Decree 54/2017 for drug imports

What changed

Vietnam's amended Law on Pharmacy and its implementing Decree 163/2025/ND-CP took effect on 1 July 2025. Tilleke and Gibbins reports that the decree was issued on 29 June 2025 and officially replaces Decree 54/2017/ND-CP, and that Circular 31/2025/TT-BYT followed on 1 July 2025.

For overseas suppliers, the main points are these:

• Import licences for unregistered drugs. Article 54 covers special treatment needs. A licence can be granted where no registered drug with the same active ingredient, strength and dosage form is available, or supply is insufficient. The need must fall in a listed case, such as emergency care, antidotes, transplant rejection, rare diseases, or a specific patient with cancer, HIV, tuberculosis, malaria or another serious disease named by the Minister.
• Time limits. Under Article 62, the Ministry of Health decides an Article 54 licence within 15 days of the receipt slip if no more documents are requested, 5 days less for priority categories. Licences for new drugs and rare drugs under Articles 51, 52 and 55 take 60 days, or 90 days where clinical or comparability data are needed, 10 days less for priority categories. The Ministry publishes licences for Articles 51 to 55 on its portal within 5 working days.
• Shelf life at clearance. Tilleke and Gibbins reports that drugs with a total shelf life of nine months or less must keep at least one third of it at customs clearance, and drugs with a shelf life of 30 days or less must still be in date.
• Advance notice. According to the same summary, import control now covers drugs with a Vietnamese marketing authorisation, with narrow exceptions, and importers must notify the provincial People's Committee at least five working days before the customs declaration. The Committee can flag non-compliance to customs.

The decree text was read on an unofficial consolidation, not the Official Gazette, so confirm details with the Drug Administration of Vietnam or a local agent.

Who it affects

• Vietnamese hospitals and licensed importers that request drugs without a Vietnamese marketing authorisation.
• Indian manufacturers and exporters that supply those drugs, since the dossier includes their signed commitments and licence documents.

What it means for buyers

The structure is familiar from Decree 54, but the dossier is specific. For an Article 54 licence, the hospital gives a letter with the reason, expected number of patients and quantity, and takes responsibility for use. It adds the minutes of its drug and therapeutics committee, except in some emergency and antidote cases, and a usage report. The foreign manufacturer and supplier sign a commitment on quality, safety and efficacy. Article 54 also refers to a certified and legalised copy of the foreign supplier's pharmaceutical business licence.

A request for more documents restarts the clock, so a complete first file matters more than the 15 day headline.

What to do now

1. Confirm with the importer which article of Decree 163 applies before quoting a lead time.
2. Ask the Indian supplier for the signed manufacturer and supplier commitment and a legalised business licence early, since legalisation takes time.
3. Check the remaining shelf life at the planned clearance date, especially for short-dated products.
4. For registered drugs, allow at least five working days for the importer's notice before the customs declaration.

For country details, see the Vietnam import guide and shelf-life requirements in medicine supply.