Drug Pricing and Price Declaration Duties After 2025-2026

The same box of medicine can differ by tens of thousands of dong between two pharmacies one street apart, but that does not make drug pricing in Vietnam a free market. Medicines are essential goods under sector price management: importers and wholesalers must declare expected wholesale prices before the drug reaches the market, retail prices are formed through distribution margins and must be publicly displayed at the point of sale, and the State keeps a price stabilisation power for abnormal market swings. After the 2025-2026 amendment round, comprising Law 44/2024/QH15 amending the Pharmacy Law and the new 2026 penalty framework, the duties of importers and distributors need a fresh review from the ground up, above all at the declaration step and in the sanction frame applied to pricing violations.

The architecture of drug price management: declaration, display and stabilisation

The Pharmacy Law 105/2016/QH13, as amended by Law 44/2024/QH15, devotes a set of provisions to drug price management built on three instruments. The first is price declaration: drug businesses declare expected wholesale prices to the management authority before selling the first batch onto the market, and re-declare whenever they raise the price or change the price composition basis. The second is price display at retail establishments and selling exactly at the displayed price, giving patients a comparison point and regulators an anchor for inspection. The third is drug price stabilisation in sharp market fluctuations or disease emergencies, when competent State bodies may apply measures such as specific prices or ceiling prices for a stabilised drug list. Importers and distributors stand at the centre of the first instrument, because the wholesale price they declare is the starting point of the whole price chain down to the patient.

The first misunderstanding to clear away is that declaration is not price approval: the authority does not pre-approve a specific price per drug the way it grants a licence, but receives the declaration, publishes the information and monitors the reasonableness of declared prices by comparison with similar drugs domestically, reference-country prices and input cost movements. The post-check nature of the mechanism does not lighten the declaration duty, however: selling a drug whose price was never declared, or selling above the declared price without re-declaring, are standalone violations, separate from whether the price level itself was reasonable. A company can be sanctioned for a declaration procedure failure while its price sits inside the market band, and that is precisely the commonest violation of importers newly entering the Vietnamese market.

Concrete duties of importers and of distribution and wholesale establishments

For each imported drug, the importer must declare the expected wholesale price to the pharmaceutical management authority before the first batch under that marketing authorisation is sold onto the Vietnamese market. The declaration shows the price composition elements, including the import price on its delivery terms, import duty where applicable, and the legitimate costs forming the expected wholesale price, giving the authority its comparison base when large movements occur. When the enterprise raises its wholesale price, the re-declaration duty arises before the new price is applied, with an explanation of the adjustment basis such as exchange rate movement, the manufacturer purchase price or logistics costs; a wholesaler buying the drug onward for distribution must likewise declare its own wholesale price under the same mechanism, so in a multi-tier distribution chain each wholesale tier carries its own declaration duty attached to its own price level.

The retail tier receives its duties at both ends. Its input side is anchored by retail margins and the retail price management frame for essential-list or sector-managed drugs, and its output side is the display duty: the pharmacy must display the retail price of each drug at the premises, sell at the displayed price and be able to show the price formation basis on inspection. A wholesale distributor operating an affiliated pharmacy network should note carefully that the distribution company wholesale declaration duty and each retail outlet display duty are independent duties of two different legal persons, even inside one group; standardising both layers inside a single internal process, with one price owner accountable for the whole chain, is how large distributors drive declaration errors to a minimum.

Sanctions for pricing violations: the current frame in Decree 90/2026/ND-CP

Administrative sanctions in the health sector, including violations of drug pricing rules, currently run under Decree 90/2026/ND-CP issued on 30 March 2026 and effective from 15 May 2026. At Article 66 of Decree 90/2026/ND-CP, the sanction frame covers drug price declaration violations such as failing to declare, declaring incorrectly or failing to re-declare on a price adjustment as required. This is the pinpoint businesses and advisers must use when looking up sanctions today: the earlier health-sector penalty instrument ceased to apply once Decree 90/2026/ND-CP took effect on 15 May 2026, so every internal lookup table, training deck or contract clause still citing the old penalty framework has to be updated, to avoid misjudging the risk level of a pricing violation in pharmaceutical company transactions.

Beyond the fine, pricing violations drag supplementary and remedial measures with more operational weight than the fine itself: being compelled to declare, re-declare and publish the correct price, being compelled to refund buyers the excess collected above the declared or displayed price, and, for repeat violations or violations inside hospital drug procurement, consequences that can spread into bidder qualification assessment and the enterprise capability record. For an importer whose drugs join centralised hospital tenders, the declared price is also a reference base for winning bid prices, so a divergence among three number sets, the price declared to the pharmaceutical authority, the tender price and the actual selling price, is a risk signal that both regulators and distribution partners will chase. Governing one single price data source consistently for all three uses is mandatory practice in pharmaceutical companies with a mature compliance system.

After the 2025-2026 amendments: what to re-audit inside the pricing compliance system

The 2025-2026 amendment round reaches enterprises in three concrete directions. First, the texts: Law 44/2024/QH15 amended and supplemented many provisions of the Pharmacy Law 105/2016/QH13 from 1 July 2025, and Circular 32/2026/TT-BYT, effective 1 October 2026, replaced Circular 12/2025/TT-BYT on marketing authorisation, changing the dossier backdrop of circulating drugs to which declared prices attach. Second, the sanctions: Decree 90/2026/ND-CP, applicable from 15 May 2026, is now the single frame to consult for drug pricing violations, and the principle that penalty law follows the time of the act requires enterprises to layer old and new violation files in every self-audit. Third, the data: transparency requirements for drug price information on the sector public service systems keep tightening, so enterprises need a process that updates declared prices in step with price changes inside the distribution system, instead of letting the sales department change prices first and legal declare afterwards.

A practical five-item audit list closes out the pricing risk of a typical importer-distributor: reconciling the catalogue of drugs on sale against the catalogue of declared prices to find anything sold before it was declared; checking whether every price increase in the last twelve months has a matching re-declaration with explanation; reviewing distribution contracts so that pricing clauses and declaration responsibility are allocated clearly between the importer and each distributor; updating every internal document still citing the old penalty framework to Decree 90/2026/ND-CP; and training the sales force on the line between lawful trade discounts and selling off the declared price, because most real-world pricing violations are born from sales decisions in the field, not from the legal department. Running these five items on an annual cycle turns the pricing duty from a passive risk into a provable part of the compliance system when the management authority inspects.

Frequently Asked Questions

What drug price declaration duties do drug importers and distributors have?

An importer must declare the expected wholesale price of a drug to the pharmaceutical management authority before selling the first batch onto the market, and re-declare before applying a wholesale price increase, with an explanation of the adjustment basis. A wholesaler distributing onward declares its own tier wholesale price as well. Declaration is a standalone procedural duty: selling an undeclared drug, or selling above the declared price, is a violation even if the price level is reasonable.

How are wholesale and retail drug prices managed after the recent amendments?

Wholesale prices are managed through the declaration mechanism plus reasonableness monitoring by comparison with similar drugs, foreign reference prices and input costs. Retail prices form from the wholesale price plus distribution margins under the management frame, and pharmacies must display prices and sell at the displayed price. After the 2025-2026 amendments (Law 44/2024/QH15 amending the Pharmacy Law, effective 1 July 2025), declaration, display and price stabilisation remain the three central instruments of drug price management.

How are violations of drug pricing rules sanctioned?

Drug pricing violations are sanctioned under the current framework of Decree 90/2026/ND-CP (issued 30 March 2026, effective 15 May 2026), where Article 66 provides sanctions for price declaration violations such as failing to declare, declaring incorrectly or failing to re-declare on a price adjustment. Beyond the fine, remedial measures include being compelled to re-declare the correct price and to refund buyers the excess collected.