The problem: a great drug with no licence sells nothing
French pharmaceutical companies eyeing Vietnam face a market where hospital sales run through public tenders and every product needs a Vietnamese marketing authorisation before a single box can be sold. The registration queue is long, the tender rules are strict, and the price you declare follows you for years. Strategy beats speed here: the companies that plan the authorisation, pricing and tender sequence together win; those that chase each step separately stall.
The legal basis
- Marketing authorisation: drugs may only be circulated in Vietnam with a valid marketing authorisation (giay dang ky luu hanh) issued by the Drug Administration of Vietnam (DAV) under the pharmaceutical legal framework. The dossier must meet Vietnamese technical requirements — a French or EU authorisation does not substitute for it, though it supports the file.
- Public procurement: hospital drug purchasing runs under the Bidding Law 22/2023/QH15 (effective 1 January 2024) and its drug-bidding guidance — centralised and facility-level tenders with strict eligibility, technical scoring and price evaluation rules.
- Price management: declared drug prices are published and monitored; the declared price constrains tender participation and later adjustments. Declare strategically — a low entry price is hard to raise later.
- Distribution: wholesale and retail of pharmaceuticals require appropriate licences and GDP/GSP-compliant facilities; foreign-invested distributors operate within Vietnam’s committed market-access framework.
A market-entry sequence that works
Phase the entry. First, confirm the product’s classification and the exact DAV dossier requirements — innovative drugs, generics and biosimilars travel different tracks with different timelines. Second, run the price-declaration strategy in parallel with registration, not after: model the tender price bands you will need for the target hospitals and declare accordingly. Third, build the tender capability early — bid documentation, pharmacovigilance commitments and supply guarantees are scored, not just the molecule. Fourth, secure distribution: either a licensed Vietnamese distributor with hospital-tender experience or your own licensed operation, decided before the authorisation lands so launch is not delayed by logistics. Throughout, keep the French headquarters’ expectations honest about timelines: Vietnamese drug registration is measured in many months, and tender cycles add more.
Frequently asked questions
Can we sell while the marketing authorisation is pending?
No. Circulation without a valid authorisation is a violation. Plan launch timelines from the authorisation date, not the submission date.
Does an EU marketing authorisation speed up Vietnamese registration?
It strengthens the dossier and may support reliance pathways, but it does not replace the Vietnamese authorisation. Budget the full local timeline.
Are hospital tenders winnable for a premium-priced French drug?
Yes, where clinical differentiation is demonstrable and documented — tenders score technical merit alongside price. Premium without evidence loses to cheaper alternatives; premium with evidence wins its segment.
This article has been quality-reviewed by the FLAW AI Legal Council