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Law 44/2024/QH15 amends 50 articles, abolishes 2 points, 2 clauses, and 1 article of the 2016 Pharmacy Law, and adds 3 new articles. The reform addresses four structural gaps that had constrained pharmaceutical FDI in Vietnam:
1. FDI distribution rights liberalisation (Article 53 amendment) Prior to the amendment, foreign-invested enterprises (FIEs) could manufacture in Vietnam but were prohibited from wholesale distribution of self-imported drugs and drug materials, and from operating pharmacy chains (retail distribution networks). The 2024 law removes both restrictions. FIEs may now: (a) wholesale self-imported drugs and APIs they have brought into Vietnam; (b) acquire drugs and APIs manufactured under technology-transfer agreements with the same FIE and distribute them; and (c) operate pharmacy chains as a fully recognised business form.
2. Online drug retail legalisation The law formally creates online pharmaceutical retail as a distinct business category. E-commerce channels — including trading platforms, sales applications, and dedicated e-commerce websites with ordering functionality — may sell non-prescription drugs that are not specially controlled and not on the restricted-retail list. This regularises a channel that had operated in a legal grey zone and introduces a formal regulatory framework for digital pharmacy operations.
3. Special investment-incentive tier New pharmaceutical manufacturing investments meeting dual thresholds — registered capital ≥ VND 3,000 billion (≈ USD 118–120m at mid-2025 rates) and disbursement of ≥ VND 1,000 billion within three years — qualify for a dedicated incentive tier. Eligible project types include R&D of new medicines, original branded medicines, vaccines, and biological products. The incentive instruments (tax holidays, land-use fees, accelerated depreciation) are specified in Decree 163/2025/ND-CP.
4. Pharmacy chain as distinct legal form "Pharmacy chain" is codified as a separate pharmaceutical business type, distinct from individual retail pharmacies. This creates a clear regulatory basis for national and regional pharmacy-chain operators, including foreign-invested chains, to structure their Vietnam presence.
2020-07-21-india-pli-bulk-drugs-ksm-di-api) in intent — incentivising domestic manufacturing capacity in a sector with heavy import dependence — but executed as FDI liberalisation + investment-incentive rather than production-linked subsidy.