Law 44/2024/QH15 amending Pharmacy Law 105/2016/QH13, effective 01/7/2025, is the largest framework change for the pharmaceutical sector in almost a decade. For FDI drug companies, three areas are directly affected — marketing authorisation, price management and distribution — and the registration procedure has just been re-framed from 01/10/2026. This article analyses what is already in force and what companies must do now.
Marketing authorisation: a newly replaced procedure
The amendment simplifies dossiers and shortens appraisal timelines for granting and renewing registrations, and adds priority mechanisms for innovative drugs and meaningful generics. At guidance level, Circular 32/2026/TT-BYT dated 29/7/2026 — effective 01/10/2026 — replaced Circular 12/2025/TT-BYT on registration of drugs and medicinal ingredients. In practice, dossiers prepared under Circular 12/2025 forms and process must be fully re-checked against the new framework, especially dossier classification, data requirements and appraisal sequence; citing Circular 12/2025 as current after 01/10/2026 misstates the law. Companies with large portfolios should build a per-registration table: remaining validity, renewal milestones under the new law and conversion filing plans.
Drug pricing and procurement
The amendment refines price declaration and listing mechanisms toward supply-chain transparency. Centralised drug procurement continues under the Bidding Law 22/2023/QH15 for public facilities; registration and declared-price changes feed directly into bid eligibility — an expired registration or an inconsistent declared price disqualifies at dossier evaluation. FDI companies selling through the ETC channel should synchronise three data sets: registration numbers, declared prices and historical winning prices, instead of letting each department keep its own version.
Distribution channels and online sales
The amendment opens a controlled framework for online retail of medicines, with tight conditions on eligible products, pharmacist consultation and traceability — an area where companies must track detailed guidance before designing operating models. GMP, GSP and GDP conditions in manufacturing, storage and distribution remain foundational; warehouse expansions or line changes must budget facility-appraisal time into product launch plans, not just registration timelines.
Recommendations
Prioritise three actions this quarter: audit the whole registration portfolio against Circular 32/2026/TT-BYT and schedule renewals; verify consistency between declared prices, listed prices and tender data; and update every internal document and bid dossier still citing Circular 12/2025 or the pre-amendment Pharmacy framework as current law. Specific appraisal timelines per dossier type should be checked directly against Circular 32/2026 forms and annexes when filing.
Frequently Asked Questions
What is the core change in the amended Pharmacy Law?
Law 44/2024/QH15 (effective 01/7/2025) simplifies marketing authorisation, adds priority for innovative and generic drugs, refines price management and opens controlled online sales. Current registration guidance is Circular 32/2026/TT-BYT, replacing Circular 12/2025 from 01/10/2026.
Which instrument now governs drug registration?
Circular 32/2026/TT-BYT, effective 01/10/2026, replacing Circular 12/2025/TT-BYT. Dossiers prepared under the old framework must be re-checked on forms, classification and appraisal sequence before filing.
How did drug price management change?
The amendment tightens declaration and listing toward supply-chain transparency. Companies must keep declared prices consistent with tender data — mismatch between the two is a common reason drug bids are rejected.
What is the impact on centralised drug procurement?
Bidding Law 22/2023/QH15 still governs drug packages at public facilities. The main impact runs through product eligibility: a valid registration and a consistent declared price are prerequisites, so renewal schedules must align with tender calendars.
This article has been quality-reviewed by the FLAW AI Legal Council