The Amended Pharmacy Law 2024: A New Legal Framework for Pharmaceutical Businesses to Soar

On November 21, 2024, the National Assembly officially passed the Amended Pharmacy Law 2024, effective July 1, 2025 (with certain provisions effective January 1, 2025). The new law opens significant opportunities for pharmaceutical businesses amid international integration and digital transformation.

Below are the most important changes companies should grasp:

1. Expanded investment incentives for large projects

  • Broader eligibility for incentives under the Law on Investment.
  • Projects from VND 3,000 billion and up receive special incentives:
    • CIT incentive rate: 7% for 33 years.
    • Tax holiday of 6 years, followed by a 50% CIT reduction for the next 12 years.
    • Land-rent exemption for 20 years, then a 65% reduction for the remaining term.

2. Streamlined marketing authorization (MA) procedures

  • Dossier categories reduced from 6 types to 3 types.
  • Processing time for dossier variations/supplements: 20 days (previously 3 months).
  • MA issuance time limit: 9 months (previously 12 months).

3. Recognition of international assessment results

  • Acceptance of approvals from reputable authorities: US-FDA, EMA, MHRA, PMDA, Health Canada, etc.
  • No re-assessment of technical dossiers and GMP required for new drugs serving the prevention and control of Group A infectious diseases.

4. Greater transparency in medicine pricing

  • Additional obligation to publish the projected wholesale price (besides price declaration under the 2023 Law on Prices).
  • Maximum wholesale prices must be publicly posted on the Ministry of Health (MOH) portal.
  • Enhances transparency and tighter price control.

5. Legal framework for online pharmaceutical business

  • Allows sale of OTC medicines via e-commerce marketplaces, websites, and apps.
  • Requirements: pharmaceutical business license, public pricing, traceability, and customer data protection.
  • During Group A epidemics: permitted to sell prescription medicines in line with MOH regulations.

6. Pharmacy chain model codified

  • Chains such as Long Châu, Pharmacity, An Khang are legally recognized.
  • New entitlements:
    • Intra-chain distribution of medicines.
    • Rotation of responsible pharmacists among stores.
    • Simplified procedures: only notify changes to the MOH/Department of Health.
  • Higher standards: the chain’s responsible pharmacist must hold a pharmacy degree and have at least 2 years of experience.

7. Broader business rights for FDI enterprises

  • Foreign-invested enterprises (FIEs) may wholesale, deliver, and transport medicines/ingredients they manufacture or contract-manufacture in Vietnam.
  • Facilitates capital and technology inflows, strengthening domestic manufacturing capacity.

CONCLUSION

The Amended Pharmacy Law 2024 presents major opportunities for the pharmaceutical sector while requiring careful compliance preparation.

Businesses should:

  • Assess the law’s impact on investment, distribution, and commercial plans.
  • Prepare internal dossiers and processes aligned with the new procedures.
  • Proactively leverage incentives and supportive policies.
  • Contact ATIM LAW FIRM for in-depth advice and implementation support.

Read the full analysis here: Detailed Analysis of the Amended Pharmacy Law 2024 and Key Changes.

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