Regulatory Update: Decision No. 359/QĐ-QLD on Issuing a List of Foreign Drugs Approved for Marketing Authorization
Announcement of 103 Foreign Drugs Granted or Renewed Registration Certificates in Vietnam (Batch 125.2)
Decision No. 359/QĐ-QLD, issued by the Drug Administration of Vietnam (DAV) on July 17, 2025, officially announces the list of 103 foreign-manufactured drugs that have been successfully granted or renewed their Marketing Authorization Certificates (Giấy đăng ký lưu hành) in Vietnam. This public announcement ensures that these drugs can be legally imported, circulated, and supplied within the Vietnamese market.
Key Highlights
- Scope of Application: The Decision directly impacts pharmaceutical companies, importers, and distributors, allowing the legal circulation of the newly registered or renewed drugs listed in the accompanying annex.
- Key Updates/Content:
- List of Drugs: The core content is the appended list detailing the trade name, active ingredients (hoạt chất), strength (hàm lượng), dosage form (dạng bào chế), packaging (quy cách đóng gói), manufacturer, shelf life (Hạn dùng), and registration number of the 103 approved foreign drugs.
- Legal Basis: The decision is based on the Law on Pharmacy and several related decrees, including Decree No. 163/2025/NĐ-CP (chi tiết thi hành Luật Dược) and Decree No. 42/2025/NĐ-CP (quy định chức năng của Bộ Y tế).
- Effective Date: The Decision takes effect from the date of signing (July 17, 2025).
-
Compliance Obligation: Concerned organizations are responsible for complying with all relevant regulations regarding drug registration, distribution, quality, advertising, and price management.
This summary is provided for reference purposes only and highlights key aspects of Decision No. 359/QĐ-QLD. For full and legally binding content, please refer strictly to the attached official document.
Attached File:
📎 Decision No. 359/QĐ-QLD 2025 (Official PDF – signed & sealed)
\
