Regulatory Update: Decision No. 629/QĐ-QLD on Renewing Marketing Authorization for Vaccines and Biological Products

Decision No. 629/QĐ-QLD, issued by the Drug Administration of Vietnam (DAV) on October 31, 2025, officially announces the list of 05 Vaccines and Biological Products (vắc xin, sinh phẩm) that have been successfully renewed their Marketing Authorization Certificates (Giấy đăng ký lưu hành) in Vietnam. This public announcement ensures the continued legal importation, circulation, and supply of these essential products within the Vietnamese market.

Key Highlights

• Scope of Application: The Decision applies to the manufacturers, registration holders, and distribution channels for the 05 specific vaccines and biological products listed, allowing their continued legal business operations in Vietnam.
• Key Updates/Content:
  • List of Products: 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, and registration number of the 05 approved vaccines and biological products. Ví dụ, các sản phẩm Lomoh 40 và Enoxaparin natri được gia hạn.
  • Legal Basis: The decision is based on the Law on Pharmacy and 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 (October 31, 2025).

• This summary is provided for reference purposes only and highlights key aspects of Decision No. 629/QĐ-QLD. For full and legally binding content, please refer strictly to the attached official document.

Attached File:

📎 Decision No. 629/QĐ-QLD 2025 (Official PDF – signed & sealed)