Import & Export
Regulatory Update: Circular No. 39/2025/TT-BYT on Delegating Authority for Pharmaceutical Tasks and Administrative Procedures
Clarifying Responsibilities and Procedures between the Ministry of Health, Drug Administration of Vietnam (DAV), and Traditional Medicine Administration of Vietnam (TMAV)
Circular No. 39/2025/TT-BYT, issued by the Ministry of Health (MoH) on September 20, 2025, details the delegation of certain duties and administrative procedures within the pharmaceutical sector, previously under the MoH’s authority, to the Drug Administration of Vietnam (Cục Quản lý Dược) and the Traditional Medicine Administration of Vietnam (Cục Quản lý Y, Dược cổ truyền). This aims to streamline management activities following the issuance of Decree No. 163/2025/NĐ-CP.
Key Highlights
- Scope of Application: The Circular regulates the delegation of authority for tasks and administrative procedures within the pharmaceutical field belonging to the MoH’s jurisdiction.
- Delegated Authority (Cục Quản lý Dược – DAV): DAV is assigned to handle procedures for:
- Licensing the import of most chemical drugs, vaccines, and bio-products, including those not yet registered in Vietnam (e.g., hiếm, điều trị đặc biệt, giá thấp hơn biệt dược gốc).
- Licensing the import of controlled raw materials (trừ dược liệu độc).
- Licensing the export of controlled drugs and raw materials.
- Reviewing price announcements and making recommendations on the wholesale price of prescription chemical drugs, vaccines, and bio-products.
- Handling licensing procedures for drug manufacturing, import/export, and chain pharmacy businesses.
- Delegated Authority (Cục Quản lý Y, Dược cổ truyền – TMAV): TMAV is specifically assigned to handle procedures for:
- Licensing the import/export of traditional medicines and herbal raw materials (dược liệu).
- Handling licensing procedures for businesses that only produce, import/export, or store traditional medicines, herbal medicines, or raw materials.
- Reviewing price announcements for traditional prescription medicines.
- Effective Date: The Circular is effective from September 20, 2025.
This summary is provided for reference purposes only and highlights key aspects of Circular No. 39/2025/TT-BYT. For full and legally binding content, please refer strictly to the official document.
Attached File:
📎 Circular No. 39/2025/TT-BYT (Official PDF – signed & sealed)
