Regulatory Update: Circular No. 31/2025/TT-BYT on Drug Labeling and Package Inserts

Circular No. 31/2025/TT-BYT, issued by the Ministry of Health on August 15, 2025, provides comprehensive regulations on the content and presentation of drug labeling and package inserts (Patient Information Leaflets). The Circular aims to ensure that medicines circulated in Vietnam carry accurate, complete, and legally compliant information, facilitating safe and effective use by both healthcare professionals and patients.

Key Highlights

• Scope of Application: The Circular applies to organizations and individuals involved in the production, processing, import, export, or distribution of medicines in Vietnam, ensuring compliance with labeling standards for both domestically manufactured and imported drugs.
• Key Updates/Content:
  • Mandatory Label Content: Details the specific information required on primary and secondary drug packaging, including dosage form, active ingredients, excipients (tá dược), manufacturer/importer information, batch number, expiry date, and warning symbols.
  • Package Insert (Tờ Hướng Dẫn Sử Dụng Thuốc): Stipulates the detailed structure and mandatory information for patient information leaflets, such as indications, contraindications, dosage, administration, side effects, and storage conditions.
  • Language and Format: Specifies the language requirements (Vietnamese is mandatory) and standards for font size, clarity, and durability of labeling materials.
  • Special Drug Labeling: Includes provisions for specific types of drugs, such as controlled substances or vaccines, requiring additional information or warning statements.

This summary is provided for reference purposes only and highlights key aspects of Circular No. 31/2025/TT-BYT. For full and legally binding content, please refer strictly to the attached official document.

Attached File:

📎 Circular No. 31/2025/TT-BYT (Official PDF – signed & sealed)