Regulatory Update: Decree No. 163/2025/ND-CP on Detailed Regulations and Measures for Implementing the Law on Pharmacy
Key Provisions on Licensing, Shelf Life, and Customs Procedures for Pharmaceutical Import and Export Activities.
This decree, issued by the Government of Vietnam on June 29, 2025, provides updated regulations on pharmaceutical activities, detailing several articles and offering measures to guide the implementation of the Law on Pharmacy. It includes new provisions on licensing requirements, documentation for import/export, and compliance obligations for pharmaceutical enterprises operating in Vietnam.
Key Highlights
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Scope of Application: This Decree applies to agencies, organizations, and individuals both domestic and foreign involved in pharmaceutical activities in Vietnam. It details regulations covering activities such as managing the import of unregistered medicines, and rules on the remaining shelf life of imported medicines and raw Materials.
Key Updates related to Import/Export Procedures (Chapter IV):
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- Management of Unregistered Medicines: Specifies criteria and procedures for obtaining import licenses for medicines not yet registered in Vietnam (e.g., for urgent treatment needs, clinical trials, or special treatment needs).
- Remaining Shelf Life (Hạn Dùng): Details the minimum remaining shelf life for imported medicines and raw materials at the time of customs clearance. For example, a product with a shelf life over 24 months must have a remaining shelf life of at least 18 months, and vaccines must have at least $1/2$ of their shelf life remaining.
- Specialized Documents: Lists specialized documents required for customs clearance of exported and imported medicines/raw materials.
- Effective Date: The Decree takes effect from July 01, 2025.
This summary is provided for reference purposes only and highlights key aspects of Decree No. 163/2025/ND-CP. For full and legally binding content, please refer strictly to the attached official document.
Attached File:
📎 Decree No. 163/2025/NĐ-CP (Official PDF – signed & sealed)
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