On June 29, 2025, the government of Vietnam issued Decree No. 163/2025/ND-CP providing detailed guidance on the implementation of the amended Law on Pharmacy (Decree 163). Decree 163, like the amended Law on Pharmacy, took effect on July 1, 2025, officially replacing Decree No. 54/2017/ND-CP (Decree 54). The new decree introduces comprehensive regulations across key areas of pharmaceutical management such as pharmacy practice certificates, certificates of eligibility for pharmaceutical business, import and export of drugs and drug materials, GMP inspection of foreign manufacturers, drug and drug material recall, certificates of drug advertising content, and drug price management. Key Changes in Decree 163 Some outstanding changes and additions in Decree 163 are presented below. Destruction of Specially Controlled Drugs It is no longer required to obtain approval from the competent authority before the destruction of narcotic, psychotropic, and precursor drugs, and pharmaceutical ingredients that are narcotic or psychotropic substances, or precursors used in drugs. Instead, notification must be provided at least seven working days in advance, including the proposed destruction date and a detailed list of items to be destroyed. E-commerce in Pharmaceuticals Pharmaceutical businesses operating via e-commerce platforms must publicly disclose the following information to ensure transparency and consumer safety: (i) certificate of eligibility for pharmaceutical business, (ii) pharmacy practice certificate of the person responsible for pharmaceutical expertise, and (iii) drug information. Shelf-Life Requirements for Imported Products For drugs and ingredients with a total shelf life of nine months or less, at least one-third of the shelf life must remain at the time of customs clearance. Drugs with a shelf life of 30 days or less must still be within their shelf life at the time of clearance. Control of Imported Products Drugs subject to import control include all drugs with marketing authorization (MA), except for (i) drugs that

On May 16, 2025, Vietnam’s Ministry of Health (MOH) issued Circular No. 12/2025/TT-BYT on registration of drugs and drug materials (Circular 12). Circular 12 will come into effect on July 1, 2025, replacing Circular No. 08/2022/TT-BYT (as amended), which provides the current regulations on drug registration, along with Circular No. 16/2023/TT-BYT on registration of drugs under toll manufacturing and technology transfer, and Circular No. 07/2017/TT promulgating the list of non-prescription drugs. Some of the key stipulations of Circular 12 are outlined below. Regulation of non-prescription drugs Circular 12 abolishes the detailed list of over-the-counter (OTC) drugs previously stipulated in Circular No. 07/2017/TT-BYT. Instead of relying on a fixed list for classification, Circular 12 introduces a new framework based on principles, criteria, and specific methods for determining the status of non-prescription/OTC drugs. This approach aims to enhance safety, ensure timely access, reflect actual usage and supply conditions, and align with international standards. Drugs that have already been approved will retain their classification (i.e., as prescription or non-prescription) throughout the validity of their marketing authorization (MA), and reclassification will be considered when the MA is renewed. If a change in classification is requested, the MA holder must submit a variation registration dossier to the Drug Administration of Vietnam (DAV). For drug registration dossiers currently under evaluation by the DAV, the classification will be assessed in accordance with the new provisions set out in Circular 12. Drug registration The new regulations under Circular 12 loosen the requirements on providing a Certificate of Pharmaceutical Product (CPP). For all drug registration cases, a single CPP will suffice, provided it is issued by the competent authority of the manufacturing country or by an authority from a country that is a member of the European Medicines Agency (EMA) or a Stringent Regulatory Authority (SRA), and confirms

Experts from Tilleke & Gibbins have provided updates for the latest edition of The Pharma Legal Handbook: Vietnam, published by Pharma Boardroom. This comprehensive guide to the legal framework regulating the healthcare and life sciences industries in Vietnam was authored by by the Hanoi-based team of Hien Thi Thu Vu, head of regulatory affairs for Vietnam, and Mai Thi Le, regulatory affairs consultant, the handbook is a must-read for healthcare and life sciences companies that are interested in the Vietnam market. The guide includes eight sections on various important aspects of local regulations: Regulatory, Pricing, and Reimbursement Overview Preclinical & Clinical Trial Requirements Marketing, Manufacturing, Packaging & Labeling, and Advertising Traditional Medicines and Over-the-Counter Products Product Liability Patents and Trademarks Regulatory Reforms Orphan Drugs and Rare Diseases Tilleke & Gibbins has also authored The Pharma Legal Handbook: Thailand, which was updated at the same time as the Vietnam guide. The Pharma Legal Handbook: Vietnam, like all of the country guides from Pharma Boardroom, is available for purchase on the Pharma Boardroom website.

On November 21, 2024, the National Assembly of Vietnam adopted a law amending and supplementing the 2016 Law on Pharmacy (“Amended Law on Pharmacy”). The Amended Law on Pharmacy simplifies some procedures for the pharmaceutical field, and will take effect on July 1, 2025, except for regulations on drug registration and rights and responsibilities of certain types of pharmaceutical business. Some outstanding points in the Amended Law on Pharmacy are presented below. E-commerce Distribution The Amended Law on Pharmacy allows trading in pharmaceutical products by the e-commerce channel, including e-commerce trading floors, e-commerce sales applications, and e-commerce sales websites with online ordering functions. Accordingly, e-commerce retail of non-prescription drugs is permitted if the drugs are neither specially controlled drugs nor drugs included in the list of drugs restricted for retail sale, and e-commerce wholesale of drugs and drug materials is permitted, as long as they are not specially controlled drugs. New Rights for Import FIEs The amendment provides some additional rights to foreign-invested enterprises (“FIEs”) that import drugs, including the rights to: Repurchase drugs and drug materials manufactured through the technology transfer of the FIE itself in Vietnam, and sell such products to wholesalers; Import drug materials to supply to drug manufacturers in Vietnam that are hired by or receive technology transfer from the FIE itself under a processing contract or technology transfer contract; Deliver and transport drugs and drug materials the FIE has imported, outsourced for processing, or transferred technology for in Vietnam, from the FIE’s warehouse to its wholesalers; Deliver and transport drugs used in aid, sponsorship, humanitarian, and disease prevention and control programs to medical facilities receiving funding; and Transport drug materials imported by the FIE from its warehouse to drug manufacturers that are hired by or receive technology transfer from the FIE itself under a