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

Tilleke & Gibbins attorneys in Vietnam have contributed the 2025 edition of Doing Business in Vietnam, a comprehensive Q&A-style resource from Thomson Reuters Practical Law that provides essential insights for companies navigating business operations in Vietnam. The guide presents a detailed overview of the country’s legal framework and regulatory environment, reflecting recent updates in Vietnamese legislation and practice. This annually updated guide offers key information on the following areas: Legal system: Structure of the Vietnamese judiciary and the role of codified law. Foreign investment: Conditions for market access, licensing requirements, foreign ownership restrictions, and investment incentives. Business vehicles: Formation and operation of legal entities, including limited liability companies, joint-stock companies, and representative offices. Employment: Employment contracts, social insurance, labor rights, and procedures for hiring foreign nationals. Tax: Overview of corporate income tax, personal income tax, value-added tax, and other tax obligations. Intellectual property: Procedures for protecting and enforcing patents, trademarks, copyrights, and other IP rights. Data protection: Compliance requirements under Vietnam’s data privacy laws, including the Personal Data Protection Decree. Competition law: Antitrust rules and regulatory oversight under the Law on Competition. Anti-bribery and corruption: Legal framework and enforcement practices aimed at curbing corrupt activities. E-commerce and digital business: Regulations governing online platforms, digital content, and cross-border services. Marketing and advertising: Laws and guidelines on advertising standards and consumer protection. Product regulation and liability: Safety requirements, product liability issues, and roles of relevant authorities. Doing Business in Vietnam is part of Practical Law’s global series of legal guides designed to support international practitioners and businesses. To access the most recent edition of the Vietnam guide, visit the Practical Law website and sign up for a free trial.

Thailand’s Food and Drug Administration (FDA) has launched a strategic collaboration with leading e-commerce platforms Lazada and Shopee to strengthen regulatory oversight of health-related products sold online. This partnership is part of a broader initiative to enhance consumer protection, enforce compliance with Thai health regulations, and foster a safer digital marketplace for health products. As part of this initiative, the Thai FDA is urging all sellers—particularly cross-border vendors—to secure proper FDA registration for their products before market entry. The objective is to ensure that only legally authorized, safe, and quality-assured healthcare products are available to Thai consumers. In pursuit of this goal, the FDA has been working closely with Lazada and Shopee to implement proactive surveillance mechanisms aimed at identifying and removing noncompliant, substandard, or unregistered products. This collaboration has already yielded measurable results. Between September 2023 and 2024, Lazada supported regulatory enforcement by removing 9,454 noncompliant listings and delisting 30 vendors. In addition, 134 sellers were subjected to legal proceedings for regulatory violations. Shopee has taken a similarly rigorous stance, committing to the immediate removal of products found to be in breach of FDA regulations. The platform has also provided educational materials for merchants and implemented consumer complaint mechanisms to enhance accountability. Looking ahead, the Thai FDA plans to roll out a data integration system utilizing API technology, enabling seamless and secure exchange of regulatory data between the agency and e-commerce platforms. This system will be supported by comprehensive training for both Thai FDA officials and e-commerce staff, with a particular focus on the use of the Thai government’s Law Enforcement Request Portal, a secure communication channel for coordinating enforcement actions between government agencies and platform operators. Additionally, a joint product inspection framework is currently under development in partnership with Lazada and Shopee. This framework will incorporate strict

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