On May 25, 2026, Vietnam’s Ministry of Health issued Circular No. 16/2026/TT-BYT governing free-of-charge medicine support programs for medical establishments (Circular 16). Circular 16 will take effect on July 10, 2026, replacing Circular No. 31/2018/TT-BYT, which currently regulates the same subject matter. Circular 16 introduces several significant changes compared to the existing legal framework. Removal of Prior Approval Requirement Under the current regulations, free-of-charge medicine support programs are divided into two categories: (1) entirely free-of-charge provision of medicines for all types of drugs and (2) partially free-of-charge provision applicable only to brand-name drugs under patent protection or drugs whose generic products with identical active ingredients and dosage forms are available in Vietnam. Under the current regulations, partially free-of-charge programs are subject to mandatory registration with the competent authority, while entirely free-of-charge programs could be implemented without prior approval. A key reform under Circular 16 is that it stipulates only entirely free-of-charge medicine support programs applicable to all types of medicines, thereby eliminating the partially free-of-charge category. In addition, free-of-charge medicine support programs may be carried out solely based on a written agreement between the pharmaceutical company and the medical establishment, without any requirement for prior approval from competent authorities prior to implementation. Written Agreement Requirements Circular 16 requires the pharmaceutical company and medical establishment to enter into a written agreement in accordance with a prescribed template. This agreement must include the following compulsory information: Information on the supported medicines Form of support (entirely free-of-charge provision to patients) Quantity of medicines provided Target patient groups and applicable indications Duration of the program Rights and obligations of each party Transitional provisions on the protection of patients’ rights upon completion of the program The agreement may contain other contents as agreed by the parties, provided that these do not contradict applicable laws.

Vietnam’s AI regulatory framework has reached an important milestone. While the Law on Artificial Intelligence No. 134/2025/QH15 (AI Law) established the foundation for AI governance, many practical compliance requirements were left to implementing regulations. On April 30, 2026, the government issued Decree No. 142/2026/ND-CP (Decree 142), which took effect on May 1, 2026, and provides the first detailed guidance on the implementation of the AI Law. Although an official list of high-risk AI systems is still pending from the prime minister, Decree 142 provides valuable insight into how Vietnam’s risk-based AI regulatory framework will operate in practice. Risk Classification Framework The AI Law adopts a risk-based approach under which AI systems are classified as high-risk, medium-risk, or low-risk. Decree 142 builds on this framework by providing detailed guidance on how these classifications are determined. High-risk AI systems are determined based on factors such as (i) their potential impact on life, health, property, human rights, public interests, or national security; (ii) the sector in which they are deployed; and (iii) the scale of affected users or integration with critical infrastructure. The latest draft list of high-risk AI systems appears to follow these same principles. Medium-risk AI systems generally include systems that may mislead, influence, or manipulate users, particularly where users may not realize they are interacting with AI or AI-generated content. The focus is therefore on transparency and authenticity risks rather than broader societal or safety concerns. Low-risk AI systems are those that do not meet the criteria for either high-risk or medium-risk classification. Importantly, Decree 142 seeks to avoid over-classification. Certain systems may fall outside the high-risk or medium-risk regimes, including internal-use systems, office-support tools, technical editing applications, certain back-end processing systems, and AI systems used in artistic, gaming, cinematic, or other creative contexts. Providers must also review and

Intellectual property specialists from Tilleke & Gibbins in Vietnam have contributed an updated Intellectual Property Transactions in Vietnam overview for Thomson Reuters Practical Law, an online publication that provides comprehensive legal guides for jurisdictions worldwide. The Vietnam overview was authored by Linh Thi Mai Nguyen, Thanh Phuong Vu, Chi Lan Dang, Son Thai Hoang, and Duc Anh Tran. The chapter provides a high-level examination of key aspects of IP transactions law in Vietnam, including IP assignment and licensing, research and development collaborations, IP in mergers and acquisitions (M&A), lending and taking security over intellectual property rights, settlement agreements, employee- and consultant-created IP, competition law, taxation, and non-tariff trade barriers. Key topics covered in the chapter include: IP assignment: Basis and formalities for assignments of patents, utility models, trade marks, copyright, design rights, trade secrets, confidential information, and domain names in Vietnam. IP licensing: Scope, formalities, and recordal requirements for licensing patents, trade marks, copyright, design rights, and trade secrets. Research and development collaborations: Treatment of improvements, derivatives, and joint ownership of IP, including exploitation and enforcement issues. IP aspects of M&A and security: Due diligence, warranties, transfer formalities, and taking security over intellectual property rights. Practical Law, a legal reference resource from Thomson Reuters, publishes a range of guides for hundreds of jurisdictions and practice areas. The Intellectual Property Transactions Global Guide is a valuable resource for legal practitioners seeking comparative insight into transactional IP issues across multiple jurisdictions. To view the latest version of the Intellectual Property Transactions in Vietnam overview, please visit the Practical Law website and enroll in the free Practical Law trial to gain full access.

Vietnam’s legal framework governing chemicals has undergone significant reform, with the Law on Chemicals No. 69/2025/QH15 (Law on Chemicals 2025) taking effect on January 1, 2026. Together with a comprehensive set of implementing instruments issued in January 2026, including three decrees (No. 24/2026/ND‑CP, No. 25/2026/ND‑CP, and No. 26/2026/ND‑CP) and two circulars (No. 01/2026/TT‑BCT and No. 02/2026/TT‑BCT), the Law on Chemicals 2025 has significantly reshaped chemical registration and management requirements. Determining What Constitutes a “New Chemical” Among the most notable changes introduced under the Law on Chemicals 2025 are the rules governing the registration and management of new chemicals, which must be registered with the authority before being placed on the Vietnam market. Although the concept of new chemical registration was first introduced under the Law on Chemicals 2007, the corresponding registration mechanism has remained largely dormant in practice. Under the Law on Chemicals 2025, a “new chemical” is defined as a substance that is not yet included in Vietnam’s National Chemical Inventory and the list of foreign chemical inventories recognized by the competent Vietnamese authority (List of Foreign Chemicals). On a literal reading, the definition in the new law may suggest that a substance qualifies as a new chemical only if it is absent from both lists. Accordingly, a chemical present in either list should be treated as an existing chemical without the registration burden. However, a different interpretation emerges from Decree 26, which specifically requires registration of “new chemicals” even where such substances already appear in the List of Foreign Chemicals. This implies that inclusion in a recognized foreign inventory does not automatically exempt a substance from new chemical registration in Vietnam. This inconsistency between the statutory definition in the Law on Chemicals 2025 and the implementing provisions of Decree 26 creates significant interpretative and compliance challenges. At