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 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

A new decree in Vietnam brings significant implementation clarity to the country’s existing extended producer responsibility (EPR) legal framework. An EPR mechanism was first codified in Vietnam in the 2020 Law on Environmental Protection amid ongoing challenges surrounding the collection and treatment of product and packaging waste. The mechanism was progressively detailed through Decree No. 08/2022/ND‑CP and its successive amendments, but the regulatory framework remained insufficiently developed, notably in terms of support mechanisms for waste collection, recycling, and treatment. The newly launched regulations in Decree No. 110/2026/ND-CP (Decree 110), issued on April 1, 2026, and taking effect on May 25, 2026, stipulate fully and clearly the responsibility of manufacturers and importers to recycle products and packaging and to treat waste. Some key provisions of Decree 110 for manufacturers, importers, and related stakeholders are presented below. Subjects of EPR The Law on Environmental Protection assigns responsibility to manufacturers and importers for product and packaging recycling (under Article 54) or waste collection and treatment (under Article 55), depending on the type of products and packaging they produce or import. Decree 110 elaborates on these EPR provisions by specifying the responsible entities and listing out the types of products and packaging subject to recycling and waste treatment responsibilities. Decree 110 clarifies the responsible entities in special cases, such as when products under the same brand are made by multiple manufacturers, when there is a contract manufacturing or entrusted import relationship, and when the manufacturer or importer is part of a corporate group. Notably, exemptions may be applied in some scenarios, such as for manufacturers and importers of products and packaging exclusively for export, temporary import and re-export, or research and testing purposes, as well as for entities with annual revenue from related products not exceeding VND 30 billion. Recycling Responsibilities Decree 110

On December 31, 2025, Vietnam’s Ministry of Health (MOH) issued Circular No. 57/2025/TT-BYT providing guidance on the classification of medical devices according to technical standards and quality requirements (Circular 57), applicable to procurement activities for medical devices in Vietnam. According to the MOH, the purpose of the classification is to establish a principle-based legal framework and regulations that enable purchasers to easily identify groups of medical devices aligned with their professional requirements and financial capacity. Some of the key stipulations of Circular 57 are outlined below. Basis for Determining Technical Standards and Quality Under Circular 57, the technical standards of medical devices are determined in accordance with Vietnamese laws on standards and technical regulations, through the following means: Certification of conformity with standards in accordance with Vietnamese laws on standards and technical regulations; Results of conformity assessment conducted by an internationally recognized conformity assessment organization or a legally established domestic or foreign conformity assessment organization operating in Vietnam; and Documentation evidencing compliance provided by the medical device owner. The quality of medical devices is determined based on whether the device has been approved for circulation by the relevant marketing authority of one or more jurisdictions. Classification of Medical Devices Circular 57 classifies medical devices into six groups (from Group 1 to Group 6) based on technical standards and quality. Medical devices subject to classification must simultaneously meet technical standards and quality requirements in accordance with professional specifications and user needs, and must be lawfully marketed in Vietnam. Medical devices manufactured in Vietnam may participate in all corresponding groups, provided they meet the technical standards required by the user and are lawfully marketed in Vietnam. Outlook Circular No. 57 will take effect on February 15, 2026, while the classification requirements will become effective on January 1, 2027. Holders of medical