June 5, 2026
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.
Reporting and Record Retention
Circular 16 proposes a reduction in administrative burden by simplifying reporting