Vietnam’s New Pharmaceutical Law Set to Enter into Force
On 1 July 2025, Vietnam’s amended Pharmaceutical Law will enter into force. Ratified in the National Assembly on 21 November 2024, the new law will replace the previous legislation regulating the domestic pharmaceutical sector, issued in 2016 (Law No. 105/2016/QH13).
Through these amendments to the law, the government is hoping to modernise the domestic pharmaceutical sector, streamline administrative procedures, and address the challenges that pharmaceutical companies, healthcare providers, and patients have faced over the last decade under the previous legal framework.
The amended Pharmaceutical Law at a glance
The Pharmaceutical Law regulates the production, administration, and distribution of drugs and raw pharmaceutical materials in Vietnam. It applies to drug manufacturers, pharmacies and retailers, health and medical care providers, as well as drug importers and exporters.
The new law is designed to ensure that patients in Vietnam have access to reliable, reasonably priced drugs to effectively prevent and treat disease. To that end, it aims to facilitate growth in the domestic pharmaceutical industry, encouraging technology transfer and local research and development (R&D); facilitate the sale of non-prescription (over-the-counter or “OTC”), non-controlled drugs online through e-commerce platforms and healthcare websites; and introduce new rights for foreign pharmaceutical companies.
Implications for foreign pharmaceutical enterprises
Of particular interest to foreign pharmaceutical companies importing drugs to Vietnam, the amended Pharmaceutical Law will allow them greater freedom to transport imported drugs throughout Vietnam in specific circumstances.
For example, these companies will be permitted to transport imported drugs from their warehouses to wholesale retailers, deliver drugs to be used for humanitarian purposes or in international aid, and transport drugs to medical facilities for use in clinical trials where the foreign enterprise is a sponsor.
Meanwhile, foreign pharmaceutical companies will also be able to repurchase and sell drugs manufactured by domestic enterprises under technology-transfer agreements and import raw materials for Vietnamese companies where such an agreement is in place. This is designed to encourage knowledge transfer and, in turn, boost the development of Vietnam’s domestic pharmaceutical sector.
Other notable changes
The amended Pharmaceutical Law includes incentives to encourage investment in domestic pharmaceutical manufacturing, particularly in R&D, cultivation of medicinal plants in deprived areas, and research to preserve rare medicinal species. It also introduces provisions to ensure that drugs manufactured in Vietnam are cheaper, or at least maintain consistent prices.
Meanwhile, for pharmaceutical chains, the law outlines a series of obligations. Some of these entail the logistics and infrastructure of drug management, such as the need to have suitable storage facilities and means of transportation. Others focus on management and human resources, such as the need to have a unified management structure across the chain and a responsible pharmacist in each branch.
Finally, the amended Pharmaceutical Law streamlines and simplifies the drug registration process. For instance, it reduces the time it takes to bring new drugs to the market and cuts administrative procedures for pharmaceutical companies.
Disclaimer: This article and its content are for information only and are not given as legal or professional advice. they do not necessarily reflect all relevant legal provisions with respect to the subject matter. Readers should seek legal or professional advice before taking or refraining to take any action.
