You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

July 8, 2025

Vietnam Issues New Guidance for Amended Law on Pharmacy

Subscribe to Updates

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 meet the needs of prevention and treatment of group-A infectious diseases that have been declared epidemics according to the provisions of the Law on Prevention and Control of Infectious Diseases and (ii) drugs with a shelf life of less than 30 days.

Importers must notify the provincial People’s Committee at least five working days prior to customs declaration. The People’s Committee may then issue a written notice of noncompliance to the customs authority within five working days of receiving the notification.

Drug Advertising

Decree 163 supplements a procedure that allows an approved drug advertising certificate to be adjusted for some changes (such as a change to the MA holder or a change to manufacturer information), instead of reconducting the first registration for drug advertising content as under the previous regulation.

Drug Price Management

Entities must announce or reannounce wholesale prices, similar to the drug price declaration procedure under Decree 54. Certain drugs are exempt from this requirement, including those provided free of charge for emergency response, national health programs, humanitarian aid, clinical trials, scientific research, or exhibition purposes, and drugs carried as personal luggage.

The Ministry of Health (MOH) can issue recommendations if the announced or reannounced price is significantly higher than comparable drugs already on the market. This includes cases when:

  • The announced or reannounced wholesale price of the drug exceeds the highest price of similar drugs.
  • The price difference exceeds 35% (for drugs priced under VND 1 million) or 15% (for drugs priced at VND 1 million and above) compared to winning bid prices in tenders.
  • The announced or reannounced price is higher than prices in the country of origin or other markets (if no similar product exists in Vietnam).

When such discrepancies are identified, the MOH issues a formal recommendation to the announcing entity and publishes it online to ensure transparency and accountability.

Further Guidance Provided in New Circular

On July 1, 2025, the MOH issued Circular No. 31/2025/TT-BYT further detailing the implementation of the amended Law on Pharmacy as well as Decree163 (Circular 31). Circular 31 officially replaces Circular No. 07/2018/TT-BYT and Decree 54, and took effect immediately upon issuance.

Key provisions of Circular 31 include the following:

Notification of Practicing Pharmacists

Pharmaceutical businesses that are not part of a pharmacy chain must notify the competent authority of a list of people currently practicing at the business who hold pharmacy practice certificates. The notification must be submitted within 15 days from the issuance date of the certificate of eligibility for pharmaceutical business or from when there are any changes to the list. This shortens the previous deadline of 30 days under earlier regulations.

Pharmacy chains are subject to similar notification obligations and timelines. Specifically, the chain operator must notify the provincial authority where each pharmacy in the chain is located of the list of practicing pharmacists at those locations. In addition, pharmacy chains must notify the authority in cases of addition or removal of pharmacies from the chain, and any rotation of the persons responsible for pharmaceutical expertise between pharmacies within the chain.

Drug Information Activities

Under Circular 31, drug information may still be delivered to healthcare professionals through dissemination of drug information materials, drug introduction seminars, and medical representatives.

However, Circular 31 introduces a significant change by eliminating the requirement to obtain a certificate of drug information content prior to conducting drug information activities. Under the new regulation, pharmaceutical businesses, representative offices of foreign pharmaceutical companies in Vietnam, and MA holders are now responsible for developing and disseminating drug information materials in compliance with package inserts for drugs approved by the MOH, the Vietnamese National Drug Formulary, and documents and professional instructions related to the drug issued or recognized by the MOH.

Outlook

Pharmaceutical business establishments, representative offices of foreign traders operating in the pharmaceutical sector, and drug registrants in Vietnam are advised to review the new regulations thoroughly to ensure timely compliance with the amended provisions.

Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

January 6, 2026
On December 30, 2025, Thailand’s Electronic Transactions Development Agency (ETDA) notified digital marketplace operators of a consolidated list of “high‑risk products” that are subject to strict monitoring on digital platforms. The list was jointly prepared by the Thai Industrial Standards Institute (TISI) and the Food and Drug Administration (FDA) to guide platform compliance in the initial phase of implementation of the Electronic Transaction Committee’s Notification on Other Measures for Marketplace for Goods with Specific Characteristics under Section 18(2) of the 2022 Royal Decree on Digital Platform Businesses Requiring Notification B.E.2568 (2025). The notice is addressed to operators of digital platform services that function as product marketplaces with specific characteristics laid out in the notification. The ETDA states that the TISI and the FDA are closely monitoring the high‑risk product categories on digital platforms, and the published list serves as the baseline reference for platform screening during the initial phase of the notification’s implementation. High‑Risk Product List The list aggregates categories of products that are illegal to sell online or are otherwise tightly regulated under Thai law, with an emphasis on health-related products, controlled substances, medical devices, and a wide range of industrial products that require certification or compliance with specified Thai Industrial Standards, as detailed below. Prohibited and tightly controlled health products. This includes all categories of modern medicines subject to control other than general household remedies; all categories of controlled herbal products except for over-the-counter herbal products; narcotics; psychotropic substances; and medical devices requiring use in medical facilities or a physician’s prescription. Selected industrial products requiring heightened controls. The list highlights dozens of TISI-regulated items commonly sold online. Examples include pacifiers, rice cookers, electrical wire, food wrap film, crayons, washing machines and dryers, air conditioners, electric cookers and air fryers, water heaters, microwave ovens, LED luminaires, hair dryers
Read More
January 5, 2026
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
Read More
December 30, 2025
The Intellectual Property Office of Vietnam (IP Office), with support from the Japan International Cooperation Agency (JICA), is drafting additional annexes to its Guidelines for Patent Examination, focusing on the examination of patent applications in the pharmaceutical and biotechnology sectors. The new annexes are expected to be officially issued in early 2026 as Annexes III and IV, following the successful issuance in 2023 of Annexes I and II addressing computer program-related inventions. The IP Office recently organized a seminar to gather feedback on the draft annexes from intellectual property representatives, academic institutions, research institutes, and other interested parties, emphasizing its intention to receive further constructive opinions to refine the guidelines for pharmaceuticals and biotechnology. Why These Guidelines Matter Patent examination in Vietnam has traditionally relied on the Guidelines for Patent Examination issued under Decision No. 487/QD-SHTT (2010), recently supplemented by Annexes I and II. While these documents provide a solid foundation, they do not fully address practical challenges in examining pharmaceutical and biotech inventions, particularly issues related to clarity, sufficiency of disclosure, enablement, features of function and utility, combination therapies, and inventions involving artificial intelligence (AI) applications in these fields. Annexes III and IV aim to close these gaps by introducing structured principles and illustrative examples. Guidance on Patent Specification Requirements Annex III provides detailed guidance on the requirements for patent specifications in pharmaceuticals and biotechnology, covering two main parts: Part A addresses sufficiency of disclosure, clarity of specifications, and consistency between claims and descriptions. Part B covers inventions related to Markush-type compounds, claims containing exclusion statements (disclaimers), and additional experimental data submitted during examination. The Guidelines outline specific disclosure requirements for subject matters such as compounds, formulations, pharmaceutical compositions, genes, polypeptides, proteins, vectors, transgenic organisms, modified organisms, and hybrid cells. Annex III emphasizes that disclaimers are not accepted
Read More
November 25, 2025
Food safety incidents can emerge without warning, requiring businesses to act swiftly to protect consumers and comply with regulatory obligations. Across Southeast Asia, Thailand, Vietnam, and Indonesia have each developed comprehensive food recall frameworks designed to ensure rapid removal of unsafe products from the market while holding businesses accountable for compliance failures. While these three jurisdictions share common objectives—protecting public health and ensuring food safety—each has crafted distinct regulatory approaches reflecting their unique administrative structures, enforcement priorities, and legal traditions. Understanding these differences is essential for food businesses operating in the region, as recall procedures, timelines, reporting requirements, and penalties vary significantly across borders. This guide, available through the button below, examines the food recall regulations in Indonesia, Thailand, and Vietnam, providing practical guidance on legal requirements, procedural steps, and compliance obligations in each market.
Read More