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​ 

February 21, 2023
On December 28, 2022, the Ministry of Health of Laos issued Decision No. 3789/MOH on the Control of Hemp for Medication and Products (the “Decision”). The Decision approves the regulated cultivation, extraction, production, processing, storage, distribution, utilization, import-export, and transport of hemp. The Decision also authorizes the use of hemp and hemp-related products by the general population, although use of certain products is limited to those with medical prescriptions. Background In 2019, the Lao government established an ad hoc committee to consider the legalization of cannabis, as reported previously. The government permitted certain local companies to grow cannabis in specific zones under pilot programs, although it continued to strictly prohibit the use and commercialization, as well as consumption, of cannabis-related products, regardless of the level of psychoactive tetrahydrocannabinol (THC) in the products. Overview of the Decision The Decision was issued by the Ministry of Health (which led the ad hoc committee) and permits authorized companies to engage in certain activities involving the use of hemp and the consumption of hemp and hemp-related products. The Decision defines hemp (“porkeo” in Lao) as a “plant that belongs to the same family as ganja and bears the scientific name Cannabis Sativa L. (Cannabis sativa L. subsp. sativa var. sativa) which is a subspecies of ganja (Cannabis Sativa L.).” This definition aims at differentiating hemp from the general definition of ganja or marijuana, which continues to be listed as a prohibited narcotic in Laos. The Law on Narcotics (2007) and the Penal Code (2017) still prohibit the production, trade and use of all types of cannabis. These laws will need to be amended to ensure that they are aligned with changes set out in the Decision.  Authorized Hemp Activities The Decision allows approved companies to engage in the cultivation, extraction, production, processing, storage,
Read More
February 9, 2023
Vietnam’s Ministry of Finance is drafting a circular on determining the origin of imported and exported goods. This circular, a draft version of which has been released for public comment (“Draft Circular”), consolidates prevailing regulations and guidelines on determining the origin of imported and exported goods that are stipulated in the following legal documents, which the Draft Circular would replace when it comes into effect: Circular No. 38/2018/TT-BTC dated April 20, 2018, of the Ministry of Finance regulating the determination of origin of imported and exported goods, as amended by Circular No. 62/2019/TT-BTC dated September 5, 2019, of the Ministry of Finance; Circular No. 47/2020/TT-BTC dated May 27, 2020, regulating the time to submit documents proving the origin of goods and form of the documents proving the origin of imported goods applied during the Covid-19 pandemic; and Circular No. 07/2021/TT-BTC dated January 25, 2021, regulating the time to submit documents proving the origin of imported goods under the EU-Vietnam Free Trade Agreement (EVFTA). Generally speaking, the Draft Circular does not increase the administrative procedures for importers and exporters, but rather seeks to codify the recent practices implemented by the customs authorities. The Draft Circular focuses on providing comprehensive guidance for importing/exporting companies when carrying out administrative procedures to certify the origins of imported and exported goods to be in line with current trade practices and international commitments under new-generation free trade agreements. In particular, the Draft Circular supplements guidelines on declaring origins and submitting Certificates of Origin (C/Os) of imported goods under the EVFTA and the Regional Comprehensive Economic Partnership Agreement (RCEP). The Draft Circular also provides some new guidelines to facilitate exports (and imports) and overcome some obstacles and issues when implementing the prevailing regulations. For example, the submission of C/Os online, which was only applicable during the
Read More
January 27, 2023
The opening weeks of 2023 have already seen a sharp increase in enforcement against violations of product labeling and advertising rules in Cambodia, in line with a notice issued by the country’s Directorate-General for Consumer Protection, Competition, and Fraud Repression (CCF) last year. Since the Law on Consumer Protection was adopted in 2019, a major legislative push has been seen, with general rules coming out focusing on providing consumers with sufficient information on products and services, for example via product labeling or advertising rules. Then, more detailed regulations were adopted for specific product categories, for example for food products and cosmetics. Khmer language requirements have been a key feature of the recently adopted rules on advertising and labeling. Despite the Khmer language mandates in consumer protection laws and regulations, enforcement and compliance was low. Most products on the market—especially imports—did not comply with the language requirement. In line with the revamped regulatory framework, the CCF has increased its enforcement, enabled by recent substantial budget increases. They have adopted clear implementing regulations for their officers to enforce in a practical yet effective manner, and they have been issuing notices reminding companies to comply with the new rules. A September 2022 notice announced that increased CCF enforcement of product labeling rules would start on January 1, 2023. As noted above, this has already proven to be true, and enforcement is now proceeding in earnest. Companies should take heed of this notice and ensure compliance with the Khmer language requirements (detailed below), as the CCF has shown that it readily acts against violators, from small retailers to large conglomerates. Khmer Language Requirement A sub-decree issued November 4, 2022 requires all commercial advertising of products and services—by any channel—to use Khmer as the primary language. If foreign-language text is used in advertisements, it
Read More
January 10, 2023
On January 9, 2023, Vietnam’s National Assembly voted to approve a draft resolution on the continued implementation of policies for the prevention and control of the Covid-19 pandemic. Under this resolution, marketing authorizations (MAs) for the following drugs and medicinal ingredients will be extended to December 31, 2024, allowing continued use in Vietnam: Drugs and medicinal ingredients whose MAs expire from January 1, 2023, to December 12, 2024, and whose extension dossiers have been submitted but have not yet been approved in accordance with the Law on Pharmacy; and Drugs and medicinal ingredients whose MAs have been extended as per Resolution No. 12/2021/UBTVQH15 and have not been extended in accordance with the Law on Pharmacy. The extension does not apply to the following cases: Drugs and medicinal ingredients that have been recalled by the Law on Pharmacy; Drugs with signs of being unsafe for users that have been suspended from circulation/use and sealed for preservation in accordance with the Law on Pharmacy; and Drugs with MAs having a validity term of three years in accordance with the Law on Pharmacy. The Ministry of Health will announce the list of drugs and medicinal ingredients whose MAs are subject to be extended as described above.
Read More