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​ 

March 24, 2023
Attorneys in Tilleke & Gibbins’ Jakarta office have contributed a new “Life Sciences Regulation in Indonesia” chapter to Practical Law’s updated Life Sciences Global Guide. The chapter covers a range of regulatory issues related to the development, manufacturing, and selling of pharmaceutical products and medical devices, including the following topics: Pharmaceuticals: Laws and regulatory authorities Clinical trials: Legal, regulatory, and procedural requirements Manufacturing and distribution Marketing: Authorization for marketing medicinal products, monitoring compliance and penalties, pharmacovigilance and other commitments, foreign marketing authorizations Data privacy Packaging, labeling, and tracking Biological medicines Medical devices: Legislation and regulatory authorities, definition and classification Healthcare IT Combination products and borderlines Natural health products Developments, reforms, and proposals Practical Law, produced by Thomson Reuters, is the world’s leading legal know-how resource for business lawyers, publishing a huge range of guides covering hundreds of jurisdictions and practice areas. The full “Life Sciences Regulation in Indonesia” chapter can be accessed on the Practical Law website
Read More
March 24, 2023
Tilleke & Gibbins’ life sciences specialists in Indonesia have contributed a new “Life Sciences Commercialization in Indonesia” chapter to the Life Sciences Global Guide from Practical Law. This Q&A guide to commercializing life sciences innovations in Indonesia provides important information that companies can use to shape their strategies for life sciences products and activities in the jurisdiction. Specifically, the chapter covers: Overview of the life sciences sector Pricing, government funding, and reimbursement: National health care system, price regulation and reimbursement Distribution and sale Cross-border trade and parallel imports Advertising and engagement with patient organizations Patents: Conditions for patentability, registration, length of protection, infringement, international treaties Trademarks: Requirements, registration Competition law issues: Authorities and legislation, commercial contracts and competition law, licensing approvals and formalities Product liability: Regulators, medicinal product liability law, liable partners, defenses, product liability claims, remedies Practical Law, produced by Thomson Reuters, is the world’s leading legal know-how resource for business lawyers, publishing a huge range of guides covering hundreds of jurisdictions and practice areas. The full “Life Sciences Commercialization in Indonesia” section can be found on the Practical Law website.
Read More
March 7, 2023
On March 3, 2023, the government of Vietnam issued Decree No. 07/2023/ND-CP (Decree 07) amending Decree 98/2021/ND-CP on medical device management (Decree 98) to resolve many urgent problems in the healthcare sector in Vietnam. Decree 07 took effect on the same day and amends and supplements several articles in its predecessor, Decree 98, which originally took effect on January 1, 2022. Some outstanding points of Decree 07 are summarized below. 1. Registration of Medical Devices The compulsory implementation of the ASEAN Common Submission Dossier Template (CSDT) in registration applications for medical devices will be delayed until January 1, 2024, instead of the deadline of January 1, 2023 under Decree 98. In addition, if after three rounds of amendment/supplementation as requested by the authority, the registration dossiers still have not been approved, the applicants must submit new registration dossiers. 2. Withdrawal of Registration Number Decree 98 adds one case for withdrawing the registration number of a medical device, which is when the documents in the registration dossier are concluded by the authority to be noncompliant with the provisions of law. 3. Listing Price of Medical Devices It is required for establishments manufacturing or trading medical devices to list their prices in locations stipulated under Article 17 of Decree No. 177/2013/ND-CP implementing the Law on Prices (such as at transaction or selling locations of the trading establishments) or on the online portal of the Department of Medical Equipment and Construction’s (DMEC). 4. Price Declaration It is no longer required to declare prices of all medical devices circulating on the Vietnam market. Instead, the Ministry of Health will issue and adjust the list of medical devices subject to price declaration, depending on management requirements and the actual situation, especially when there are abnormal fluctuations in prices affecting the supply of medical devices,
Read More
March 7, 2023
According to the Ministry of Health of Vietnam, many healthcare facilities in the country are facing a shortage of drugs, medical devices, and materials/chemicals. To address the urgent needs of medical examination and treatment in public healthcare facilities, on March 4, 2023, the government of Vietnam promulgated Resolution No. 30/NQ-CP on continuing to implement solutions to ensure the availability of drugs, medical equipment, and healthcare supplies (“Resolution 30”). Resolution 30 amends item 4 of Resolution No. 144/NQ-CP dated November 5, 2022, allowing medical examination and treatment expenses to continue to be covered by health insurance for technical services carried out with medical devices supplied by contractors after winning tenders to supply materials and chemicals. The new mechanism brings more benefit to patients by removing the previous ending date of November 5, 2023, and will be applicable until there is further guidance from the government. Resolution 30 also allows the use of medical devices that were donated or gifted by domestic and foreign entities (including those that were provided under now-expired joint ventures or cooperation contracts) regardless of whether those entities have fulfilled the procedures for ownership establishment. Technical services that are performed by such devices will be covered by health insurance. This provision will help address the shortage of medical devices used in public hospitals. The determination of bid price is also a highlight of Resolution 30, which pilots a simpler price determination procedure for the purchase of drugs and medical devices. Instead of requiring purchasers to obtain quotations from three suppliers, Resolution 30 allows them to compare prices based on the quotations actually received, even from only one or two suppliers. Alternatively, price determination can be based on the winning bid price for a similar medical device procurement package that was awarded within the last 120 days. This
Read More