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 22, 2021
Following the recent imposition of sanctions on Myanmar individuals and companies by the US, the UK and Canada have now imposed new sanctions. As with the US sanctions, these new measures impact UK and Canadian citizens and companies, and non-UK and non-Canadian companies and citizens with interests in those jurisdictions. The EU has indicated that it is planning to issue similar sanctions in the near future. New UK Sanctions In addition to the 16 individuals already sanctioned by the UK government, on February 18, 2021, the UK government announced that three individuals have been sanctioned for serious human rights violations and are now subject to asset freezes and travel bans. The full list of Myanmar individuals and companies sanctioned by the UK is available on the website of the Office of Financial Sanctions Implementation. Breaches of UK financial sanctions are criminal offences punishable in the UK by up to 7 years imprisonment and heavy fines. New Canadian Sanctions Also on February 18, timed to coincide with the UK sanctions, new Canadian sanctions were imposed on nine individuals. As with the UK, Canada already had a number of individuals in the Myanmar military on its sanctions list, and the new additions bring the total number of individuals sanctioned by Canada to 54. All assets of these individuals in Canada are now frozen, and they are banned from travelling to Canada. Canadian businesses or entities may not do business with any of the 54 individuals. Full details of the impact of the sanctions are available on the Government of Canada’s website, as is a database of the Myanmar individuals and companies subject to them. Breach of Canadian sanctions carries with it up to 5 years’ imprisonment in Canada and/or a large fine. Other Countries The EU is reportedly drawing up sanctions
Read More
February 18, 2021
As you will no doubt know, on February 1, 2021, the Myanmar military declared a state of emergency in Myanmar for a period of one year. State Counsellor Daw Aung Sang Su Kyi was detained, as were the president and various significant political and civil leaders. Min Aung Hlaing, commander-in-chief of the Tatmadaw (Myanmar armed forces) has installed himself as chairman of the State Administration Council, the current administration. New sanctions The reaction of the Biden administration has been swift. On February 10, 2021, President Biden issued Executive Order 14014, which provides bases to impose sanctions on individuals and companies deemed by the US to, among other things: operate in the defense sector of Myanmar; be responsible for policies that undermine democratic processes in Myanmar; have taken actions to undermine democratic processes or institutions, or prohibit, limit, or penalize the exercise of free speech, in Myanmar; or be a spouse or child of the foregoing. On the next day, February 11, the US Office of Foreign Assets Control (OFAC), imposed sanctions under the new executive order on ten individuals—including General Min Aung Hlaing—and three companies, including Cancri Gems & Jewelry Co, Myanmar Imperial Jade Co, and Myanmar Ruby Enterprise.  All such individuals and companies have now been designated on the US list of specially designated nationals (SDNs). Effect of sanctions As a result of such sanctions, the property of these individuals or companies that is located in the US or is under the possession or control of US companies and citizens is frozen, and US companies and citizens are generally prohibited from dealing deal with any such property.  Reportedly, roughly USD 1 billion of funds belonging to the individuals and companies blocked on February 11 are located in the US and thus now frozen. The SDN list As many
Read More
February 1, 2021
The latest edition of Practical Law’s Life Sciences Global Guide features contributions from Tilleke & Gibbins attorneys in the firm’s Yangon office. One of the sections they have provided for the Myanmar chapter of this Q&A-style guide to life sciences regulatory frameworks worldwide is “Medicinal Product Regulation and Product Liability in Myanmar.” The section includes discussion of a range of regulatory issues related to the marketing and selling of pharmaceutical products, including the following topics: Regulatory overview: Authorities, scope, and general procedures for pharmaceuticals, biologicals, and medical devices and health care IT Pricing, government funding, and reimbursement: National health care system, price regulation, and reimbursement Clinical trials Manufacturing and distribution Marketing: Authorization for marketing medicinal products, parallel imports and cross-border trade in medicines Restrictions on dealings with health care professionals Selling restrictions Advertising and promotion Data privacy Packaging, labeling, and tracking Product safety, quality, and liability Local establishment, representation, and residency requirements Reform The full “Medicinal Product Regulation and Product Liability in Myanmar” section can be accessed on the Practical Law website. 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. Tilleke & Gibbins also supplied “Pharmaceutical IP and Competition Law in Myanmar,” which was published in the Life Sciences Global Guide  at the same time.
Read More
February 1, 2021
Attorneys from Tilleke & Gibbins in Myanmar have contributed to the latest edition of Practical Law’s online Life Sciences Global Guide. The guide is a Q&A-style overview of the regulatory frameworks for the life sciences industry across multiple jurisdictions worldwide, and this year the Myanmar chapter includes two sections, one of which is “Pharmaceutical IP and Competition Law in Myanmar.” This section runs through the country’s legal and regulatory environment for patents and trademarks—particularly as they relate to pharmaceutical business in the jurisdiction. The section then turns to IP and competition law issues, with questions and answers focusing on how the country’s competition laws and regulations affect the pharmaceutical sector. Readers are also given information on how to properly comply with Myanmar law on competition, including when it comes to licensing of medicines and pharmaceutical technology. The full Pharmaceutical Intellectual Property and Competition Law in Myanmar guide can be accessed on the Practical Law website. 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. Tilleke & Gibbins also supplied the “Medicinal Product Regulation and Product Liability in Myanmar,” which Practical Law published in its Life Sciences Global Guide  at the same time.
Read More