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July 8, 2025

Vietnam Issues New Guidance for Amended Law on Pharmacy

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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.

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