Circular No. 31/2025/TT-BYT guides the Drug Law and Decree No. 163/2025/NĐ-CP provides guidance and measures for the implementation of the Drug Law issued by the Minister of Health.

 

CIRCULAR

Detailed regulations on certain provisions of the Medicine Law and Decree No. 163/2025/NĐ-CP dated June 29, 2025, of the Government detailing certain provisions and measures to organize and guide the implementation of the Medicine Law

Pursuant to the Medicine Law 2016;

Pursuant to the Law Amending and Supplementing Certain Provisions of the Medicine Law 2024;

Pursuant to Decree No. 163/2025/NĐ-CP dated June 29, 2025, of the Government detailing certain provisions and measures to organize and guide the implementation of the Medicine Law;

Pursuant to Decree No. 42/2025/NĐ-CP dated February 27, 2025 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Drug Administration Department,

The Minister of Health issues this Circular detailing certain provisions of the Medicine Law and Decree No. 163/2025/NĐ-CP dated June 29, 2025, of the Government detailing certain provisions and measures to organize and guide the implementation of the Medicine Law.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular details and guides the implementation of certain provisions of the Medicine Law dated April 6, 2016, and the Law Amending and Supplementing Certain Provisions of the Medicine Law dated November 21, 2024 (hereinafter referred to as the Medicine Law) and Decree No. 163/2025/NĐ-CP dated June 29, 2025, of the Government detailing certain provisions and measures to organize and guide the implementation of the Medicine Law (hereinafter referred to as Decree No. 163/2025/NĐ-CP), including:

1. Announcing, updating, and publicly listing individuals with a Professional Practice Certificate in Pharmacy according to Point g Clause 2 Article 42 of the Medicine Law; the list of pharmacies within a pharmacy chain and the rotation of the person responsible for pharmaceutical matters among pharmacies within a pharmacy chain according to Point g Clause 2 Article 47a of the Medicine Law.

2. Establishments engaged in pharmaceutical activities that are not subject to obtaining a Business License for Pharmaceutical Operations according to Article 35 of the Medicine Law.

3. Selling medicines listed in the Restricted Retail Medicines List according to Clause 2 Article 34 and Point k Clause 2 Article 42 of the Medicine Law.

4. Selling additional medicines at pharmacy counters in areas inhabited by ethnic minorities, mountainous regions, islands, and areas with particularly difficult economic and social conditions according to Point b Clause 1 Article 48 of the Medicine Law.

5. Personnel from pharmaceutical business establishments introducing medicines to medical practitioners and pharmacists according to Point b Clause 6 Article 76 of the Medicine Law; forms and methods of drug information according to Clause 2 Article 78 of the Medicine Law.

6. Requirements for language use in pharmaceutical practice in Vietnam for foreigners and overseas Vietnamese according to Clause 2 Article 14 of the Medicine Law.

7. Organization and operation of the Advisory Council for Issuing Professional Practice Certificates in Pharmacy according to Clause 10 Article 6 of Decree No. 163/2025/NĐ-CP.

Chapter II

ANNOUNCEMENT, UPDATE, AND PUBLIC DISCLOSURE OF THE LIST OF INDIVIDUALS WITH A PROFESSIONAL PRACTICE CERTIFICATE IN PHARMACY; LIST OF PHARMACIES IN A PHARMACY CHAIN; ROTATION OF THE PERSON RESPONSIBLE FOR PHARMACEUTICAL MATTERS AMONG PHARMACIES IN A PHARMACY CHAIN

Article 2. Announcement and update of the list of individuals with a Professional Practice Certificate in Pharmacy currently practicing at the establishment to the competent authority

1. Pharmaceutical business establishments, except for pharmacies within a pharmacy chain, shall directly notify or send via postal service or online to the People's Committee of the province (the specialized health agency under the People's Committee of the province) where the pharmaceutical business establishment operates the list of individuals with a Professional Practice Certificate in Pharmacy currently practicing at the establishment within fifteen days from the date of issuance of the Business License for Pharmaceutical Operations or when there is a change in the individual holding the Professional Practice Certificate in Pharmacy currently practicing at the establishment according to Form No. 02 stipulated in Appendix I attached to this Circular.

2. Establishments organizing a pharmacy chain shall directly notify or send via postal service or online to the specialized health agency under the People's Committee of the province where pharmacies within the pharmacy chain are operating the list of individuals with a Professional Practice Certificate in Pharmacy currently practicing at the pharmacies within the pharmacy chain within fifteen days from the date of issuance of the Business License for Pharmaceutical Operations or when there is a change in the individual holding the Professional Practice Certificate in Pharmacy currently practicing at the establishment according to Form No. 02 stipulated in Appendix I attached to this Circular.

Article 3. Notification and updating of lists of pharmacists practicing; pharmacies in chains when there is rotation of the person responsible for pharmaceutical affairs or changes to pharmacies within the chain of pharmacies

1. When there is a change in pharmacies within the chain of pharmacies:

At least seven (7) working days before adding or removing a pharmacy from the chain of pharmacies, the entity organizing the chain of pharmacies must send a direct notification or through postal service or online to the Ministry of Health and the health administration agency under the People's Committee of the province where the pharmacy being added or removed is located. The notification shall be carried out according to Model No. 03 prescribed in Appendix I issued together with this Circular. The addition or removal of a pharmacy is calculated from the date stated in the notification document of the entity organizing the chain of pharmacies.

2. When there is rotation of the person responsible for pharmaceutical affairs among pharmacies within the chain of pharmacies:

At least seven (7) working days before implementing the rotation, the entity organizing the chain of pharmacies must send a direct notification or through postal service or online along with an electronic file to the health administration agency under the People's Committee of the province where the pharmacy has rotational activities. The notification shall be carried out according to Model No. 04 prescribed in Appendix I issued together with this Circular.

3. In cases where there is a change in the person responsible for pharmaceutical affairs of a pharmacy within the chain of pharmacies that is not a rotation of the person responsible for pharmaceutical affairs within the chain of pharmacies, the pharmacy with the change must carry out procedures to adjust the Certificate of Compliance with Conditions for Pharmaceutical Business Operations in accordance with point c, Clause 3, Article 36 of the Drug Law.

Article 4. Updating and publicizing the list of persons holding a Pharmaceutical Practice Certificate, the list of pharmacies belonging to the chain of pharmacies

1. Within five (5) working days from the date of receiving the list of persons holding a Pharmaceutical Practice Certificate currently practicing at the premises operating in the area as prescribed in Article 2 of this Circular, the health administration agency under the People's Committee of the province shall be responsible for publicly disclosing on the Electronic Information Portal of the health administration agency under the People's Committee of the province the list of persons holding a Pharmaceutical Practice Certificate currently practicing at those premises.

2. Within fifteen (15) days from the date of receiving the notification from the entity organizing the chain of pharmacies as prescribed in Clause 1, Article 3 of this Circular, the Ministry of Health shall be responsible for updating and publicly disclosing the list of pharmacies belonging to the chain of pharmacies on the Ministry of Health's Electronic Information Portal.

3. Within fifteen (15) days from the date of receiving the notification from the entity organizing the chain of pharmacies regarding the rotation of the person responsible for pharmaceutical affairs among pharmacies within the chain of pharmacies as prescribed in Clause 2, Article 3 of this Circular, the health administration agency under the People's Committee of the province shall be responsible for updating and publicly disclosing information about the person responsible for pharmaceutical affairs of the pharmacies that have changed on the Electronic Information Portal of the health administration agency under the People's Committee of the province.

Chapter III

PHARMACEUTICAL ACTIVITY UNITS NOT FALLING WITHIN THE SCOPE OF ISSUANCE OF THE CERTIFICATE OF COMPLIANCE WITH CONDITIONS FOR PHARMACEUTICAL BUSINESS OPERATIONS

Article 5. General Provisions on Entities Engaging in Pharmaceutical Activities Not for Commercial Purposes

1. Entities engaging in pharmaceutical activities not for commercial purposes include the following entities:

a) Public service units;

b) Entities under armed forces that engage in pharmaceutical activities but are not pharmaceutical business entities and are not subject to the provisions of point d, Clause 1, Article 35 of the Medicine Law;

c) Medical examination and treatment facilities, drug rehabilitation facilities, other healthcare facilities with pharmacy departments, pharmacy sections, or activities specified in Clause 2 of this Article; vaccination centers; scientific and technological organizations, training institutions engaged in research and teaching related to pharmaceuticals.

2. Pharmaceutical activities not for commercial purposes include production, compounding, processing, storage, transportation, distribution of medicines and raw materials for medicines, testing of medicines and raw materials for medicines, biological equivalence testing of medicines, clinical trials of medicines conducted by entities specified in Clause 1 of this Article without generating profit.

3. The assessment of compliance with Good Practices for entities engaging in pharmaceutical activities not for commercial purposes shall be carried out in accordance with the regulations on Good Practices issued by the Minister of Health.

Article 6. Documents and Procedures for Announcing Business Entities Organizing Pharmacy Shelves

1. Documents:

a) A declaration form for business entities organizing pharmacy shelves according to Form No. 05 stipulated in Appendix I attached hereto;

b) A certified copy with the signature and stamp of the entity confirming legal documents proving the establishment of the entity for entities without an Investment Certificate or Enterprise Registration Certificate;

c) A certified copy of the primary-level or higher pharmaceutical qualification certificate of the person responsible for professional matters, except in cases where the shared database of certificates is utilized;

d) A list of medicines intended to be sold at the pharmacy shelf. Medicines in this list must be included in the List of Medicines Allowed to Be Sold at Pharmacy Shelves as prescribed in Appendix II attached hereto;

đ) A photograph of the medicine storage cabinets, counters, and shelves;

e) Quality control and supervision procedures; import and export procedures of medicines of the entity.

2. Procedures:

a) Prior to commencing operations, business entities organizing pharmacy shelves shall submit one set of documents for announcing business entities organizing pharmacy shelves as prescribed in Clause 1 of this Article to the specialized health authority of the provincial People's Committee where the pharmacy shelf is located. The submission of documents shall be carried out in accordance with Article 15 of Decree No. 118/2025/NĐ-CP dated June 9, 2025, of the Government on implementing administrative procedures through a single window mechanism and a single gateway interconnection system at the One-Stop Service Center and National Public Service Portal.

In cases where the submission of documents is made online via the Online Public Service Portal, the entity shall submit documents in accordance with Decree No. 45/2020/NĐ-CP dated April 8, 2020, of the Government on implementing administrative procedures in an electronic environment, which has been amended and supplemented by Decree No. 59/2022/NĐ-CP dated September 5, 2022, of the Government on electronic identification and authentication, Decree No. 68/2024/NĐ-CP dated June 25, 2024, of the Government on special-purpose digital signatures, and Decree No. 69/2024/NĐ-CP dated June 25, 2024, of the Government on electronic identification and authentication;

b) Upon receipt of the documents, the specialized health authority of the provincial People's Committee shall issue a document receipt for the announcement of business entities organizing pharmacy shelves according to Form No. 01 stipulated in Appendix I attached hereto to the business entity organizing pharmacy shelves;

c) Within five working days from the date recorded on the document receipt, the specialized health authority of the provincial People's Committee shall issue a decision announcing the business entity meeting the conditions to organize a pharmacy shelf, and publish a list of business entities organizing pharmacy shelves meeting the conditions on the website of the specialized health authority of the provincial People's Committee. In cases where the announcement is not made, a written response stating the reasons must be provided.

Article 7. Cases for Revoking the Announcement of Business Establishments with Medicine Shelves

1. Termination of the operation of medicine shelves or termination of the operation of business establishments with medicine shelves.

2. Business establishments with medicine shelves failing to meet one of the provisions set out in point b, Clause 2, Article 35 of the Drug Law.

3. The content of the announcement of business establishments with medicine shelves not being within the authority or containing content contrary to the law.

4. Forgery of documents in the announcement file of business establishments with medicine shelves.

5. Business establishments with medicine shelves or medicine shelves not operating for a continuous period of 12 (twelve) months without notifying the specialized agency on health under the provincial People's Committee where the establishment is located.

Article 8. Publicizing the Revocation of the Announcement of Business Establishments with Medicine Shelves

1. Within five working days from the date of the conclusion of the competent authority containing a recommendation to revoke the announcement or receiving a request to revoke the announcement related to the cases stipulated in Article 7 of this Circular, the specialized agency on health under the provincial People's Committee shall issue a Decision to revoke the announcement of business establishments meeting the conditions to organize medicine shelves; in case of not revoking the announcement, it must provide a response letter to the organization or individual requesting the revocation and clearly state the reasons.

2. Within five working days from the date of issuance of the Decision to revoke the announcement of business establishments meeting the conditions to organize medicine shelves, the specialized agency on health under the provincial People's Committee shall be responsible for:

a) Publishing the Decision to revoke the announcement of business establishments meeting the conditions to organize medicine shelves on the Electronic Information Portal of the specialized agency on health under the provincial People's Committee and sending this Decision to the Ministry of Health;

b) Updating information on the revocation of the announcement of business establishments with medicine shelves on the Electronic Information Portal of the specialized agency on health under the provincial People's Committee.

Article 9. Responsibilities of Business Establishments Engaging in Pharmaceutical Activities Not Requiring a Certificate of Eligibility for Pharmaceutical Business

1. Must have signage for areas engaged in pharmaceutical activities placed in easily observable locations and of appropriate size for easy recognition by the public and comply with the following requirements:

a) For business establishments engaging in pharmaceutical activities not for commercial purposes: The signage must contain information about the pharmaceutical activities carried out;

b) For business establishments organizing medicine shelves: The signage must include the name and address of the establishment, and the name of the person responsible for professional matters;

c) For business establishments cultivating and harvesting medicinal herbs: The signage must include the name, address of the establishment, and scope of operations;

d) For medical facilities under the people's armed forces, military-civilian medical facilities providing medicines in ethnic minority regions, mountainous areas, islands, and economically disadvantaged regions: The signage must include the scope of operations and the name of the person responsible for professional matters.

Signage at mobile retail drug sales points of medical facilities under the people's armed forces, military-civilian medical facilities providing medicines in ethnic minority regions, mountainous areas, islands, and economically disadvantaged regions shall be implemented in accordance with Clause 4, Article 26 of Decree No. 163/2025/NĐ-CP.

2. Shall be responsible for ensuring and maintaining the operational conditions of the establishment as prescribed in Clause 2, Article 35 of the Drug Law, the source of drugs, and the quality of drugs supplied by the establishment.

Chapter IV

SELLING DRUGS IN THE LIST OF DRUGS WITH RESTRICTED RETAIL SALES AND ADDITIONAL SALE OF DRUGS AT PHARMACY COUNTERS

Article 10. List of restricted over-the-counter drugs

1. Restricted over-the-counter drugs are those requiring strict monitoring of prescription writing, drug dispensing according to prescriptions, and usage to ensure safety, efficacy, and prevent drug abuse during treatment which may lead to drug dependence or non-response when using such drugs or other drugs.

2. The list of restricted over-the-counter drugs is specified in Appendix III attached to this Circular.

3. Based on the local disease structure, the Department of Health shall issue a document allowing the sale of certain restricted over-the-counter drugs listed in Article 40 of Decree No. 163/2025/NĐ-CP. The local disease structure is determined based on the health statistics yearbook, surveys, and scientific research that have been published.

Article 11. Selling additional prescription drugs at pharmacies in ethnic minority areas, mountainous regions, islands, and areas with extremely difficult socio-economic conditions

Based on the local disease structure and epidemic situation, the specialized agency under the provincial People's Committee shall issue a document allowing pharmacies in ethnic minority areas, mountainous regions, islands, and areas with extremely difficult socio-economic conditions to sell additional prescription drugs not included in the Essential Medicines List.

Chapter V

PROVISIONS ON THE METHODS AND FORMS OF DRUG INFORMATION AND DRUG INTRODUCERS BY PHARMACEUTICAL BUSINESS ENTITIES

Article 12. Methods of drug information dissemination

1. Drug information dissemination by pharmaceutical business entities, foreign traders' representative offices operating in the pharmaceutical sector in Vietnam, and registration agencies for practitioners of medical examination and treatment and pharmacy professionals shall be carried out through the following methods:

a) Through "Drug Introducers";

b) Providing drug information materials;

c) Drug introduction seminars.

2. Drug information dissemination to drug users shall be carried out through the following methods:

a) Through guidance on drug use provided by medical examination and treatment practitioners; advice from pharmacy professionals engaged in clinical pharmacy and drug use consultants at retail pharmacies;

b) Through drug use instruction leaflets approved by competent authorities;

c) Pharmaceutical business entities, foreign traders' representative offices operating in the pharmaceutical sector in Vietnam, and registration agencies shall provide drug information materials to patients and their representatives to guide them on drug use and monitor drug safety.

Article 13. Provisions on implementing methods of drug information dissemination

1. Through "Drug Introducers": implemented in accordance with Articles 14, 15, and 16 of this Circular.

2. Provision of drug information materials:

a) Pharmaceutical business entities, foreign traders' representative offices operating in the pharmaceutical sector in Vietnam, and registration agencies shall develop drug information materials suitable for the target audience in accordance with Clause 5 of Article 76 of the Pharmacy Law and Articles 19 and 20 of this Circular. The drug information material must clearly state the name of the entity providing the material; for paper-based materials, they must bear the seal of the entity providing the material;

b) When disseminating drug information, pharmaceutical business entities, foreign traders' representative offices operating in the pharmaceutical sector in Vietnam, and registration agencies must provide drug information materials to the correct target audience;

c) Pharmaceutical business entities, foreign traders' representative offices operating in the pharmaceutical sector in Vietnam, and registration agencies must retain samples of drug information materials and related documents used to develop such materials at their premises for presentation to competent authorities upon request.

3. Drug introduction seminars:

a) Drug introduction seminars are sessions introducing drugs or discussing topics related to drugs for medical examination and treatment practitioners and pharmacy professionals;

b) Drugs not yet registered for circulation in Vietnam but permitted for importation can only be disseminated through drug introduction seminars organized by the importing entity or another authorized pharmaceutical business entity. Drugs with circulation registration certificates can be disseminated through drug seminars organized by entities specified in point b of Clause 6 of Article 76 of the Pharmacy Law;

c) Reporters at the seminar must be individuals with medical or pharmaceutical expertise, knowledgeable and experienced in the type of drug being introduced;

d) At least two working days before conducting drug information dissemination through drug introduction seminars, the organizing entity must notify the specialized health agency under the provincial People's Committee about the seminar program, presentations to be used, participants, time, and location of the drug introduction seminar;

đ) The entity organizing the drug introduction seminar must ensure that drug information is disseminated to the correct target audience as prescribed, and must retain all relevant seminar-related documents for presentation to competent authorities upon request.

Article 14. Requirements for drug promoters

1. A drug promoter is a person hired by a pharmaceutical business establishment and issued a "Drug Promoter" card by the head of that establishment to provide information about the drugs sold by that business to medical practitioners and pharmacists.

2. Drug promoters must meet the following requirements:

a) Possess a college degree or higher in a specialized field of medicine or pharmacy;

b) Be hired and trained by the pharmaceutical business establishment in skills and professional knowledge related to drug promotion activities and pharmaceutical laws and regulations;

c) Not be under criminal investigation, serving a court judgment or decision, or prohibited from practicing their profession or engaging in work related to pharmaceutical activities according to a court judgment or decision; not have lost civil capacity or have difficulty in understanding or controlling their actions, or have limited civil capacity.

Article 15. Responsibilities of drug promoters

1. Must wear the "Drug Promoter" card issued by the pharmaceutical business establishment and comply with internal rules established by the medical and healthcare facility as stipulated in Clause 2, Article 17 of this Circular when promoting drugs. A drug promoter may only promote drugs with the consent of medical practitioners and pharmacists.

2. Promote drugs that have been granted circulation permits in Vietnam according to the list assigned by the pharmaceutical business establishment and can only provide information about the drugs as recorded on the label, the approved drug usage guide, and other materials specified in Clause 3, Article 76 of the Pharmacy Law.

3. Present legal documents proving the legitimacy of the drug information provided upon request by the head of the medical and healthcare facility or medical practitioners and pharmacists.

4. Collect information and report to the pharmaceutical business establishment about adverse drug reactions and quality-related information during the promotion process so that the business establishment can promptly compile and report to the competent authority of the Ministry of Health according to the National Medication Alert Guidelines issued by the Ministry of Health.

5. Shall not engage in the following acts:

a) Promoting drugs without being assigned to do so by the pharmaceutical business establishment;

b) Using material benefits in any form to influence medical practitioners and pharmacists to promote drug prescriptions, sales, and use;

c) Providing drug information inconsistent with the materials specified in Clause 3, Article 76 of the Pharmacy Law;

d) Comparing and promoting their own drugs as superior to those of other establishments without scientific evidence approved by the competent authority attached to prove such claims;

e) Promoting products that are not drugs;

f) Engaging in activities related to buying, selling, or storing drugs with medical practitioners;

g) Accessing patients, medical records, prescriptions, discussions, or requesting information related to patients;

h) Providing drug information materials to unauthorized recipients.

Article 16. Responsibilities of the Head of a Pharmaceutical Business with Drug Promoters

1. Shall be responsible for the activities and information about drugs promoted by drug promoters at the pharmaceutical business.

2. Train and instruct persons recruited to perform the role of drug promoters to meet the requirements stipulated in Clause 2 of Article 14 of this Circular.

3. Provide drug promoters with all necessary legal documents and technical materials to ensure that the drug promotion information provided by drug promoters is lawful as prescribed in this Circular.

4. Issue the "Drug Promoter Card" according to Form No. 06 prescribed in Appendix I attached to this Circular to persons of the business who meet the requirements stipulated in Clause 2 of Article 14 of this Circular.

5. Within the latest three (3) working days from the date of issuing the card, the pharmaceutical business must directly send or send through postal services or online the list of persons issued the "Drug Promoter Card" according to Form No. 07 prescribed in Appendix I attached to this Circular to the health administration agency under the provincial People's Committee where the drug promoter conducts promotional activities.

In case of adding new drug promoters or changing information on the drug promoter card, the pharmaceutical business must issue the "Drug Promoter Card" in accordance with Clause 4 of this Article and update the list of drug promoters as prescribed in this Article.

6. Revoke the "Drug Promoter Card" already issued in the following cases:

a) The drug promoter terminates their labor contract with the pharmaceutical business;

b) The drug promoter ceases to perform the role of promoting drugs;

c) After being issued the card, the drug promoter does not meet the requirements stipulated at points a and c of Clause 2 of Article 14 of this Circular;

d) The drug promoter commits one of the acts prescribed in Clause 5 of Article 15 of this Circular.

7. Within the maximum period of three (3) working days from the date of revoking the card, the pharmaceutical business must directly send or send through postal services or online the list of persons whose cards have been revoked according to Form No. 08 prescribed in Appendix I attached to this Circular to the health administration agency under the provincial People's Committee where the drug promoter conducts promotional activities.

8. Not to reissue the "Drug Promoter Card" within at least twelve (12) months from the date of revoking the card for persons of the business who have had their cards revoked due to the circumstances specified at point d of Clause 6 of this Article.

Article 17. Responsibilities of the Head of a Medical Examination and Treatment Facility when there are Drug Promoters Engaged in Promotion Activities

1. Only allow those with a "Drug Promoter Card" and listed in the list of persons issued the "Drug Promoter Card" on the website of the health administration agency under the provincial People's Committee to conduct drug promotion activities and provide drug information materials that comply with relevant laws.

2. Enact and implement internal regulations specifying the components, location, time for organizing drug information dissemination to medical practitioners and other related provisions to ensure that drug promoters conducting drug promotion activities at the facility comply with the drug promotion regulations set forth in this Circular.

3. Regularly inspect, supervise, and take measures to prevent the act of prescribing and guiding the use of drugs by medical practitioners of the facility for profit purposes influenced by material, financial, or any other form of inducement from drug promoters.

4. Immediately suspend the activity of drug promoters within the scope of the facility upon discovering that they fail to fulfill the responsibilities of drug promoters as prescribed in Article 15 of this Circular and inform the head of the pharmaceutical business with drug promoters who violate the rules.

Article 18. Responsibilities of the health administration agency under the People's Committee of the province where the person introducing drugs is located

1. Announce or cancel the announcement of the list of persons who have been issued a "Drug Introducer Card" on the website of the health administration agency under the People's Committee of the province within three (3) working days from the date of receipt of the list of persons who have been issued or whose card has been revoked by the pharmaceutical business entity in accordance with Clause 5 or Clause 7 of Article 16 of this Circular.

2. Direct healthcare facilities within its jurisdiction to fully and properly fulfill the responsibilities of the heads of healthcare facilities as stipulated in Article 17 of this Circular when drug introducers are operating.

3. Inspect and supervise drug introduction activities; handle violations committed by drug introducers and pharmaceutical business entities operating drug introducers within its jurisdiction in compliance with the regulations on drug introduction set forth in this Circular.

Article 19. Provisions for drug information formats

1. Drug information materials must display all required drug information contents as prescribed in Point a and b of Clause 5 of Article 76 of the Medicine Law; they shall not contain unrelated information or images that are not directly related to the drug or its usage, nor shall they include information or images as prescribed in Article 20 of this Circular. In cases where drug information materials are presented in audio or video form, the drug information must be read out loud and clearly or displayed fully in accordance with the regulations.

2. Drug information materials must clearly annotate the source material and specify the portion of information cited from the source material. Citations must accurately convey the information without inference or addition/subtraction that could mislead about the safety or efficacy of the drug.

3. The basis for constructing drug information must comply with the provisions of Clause 3 of Article 76 of the Medicine Law. Where drug information in the materials specified in Clause 3 of Article 76 of the Medicine Law is inconsistent, the drug information must be based on the Drug Usage Instructions approved by the Ministry of Health.

4. Drug information materials must have the phrase "Drug Information Material" at the beginning of the document. For multi-page materials, the phrase "Drug Information Material" must appear at the top of each page, pages must be numbered, and the first page must clearly indicate the detailed product information available on which specific page (specify the page number).

5. Drug information content must be in Vietnamese, except in cases where the information cannot be translated into Vietnamese or would lose meaning if translated into Vietnamese.

6. The font size in drug information content must be clear and legible but not smaller than size 12 of the VnTime or Times New Roman font on A4 paper.

7. In cases where drug information is provided through a drug introduction seminar, the drug information must include the name and scientific title of the presenter.

8. In cases where drug information is provided through materials guiding the use of drugs and monitoring their safety, it must clearly state "drug information material for patients/patients' representatives."

Article 20. Information and images that shall not be used in drug information

1. Information and images prohibited under the Advertising Law 2012, amended and supplemented in 2018 and 2024.

2. Information and images causing misunderstanding about the ingredients, effects, functions, indications, origin of drugs.

3. Information and images creating the impression: This drug is number one; this drug is better than all others; using this drug is the best measure; using this drug does not require a doctor's opinion; this drug is completely harmless; this drug has no contraindications; this drug has no adverse effects; this drug is safe; this drug has no harmful effects.

4. Phrases, words, images that exaggerate to the point of misleading regarding the effects, functions, indications, efficacy of the drug or exceeding the approved effects, functions, indications, and efficacy of the drug.

5. Stating the effect of each component in the drug to overstate the function of the drug or cause confusion between the effect of each component and the effect of the drug.

6. Words and phrases: "treat the root cause", "eradicate", "specialize in treating", "top", "first place", "first choice", "high quality", "guaranteed 100%", "stop", "cut off", "halt", "reduce immediately", "reduce instantly", "immediately cured", "completely cured", "rest assured", "no worries", "no need to worry", "recommended", "hotline" and other words and phrases with similar meanings.

7. Quality testing results of drugs and raw materials for drugs.

8. Preclinical research results.

9. Clinical research results or bioequivalence test results not recognized by the Ministry of Health.

10. Using unapproved certifications, using images, names, symbols of healthcare staff; exploiting the name of organizations, individuals, various symbols, images, positions, reputation, letters, thank-you letters to provide drug information.

11. Incomplete information on the origin of drugs and raw materials for drugs.

12. Images of animals and plants listed in the priority protection endangered, precious, and rare species catalog.

13. Phrases and words that suggest or spread orally to guide or recommend drug usage.

14. Using patient images to describe disease conditions or drug functions not consistent with relevant drug documentation and clinical guidelines issued or recognized by the Ministry of Health.

Chapter VI

REQUIREMENTS FOR THE USE OF LANGUAGE IN PHARMACEUTICAL PRACTICE FOR FOREIGNERS AND VIETNAMESE RESIDENTS ABROAD; ORGANIZATION AND ACTIVITIES OF THE BOARD FOR ISSUING PHARMACEUTICAL PRACTICE LICENSES

Article 21. Requirements for the use of language in pharmaceutical practice for persons responsible for pharmacy at retail drug outlets and persons in charge of clinical pharmacy work at medical examination and treatment facilities

1. Persons responsible for pharmacy at retail drug outlets and persons in charge of clinical pharmacy work at medical examination and treatment facilities who are foreigners and Vietnamese residents abroad must be proficient in Vietnamese; if they are not proficient in Vietnamese, they must register the language to be used and have an interpreter.

2. Foreigners and Vietnamese residents abroad who are not yet proficient in Vietnamese in pharmaceutical practice, the Pharmaceutical Practice License must state "interpreter required during practice." When practicing pharmacy, the application for a Drug Business Qualification Certificate must include a contract with an interpreter.

3. If it is found during practice that foreign persons and Vietnamese residents abroad engaged in pharmaceutical practice do not meet the language requirements for pharmaceutical practice stipulated in Clause 1 and Clause 2 of this Article, the competent authority shall revoke the Pharmaceutical Practice License.

A retail drug outlet with a person responsible for pharmacy whose Pharmaceutical Practice License has been revoked according to this provision will have its Drug Business Qualification Certificate revoked; the head of a medical examination and treatment facility with a person in charge of clinical pharmacy work whose Pharmaceutical Practice License has been revoked according to this provision must arrange a replacement to ensure compliance with legal regulations on the organization and operation of clinical pharmacy.

Article 22. Establishment of the Advisory Council for Issuing Pharmaceutical Practice Certificates

1. The Minister of Health shall issue a decision to establish the Advisory Council for Issuing Pharmaceutical Practice Certificates in the form of an examination (hereinafter referred to as the Advisory Council for Issuing Pharmaceutical Practice Certificates of the Ministry of Health).

2. The Director of the Department of Health shall issue a decision to establish the Advisory Council for Issuing Pharmaceutical Practice Certificates in the form of a review of application files (hereinafter referred to as the Advisory Council for Issuing Pharmaceutical Practice Certificates of the Department of Health).

Article 23. Composition of the Advisory Council for Issuing Pharmaceutical Practice Certificates

1. The Advisory Council for Issuing Pharmaceutical Practice Certificates of the Ministry of Health must include the following components: Chairman of the Council, Vice-Chairman of the Council, Secretary, and members, specifically: Leaders of the Ministry of Health, Leaders of the Drug Administration, Leaders of the Traditional Medicine and Drugs Management Bureau for cases where certificates are issued for the scope of only trading in medicinal herbs and traditional drugs, Leaders of the Science, Technology and Training Bureau, Leaders of the Legal Affairs Department, representatives of pharmaceutical associations, and staff from relevant units under the Ministry of Health.

2. The Advisory Council for Issuing Pharmaceutical Practice Certificates of the Department of Health must have at least three (3) members, including one member who is a representative of a pharmaceutical association.

Article 24. Activities of the Advisory Council for Issuing Pharmaceutical Practice Certificates

1. The Advisory Council for Issuing Pharmaceutical Practice Certificates is responsible for drafting the Rules of Operation of the Advisory Council to be submitted to the Minister of Health or the Director of the Department of Health for approval and implementation after approval.

2. The Advisory Council for Issuing Pharmaceutical Practice Certificates is responsible for advising the issuing authority on matters related to issuing, reissuing, and revoking Pharmaceutical Practice Certificates.

Chapter VII

IMPLEMENTING PROVISIONS

Article 25. Effective Date

Article 32. Responsibilities of Agencies

2. Circular No. 07/2018/TT-BYT dated April 12, 2018, detailing certain provisions of the Pharmacy Law and Decree No. 54/2017/NĐ-CP dated May 8, 2017, detailing certain provisions and measures for implementing the Pharmacy Law, shall cease to be effective from July 1, 2025.

Article 26. Cross-referencing Provisions

In case the regulatory legal documents and provisions cited in this Circular are amended, supplemented, or replaced, they shall be implemented according to the new regulatory legal documents.

Article 27. Responsibility for Implementation

1. The Drug Administration; the Traditional Medicine and Drugs Management Bureau; units under the Ministry of Health; Departments of Health of provinces and centrally-administered cities; provincial People's Committees; agencies, organizations, and individuals concerned are responsible for organizing the implementation and monitoring the implementation of the provisions of this Circular.

2. Entities specified in Clause 1 of Article 5 of this Circular are responsible for ensuring the implementation of good practices according to the schedule set out in Article 122 of Decree No. 163/2025/NĐ-CP. An entity may only carry out commercial activities related to the pharmaceutical sector when it has been granted a Certificate of Eligibility for Pharmaceutical Business by the competent authority in accordance with the Pharmacy Law and Decree No. 163/2025/NĐ-CP. During the implementation process, if there are difficulties or obstacles, agencies, organizations, and individuals should report to the Ministry of Health (Drug Administration; Traditional Medicine and Drugs Management Bureau) for consideration and resolution.

During the implementation process, if there are difficulties or obstacles, agencies, organizations, and individuals should report to the Ministry of Health (Drug Administration; Traditional Medicine and Drugs Management Bureau) for consideration and resolution./.

 

 

ANNEX I

SAMPLE FORMS
(Attached to Circular No. 31/2025/TT-BYT dated July 1, 2025, issued by the Minister of Health)

 

Form No. 01. Application Form

 

1. Declaring entity:

APPLICATION FILE…⁽²⁾……………………….

1. Submitting Unit: …

2. Address of submitting unit (if submitting via postal service):

3. Method of submission: Directly □             Postal Service □

First submission □                              Supplementary submission number ...⁽³⁾... □

4. Number and date of document of the submitting unit (if any): …

5. List of documents ⁽⁴⁾:......................................................................................

When collecting results, please bring this Application Form and present your Identity Card or equivalent identification of the person collecting.⁽⁵⁾

Note:

(1) Application Form Number

(2) Name of administrative procedure.

(3) Record supplementary submissions.

(4) Corresponding documents according to the administrative procedures stipulated in the Circular (list in detail or attach a list).

(5) In case the person collecting is not named on the Pharmaceutical Practice Certificate or the Certificate of Eligibility for Pharmaceutical Business, a Power of Attorney or Introduction Letter from the facility is required.

 

Form No. 02. List of Individuals with Pharmaceutical Practice Certificates Currently Practicing at the Facility

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
---------------

LIST OF INDIVIDUALS WITH PHARMACEUTICAL PRACTICE CERTIFICATES

Respectfully submitted to:...

1. Name of pharmaceutical business facility:…

Number of Certificate of Eligibility for Pharmaceutical Business, date of issuance:

2. Address:…

3. Duration of operation of the pharmaceutical business facility: ⁽¹⁾...........................

4. List of individuals with Pharmaceutical Practice Certificates currently practicing at the facility (for newly licensed facilities) and list of additional practitioners (for facilities that have already reported but added more practitioners) ⁽²⁾:

5. List of individuals with Pharmaceutical Practice Certificates no longer practicing at the facility:

Basis for commitment and full responsibility for the accuracy of the provided information.

Note:

(1) Specify from what time to what time on the day and how many days of the week;

(2) In cases where there has been a notification but additional practitioners are added, the establishment only lists the supplementary individuals.

The document uses Vietnamese font, Times New Roman style, Unicode character set according to Vietnam Standard TCVN 6909:2001.

 

Form number 03. List of pharmacies added to or removed from the pharmacy chain

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
---------------

LIST OF PHARMACIES ADDED TO OR REMOVED FROM THE PHARMACY CHAIN
AND THE PHARMACY CHAIN

Respectfully submitted to: ...

1. Name of the organization operating the pharmacy chain:...

2. Address:…

3. List of pharmacies added to or removed from the pharmacy chain

Basis for commitment and full responsibility for the accuracy of the provided information.

Note: The document uses Vietnamese font, Times New Roman style, Unicode character set according to Vietnam Standard TCVN 6909:2001.

 

Form number 04. List of pharmacists responsible for professional duties transferred between pharmacies within the pharmacy chain

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
---------------

LIST OF PHARMACISTS RESPONSIBLE FOR PROFESSIONAL DUTIES
TRANSFERRED BETWEEN PHARMACIES WITHIN THE PHARMACY CHAIN

Respectfully submitted to: ...

1. Name of the organization operating the pharmacy chain:...

2. Address:…

3. List of pharmacists responsible for professional duties transferred between pharmacies within the pharmacy chain:

Basis for commitment and full responsibility for the accuracy of the provided information.

Remarks:

The document uses Vietnamese font, Times New Roman style, Unicode character set according to Vietnam Standard TCVN 6909:2001.

 

Form number 05. Announcement of business establishment with organized medicine shelves

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
---------------

ANNOUNCEMENT

Business establishment with organized medicine shelves

Respectfully submitted to: ...

1. Name of establishment:...

3. Telephone: …;   Fax: …; Email: …

3. Telephone:... Email (if available)... Website (if available)...

4. After studying Circular No. .../2025/TT-BYT dated...../.../2025 of the Minister of Health detailing certain provisions of the Medicine Law and Decree No. 163/2025/NĐ-CP dated June 29, 2025 of the Government detailing certain provisions of the Medicine Law and measures to organize and guide the implementation of the Medicine Law and other current guiding documents, we hereby announce our business establishment with organized medicine shelves.

Attached to this announcement are the documents submitted as prescribed in Clause 1, Article 6 of the Circular.

The establishment commits and fully accepts responsibility for the accuracy and validity of the documents and information provided in the dossier.

Note:

The document uses Vietnamese font, Times New Roman style, Unicode character set according to Vietnam Standard TCVN 6909:2001.

 

Form number 06. "Pharmaceutical Product Promoter" card

Note:

- Card size: 5.5 x 9.0 cm.

- Vietnamese font, Times New Roman style, Unicode character set according to Vietnam Standard TCVN 6909:2001.

- Font size:

+ (1): 10, bold

+ (2): 12, bold

+ (3): 12

+ (4): 14, bold

+ (5): 12

 

Form number 07. List of persons issued "Pharmaceutical Product Promoter" cards

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
---------------

LIST OF PERSONS ISSUED "PHARMACEUTICAL PRODUCT PROMOTER" CARDS

Respectfully submitted to: ...

1. Name of pharmaceutical business facility:…

2. Address:…

3. List of persons issued "Pharmaceutical Product Promoter" cards belonging to the establishment conducting promotional activities in the area:

Basis for commitment and full responsibility for the accuracy of the provided information.

Note: Document uses Vietnamese font, Times New Roman style, Unicode character set according to Vietnam Standard TCVN 6909:2001.

 

Form number 08. List of persons whose "Pharmaceutical Product Promoter" cards have been revoked

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
---------------

LIST OF REVOKED "PHARMACEUTICAL PRODUCT PROMOTER" CARDS

Respectfully submitted to: ...

1. Name of pharmaceutical business facility:…

2. Address:…

3. List of persons issued "Pharmaceutical Product Promoter" cards that have been revoked:

Basis for commitment and full responsibility for the accuracy of the provided information.

Note: Document uses Vietnamese font, Times New Roman style, Unicode character set according to Vietnam Standard TCVN 6909:2001.

 

ANNEX II

LIST OF MEDICINES SOLD AT MEDICINE SHELVES
(Attached to Circular No. 31/2025/TT-BYT dated July 1, 2025, issued by the Minister of Health)

 

ANNEX III

Retail sale restricted for indications specified on prescriptions (*)
(Attached to Circular No. 31/2025/TT-BYT dated July 1, 2025, issued by the Minister of Health)

Data quality is evaluated based on the following table:: For medicines listed in items from number 1 to 22, if the prescription does not specify the restriction on retail sale as indicated in the column "Retail sale restrictions for indications on prescriptions," then the regulation on restricting retail sale shall not be applied.