Circular 31/2025/TT-BYT detailing the Law on Pharmacy and Decree 163/2025/ND-CP

CIRCULAR
Detailing a number of articles of the Law on Pharmacy and
the Government’s Decree No. 163/2025/ND-CP dated June 29, 2025
detailing a number of articles and measures to organize and guide the implementation of the Law on Pharmacy

Pursuant to the 2016 Law on Pharmacy;

Pursuant to the 2024 Law Amending and Supplementing a Number of Articles of the Law on Pharmacy;

Pursuant to the Government’s Decree No. 163/2025/ND-CP dated June 29, 2025, detailing a number of articles and measures to organize and guide the implementation of the Law on Pharmacy;

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

At the proposal of the Director General of the Drug Administration of Vietnam;

The Minister of Health promulgates this Circular detailing a number of Articles of the Law on Pharmacy and the Government’s Decree No. 163/2025/ND-CP dated June 29, 2025, detailing a number of Articles and measures to organize and guide the implementation of the Law on Pharmacy.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Circular details and guides the implementation of a number of articles of the Law on Pharmacy dated April 6, 2016, and the Law Amending and Supplementing a Number of Articles of the Law on Pharmacy dated November 21, 2024 (hereinafter referred to as the Law on Pharmacy), and the Government’s Decree No. 163/2025/ND-CP dated June 29, 2025, detailing a number of Articles and measures to organize and guide the implementation of the Law on Pharmacy (hereinafter referred to as Decree No. 163/2025/ND-CP), including:

1. Notification, updating and publication of the list of persons possessing pharmacy practice certificates as prescribed at Point g, Clause 2, Article 42 of the Law on Pharmacy; the list of drugstores in a drugstore chain and the rotation of persons in charge of professional pharmacy activities among drugstores in a drugstore chain as prescribed at Point g, Clause 2, Article 47a of the Law on Pharmacy.

2. Establishments engaged in pharmacy activities not required to have a certificate of eligibility for pharmaceutical business as prescribed in Article 35 of the Law on Pharmacy.

3. Sale of drugs on the List of drugs restricted from retail as prescribed in Clause 2, Article 34, and Point k, Clause 2, Article 42 of the Law on Pharmacy.

4. Additional retail sale of drugs at dispensaries located in ethnic minority areas, mountainous areas, islands, and areas with extremely difficult socio-economic conditions as prescribed at Point b, Clause 1, Article 48 of the Law on Pharmacy.

5. Employees of pharmaceutical business establishments introducing drugs to medicine practitioners and pharmacy practitioners as prescribed at Point b, Clause 6, Article 76 of the Law on Pharmacy; forms and methods of drug information as prescribed in Clause 2, Article 78 of the Law on Pharmacy.

6. Requirements on language use in pharmacy practice in Vietnam applicable to foreigners and overseas Vietnamese as prescribed in Clause 2, Article 14 of the Law on Pharmacy.

7. Organization and operation of the Advisory Council for Grant of Pharmacy Practice Certificates as prescribed in Clause 10, Article 6 of Decree No. 163/2025/ND-CP.

Chapter II

NOTIFICATION, UPDATING AND PUBLICATION OF THE LIST OF PERSONS POSSESSING PHARMACY PRACTICE CERTIFICATES; THE LIST OF DRUGSTORES IN A DRUGSTORE CHAIN; AND THE ROTATION OF PERSONS IN CHARGE OF PROFESSIONAL PHARMACY ACTIVITIES AMONG DRUGSTORES IN A DRUGSTORE CHAIN

Article 2. Notification and updating of the list of persons possessing pharmacy practice certificates practicing at establishments to competent agencies

1. Pharmaceutical business establishments, except for drugstores in a drugstore chain, shall send a notification, either directly, by postal service or electronically, to the provincial-level People’s Committee (the health professional agency under the provincial-level People’s Committee) where the pharmaceutical business establishment operates, of the list of persons possessing pharmacy practice certificates who are practicing pharmacy at the establishment, within 15 (fifteen) days from the date of issuance of the certificate of eligibility for pharmaceutical business or upon any change in the persons possessing pharmacy practice certificates practicing pharmacy at the establishment, using Form No. 02 provided in Appendix I to this Circular.

2. A drugstore chain-organizing establishment shall send a notification, either directly, by postal service or electronically, to the health professional agency under the provincial-level People’s Committee where drugstores of the drugstore chain are operating, of the list of persons possessing pharmacy practice certificates who are practicing pharmacy at the drugstores in the chain, within 15 (fifteen) days from the date of issuance of the certificate of eligibility for pharmaceutical business or upon any change in the persons possessing pharmacy practice certificates practicing pharmacy at the establishments, using Form No. 02 provided in Appendix I to this Circular.

Article 3. Notification and updating of the list of pharmacy practitioners and drugstores in a drugstore chain upon the rotation of persons in charge of professional pharmacy activities or upon changes in drugstores of a drugstore chain

1. Upon changes in drugstores in a drugstore chain:

At least 07 (seven) working days before adding a drugstore to or removing a drugstore from a drugstore chain, the drugstore chain-organizing establishment shall send a notification, either directly, by postal service or electronically, to the Ministry of Health and to the health professional agency under the provincial-level People’s Committee where the drugstore to be added or removed is located. The notification shall be made according to Form No. 03 provided in Appendix I to this Circular. The addition or removal of a drugstore shall take effect from the time stated in the written notification of the drugstore chain-organizing establishment.

2. Upon the rotation of persons in charge of professional pharmacy activities among drugstores in a drugstore chain:

At least 07 (seven) working days before the rotation, the drugstore chain-organizing establishment shall send a notification, either directly, by postal service or electronically, together with an electronic file, to the health professional agency under the provincial-level People’s Committee where the drugstore subject to the rotation is located. The notification shall be made according to Form No. 04 provided in Appendix I to this Circular.

3. In the case where there is a change in the person in charge of professional pharmacy activities of a drugstore in a drugstore chain, other than the case of rotation of persons in charge of professional pharmacy activities within the drugstore chain, the drugstore subject to the change shall carry out procedures for modification of the certificate of eligibility for pharmaceutical business as prescribed at Point c, Clause 3, Article 36 of the Law on Pharmacy.

Article 4. Updating and publication of the list of persons possessing pharmacy practice certificates and the list of drugstores in a drugstore chain

1. Within 05 (five) working days from the date of receipt of the list of persons possessing pharmacy practice certificates who are practicing pharmacy at establishments operating in the locality as prescribed in Article 2 of this Circular, the health professional agency under the provincial-level People’s Committee shall be responsible for publishing on its portal the list of persons possessing pharmacy practice certificates currently practicing pharmacy at such establishments.

2. Within 15 (fifteen) days from the date of receipt of the notification of a drugstore chain-organizing establishment as prescribed in Clause 1, Article 3 of this Circular, the Ministry of Health shall be responsible for updating and publishing on its portal the list of drugstores in the drugstore chain.

3. Within 15 (fifteen) days from the date of receipt of the notification of a drugstore chain-organizing establishment regarding the rotation of persons in charge of professional pharmacy activities among drugstores in a drugstore chain as prescribed in Clause 2, Article 3 of this Circular, the health professional agency under the provincial-level People’s Committee shall be responsible for updating and publishing on its portal information on the persons in charge of professional pharmacy activities of the drugstores subject to change.

Chapter III

ESTABLISHMENTS ENGAGED IN PHARMACY ACTIVITIES NOT REQUIRED TO HAVE A CERTIFICATE OF ELIGIBILITY FOR PHARMACEUTICAL BUSINESS

Article 5. General provisions on establishments engaged in pharmacy activities not for commercial purposes

1. Establishments engaged in pharmacy activities not for commercial purposes include the following:

a) Public non-business units;

b) Establishments of the people’s armed forces engaged in pharmacy activities but not being pharmaceutical business establishments and not falling into the case prescribed at Point d, Clause 1, Article 35 of the Law on Pharmacy;

c) Medical examination and treatment establishments, drug rehabilitation establishments, and other health establishments having a pharmacy department, pharmacy unit, or engaged in the activities specified in Clause 2 of this Article; vaccination establishments; science and technology organizations; training institutions engaged in research and teaching related to pharmacy.

2. Pharmacy activities not for commercial purposes include the manufacturing, compounding, processing, preservation, transportation, dispensing of drugs and drug materials, testing of drugs and drug materials, bioequivalence trials of drugs, and clinical trials of drugs by the establishments specified in Clause 1 of this Article without generating profits.

3. The assessment of compliance with Good Practices by establishments engaged in pharmacy activities not for commercial purposes shall be carried out in accordance with the regulations on Good Practices promulgated by the Minister of Health.

Article 6. Dossiers and procedures for declaration of pharmaceutical business establishments having drug shelves

1. Dossiers:

a) Declaration of pharmaceutical business establishments having drug shelves, made using Form No. 05 provided in Appendix I to this Circular;

b) A copy certified by the establishment with its signature and seal of legal documents proving the establishment of the entity, in case the establishment does not have an investment certificate or enterprise registration certificate;

c) A certified copy of a diploma or certificate of primary pharmacy or higher of the person in charge of professional pharmacy activities, except where the shared common database of diplomas and certificates is available;

d) The list of drugs expected to be sold at the drug shelf. Such drugs must be included in the List of drugs permitted for sale at drug shelves as provided in Appendix II to this Circular;

dd) A photo of the cabinet, counter, or shelf for drug storage;

e) The process for inspection and supervision of drug quality; drug import and export of the establishment.

2. Procedures:

a) Before operation, a pharmaceutical business establishment having drug shelves shall submit 01 dossier for declaration of pharmaceutical business establishments having drug shelves as prescribed in Clause 1 of this Article to the health professional agency under the provincial-level People’s Committee where the drug shelves are located. The submission of the dossier shall comply with the provisions of Article 15 of the Government’s Decree No. 118/2025/ND-CP dated June 9, 2025, on the implementation of administrative procedures under the one-single-window and inter-agency single-window mechanism at the single-window unit and the National Public Service Portal.

In case of submission via the online public service portal, the establishment shall submit the dossier in accordance with the Government’s Decree No. 45/2020/ND-CP dated April 8, 2020, on administrative procedures in the electronic environment, as amended and supplemented under the Government’s Decree No. 59/2022/ND-CP dated September 5, 2022, on electronic identification and authentication, the Government’s Decree No. 68/2024/ND-CP dated June 25, 2024, on the use of specialized digital signatures for official duties, and the Government’s Decree No. 69/2024/ND-CP dated June 25, 2024, on electronic identification and authentication;

b) Upon receipt of dossiers, the health professional agency under the provincial-level People’s Committee shall issue to the pharmaceutical business establishment having drug shelves a receipt of declaration dossier, made using Form No. 01 provided in Appendix I to this Circular;

c) Within 05 (five) working days from the date stated on the receipt of declaration dossier, the health professional agency under the provincial-level People’s Committee shall issue a decision on declaration of pharmaceutical business establishments eligible to have drug shelves, and publish on its portal the list of pharmaceutical business establishments having drug shelves that are eligible. In case of refusal to declare, a written response stating the reasons must be provided.

Article 7. Cases of annulment of declaration of pharmaceutical business establishments having drug shelves

1. The drug shelves or the pharmaceutical business establishments having drug shelves terminate their operation.

2. The pharmaceutical business establishments having drug shelves fail to comply with the provisions at Point b, Clause 2, Article 35 of the Law on Pharmacy.

3. The declaration of pharmaceutical business establishments having drug shelves is made ultra vires or contains unlawful contents.

4. Documents in the dossier for declaration of pharmaceutical business establishments having drug shelves are forged.

5. The pharmaceutical business establishments having drug shelves or the drug shelves remain inactive for 12 (twelve) consecutive months without notification to the health professional agency under the provincial-level People’s Committee where the drug shelves are located.

Article 8. Publication of annulment of declaration of pharmaceutical business establishments having drug shelves

1. Within 05 (five) working days from the date of conclusion by a competent agency containing a recommendation for annulment of declaration or from the date of receipt of a request for annulment of declaration related to the cases specified in Article 7 of this Circular, the health professional agency under the provincial-level People’s Committee shall issue a decision on revocation of declaration of pharmaceutical business establishments eligible to have drug shelves; in case of non-annulment, a written response stating the reasons shall be provided to the organization or individual requesting the annulment.

2. Within 05 (five) working days from the date of issuance of the decision on revocation of declaration of pharmaceutical business establishments eligible to have drug shelves, the health professional agency under the provincial-level People’s Committee shall:

a) Publish the decision on revocation of declaration of pharmaceutical business establishments eligible to have drug shelves on its portal and send this decision to the Ministry of Health;

b) Update on its portal the information on annulment of declaration of pharmaceutical business establishments having drug shelves.

Article 9. Responsibilities of establishments engaged in pharmacy activities not required to have a certificate of eligibility for pharmaceutical business

1. Displaying signboards for areas engaged in pharmacy activities in visible locations with appropriate size so that people can easily recognize them, and complying with the following requirements:

a) For establishments engaged in pharmacy activities not for commercial purposes: the signboards must contain information on the pharmacy activities carried out;

b) For pharmaceutical business establishments having drug shelves: the signboards must contain the name and address of the establishment, and the name of the person in charge of professional pharmacy activities;

c) For establishments cultivating and harvesting medicinal materials: the signboards must contain the name and address of the establishment, and the scope of activities;

d) For health establishments of the people’s armed forces, and combined military-civilian medical establishments providing drug supply in ethnic minority areas, mountainous areas, islands, areas with difficult socio-economic conditions, and areas with extremely difficult socio-economic conditions: the signboards must contain the scope of activities and the name of the person in charge of professional pharmacy activities.

The signboards at mobile drug retail locations of health establishments of the people’s armed forces and combined military-civilian medical establishments providing drug supply in ethnic minority areas, mountainous areas, islands, areas with difficult socio-economic conditions, and areas with extremely difficult socio-economic conditions shall comply with Clause 4, Article 26 of Decree No. 163/2025/ND-CP.

2. Being responsible for ensuring compliance with and maintenance of the operational conditions of the establishment as prescribed in Clause 2, Article 35 of the Law on Pharmacy, and for the origin and quality of drugs supplied by the establishment.

Chapter IV
SALE OF DRUGS ON THE LIST OF DRUGS RESTRICTED FROM RETAIL AND ADDITIONAL SALE OF DRUGS AT DISPENSARIES

Article 10. List of drugs restricted from retail

1. Drugs restricted from retail are those subject to strict supervision of prescribing, retail by prescription, and use in order to ensure safety and effectiveness, and to prevent abuse in treatment, where such abuse may cause drug dependence or therapeutic non-responsiveness to that drug or to other drugs.

2. The list of drugs restricted from retail is provided in Appendix III to this Circular.

3. Based on the morbidity pattern of the locality, the provincial-level Department of Health shall issue a written approval for the retail of certain drugs on the List of drugs restricted from retail as prescribed in Article 40 of Decree No. 163/2025/ND-CP. The morbidity pattern of the locality shall be determined on the basis of health statistical yearbooks, published surveys, and scientific studies.

Article 11. Additional sale of drugs at dispensaries in ethnic minority areas, mountainous areas, islands, and areas with extremely difficult socio-economic conditions

Based on the morbidity pattern and epidemic situation of the locality, the health professional agency under the provincial-level People’s Committee shall issue a written approval for dispensaries in ethnic minority areas, mountainous areas, islands, and areas with extremely difficult socio-economic conditions to additionally sell certain prescription drugs not included in the List of essential drugs.

Chapter V
PROVISIONS ON METHODS AND FORMS OF DRUG INFORMATION AND DRUG INFORMATION REPRESENTATIVES OF PHARMACEUTICAL BUSINESS ESTABLISHMENTS

Article 12. Methods of drug information

1. Drug information provided by pharmaceutical business establishments, representative offices of foreign traders operating in the pharmaceutical sector in Vietnam, and drug registration establishments to medical practitioners and pharmaceutical practitioners shall be carried out through the following methods:

a) Through “drug information representatives”;

b) Provision of drug information materials;

c) Drug introduction seminars.

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

a) Through counseling on drug use by medical practitioners; counseling by pharmaceutical practitioners engaged in clinical pharmacy activities or in drug use counseling at drug retail establishments;

b) Through package inserts approved by competent agencies;

c) Through provision of drug information materials by pharmaceutical business establishments, representative offices of foreign traders operating in the pharmaceutical sector in Vietnam, and drug registration establishments to patients or their representatives for the purpose of guiding drug use and monitoring drug safety.

Article 13. Regulations on the implementation of methods of drug information

1. Through “drug information representatives”: complying with Articles 14, 15, and 16 of this Circular.

2. Provision of drug information materials:

a) Pharmaceutical business establishments, representative offices of foreign traders operating in the pharmaceutical sector in Vietnam, and drug registration establishments shall develop drug information materials suitable to the intended audience as prescribed in Clause 5, Article 76 of the Law on Pharmacy and in Articles 19 and 20 of this Circular. Drug information materials must clearly state the name of the establishment providing the materials; in the case of printed materials, they must bear the seal of the establishment providing such materials;

b) When providing drug information, pharmaceutical business establishments, representative offices of foreign traders operating in the pharmaceutical sector in Vietnam, and drug registration establishments must provide drug information materials to the correct intended audience;

c) Pharmaceutical business establishments, representative offices of foreign traders operating in the pharmaceutical sector in Vietnam, and drug registration establishments must keep samples of drug information materials and supporting documents serving as the basis for developing such drug information materials at their premises for submission to competent agencies upon request.

3. Drug introduction seminars:

a) A drug introduction seminar is a session for introducing drugs or discussing specialized topics related to drugs for medical practitioners and pharmaceutical practitioners;

b) Drugs that do not yet have marketing authorization in Vietnam but have been granted import licenses may only be introduced through drug introduction seminars organized by the importing establishment itself or by another pharmaceutical business establishment authorized by the importer. Drugs with marketing authorization shall be introduced through seminars organized by establishments prescribed at Point b, Clause 6, Article 76 of the Law on Pharmacy;

c) Presenters at seminars must have medical or pharmaceutical qualifications and professional knowledge and experience related to the drugs being introduced;

d) At least 02 (two) working days before conducting drug information through drug introduction seminars, the establishment organizing a seminar must send a written notice to the health professional agency under the provincial-level People’s Committee where the seminar is held, providing details on the seminar program, reports to be presented, participants, time, and venue of the seminar;

dd) The organizing establishment must ensure that drug information is provided to the proper audience in accordance with regulations and must keep all documents related to the drug introduction seminar for submission to competent agencies upon request.

Article 14. Requirements for drug information representatives

1. A drug information representative is a person recruited by a pharmaceutical business establishment and issued a “drug information representative card” by the head of such establishment in order to provide drug information of that establishment to medical practitioners and pharmaceutical practitioners.

2. A drug information representative must satisfy the following requirements:

a) Having a college degree or higher in medicine or pharmacy;

b) Being recruited, trained, and instructed by the pharmaceutical business establishment in skills, professional knowledge related to drug information activities, and legal documents on pharmacy;

c) Not being under criminal prosecution, not serving a court judgment or decision, not being banned from practicing or from performing jobs related to pharmaceutical activities under a court judgment or decision; not being deprived of civil act capacity, not having difficulty in cognition or behavior control, and not having restricted civil act capacity.

Article 15. Responsibilities of drug information representatives

1. Wearing the “drug information representative” card issued by the pharmaceutical business establishment and complying with the internal regulations issued by medical examination and treatment establishments as prescribed in Clause 2, Article 17 of this Circular when conducting drug information activities. Drug information representatives may only conduct drug introduction upon the consent of medical practitioners or pharmaceutical practitioners.

2. Introducing drugs that have been granted marketing authorization in Vietnam in accordance with the list of drugs assigned by the pharmaceutical business establishment, and only providing information recorded on the label, package insert approved under the marketing authorization, and other materials prescribed in Clause 3, Article 76 of the Law on Pharmacy.

3. Presenting legal documents proving the validity of drug information contents as prescribed when requested by the head of the medical examination and treatment establishment, or by medical practitioners or pharmaceutical practitioners.

4. Collecting information and reporting to the pharmaceutical business establishment on adverse drug reactions and information related to drug quality during the course of drug information activities, so that the pharmaceutical business establishment can promptly consolidate and report to the competent agency of the Ministry of Health in accordance with the national pharmacovigilance guidelines issued by the Ministry of Health.

5. Not committing the following acts:

a) Introducing drugs without being assigned by the pharmaceutical business establishment;

b) Using material benefits in any form to influence medical practitioners, pharmaceutical practitioners, or drug users to promote prescribing, purchasing, or using drugs;

c) Introducing or providing drug information inconsistent with the materials prescribed in Clause 3, Article 76 of the Law on Pharmacy;

d) Comparing or introducing drugs of their establishment as better than those of another establishment without scientific materials approved by competent agencies as evidence;

dd) Introducing products that are not drugs;

e) Engaging in activities related to the purchase, sale, or consignment of drugs with medical practitioners;

g) Accessing patients, medical records, or prescriptions, or discussing or requesting the provision of patient-related information;

h) Providing drug information materials to the wrong audience.

Article 16. Responsibilities of heads of pharmaceutical business establishments having drug information representatives

1. Being responsible for drug information activities and information provided by drug information representatives of the pharmaceutical business establishment.

2. Training and retraining persons recruited by the establishment as drug information representatives to meet the requirements specified in Clause 2, Article 14 of this Circular.

3. Providing drug information representatives with sufficient legal documents and technical-professional materials to ensure the validity of drug information in accordance with this Circular.

4. Issuing the “drug information representative card” using Form No. 06 provided in Appendix I to this Circular to persons of the establishment who meet the requirements specified in Clause 2, Article 14 of this Circular.

5. No later than 03 (three) working days from the date of issuance of the card, sending the list of persons granted the “drug information representative card” using Form No. 07 provided in Appendix I to this Circular to the health professional agency under the provincial-level People’s Committee where the drug information representatives carry out their activities, either directly, by post, or online.

In case of additional recruitment of drug information representatives or changes in the information on the card, the pharmaceutical business establishment must issue the “drug information representative card” in accordance with Clause 4 of this Article and update the list of drug information representatives as prescribed in this Clause.

6. Withdrawing the “drug information representative card” already issued in the following cases:

a) The drug information representative terminates the labor contract with the pharmaceutical business establishment;

b) The drug information representative ceases to perform drug information duties;

c) The drug information representative, after being issued the card, no longer meets the requirements prescribed at Points a and c, Clause 2, Article 14 of this Circular;

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

7. Within a maximum of 03 (three) working days from the date of withdrawal of the card, sending the list of persons whose “drug information representative card” has been withdrawn using Form No. 08 provided in Appendix I to this Circular to the health professional agency under the provincial-level People’s Committee where the drug information representatives carry out their activities, either directly, by post, or online.

8. Not reissuing the “drug information representative card” for at least 12 (twelve) months from the date of withdrawal of the card to persons of the establishment whose cards have been withdrawn under Point d, Clause 6 of this Article.

Article 17. Responsibilities of heads of medical examination and treatment establishments when drug information representatives operate

1. Allowing only those who hold a “drug information representative” card and whose names are included in the list of persons granted such cards published on the portal of the health professional agency under the provincial-level People’s Committee to conduct drug information activities and to provide drug information materials in compliance with relevant laws and regulations.

2. Issuing and organizing the implementation of internal regulations specifying the participants, venues, timeframes, and other relevant requirements for drug information activities targeting medical practitioners, thereby ensuring that drug information representatives conduct their activities at the establishment in compliance with the provisions of this Circular.

3. Regularly inspecting, supervising, and taking measures to prevent acts of prescribing or counseling on drug use by medical practitioners of the establishment for profit-making purposes under material, financial, or any other influence from drug information representatives.

4. Immediately suspending the activities of a drug information representative within the establishment upon detecting non-compliance with the responsibilities prescribed in Article 15 of this Circular, and notifying the head of the pharmaceutical business establishment that employs the violating drug information representative.

Article 18. Responsibilities of health professional agencies under provincial-level People’s Committees where drug information representatives operate

1. Publishing or annulling the publication of the list of persons granted “drug information representative” cards on the portal of the health professional agency under the provincial-level People’s Committee within 03 (three) working days from the date of receipt of the list of persons granted or withdrawn such cards, as provided by pharmaceutical business establishments in accordance with Clause 5 or Clause 7, Article 16 of this Circular.

2. Directing medical examination and treatment establishments within the locality to fully and properly perform the responsibilities of their heads as prescribed in Article 17 of this Circular when drug information representatives operate.

3. Inspecting and examining drug information activities; handling violations committed by drug information representatives and pharmaceutical business establishments having drug information representatives operating within the locality, ensuring compliance with the provisions on drug information under this Circular.

Article 19. Regulations on forms of drug information

1. Drug information materials must fully present the drug information contents as prescribed at Points a and b, Clause 5, Article 76 of the Law on Pharmacy; and must not contain information or images not directly related to the drug or its use, or the information and images specified in Article 20 of this Circular. In case drug information materials are presented in the form of audio or video recordings, the drug information must be read aloud, clearly, or fully displayed as prescribed.

2. Drug information materials must clearly cite supporting documents and specify the sections of information quoted therefrom. Citations must accurately convey the information, without interpretation, omission, or addition in a manner that may mislead regarding the safety or efficacy of the drug.

3. The basis for developing drug information shall comply with Clause 3, Article 76 of the Law on Pharmacy. In case the drug information provided in the documents specified in Clause 3, Article 76 of the Law on Pharmacy is inconsistent, the drug information must be based on the package insert approved by the Ministry of Health.

4. Drug information materials must contain the phrase “Drug information material” at the beginning of the document. For multi-page documents, the phrase “Drug information material” must appear at the top of every page, the pages must be numbered, and the first page must clearly indicate the page(s) where detailed product information can be found (specifying the exact page number).

5. Drug information contents must be presented in Vietnamese, unless such information cannot be translated into Vietnamese or would lack meaning in Vietnamese.

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

7. In case drug information is provided in the form of a drug introduction seminar, the drug information must include the name and scientific title of the presenter.

8. In case drug information is provided in the form of materials guiding the use of the drug or monitoring its safety, the materials must clearly state “Drug information material for patients/patient representatives”.

Article 20. Information and images prohibited in drug information

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

2. Information and images that may cause misunderstanding about the composition, effects, uses, indications, or origin of the drug.

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

4. Sentences, words, or images that are excessively suggestive, leading to misunderstandings regarding the effects, uses, indications, or efficacy of the drug, or exceeding the approved effects, uses, indications, or efficacy of the drug.

5. Stating the effects of each component in the drug in a manner that exaggerates the drug’s effects or causes confusion between the effects of each component and the effects of the drug.

6. Words or phrases such as: “radical treatment”, “eradicate”, “specialized treatment”, “leading”, “top-ranking”, “foremost”, “best choice”, “high quality”, “100% guaranteed”, “completely cured”, “cut off”, “stop immediately”, “instant reduction”, “immediate relief”, “completely recovered”, “assured”, “worry-free”, “recommended”, “hotline”, and other words or phrases with similar meanings.

7. Results of quality testing of drugs or drug materials.

8. Results of preclinical studies.

9. Results of clinical studies or bioequivalence trials not yet recognized by the Ministry of Health.

10. Using certifications not recognized by the Ministry of Health, or using images, names, or symbols of healthcare professionals; exploiting the name of organizations or individuals, or using symbols, images, status, reputation, letters, or thank-you notes to provide drug information.

11. Incomplete information regarding the origin of drugs or drug materials.

12. Images of animals or plants listed as endangered, rare, or precious species prioritized for protection.

13. Sentences or words that are suggestive, anecdotal, or intended to direct or recommend drug use.

14. Using images of patients to depict medical conditions or drug effects in a manner inconsistent with drug-related documents and professional guidelines issued or recognized by the Ministry of Health.

Chapter VI
REQUIREMENTS ON LANGUAGE USE IN PHARMACY PRACTICE FOR FOREIGNERS AND OVERSEAS VIETNAMESE; ORGANIZATION AND OPERATION OF THE ADVISORY COUNCIL FOR GRANT OF PHARMACY PRACTICE CERTIFICATES

Article 21. Requirements on language use in pharmacy practice of persons in charge of professional pharmacy activities at drug retail establishments and persons responsible for clinical pharmacy at medical examination and treatment establishments

1. Persons in charge of professional pharmacy activities at drug retail establishments and persons responsible for clinical pharmacy at medical examination and treatment establishments who are foreigners or overseas Vietnamese must be proficient in Vietnamese; if not proficient in Vietnamese, they must register the language to be used and have an interpreter.

2. Foreigners and overseas Vietnamese who are not yet proficient in Vietnamese in pharmacy practice must have the phrase “interpreter required for pharmacy practice” indicated on their pharmacy practice certificate. During pharmacy practice, the dossier for application for a certificate of eligibility for pharmaceutical business must include a contract with an interpreter.

3. In case a foreigner or overseas Vietnamese practicing pharmacy is found not to meet the language use requirements prescribed in Clauses 1 and 2 of this Article during practice, the competent agency shall revoke the pharmacy practice certificate.

A drug retail establishment with a person in charge of professional pharmacy activities whose pharmacy practice certificate is revoked under this Clause shall have its certificate of eligibility for pharmaceutical business revoked; the head of a medical examination and treatment establishment with a person responsible for clinical pharmacy whose pharmacy practice certificate is revoked under this Clause 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 Grant of Pharmacy Practice Certificates

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

2. The Director of the provincial-level Department of Health shall issue a decision to establish the Advisory Council for Grant of Pharmacy Practice Certificates in the dossier-evaluation form (hereinafter referred to as the Advisory Council for Grant of Pharmacy Practice Certificates under the provincial-level Department of Health).

Article 23. Composition of the Advisory Council for Grant of Pharmacy Practice Certificates

1. The Advisory Council for Grant of Pharmacy Practice Certificates under the Ministry of Health shall include the following members: Chairperson, Vice-Chairperson, Secretary, and council members, specifically: leaders of the Ministry of Health, leaders of the Drug Administration, leaders of the Agency of Traditional Medicine Administration in the cases where the certificate is limited to herbal drugs and traditional medicines, leaders of the Administration of Science, Technology and Training, leaders of the Department of Legal Affairs, representatives of the Pharmaceutical Association, and officers from relevant units under the Ministry of Health.

2. The Advisory Council for Grant of Pharmacy Practice Certificates under the provincial-level Department of Health shall have at least three (03) members, including one member representing the Pharmaceutical Association.

Article 24. Operation of the Advisory Council for Grant of Pharmacy Practice Certificates

1. The Advisory Council for Grant of Pharmacy Practice Certificates shall be responsible for drafting the Regulations on Council Operations to submit to the Minister of Health or the Director of the provincial-level Department of Health for approval and shall implement the Regulations after approval.

2. The Advisory Council for Grant of Pharmacy Practice Certificates shall provide advisory services to the competent agency in granting, re-granting, or revoking pharmacy practice certificates.

Chapter VII
IMPLEMENTATION PROVISIONS

Article 25. Effect

1. This Circular takes effect from July 01, 2025.

2. The Minister of Health’s Circular No. 07/2018/TT-BYT dated April 12, 2018, detailing a number of articles of the Law on Pharmacy regarding pharmaceutical business, and the Government’s Decree No. 54/2017/ND-CP dated May 8, 2017, detailing a number of articles of and measures for implementing the Law on Pharmacy, shall cease to be effective from July 1, 2025.

Article 26. Reference provisions

In cases where legal documents or regulations cited in this Circular are amended, supplemented, or replaced, the new legal documents or regulations shall prevail.

Article 27. Responsibility for implementation

1. The Drug Administration of Vietnam; Agency of Traditional Medicine Administration; units under the Ministry of Health; Departments of Health of provinces and centrally-run cities; provincial-level People’s Committees; and relevant agencies, organizations, and individuals shall be responsible for organizing the implementation, inspecting, and supervising the compliance with the provisions of this Circular.

2. Establishments specified in Clause 1, Article 5 of this Circular shall be responsible for ensuring the implementation of good practices in accordance with the roadmap prescribed in Article 122 of the Decree No. 163/2025/ND-CP. Establishments may only conduct commercial activities related to the pharmaceutical sector upon being granted a certificate of eligibility for pharmaceutical business by competent agencies in accordance with the provisions of the Law on Pharmacy and the Decree No. 163/2025/ND-CP.

Any difficulties or obstacles arising during the course of implementation shall be reported to the Ministry of Health (Drug Administration of Vietnam; Agency of Traditional Medicine Administration) for consideration and resolution.

For the Minister

The Deputy Minister

DO XUAN TUYEN
* All Appendices are not translated herein.