Circular 18/2026/TT-BYT detailing Law on Pharmacy and Decree 163/2025/ND-CP on drugs under special control

CIRCULAR

Detailing a number of articles of the Law on Pharmacy and the Decree No. 163/2025/ND-CP concerning drugs and drug materials under special control

Pursuant to the Law No. 105/2016/QH13 on Pharmacy, which was amended and supplemented by the Law No. 44/2024/QH15;

Pursuant to the Decree No. 163/2025/ND-CP detailing a number of articles, and prescribing measures for organizing and guiding the implementation, of the Law on Pharmacy;

Pursuant to the Decree No. 28/2026/ND-CP prescribing the lists of narcotic substances and precursors;

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

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

The Minister of Health hereby promulgates the Circular detailing a number of articles of the Law on Pharmacy and the Decree No. 163/2025/ND-CP concerning drugs and drug materials under special control.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Circular details a number of articles of Law on Pharmacy No. 105/2016/QH13 as amended and supplemented by Law No. 44/2024/QH15 (hereinafter referred to as the Law on Pharmacy) and Decree No. 163/2025/ND-CP regarding:

1. Lists of drugs and drug materials under special control, including:

a) List of habit-forming pharmaceutical ingredients as defined in Clause 17 Article 2 of the Law on Pharmacy;

b) List of psychotropic pharmaceutical ingredients as defined in Clause 18 Article 2 of the Law on Pharmacy;

c) List of precursors used as drugs as defined in Clause 19 Article 2 of the Law on Pharmacy;

d) Table of concentration and strength limits of habit-forming pharmaceutical ingredients in combination drugs as prescribed in Clause 20 Article 2 of the Law on Pharmacy;

dd) Table of concentration and strength limits of psychotropic pharmaceutical ingredients in combination drugs as prescribed in Clause 21 Article 2 of the Law on Pharmacy;

e) Table of concentration and strength limits of precursors used as drugs in combination drugs as prescribed in Clause 22 Article 2 of the Law on Pharmacy;

g) List of drugs and pharmaceutical ingredients on the list of substances banned from use in a number of sectors and fields, announced under a decision of the Minister of Health as prescribed at Point b Clause 2 Article 29 of Decree No. 163/2025/ND-CP.

2. Activities of storage, manufacture, preparation, dispensing, use, destruction, handover and receipt, transportation, reporting, and management of dossiers and records related to drugs and drug materials under special control applicable to establishments engaged in pharmacy activities for non-commercial purposes as prescribed in Clause 3 Article 35 of the Law on Pharmacy.

3. Supply of radioactive drugs defined in Clause 3 Article 85 of the Law on Pharmacy;

4. Dossiers, records relating to drugs and drug materials under special control and retention of documents thereof as prescribed in Article 31 of Decree No. 163/2025/ND-CP.

Article 2. Promulgating lists of drugs under special control and tables of concentration and strength limits of habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, and precursors used as drugs in combination drugs

1. The List of habit-forming pharmaceutical ingredients prescribed in Appendix I issued together with this Circular and the Table of concentration and strength limits of habit-forming pharmaceutical ingredients in combination drugs prescribed in Appendix IV issued together with this Circular.

2. The List of psychotropic pharmaceutical ingredients prescribed in Appendix II issued together with this Circular and the Table of concentration and strength limits of psychotropic pharmaceutical ingredients in combination drugs prescribed in Appendix V issued together with this Circular.

3. The List of precursors used as drugs prescribed in Appendix III issued together with this Circular and the Table of concentration and strength limits of precursors used as drugs in combination drugs prescribed in Appendix VI issued together with this Circular.

4. The classification of habit-forming drugs, psychotropic drugs, pre-substance drugs, combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients, and combination drugs containing precursors shall comply with Appendix VII issued together with this Circular.

5. Drugs and pharmaceutical ingredients on the list of drugs and pharmaceutical ingredients in the list of substances banned from use in a number of sectors and fields is announced by the Ministry of Health in accordance with Clause 2 Article 29 of Decree No. 163/2025/ND-CP.

Chapter II

ACTIVITIES OF STORAGE, MANUFACTURE, PREPARATION, DISPENSING, USE, DESTRUCTION, HANDOVER AND RECEIPT, TRANSPORTATION, REPORTING ON DRUGS AND DRUG MATERIALS UNDER SPECIAL CONTROL APPLICABLE TO ESTABLISHMENTS ENGAGED IN PHARMACY ACTIVITIES FOR NON-COMMERCIAL PURPOSES

Article 3. Storage

1. Establishments engaged in pharmacy activities for non-commercial purposes must comply with Good Storage Practice standards. To be specific:

a) Habit-forming drugs, psychotropic drugs, pre-substance drugs, drug materials that are habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, or precursors used as drugs must be stored in separated and safely locked warehouses or cabinet. If separate warehouses or cabinets are not available, habit-forming drugs may be stored in the same cabinet, shelf or rack as psychotropic drugs and pre-substance drugs, provided that each category of drugs must be arranged separately and clearly labelled to avoid confusion; psychotropic drugs of a commune-level health station or infirmary must be stored in safely locked cabinet and monitored by a specific person;

b) Combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients, and combination drugs containing precursors must be stored in a separate area;

c) Radioactive drugs must be stored in a separated and safely locked warehouses or cabinet, which ensures radiation safety and security, prevention of environmental radiation exposure in accordance with the law regulations on atomic energy;

d) Toxic drugs and toxic drug materials must be stored in a separate area and neatly arranged to avoid confusion and facilitating observation within the storage area;

dd) Habit-forming drugs, psychotropic drugs, and pre-substance drugs kept must be placed in a separate compartment or slot in drug cabinets for duty shifts and emergency drug cabinets, and shall be kept and dispensed by the nurse on duty in accordance with medical orders. The drug cabinets for duty shifts and emergency drug cabinets must be safely locked. The quantity and categories of drugs under special control permitted to be kept therein shall be prescribed in writing by the heads of the establishments. When changing shift, the person in charge of drugs for the previous shift must inform the person in charge of drugs for the next shift of the quantities of drugs and hand over the drug logbook, which must fully bear their signatures.

e) The persons in charge of drugs under special control at the departments of establishments engaged in pharmacy activities for non-commercial purposes shall be responsible for managing, dispensing, and fully recording the quantities of issues, receipts, and inventories of habit-forming drugs, psychotropic drugs, pre-substance drugs, drug materials that are habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, or precursors used as drugs in a logbook, using the form prescribed in Appendix VIII issued together with this Circular.

2. The warehouse keeper at the pharmacy department of a hospital, the person in charge of drugs and drug materials under special control at an establishment engaged in pharmacy activities for non-commercial purposes (hereinafter referred to as the drug manager) must possess appropriate professional qualifications, specifically as follows:

a) For habit-forming drugs and drug materials that are habit-forming pharmaceutical ingredients: the drug manager at the pharmacy department of a hospital must satisfy the requirements prescribed in Clause 1 Article 9 of Circular No. 22/2011/TT-BYT prescribing the organization and operation of pharmacy departments at hospitals; the drug manager at other establishment engaged in pharmacy activities for non-commercial purposes must possess a professional secondary school degree in pharmacy or higher;

b) For psychotropic drugs, pre-substance drugs, drug materials that are psychotropic pharmaceutical ingredients, and precursors used as drugs: the drug manager at an establishment engaged in pharmacy activities for non-commercial purposes must possess a professional secondary school degree in pharmacy or higher;

c) For radioactive drugs: the drug manager shall possess professional secondary school degree in pharmacy or higher, or be a physician, technician or nurse who has been trained in radiation safety and assigned such duty in writing by the head of the establishment;

d) In addition to the personnel prescribed at Points a, b and c of this Clause, the head of the establishment shall be responsible for assigning personnel to manage drugs at departments, divisions, and units using drugs in accordance with the actual human resources available at the establishment, ensuring that no drugs under special control are lost;

dd) In case an establishment engaged in pharmacy activities for non-commercial purposes do not have the personnel satisfying the requirements prescribed at Points a and b of this Clause, the head of the establishment shall assign such duty in writing to a drug manager possessing professional qualifications of assistant doctors or higher.

Article 4. Manufacture and preparation

1. The manufacture of drugs under special control at establishments engaged in pharmacy activities for non-commercial purposes shall comply with Circular No. 28/2025/TT-BYT prescribing Good Manufacturing Practices for drugs and drug materials.

2. The preparation of drugs under special control at medical examination and treatment establishments shall comply with Circular No. 30/2021/TT-BYT prescribing the preparation of drugs for treatment of patients at medical examination and treatment establishments.

Article 5. Dispensing, use and destruction of drugs and drug materials

1. For medical examination and treatment establishments, except establishments providing opioid substitution therapy, drug rehabilitation facilities, and infirmaries of detention facilities under the management of the Ministry of Public Security: the dispensing and use of drugs under special control shall comply with Circular No. 23/2011/TT-BYT guiding the use of drugs at health establishments with inpatient beds, as amended and supplemented by Circular No. 50/2017/TT-BYT (hereinafter referred to as Circular No. 23/2011/TT-BYT).

In case a medical examination and treatment establishment uses drug materials under special control for the preparation of drugs at the establishment, the dispensing and use of drug materials under special control shall comply with Clause 3 of this Article.

2. For establishments providing opioid substitution therapy:

The dispensing and use of methadone shall comply with Circular No. 26/2023/TT-BYT promulgating the guidance on management of methadone. The dispensing and use of other drugs under special control at the establishments providing treatment of addiction to opium-related substances with substitute substances shall be carried out as follows:

a) The treatment and diagnosis departments shall complete a medication request form for habit-forming drugs, psychotropic drugs, and pre-substance drugs, using the form No. 1 issued together with Circular No. 23/2011/TT-BYT;

b) The dispensary shall dispense drugs to treatment and diagnosis departments according to the medication request form and shall monitor and fully record the quantities of issues, receipts and inventories of habit-forming drugs, psychotropic drugs, and pre-substance drugs according to the form prescribed in Appendix VIII issued together with this Circular;

c) At treatment and diagnosis departments, after receiving the drugs, the assigned person shall check the drug names, concentrations, strengths, expiry dates, and quantities of drugs before administration or dispensing, provide instructions for use, and directly dispense the drugs to patients;

d) In case the habit-forming drugs, psychotropic drugs, and pre-substance drugs are not fully used or the patients using the habit-forming drugs, psychotropic drugs, and pre-substance drugs are transferred to another establishment or die, the concerned treatment and diagnosis department shall return such drugs to the dispensary. Such return must be recorded in writing. The head of the dispensary shall, based on specific conditions, decide to reuse or destroy the drugs in accordance with regulations and prepare and retain the minutes at the establishment;

dd) The head of the dispensary or a person holding at least a college degree in pharmacy and assigned such duty in writing by the head of the establishment shall sign for approval medication request forms for habit-forming drugs, psychotropic drugs, and pre-substance drugs of treatment and diagnosis departments;

e) The heads or the deputy heads, if authorized in writing by the heads, of treatment departments and diagnosis departments, shall sign for approval medication request forms for habit-forming drugs, psychotropic drugs, and pre-substance drugs for their respective departments. For medication request forms on holidays or urgent requests for drug supply, the doctor on duty or assistant doctor on duty may sign the medication request forms.

3. The dispensing and use of drugs under special control at infirmaries of detention facilities under the management of the Ministry of Public Security, drug rehabilitation facilities, and other establishments engaged in pharmacy activities for non-commercial purposes (except the establishments prescribed in Clauses 1 and 2 of this Article), and the dispensing and use of drug materials under special control at all establishments engaged in pharmacy activities for non-commercial purposes shall be carried out as follows:

a) The heads of departments requiring use or the assigned persons shall approve the drug and drug material request form, made using the form prescribed in Appendix XII issued together with this Circular;

b) The heads of the using departments and the persons receiving drugs and drug materials under special control shall be responsible for using the drugs and drug materials for the intended purposes and shall return them to the departments or the persons in charge of drugs and drug materials under special control in cases where they are not used up.

4. Establishments engaged in pharmacy activities for non-commercial purposes shall destroy drugs under special control (including packaging in direct contact with habit-forming drugs, psychotropic drugs, pre-substance drugs, habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, and precursors used as drugs) in accordance with Article 36 of Decree No. 163/2025/ND-CP. In case an establishment does not have a person responsible for professional pharmacy activities, the drug destruction council must include the head of the pharmacy department or a person assigned by the head of the establishment.

Article 6. Handover, receipt, and transportation

1. The handover, receipt, and transportation of drugs and drug materials under special control between establishments shall comply with the general regulations on the handover, receipt, and transportation of drugs and drug materials and Article 33 of Decree No. 163/2025/ND-CP, in which the person handing over and the person receiving drugs and drug materials under special control must possess at least a professional secondary school degree in pharmacy or be a person assigned in writing by the head of the establishment.

2. In case the habit-forming drugs, psychotropic drugs, and pre-substance drugs are not fully used or the patients using the habit-forming drugs, psychotropic drugs, and pre-substance drugs die, the drug retailing establishments or medical examination and treatment establishments receiving back such drugs shall make 02 minutes on receipt of returned drugs, using the form prescribed in Appendix XVIII issued together with this Circular. The returned drugs shall be stored securely in a separate area and shall be destroyed in accordance with the law regulations.

Article 7. Reporting

1. a) Before January 15, establishments engaged in pharmacy activities for non-commercial purposes shall prepare a report on issues, receipts, inventory and use of habit-forming drugs, psychotropic drugs, pre-substance drugs, radioactive drugs, and combination drugs containing precursors, using the reporting form prescribed in Appendix IX issued together with this Circular and submit them to the following agencies:

a) The Military Medical Department - the Ministry of National Defence, for establishments under the management of the Ministry of National Defence;

b) The Health Department - the Ministry of Public Security, for establishments under the management of the Ministry of Public Security;

c) The specialized health agency under the provincial-level People's Committee where the establishment is headquartered, for the cases other than those specified at Points a and b of this Clause.

2. Before February 15 every year, the Military Medical Department - the Ministry of National Defence and the Health Department - the Ministry of Public Security shall make their annual reports on the use of habit-forming drugs, psychotropic drugs, pre-substance drugs, radioactive drugs, and combination drugs containing precursors by establishments under their management; the specialized health agencies under the provincial-level People's Committees shall make their annual reports on the use of habit-forming drugs, psychotropic drugs, pre-substance drugs, radioactive drugs, and combination drugs containing precursors by establishments in their localities (excluding establishments under the management of the Ministry of National Defence and the Ministry of Public Security) and submit such reports to the Ministry of Health, using the reporting form prescribed in Appendix X issued together with this Circular.

3. Ad hoc reporting: Within 48 (forty-eight) hours from the time of detecting any error or loss involving radioactive drugs; habit-forming drugs; psychotropic drugs; pre-substance drugs; combination drugs containing precursors; or drug materials that are habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, or precursors used as drugs, establishments engaged in pharmacy activities for non-commercial purposes shall submit a written report to the corresponding agency prescribed in Clause 1 of this Article, made using the reporting form prescribed in Appendix XI issued together with this Circular.

4. The reports prescribed in Clauses 1, 2 and 3 of this Article shall be submitted online when the Military Medical Department - the Ministry of National Defence, the Health Department - the Ministry of Public Security, the specialized health agencies under provincial-level People's Committees, and the Ministry of Health deploy reporting receipt software.

Chapter III

SUPPLY OF RADIOACTIVE DRUGS

Article 8. Supply of radioactive drugs

1. A medical examination and treatment establishment that is permitted to manufacture and prepare radioactive drugs may supply radioactive drugs manufactured and prepared by itself to other medical examination and treatment establishments in case the quantity of the drugs manufactured and prepared for treatment activities at such supplying establishment exceeds its actual demand for use.

2. The medical examination and treatment establishment having radioactive drugs manufactured and prepared and the medical examination and treatment establishment receiving radioactive drugs as prescribed in Clause 1 of this Article shall be responsible for the quality, safety, and efficacy of such drugs.

3. Before January 31 each year, an establishment supplying radioactive drugs as prescribed in Clause 1 of this Article shall prepare a report on the supply of radioactive drugs in the preceding year and submit it to the Ministry of Health (the Drug Administration of Vietnam) and the specialized health agency under the provincial-level People's Committee where the supplying establishment's manufacturing and preparation site is located, using the reporting form prescribed in Appendix XIII issued together with this Circular.

Chapter IV

DOSSIERS, RECORDS RELATING TO DRUGS AND DRUG MATERIALS UNDER SPECIAL CONTROL AND RETENTION OF DOCUMENTS THEREOF

Article 9. Dossiers and records applicable to manufacturing establishments

1. A manufacturer of habit-forming drugs; psychotropic drugs; pre-substance drugs; and drug materials that are habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, or precursors used as drugs shall prepare, manage, and retain in full the following dossiers and records:

a) Record of preparation and manufacture of habit-forming drugs, psychotropic drugs, and pre-substance drugs, made using the form prescribed in Appendix XIV issued together with this Circular;

b) Record of receipts, issues, and inventories of habit-forming drugs; psychotropic drugs; pre-substance drugs; and drug materials that are habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, or precursors used as drugs, made using the form prescribed in Appendix VIII issued together with this Circular;

c) Note of delivery for habit-forming drugs; psychotropic drugs; pre-substance drugs; and drug materials that are habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, or precursors used as drugs, made using the form prescribed in Appendix XV issued together with this Circular;

d) Documents relating to the purchase and sale of habit-forming drugs; psychotropic drugs; pre-substance drugs; and drug materials that are habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, or precursors used as drugs.

2. A manufacturer of combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients, combination drugs containing precursors, toxic drugs, toxic drug materials, and drugs and pharmaceutical ingredients on the list of substances banned from use in a number of sectors and fields shall prepare, manage, and retain in full the following dossiers and records:

a) Record of receipts, issues, and inventories of drug materials that are habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, or precursors used as drugs, made using the form prescribed in Appendix VIII issued together with this Circular; record of receipts, issues, and inventories of combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients, and combination drugs containing precursors, made using the form prescribed in Appendix XVI issued together with this Circular;

b) Note of delivery for drug materials that are habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, or precursors used as drugs, made using the form prescribed in Appendix XV issued together with this Circular;

c) Record of receipts, issues, and inventories of toxic drugs, toxic drug materials, and drugs and pharmaceutical ingredients on the list of substances banned from use in a number of sectors and fields, made using the form prescribed in Appendix XVI issued together with this Circular;

d) Documents relating to the purchase and sale of drug materials that are habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, or precursors used as drugs; combination drugs containing habit-forming pharmaceutical ingredients; combination drugs containing psychotropic pharmaceutical ingredients; combination drugs containing precursors; toxic drugs; toxic drug materials; and drugs and pharmaceutical ingredients on the list of substances banned from use in a number of sectors and fields .

3. A manufacturer of radioactive drugs shall prepare, manage, and retain in full the following dossiers and records:

a) Record of preparation and manufacture of radioactive drugs, made using the form prescribed in Appendix XVII issued together with this Circular;

b) Record of receipts, issues, and inventories of radioactive drugs, made using the form prescribed in Appendix VIII issued together with this Circular;

c) Note of delivery for radioactive drugs, made using the form prescribed in Appendix XV issued together with this Circular;

d) Documents relating to the purchase and sale of radioactive drugs.

Article 10. Dossiers and records applicable to exporters and importers

1. An exporter or importer of habit-forming drugs; psychotropic drugs; pre-substance drugs; and drug materials that are habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, or precursors used as drugs shall prepare, manage, and retain in full the following dossiers and records:

a) Record of receipts, issues, and inventories of habit-forming drugs; psychotropic drugs; pre-substance drugs; and drug materials that are habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, or precursors used as drugs, made using the form prescribed in Appendix VIII issued together with this Circular;

b) Note of delivery for habit-forming drugs, psychotropic drugs, and pre-substance drugs, made using the form prescribed in Appendix XV issued together with this Circular;

c) Documents relating to the export, import, purchase, and sale of habit-forming drugs, psychotropic drugs, and pre-substance drugs.

2. An exporter or importer of combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients, combination drugs containing precursors, toxic drugs, toxic drug materials, and drugs and pharmaceutical ingredients on the list of substances banned from use in a number of sectors and fields shall prepare, manage, and retain in full the following dossiers and records:

a) Record of receipts, issues, and inventories of combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients, and combination drugs containing precursors, made using the form prescribed in Appendix XVI issued together with this Circular;

b) Record of receipts, issues, and inventories of toxic drugs, toxic drug materials, and drugs and pharmaceutical ingredients on the list of substances banned from use in a number of sectors and fields, made using the form prescribed in Appendix XVI issued together with this Circular;

c) Documents relating to the export, import, purchase, and sale of combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients, combination drugs containing precursors, toxic drugs, toxic drug materials, and drugs and pharmaceutical ingredients on the list of substances banned from use in a number of sectors and fields.

3. An exporter or importer of radioactive drugs shall prepare, manage, and retain in full the following dossiers and records:

a) Record of receipts, issues, and inventories of radioactive drugs, made using the form prescribed in Appendix VIII issued together with this Circular;

b) Note of delivery for radioactive drugs, made using the form prescribed in Appendix XV issued together with this Circular;

c) Documents relating to the export, import, purchase, and sale of radioactive drugs.

Article 11. Dossiers and records applicable to drug wholesaling establishments and drugstore chain-organizing establishments

1. A drug wholesaling establishment or a drugstore chain-organizing establishment engaged in the trading of habit-forming drugs, psychotropic drugs, and pre-substance drugs shall prepare, manage, and retain in full the following dossiers and records:

a) Record of receipts, issues, and inventories of habit-forming drugs, psychotropic drugs, and pre-substance drugs, made using the form prescribed in Appendix VIII issued together with this Circular;

b) Note of delivery for habit-forming drugs, psychotropic drugs, and pre-substance drugs, made using the form prescribed in Appendix XV issued together with this Circular;

c) Documents relating to the purchase and sale of habit-forming drugs, psychotropic drugs, and pre-substance drugs.

2. A drug wholesaling establishment or a drugstore chain-organizing establishment engaged in the trading of combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients, combination drugs containing precursors, toxic drugs, toxic drug materials, and drugs and pharmaceutical ingredients on the list of substances banned from use in a number of sectors and fields shall prepare, manage, and retain in full the following dossiers and records:

a) Record of receipts, issues, and inventories of combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients, and combination drugs containing precursors, made using the form prescribed in Appendix XVI issued together with this Circular;

b) Record of receipts, issues, and inventories of toxic drugs, toxic drug materials, and drugs and pharmaceutical ingredients on the list of substances banned from use in a number of sectors and fields, made using the form prescribed in Appendix XVI issued together with this Circular;

c) Documents relating to the purchase and sale of combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients, combination drugs containing precursors, toxic drugs, toxic drug materials, and drugs and pharmaceutical ingredients on the list of substances banned from use in a number of sectors and fields.

3. A drug wholesaling establishment or a drugstore chain-organizing establishment engaged in the trading of radioactive drugs shall prepare, manage, and retain in full the following dossiers and records:

a) Record of receipts, issues, and inventories of radioactive drugs, made using the form prescribed in Appendix VIII issued together with this Circular;

b) Note of delivery for radioactive drugs, made using the form prescribed in Appendix XV issued together with this Circular;

c) Documents relating to the purchase and sale of radioactive drugs.

Article 12. Dossiers and records applicable to drug retailing establishments

1. An establishment retailing habit-forming drugs, psychotropic drugs, and pre-substance drugs shall prepare, manage, and retain in full the following dossiers and records:

a) Record of receipts, issues, and inventories of habit-forming drugs, psychotropic drugs, and pre-substance drugs, made using the form prescribed in Appendix VIII issued together with this Circular;

b) Note of delivery for habit-forming drugs, psychotropic drugs, and pre-substance drugs issued by the supplier;

c) Prescriptions for habit-forming drugs and psychotropic drugs retained at the establishment after dispensing;

d) Minutes on receipt of returned habit-forming drugs, psychotropic drugs, and pre-substance drugs, made using the form prescribed in Appendix XVIII issued together with this Circular;

dd) Record of detailed customer information, made using the form prescribed in Appendix XIX issued together with this Circular.

2. An establishment retailing combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients, and combination drugs containing precursors shall prepare, manage, and retain in full the record of detailed customer information, made using the form prescribed in Appendix XIX issued together with this Circular.

3. An establishment retailing combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients, combination drugs containing precursors, toxic drugs, and drugs on the list of drugs and pharmaceutical ingredients on the list of substances banned from use in a number of sectors and fields shall prepare, manage, and retain in full the record of receipts, issues, and inventories, made using the form prescribed in Appendix XVI issued together with this Circular.

4. A drug retailing establishment shall retain documents relating to the purchase and sale of drugs under special control.

Article 13. Dossiers and records applicable to establishments providing the service of preserving drugs, the service of clinical trial of drugs, the service of bioequivalence trial of drugs, and the service of testing drugs

1. For habit-forming drugs; psychotropic drugs; pre-substance drugs; and drug materials that are habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, or precursors used as drugs, such an establishment shall prepare, manage, and retain in full the following dossiers and records:

a) Record of receipts, issues, and inventories of habit-forming drugs; psychotropic drugs; pre-substance drugs; and drug materials that are habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, or precursors used as drugs, made using the form prescribed in Appendix VIII issued together with this Circular;

b) Note of delivery for habit-forming drugs, psychotropic drugs, and pre-substance drugs, made using the form prescribed in Appendix XV issued together with this Circular.

2. For combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients, combination drugs containing precursors, toxic drugs, toxic drug materials, and drugs and pharmaceutical ingredients on the list of substances banned from use in a number of sectors and fields , an establishment shall prepare, manage, and retain in full the record of receipts, issues, and inventories of the drugs, made using the form prescribed in Appendix XVI issued together with this Circular.

3. For radioactive drugs, an establishment shall prepare, manage, and retain in full the record of receipts, issues, and inventories of the drugs, made using the form prescribed in Appendix VIII issued together with this Circular.

4. Establishments providing the service of preserving drugs, the service of clinical trial of drugs, the service of bioequivalence trial of drugs, and the service of testing drugs must retain the documents relating to their purchase and sale of drugs under special control.

Article 14. Dossiers and records applicable to establishments engaged in pharmacy activities for non-commercial purposes

1. Establishments engaged in pharmacy activities for non-commercial purposes, except establishments providing opioid substitution therapy and drug rehabilitation facilities, shall prepare, manage, and retain in full the following dossiers and records:

a) Record of preparation of habit-forming drugs, psychotropic drugs, pre-substance drugs, and radioactive drugs, made using the forms prescribed in Appendices XIV and XVII issued together with this Circular;

b) Record of receipts, issues, and inventories of habit-forming drugs; psychotropic drugs; pre-substance drugs; drug materials that are habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, or precursors used as drugs; and radioactive drugs, made using the form prescribed in Appendix VIII issued together with this Circular;

c) Note of delivery for habit-forming drugs; psychotropic drugs; pre-substance drugs; drug materials that are habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, or precursors used as drugs; and radioactive drugs, made using the form prescribed in Appendix XV issued together with this Circular, in cases where the drugs are delivered to another establishment.

2. Drug rehabilitation facilities and establishments providing opioid substitution therapy shall prepare, manage, and retain in full the dossiers and records prescribed at Points b and c Clause 1 of this Article.

3. The establishment shall retain the minutes on receipt of returned habit-forming drugs, psychotropic drugs, and pre-substance drugs, made using the form prescribed in Appendix XVIII issued together with this Circular, and documents relating to the purchase of drugs under special control.

Article 15. Electronic dossiers and records and retention of dossiers and records

1. An establishment may use dossiers and records on electronic applications or software provided that the following requirements are satisfied:

a) Electronic information and data must be complete in accordance with the prescribed forms, encrypted, ensuring data integrity, and they must be protected from alteration during connection, sharing, and transmission of data through computer networks, telecommunications networks, or information carriers;

b) The accuracy, confidentiality, and preservation of data and information during use and retention must be ensured. Any changes to the contents of information and data relating to drugs and drug materials must be fully traceable in accordance with the law regulations on data;

c) Information and data must be managed, inspected, and capable of being retrieved throughout the retention period; information and data must be readily recoverable and capable of being extracted from electronic dossiers when necessary for reference, comparison, exploitation, and management purposes;

d) The person responsible for monitoring or confirming information and data recorded in the records shall use electronic authentication techniques or digital signatures to sign the relevant forms.

2. Pharmaceutical business establishments and establishments engaged in pharmacy activities for non-commercial purposes conducting activities relating to drugs and drug materials under special control shall retain documents relating to drugs and drug materials under special control in the form of paper or electronic dossiers and records.

3. Periods of retention for dossiers and records:

a) Prescriptions for habit-forming drugs, psychotropic drugs, and precursors shall be retained in accordance with Circular No. 26/2025/TT-BYT providing for prescriptions and the prescribing of pharmacochemical drug and biological products in outpatient treatment at medical examination and treatment establishments.

b) For other dossiers and records relating to drugs and drug materials under special control, the retention period shall be determined corresponding to each type of dossier and record in accordance with Circular No. 33/2025/TT-BYT providing for periods of retention for dossiers and documents in the health sector.

4. Upon expiry of the retention period, the head of the establishment shall establish a council to destroy the documents, make the minutes on document destruction, and retain the dossiers relating to the destruction of dossiers and documents at the establishment.

CHAPTER V

IMPLEMENTATION PROVISIONS

Article 16. Effect

1. This Circular takes effect on July 16, 2026, except for cases prescribed in Clauses 2 and 3 of this Article.

2. The pharmaceutical ingredients of Etomidate and Carisoprodol shall be classified as psychotropic pharmaceutical ingredients; drugs containing Etomidate and drugs containing Carisoprodol shall be classified as psychotropic drugs from June 01, 2026.

3. Clause 1 Article 17 of this Circular shall take effect from June 01, 2026.

4. From the effective date of this Circular, the following documents cease to be effective:

a) Circular No. 20/2017/TT-BYT on detailing a number of articles of the Law on Pharmacy and the Decree No. 54/2017/ND-CP dated May 08, 2017 of the Government on concerning drugs and drug materials under special control;

b) Circular No. 27/2024/TT-BYT amending and supplementing a number of articles of Circular No. 20/2017/TT-BYT.

Article 17. Transitional provision

1. The management of the pharmaceutical ingredients of Etomidate and Carisoprodol and drugs containing Etomidate or Carisoprodol from June 01, 2026 until the date preceding the effective date of this Circular shall comply with the regulations on psychotropic drugs and drug materials being psychotropic pharmaceutical ingredients prescribed in Circular No. 20/2017/TT-BYT as amended and supplemented by Circular No. 27/2024/TT-BYT and other relevant law regulations on psychotropic drugs and drug materials being psychotropic pharmaceutical ingredients.

2. Decision No. 3235/QD-BYT dated November 01, 2024 of the Minister of Health on the promulgation of the list of drugs and pharmaceutical materials banned from use in a number of sectors and fields as prescribed in Clause 1 Article 1 of Circular No. 27/2024/TT-BYT shall continue to remain effective until a Decision promulgating a replacing list is issued.

Article 18. Reference clauses

In case the legal normative documents mentioned in this Circular are amended, supplemented, or replaced, the new legal normative documents shall apply.

Article 19. Responsibility of implementation

The Chief of the Ministry Office, Directors of Departments of the Ministry of Health, heads of agencies and units under the Ministry, specialized health agencies under provincial-level People's Committees, heads of health agencies of relevant ministries and sectors shall be responsible for implementation of this Circular.

Any difficulties arising in the course of implementation of this Circular should be reported to the Ministry of Health (the Drug Administration of Vietnam) for consideration and settlement./.

* All Appendices are not translated herein.