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MINISTRY OF HEALTH OF VIETNAM |
SOCIALIST REPUBLIC OF VIETNAM |
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No: 18/2026/TT-BYT |
Hanoi, June 01, 2026 |
CIRCULAR
ELABORATING SOME ARTICLES OF LAW ON PHARMACY AND DECREE NO. 163/2025/ND-CP ON DRUGS AND DRUG INGREDIENTS SUBJECT TO SPECIAL CONTROL
Pursuant to the Law on Pharmacy No. 105/2016/QH13, as amended by the Law No. 44/2024/QH15;
Pursuant to Decree No. 163/2025/ND-CP dated June 29, 2025 elaborating certain articles and measures for the implementation of the Law on Pharmacy;
Pursuant to Decree No. 28/2026/ND-CP on Lists of narcotics and precursors;
Pursuant to Decree No. 42/2025/ND-CP dated February 27, 2025 defining the functions, tasks, powers and organizational structure of the Ministry of Health of Vietnam;
At the request of the Director of the Drug Administration of Vietnam
The Minister of Health hereby issues this Circular elaborating some articles of Law on Pharmacy and Decree No. 163/2025/ND-CP on drugs and drug ingredients subject to special control.
Chapter I
GENERAL PROVISIONS
Article 1. Scope
This Circular elaborates some Articles of the Law on Pharmacy No. 105/2016/QH13, as amended by the Law No. 44/2024/QH15 (hereinafter referred to as “Law on Pharmacy”) and Decree No. 163/2025/ND-CP on:
1. Lists of drugs and drug ingredients subject to special control, including:
a) List of narcotic active ingredients in accordance with Clause 17 Article 2 of the Law on Pharmacy;
b) List of psychotropic active ingredients in accordance with Clause 18 Article 2 of the Law on Pharmacy;
c) List of drug precursors in accordance with Clause 19 Article 2 of the Law on Pharmacy;
d) Table of concentration and content limits of narcotic active ingredients in combination drugs in accordance with Clause 20 Article 2 of the Law on Pharmacy;
dd) Table of concentration and content limits of psychotropic active ingredients in combination drugs in accordance with Clause 21 Article 2 of the Law on Pharmacy;
e) Table of concentration and content limits of drug precursors in combination drugs in accordance with Clause 22 Article 2 of the Law on Pharmacy;
g) List of drugs and active ingredients on the list of substances banned from use in certain fields, which is promulgated under the decision of the Minister of Health in accordance with point b Clause 2 Article 29 of Decree No. 163/2025/ND-CP.
2. Storage, manufacture, preparation, dispensing, use, disposal, delivery, transport, reporting, documents, and logbooks prepared by drugs and drug ingredients subject to special control for facilities conducting non-commercial pharmaceutical activities in accordance with Clause 3 Article 35 of the Law on Pharmacy.
3. Supply of radiopharmaceuticals in accordance with Clause 3 Article 35 of the Law on Pharmacy.
4. Documents, logbooks, and retention of relevant records and documents on drugs and drug ingredients subject to special control in accordance with Article 31 of Decree No. 163/2025/ND-CP.
Article 2. Promulgation of lists of drugs subject to special control and tables of concentration and content limits of narcotic active ingredients, psychotropic active ingredients, and drug precursors in combination drugs
1. The list of narcotic active ingredients specified in Appendix I and the table of concentration and content limits of narcotic active ingredients in combination drugs specified in Appendix IV enclosed herewith.
2. The list of psychotropic active ingredients specified in Appendix II and the table of concentration and content limits of psychotropic active ingredients in combination drugs specified in Appendix V enclosed herewith.
3. The list of drug precursors specified in Appendix III and the table of concentration and content limits of drug precursors in combination drugs specified in Appendix VI enclosed herewith.
4. Classification of narcotic drugs, psychotropic drugs, precursor drugs, and combination drugs containing narcotic active ingredients, psychotropic active ingredients, and drug precursors specified in Appendix VII enclosed herewith.
5. Drugs and active ingredients on the list of substances banned from use in certain fields promulgated under the decision of the Minister of Health in accordance with Clause 2 Article 29 of Decree No. 163/2025/ND-CP.
Chapter II
STORAGE, MANUFACTURE, PREPARATION, DISPENSING, USE, DISPOSAL, DELIVERY, TRANSPORT, REPORTING, RECORDS, AND LOGBOOKS PREPARED BY DRUGS AND DRUG INGREDIENTS SUBJECT TO SPECIAL CONTROL OF FACILITIES CONDUCTING NON-COMMERCIAL PHARMACEUTICAL ACTIVITIES
Article 3. Storage
1. Facilities conducting non-commercial pharmaceutical activities must comply with the requirements of Good Storage Practices (GSP) for drugs and drug ingredients. To be specific:
a) Narcotic drugs, psychotropic drugs, precursor drugs, and drug ingredients which are narcotic active ingredients, psychotropic active ingredients, and drug precursors must be stored in separate and locked warehouses or cabinets and must not be stored together with other drugs or drug ingredients. If separate warehouses or cabinets are unavailable, narcotic drugs may be stored in the same cabinet, shelf, or rack with psychotropic drugs and precursor drugs; however, they must be labeled and separated from each other. Psychotropic drugs of a commune-level health station must be stored in locked cabinet and monitored by a specific person;
b) Combination drugs containing narcotic active ingredients, combination drugs containing psychotropic active ingredients and combination drugs containing precursors must be stored in separate areas and must not be stored with other drugs;
c) Radiopharmaceuticals must be stored in separate and locked warehouses or cabinets, ensuring radiation safety and security and prevention of environmental radiation exposure in accordance with laws on atomic energy;
d) Toxic drugs and toxic drug ingredients must be stored in separate areas, must not be stored with other drugs, and must be arranged to avoid confusion and facilitate inspection within the storage area;
dd) Narcotic drugs, psychotropic drugs, and precursor drugs in duty cabinets or emergency drug cabinets must be in a separate slot, must not be stored with other drugs, and shall be kept and dispensed by the on-duty nurse according to prescriptions. The emergency drug cabinet must be safely locked; The quantities and categories of controlled drugs therein shall be specified in writing by the head of the facility. When changing shift, the person working the previous shift must inform the person working the next shift of the quantities of drugs and the drug logbook, which has to bear their signatures.
e) The person managing drugs subject to special control at departments of facilities conducting non-commercial pharmaceutical activities shall manage, dispense, and fully record the receipts, issues, and stock on hand of narcotic drugs, psychotropic drugs, precursor drugs, and drug ingredients that are narcotic active ingredients, psychotropic active ingredients, and precursors into the logbook in accordance with the forms specified in Appendix VIII attached hereto.
2. Warehouse keepers at hospital pharmacies, persons managing drugs subject to special control at departments of facilities conducting non-commercial pharmaceutical activities (hereinafter referred to as “drug manager”) must possess appropriate qualifications. To be specific:
a) Regarding narcotic drugs and narcotic active ingredients: the manager of the hospital pharmacy must meet the provisions of Clause 1, Article 9 of Circular No. 22/2011/TT-BYT; drug managers at other facilities conducting non-commercial pharmaceutical activities must hold an associate degree in pharmacy or higher;
b) Regarding psychotropic drugs, precursor drugs, and drug ingredients that are psychotropic active ingredients or precursors: drug managers at other facilities conducting non-commercial pharmaceutical activities must hold an associate degree in pharmacy or higher;
c) Regarding radiopharmaceuticals: drug managers must hold an associate degree in pharmacy or higher; or be physicians, technicians or nurses who have been trained in radiation safety and assigned in writing by the head of the facility
d) Other than the personnel specified in points a, b, and c of this Clause, the head of the facility shall assign drug managers at departments, rooms, and units using drugs in accordance with the actual human resources of the facility, provided there is no loss of drugs subject to special control.
dd) If no one in an facility conducting non-commercial pharmaceutical activities has the required qualifications specified in points a ad b of this Clause, the head of the facility shall assign, in writing, a person who has a medical assistant qualification or higher.
Article 4. Manufacture and preparation
1. The manufacture of drugs subject to special control at facilities conducting non-commercial pharmaceutical activities shall comply with the provisions of Circular No. 28/2025/TT-BYT on Good Manufacturing Practices (GMP) for drugs and drug ingredients.
2. The preparation of drugs subject to special control at healthcare facilities shall comply with the provisions of Circular No. 30/2021/TT-BYT on drug preparation for patient treatment at healthcare facilities.
Article 5. Dispensing, use, and disposal of drugs and drug ingredients
1. In healthcare facilities other than facilities providing opioid substitution therapy, drug rehabilitation centers, and dispensaries of detention facilities under the management of the Ministry of Public Security, controlled drugs shall be dispensed and used in accordance with Circular No. 23/2011/TT-BYT dated June 10, 2011 of the Minister of Health (hereinafter referred to as “Circular No. 23/2011/TT-BYT”)
Where a healthcare facility uses controlled drug ingredients to prepare drugs in-house, such drug ingredients shall be dispensed and used in accordance with Clause 3 hereof.
2. In facilities providing opioid substitution therapy, methadone shall be dispensed and used in accordance with the provisions of Circular No. 26/2023/TT-BYT. Other controlled drugs shall be dispensed and used as follows:
a) The treating and diagnosing departments shall complete the medication request form (MRF) using the form No. 1 enclosed with Circular No. 23/2011/TT-BYT;
b) The dispensary shall dispend drugs to treating and diagnosing departments according to the MRFs, record the receipts, issues, and stock on hand of narcotic drugs, psychotropic drugs, precursor drugs using the form in Appendix VIII hereof;
c) After receiving the drugs, the persons in charge of the treating and diagnosing departments shall check the drug names, concentrations, expiry dates and quantities before and after administering or give the drugs to the patients;
d) Unused narcotic drugs, psychotropic drugs and precursor drugs, or those left over due to patient transfer or death, shall be returned to the dispensary. Such return must be recorded in writing. The dispensary manager shall decide on reuse or disposal according to regulations based on specific conditions, prepare and retain a record;
dd) The dispensary manager shall have at least an associate degree in pharmacy and be assigned in writing the be head of the facility to sign the MRFs;
e) The managers or deputy managers, if authorized in writing by the managers, of treating departments and diagnosing departments shall sign the MRFs. MRFs on days off and emergency MRFs may be signed by the on-duty physician or medical assistant.
3. The dispensing and use of controlled drugs at dispensaries of detention facilities managed by the Ministry of Public Security, drug rehabilitation centers, and other facilities conducting non-commercial pharmaceutical activities (except for facilities specified in Clauses 1 and 2 of this Article) and the dispensing and use of controlled drug ingredients at all facilities conducting non-commercial pharmaceutical activities shall be carried out as follows:
a) The head of the department requiring the use or the assigned person shall approve the MRF made using the form in Appendix XII attached hereto;
b) The head of the department and the recipient shall use controlled drugs or drug ingredients for the correct purpose and must return any unused controlled drugs or drug ingredients to the managing department/manager.
4. A facility conducting non-commercial pharmaceutical activities shall dispose controlled drugs (including primary packages of narcotic drugs, psychotropic drugs, precursor drugs, narcotic active ingredients, psychotropic active ingredients, and precursors) in accordance with Article 36 of Decree No. 163/2025/ND-CP. If the facility does not have a person in charge of pharmacy operations, a drug disposal council must include the head of the pharmacy or the person authorized by the head of the facility.
Article 6. Delivery, receipt, and transport
1. The delivery, receipt, and transport of controlled drugs and drug ingredients between facilities must comply with general regulations on the delivery, receipt, and transport of drugs and drug ingredients and provisions of Article 33 of Decree No. 163/2025/ND-CP; the deliverer and recipient must possess an associate degree in pharmacy or higher, or be the person authorized in writing by the head of the facility.
2. In the case where a drug retailer or healthcare facility receives back narcotic drugs, psychotropic drugs, or precursor drugs when the patient does not use them all or dies, a record of drug return shall be made in duplicate using the form specified in Appendix XVIII enclosed herewith. The drugs returned shall be quarantined in a secure area to prevent loss and disposed in accordance with the law.
Article 7. Reporting
1. Before January 15 every year, a facility conducting non-commercial pharmaceutical activities shall prepare a report on the receipt, issue, stock on hand, and use of narcotic drugs, psychotropic drugs, precursor drugs, radiopharmaceuticals, and combination drugs containing precursors using the form in Appendix IX attached hereto and submit it to the following agencies:
a) The Department of Military Medicine – the Ministry of National Defense, if such facility is under the management of the Ministry of National Defense;
b) The Department of Health – the Ministry of Public Security, if such facility is under the management of the Ministry of Public Security;
c) The specialized health agency affiliated to the People’s Committee of the province where its head office is located, if such facility does not fall under points a and b of this Clause.
2. Before February 15 every year, the Department of Military Medicine – the Ministry of National Defense and the Department of Health – the Ministry of Public Security shall submit an annual report on use of narcotic drugs, psychotropic drugs, precursor drugs, radiopharmaceuticals and combination drugs containing precursors of facilities under their management; the specialized health agency affiliated to the provincial People’s Committee shall submit an annual report on use of narcotic drugs, psychotropic drugs, precursor drugs, radiopharmaceuticals, and combination drugs containing precursors of facilities within its administrative area (excluding those under the management of the Ministry of National Defense and the Ministry of Public Security) to the Ministry of Health using the form specified in Appendix X hereof.
3. Ad-hoc reporting: Within 48 hours from the detection of any mix-up or loss of radiopharmaceuticals , narcotic drugs, psychotropic drugs, precursor drugs, combination drugs containing precursors, or drug ingredients which are narcotic active ingredients, psychotropic active ingredients, or precursors, the facility conducting non-commercial pharmaceutical activities shall prepare a written report using the form specified in Appendix XII hereof and submit it to the respective agency specified in Clause 1 of this Article.
4. The reports specified in Clauses 1, 2, and 3 of this Article must be submitted online as soon as a software to receive reports of the Department of Military Medicine – the Ministry of National Defense and the Department of Health – the Ministry of Public Security, specialized medical agencies of provincial People’s Committees, and the Ministry of Health is available.
Chapter III
SUPPLY OF RADIOPHARMACEUTICALS
Article 8. Supply of radiopharmaceuticals
1. A healthcare facility permitted to manufacture/prepare radiopharmaceuticals may supply radiopharmaceuticals for other healthcare facilities if the quantity of radiopharmaceuticals manufactured/prepared exceeds the demand of such facility.
2. The manufacturing/preparing healthcare facility and the receiving facility specified in Clause 1 hereof shall be held accountable for the quality, safety, and effectiveness of the drugs.
3. Before January 31 every year, the radiopharmaceutical supplier specified in Clause 1 hereof shall prepare a report on the supply of radiopharmaceuticals of the preceding year, using the form in Appendix XIII attached hereto, and submit it to the Ministry of Health (Drug Administration of Vietnam) and the specialized medical agency affiliated to the People’s Committee of the province where the supplier is located.
Chapter IV
DOCUMENTS, LOGBOOKS, AND RETENTION OF RELEVANT RECORDS AND DOCUMENTS ON DRUGS AND DRUG INGREDIENTS SUBJECT TO SPECIAL CONTROL
Article 9. Dossiers and logbooks prepared by manufacturers
1. A manufacturer of narcotic drugs, psychotropic drugs, precursor drugs, drug ingredients that are narcotic active ingredients, psychotropic active ingredients or drug precursors shall establish, manage, and retain the following dossiers and logbooks:
a) Logbook of preparation and manufacture of narcotic drugs, psychotropic drugs, precursor drugs in accordance with the logbook template specified in Appendix XIV attached hereto;
b) Logbook of the receipt, issue, and inventory of narcotic drugs, psychotropic drugs, precursor drugs, drug ingredients that are narcotic active ingredients, psychotropic active ingredients or drug precursors in accordance with the template specified in Appendix VIII attached hereto
c) Delivery slips for narcotic drugs, psychotropic drugs, precursor drugs, drug ingredients that are narcotic active ingredients, psychotropic active ingredients or drug precursors in accordance with the form specified in Appendix XV attached hereto
d) Records on to the purchase and sale of narcotic drugs, psychotropic drugs, precursor drugs, drug ingredients that are narcotic active ingredients, psychotropic active ingredients or drug precursors.
2. Manufacturers of combination drugs containing narcotic active ingredients/psychotropic active ingredients/drug precursors, toxic drugs, toxic drug ingredients, and drugs/active ingredients on the list of drugs and active ingredients
b) Logbook of the receipt, issue, and inventory of drug ingredients that are narcotic active ingredients, psychotropic active ingredients or drug precursors in accordance with the template specified in Appendix VIII attached hereto; logbook of the receipt, issue, and inventory of combination drugs containing narcotic active ingredients, psychotropic active ingredients or drug precursors in accordance with the template specified in Appendix XVI attached hereto;
b) Delivery slips for drug ingredients that are narcotic active ingredients, psychotropic active ingredients or drug precursors in accordance with the form specified in Appendix XV attached hereto;
c) Logbook of the receipt, issue, and inventory of toxic drugs, toxic drug ingredients, and drugs/active ingredients on the list of the drugs and active ingredients banned from use in certain fields in accordance with the template specified in XVI attached hereto;
d) Records relevant to the purchase and sale of drug ingredients which are narcotic active ingredients, psychotropic active ingredients or drug precursors, combination drugs containing narcotic active ingredients, combination drugs containing psychotropic active ingredients, combination drugs containing precursors, toxic drugs, toxic drug ingredients, and drugs or active ingredients on the list of drugs and active ingredients banned from use in certain fields.
3. Manufacturers of radiopharmaceuticals shall prepare, manage, and retain the following dossiers and logbooks:
a) Logbook on preparation and manufacture of radiopharmaceuticals in accordance with the template specified in Appendix XVII attached hereto;
b) Logbook on receipt, issue, and inventory of radiopharmaceuticals in accordance with the template specified in Appendix VIII attached hereto;
c) Delivery slips for radiopharmaceuticals in accordance with the form specified in Appendix XV attached hereto;
d) Records relevant to the purchase and sale of radiopharmaceuticals
Article 10. Dossiers and logbooks prepared by importers and exporters
1. Importers and exporters of narcotic drugs, psychotropic drugs, precursor drugs, drug ingredients that are narcotic active ingredients, psychotropic active ingredients or drug precursors shall establish, manage, and retain the following dossiers and logbooks:
a) Logbook of the receipt, issue, and inventory of narcotic drugs, psychotropic drugs, precursor drugs, drug ingredients that are narcotic active ingredients, psychotropic active ingredients or drug precursors in accordance with the template specified in Appendix VIII attached hereto;
b) Delivery slips for drug ingredients that are narcotic active ingredients, psychotropic active ingredients or drug precursors in accordance with the form specified in Appendix XV attached hereto;
c) Records relevant to the import, export, purchase, and sale of narcotic drugs, psychotropic drugs, and precursor drugs.
2. Importers and exporters of combination drugs containing narcotic active ingredients/psychotropic active ingredients/drug precursors, toxic drugs, toxic drug ingredients, and drugs/active ingredients on the list of drugs and active ingredients banned from use in certain fields shall prepare, manage, and retain the following dossiers and logbooks:
a) Logbook of the receipt, issue, and inventory of combination drugs containing narcotic active ingredients, psychotropic active ingredients or drug precursors in accordance with the template specified in Appendix XVI attached hereto;
b) Logbook of the receipt, issue, and inventory of toxic drugs, toxic drug ingredients, and drugs/active ingredients on the list of the drugs and active ingredients banned from use in certain fields in accordance with the template specified in XVI attached hereto;
c) Records relevant to the import and export of combination drugs containing narcotic active ingredients/psychotropic active ingredients/precursors, toxic drugs, toxic drug ingredients, and drugs or active ingredients on the list of drugs and active ingredients banned from use in certain fields.
3. Importers and exporters of radiopharmaceuticals shall prepare, manage, and retain the following dossiers and logbooks:
a) Logbook on receipt, issue, and inventory of radiopharmaceuticals in accordance with the template specified in Appendix VIII attached hereto;
b) Delivery slips for radiopharmaceuticals in accordance with the form specified in Appendix XV attached hereto;
c) Records relevant to the import, export, purchase and sale of radiopharmaceuticals;
Article 11. Dossiers and logbooks prepared by wholesalers and pharmacy chains
1. Wholesalers and pharmacy chains trading in narcotic drugs, psychotropic drugs, and precursor drugs shall prepare, manage, and retain the following dossiers and logbooks:
a) Logbook on receipt, issue, and inventory of narcotic drugs, psychotropic drugs, precursor drugs in accordance with the logbook template specified in Appendix VIII attached hereto;
b) Delivery slips for drug ingredients that are narcotic active ingredients, psychotropic active ingredients or drug precursors in accordance with the form specified in Appendix XV attached hereto;
c) Records relevant to the purchase and sale of narcotic drugs, psychotropic drugs, and precursor drugs.
2. Wholesalers and pharmacy chains trading in combination drugs containing narcotic active ingredients/psychotropic active ingredients/drug precursors, toxic drugs, toxic drug ingredients, and drugs/active ingredients on the list of drugs and active ingredients shall prepare, manage, and retain the following dossiers and logbooks:
a) Logbook of the receipt, issue, and inventory of combination drugs containing narcotic active ingredients, psychotropic active ingredients or drug precursors in accordance with the template specified in Appendix XVI attached hereto;
b) Logbook of the receipt, issue, and inventory of toxic drugs, toxic drug ingredients, and drugs/active ingredients on the list of the drugs and active ingredients banned from use in certain fields in accordance with the template specified in XVI attached hereto;
c) Records relevant to the purchase and sale of combination drugs containing narcotic active ingredients/psychotropic active ingredients/precursors, toxic drugs, toxic drug ingredients, and drugs or active ingredients on the list of drugs and active ingredients banned from use in certain fields.
3. Wholesalers and pharmacy chains trading in radiopharmaceuticals shall prepare, manage, and retain the following dossiers and logbooks:
a) Logbook on receipt, issue, and inventory of radiopharmaceuticals in accordance with the template specified in Appendix VIII attached hereto;
b) Delivery slips for radiopharmaceuticals in accordance with the form specified in Appendix XV attached hereto;
c) Records relevant to the purchase and sale of radiopharmaceuticals.
Article 12. Dossiers and logbooks prepared by retailers
1. Retailers trading in narcotic drugs, psychotropic drugs, and precursor drugs shall prepare, manage, and retain the following dossiers and logbooks:
a) Logbook on receipt, issue, and inventory of narcotic drugs, psychotropic drugs, precursor drugs in accordance with the logbook template specified in Appendix VIII attached hereto;
b) Delivery slips for narcotic drugs, psychotropic drugs, and precursor drugs issued by the drug supplier;
c) Prescriptions for narcotic drugs and psychotropic drugs retained after sale;
d) Record of drug return for narcotic drugs, psychotropic drugs, and precursor drugs in accordance with the form specified in Appendix XVIII attached hereto;
dd) Logbook for customer information in accordance with the template specified in Appendix XIX attached hereto.
2. Retailers trading combination drugs containing narcotic active ingredients, psychotropic active ingredients or drug precursors shall prepare, manage, and retain customer information logbook in accordance with the template specified in Appendix XIX attached hereto;
3. Retailers trading combination drugs containing narcotic active ingredients/psychotropic active ingredients/drug precursors, toxic drugs, and drugs/active ingredients on the list of drugs and active ingredients banned from use in certain fields shall prepare, manage, and retain the logbook for receipt, issue, and inventory in accordance with the template specified in Appendix XVI attached hereto.
4. Drug retailers shall retain purchase and sale records of controlled drugs.
Article 13. Dossiers and logbooks prepared by providers of storage services, clinical study services, bioequivalence study services, and testing services
1. Regarding narcotic drugs, psychotropic drugs, precursor drugs, drug ingredients that are narcotic active ingredients, psychotropic active ingredients or drug precursors, service providers shall prepare, manage, and retain the following dossiers and logbooks:
a) Logbook of the receipt, issue, and inventory of narcotic drugs, psychotropic drugs, precursor drugs, drug ingredients that are narcotic active ingredients, psychotropic active ingredients or drug precursors in accordance with the template specified in Appendix VIII attached hereto;
b) Delivery slips for drug ingredients that are narcotic active ingredients, psychotropic active ingredients or drug precursors in accordance with the form specified in Appendix XV attached hereto.
2. Regarding combination drugs containing narcotic active ingredients/psychotropic active ingredients/drug precursors, toxic drugs, toxic drug ingredients, and drugs/active ingredients on the list of drugs and active ingredients banned from use in certain fields, service providers shall prepare, manage, and retain the logbook for receipt, issue, and inventory in accordance with the template specified in Appendix XVI attached hereto.
3. Regarding radiopharmaceuticals, service providers shall prepare, manage, and retain the logbook for receipt, issue, and inventory in accordance with the template specified in Appendix VIII attached hereto.
4. Providers of storage services, clinical study services, bioequivalence study services, and testing services shall retain purchase and sale records of controlled drugs.
Article 14. Dossiers and logbooks prepared by facilities conducting non-commercial pharmaceutical activities
1. Facilities conducting non-commercial pharmaceutical activities, other than facilities providing opioid substitution therapy and drug rehabilitation centers, shall prepare, manage, and retain the following dossiers and logbooks:
a) Logbook for preparation of narcotic drugs, psychotropic drugs, precursor drugs in accordance with the template specified in Appendix XIV and Appendix XVII attached hereto;
b) Logbook of the receipt, issue, and inventory of narcotic drugs, psychotropic drugs, precursor drugs, drug ingredients that are narcotic active ingredients, psychotropic active ingredients or drug precursors, radiopharmaceuticals in accordance with the template specified in Appendix VIII attached hereto;
c) Delivery slips for narcotic drugs, psychotropic drugs, precursor drugs, drug ingredients that are narcotic active ingredients, psychotropic active ingredients or drug precursors, or radiopharmaceuticals in accordance with the form specified in Appendix XV attached hereto, in cases where the drugs are issued to another facility.
2. Drug rehabilitation centers and facilities providing opioid substitution therapy shall prepare, manage, and retain dossiers and logbooks specified in Points b and c, Clause 1 of this Article.
3. Facilities shall retain records of drug return for narcotic drugs, psychotropic drugs, and precursor drugs and purchase records of controlled drugs in accordance with the form specified in Appendix XVIII attached hereto.
Article 15. Electronic dossiers and logbooks; retention thereof
1. Facilities may use dossiers and logbooks on electronic applications or software, provided that:
a) Electronic information and data are complete in accordance with the prescribed forms, encrypted, and integrated with data integrity and are not altered during connection, sharing, and transmission over computer networks, telecommunications networks, or data carriers;
b) Data and information are accurate, confidential, and preserved during use and storage. Any changes to the content of information or data related to drugs and drug ingredients must be traceable in accordance with the law on data;
c) Information and data must be managed, audited, and searchable throughout the retention period; available for restoration; and retrievable from electronic records when necessary for reference, comparison, utilization, and management;
d) Persons monitoring or verifying information and data in documents must use electronic verification techniques or digital signatures to sign the relevant forms.
2. Pharmaceutical business facilities or facilities conducting non-commercial pharmaceutical activities with operations related to controlled drugs and drug ingredients shall retain records and documents about such drugs and drug ingredients in the physical and electronic forms.
3. Retention period for dossiers and documents:
a) Prescriptions for narcotic drugs, psychotropic drugs, and precursors shall be retained in accordance with Circular No. 26/2025/TT-BYT.
b) Other relevant dossiers and documents shall be retained in accordance with the respective types specified in Circular No. 33/2025/TT-BYT.
4. Upon expiry of the retention period, the head of the facility shall establish a council to destroy documents; a destruction report shall be prepared and retained at the facility.
Chapter V
IMPLEMENTATION
Article 16. Effect
1. This Circular shall come into force from July 16, 2026, except for the cases specified in Clauses 2 and 3 of this Article/
2. Etomidate and Carisoprodol shall be classified as psychotropic active ingredients, and drugs containing Etomidate or Carisoprodol shall be classified as psychotropic drugs from June 1, 2026.
3. Clause 1, Article 17 of this Circular shall come into force from June 1, 2026.
4. The following documents shall cease to be effective from the effective date of this Circular:
a) Circular No. 20/2017/TT-BYT elaborating some articles of Law on Pharmacy and Decree No. 163/2025/ND-CP on drugs and drug ingredients subject to special control
b) Circular No. 27/2024/TT-BYT amending and supplementing some articles of Circular No. 20/2017/TT-BYT.
Article 17. Transition clauses
1. The management of Etomidate and Carisoprodol and drugs containing Etomidate or Carisoprodol, from June 1, 2026 until before the effective date of this Circular, shall comply with the regulations on psychotropic drugs and drug ingredients which are psychotropic active ingredients in accordance with Circular No. 20/2017/TT-BYT (as amended and supplemented by Circular No. 27/2024/TT-BYT) and other relevant legal provisions on psychotropic drugs and drug ingredients which are psychotropic active ingredients.
2. Decision No. 3235/QD-BYT dated November 1, 2024 of the Minister of Health on the promulgation of the list of drugs and active pharmaceutical ingredients banned from certain fields in accordance with Clause 1, Article 1 of Circular No. 27/2024/TT-BYT shall remain effective until a Decision promulgating a replacement list is issued.
Article 18. Terms of reference
In case any of the documents cited in this Circular is superseded or amended, the newest document shall apply.
Article 19. Responsibility for implementation
Chief of the Ministry Office, Directors of Departments under the Ministry of Health, Heads of agencies and units affiliated to the Ministry, specialized medical agencies under the provincial People’s Committees, and Heads of medical agencies of relevant Ministries and center authorities shall implement this Circular.
Any difficulties that arise during the implementation of this document should be reported to the Ministry of Health (Drug Administration of Vietnam – Ministry of Health) for further study and resolution./.
|
PP. MINISTER Nguyen Tri Thuc |
LIST OF APPENDICES
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NO. |
APPENDIX NO. |
APPENDIX TITLE |
|
1 |
Appendix I |
List of narcotic active ingredients |
|
2 |
Appendix II |
List of psychotropic active ingredients |
|
3 |
Appendix III |
List of drug precursors |
|
4 |
Appendix IV |
Table of concentration and content limits of narcotic active ingredients in combination drugs |
|
5 |
Appendix V |
Table of concentration and content limits of narcotic active ingredients in combination drugs |
|
6 |
Appendix VI |
Table of concentration and content limits of drug precursors in combination drugs |
|
7 |
Appendix VII |
Classification of narcotic drugs, psychotropic drugs, precursor drugs, and combination drugs containing narcotic active ingredients, psychotropic active ingredients, or drug precursors. |
|
8 |
Appendix VIII |
Logbook of the receipt, issue, and inventory of narcotic drugs, psychotropic drugs, precursor drugs, drug ingredients that are narcotic active ingredients, psychotropic active ingredients or drug precursors, radiopharmaceuticals |
|
9 |
Appendix IX |
Report on the receipt, issue, inventory, and use of narcotic drugs, psychotropic drugs, precursor drugs and combination drugs that contain precursors |
|
10 |
Appendix X |
Report on the use of narcotic drugs, psychotropic drugs, precursor drugs, radiopharmaceuticals, and combination drugs containing precursors |
|
11 |
Appendix XI |
Report on the mix-up or loss of narcotic drugs, psychotropic drugs, precursor drugs, radiopharmaceuticals, combination drugs containing precursors, and drug ingredients containing narcotic active ingredients, psychotropic active ingredients, or drug precursors |
|
12 |
Appendix XII |
Medication request form (MRF) for controlled drugs and drug ingredients |
|
13 |
Appendix XIII |
Report on the supply of radiopharmaceuticals |
|
14 |
Appendix XIV |
Logbook for the manufacture and preparation of narcotic drugs, psychotropic drugs, and precursor drugs |
|
15 |
Appendix XV |
Delivery slips for narcotic drugs, psychotropic drugs, precursor drugs, radiopharmaceuticals; drug ingredients that are narcotic active ingredients, psychotropic active ingredients or drug precursors |
|
16 |
Appendix XVI |
Logbook of the receipt, issue, and inventory of combination drugs containing narcotic active ingredients/psychotropic active ingredients/drug precursors, toxic drugs, toxic drug ingredients, and drugs/active ingredients on the list of drugs and active ingredients banned from use in certain fields |
|
17 |
Appendix XVII |
Logbook for the manufacture and preparation of radiopharmaceuticals |
|
18 |
Appendix XVIII |
Record of drug return for narcotic drugs, psychotropic drugs, and precursor drugs |
|
19 |
Appendix XIX |
Logbook for customer information |
Appendix I
LIST OF NARCOTIC ACTIVE INGREDIENTS (*)
(Attached to Circular No. 18/2026/TT-BYT dated June 1, 2026 of the Minister of Health)
|
NO. |
INTERNATIONAL NAME |
SCIENTIFIC NAME |
|
1 |
ACETYLDIHYDROCODEINE | (5α, 6α)- 4,5- epoxy-3-methoxy-17- methyl- morphinan-6-ol acetate |
|
2 |
ALFENTANIL | N-[1-[2-(4-ethyl-4,5-dihydro-5-oxo-1H- tetrazol-1-yl)ethyl]-4-(methoxymethyl)-4- piperidinyl]-N-phenylpropanamide |
|
3 |
ALPHAPRODINE | (α)-1,3-dimethyl-4-phenyl-4- propionoxypiperidine |
|
4 |
ANILERIDINE | 1-para-aminophenethyl-4- phenylpiperidine-4-carboxylic acid ethyl ester |
|
5 |
BEZITRAMIDE | 1-(3-cyano-3,3-diphenylpropyl)-4-(2-oxo- 3-propionyl-1-benzimidazolinyl)piperidine |
|
6 |
BUTORPHANOL | (-)-17-(cyclobutylmethyl) morphinan-3,14 diol |
|
7 |
CIRAMADOL | (-)-2-(α-Dimethylamino-3-hydroxybenzyl) cyclohexanol |
|
8 |
COCAINE | Benzoylecgonine, methylester |
|
9 |
CODEINE; 3-METHYLMORPHINE | (5α,6α)-7,8-didehydro-4,5-epoxy-3- methoxy-17-methylmorphinan-6-ol |
|
10 |
DEXTROMORAMIDE | (+)-4-[2-methyl-4-oxo-3,3-diphenyl-4-(1- pyrrolidinyl)butyl] morpholine |
|
11 |
DEZOCINE | (-)-13β-Amino- 5,6,7,8,9,10,11α, 12 octahydro- 5α-methyl-5,11-methanobenzo- cyclodecen-3-ol |
|
12 |
DIFENOXIN | 1-(3-cyano-3,3-diphenylpropyl)-4- phenylisonipecotic acid |
|
13 |
DIHYDROCODEINE | 4,5α-epoxy-3-methoxy-17- methylmorphinan-6α-ol |
|
14 |
DIPHENOXYLATE | 1-(3-cyano-3,3-diphenylpropyl)-4- phenylpiperidine- 4- carboxylic acid ethyl ester |
|
15 |
DIPIPANONE | 4,4-diphenyl-6-piperidine-3-heptanone |
|
16 |
DROTEBANOL | 3,4-dimethoxy- 17 methylmorphinan- 6β, 14- diol |
|
17 |
ETHYLMORPHINE | 3- Ethylmorphine |
|
18 |
FENTANYL | 1- phenethyl- 4- N- propionylanilinopiperidine |
|
19 |
HYDROMORPHONE | Dihydromorphinone |
|
20 |
LEVOMETHADONE | (3- Heptanone, 6- (dimethylamino)-4,4- Diphenyl, (R)) |
|
21 |
LEVORPHANOL | (-)- 3- hydroxy- N- methylmorphinan |
|
22 |
MEPTAZINOL | (3(3- Ethyl- 1- methylperhydroazepin-3- yl) phenol) |
|
23 |
METHADONE | 6- dimethylamino- 4,4- diphenyl- 3- heptanone |
|
24 |
MORPHINE | (5α,6α)-7,8-didehydro-4,5-epoxy-17- methylmorphinan-3,6-diol |
|
25 |
MYROPHINE | Myristylbenzylmorphine |
|
26 |
NALBUPHINE | 17- Cyclobutylmethyl- 7,8- dihydro- 14- hydroxy- 17- normorphine |
|
27 |
NICOCODINE<0} | 6- nicotinylcodeine |
|
28 |
NICODICODINE | 6- nicotinyldihydrocodeine |
|
29 |
NICOMORPHINE | 3,6- dinicotinylmorphine |
|
30 |
NORCODEINE | N- demethylcodeine |
|
31 |
OXYCODONE | 14- hydroxydihydrocodeinone |
|
32 |
OXYMORPHONE | 14- hydroxydihydromorphinone |
|
33 |
PETHIDINE | 1- methyl- 4- phenylpiperidine- 4- carboxylic acid ethyl ester |
|
34 |
PHENAZOCINE | 1- methyl- 4- phenylpiperidine- 4- carboxylic acid ethyl ester |
|
35 |
PHOLCODINE | 3- morpholinylethylmorphine |
|
36 |
PIRITRAMIDE | 1-(3- cyano- 3,3- diphenylpropyl)- 4- (1- piperidino)- piperidine- 4- carboxylic acid amide |
|
37 |
PROPIRAM | N-(1- methyl- 2- piperidinoethyl)- N- 2- pyridylpropionamide |
|
38 |
REMIFENTANIL | 1-(2- methoxycarbonylethyl)- 4- (phenylpropionylamino)- piperidine- 4carboxylic acid methyl ester |
|
39 |
SUFENTANIL | N-[4-(methoxymethyl)- 1- [2- (2- thienyl)- ethyl]- 4- piperidyl] propionanilide |
|
40 |
THEBACON; ACETYLDIHYDROCODEINONE | (4,5α-epoxy-3-methoxy-17- methylmorphinan-6-en-6-yl) acetate |
|
41 |
TONAZOCINE MESYLATE | (±)-1-[(2R*,6S*,11S*)- 1,2,3,4,5,6- hexahydro- 8- hydroxy- 3,6,11- trimethyl- 2,6- methano- 3- benzazocin- 11- yl]-3- one-methanesulphonate |
|
42 |
TRAMADOL | (±)-Trans-2-Dimethylaminomethyl-1-(3- methoxyphenyl) cyclohexan-1-ol |
Note: (*) This list includes narcotic substances and their salts, isomers, esters, ethers, and salts of such isomers, esters, and ethers that may exist (unless an ester or ether of such substance is specified in Appendix II or Appendix III attached to this Circular).
Appendix II
LIST OF PSYCHOTROPIC ACTIVE INGREDIENTS (*)
(Attached to Circular No. 18/2026/TT-BYT dated June 1, 2026 of the Minister of Health)
|
NO. |
INTERNATIONAL NAME |
OTHER COMMON NAMES |
SCIENTIFIC NAME |
|
1 |
ALLOBARBITAL | 5,5-diallylbarbituric acid | |
|
2 |
ALPRAZOLAM | 8-chloro-1-methyl-6-phenyl-4H-s- triazolo[4,3-a][1,4]benzodiazepine | |
|
3 |
AMFEPRAMONE | Diethylpropion | 2-(diethylamino)propiophenone |
|
4 |
AMINOREX | 2-amino-5-phenyl-2-oxazoline | |
|
5 |
AMOBARBITAL | 5-ethyl-5-isopentylbarbituric acid | |
|
6 |
BARBITAL | 5,5-diethylbarbituric acid | |
|
7 |
BENZFETAMINE | Benzphetamine | N-benzyl-N,α- dimethylphenethylamine |
|
8 |
BROMAZEPAM | 7-bromo-1,3-dihydro-5-(2- pyridyl)-2H-1,4-benzodiazepin-2- one | |
|
9 |
BROTIZOLAM | 2-bromo-4-(o-chlorophenyl)-9- methyl-6H-thieno[3,2-f]-s- triazolo[4,3-a][1,4]diazepine | |
|
10 |
BUPRENORPHINE | 21-cyclopropyl-7-α-[(S)-1- hydroxy-1,2,2-trimethylpropyl]- 6,14-endo-ethano-6,7,8,14- tetrahydrooripavine | |
|
11 |
BUTALBITAL | 5-allyl-5-isobutylbarbituric acid | |
|
12 |
BUTOBARBITAL | 5-butyl-5-ethylbarbituric acid | |
|
13 |
CAMAZEPAM | 7-chloro-1,3-dihydro-3-hydroxy-1- methyl-5-phenyl-2H-1,4- benzodiazepin-2-one dimethylcarbamate(ester) | |
|
14 |
CHLORDIAZEPOXIDE | 7-chloro-2-(methylamino)-5-phenyl- 3H-1,4-benzodiazepine-4-oxide | |
|
15 |
CATHINE | (+)-norpseudo- ephedrine | (+)-(R)-α-[(R)-1- aminoethyl]benzylalcohol |
|
16 |
CLOBAZAM | 7-chloro-1-methyl-5-phenyl-1H- 1,5-benzodiazepine-2,4(3H,5H)- dione | |
|
17 |
CLONAZEPAM | 5-(o-chlorophenyl)-1,3-dihydro-7- nitro-2H-1,4-benzodiazepine-2- one | |
|
18 |
CLORAZEPATE | 7-chloro-2,3-dihydro-2-oxo-5- phenyl-1H-1,4-benzodiazepine-3- carboxylic acid | |
|
19 |
CLOTIAZEPAM | 5-(2-chlorophenyl)-7-ethyl-1,3- dihydro-1-methyl-2H-thieno[2,3- e]-1,4-diazepin-2-one | |
|
20 |
CLOXAZOLAM | 10-chloro-11b-(o-chlorophenyl)- 2,3,7,11b-tetrahydrooxazolon-[3,2- d][1,4]benzodiazepin-6(5H)-one | |
|
21 |
DELORAZEPAM | 7-chloro-5-(o-chlorophenyl)-1,3- dihydro-2H-1,4-benzodiazepin-2- one | |
|
22 |
DIAZEPAM | 7-chloro-1,3-dihydro-1-methyl-5- phenyl-2H-1,4-benzodiazepin-2- one | |
|
23 |
ESTAZOLAM | 8-chloro-6-phenyl-4H-s- triazolo[4,3-a][1,4]benzodiazepine | |
|
24 |
ETHCHLORVYNOL | 1-chloro-3-ethyl-1-penten-4-yn-3-ol | |
|
25 |
ETHINAMATE | 1-ethynylcyclohexanol carbamate | |
|
26 |
ETHYLLOFLAZEPATE | ethyl-7-chloro-5-(o-fluorophenyl)- 2,3-dihydro-2-oxo-1H-1,4- benzodiazepine-3-carboxylate | |
|
27 |
ETILAMFETAMINE | N-ethylamphetamine | N-ethyl-α-methylphenethylamine |
|
28 |
FENCAMFAMINE | N-ethyl-3-phenyl-2- norbornanamine | |
|
29 |
FENPROPOREX | (±)-3-[(α- methylphenethyl)amino]propionitrile | |
|
30 |
FLUDIAZEPAM | 7-chloro-5-(o-fluorophenyl)-1,3- dihydro-1-methyl-2H-1,4- benzodiazepin-2-one | |
|
31 |
FLUNITRAZEPAM | 5-(o-fluorophenyl)-1,3-dihydro-1- methyl-7-nitro-2H-1,4- benzodiazepin-2-one | |
|
32 |
FLURAZEPAM | 7-chloro-1-[2- (diethylamino)ethyl]-5-(o- fluorophenyl)-1,3-dihydro-2H-1,4- benzodiazepin-2-one | |
|
33 |
GLUTETHIMIDE | 2-ethyl-2-phenylglutarimide | |
|
34 |
HALAZEPAM | 7-chloro-1,3-dihydro-5-phenyl-1- (2,2,2-trifluoroethyl)-2H-1,4- benzodiazepin-2-one | |
|
35 |
HALOXAZOLAM | 10-bromo-11b-(o-fluorophenyl)- 2,3,7,11b-tetrahydrooxazolo[3,2- d][1,4]benzodiazepin-6(5H)-one | |
|
36 |
KETAZOLAM | 11-chloro-8,12b-dihydro-2,8- dimethyl-12b-phenyl-4H-[1,3]- oxazino[3,2-d][1,4]benzodiazepin- 4,7(6H)-dione | |
|
37 |
KETAMINE | (±)-2-(2-chlorophenyl)-2- methylaminocyclohexanone | |
|
38 |
LEFETAMINE | SPA | (-)-N,N-dimethyl-1,2- diphenylethylamine |
|
39 |
LISDEXAMFETAMINE | (2S)-2,6-diamino-N-[(1S)-1- methyl-2-phenylethyl]hexanamide dimethanesulfonate | |
|
40 |
LOPRAZOLAM | 6-(o-chlorophenyl)-2,4-dihydro-2- [(4-methyl-1- piperazinyl)methylene]-8-nitro- 1H-imidazo[1,2- a][1,4]benzodiazepin-1-one | |
|
41 |
LORAZEPAM | 7-chloro-5-(o-chlorophenyl)-1,3- dihydro-3-hydroxy-2H-1,4- benzodiazepin-2-one | |
|
42 |
LORMETAZEPAM | 7-chloro-5-(o-chlorophenyl)-1,3- dihydro-3-hydroxy-1-methyl-2H- 1,4-benzodiazepin-2-one | |
|
43 |
MAZINDOL | 5-(p-chlorophenyl)-2,5-dihydro- 3H-imidazo[2,1-a]isoindol-5-ol | |
|
44 |
MEDAZEPAM | 7-chloro-2,3-dihydro-1-methyl-5- phenyl-1H-1,4-benzodiazepine | |
|
45 |
MEFENOREX | N-(3-chloropropyl)-α- methylphenethylamine | |
|
46 |
MEPROBAMATE | 2-methyl-2-propyl-1,3-propanediol dicarbamate | |
|
47 |
MESOCARB | 3-(α-methylphenethyl)-N- (phenylcarbamoyl)sydnone imine | |
|
48 |
METHYLPHENIDATE | methyl-α-phenyl-2- piperidineacetate | |
|
49 |
METHYLPHENO- BARBITAL | 5-ethyl-1-methyl-5- phenylbarbituric acid | |
|
50 |
METHYPRYLON | 3,3-diethyl-5-methyl-2,4- piperidine-dione | |
|
51 |
MIDAZOLAM | 8-chloro-6-(o-fluorophenyl)-1- methyl-4H-imidazo[1,5- a][1,4]benzodiazepine | |
|
52 |
NIMETAZEPAM | 1,3-dihydro-1-methyl-7-nitro-5- phenyl-2H-1,4-benzodiazepin-2-one | |
|
53 |
NITRAZEPAM | 1,3-dihydro-7-nitro-5-phenyl-2H- 1,4-benzodiazepin-2-one | |
|
54 |
NORDAZEPAM | 7-chloro-1,3-dihydro-5-phenyl- 2H-1,4-benzodiazepin-2-one | |
|
55 |
OXAZEPAM | 7-chloro-1,3-dihydro-3-hydroxy-5- phenyl-2H-1,4-benzodiazepin-2-one | |
|
56 |
OXAZOLAM | 10-chloro-2,3,7,11b-tetrahydro-2- methyl-11b-phenyloxazolo[3,2- d][1,4]benzodiazepin-6(5H)-one | |
|
57 |
PENTAZOCINE | (2R*,6R*,11R*)-1,2,3,4,5,6- hexahydro-6,11-dimethyl-3-(3- methyl-2-butenyl)-2,6-methano-3- benzazocin-8-ol | |
|
58 |
PENTOBARBITAL | 5-ethyl-5-(1- methylbutyl)barbituric acid | |
|
59 |
PHENDIMETRAZINE | (+)-(2S,3S)-3,4-dimethyl-2- phenylmorpholine | |
|
60 |
PHENOBARBITAL | 5-ethyl-5-phenylbarbituric acid | |
|
61 |
PHENTERMINE | α,α-dimethylphenethylamine | |
|
62 |
PINAZEPAM | 7-chloro-1,3-dihydro-5-phenyl-1- (2-propynyl)-2H-1,4- benzodiazepin-2-one | |
|
63 |
PRAZEPAM | 7-chloro-1-(cyclopropylmethyl)- 1,3-dihydro-5-phenyl-2H-1,4- benzodiazepin-2-one | |
|
64 |
PYROVALERONE | 4′-methyl-2-(1- pyrrolidinyl)valerophenone | |
|
65 |
SECBUTABARBITAL | 5-sec-butyl-5-ethylbarbituric acid | |
|
66 |
TEMAZEPAM | 7-chloro-1,3-dihydro-3-hydroxy-1- methyl-5-phenyl-2H-1,4- benzodiazepin-2-one | |
|
67 |
TETRAZEPAM | 7-chloro-5-(1-cyclohexen-1-yl)- 1,3-dihydro-1-methyl-2H-1,4- benzodiazepin-2-one | |
|
68 |
TRIAZOLAM | 8-chloro-6-(o-chlorophenyl)-1- methyl-4H-s-triazolo[4,3- a][1,4]benzodiazepine | |
|
69 |
VINYLBITAL | 5-(1-methylbutyl)-5- vinylbarbituric acid | |
|
70 |
ZOLPIDEM | N,N,6-trimethyl-2-p- tolylimidazo[1,2-a]pyridine-3- acetamide | |
|
71 |
CARISOPRODOL | [2-(carbamoyloxymethyl)-2- methylpentyl]N-propan-2-yl carbamate | |
|
72 |
ETOMIDATE | Ethyl 3-[(1R)-1- phenylethyl]imidazole-5- carboxylate |
Note: (*) This list also includes the salts and isomers of the substances specified in this List, and the salts of such isomers that may exist.
Appendix III
LIST OF DRUG PRECURSORS (*)
(Attached to Circular No. 18/2026/TT-BYT dated June 1, 2026 of the Minister of Health)
|
NO. |
INTERNATIONAL NAME |
SCIENTIFIC NAME |
|
1 |
EPHEDRINE | ([R-(R*, S*)]–[1-(methylamino)ethyl]- Benzenemethanol |
|
2 |
N-ETHYLEPHEDRINE | (1R,2S)-2- [ethyl(methyl)amino]-1- phenylpropan-1-ol |
|
3 |
N-METHYLEPHEDRINE/ METHYLEPHEDRINE/ DL-METHYLEPHEDRINE | (1R, 2S)-2- (dimethylamino)-1 – phenyl- propanol |
|
4 |
PSEUDOEPHEDRINE | [S-(R*,R*)]–[1- (methylamino)ethyl]- Benzenemethanol |
|
5 |
ERGOMETRINE | Ergoline-8-carboxamide,9,10- didehydro-N-(2- hydroxy-1 – methylethyl)-6-methyl- [8 β(s)]. |
|
6 |
ERGOTAMINE | Ergotaman-3’, 6’, 18 ’-trione, 12’- hydroxy- 2 ’ -methyl- 5’ – (phenylmethyl)-(5) |
|
7 |
N-ETHYLPSEUDOEPHEDRINE | (1S,2S)-2- [ethyl(methyl)amino]-1- phenylpropan-1-ol |
|
8 |
N-METHYLPSEUDOEPHEDRINE |
(1S,2S)-2- (dimethylamino)-1- phenylpropan-1-ol |
Note: (*) This list also includes the salts, esters, and isomers of the substances specified in this List, and the salts of such isomers that may exist.
Appendix IV
TABLE OF CONCENTRATION AND CONTENT LIMITS OF NARCOTIC ACTIVE INGREDIENTS IN COMBINATION DRUGS (*)
(Attached to Circular No. 18/2026/TT-BYT dated June 1, 2026 of the Minister of Health)
|
NO. |
NAME OF NARCOTIC ACTIVE INGREDIENTS |
ACTIVE INGREDIENT CONTENT CALCULATED AS BASE PER SINGLE-DOSE UNIT (In mg) |
ACTIVE INGREDIENT CONCENTRATION CALCULATED AS BASE IN MULTI-DOSE PRODUCTS (In %) |
|
1 |
ACETYLDIHYDROCODEINE | 100 | 2,5 |
|
2 |
COCAINE | 0,1 | |
|
3 |
CODEINE | 100 | 2,5 |
|
4 |
DIFENOXIN | ≤ 0.5 mg of Difenoxin and ≥ 0.025 mg of Atropine Sulfate per single-dose unit. | |
|
5 |
DIPHENOXYLATE | ≤ 2.5 mg of Difenoxin and ≥ 0.025 mg of Atropine Sulfate per single-dose unit. | |
|
6 |
DIHYDROCODEINE | 100 | 2,5 |
|
7 |
ETHYLMORPHINE | 100 | 2,5 |
|
8 |
NICODICODINE | 100 | 2,5 |
|
9 |
NORCODEINE | 100 | 2,5 |
|
10 |
PHOLCODINE | 100 | 2,5 |
|
11 |
PROPIRAM | 100 | 2,5 |
|
12 |
MORPHINE | 0.2 (calculated as anhydrous morphine base) | |
|
13 |
TRAMADOL | 37,5 |
Note: (*) This list includes narcotic substances and their salts, isomers, esters, ethers, and salts of such isomers, esters, and ethers that may exist (unless an ester or ether of such substance is specified in Appendix II or Appendix III attached to this Circular).
Appendix V
TABLE OF CONCENTRATION AND CONTENT LIMITS OF PSYCHOTROPIC ACTIVE INGREDIENTS IN COMBINATION DRUGS (*)
(Attached to Circular No. 18/2026/TT-BYT dated June 1, 2026 of the Minister of Health)
|
NO. |
NAME OF PSYCHOTROPIC ACTIVE INGREDIENTS |
MAXIMUM CONTENT PER SINGLE-DOSE UNIT (mg) |
|
1 |
ALLOBARBITAL |
10 |
|
2 |
ALPRAZOLAM |
0,25 |
|
3 |
AMOBARBITAL |
10 |
|
4 |
BARBITAL |
10 |
|
5 |
BROMAZEPAM |
1 |
|
6 |
BROTIZOLAM |
0,25 |
|
7 |
BUTOBARBITAL |
10 |
|
8 |
CAMAZEPAM |
5 |
|
9 |
CHLORDIAZEPOXIDE |
5 |
|
10 |
CLOBAZAM |
5 |
|
11 |
CLONAZEPAM |
0,5 |
|
12 |
CLORAZEPATE |
10 |
|
13 |
CLOTIAZEPAM |
5 |
|
14 |
DIAZEPAM |
5 |
|
15 |
ESTAZOLAM |
0,5 |
|
16 |
FLUDIAZEPAM |
0,5 |
|
17 |
FLUNITRAZEPAM |
0,5 |
|
18 |
FLURAZEPAM |
5 |
|
19 |
HALAZEPAM |
5 |
|
20 |
KETAZOLAM |
5 |
|
21 |
LOPRAZOLAM |
0,25 |
|
22 |
LORAZEPAM |
0,5 |
|
23 |
LORMETAZEPAM |
0,25 |
|
24 |
MEPROBAMAT |
100 |
|
25 |
MEDAZEPAM |
5 |
|
26 |
METHYLPHENOBARBITAL |
10 |
|
27 |
MIDAZOLAM |
5 |
|
28 |
NITRAZEPAM |
5 |
|
29 |
NORDAZEPAM |
0,25 |
|
30 |
OXAZEPAM |
10 |
|
31 |
PRAZEPAM |
5 |
|
32 |
PENTOBARBITAL |
10 |
|
33 |
PHENOBARBITAL |
25 |
|
34 |
SECBUTABARBITAL |
10 |
|
35 |
TEMAZEPAM |
25 |
|
36 |
TETRAZEPAM |
5 |
|
37 |
VINYLBITAL |
10 |
|
38 |
CLOXAZOLAM |
1 |
|
39 |
DELORAZEPAM |
0,25 |
|
40 |
ETHYLLOFLAZEPATE |
0,25 |
|
41 |
NIMETAZEPAM |
0,25 |
|
42 |
OXAZOLAM |
5 |
|
43 |
PINAZEPAM |
1 |
Note: (*) This list also includes the salts and isomers of the substances specified in this List, and the salts of such isomers that may exist.
Appendix VI
TABLE OF CONCENTRATION AND CONTENT LIMITS OF DRUG PRECURSORS IN COMBINATION DRUGS (*)
(Attached to Circular No. 18/2026/TT-BYT dated June 1, 2026 of the Minister of Health)
|
NO. |
NAME OF DRUG PRECURSORS |
MAXIMUM CONTENT PER SINGLE-DOSE UNIT (mg) |
MAXIMUM CONCENTRATION IN A MULTI-DOSE UNIT |
|
1 |
EPHEDRINE | 50 | 1,5% |
|
2 |
ERGOMETRINE | 0,125 | |
|
3 |
N-ETHYLEPHEDRINE | 12,5 | |
|
4 |
N-METHYLEPHEDRINE/ METHYLEPHEDRINE/ DL-METHYLEPHEDRINE | 31,1 | 0,0625% |
|
5 |
ERGOTAMINE | 01 | |
|
6 |
PSEUDOEPHEDRINE | 120 | 0,5% |
Note: (*) This list also includes the salts, esters, and isomers of the substances specified in this List, and the salts of such isomers that may exist.
Appendix VII
CLASSIFICATION OF NARCOTIC DRUGS, PSYCHOTROPIC DRUGS, PRECURSOR DRUGS, AND COMBINATION DRUGS CONTAINING NARCOTIC ACTIVE INGREDIENTS, PSYCHOTROPIC ACTIVE INGREDIENTS, OR DRUG PRECURSORS
(Attached to Circular No. 18/2026/TT-BYT dated June 1, 2026 of the Minister of Health)
|
No. |
Classification |
Criteria |
|
1 |
Narcotic drugs | Drugs containing at least a narcotic active ingredient, without any active ingredients of other groups. |
|
2 |
Narcotic drugs | Drugs simultaneously satisfying the following criteria:
– Containing multiple active ingredients; – Containing at least a narcotic active ingredient with a concentration or content greater than the limit specified in Appendix IV attached hereto. |
|
3 |
Psychotropic drugs | Drugs containing at least a narcotic active ingredient, without any active ingredients of other groups. |
|
4 |
Psychotropic drugs | Drugs simultaneously satisfying the following criteria:
– Containing multiple active ingredients; – Containing at least a psychotropic active ingredient with a concentration or content greater than the limit specified in Appendix V attached hereto. – Containing no narcotic active ingredients, or containing narcotic active ingredients with a concentration or content not greater than the limit specified in Appendix IV attached hereto. |
|
5 |
Precursor drugs | Drugs containing at least a drug precursor, without any active ingredients of other groups. |
|
6 |
Precursor drugs | Drugs simultaneously satisfying the following criteria:
– Containing multiple active ingredients; – Containing at least a drug precursor with a concentration or content greater than the limit specified in Appendix VI attached hereto. – Containing no narcotic active ingredients, or containing narcotic active ingredients with a concentration or content not greater than the limit specified in Appendix IV attached hereto. – Containing no psychotropic active ingredients, or containing psychotropic active ingredients with a concentration or content not greater than the limit specified in Appendix V attached hereto. |
|
7 |
Combination drugs containing narcotic active ingredients | Drugs simultaneously satisfying the following criteria:
– Containing at least a narcotic active ingredient, in which all narcotic active ingredients has concentration or content not greater than the limit specified in Appendix IV attached hereto. – Containing at least one ingredient which is not a narcotic active ingredient; – Containing no psychotropic active ingredients, or containing psychotropic active ingredients with a concentration or content not greater than the limit specified in Appendix V attached hereto. – Containing no drug precursor or containing precursors with a concentration or content not greater than the limit specified in Appendix VI attached hereto. |
|
8 |
Combination drugs containing narcotic active ingredients | Drugs simultaneously satisfying the following criteria:
– Containing at least a psychotropic active ingredient, in which all psychotropic active ingredients has concentration or content not greater than the limit specified in Appendix V attached hereto. – Containing at least one ingredient which is not a psychotropic active ingredient; – Containing no narcotic active ingredients; – Containing no drug precursor or containing precursors with a concentration or content not greater than the limit specified in Appendix VI attached hereto. |
|
9 |
Combination drugs containing precursors | Drugs simultaneously satisfying the following criteria:
– Containing at least a drug precursor, in which all drug precursors have concentration or content not greater than the limit specified in Appendix VI attached hereto. – Containing at least one ingredient which is not a drug precursor; – Containing no narcotic active ingredients; – Containing no psychotropic active ingredients. |
Appendix VIII
LOGBOOK OF THE RECEIPT, ISSUE, AND INVENTORY OF NARCOTIC DRUGS, PSYCHOTROPIC DRUGS, PRECURSOR DRUGS, DRUG INGREDIENTS THAT ARE NARCOTIC ACTIVE INGREDIENTS, PSYCHOTROPIC ACTIVE INGREDIENTS OR DRUG PRECURSORS, RADIOPHARMACEUTICALS
(Attached to Circular No. 18/2026/TT-BYT dated June 1, 2026 of the Minister of Health)
Name of Facility: ……………………………………………………………………………………………………
Address: ………………………………………………………………………………………………………..
Telephone:…………………………………………………………………………………………………….
LOGBOOK OF THE RECEIPT, ISSUE, AND INVENTORY OF NARCOTIC DRUGS, PSYCHOTROPIC DRUGS, PRECURSOR DRUGS, DRUG INGREDIENTS THAT ARE NARCOTIC ACTIVE INGREDIENTS, PSYCHOTROPIC ACTIVE INGREDIENTS OR DRUG PRECURSORS, RADIOPHARMACEUTICALS (*)
(From (date) to (date)) <0}
Name of drug ingredient/drug, concentration/content: ………………………………………………….
Marketing authorization/Import license number: ……………………………………
Unit of measurement: ………………………………………………………………………………………………………
|
Date |
Location of issue/receipt |
Delivery slip/Receiving voucher No. |
Quantity |
Batch No. and expiry date |
Note |
||
|
Receipt |
Issue |
Balance |
|
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|||
|
(1) |
(2) |
(3) |
(4) |
(5) |
(6) |
(7) |
(8) |
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|
Note:
(*)This logbook shall be prepared as follows
– In the case where the logbook is maintained on an electronic application or software, tracking data must be extracted, printed, and archived at the end of each day, with each page signed by the drug/drug ingredient manager and the head of the department. In the case where the paper logbook is used, pages must be numbered consecutively from 01 onwards and stamped with an overlapping seal.
– Allocate a specific number of pages must for each drug based on the frequency of its receipts and issues.
– For radiopharmaceuticals, the expiry date is not required.
– Keep separate logbook for each drug or drug ingredient, clearly labeling the corresponding name of drug/drug ingredient on the cover.
Appendix IX
REPORT FORM ON THE RECEIPT, ISSUE, INVENTORY, AND USE OF NARCOTIC DRUGS, PSYCHOTROPIC DRUGS, PRECURSOR DRUGS AND COMBINATION DRUGS THAT CONTAIN PRECURSORS
(Attached to Circular No. 18/2026/TT-BYT dated June 1, 2026 of the Minister of Health)
Name of Facility: …………………………………………………………………………….
No: ..……………………………………………………………………………………..
REPORT ON THE RECEIPT, ISSUE, INVENTORY, AND USE OF NARCOTIC DRUGS, PSYCHOTROPIC DRUGS, PRECURSOR DRUGS AND COMBINATION DRUGS THAT CONTAIN PRECURSORS
(From (date) to (date))
To:………………………………………………………………………………
|
No. |
Drug name, dosage form, and packaging specification |
Composition, concentration/content |
Name of narcotic, psychotropic, or precursor active ingredient and corresponding concentration/content |
Marketing authorization No./Import license No. (for drugs without a marketing authorization) |
Unit of measurement |
Opening stock balance |
Quantity received |
Total quantity |
Quantity issued |
Quantity lost/wasted (*) |
Closing stock balance |
|
(1) |
(2) |
(3) |
(4) |
(5) |
(6) |
(7) |
(8) |
(9)=(7) + (8) |
(10) |
(11) |
(12)=(9)- (10)-(11) |
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Receipt: – As above – Achieved at facility |
(location and date) |
Note:
(*) The quantity lost/wasted includes damaged, broken, or expired items, etc. (if any); the specific reason for such loss/waste must be stated.
Appendix X
REPORT FORM ON THE USE OF NARCOTIC DRUGS, PSYCHOTROPIC DRUGS, PRECURSOR DRUGS, RADIOPHARMACEUTICALS, AND COMBINATION DRUGS CONTAINING PRECURSORS
(Attached to Circular No. 18/2026/TT-BYT dated June 1, 2026 of the Minister of Health)
|
HEALTH SPECIALIZED AGENCY/MILITARY MEDICINE DEPARTMENT/HEALTH DEPARTMENT |
SOCIALIST REPUBLIC OF VIETNAM |
|
No: |
………… (location and date) |
REPORT ON THE USE OF NARCOTIC DRUGS, PSYCHOTROPIC DRUGS, PRECURSOR DRUGS, RADIOPHARMACEUTICALS, AND COMBINATION DRUGS CONTAINING PRECURSORS
Year: ……………..
To: ………….
|
No. |
Drug name, dosage form, and packaging specification |
Composition, concentration/content |
Name of narcotic, psychotropic, or precursor active ingredient and corresponding concentration/content |
Marketing authorization No./Import license No. (for drugs without a marketing authorization) |
Unit of measurement |
Opening stock balance |
Quantity received |
Total quantity |
Quantity issued |
Quantity lost/wasted (*) |
Closing stock balance |
|
(1) |
(2) |
(3) |
(4) |
(5) |
(6) |
(7) |
(8) |
(9)=(7) + (8) |
(10) |
(11) |
(12)=(9)- (10)-(11) |
|
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Representative of the unit |
Note:
(*)The specific reason for the loss/waste must be provided.
Appendix XI
REPORT FORM ON THE MIX-UP OR LOSS OF NARCOTIC DRUGS, PSYCHOTROPIC DRUGS, PRECURSOR DRUGS, RADIOPHARMACEUTICALS, COMBINATION DRUGS CONTAINING PRECURSORS, AND DRUG INGREDIENTS CONTAINING NARCOTIC ACTIVE INGREDIENTS, PSYCHOTROPIC ACTIVE INGREDIENTS, OR DRUG PRECURSORS
(Attached to Circular No. 18/2026/TT-BYT dated June 1, 2026 of the Minister of Health)
|
NAME OF FACILITY |
SOCIALIST REPUBLIC OF VIETNAM |
|
No: |
………… (location and date) |
REPORT ON THE MIX-UP OR LOSS OF NARCOTIC DRUGS, PSYCHOTROPIC DRUGS, PRECURSOR DRUGS, RADIOPHARMACEUTICALS, COMBINATION DRUGS CONTAINING PRECURSORS, AND DRUG INGREDIENTS CONTAINING NARCOTIC ACTIVE INGREDIENTS, PSYCHOTROPIC ACTIVE INGREDIENTS, OR DRUG PRECURSORS
To: ……………………………………………………
|
No. |
Drug ingredients/Drug name; dosage form; concentration/content; packaging specification; Import license/Marketing authorization No. |
Unit of measurement |
Quantity lost/mixed up |
Reason |
Corrective measures |
Note |
|
(1) |
(2) |
(3) |
(4) |
(5) |
(6) |
(7) |
|
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|
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|
|
|
|
Receipt: – As above – Achieved at facility. |
……… (location and date) |
Appendix XII
MEDICATION REQUEST FORM FOR CONTROLLED DRUGS AND DRUG INGREDIENTS
(Attached to Circular No. 18/2026/TT-BYT dated June 1, 2026 of the Minister of Health)
MEDICATION REQUEST FORM FOR CONTROLLED DRUGS AND DRUG INGREDIENTS (*)
Form No.
Name of facility:
Receiving department:
|
No. |
Name of drug/drug ingredient |
Active ingredient, concentration, content |
Unit of measurement |
Quantity |
Note |
|
|
Request |
Issue |
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| Total: |
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(Date approved) |
(Date approved) |
(Date distributed) |
(Date received) |
Note:
(*) For electronic medication request form (MRF) for controlled drugs and drug, the receiver, issuer, head of the receiving department, and head of the distributing department shall use verification techniques or digital signatures in accordance with regulations.
Appendix XII
REPORT ON THE SUPPLY OF RADIOPHARMACEUTICALS
(Attached to Circular No. 18/2026/TT-BYT dated June 1, 2026 of the Minister of Health)
|
NAME OF FACILITY |
SOCIALIST REPUBLIC OF VIETNAM |
|
No: |
………… (location and date) |
REPORT ON THE SUPPLY OF RADIOPHARMACEUTICALS IN (YEAR)
To: ……………………………………………………
I. General status of radiopharmaceutical manufacture:
– Name of facility:
– Manufacturing location:
– Good Manufacturing Practices (GMP) Certificate issued (if any):
II. Report on the supply of radiopharmaceuticals to other healthcare facilities:
|
No. |
Estimated equipment capacity |
Name of manufactured drug – concentration, content |
Manufactured quantity (with unit of measurement) |
Quantity used for patients |
Quantity supplied to other healthcare facilities |
Receiving healthcare facility |
|
(1) |
(2) |
(3) |
(4) |
(5) |
(6) |
(7) |
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(date) |
Appendix XIV
LOGBOOK FOR THE MANUFACTURE AND PREPARATION OF NARCOTIC DRUGS, PSYCHOTROPIC DRUGS, AND PRECURSOR DRUGS
(Attached to Circular No. 18/2026/TT-BYT dated June 1, 2026 of the Minister of Health)
Name of facility:
LOGBOOK FOR THE MANUFACTURE AND PREPARATION OF NARCOTIC DRUGS, PSYCHOTROPIC DRUGS, AND PRECURSOR DRUGS (*)
(From (Date) to (Date)
|
|
No. |
Name of drug – concentration, content |
Batch No. |
Preparation formula (per 1 product batch) |
Theoretical yield of finished drugs |
Actual yield of finished drugs |
Full name, signature of preparer |
Full name, signature of controller |
Note |
|
(1) |
(2) |
(3) |
|
(4) |
(5) |
(6) |
(7) |
(8) |
(9) |
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Note:
(*) For electronic logbook, the preparer and the controller shall use electronic verification techniques and digital signatures in accordance with regulations. For paper logbooks, pages must be numbered consecutively from 01 onwards and stamped with an overlapping seal.
(**) The start time and end time of the production/preparation of the drug batch must be specified.
Appendix XV
DELIVERY SLIPS FOR NARCOTIC DRUGS, PSYCHOTROPIC DRUGS, PRECURSOR DRUGS, RADIOPHARMACEUTICALS; DRUG INGREDIENTS THAT ARE NARCOTIC ACTIVE INGREDIENTS, PSYCHOTROPIC ACTIVE INGREDIENTS OR DRUG PRECURSORS
(Attached to Circular No. 18/2026/TT-BYT dated June 1, 2026 of the Minister of Health)
Name of facility:
Address:
DELIVERY SLIPS FOR NARCOTIC DRUGS, PSYCHOTROPIC DRUGS, PRECURSOR DRUGS, RADIOPHARMACEUTICALS; DRUG INGREDIENTS THAT ARE NARCOTIC ACTIVE INGREDIENTS, PSYCHOTROPIC ACTIVE INGREDIENTS OR DRUG PRECURSORS (*)
Receiving facility:
Address:
|
No. |
Name of drug ingredient/drug, concentration/content |
Unit of measurement |
Delivered quantity |
Production batch No., expiry date (**) |
Manufacturer name, manufacturing country |
Note |
|
Deliverer |
Receiver |
(date) |
Note:
(*)This form may be used for:
– Internal delivery: Specify the receiving department/unit
– Delivery to external entities:
+ Specify full name and citizen ID number of the recipient.
+ The facility may use a financial invoice instead of delivery slip, provided that it contains at least all the information specified in this form or enclosed with a lot report.
(**) For radiopharmaceuticals, the expiry date is not required.
(***) Legal representative or authorized person.
Appendix XVI
LOGBOOK OF THE RECEIPT, ISSUE, AND INVENTORY OF COMBINATION DRUGS CONTAINING NARCOTIC ACTIVE INGREDIENTS /PSYCHOTROPIC ACTIVE INGREDIENTS/DRUG PRECURSORS, TOXIC DRUGS, TOXIC DRUG INGREDIENTS, AND DRUGS/ACTIVE INGREDIENTS ON THE LIST OF DRUGS AND ACTIVE INGREDIENTS BANNED FROM USE IN CERTAIN FIELDS
(Attached to Circular No. 18/2026/TT-BYT dated June 1, 2026 of the Minister of Health)
LOGBOOK OF THE RECEIPT, ISSUE, AND INVENTORY OF COMBINATION DRUGS CONTAINING NARCOTIC ACTIVE INGREDIENTS /PSYCHOTROPIC ACTIVE INGREDIENTS/DRUG PRECURSORS, TOXIC DRUGS, TOXIC DRUG INGREDIENTS, AND DRUGS/ACTIVE INGREDIENTS ON THE LIST OF DRUGS AND ACTIVE INGREDIENTS BANNED FROM USE IN CERTAIN FIELDS (*)
Name of drug ingredient/drug, concentration/content: ……………………………………………………
Marketing authorization/Import license number: ……………………………………
Unit of measurement: …………………………………………………………………………………………………..
Manufacturer: ………………………………………………………………………………………………..
|
Date |
Location of issue/receipt |
Delivery slip/Receiving voucher No. |
Quantity |
Batch No. and expiry date |
Note |
||
|
Receipt |
Issue |
Balance |
|
|
|||
|
(1) |
(2) |
(3) |
(4) |
(5) |
(6) |
(7) |
(8) |
|
|
|
|
|
|
|
|
|
Note:
(*) Pages of the logbook must be numbered consecutively from 01 onwards (applicable when the facility does not use an electronic application or software for tracking)
Appendix XVII
LOGBOOK FOR THE MANUFACTURE AND PREPARATION OF RADIOPHARMACEUTICALS
(Attached to Circular No. 18/2026/TT-BYT dated June 1, 2026 of the Minister of Health)
Name of facility:
LOGBOOK FOR THE MANUFACTURE AND PREPARATION OF RADIOPHARMACEUTICALS
(*)
(From (Date) to (Date))
|
Date (**) |
No. |
Drug name |
Batch No. |
Radioactive activity |
Theoretical yield of finished drugs |
Actual yield of finished drugs |
Full name, signature of preparer |
Full name, signature of controller |
Quality of prepared drugs |
Note |
|
(1) |
(2) |
(3) |
|
(4) |
(5) |
(6) |
(7) |
(8) |
|
(9) |
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Note:
(*) For electronic logbook, the preparer and the controller shall use electronic verification techniques and digital signatures in accordance with regulations. For paper logbooks, pages must be numbered consecutively from 01 onwards and stamped with an overlapping seal.
(**) The start time and end time of the production/preparation of the drug batch must be specified.
Appendix XVIII
RECORD OF DRUG RETURN FOR NARCOTIC DRUGS, PSYCHOTROPIC DRUGS, AND PRECURSOR DRUGS
(Attached to Circular No. 18/2026/TT-BYT dated June 1, 2026 of the Minister of Health)
SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
—————
RECORD OF DRUG RETURN FOR NARCOTIC DRUGS, PSYCHOTROPIC DRUGS, AND PRECURSOR DRUGS
1. Full name of deliverer:
– Address:
– ID card/Passport/Equivalent document No.
Issued by: Date of issuance:
– Patient □ Representative of the patient □
2. Name of receiving facility (*):
– Address:
3. List of returned drugs:
|
No. |
Drug ingredients/Drug name; dosage form; concentration/content; packaging specification; Import license/Marketing authorization No. |
Unit of measurement |
Quantity |
Batch No. |
Expiry date |
Condition of the drug (**) |
Reason for return |
Note |
|
1 |
|
|
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|
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|
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|
2 |
|
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|
4. Time of delivery: The above item(s) was/were delivered and received at (time and date)
5. Place of delivery (actual delivery address):
This minute is agreed upon by both parties and made in 02 copies, with each party keeping 01 copy.
|
|
….. (date) |
Note:
(*) In case the receiving facility is a drug retailer: Specify name of the person in charge of pharmacy operations:
In case the receiving facility is a healthcare facility: Specify the name of the facility and the receiving department/division.
(**) Record the sensory evaluation, including: color of tablet/solution; clarity of solution; and condition of packaging and drug label.
Appendix XIX
CUSTOMER INFORMATION LOGBOOK
(Attached to Circular No. 18/2026/TT-BYT dated June 1, 2026 of the Minister of Health)
Name of facility:
CUSTOMER INFORMATION LOGBOOK (*)
(From (Date) to (Date))
|
Date |
No. |
Drug name; packaging specification; Import license/Marketing authorization No. |
Active ingredient, concentration/content |
Unit of measurement |
Quantity sold |
Customer name |
Address |
Note |
|
(1) |
(2) |
(3) |
(4) |
|
(5) |
(6) |
(7) |
(8) |
|
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|
Note:
(*) Pages of the logbook must be numbered consecutively from 01 onwards (applicable when the facility does not use an electronic application or software for tracking).
