Circular No. 11/2010/TT-BYT guiding activities related to psychotropic medicines đã được thay thế bởi Circular No. 19/2014/TT-BYT management of addictive drug psychotropic drugs and drug precursors và được áp dụng kể từ ngày 15/07/2014.
Nội dung toàn văn Circular No. 11/2010/TT-BYT guiding activities related to psychotropic medicines
THE MINISTRY OF HEALTH | SOCIALIST REPUBLIC OF VIET NAM |
No. 11/2010/TT-BYT | Hanoi, April 29, 2010 |
CIRCULAR
GUIDING ACTIVITIES RELATED TO PSYCHOTROPIC MEDICINES AND PRE-SUBSTANCES USED AS MEDICINES
Pursuant to the Government's Decree No. I88/2007/ND-CP of December 27, 2007, defining the functions, tasks, powers and organizational structure of the Ministry of Health;
Pursuant to June 14, 2005 Pharmacy Law No. 34/2005/QH11;
Pursuant to the Government's Decree No. 79/ 2006/ND-CP of August 9, 2006, detailing a number of articles of the Pharmacy Law;
Pursuant to December 19, 2000 Law No. 23/ 2000/QH10 on Drug Prevention and Fighting;
Pursuant to the Government's Decree No. 80/ 2001/ND-CP of November 5, 2001, guiding the control of domestic lawful activities related to drug;
Pursuant to the Government's Decree No. 67/ 2001/ND-CP of October 1, 2001, promulgating the lists of narcotics and pre-substances;
Pursuant to the Government's Decree No. 58/ 2003/ND-CP of May 19, 2003, providing for the control of import, export and transit via the Vietnamese territory of narcotics, pre-substances, habit-forming medicines and psychotropic medicines;
Pursuant to the Government's Decree No. 133/2003/ND-CP of November 6, 2003, adding a number of substances to the list of narcotics and pre-substances promulgated together with the Government's Decree No. 67/2001/ND-CP of October 1, 2001;
Pursuant to the Government's Decree No. 163/2007/ND-CP of November 12, 2007, renaming, adding, transferring or removing a number oj substances on the list of narcotics and pre-substances promulgated together with the Government's Decree No. 67/2001/ND-CP of October 1. 2001;
The Ministry of Health guides activities related to psychotropic medicines and pre-substances used as medicines in Vietnam.
Chapter 1
GENERAL PROVISIONS
Article 1. Scope of regulation
1. This Circular guides activities related to psychotropic medicines and pre-substances used as medicines (below referred to as pre-substances) in the health sector and for analysis, testing and scientific research which are on the lists of psychotropic medicines (Appendices I and III) or the lists of pre-substances (Appendices II and IV) to this Circular.
2. Finished-product medicines with different active ingredients which contain psychotropic active ingredients or pre-substances combined with other active ingredients (other than habit-forming medicines, psychotropic medicines or pre-substances) with the content of psychotropic active ingredients or pre-substances equal to or smaller than the content specified in the list of combined psychotropic medicines (Appendix III) or the list of combined pre-substances used as medicines (Appendix IV) are free from being compliant with the provisions of this Circular, except Article 4; Point b. Clause 1. Article 7; Clause 2. Article 9; Clauses 1 and 3. Article 11; Clauses 2 and 4. Article 12; Article 15; and Clause 1. Article 20.
Article 2. Subjects of application
This Circular applies to domestic and foreign individuals and organizations engaged in activities related to psychotropic medicines or pre-substances in the health sector and for analysis, testing or scientific research in Vietnam.
Article 3. Prescription
The prescription of psychotropic medicines and pre-substances for outpatients complies with the Regulation on medicine prescription for outpatient treatment promulgated by the Minister of Health.
Article 4. Medicine labeling
Medicine labeling complies with the Health Minister's Circular guiding the labeling of medicines.
Article 5. Delivery and receipt
When ex-warehousing and warehousing psychotropic medicines or pre-substances. it is necessary to check names, concentration, content, quantity, manufacture lot number, expiry date, and sensory quality of medicines. The deliverer and recipient shall sign and write their full names in the ex-warehousing and warehousing documents.
Article 6. Transportation
1. In the course of transportation, psychotropic medicines and pre-substances must be packed, sealed up. and subject to measures to ensure their safety and to avoid any loss. The exporter, importer, names and quantity of medicines must be clearly indicated on the packing.
2. The head of an establishment having psychotropic medicines and pre-substances shall issue a document assigning its employee to transport psychotropic medicines and pre-substances. This employee must possess assignment document, identity card (or another lawful personal identification paper), sale invoice or ex-warehousing bill, and shall take- responsibility for the sensory quality, quantity and categories of psychotropic medicines and pre-substances in the course of transportation and deliver all psychotropic medicines and pre-substances to persons responsible for keeping them.
3. When a psychotropic medicine and pre-substance trader needs to hire a transporter, the hirer and transporter shall sign a written contract indicating conditions related to the storage and transportation of psychotropic medicines or pre-substances as prescribed. The transporter must satisfy these conditions in the course of transportation and ensure that no medicine or pre-substance is lost.
The hirer and transporter shall take responsibility for matters related to psychotropic medicines and pre-substances in the course of transportation.
Article 7. Reporting
1. Reporting on export and import:
a/ For psychotropic medicines and pre-substances: Within 10 days after exporting or importing psychotropic medicines and pre-substances. the exporter or importer shall send a report (made according to form No. 1A or IB -not printed herein) to the Ministry of Health (the Drug Administration of Vietnam) and the Ministry of Public Security (the Standing Office for Drug Prevention and Fighting);
b/ For psychotropic finished-product medicines and combined pre-substances specified in Clause 2. Article 1 of this Circular: For every year, the exporter or importer shall send a report on the quantity of exported or imported medicines and pre-substances (made according to form No. 2A or 2B - not printed herein) to the Ministry of Health (the Drug Administration of Vietnam) no later than January 15 of the subsequent year.
2. Reporting on inventory and use:
a/ Psychotropic medicine and pre-substance traders and users shall make inventories and send monthly, biannual and annual reports (made according to forms No. 3A and 3B - not printed herein) to estimate-approving or export/import licensing agencies no later than the 15"' of the subsequent month (for monthly reports). July 15 (for biannual reports) or January 15 of the subsequent year (for annual reports);
b/ Provincial-level Health Departments shall send reports on the use of psychotropic medicines and pre-substances by establishments in their localities (made according to form No. 4 - not printed herein). The Military Medical Department of the Ministry of National Defense shall send annual reports on the use of psychotropic medicines and pre-substances in the Army (made according to form No. 3A - not printed herein) to the Ministry of Health (the Drug Administration of Vietnam) no later than January 30 of the subsequent year.
3. Irregular reporting:
Psychotropic medicine and pre-substance traders and users shall urgently report mistakes or losses or doubtful losses to estimate-approving agencies. When receiving these reports, estimate-approving agencies shall verify them and take appropriate handling measures.
Provincial-level Health Departments shall send urgent reports to the Ministry of Health (the Drug Administration of Vietnam).
Article 8. Archive of dossiers and books
1. Psychotropic medicine and pre-substance trading, preparing and dispensing establishments shall record, monitor and archive documents related to psychotropic medicine and pre-substance materials and psychotropic finished-product medicines and pre-substances for at least 2 years after the expiry date of these medicines or pre-substances.
2. Past the above archival duration, the head of an establishment shall set up a council for destroying psychotropic medicines or pre-substances. make and archive destruction records at the establishment.
Article 9. Destruction of medicines
1. Materials, psychotropic finished-product medicines and pre-substances which expire, are of inferior quality or out of the storage duration of samples, medicines returned from treatment wards, and medicines returned due to patients' death must be destroyed. An establishment shall destroy medicines as follows:
a/ It shall send a written request for medicine destruction to the estimate-approving agency, which must indicate the names, concentration-content and quantity of medicines to be destroyed, reason for and methods of destruction. Medicines will be destroyed only after such destruction is approved by the estimate-approving agency;
b/ It shall set up a medicine destruction council under its head's decision. Such council consists of at least 3 members including the officer in charge of the establishment;
c/It shall make a written record of destruction and archive it at the establishment:
d/ It shall report on the destruction of medicines to the estimate-approving agency (enclosed with the medicine destruction record).
2. To-be-destroyed residual products and wastes in the course of manufacturing psychotropic medicines and pre-substances shall be collected and destroyed under Points b and c. Clause 1 of this Article.
3. Direct containers of unused psychotropic medicines and pre-substances shall be collected and destroyed under Points b and c. Clause 1 of this Article.
4. Psychotropic medicines and pre-substances must be destroyed separately from other medicines. The destruction of medicines must be thorough and safe for humans and livestock and prevent environmental pollution under the law on environmental protection.
Article 10. Preparation and use of psychotropic medicines and pre-substances al specialized medicine and pharmacy research and training institutions
1. Specialized medicine and pharmacy research and training institutions may prepare and use psychotropic medicines and pre-substances for teaching and scientific research activities. Such an institution must have a university pharmacist who shall keep preparation books, record quantities of ex-warehoused and warehoused medicines and report under this Circular.
2. Prepared psychotropic medicines and pre-substances must be immediately packed and labeled to avoid confusion. A label must contain at least the following information: name of the institution; name, concentration and content (capacity) of medicine, preparer, supervisor, and date of preparation.
3. Psychotropic medicines and pre-substances shall be preserved in separate cabinets with equipment and measures to ensure safety for and avoid loss of medicines and pre-substances.
Chapter II
TRADING IN PSYCHOTROPIC MEDICINES AND PRE-SUBSTANCES
Article 11. General principles
1. Psychotropic medicine and pre-substance manufacturers, exporters, importers, wholesalers and retailers shall satisfy medicine trading conditions specified in Chapter II of the Pharmacy Law and Chapter IV of the Government's Decree No. 79/2006/ND-CP of August 9. 2006. detailing a number of articles of the Pharmacy Law. and observe this Circular.
2. Psychotropic medicine and pre-substance traders shall develop and follow standard operation procedures (SOP) in written form in all professional activities suitable to each type of business for application by all employees.
They must have at least the following procedures:
a/ Procedures for exporting, importing, purchasing and selling psychotropic medicines and pre-substances;
b/ Procedures for storing psychotropic medicines and pre-substances;
c/ Procedures for delivering and transporting psychotropic medicines or pre-substances;
d/ Procedures for destroying psychotropic medicines and pre-substances (psychotropic materials and pre-substances. psychotropic finished-product medicines and pre-substances. residual products, wastes and direct containers).
The development of SOP must observe the following regulations:
- Ensuring safety and avoiding loss of psychotropic medicines or pre-substances;
- Conducting handover in each stage with written records made and signed for certification to clarify responsibilities of each individual in each stage.
3. All employees engaged in trading in psychotropic medicines and pre-substances must be provided with initial and continuous training on legal documents and SOP related to psychotropic medicines and pre-substances. Training dossiers must be kept at establishments.
4. Storage: Manufacturers, exporters, importers and wholesalers must have warehouses satisfying good storage practices (GSP) standards promulgated by the Ministry of Health. A warehouse for storing psychotropic medicines and pre-substances must have a firm lock with safety assurance measures to avoid loss of medicines or pre-substances. If no separate warehouse is available for psychotropic medicines and pre-substances. they must be stored in an isolated area within a GSP warehouse with a firm lock and safety assurance measures to avoid loss of medicines or pre-substances.
Article 12. Manufacture
1. Annually, the Ministry of Health (the Drug Administration of Vietnam) shall, based on practical conditions, promulgate a list of licensed manufacturers of psychotropic medicines and pre-substances.
2. A psychotropic medicine and pre-substance manufacture establishment shall observe the following regulations:
a/ Satisfying good manufacture practices (GMP) standards suitable to each type of preparation for at least 2 years:
b/ Personnel:
- The storekeeper must be a university pharmacist or intermediate pharmacist (authorized in writing by the head of a unit with each authorization period not exceeding 12 months);
- The person supervising research, manufacture, analysis and testing processes and recording and reporting must be a university pharmacist who has practiced for at least 2 years at the establishment.
c/ Dossiers and books:
- Book guiding the preparation of psychotropic medicines and pre-substances (made according to form No. 5 - not printed herein):
- Book for monitoring the ex-warehousing and warehousing of psychotropic medicines and pre-substances (made according to form No. 6A - not printed herein);
- Book for monitoring the ex-warehousing of psychotropic finished-product medicines and combined pre-substances specified in Clause 2. Article 1 of this Circular (made according to form No. 6B - not printed herein):
- Bill of ex-warehousing psychotropic medicines and pre-substances (made according to form No. 7 - not printed herein);
3. Scope of operation of a psychotropic medicine and pre-substance manufacture establishment:
a/ Purchasing and importing psychotropic materials and pre-substances for the manufacture of its own medicines containing psychotropic active ingredients and pre-substances:
b/ Exporting its own psychotropic finished-product medicines and pre-substances;
c/ Selling its psychotropic finished-product medicines and pre-substances to establishments defined in Clause 1. Article 13 of this Circular.
4. When wishing to have psychotropic materials and pre-substances for research and manufacture of commodities newly registered for sale, a manufacturer shall make a written request for purchase/import of psychotropic materials and pre-substances (made according to form No. 8 A - not printed herein) and report on the quantity of psychotropic materials and pre-substances already used for research or trial manufacture (made according to form No. 8B - not printed herein).
Article 13. Export, import and wholesale
1. Central Pharmaceutical Company 1. Central Pharmaceutical Company 2. Central Pharmaceutical Company 3. Sai Gon Pharmaceutical Company. Ho Chi Minh City Medical Export-Import Joint-Stock Company (YTECO) and Hanoi Pharmaceutical-Medical Equipment Joint-Stock Company (HAPHARCO) shall supply psychotropic and pre-substance materials and finished-product medicines to traders and users nationwide.
2. Personnel: The storekeeper must be a university pharmacist or intermediate pharmacist (authorized in writing by the head of a unit with each authorization period not exceeding 12 months).
3. Dossiers and books:
a/ Book for monitoring the ex-warehousing and warehousing of psychotropic medicines and pre-substances (form No. 6A - not printed herein);
b/ Hill of ex-warehousing psychotropic medicines and pre-substances (form No. 7 - not printed herein):
c/ Documents related to the export, import, purchase and sale of psychotropic medicines and pre-substances.
4. Scope of operation:
a/ Exporting and importing psychotropic and pre-substance materials and finished-product medicines;
b/ Purchasing psychotropic finished product medicines and pre-substances from manufacturers:
c/ Selling psychotropic finished-product medicines and pre-substances to wholesalers and retailers of habit-forming medicines, medical establishments, specialized medicine and pharmacy research and training institutions and detoxication centers nationwide:
d/ Selling psychotropic medicine and pre-substance materials to licensed manufacturers and preparers of psychotropic medicines and pre-substances.
5. Provincial-level pharmaceutical companies (both state and equitized) may purchase psychotropic finished-product medicines and pre-substances from pharmaceutical companies defined in Clause I of this Article for supply to medical establishments, specialized medicine and pharmacy research and training institutions and detoxication centers in localities.
6. University pharmacists or intermediate pharmacists (authorized in writing by the head of a unit with each authorization period not exceeding 12 months) may directly wholesale psychotropic medicines and pre-substances.
Article 14. Retail
I. For pharmacies and drugstores
a/ Satisfying good pharmacy practices (GPP) standards:
b/ University pharmacists being owners of pharmacies or intermediate pharmacists being owners of drugstores shall directly manage and retail psychotropic medicines and pre-substances:
c/ Storage: Psychotropic medicines and pre-substances must be stored in separate cabinets with firm locks and safety assurance measures to avoid loss of medicines and pre-substances:
Psychotropic medicines and pre-substances in a small quantity may be stored together with habit-forming medicines in the same cabinets but in separate compartments to avoid confusion. These cabinets must have firm locks and safety assurance measures to avoid loss of medicines and pre-substances;
d/ Dossiers and books: A book for monitoring the ex-warehousing and warehousing of psychotropic finished-product medicines and pre-substances (made according to form No. 6A - not printed herein); and a bill of ex-warehousing psychotropic medicines and pre-substances, made by medicine suppliers;
e/ Scope of operation:
- Purchasing and retailing psychotropic finished-product medicines and pre-substances under the Regulation on prescription for outpatient treatment;
- Refraining from purchasing and selling psychotropic or pre-substance materials:
2. Enterprises' medicine sale agents and commune health stations' medicine cabinets:
a/ Physical foundations: Stalls and cabinets must have firm locks: psychotropic medicines and pre-substances must be stored in safe places to avoid confusion;
b/ Dossiers and books: A book for monitoring the ex-warehousing and warehousing of psychotropic finished-product medicines and pre-substances (made according to form No. 6A - not printed herein);
c/ Scope of operation:
- Enterprises' medicine sale agents may sell psychotropic medicines and pre-substances on Vietnam's list of essential medicines:
- Commune health stations' medicine cabinets may sell psychotropic medicines and pre-substances on Vietnam's list of essential medicines used for commune-level health centers.
Chapter III
PREPARATION. ALLOCATION, USE AND STORAGE OF PSYCHOTROPIC MEDICINES AND PRE-SUBSTANCES AT MEDICAL ESTABLISHMENTS AND DETOXICATION CENTERS
Article 15. Preparation
1. A medical examination and treatment establishment with the function to prepare psychotropic medicines and pre-substances must arrange a preparation zone satisfying the following conditions:
a/ Physical foundations:
- The preparation room must have an anti-dust ceiling. The floor and walls must be made of easy-to-clean materials for sterilization when necessary. This room must be built in an airy, isolated and safe place far from a polluting source. The room's minimum area must be 10 m2. The room's sections must be arranged on a unidirectional principle:
- Having a place for washing hand and preparation tools:
- Having sufficient tools suitable to preparation, storage and testing of medicines:
b/ Personnel:
- The person supervising, recording, reporting, and inspecting the quality of prepared medicines must be a university pharmacist:
- The person storing prepared psychotropic medicines and pre-substances must be a pharmacist of intermediate or higher level:
c/ Packing, labeling and storage:
- Prepared psychotropic medicines and pre-substances must be packed and labeled immediately to avoid confusion. A label must contain at least the following information: name of the preparation establishment, name of medicine, form of preparation, active ingredients, concentration or content, preparer, supervisor, and date of preparation:
- Psychotropic medicines and pre-substances must be stored in separate cabinets with safety assurance measures and equipment to avoid loss of medicines and pre-substances:
d/ Dossiers and books:
- A book guiding the preparation of psychotropic medicines and pre-substances (made according to form No. 5 - not printed herein):
- A book for controlling the quality of medicines:
- The process of preparing medicines based on prescriptions;
- SOP in medicine preparation.
2. Scope of operation:
a/ A medicine-preparing medical establishment may distribute prepared medicines only based on descriptions to inpatients and outpatients of the establishment;
b/ Such establishment may prepare only medicines with preparation formulas and procedures and quality standards approved by its head and taking responsibility for the safety and effect of these medicines:
c/ Refraining from preparing medicines for injection.
Article 16. Distribution and use
1. Pharmacy wards shall distribute psychotropic medicines and pre-substances to treatment wards based on cards of receipt of psychotropic medicines and pre-substances (form No. 9 - not printed herein) and directly allocate them to outpatients. Heads of pharmacy wards or their authorized university pharmacists shall sign for approval these cards.
After receiving medicines from pharmacy wards, treatment wards' nurses shall check the names, concentration, content and quantity of medicines before injecting or distributing them to patients.
Treatment wards shall return to pharmacy wards psychotropic medicines or pre-substances which are not used up or left due to patients' transfer to other hospitals or death and make records of such return. Heads of pharmacy wards shall, based on specific conditions, decide to reuse or destroy such medicines or pre-substances under regulations and make records thereof for preservation at pharmacy wards.
Pharmacy wards shall monitor and fully record the quantity of psychotropic medicines and pre-substances ex-warehoused, warehoused and left in stock (form 6A - not printed herein).
2. Keep-watch nurses shall keep and allocate at medical instructions psychotropic medicines or pre-substances of keep-watch or first-aid medicine cabinets at wards and divisions in medical establishments using these medicines or pre-substances. When changing watch-shifts, the medicine keeper of the previous watch-shift shall hand over medicines and monitoring books to the medicine keeper of the subsequent watch-shift.
3. For detoxication centers, pharmacists of intermediate or higher level shall receive, manage and allocate psychotropic medicines and pre-substances.
Article 17. Storage
1. Storage of psychotropic medicines and pre-substances at pharmacy wards:
a/ Physical foundations: Psychotropic medicines and pre-substances must be stored in warehouses in compliance with GSP regulations. Warehouses and cabinets for storing psychotropic medicines and pre-substances must have firm locks to ensure safety and avoid loss of medicines or pre-substances. If no separate warehouses or cabinets are available, psychotropic medicines and pre-substances may be stored together with habit-forming medicines in the same warehouses or cabinets but must be arranged in separate compartments to avoid confusion.
b/ The storekeeper must be a pharmacist of intermediate or higher level.
2. Storage of psychotropic medicines and pre-substances in keep-watch or first-aid medicine cabinets: Psychotropic medicines and pre-substances in keep-watch or first-aid medicine cabinets must be stored in separate compartments or boxes in cabinets with firm locks. The head of a medical establishment shall specify in writing the quantity and categories of psychotropic medicines and pre-substances to be stored in keep-watch or first-aid medicine cabinets.
Chapter IV
DOSSIERS AND PROCEDURES FOR ESTIMATION. PURCHASE SALE, EXPORT AND IMPORT
Article 18. Estimation
1. Annually, psychotropic medicine and pre-substance traders and users shall estimate the quantity of psychotropic medicines and pre-substances to be purchased (form No. 10 - not printed herein). Such an estimate shall be made in 4 copies (to be kept by the estimate-approving agency (two copies), trader or user (one copy)., and seller (one copy)).
2. Psychotropic medicine and pre-substance traders and users may purchase, sell, allocate and use these medicines and pre-substances only when they have estimates approved under Article 19 of this Circular.
3. Heads of trading and using establishments shall take responsibility for the estimated quantity of psychotropic medicines and pre-substances Such quantity must meet user needs. When the estimated quantity of psychotropic medicines and pre-substances exceeds 50% of the quantity used in the previous period, the estimating establishment shall clearly state the reason.
When the quantity of psychotropic medicines and pre-substances purchased as estimated fails to meet use needs, establishments may make additional estimates and state the reason.
4. Within 7 working days after receiving valid estimates, the estimate-approving agency shall approve such estimates or give a written reply, stating the reason for refusal to approve them.
Article 19. Approval of estimates
1. The Ministry of Health (the Drug Administration of Vietnam) shall:
a/Approve estimates of psychotropic and pre-substance materials for medicine manufacturers, medical establishments, research institutions, specialized medicine and pharmacy training institutions and detoxication centers.
b/ Approve estimates of psychotropic finished-product medicines and pre-substances for the establishments defined in Clause 1. Article 13 of this Circular.
c/ Approve estimates of psychotropic medicines and pre-substances for establishments which are not managed by the health sector but wish to purchase psychotropic medicines and pre-substances for scientific research. Establishments shall enclose estimates with official letters stating the reason for purchase and have them certified by heads of departmental-or higher-level agencies directly managing the establishments.
d/ Approve estimates of psychotropic finished-product medicines and pre-substances for the Army Medicine Department of the Ministry of National Defense.
2. Provincial-level Health Departments shall approve estimates of psychotropic finished-product medicines and pre-substances for medicine wholesalers and retailers, medical establishments, research institutions, specialized medicine and pharmacy training institutions and detoxication centers in localities. Depending on local conditions, provincial-level Health Departments may decentralize or authorize district-level Health Divisions or health centers (which have pharmaceutical officers) to approve estimates of psychotropic finished-product medicines and pre-substances for commune-level health stations.
3. The Army Medicine Department of the Ministry of National Defense shall approve estimates of psychotropic finished-product medicines and pre-substances for hospitals and units under the Ministry.
4. Heads of treatment wards or medical examination divisions shall sign for approval cards of receipt of psychotropic medicines and pre-substances for their wards or divisions (form No. 9 - not printed herein). Heads of pharmacy wards shall sign for approval cards of receipt of psychotropic medicines and pre-substances for watch-shifts of their wards.
Article 20. Export and import dossiers and procedures
1. Dossiers and procedures for the export or import of psychotropic medicines and pre-substances comply with the Health Ministry's Circular guiding the export and import of medicines and their direct containers.
2. A permit for export or import of psychotropic medicines (in blue) and pre-substances (in pink) will be issued upon each export or import and valid for up to one year from the date of its signing.
3. An export or import permit shall be sent to the applicant. Vietnam Standing Office for Drug Prevention and Fighting, the border-gate customs office carrying out export or import procedures, the Ministry of Finance, the International Drug Control Committee, and the managing agency of the importing country (for export permits).
4. Psychotropic medicine and pre-substance materials and finished-products may be exported or imported through Vietnam's international border gates.
Chapter V
INSPECTION. EXAMINATION. AND HANDLING OF VIOLATIONS
Article 21. Examination and inspection
1. The Drug Administration of Vietnam and the Inspectorate of the Ministry of Health shall examine and inspect according to their competence the implementation of this Circular by organizations and individuals engaged in activities related to psychotropic medicines and prc-substances in the Vietnamese territory.
2. Provincial-level Health Departments shall examine and inspect the implementation of this Circular in their localities.
Article 22. Handling of violations
All violators of this Circular shall, depending on the severity and nature of their violations, be administratively sanctioned, be suspended from grant of permits, have granted permits revoked, or be examined for penal liability under law.
Chapter VI
IMPLEMENTATION PROVISIONS
Article 23. Implementation roadmap
Pharmacies and drugstores may continue to purchase and sell psychotropic medicines and pre-substances according to the roadmap for compulsory application of GPP principles and standards as prescribed by the Ministry of Health.
Article 24. Effect
1. This Circular takes effect 45 days from the date of its signing. To annul the Health Minister's Decision No. 3047/200l/QD-BYT of July 12. 2001. promulgating the Regulation on management of psychotropic medicines, the list of psychotropic medicines and pre-substances used as medicines and the list of psychotropic medicines and combined pre-substances used as medicines; Decision No. 1443/2002/QD-BYT of April 25. 2002. amending and supplementing a number of articles of the Regulation on management of psychotropic medicines promulgated together with Decision No. 3047/2001/QD-BYT of July 12. 2001: and Decision No. 71/2004/QD-BYT of January 9. 2004. adding a number of substances to the list of psychotropic medicines promulgated together with Decision No. 3047/ 2001/QD-BYT of July 12. 2001.
2. The Drug Administration of Vietnam and units under the Ministry of Health, provincial-level Health Departments, the Vietnam Pharmaceutical Corporation, organizations and individuals engaged in activities related to psychotropic medicines and pre substances, foreign organizations and individuals providing psychotropic medicines and pre-substances into Vietnam, medical establishments, research institutions and specialized medicine and pharmacy training institutions shall implement this Circular.
Any problems arising in the course of implementation should be reported to the Ministry of Health (the Drug Administration of Vietnam) for consideration and settlement.
| FOR THE MINISTER OF HEALTH |
APPENDIX I
LIST OF PSYCHOTROPIC MEDICINES
(To the Health Minister's Circular No. 11/201 OH'V-BYT of April 29, 2010)
No. | International name | Other common name | Scientific name |
1 | Allobarbital |
| 5,5-dia llylbarbituric acid |
2 | Alprazolam |
| 8- cloro -1- methy -6- phenyl - 4H -s-triaz.olo [4,3-aJ [1,4] benzodiazepin |
3 | Amfepramon | Diethylpropion | 2-(dielhylamino) propiophenone |
4 | A mi nor ex |
| 2- amino-5- phenyl- 2-oxazolinc |
5 | Amobarbital |
| 5-ethyl-5-isopentylbarbituric acid |
6 | Barbital |
| 5,5-diethylbarbituric acid |
7 | Benzfetamin | Benzphetamine | N-benzyl-N, a- diethylphenethylaminc |
8 | Bromazepam |
| 7-bromo-L3-dihydro-5-(2-pyridyl)-2H-l,4-benzodiazepin-2-one |
9 | Brotizolam |
| 2- bromo-4-(o-chlorophenyl)-9-6H-thieno(3.2-f)-s-triazolo( 4.3- «)(1,4) diazep |
10 | Buprenorphin |
| 21-cvclopropyl-7-a|(S)-l-hydroxy-1,2.2-trimethylpropyl |
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-l,4-benzodiazepin-2-one dimcthylcarbamate (ester) |
14 | Chlodiazepoxid |
| 7-chloro-2-(methylamino)-5-phenyl-3H-1,4-bcnzodiazepine-4-oxide |
15 | Cathine | (+)-norpseudo-ephedrine | (+H/0-(x-|(R)-l-aminoethyl|benzykl ancohol |
16 | Clobazam |
| 7-chloro-1 -methyl-5-phenyl-1H-1.5-benzodiazepin-2,4 (3H.5H) dione |
17 | Clonazepam |
| 5- (t)-chlorophenyl)-1,3-dihydro-7-nitro- 211 -1.4 -benzodiazcpine-2 –one |
18 | Clorazepat |
| 7- chloro - 2,3 - dihydro - 2 - oxo -5-phenyl-lH-I.4-benzodiazepine -3-carbocilic acid |
19 | Clonazepam |
| 5-(o-chlorophenyl)-7-ethy 1-1.3 dihydro-1 methyl-2H-thieno|2.3e|-1.4 -diazepin -2- one |
20 | Cloxazolam |
| 10-chloro-l lb-(o-chlorophenyl) 2,3.7.1 lb-tetrahydrooxazolo-|3.2-d| [ 1.4|benzodiazepin-6(5H) -one |
21 | Delorazcpam |
| 7-chloro-5- (o-chlorophenyl)-1.3 dihydro-2H-1.4 benzodiazepin-2 - one |
22 | Diazepam |
| 7-chloro-1.3-dihydro-l-methyl-5-phenyl-2H-1.4 benzodiazepin-2 - one |
23 | Estazolam |
| 8-chloro-6-phenyl-4H-s-triazolo[4,3-a|[ 1.4|benzodiazcpin |
24 | Ethchlorvynol |
| 1 - chloro -3- ethyl -1- penten -4 - yn -3-ol |
25 | Ethinamat |
| 1- ethynylcyclohexanol carbamate |
26 | Ethylloflazepat |
| ethyl -7- chloro -5- (O-fluorophe.'iyl) -2.3 - dihydro -2 - oxo -1H-1.4 -benzodiazepine -3- carboxylate |
27 | Etilamfetamin | N-ethylamphetamine | N-ethyl-a-mcthylphenethylamine |
28 | Fencamfamin |
| N- ethyl-3- phenyl-2- norbornanamine |
29 | Fenproporex |
| (±) -3- ( (ex- methylphenethyl) amino] propionitrile |
30 | Fludiazepam |
| 7-chloro -5- (o-fluorophenyl) -1.3-dihydro -1- methy 1-7-nitro - 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-l-|2-(diethylamino)ethyll -5-(o-fluorophenyl)-1.3-dihydro-2H-l,4-benzodiazepin -2 - one |
33 | Glutelhimid |
| 2-ethyl-2-phenylgIutarimide |
34 | Halazepam |
| 7-chloro-1,3- dihydro -5- phenyl-1-(2,2,2 -trifluoroethyl)-2H-I,4-' benzodiazepin -2 - one |
35 | Haloxazolam |
| 10-bromo-l lb -(o-fluorophenyl)-2.3.7.1 lb tetrahydrooxazolo |3.2-d] 11,4J benzodiazepin -2 -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 | Ketamin |
| (+) -2- (2-Clorophenyl)-2-meth\ laminocyclohexanone. |
38 | Lefetamin | SPA | (-)-N.N-dimethy 1-1,2-diphenylethylamine |
39 | Loprazolam |
| 6-(o-chlorophenyl)-2.4-dihydro-2-|(4-methyl-1-piperazinyl) methylene] -8-nitro-lH-imidazol| 1.2-a] 11,4] benzodiazepin-1 -one |
40 | Lprazepam |
| 7-chloro-5'(o-chlorophenyl)-l,3-dihydi o-3-hydroxy-2H-1.4 benzodiazepin -2 - one |
41 | Lormctazepam |
| 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-1 -methyl-2H-1.4 benzodiazepin -2 - one |
42 | Mazindol |
| 5-(p-chlorophenyl)- 2,5-dihydro -3H-imida/.o[2.1-a| isoindol-5-ol |
43 | Medazepam |
| 7-chloro-2.3-dihydro-1-mcthyl-5-pheny 1-1H-1.4 benzodiazepine |
44 | Mefcnorex |
| N-(3- chloropropyl)- a -meth) Iphenethylamine |
45 | Meprobamal |
| 2-methyl-2-propyl - 1,3-propanediol. dicarbamate |
46 | Mesocarb |
| 3- (ainethylphenethyl)- N-(phenylcarbamoyl) sydnone imine |
47 | Mcthylphenidate |
| Methyl a -phenyl-2-piperidineacetate |
48 | Methylpheno-barbital |
| 5-eth) 1-1 -methyl -5- phenylbarbituric acid |
49 | Methyprylon |
| 3.3 dicthyl-5- methyl-2.4 piperydine-dione |
50 | Midazolam |
| 8- chloro- -6- (o-fluorophenyl) -1-methyl-4H'imidazol| 1.5-a|[ 1,4] benzodiazepine |
51 | Nimetazepam |
| 1.3 dihydro-1- methyl-7-nitro-5-phenyl-2H-1.4 benzodia/.epin-2-one |
52 | Nitrazepam |
| 1.3 dihydro -7-nitro-5-phenyl-2H-1.4 benzodiazepin-2-one |
53 | Nordazepam |
| 7-chloro- 1,3 dihydro-5- phenyl-2H-1.4 benzodiazepin-2-one |
54 | Oxazepam |
| 7-chloro- 1.3 dihydro- 3hydroxy-5-pheny 1-211-1.4 benzodiazepin-2-one |
55 | Oxazolam |
| l()-chloro-2.3.7.1 lb- tetrahydro-2-methyl-l lb-phenyloxazolo|3.2-d] [1,4] benzodia/.epin-6(5H) -one |
56 | Pentazocin |
| (2*.6R*,llR*)-1.2.3.4,5.6-hexahydro-6.1 l-dimethyl-3-(3-mcthyl-2-butenyl)-2.6-methano-3-benzazocin-8-ol |
57 | Penlobarbital |
| 5-ethyl-5-(l-methylbutyl) barbituric acid |
58 | Phendimetrazin |
| (+)-(2S,3S)-3.4-dimethyl-2-phenylmorpholine |
59 | Phenobarbital |
| 5-ethyl-5-phenylbarbituric acid |
60 | Phentermin |
| a, a- dimethylphenethylamine |
61 | Pinazepam |
| 7-chloro-1.3-dihydro-5-phenyl-1 -(2-propynyl)-2H-1.4-benzodia/epin-2-one |
62 | Prazepam |
| 7-chloro -1- (cyclopropylmethyl) - 1.3 -dihydro -5- phenyl -2H- 1,4-benzodiazepin-2-one |
63 | Pyrovaleron |
| 4-methyl-2-(l-pyrrolidiny) valerophenonc |
64 | Secbutabarbital |
| 5-scc- butyl-5-ethylbarbituric acid |
65 | Temazepam |
| 7 - chloro -5- 1.3 - dihydro -3-hydroxy-1 -methyl-5-phenyl -2H- 1.4-benzodiazepin -2- one |
66 | Tetrazepam |
| 7-chloro-5-( 1-cyclohexen-1 - vl)-1.3dihydro-1 -methy 1-2H-1.4 benzodiazepin -2- one |
67 | Triazolam |
| 8-chloro-6-(o-chlorophcnyl)-1-methyl-4H-s-triazolo|4.3-a|[ 1.4] benzodiazepin |
68 | Vinylbital |
| 5-( 1 -methylbutyl)-5-vinylbarbituric acid |
69 | Zolpidem |
| Imidazol [1,2-a ] pyrimidin-3-acetamid, N.N.6-Trimethyl-2- (4-methylphenyl) |
APPENDIX II
LIST OF PRE-SUBSTANCES USED AS MEDICINES
(To the Health Minister's Circular No. 11/2010/TT-BYT of April 29, 2010)
No. | International name | Scientific name |
1 | Ephedrin | Benzcncmcthanol, -| 1α -(methylamino)ethyl ] |
2 | N-Ethylcphedrin | l-Ethylephcdrin |
3 | N-mEthylephedrin | a-[-l-(Dimethylamino)Ethyll Benzene methanol |
4 | Pseudocphcdiin | Bcn/.enemcthanol,a-2-(methylamino)-l-phenylpropan-1-ol |
5 | Ergo met rin | Ergoline-8-carboxamide,9,10-dihydro-N-(2-hydro-l-methylethyl)-6-methy- [8(s)J. |
6 | Ergotamin | Ergotaman-3',6',18-trione, 12'-hydroxy-2'-methyl-5*-(phenvlmethyl)-(5'a) |
7 | N-Ethylpscudocphedrin |
|
8 | N-mEthylpscudoephedrin |
|
APPENDIX III
LIST OF COMBINED PSYCHOTROPIC MEDICINES
(To the Health Minister's Circular No. 11/2010/TT-BYT of April 29. 2010)
No. | Name of psychotropic substance or pre-substance | Maximum content in a dosed unit |
1 | Allobarbital | 10 mp |
2 | Alprazolam | 0.25 mjz |
3 | Amobarbital | 10 mg |
4 | Barbital | 10 mg |
5 | Bromazepam | 1 mg |
6 | Brotizolam | 0.25 mg |
7 | Butobarbital | 10 mg |
8 | Camazepain | 5 mg |
9 | Chlodiazepoxid | 5 mg |
10 | Clobazam | 5 mg |
11 | Clonazepam | 0.5 mg |
12 | Clorazepat | 10 mg |
13 | Clonazepam | 5 mg |
14 | Diazepam | 5 mg |
15 | Estazolam | 0.5 mg |
16 | Fludiazepam | 0.5 mg |
17 | Flunitrazepam | 0.5 mg |
18 | Flurazepam | 5 mg |
19 | Ha tazepam | 5 mg |
20 | Kctazolam | 5 mg |
21 | Loprazolam | 0.25 mg |
22 | Lorazepam | 0.5 mg |
23 | Lormetazepam | 0.25 mg |
24 | Meprobamat | 100 mg |
25 | Medazepam | 5 mg |
26 | Methylphenobarbital | 10 mg |
27 | Midazolam | 5 mg |
28 | Nitrazepam | 5 mg |
29 | Nordrazepam | 0.25 mg |
30 | Oxazepam | 10 mg |
31 | Parazepam | 5 mg |
32 | Pentobarbital | 10 mg |
33 | Phenobarbital | 25 mg |
34 | Secbutabarbital | 10 mg |
35 | Temazepam | 25 mg |
36 | Tetrazepam | 5 mg |
37 | Vinylbital | 10 mg |
38 | Cloxazolam | 1 mg |
39 | Delorazepam | 0.25 mg |
40 | Ethylcloflazepat | 0.25 mg |
41 | Nimetazepam | 0.25 mg |
42 | Oxazolam | 5 mg |
43 | Pinazepam | 1 mg |
APPENDIX IV
LIST OF COMBINED PRE-SUBSTANCES USED AS MEDICINES
(To the Health Minister's Circular No. 11/2010 Off- BYT of April 29, 2010)
No. | Name of pro-substance | Maximum content in a dosed unit | Maximum concentration in a unit no yet dosed |
1 | Ephedrin | 50 mg | 1.5% |
2 | Ergometrin | 0.125 mg | |
3 | N- Ethylephedrin | 12.5 mg | |
4 | N- Methylephedi'in | 31.1 mg | |
5 | Ergotamin | 1 mg | |
6 | Pscudoephedrin | 120 mg | 0.5% |
