Circulars of the activities related to the addictive drug _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ pursuant to Decree No. 188/2007/ND-CP on December 27, 2007 of the Government functions, tasks, powers and organization of the Ministry of health;
Pursuant to the law No. 34/2005/QH11 Pharmacy on June 14, 2005;
Pursuant to Decree No. 79/2006/ND-CP dated 9/8/2006 detailing the Government's implementation of some articles of the law on Pharmaceuticals;
Drug prevention pursuant to the law No. 23/2000/QH10 on 19/12/2000;
Pursuant to Decree No. 80/2001/ND-CP on 05/11/2001 directions Government controlling legal activities related to drug trafficking in the country;
Pursuant to Decree No. 67/2001/ND-CP dated 01/10/2001 of the Government on the issue category narcotics and precursors;
Pursuant to Decree No. 58/2003/ND-CP dated 19/5/2003 of government regulations about the import controls, export, Vietnam territory transit narcotics, precursors, addictive drugs, smoking mental direction;
Pursuant to Decree No. 133/2003/ND-CP dated 06/11/2003 by the Government on the addition of certain substances to the list of narcotics and precursor attached to Decree No. 67/2001/ND-CP dated 01/10/2001 of the Government;
Pursuant to Decree No. 163/2007/ND-CP on November 12, 2007 by the Government about this page name, add, move, remove some of the substance in the list of narcotics and precursor attached to Decree No. 67/2001/ND-CP dated 01/10/2001 of the Government;
The Health Ministry instructed the activities related to the addictive drug use in Vietnam.
 
Chapter I GENERAL PROVISIONS article 1. Scope 1. This circular guides the activities related to addictive drugs used in the medical field and in the analysis, testing, scientific research provisions of addictive drugs list (annex I, Appendix II) attached to this circular.
2. Smoking finished products include many of the active ingredients in the formula contains an addictive substance combined with other active substances (not that addictive drugs, mental direction or precursor drugs used as medicines), the active substance content equal to or less than the prescribed levels in this addictive drug in the form of coordination (annex II) are exempt from performing a number of circular provisions except in the following terms: this article 4, point b article 7 paragraph 1, paragraph 2 article 9, paragraph 1 and paragraph 3 article 11, paragraph 2 and paragraph 4 Article 12, article 15, article 20 paragraph 1.
Article 2. The object that applies to this circular apply to individuals, domestic and foreign organizations have activities related to addictive drugs used in the medical field and in the analysis, testing, scientific research in Vietnam.
Article 3. Prescribe The addictive prescription for outpatients is made according to the provisions of the "regulations prescribe drugs in outpatient treatment" by the Minister of health.
Article 4. Drug labels made under the provisions of the circular label smoking by the Minister of health.
Article 5. Delivery upon delivery, get addictive drugs: should conduct checked drug name, concentration, concentration, quantity, batch number, production limits, drug quality in terms of perception; the delivery, the recipient must sign and specify the name in the document repository, enter the repository.
Article 6. Shipping 1. In transit: Addictive Drugs must be packed, sealed and take measures to ensure safety, not to loss in transit; on the packaging should indicate where, where, name of medication, the number of smoking.
2. The head of the facility have addictive drugs must have the text of its base is responsible for shipping the addictive drug; Who is responsible for shipping the addictive drug to carry the text above, demonstrate people's mail (or identification), sales invoice or inventory manufacturing votes; responsible type, quantity, quality drugs in terms of perception in the process of transportation and delivery of full responsibility for keeping the addictive drug.
3. in case of addictive drugs businesses need to hire to transport the drug addictive: party rental and party transported must sign a contract in writing, which stated the conditions relating to the preservation, transmission, and delivery of prescribed addictive drugs. The receiving party must meet the transport conditions in the shipping process, ensuring the medication not be time-consuming.
Parties and party rental, transport must take responsibility for the issues related to addictive drugs in transit.
Article 7. The report 1. Report export/import: a) Smoking addictive: the latest ten days after the export, import, export, and import establishments report (model No. 1A, model No. 1B) to the Ministry of health (pharmaceutical Management Bureau) and the Ministry of public security (Office of the permanent task);
b) Smoking addictive form of coordinated products prescribed in clause 2 1 of this circular: every year, the basis of the report the number of export/import (form No. 2A, model No. 2B) to the Ministry of health (pharmaceutical Management Bureau); the latest is May 15 in January next year.
2. inventory reports, use: a) The base business, addictive drug use to inventory, reporting the number of addictive drug inventory every month, 6 months and years (model No. 3A, model No. 3B) to the plan review agency, licensing; the latest was on 15 months later (for the reporting month), on July 15 (for the first 6 months report) and on October 15, 1 year later (for reports);
b) the Department of health of the province of the central cities, reported the situation to use addictive drugs of local institutions themselves (model 4), Army Medical Department-the Department of Defense reported the use of addictive drugs his industry (3A) to the Ministry of health (pharmaceutical Management Bureau); on 30 November at the latest 1 year later.
3. irregular reports: The business establishments, addictive drug use to report an emergency to the plan review agency in case of confusion, loss or when there is doubt losses. When receiving an emergency report, plan review agency to conduct the investigation and take measures appropriate handling;
The Department of health of the province of the central cities, and an emergency report to the Ministry of health (pharmaceutical Management Bureau).
Article 8. Retention of records, books 1. The business establishment, blending, addictive medications to record, track and retain records, books and documents related to the addictive drug raw materials, finished products addictive drug after expiry drugs used for at least two years.
2. Expiry of the storage on the base, who heads up the Board to quash, set the minutes cancel and save the minutes cancel at the base.
Article 9. Cancel the drug 1. Raw materials, finished products addictive drugs expired, poor quality, samples of the drug store when time runs out, the drug received from the Faculty of medicine and the treatment received by a patient death need to cancel, do cancel the drug as follows: a) have written to recommend canceling the drug sent the plan review agency. The text suggested canceling the drug must specify the name of the drug, the concentration-, number, reason please cancel, the Cancel method. Canceling the drug only after the Agency browse the plan approval;
b) established the Council to cancel the drug due to the head of the basis of the decision. The Council has at least 3 people, which must have officers;
c) Set the minutes cancel and save at the facility;
d) after canceling, must send report cancel smoking up the browse agency plan (attached to minutes of canceling the drug).
2. The residual products category, in the process of producing addictive drugs need to cancel, must be gathered and cancel as specified in point b and point c of paragraph 1 of this Article.
3. packaging types directly contain addictive drugs are not used any more to be gathered and cancel as specified in point b and point c of paragraph 1 of this Article.
4. The discard the addictive drugs must separately with other drugs; to ensure thorough, safe for people, animals and avoid environmental pollution under the provisions of the law on the protection of the environment.
Article 10. Blending, addictive drug use at the base of research, training of specialized medicine-medicine 1. The basis of research, training of specialized medicine-medicine is concocted, addictive drug use serve teaching and scientific research; must have pharmacists oversee the University and is responsible for processing book recording mode, import as addictive drugs and reported in accordance with the provisions of this circular.
2. the addictive Drug dispensing is completed must be packaged, labelled to avoid confusion. The label must have at least the following information: name, name of medication, dosage, active ingredients, concentration or the concentration, volume, mixed, people on monitoring.
3. addictive Drugs must be stored in separate cabinets; have the equipment, ensure the security measures, against losses.
 
Chapter II article 11 ADDICTIVE DRUG BUSINESS. General principles 1. The basis of the production, export, import, wholesale, retail addictive drugs must meet the condition that menstrual drug list as specified in chapter II of the Pharmaceutical Law and chapter IV of the Decree 79/2006/ND-CP dated 9/8/2006 detailing the Government's implementation of some articles of the law and in compliance with the provisions of this circular.
2. The basis of addictive drugs business to build and follow the standard operation procedures (SOP) as text for all professional activities to suit every type of business to all employees concerned to apply, the minimum must have the following: a) the export process , import, purchase, sale of addictive drugs;
b) preservation process medications addictive;
c) delivery process, shipping the addictive drug;
d the cancellation process addictive drug) (drug raw materials, finished products addictive drugs, residual products, scrap, packaging directly).
The construction of the SOP should meet the following rules:-the safety, not loss addictive drugs;
-Each stage must be delivered by the books, have the signatures in order to clearly define the responsibilities of each individual in each stage;
3. All individuals involved in the addictive drug business must be a basis of initial training and continuous training on the legal text and the standard operation procedures related to addictive drugs; training records must be kept at the facility.

4. Maintenance: the base of production, export, import, wholesale warehouse must have good practice standards to preserve (GSP) issued by the Ministry of health; in that addictive drugs preservation repository must have tags for sure, there are measures to ensure safety, not for losses. If no private warehouse, the addictive drug to a separate area in the repository reached GSP, have sure and lock the safety measures against loss.
Article 12. The production of 1. Every year, the Ministry of health (pharmaceutical Management Bureau) based on the practical situation to issued the list of the allowed base produces addictive drugs 2. The addictive drug production facilities must comply with the following rules: a) of standard drug good manufacturing practices (GMP) match each dosage form for at least 2 years;
b) personnel:-store keeper: pharmacists;
-The monitoring of the process of research, production, analysis, testing and responsible reporting, record mode: pharmacist University had time to practice for at least 10 years or more in drug production facilities;
c) records, the books:-addictive drug processing Book (form 5);
-As addictive drugs import export (model No. 6 A);
-Export as smoking addictive form of coordinated products prescribed in clause 2 1 of this circular (model No. 6B);
-Slip the addictive drug output (7);
3. scope of operation of the addictive drug production base: a) to buy, import of raw materials for production of addictive drug that contains the active substance of business administration;
b) export business own addictive drugs;
c) Sold the drug addictive products produced for the basis of the provisions of article 13 paragraph 1 of this circular.
4. When in need of drug raw materials to research the production of new items to register for circulation, the basis must have a single proposal to buy/import addictive (model No. 8A); and must report the details of the number of drug raw materials were used for research, test production (model No. 8B).
Article 13. Export imports-wholesale 1. Pharmaceutical company Central 1, Central 2 pharmaceutical companies, Pharmaceutical companies, Pharmaceutical company 3 Central Saigon, import export joint stock company health in Ho Chi Minh City (YTECO), the pharmaceutical Corporation-medical devices (HAPHARCO) is responsible for the supply of raw materials and finished products for the addictive drug business establishments , used in the country.
2. Hr: storekeepers to be pharmacists.
3. Records, books: a) as addictive drugs import export (model No. 6A);
b) addictive drug output Slip (7);
c) The documents relating to the export, import, purchase and sale of addictive drugs.
4. scope of activities: a) the export and import of raw materials and finished products addictive drugs;
b) Buy the drug addictive of the production facility;
c) Sold the drug addictive products for wholesale establishments, retail establishments addictive drugs, medical facility, facility for research, training of specialized medicine-medicine, Detox centres in the country;
d) addictive material for the base allowed the production, blending the addictive drug.
5. the pharmaceutical companies, the central cities (including State enterprises and State-owned enterprises after the capitalization) are buying finished products addictive drugs from pharmaceutical companies to the provisions in clause 1 of this Article to provide for the medical facility, facility for research specialized training, health-medicine, Detox Center.
6. The pharmacist University of addictive drug wholesalers directly.
Article 14. Retail 1. The Department of health of the province of the central cities is responsible for organizing and directing the pharmacy supplying the drug addictive products meet the demand for out-patient areas.
2. Drugstore selling addictive drugs to achieve standards of pharmacy practice (GPP);
3. The pharmacist pharmacy owners University directly managed retail and addictive drugs.
4. Maintenance: addictive drugs must be stored in a separate locked cabinets for sure, there are measures to ensure safety, not for losses.
If the number is less addictive drugs, can do the same with mental direction and medicine cabinets of precursors used to own, but to avoid confusion; There are tags for sure, there are measures to ensure safety, not for losses.
5. Records, books: a) as addictive drugs import export (model No. 6A);
b) addictive drug output of Votes where the drug supply;
c) prescription drug store at the facility after the sale;
d) minutes of receiving the drug addictive products due to the patient's return.
5. scope of activities: a) Buy smoking addictive and retail products as defined in the regulations prescribe drugs in outpatient treatment;
b) aren't buying, selling addictive drug ingredients.
 
Chapter III the BLENDING, ALLOCATE, USE, PRESERVING the ADDICTIVE DRUG in the medical DETOX CENTER, article 15. Blending 1. Medical consultation function, cure has concocted the addictive drug to layout the area blending meets the following conditions: a) the base material:-processing Room: dust ceiling, wallpaper and wall House by easy hygiene materials, when necessary can disinfect work done. The room must be built in a cool place, separate, safe, far from the source of pollution. Minimum ground area is 10m2. The parts are arranged according to the principles of direct current;
-Wash hands, wash the mixing tools;
-Have enough suitable instrument with the blending, storage and drug testing;
b) Manpower: supervisor, responsible for the mode of recording, reporting, quality control of drugs and addictive drug management after blending: is a pharmacist.
c) packaging, labelling, storage:-addictive Drug dispensing is completed must be packaged, labelled to avoid confusion. The label must have at least the following information: name, name of medication, dosage, active ingredients, concentration or concentration, the pha, the supervisor, on blending;
-Addictive Drugs must be to preserve in a private Cabinet; measures, equipment to ensure safety, loss prevention;
d) records, the books:-addictive drug processing Book (form 5);
-Window check the quality control of drugs;
-The process of dispensing the medication according to the menu;
-Must have rules, standard operation procedures (SOP) in the dispensing of medication;
2. scope of activities: a) Drugs concocted just sold, allocated according to individual patient's inpatient and outpatient basis own;
b) Only be concocted the smoking formula, mixing processes, quality standards is the right person to head the facility approval and take responsibility for the safety and efficacy of the drug;
c) Not be dispensing injections.
Article 16. Allocate, use 1. Pharmacy drug medications for the treatment of faculty according to the addictive drug chiefs Votes (model No. 9) and medications directly to patients outpatient treatment. Dean of Faculty of pharmacy or pharmacist University was the Dean of the mandated in writing signed by the addictive drug chiefs votes Faculty of treatment;
In the treatment, after receiving medication from the pharmacy, nurses are assigned the task to collate the names of drugs, concentration, concentration, amount of drugs before injecting or delivered to the patient;
Addictive drugs admit do not handled or by disease or death, Faculty of treatment to make paper return pharmacy. Dean of Faculty of Pharmacy pursuant to specific conditions to the decision to reuse or discard as defined and set the minutes stored in pharmacy;
Faculty of Pharmacy must monitor and record the amount of addictive drug inventory, import export (model No. 6A).
2. for online medicine cabinet, medicine cabinet in emergency departments in the medical establishment have used addictive drugs: the drug addictive due to the nurses, direct and allocated according to the y command. When the shift was changed, the holder of the previous shift to drug delivery and as for the people who keep smoking after their shift.
3. Detox Center: If there is no pharmacist University, Director of the center of written authorization (each not exceeding 12 months) for the high pharmacists receive, manage, addictive medications.
Article 17. Maintenance 1. Preserving the addictive drugs at the Pharmacy: a) infrastructure: Addictive Drugs must be stored in the repository in compliance with the rules of good practice to preserve the drugs; hospital pharmacy must deploy the application of the principle of "good storage practice" (GSP) in accordance with the agenda of the Ministry of health regulations;
Warehouse, storage chests are definitely key addictive, be equipped to ensure the appropriate security, against losses. If there is no repository, cabinets, addictive drug can so common with mental direction and drug precursors used the medicine but must arrange separately to avoid confusion.
b) store keeper: a pharmacist or pharmacist authorized school (head of the authoritative basis in writing, each authorization not more than 12 months).
2. Preserving the addictive drug in pill users, emergency medicine cabinet: addictive Medications in pill users, emergency medicine cabinet is to stay a private box or drawer, cabinets have tags for sure. The number, types of addictive drugs to online medicine cabinet in emergency medicine cabinet, the head of the basis stipulated in writing.
 
Chapter IV, PROCEDURES of PLAN, PURCHASE, SALE, IMPORT and EXPORT of 18 Thing. Plan 1. Every year, the base business, addictive drug use must set the planned purchase of addictive drugs (10). Provision was made in 4 copies (browse the scheduled save 2 a, unit stored 01, save 1 a).
2. business establishments, addictive drug use are only allowed to buy, sell, give, addictive drug use when there is a plan has been approved under the provisions of article 19 of this circular.
3. The head of the facility responsible for the addictive drug amount planned, the number of addictive drugs must match the needs of the facility; When the planned number of addictive drugs in excess of 50% compared with the amount used before: the base plan must explain the reason;
Case number addictive drugs purchased under the plan does not meet all the needs, the base can gathered supplement and explain the reason.
4. Within 7 working days from the receipt of a valid plan, plan review agency would consider approving a plan or have the written reply, stating the reason not be approved.
Article 19. Browse planned 1. The Ministry of health (pharmaceutical Management Bureau):

a) Browse planned addictive material for drug production facilities, medical facilities, research facilities, specialized medical training facility-pharmacy;
b) browse the drug addictive products planned for the basis of the provisions of article 13 paragraph 1 of this circular;
c) browse the addictive drug provision for facilities not subject to the medical industry, but management needs to purchase addictive drugs to scientific research. When making a plan, the facility must submit the text explains the reason and was the head of Agency Service, Department or over direct management functions;
d.) browsing the drug addictive products planned for the Army Medical Department-the Department of Defense.
2. the Department of health, the central cities browse planned smoking addictive products for wholesale, retail establishments, medical facilities, research facilities, specialized medical training facility-medicine, Detox Center. Depending on the locality, the Department of health can be decentralized, authorization for medical districts, town or district health centre, district, town (if the professional Pharmacy staff) browse planned smoking addictive products to clinics communes, wards and towns.
3. Military Bureau-Ministry of Defense of browser products addictive drugs intended for hospitals, subdivisions of Ministry of Defense. 
4. The Dean treatment, clinic Chief signed the addictive drug chiefs votes for the Faculty's room (9). The Dean of Pharmacy signed slips addictive drug for the field of pharmacy.
Article 20. Profile, export licensing procedures, imported 1. Profile, export licensing procedures, import the addictive drug made under the provisions of circulars, export-import operations and packaging in direct contact with the current drugs of the Ministry of health.
2. the export licence, import of raw materials, finished product addictive addictive yellow issued to each importing, exporting and valuable in the dark period đa01 years from the date of signing.
3. the export and import permits are sent to business please import, export; Permanent Office in Vietnam drug prevention, the Bureau of customs gate where the procedures for export and import; The Ministry of finance; Delegation to the International Narcotics Control Board; Water management agency of imported (for export licenses).
4. Raw materials, finished products addictive drugs are only allowed to export and import through the international border gate of Vietnam.
 
Chapter V INSPECTION-CHECK-handling VIOLATION of article 21. Test, inspection 1. Drug Administration, Ministry of health inspectors inspect, inspect the implementation of this circular by the authority for the Organization, individuals involved in activities related to addictive drugs on the territory of Vietnam.
2. The Department of health of the province, the city of centrally responsible for checking, inspection of the implementation of this circular in its local range management.
Article 22. Handle violation of All violations of this circular, customize the level and nature of the violation will be administrative sanctions or suspension, revocation of license or arrested save for criminal liability in accordance with the law.
 
Chapter VI Article 23 ENFORCEMENT TERMS. Implementation for the pharmacy business in clause 5 article 13 of this circular, if not enough pharmacists College, head of the authoritative basis for writing high pharmacists replace (each authorization not more than 6 months) retail drug addictive products to most of the time required to deploy the application of the principle of standard, "pharmacy practice" pursuant to the Ministry of health.
Article 24. Effective 1. This circular have enforceable after 45 days from the date of signing. Annuls decision No 2033/1999/QD-BYT on 09/7/1999 of the Minister of health on issuing regulations smoking addictive, addictive drug list and drug addictive in the form of coordination and decision No. 1442/2002/QD-BYT on 25/4/2002 of the Minister of health on the revision , the addition of some articles of the Statute the addictive drug management issued together with decision No. 2033/1999/QD-BYT on 09/7/1999 of the Minister of health.
2. Drug Administration, Ministry of health, the Health Department of the province, central cities, Vietnam Pharmaceutical Corporation; individual organizations have activities related to addictive drugs and the institutions, foreign individuals provide addictive drugs into Vietnam; medical institutions, research facilities, training medical-pharmacy is responsible for implementation of this circular.
In the process, if there are difficulties, obstacles and suggest the Unit reports to the Ministry of health (pharmaceutical Management Bureau) to consider and resolve.