Circulars related to activities of mental direction and precursor drugs used for smoking 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 mental direction, drug precursors used in drug use in Vietnam.
Chapter I GENERAL RULES article 1. Scope 1. This circular guides the activities of drug-related mental direction, amount of substance use as drugs (precursors) used in the medical field and in the analysis, testing, scientific research provisions of drug mental direction (annex I, Appendix III), the list used precursor (Appendix II , Appendix IV) attached to this circular.
2. Smoking finished products include many of the active ingredients in the formula contains active ingredients of mental direction, in collaboration with the precursors of other active substances (not that addictive drugs, mental direction, precursors) are the active ingredient content of mental direction, equal or smaller precursor concentrations specified in the formulary as a mental coordinate direction (annex III) and the category of drug use as a precursor in the form Coordination (annex IV) are free to make some terms of this circular except for the following provisions: 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 mental direction, drug precursors in the medical field and in the analysis, testing, scientific research in Vietnam.
Article 3. Prescribe The medication of mental direction and precursor 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. When forwarding warehouses, warehousing mental direction, drug precursors: 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: mental direction, Drug precursors should 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 mental direction, drug precursors text must be delivered to the people of his facility is responsible for transporting the drug to mental direction, money; Who is responsible for shipping the drug to mental direction, precursor to the aforesaid documents, demonstrate people's mail (or identification), sales invoice or inventory manufacturing votes; responsible for the quality of medicines in terms of perception, the number, types of mental direction, drug precursors during transportation and delivery of full responsibility for keeping a mental direction, drug precursors.
3. in case of a business establishment mental direction, drug precursors need to hire to transport the drug to mental direction, money. Hire and transport side side to sign a contract in writing, which stated the conditions regarding the preservation, transportation, mental direction drug precursors as specified. Side transport must meet the condition that during carriage; ensure the drugs were not losses.
Parties and party rental, transport must take responsibility for problems related to mental direction, drug precursors in the shipping process.
Article 7. The report 1. Report export/import: a) mental direction, Drug precursors: slow for ten days after export, import of mental direction, drug precursors report export base (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 finished products mental direction, precursor form of coordination provided for in clause 2 1 of this circular Thing: each year, the facility must 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, using mental direction, drug precursors: is inventory, inventory, report, reports, report, 6 in (model No. 3A, model No. 3B) and sent to the plan review agency, import-export license; the report was submitted on 15 months later was the slowest (if reported), on 15 July (if the report is the first 6) or September 15, 1 year later (if reported);
b) the Department of health of the province, central cities: report the situation of drug use mental direction, precursor of the local basis (model No. 4); Army Medical Department-the Department of Defense reported the situation of drug use mental direction, her industry's annual precursors (3A) to the Ministry of health (pharmaceutical Management Bureau); the report to be submitted at the latest on Jan. 30 is next year.
3. irregular reports: The business establishments, using mental direction and precursor drugs must report to an emergency 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 Health Department of the province, the city of centrally gathering and an emergency report to the Ministry of health (pharmaceutical Management Bureau).
Article 8. Retention of records, books 1. The business establishment, dispensing medications, mental direction and precursor to record, track and store the documents related to the mental orientation materials and finished products, drug precursors mental direction, after the expired drugs precursors 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 mental direction and drug precursor expired user, poor quality, out of time to save the form, the drug received from the Faculty of medicine, 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. Petition to cancel the drug must specify the name of the drug, the concentration-, number, reason please cancel, the Cancel method. Canceling the drug only after the plan review agency approvals;
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 after cancel and save at the facility;
d) after canceling, must send the report smoking up the browse agency plan (attached to the minutes cancel smoking);
2. The type of residue, scrap in the production process of mental direction, drug precursors should 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 smoking mental direction, precursors do not use again to gather and destroy as specified in point b and point c of paragraph 1 of this Article.
4. Canceling mental direction and drug precursors are separate from other medications. Canceling the drug 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, use mental direction, drug precursors in the basis of research, training of specialized medicine-medicine.
1. The basis of research, training of specialized medicine-medicine is concocted, using mental direction, precursor to serve teaching and scientific research; must have supervisory and University pharmacist responsible for processing book recording mode, the number of entry and reporting as prescribed in this circular.
2. Smoking mental direction and finish blending precursors must be packaged, labelled to avoid confusion. The label must have at least the following information: name, name of medication, the concentration, the amount (volume), the pha, the supervisor, on blending.
3. mental direction and precursor Drugs must be stored in separate cabinets, have the equipment, measures to ensure safety, against losses.
Chapter II BUSINESS SMOKING MENTAL DIRECTION and SUBSTANCE to article 11. General principles 1. The basis of the production, export, import, wholesale, retail, money-oriented drug substance must meet the conditions prescribed medications Business Law Chapter II and chapter IV of the Government Decree No. 79/2006/ND-CP dated 9/8/2006 detailing the implementation of some articles of the law and in compliance with the provisions of this circular.
2. The base business smoking mental direction, precursor to build and follow the standard operation procedures (SOP) as text for all professional activities to suit every type of business to all employees apply, minimum must have the following: a) the export process buy, sell, import, mental direction and drug precursors;
b) preservation process medications mental direction and precursors;

c) delivery processes, drug transportation, money-oriented;
d) cancellation process mental direction, drug precursors (raw mental direction, product direction, drug precursors, precursor, residual products, scrap, packaging directly).
The construction of the SOP should meet the following rules:-the safety, not loss of mental direction, drug precursors used;
-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 the personnel involved in the drug business mental direction, precursor to initial training and continuous training on the legal text and the standard operation procedures related to mental direction and precursor drugs used as medicines; 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 which the repository to preserve mental direction, drug precursors must have tags for sure, there are measures to ensure safety, not for losses. If no private repository then smoking mental direction, the precursor 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 mental direction, drug precursors.
2. The basis of the production of the drug precursors, mental direction 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: a pharmacist or pharmacist authorized secondary (heads of units authorized in writing, each authorization not more than 12 months);
-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:-Window dispensing mental direction, drug precursors (model No. 5);
-Import export as mental direction, drug precursors (model No. 6A);
-Drug product manufacturing as mental direction, precursor form of coordination prescribed in clause 2 1 of this circular (model No. 6B);
-Slip the output direction mental, drug precursors (model No. 7);
3. scope of operation of the production facilities of mental direction, drug precursors: a) to buy, import mental direction, precursor to the production of drugs containing the active ingredient of mental direction, the main precursor of his business;
b) export the drug to mental direction, the main precursor of his business;
c) Sold the drug to mental direction, products produced precursors for the base specified in article 13 paragraph 1 of this circular.
4. When material needs mental direction and money to study the production of new items subscription circulation, production facilities must have a single proposal to buy/import mental direction and precursors (model No. 8A); and the report details the number of mental direction materials, precursors 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 of mental direction , the precursor for the base business, use in the country.
2. Hr: storekeepers to be a pharmacist or pharmacist authorized secondary (heads of units authorized in writing, each authorization not more than 12 months).
3. Records, books: a) the tracking Window appears, enter a mental direction, drug precursors (model No. 6A);
b) drug output Votes mental direction, precursor (model No. 7);
c) The documents relating to the export, import, purchase and sale of the drug precursors, mental direction.
4. scope of activities: a) the export and import of raw materials and finished products of mental direction, drug precursors;
b) Buy the drug product direction, precursor of the production facility;
c) Sold the drug to mental direction drug products, precursors to wholesale establishments, retail establishments addictive drugs, medical facility, facility for research, training of specialized medicine-medicine, Detox centres in the country;
d) drug material mental direction, precursors for the base allowed the production, blending the mental direction, drug precursors.
5. the pharmaceutical companies, the central cities (including State enterprises and State-owned enterprises after privatization) are buying the products of mental direction, drug precursors from the pharmaceutical company to the provisions in clause 1 of this Article to provide for medical institutions , research facilities, training of health professions-medicine, Detox Center.
6. A pharmacist or pharmacist authorized secondary (heads of units authorized in writing, each authorization not more than 12 months) wholesale direct Mental direction, drug precursors.
Article 14. Retail 1. Pharmacy,.
a) good practice standard pharmacy (GPP);
b) pharmacist University of Pharmacy owner or secondary owner pharmacists direct drug counters retail management and mental direction, drug precursors;
c) preserving mental direction: drugs, precursors must be preserved in private cabinets have tags for sure, there are measures to ensure safety, not for losses;
If the number of mental direction and precursor drugs less, can do the same with addictive drugs Cabinet but to prevent, avoid confusion; There are tags for sure, there are measures to ensure safety, not for losses;
d) records, the books: as drug import export-oriented products, precursors (model No. 6A); Export mental direction drug warehouse voucher, the precursor of the place offers smoking;
DD) operating range:-buy medication mental direction products, retail and precursors as defined in the regulations prescribe drugs in outpatient treatment;
-Do not buy, sell, money-oriented materials;
2. sell the drug dealer's business, medical stations, social medicine cabinet: a) the base material: Countertop, cabinets must have tags for sure; The mental substance, money driven medicine must be arranged in position ensures safe, avoid confusion;
b) records, the books: as drug import export-oriented products, precursors (model No. 6A);
c) operating range:-resellers of enterprise sold the drug to mental direction, drug precursors essential Vietnam;
-Pill clinics commune sold the drug to mental direction, drug precursors essential for the social health essential medicines list in Vietnam;
Chapter III the BLENDING, ALLOCATE, USE, PRESERVE MENTAL DIRECTION, DRUG PRECURSORS in the medical DETOX CENTER, article 15. Blending.
1. Medical consultation function, cure drug dispensing functions of mental direction, precursor to the layout processing areas meet 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:-supervisors and responsible reporting, record mode, check the quality of the drug after mixing: pharmacists;
-People keep smoking mental direction, precursor after blending: pharmacist high school;
c) packaging, labelling, storage:-Smoking mental direction, finishing processing precursors 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;
-Mental direction, Drug precursors must be preserved in private cabinets: measures, equipment to ensure safety, loss prevention;
d) records, the books:-Window dispensing mental direction, drug precursors (model No. 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 dispensing drugs.
2. scope of activities: a) the drug dispensing only 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 medicine mental direction, precursor to the Faculty of the treatment according to the votes the field direction, drug precursors (model No. 9) and medications directly to patients outpatient treatment. Dean of Faculty of pharmacy or pharmacist University was the Dean of the pharmacy with a written authorization signed the slip direction of mental medicine field, the precursor of the 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.
Smoking mental direction, the precursor legacy by not used up either due to death or transfer patients, Faculty of treatment to make paper return pharmacy. Dean of Faculty of pharmacy the specific situation to base the decision to reuse or discard as required and set the minutes stored in the pharmacy.
Faculty of Pharmacy must monitor and record the amount of mental direction, drug precursor inventory, import export (model No. 6A) 2. For online medicine cabinet, medicine cabinet in emergency departments in the medical establishment have used mental direction, drug precursors by 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: middle school back-up pharmacist is responsible for receiving, managing medications, mental direction, money.
Article 17. Preservation preservation of mental direction, drug precursors in the Faculty of Pharmacy:

a) infrastructure: mental direction, Drug precursors must be preserved in the repository in compliance with the rules of good practice to preserve the drugs; Warehouse storage cabinets, mental direction, key precursors for sure, be equipped to ensure the security, against losses. If there is no repository, cabinets, mental direction, drug precursors may be to the same repository, cabinets with addictive drugs but must arrange separately to avoid confusion.
b) store keeper: pharmacist in middle school and up.
2. Preserving mental direction, precursor drugs in pill users, emergency medicine cabinet: mental direction, precursor Drugs in pill users, emergency medicine cabinet is to stay a private box or drawer, cabinets have tags for sure. The number, types of smoking mental direction, the precursor to online medicine cabinet in emergency medicine cabinet, led by the head of the basis stipulated in writing.
Chapter IV, PROCEDURES of PLAN, PURCHASE, SALE, IMPORT and EXPORT of 18 Thing. Planned.
1. Every year, the base business, using mental direction, precursor to establish planned buy of mental direction, drug precursors (model 10). Provision was made in 4 copies (browse the scheduled save 2 a, hold unit 1 a, 1 a).
2. The base business, using mental direction, drug precursors are only allowed to buy, sell, give, use smoking mental direction, when the precursors have planned has been approved according to the provisions of article 19 of this circular.
3. The head of the facility responsible for the number of mental direction, drug precursors scheduled, the number of mental direction and drug precursors should match the needs of the unit; When the planned number of mental direction and precursor drugs in excess of 50% compared with the amount used before: the base plan must explain the reason.
Number of cases of mental direction, precursor drugs purchased under the plan does not meet all the requirements, 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 mental orientation materials, precursors for drug manufacturing facility, medical facility, facility for research, training of specialized medicine-medicine, Detox Center.
b) Browse planned mental direction products, drug precursors for the base specified in article 13 paragraph 1 of this circular.
c) Browse planned mental direction, drug precursors for the base not in health sector management but need buy pills mental direction and money to scientific research. When making a plan, the facility must submit the text explains the reason and was the head of the Agency, the Bureau of management functions back up directly to confirm.
d.) Browsing planned mental direction products and drug precursors for the Army Medical Department-the Department of Defense.
2. the Department of health, the city of centrally planned medicine product browsing mental direction, precursor to the wholesale, retail establishments, medical facilities, research facilities, specialized medical training facility-medicine, Detox Center. Depending on the local health department can decentralization, delegated to the medical Room, districts, town or district health centre, district, town (if the professional Pharmacy staff) browse planned mental direction products drug, precursor to the clinics communes, wards and towns.
3. Military Bureau-Ministry of Defense of the drug plan product browsing mental direction and the money for the hospital, subdivisions of Ministry of Defense. 
4. The Dean treatment, clinic Chief signed the voucher field of mental direction and drug precursors for the Faculty's room (9). The Dean of Pharmacy signed mental direction and drug sectors Votes money for quality of Faculty of pharmacy.
Article 20. Profile, export procedures, imported 1. Profile, export-import procedures of drugs and precursors mental direction made under the provisions of circulars export activities import drugs and packaging in direct contact with the current drugs of the Ministry of health.
2. the export and import permits smoking mental direction blue and pink precursors is provided for each of the imports, exports and value within a maximum of 1 year 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 mental direction and drug precursors 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 mental direction and precursor 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. The route made the drugstore counter, smoking continues to be buying, selling the drug to mental direction, precursor route required the deployment of the application of the standard rules, "pharmacy practice" pursuant to the Ministry of health.
Article 24. Effect 1. This circular has the effect after 45 days from the date of signing. Annul the decision No 3401/2001/QD-BYT on 12/7/2001 of the Minister of health on issuing regulations smoking mental direction, mental direction, drug precursors used in drug and formulary mental direction, precursor used in the form of coordination; Decision No 1357/2002/QD-BYT on 25/4/2002 of the Minister of health about the amendments and supplements to some articles of the regulations smoking mental direction attached to decision No 3401/2001/QD-BYT on 12/7/2001 of the Minister of health; Decision No 71/2004/QD-BYT on 09/01/2004 of the Minister of health about the amendments and supplements some substances on the list of drugs, mental direction of precursor regulations smoking mental direction attached to decision No 3401/2001/QD-BYT on 12/7/2001 of the Minister of health.
2. Drug Administration, Ministry of health, the Health Department of the province, central cities, Vietnam Pharmaceutical Corporation; the organizations and individuals who have drug-related activities, and money-oriented organizations, foreign individuals providing mental direction, drug precursors 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.