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Circular 19/2014/tt-Byt: Addictive Medication Management Rules, Mental Direction And Drug Precursors Used

Original Language Title: Thông tư 19/2014/TT-BYT: Quy định quản lý thuốc gây nghiện, thuốc hướng tâm thần và tiền chất dùng làm thuốc

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MINISTRY OF HEALTH
Number: 19 /2014/TT-BYT
THE SOCIALIST REPUBLIC OF VIETNAM.
Independence-Freedom-Happiness
Hanoi, June 2, 2014

IT ' S SMART

The regulation of drug management, mental medication, and prescriptions for drugs.

____________________________

Pharmacy Law No. 34 /2005-QH-11 June 14, 2005;

Department of Laws, Anti-narcotics. 23 /2000/QH10 December 19, 2000 and the Amendment Law, which complements some of the Laws, Anti-Drug Law 16 /2008/QH12 June 3, 2008;

Base of Protocol 79 /2006/NĐ-CP August 9, 2006 of the Government Regulation Law enforcement of certain provisions of the Law of Pharmacy;

Base of Protocol 89 /2012/NĐ-CP October 24, 2012 by the Government amended, adding some of the provisions of the Digital Protocol. 79 /2006/NĐ-CP August 9, 2006, the Government rules out certain provisions of the Law of Pharmacy.

Base of Protocol 80 /2001/NĐ-CP November 5, 2001 The government guidelines for the control of drug-related legal activities in the country;

Base of Protocol 58 /2003/NĐ-CP May 19, 2003 The government provides for import control, export, transportation of the territory of Vietnam, drug, drug, drug, drug, drug, and drug abuse;

Base of Protocol 82 /2013/NĐ-CP July 19, 2013 of the Government on the Board of Drug and Precursor Categories;

Base of Protocol 63 /2012/NĐ-CP August 31, 2012 of the Government regulates the mandate function, the powers and the organizational structure of the Ministry of Health;

On the recommendation of the Director of the Department of Pharmacology Oh,

Minister of Health, Department of Health, Department of Health Management Drugs, psychos, and prescriptions for drugs.

Chapter I

COMMON RULES

What? 1. The tuning range and subject apply

This information regulates activities related to drug-induced drugs, mental medication, prescriptions for drugs and drugs into a combination of drugs, a combination of psychoactive drugs, drugs, drugs, and drugs. The form of coordination is used in the medical field and in the analysis, examination, scientific research of the institutions, organizations, domestic and foreign individuals.

What? 2. Explain the word

In this Information, the words below are understood as follows:

1. Narcotics. include:

a) The material that contains the chemical activity prescribed at Appendix I is accompanied by this message.

b) Sell the product that contains the activity that causes addiction to the Appendix I issued with this message.

c) The product medication contains a prescribed addiction in Annex I at every concentration, content.

d) The drug-containing drug that is associated with other activity in which the concentration, the concentration of addiction that is greater than the concentration, the prescribed content at Appendix II is accompanied by this message.

Drug-based drugs have a combination of addiction to other addicants; or drugs that contain addiction to mental health; or drugs that contain substance-based addiction to prescriptions. use as a medication; or drugs that contain substance-based addiction to mental health and prescriptions for drugs in which addiction, mental physical activity, prescriptions for drugs at all levels, content.

2. It's a drug addict. It ' s the prescribed medicine at points c, d, and this.

3. Mixed-form drugs that contain addictative activity. is the medication that meets the following conditions:

a) There are properties that are not active, not mental, and are not prescriptions for drugs;

b) There is an addiction activity; or whether to contain addiction in coordination with mental activity; or whether to contain addiction in coordination with prescriptions for drugs; or whether to contain addiction activity in coordination with mental and mental physical activity. The money used to be medicine.

c) (c) concentration, concentration of addicants, mental physical activity, prescriptions for the medication are smaller or equal to concentration, the prescribed content at Annex II, IV and VI issued with this message.

4. Psychos. include:

a) The material that contains the prescribed psychiatric activity at Appendix III is accompanied by this message.

b) Sell the product that contains the prescribed psychiatric activity at Annex III issued by this message.

c) The medication that contains the prescribed mental activity at Annex III is accompanied by this message at every concentration, content.

d) A product that contains a mental-oriented activity in coordination with other activity in which the concentration, the concentration of mental functions greater than the concentration, the prescribed content at Annex IV is accompanied by this message.

Drug-driven food drugs in coordination with other mental-oriented activities; or drugs that contain mental inactivity in coordination with prescriptions for drugs in which mental health, prescriptions for drugs. Every concentration, concentration.

5. I You're a psycho. is the prescribed medicine at points c, d, and this Article 4.

6. It's a coordinated form of psychoactive ingredients. is the medication that meets the following conditions:

a) There are properties that are not active, not mental, and are not prescriptions for drugs;

b) There is a mental-oriented activity or that contains a mental-oriented activity in coordination with the prescriptions for the medication;

c) The concentration, the concentration of mental-oriented activities, the prescriptions for the medication are either smaller or equal, the amount of regulation at Annex IV and VI is accompanied by this message.

7. Prescriptions for medicine include:

a) The raw material contains prescriptions for the prescribed medications at Annex V issued by this message.

b) Sell the product containing prescriptions as the prescribed medicine at Annex V issued by this message.

c) The product medication contains prescriptions as the prescribed medication at Annex V issued by this message at every concentration, content.

d) A product medication containing prescriptions for drugs in which the concentration is in the concentration, the amount of prescriptions for the medication is greater than the concentration, the prescribed content at Appendix VI is accompanied by this message.

Drug products contain prescriptions for drugs in combination with prescriptions for drugs at all levels, content.

8. Prescriptions for prescriptions. is the prescribed medicine at points c, d and clause 7 This.

9. Mixed-form drugs containing prescriptions is the medication that meets the following conditions:

a) There are properties that are not active, not mental, and are not prescriptions for drugs;

b) There are prescriptions for the medication in concentration, lower levels, or in concentration, the amount of regulation at the Appendix VI accompanied by this message.

Chapter II

DRUG BUSINESS

What? 3. Common Principles

1. Production facilities, exports, imports, wholesalers, retail, service supply facilities associated with drug-related drugs, mental health, prescriptions for drug-making and drug-based combined-form drugs, drug-based mixer drugs Containing the mental-oriented activity, the combined form of the form of a compound containing prescriptions must meet the prescribed drug conditions at Chapter II of the Law and Chapter IV of the Fourth Protocol. 79 /2006/NĐ-CP August 9, 2006 the Government and Decree No. 89 /2012/NĐ-CP October 24, 2012 by the Government amended, adding some of the provisions of the Digital Protocol. 79 /2006/NĐ-CP August 9, 2006, the government rules out certain provisions of the Law and regulations.

2. Production facilities, exports, imports, wholesalers, service supply facilities associated with drug-related drugs, mental medicines, prescriptions for the drug to build and execute on the standard action (SOP) processes on drug-based drugs, drugs and drugs. Mental, precurative use as a medication to manage export, importing, buying, selling, preserving, delivering, transporting, canceling. The construction of the SOP must ensure safety, not to be lost; it is required to have a bookkeeping, to be signed to determine the responsibility of each individual in each of the tasks.

3. Production facilities, exports, imports, wholesalers, service supply facilities related to the drug-based combination of drugs, drugs into a coordinated form of psychoactive ingredients, drugs into a coordinated form. contains the precursor to the standard operation processes in accordance with Article 2 of this. These SOPs can be written separately or together with SOP of other drugs.

4. Individuals who participate in the drug-drug business, psychos, prescriptions for drugs and drugs into a combination of drugs, drugs into a coordinated form of psychoactive ingredients, drug-driven food drugs. The pre-training with the initial training, updates on the laws that violate the law and the relevant standard action procedures; the training record must be kept at the facility.

What? 4. Production

1. The facility is being allowed to produce drug-based drugs, psychiatric and drug-based prescriptions that continue to produce drug-based drugs, mental health and prescriptions for drugs.

Prior to November 30 each year, the facilities had a need for the production of drug-induced drugs, mental health, and prescriptions for the Department of Health. The Department of Pharmacology-The Ministry of Health of the Practical Situation to enact the amendment, adds a list of facilities that are allowed to produce drug-based drugs, psychos, prescriptions for drugs.

2. The basis of drug-induced drug production, mental health, prescriptions for drugs must comply with the following regulations:

a) Achieving Good Practice Of Drug Production (GMP) in accordance with individual form of cells for at least 2 years;

b) Human Resources:

-The drug prescriptions for drug addiction must graduate from the university and have a full-time apprentication period of at least 02 years or more at the drug production facility.

-The head of a mental health care warehouse, the precurative prescriptions to the university of pharmacy or high school are authorized (the head of the governing body in writing, the mandate time every 12 months).

-The key employee is responsible for the recording regime, which has to graduate from the University of Pharmacology at least 02 years or more at the drug production facility;

c) Profile, book book: The basis of the production of drugs, the mental health, the prescriptions for the medicine to be created and fully documented the following types of tracking:

-Drug-induced drug preparation, mental health, prescriptions for the prescribed medicine at sample 01 issued by this message;

-The surveillance book, drug addiction, mental health, the prescriptions for the prescribed medicine at the number 02 sample issued by this information;

-Drug-induced drug stockpile, mental health, prescriptions for the prescribed medicine at the third sample issued by this message;

3. The basis of a combination of a combination of compounds containing an addiction, a combination of a combination of psychoactive ingredients, a form of coordination, a combination of a substance that contains the right to comply with the following regulations:

a) Achieving Good Practice Of Drug Production (GMP) in accordance with individual form of cells for at least 2 years;

b) Human Resources:

-The keeper of the repository, sold a drug-based product that had to graduate from the university at least 02 years or more at the drug production facility.

-The librarian of the material, which sells products that contain mental, raw materials, sells products that contain money to be graduated from the university of pharmacy or high school pharmacy, which is authorized (the head of the authority in writing, time of commission). It's not over 12 months.

-The key employee is responsible for the recording regime, which is reported to have graduated from the university at least 02 years or more at the drug production facility.

c) Profile, book book: The basis of a combination of drugs into a combination of drugs, drugs into a combination of psychoactive ingredients, a combination of psychoactive drugs containing prescriptions for full record of entry tracking, It is a combination of drug-based, drug-based, drug-oriented, mixed-form drugs that contain pre-denominated, four-issued materials.

4. The basis of drug-based drug production, mental health, prescriptions for drug use:

a) Buy, import raw materials, sell products that contain addiction; raw materials, sell products that contain mental inactivity; raw materials, sell products containing prescriptions to produce their own medicine;

b) Export drug-induced drug, mental health, prescriptions for the medicine of its own production facility;

c) Sell the drug to addiction, psychotherapy, the precursor to the basis of its own production facilities for the prescribed facilities at 1 Article 5.

5. The basis of a combination of drug products containing a combination of drugs, drugs into a combination of psychoactive ingredients, drugs into a combination of compounds containing prescriptions:

a) Buy, import raw materials, sell products that contain addiction; raw materials, sell products that contain mental inactivity; raw materials, sell products containing prescriptions to produce their own medicine;

b) Export the drug into a coordinated form of substance-based addiction, a combination of the form of a coordinated psychoactive substance, a medication into a combination of prescriptions;

c) Direct selling of a coordinated form of a combination of drugs, drugs into a combination of psychoactive ingredients, a combination of a combination of drugs, a combination of drugs, a combination of the facilities that you produce for your facilities, to treat diseases, to cure diseases, homes. Drugs that reach the principle of good practice of pharmacy practice (GPP) within the country;

d) Sell the drug into a coordinated form containing an addiction, a combination of a combination of psychoactive ingredients, a combination of drugs, a combination of a drug dealer, a drug trafficking facility with a certificate of experience. drug sales on the site of a province for sale to medical, healing facilities, pharmologists have the principle of good practice of pharmacy (GPP) on that province.

6. When there is a need to buy, import raw materials containing substance abuse, raw materials that contain mental activity, the material that contains the precursor to the study of newly registered items of circulation, the facility must have a proposed implementation by the regulatory process. at the sample number 05, issued by this message, and it was reported to detail the amount of raw materials used to study, the production of the trials is now prescribed at the 6th model issued by this message.

What? 5. Export, Import

1. The business is responsible for export, import and supply of drug-based drugs, mental medicines, prescriptions for business facilities, drug use in the country prescribed at Appendix VII accompanied by this Smart.

Prior to November 30, the business had a need for export, importing drugs, mental health, and prescriptions for the Department of Health. The Department of Pharmacology-Health review, report proposes to the Leader of the Department. Based on the practical situation, the Department of Pharmacology-the Department of Health has enacted amendments, adds a list of businesses that are allowed to export, import drug-based drugs, mental medicines, prescriptions for drugs to supply business facilities, use them. in the whole country.

2. Sales of the export, import of drug-induced drug, mental health, prescriptions for the medication must comply with the following regulations:

a) Human Resources: The Treasurer must graduate from the university of medicine for a period of at least 02 years or more at the base of production, drug business.

b) Profile, book book: export business, drug import, mental health, prescriptions for the drugs, and records of the following:

-The surveillance book, drug addiction, mental health, the prescriptions for the prescribed medicine at the sample number 02, issued by this message;

-Drug-induced drug stockpile, mental health, prescriptions for the prescribed medicine at the third sample issued by this message;

-The evidence involves exporting, importing, drug-smoking, psychos, prescriptions for drugs.

3. Sales of export, drug importation, mental health and prescriptions as the prescribed medicine at paragraph 1 This is:

a) Export, importing drug-induced drugs, mental health, prescriptions for drugs;

b) Buy drugs, psychotherapy, prescriptions for drugs, drugs into a combination of drugs, a combination of psychoactive drugs, a combination of psychoactive ingredients, a combination of drugs, a combination of drugs. manufacturing facilities;

c) Sell drugs to addiction, psychotherapy drugs, precurative medicines for the wholesale facilities prescribed at 1 Article 6 This information, the pharmacy stipulated at a Article 7 of this Information, the basis of the disease, the treatment, the research facility. Saving, testing, the education center-the society, the drug addiction treatment facility, the drug-intensive training facility in the country.

d) Sell the raw materials, sell products that contain addiction; raw materials, sell products that contain mental inactivity; raw materials, sell products that contain prescriptions for the facilities allowed to produce, drug-induced drug preparation, mental medicines, The prescriptions for the drug.

Only directly imported, unpurchased, drug-driven, mental and prescriptions for the export business, importing drugs. The case does not provide enough drugs for the sick, the export business, the import must report the Department of Pharmacology-the Ministry of Health to review the settlement.

4. The facility meets the prescribed drug business conditions at Chapter II of the Law of Pharmacy, Chapter IV Digital Protocol 79 /2006/NĐ-CP August 9, 2006 the Government and Decree No. 89 /2012/NĐ-CP October 24, 2012 by the Government amended, adding some of the provisions of the Digital Protocol. 79 /2006/NĐ-CP August 9, 2006 The government regulates the implementation of some of the provisions of the Imported Drug Law, importing drugs into a coordinated form of substance abuse, a combination of psychoactive drugs containing psychoactive drugs, drugs, and drugs. The form of coordination contains the precursor; it must be established and fully documented the following records:

a) Import by import, exporting the drug into a coordinated form of a substance that contains an addiction, a combination of a combination of psychoactive ingredients, a form of coordination, a form of coordination containing the preexisting substance prescribed by the order of the number 04. It ' s an attachment to this.

b) Evidence related to the export, import, purchase of a combination of drugs into a combination of substance abuse, drugs into a coordinated form of psychoactive substance, and a combination of substance-containing compounds.

5. Sales of the export, importing drugs only to be sold directly to a coordinated form of a combination of drugs, drugs into a coordinated form of psychoactive ingredients, drugs into a combination of compounds that contain prescriptions for:

a) The basis of the disease, healing, the pharmacy to GPP within the country;

b) A drug trafficking facility with a Certificate in Certificate of Drug Business on the site of a province for sale to the facilities of the disease, healing, the pharmacy that reaches the GPP on that province.

What? 6. Sell

1. The pharmaceutical business in the province, the central city of the Central City that is offering drug-based drugs, mental health care drugs, prescriptions to prescriptions for drug-driven drug addiction, mental health care, The drug products from businesses that are regulated at one Article 5 of this is to supply the province.

In the case of the provincial pharmaceutical enterprise, the Central City of China does not provide enough drugs for medical examination facilities, healing on the site, the Provincial Health Department, the Central Municipal City responsible for reporting the Department of Pharmacology-the Ministry of Health for designation. It ' s a drug-selling business that ' s certified enough drugs to provide drug-based drugs, mental health, drug products, prescriptions to prescriptions.

2. Corporate regulation at paragraph 1 This must comply with the following regulations:

a) Human Resources: Treasurer must graduate from the university of pharmacy and have an apprenticing time of at least 02 years or more at the production company, drug business.

b) Records, bookbooks:

-The surveillance book, drug addiction, mental health, the prescriptions for the prescribed medicine at the sample number 02, issued by this message;

-Drug-induced drug stockpile, mental health, prescriptions for the prescribed medicine at the third sample issued by this message;

-The evidence involves exporting, importing, drug-smoking, psychos, prescriptions for drugs.

3. Enterprise rules on this one thing:

a) Buy drugs for addiction, psychotherapy, prescriptions for export businesses, importing the prescribed drugs at one Article 5 of this.

b) Sell drugs to addiction, mental health therapy, precurative prescriptions to GPP medicines in paragraph 1 Article 7 This information, medical examination, treatment, research facility, testing, education center-labor-society The facility, the drug-addicted drug treatment facility, is an intensive training facility in the province.

4. The facility meets the prescribed drug business conditions at Chapter II of the Law of Pharmacy, Chapter IV Digital Protocol 79 /2006/NĐ-CP August 9, 2006 the Government and Decree No. 89 /2012/NĐ-CP October 24, 2012 by the Government amended, adding some of the provisions of the Digital Protocol. 79 /2006/NĐ-CP August 9, 2006 The government regulates the implementation of some of the provisions of the Drug Purchased, which sells drugs into a coordinated form of substance abuse, drugs into a combination of psychopharmaceuticals, drugs, and medications. coordination containing the precursor; must be set and fully documented the following records:

a) Handbook of ejacrotherapy, importing the drug into a coordinated form of substance, a combination of psychoactive ingredients, a combination of psychoactive ingredients, a combination of a combination that contains the preexisting substance at the order of the 04 issued. according to this message;

b) The evidence associated with the purchase of the sale of the drug into a combination of drug-containing compounds, a combination of the form of a coordinated form of psychoactive ingredient, the medication into a combination of prescriptions.

5. Sales of the drug sales into a combined form of substance abuse, drugs into a coordinated form of psychoactive ingredients, a combination of fluid-like compounds containing prescriptions in the province, inform the Department of Health, The city ' s central city, which is in the middle of the business that the facility is in business, has to announce it when there is a change and is only provided for the basis of the disease, the treatment, the pharmacy that reaches the GPP on that province.

What? 7. Retail

1. The pharmacy that reaches GPP is resold as a drug-induced drug-based drug, a precursor to mental health, prescriptions to prescriptions, drugs, and a combination of drug-based compounds, a combination of psychoactive ingredients, The form of a combination is a precursor to the outpatient.

Pharmologists have a drug-based drug organization that has to register with the Department of Health on the site and implement the regulation at this level.

2. The owner of the pharmacy, the specialized manager who must directly manage and retail the drug-based drug.

3. The high school pharmacist becomes the management and retail of mental health therapy, precurative medicine.

4. The prescribed drug at paragraph 1 This is bought into a drug-induced drug, drug-oriented drug, prefated drug, which is bought into a combination of drug-containing, mixed-form drugs containing a combination of drugs. It is a psychoactive drug that contains money from the export business, importing the prescribed drugs at 1 Article 5, the wholesale business is regulated at 1 Article 6 of this, and is retail by regulation.

For the coordinated form-form drugs that contain addiction, the medication into a coordinated form of psychoactive form, the medication into a combination form containing the prescriptions for the Department of Health is sold to the Ministry of Health. Sick people don't need to be prescribed. Each time the sale must record customer details.

5. The pharmacy is not bought, sold raw materials, sells products that contain addicing material; raw materials, selling products that contain mental inactivity; raw materials, selling products containing prescriptions.

6. Drug-based drug dealer, drug-oriented drug dealer, prescriptions for prescriptions and full records of the following types of records:

a) Handbook of ejacrotherapy, drug-induced drug addiction, mental health, prescriptions for the prescribed medications prescribed by the number 02 sample issued by this message;

b) The export of drug-induced drugs, mental health, prescriptions for the medicine of the supply site;

c) The prescription for addiction to the facility after sale;

d) The publication of the drug-induced drug was filed by the sick people.

The customer details the customer's detailed information on a 7-issue form issued by this message.

Chapter III

PRESCRIBATION, PREPARATION, INJECTION AND DRUG USE

What? 8.

1. The prescribation of the drug-induced drug, the psychotherapy and prescriptions for the outpatient to follow the provisions of the "Drug prescriptions process in outpatient treatment" issued by the Minister of Health.

2. The prescribation of the drug-induced drug, mental and drug-driven drug prescriptions for the inpatient to implement the regulation of "Medication Guidelines for Drug Use in Patient Bed Medical Facilities" issued by the Secretary of Health. Go.

3. Drugs in a coordinated form of substance that contains substance abuse, drugs into a combination of psychoactive ingredients and drugs into a combination of unprescribed medications sold to patients who do not need a prescription. according to the regulations at the "Catalogue of Prescription Drugs" issued by the Minister of Health.

4. Medication for a coordinated form of substance-based, drug-based combination drugs that contain mental and drug-oriented compounds that contain prescriptions that are not part of the "Prescription Drug Portfolio" issued by the Minister of Health. It ' s only used when a doctor ' s application has a certificate of medical treatment. The drug seller is only sold to the sick person when the doctor ' s application has a certificate of medical treatment.

What? 9. Bartender at the hospital.

1. The hospital has a drug-based drug-making drug, mental health therapy, prescriptions for prescriptions and drugs into a combination of drugs, a combination of psychoactive ingredients that contain psychoactive, successful drugs. The coordinated form containing the precursor to the phase area layout meets the following conditions:

a) The facility of matter:

-The bartender: there is anti-dust, background, and wall-like materials, when it is necessary to perform the cleaners. The room must be built in a clear, separate, safe place, far from the source of pollution. The minimum surface area is 10m2. The parts must be arranged in one dimension.

-There's a wash-up, a bartender.

-There are enough tools to fit the cooking, the preservation and testing of the drug.

b)

-The supervisor, responsible for the record, report, check out the quality of drugs after the bartender has to graduate from the university.

-The drug dealer who's addictions after the bartender's got to graduate from the university.

-The manager of the psychopharmaceutical, the precurative product after the preparation of high school medicine.

c) Close the package, paste the label, preserve:

-Drug-based, psychopytherapy drugs, drug-processed food drugs that have to be packaged, labeled right to avoid confusion. The label must have the following information: The base name, the drug name, the cytoplasm, the activity, the concentration or the content, the phagoer, the supervisor, the preparation day, the application of the drug.

Drugs, psychos, prescriptions for drugs must be preserved in the closet; there are measures, equipment to ensure safety, anti-escape.

d) Records, bookbooks:

-Drug-induced drug treatment, mental health, drug prescriptions (Form 1);

-The drug quality control test.

-Drug phase procedure.

-There must be internal, standard operation (SOP) in the drug phase.

2. Range of activity:

a) The bartender only sells, issued a prescription for the patient ' s inpatient and outpatient treatment of the facility;

b) Only the preparation of the formula with the formula, the preparation process, the quality standard is approved by the head of the facility and is responsible for the safety and effectiveness of the drug;

c) Do not phase out the injection.

What? 10. Phu, drug use at research facility, specialty training medicine-pharmacy

1. The research facility, which specializes in drug-intensive medicine, drug use, mental medication, prescriptions for drugs and drugs into a combination of addictions, drugs into a coordinated form of treatment. Psychopharmaceuticals, psychopharmaceuticals that contain prescriptions for teaching and scientific research; graduates of the pharmaceutical college supervising the preparation and responsible for the preparation of the preparation, tracking books, drug imports. Addiction, psychos, prescriptions for drugs and reports in accordance with this information.

2. Drug-based drug addiction, mental and drug-based drug products that have to be packaged, labeled, prescribed at the point of 1 Article 9 of this.

What? 11. Level and Use

1. Department of drug-grade medicine for therapeutic drug-based therapists, psychopharmaceuticals and prescriptions to prescriptions of the eight issued by this information and directly issuing drugs to the patients of treatment. I'm sorry

The Dean of the Faculty of Pharmacology or graduate of the university of Pharmacology is authorized by the dean of the drug-approved drug-based drug, drug-oriented drug, and prescriptions to the prescriptions of the treatment department; the drug vote. It ' s a drug-induced drug, a psychotherapy drug, a precursor to the drug ' s shift.

2. Head of the treatment department, head of the clinic for drug-drug, drug-driven drug, drug-based drugs, prescriptions for the department.

At the treatment department, after receiving medication from the pharmacy, nursing is assigned to the task of treating the drug name, concentration, concentration, quantity of pills before injection or giving it to the sick;

Drug-based drugs, psychotherapy and preterm prescriptions for not being used or caused by people with either hospital or death, the treatment must make a return to the pharmacy. The head of the department of pharmacy is specific to the decision to reuse or cancel the regulation and to compile a circulation at the pharmacy;

The drug must monitor and fully record the amount of drugs that are addictions, the psychopharmaceuticals, and the drugs of the precursor, entry, inventory, and existing inventory on the 02-issued model.

A drug management manager must graduate from the university of pharmacy or high school pharmacist who is the head of the commission by writing (each time the commission is no more than 12 months).

The head of the mental health care store, the prescriptions for the medication must be graduated from high school medicine.

2. Faculty, treatment room in medical examination facilities, cure: drug-induced drug drugs, mental health therapy and precurative prescriptions in the medicine cabinet, emergency medicine cabinets must be prevented from being monitored by the clinic and issued by the police. The order. In exchange for the shift, the drug holder of the previous shift must hand over the medication and the tracker to the holder of the following shift.

3. The Center for Education-Social-Labor, compulsory rehab facility, drug-addicted treatment facilities, drug-based drugs, drug-driven food drugs, mental health, and drug-induced prescriptions. An academic or middle school is on the basis of a non-12-month mandate by the head of the mandate for no more than 12 months, issuing and tracking books.

4. Medical Station, ward, town due to a person with a professional degree from the pharmacist or from a doctor who has become steward of the community mental health program and has a tracking book.

Chapter IV

DELIVERY, TRANSPORTATION, AND DRUG PRESERVATION

What? 12.

1. When delivery, drug-induced drug addiction, antipsychomedication, drug prescriptions, medications to form a combination of drugs, drugs into a combination of psychoactive ingredients, drugs into a combination of drugs. The delivery, the recipient of the drug, must conduct a test for the treatment of the name of the drug, concentration, quantity, quantity, quantity of production, restriction, drug quality, and they have to sign and specify the name of the evidence from the warehouse, enter the warehouse.

2. The delivery man, the drug recipient, the psychopharmaceutical, the prescriptions for the medicine to graduate from high school.

What? 13.

1. Drug-induced drug, antipsychoactive medication, drug prescriptions, drugs into a combination of addicants, drugs into a combination of psychoactive ingredients, drugs into a combination that contains prescriptions that must be used. packaging, sealing, and secure safeguards, not to fail during transport; on the packaging that needs to be clear where to export, where to enter, the drug name, the number of drugs.

2. The head of the facility must hand over a written mandate to the former high school graduate of the facility that is responsible for transporting drug-induced drugs, mental medicines, prescriptions for drugs; the person responsible for transporting must be carried. according to the above text, the proof of the people's letter (or legal discretionary identification), sales receipt or warehouse vote; responsible for the type, quantity, quality of the sensory drug in the transport and delivery process.

3. The case of a business facility must hire drug-based drug delivery, mental medication, prescriptions for drugs: The lease and the transport side must sign a written contract, which highlights the conditions related to the preservation, transport, delivery, and delivery. Drug addiction, mental orientation, prescriptions for the prescribed medication. The transport party must meet those conditions during the transport process, ensuring that the drug is not lost.

The rental party and the transport party are responsible for the problems associated with drug-related drugs, mental health, prescriptions for drug use during transport.

People who deliver drugs and drug addicts, psychopharmaceuticals, drug-based prescriptions for the business establishment have to graduate from high school medicine.

What? 14 Preserve.

1. The business of producing drugs must have its own warehouse that meets the "Practice of Good Practice" standard issued by the Minister of Health for the preservation of ingredients and drug-based drugs, mental health medications, prescriptions for prescriptions. In the form of a combination of drug-based, drug-based, drug-oriented, mixed-form drugs that contain prephysical activity. The depot has a door, a lock for sure, there are safeguards, not to fail.

2. Sales of the export, import of the prescribed medicine at 1 Article 5 This Privacy must have its own warehouse to meet the "Good Practice Protection" standard that fits the business size of the facility but the minimum area of 100m 2 And the maximum volume of 300m. 3 The door, the vault, the lock, there are safeguards, not to fail.

3. Sales of the Prescribed Drug at 1 Article 6 This account must have a standard "Good Practice Protection" inventory, in which drug-based drug prescriptions, medications to mental health, precurment drugs must be available. Lock-lock, secure security measures, not to fail. If there are no private warehouses, drug-based drugs, psychotherapy drugs, precurative prescriptions for a separate area in the inventory standard "Do Good Practice Protection".

4. Sales of exports, imports, businesses that sell drug trafficking into a coordinated form of drug-based, drug-based combination drugs containing psychoactive ingredients, mixed-form drugs that contain prescriptions to have a supply of supply. "Good practice of medicine", there are safeguards, not to fail.

5. The pharmacy must be equipped with a private locker that is sure to protect the drug-based drug, the psychotherapy, the precurative product.

If the number of drugs is less addicative, it is possible to leave the same cabinet as a mental health medication and a precursor to prescriptions but must be prevented from confusion; there is a certain course, there are safeguards, not to fail.

It contains a combination of drug-based, mixed-form drugs containing psychoactive ingredients, a combination medication that contains the right precursor to its own area.

6. The pharmacy cabinet, emergency medicine cabinet:

Drug-based drugs, psychotherapy drugs, prescriptions for prescriptions in the closet, the emergency medicine cabinet should be left in a compartment or a cell, the locker is solid. The number, the drug-type drug, the psychotherapy, the precursor to the medicine cabinet, the emergency medicine cabinet, the head of the database.

7. Department of Pharmacy: Drug-induced drug, mental health medication, precurative precurative medicine must be preserved in the warehouse adhering to regulations on "Good Practice Protection"; hospital pharmacy must deploy to apply the principle of "Practice." better to administer the medicine " (GSP) in accordance with the procedure for the Ministry of Health, which has safe safeguards, not to fail.

The warehouse, the prescriptions for the drug-making drugs, the psychos, the precurators, the precurators. If there is no warehouse, private cabinet, drug-based drugs can be shared with psychos and prescriptions for prescriptions but must be arranged separately to avoid confusion.

It contains a combination of drug-based, mixed-form drugs containing psychoactive ingredients, a combination medication that contains the right precursor to its own area.

8. Research facilities, training facilities and other related units: Drug-induced drugs, psychos, prescriptions for drugs to be in a compartment or private cell, a lock-up locker, which has safe safeguards, not to fail. It contains a combination of drug-based, mixed-form drugs containing psychoactive ingredients, a combination medication that contains the right precursor to its own area.

9. The medical station: The mental health care medicine must be arranged in the counter, the locked closet is certain, there are safeguards, not to fail.

Chapter V.

RECORDS, LICENSING PROCEDURES, REPORTS AND CANCELATION MODES

What? 1 5 Yeah.

1. The wholesale business, the retail base, the basis of the drug use is intended to purchase a drug-based drug, a mental-oriented drug, a precurative drug-based drug that is prescribed by the class 09.

2. Businesses produce drug-based drug, mental health, drug products, drug products, drug products, drug products, drug products, drugs, drugs, drugs, drugs, drugs, drugs, drugs, drugs, drugs, drugs, drugs, drugs, drugs, drugs, drugs, drugs, drugs, and drugs. The combined form contains a precursor to a bill that buys materials, sells products that contain addicing material; raw materials, sell products that contain mental inactivity; raw materials, sell products containing preexisting ground-based substances. The sample number 10 issued by this Smart or the order imports the raw material, selling the ingredient to addiction; the cause. For example, the sale of products is mental-oriented; raw materials, selling products containing predefined prescriptions in the Information Guide to export, import of drugs and packaging directly directly to the drug issued by the Minister of Health.

3. Sales of exporting, importing as a prescription for drug-importing drugs, mental health, prescriptions for the prescribed medication in the Prescribed Practices, importing drugs and packaging directly to the existing drug. Issued by the Minister of Health.

4. The category is made in 04 copies (the planning agency for the category 2).

5. wholesalers of wholesale businesses, retail facilities, the basis of drug-making food drugs, mental health care drugs, prescriptions to prescriptions are only allowed to buy, sell, grade, use drug-based drugs, mental health care, and more. You know, the precursors of the precursors when the bill was approved.

6. The head of the business is responsible for the number of drugs that are drug-based, mental-oriented drugs, precurative precursor medicines, the expected number of drugs to be consistent with the use of the facility; only the amount of medication is expected. Drug addiction, mental health, prescriptions for drugs in excess of 50% compared to the previous usage in the case of lack of medication, emergency, natural disasters and epidemics.

7. Manufacturing businesses, exports, imports, wholesale businesses, retail facilities, the basis of drug-based drug-based combination drugs, drugs into a combination of psychoactive ingredients, drug-based food drugs The contract contains non-programming precuration in accordance with the above regulations.

8. During the 7-day period of work, since receiving a valid bill, the planned review agency will consider approval of the project or have an answer, stating that the reason is not approved.

What? 16 -Browser.

1. Bureau of Pharmacology-Ministry of Health:

a) Browse for drug addiction, mental health, prescriptions for drug production companies, medical clinics, medical treatment, research facilities, testing, medical training facilities;

b) Browse for export, importing drug addiction, mental health, prescriptions for exporting companies, importing the prescribed medication at 1 Article 5 of this information;

c) Browse for drug addiction, mental medication, prescriptions for facilities that are not part of management, but there is a need to buy drugs to study science on the basis of scientific research that has been administered by the agency. the water has authority to approve;

d) Browse for drug-making, psychotherapy drugs, precurative medicine for the Department of Defense.

2. The provincial department of Health, the Central City of the Central Committee to browse for drug-making, drug-oriented drug, precursors for wholesale companies, drug sales facilities, disease facilities, medical treatment, and outside the industry (except for applications). It ' s in the Ministry of Defense and the Department of Transportation, the research facility, the medical specialty training facility. According to local, the Department of Health can devolve to the District Health Chamber, district, town, or District Medical Center, the district, the town (if there are graduates of the university) browse for drug-making, psychotherapy, city medicine. The money for the medical station, the ward, the town.

3. The Department of Defense-the Department of Defense approved drug-making drug drugs, mental health drugs, precursors to hospitals, units of the Defense Ministry.

4. The Department of Health-the Department of Transportation approved drug-induced drug, mental health, precursors to hospitals, units of the Department of Transport.

What? 17 Case, export licensing procedure, import

1. Records, export licensing procedures, drug importation, mental medication, prescriptions for drugs and drugs into a combination of addicants, drugs into a combination of psychoactive ingredients, drug-based drugs. The co-ordinated form contains the predefined preexisting substance in the Export Guidance, importing the drug and the packaging directly directly to the Minister of Health.

2. A export permit, imported from a yellow-color drug, a blue-color psychoactive drug, the precursor to a pink drug that is issued for each import, export, and is valid for a maximum period of 1 year, since the date of the signing.

3. export permits, drug imports, mental medication, prescriptions for drugs being sent to the importing business, export; Office of Permanent Office Against Crime and Drugs-Ministry of Public Security, Bureau of Defense Customs Enforcement, and Drug Administration Export procedures, Import; Ministry of Finance (Bureau of Customs Enforcement-General Administration); International Drug Control Commission; Import Water Authority (for export licenses).

4. Drug-induced drug addiction, prescriptions for drug use only to export, imports through Vietnam ' s international store.

What? 18 -Save the files, bookstores.

1. Manufacturing, export, wholesale, retail, retail use, manufacture, delivery, service supply base related to drug-related drugs, psychiatric and prescriptions for the drug to record, track and store records, books, and other documents. with drug-related drugs, mental medication, and prescriptions for medication after the expiration of the pill is at least two years. The prescription drug is prescribed by the Secretary of Health in Foreign Affairs.

2. The manufacturing facility, which makes a combination of a combination of addicing ingredients, drugs into a combination of drugs, a combination of psychoactive ingredients, drugs that contain prescriptions for writing, tracking and storing records, books, and books. Materials related to raw materials, selling products containing substance abuse; raw materials, selling products that contain mental and raw materials, selling products containing prescriptions after the expiration of the pill is at least two years.

3. End of the upper storage deadline, the head of the council ' s board to cancel, compile the cancellation and circulate the cancellation at the facility.

What? 19 Report.

1. export report, import:

a) Drug-induced drug, mental health, prescriptions for drug use: Slow 10 (ten) days after export, import, export base, import report by regulation at number 11A, model 11B issued with this message to the Department of Pharmacy Management- Department of Health and Office of Permanent Defence Against Crime and Drugs-Ministry of Public Security;

b) Every year, the export business, importing the export of the number of exports, importing the drug into a coordinated form of drugs, drugs into a combination of psychoactive ingredients, drugs into a form of psychoactive form. It is done in accordance with the order of 12A, the number 12B issued by this message to the Department of Pharmacology, the Health Department; the slog is on 15 January next year.

2. inventory reports, use:

a) Business exports, imports, wholesale businesses, retail facilities, drug use facilities, mental medicines, and prescriptions for the right to inventory, report the number of monthly drugs, six months before July 15 and July 15, 2017. The year after 15 January the following year after the provisions of 13A, the number 13B issued with this message to the planned, licensing review.

b) The export, import, wholesale business, the retail base of drugs into a combined form of substance abuse, drugs into a combined form of mental and drug-based combination drugs containing prescriptions. has to inventory, report the number of purchases, imports, inventory, numbers that have been sold and lived, the customer address 6 months before July 15 and every year before 15 January next year for the Department of Health on the site.

c) A manufacturing business, importing drugs into a coordinated form of drug-based, mixer-form drugs that contain mental and drug-oriented compounds with a combination of prescriptions, reports of purchase numbers, enter, inventory, number of exported and name, customer addresses each purchase, import of raw materials for the production of the drug and annually before 15 January next year (for the year report) to the Department of Pharmacology-Ministry of Health; be notified to the Provincial Health Department, the city. The city's central city centers on the basis of the business that sells the business on the site and announces it when there is a change.

d) The Department of Health of the Provinces, the Central City of Central City, reported the use of drug-induced drug, mental and prescriptions for the annual drug of the facilities on its own, according to the number 14 issued by this Information;

The U.S. Department of Defense reports the use of an annual drug-based drug use by a model number 11A issued to the Department of Health Management-Health; it was delayed on 30 January next year.

3. Wrong report, failure or when there is suspicion of failure:

Individuals, domestic and foreign organizations have activities related to drug-induced drugs, mental medication, drug prescriptions, drug-based prescriptions that contain drug-based drug-based drugs, drugs into a coordinated form of food. A combination of psychos and drugs containing precursors must report an urgent report to the intended review agency in case of confusion, failure or when the suspect fails. Upon receiving an emergency report, the planned review agency must conduct an inquiry and have the appropriate treatment;

Department of Health, Central City, and emergency report to the Department of Health.

What? 20 -Smoking.

1. The raw materials, sold products containing substance abuse; raw materials, sold products that contain mental inactivity; raw materials, selling products containing prescriptions; drug-based drugs, psychoactive drugs, and food drugs. The pre-quality, low-quality, drug-sample at the end of the period, the drug received from the medical and drug-received drugs required to be destroyed, the basis for the destruction of the drug is as follows:

a) There is a written statement of the cancellation of the expected review agency. The text of the order to cancel the drug must specify the name of the drug, the concentration-the quantity, the number, the reason for the destruction, the destructor method. The cancellation of the drug was only done after the planned approval of the browser;

b) The establishment of the board of drugs led by the head of the facility. The council has at least 03 people, including the facility in charge of the facility;

c) Set up the cancellation of the drug and save at the facility;

d) After the cancellation of the drug, it must be sent to report the cancellation of the drug to the planned browser (accompanied by the receipt of the drug).

2. Other types of food, waste during the production of drug-based drugs, mental and prescriptions for drugs, drugs into a coordinated form of drugs, a combination of psychoactive drugs containing mental and mental physical activity. A combination of a combination of compounds containing prescriptions, must be assembled and canceled as specified at point b and point 1 This thing.

3. Manufacturing business, drug business: The types of packaging that are directly exposed to drug-induced drugs, mental and prescriptions for non-use drugs must be assembled and canceled as stipulated at point b and point 1 This Article.

The facility uses drug-based drugs, mental and prescriptions for drugs: The packaging of direct contact with the drug, including bottles of bottles, cascuses, prescriptions for addiction, psychos, and prescriptions for non-use drugs must be used. sets and cancelation as regulation at point b and point c 1 This thing.

4. The destruction of addiction, mental medication, prescriptions for drugs, drugs into a combined form of substance abuse, a combination of psychoactive drugs containing mental and drug-based compounds containing prescriptions. It has to be separate from other medicines; it has to be safe to be safe for people, animals, and to avoid environmental pollution in accordance with the laws of environmental protection.

Chapter VI

EXECUTION CLAUSE

What? 21 . Execution clause

1. This message has been in effect since 15 July 2014.

2. Private 10 /2010/TT-BYT April 29, 2010 of the Minister of Health guidelines for activities related to drug-related drug and drug-related drugs. 11 /2010/TT-BYT April 29, 2010 by the Minister of Health for the Minister of Health guidelines for activities related to psychiatric and prescriptions for the medication that expires since this date is effective.

In the course of execution, if it is difficult, it is recommended that the Department of Health (Department of Health) report units to review, solve.

Minister.

(signed)

Nguyen Thi Kim