Circular No. 11/2010/TT-BYT guides activities related to psychotropic drugs and precursors used as drugs.

✦ 智能摘要

Circular No. 11/2010/TT-BYT guides activities related to psychotropic drugs and precursors used as drugs in Vietnam, applicable to individuals and organizations within and outside the country. It provides detailed regulations on prescription, labeling, delivery, transportation, reporting, record keeping, warehouse management, compounding, dispensing, storage, planning, buying and selling, import and export, inspection, supervision, and violation handling.

适用范围

Individuals and organizations within and outside the country that engage in activities related to psychotropic drugs and precursors in Vietnam.

要点

Healthcare facilities must arrange compounding areas that meet conditions regarding infrastructure, human resources, packaging, labeling, storage, and record keeping.
When psychotropic drugs and precursors are dispatched from or received into inventory: name, concentration, quantity, expiration date, and sensory quality of the drug must be checked and compared; the sender and receiver must sign the receipt.
Export and import reports for psychotropic drugs and precursors must be submitted according to the provisions of this Circular.
Businesses dealing with or using psychotropic drugs and precursors must retain records and ledgers related to raw materials and finished products for at least two years.
Compounding and using psychotropic drugs and precursors at research and specialized medical education institutions must be supervised by a university pharmacist.

🌐 本文件的社会影响

Positive impact: Helps strictly manage activities related to psychotropic drugs and precursors, reduces the risk of abuse, and protects public health.
Negative impact: Increases costs for businesses in employee training, establishing standard operating procedures, record keeping, and time spent on implementing procedures may cause difficulties.

❓ 常见问题

What conditions must healthcare facilities meet to compound psychotropic drugs?

Must arrange compounding areas that meet conditions regarding infrastructure, human resources, packaging, labeling, storage, and record keeping.

What must be done when dispatching psychotropic drugs and precursors from inventory?

Must check and compare the name, concentration, quantity, expiration date, and sensory quality of the drug; the sender and receiver must sign the receipt.

How long must businesses retain records and ledgers related to raw materials and finished products?

Retain for at least two years.

When must healthcare facilities report on the export and import of psychotropic drugs and precursors?

Within ten days after export or import; annually for combined psychotropic drug and precursor finished products.

From where can healthcare facilities purchase psychotropic drug and precursor raw materials?

From central pharmaceutical companies or enterprises permitted to produce and compound psychotropic drugs and precursors.

全文

CIRCULAR

Guidelines for activities related to psychotropic drugs and precursor substances used as drugs

Pursuant to Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to the Medicine Law No. 34/2005/QH11 dated June 14, 2005;

Pursuant to Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing the implementation of certain provisions of the Drug Law;

Pursuant to the Anti-Narcotics Law No. 23/2000/QH10 dated December 19, 2000;

Pursuant to Decree No. 80/2001/NĐ-CP dated November 5, 2001 of the Government guiding the control of lawful activities related to narcotics within the country;

Pursuant to Decree No. 67/2001/NĐ-CP dated October 1, 2001 of the Government on the issuance of lists of narcotic substances and precursors;

Pursuant to Decree No. 58/2003/NĐ-CP dated May 19, 2003 of the Government on the control of import, export, and transit through Vietnam of narcotic substances, precursors, addictive drugs, and psychotropic drugs;

Pursuant to Decree No. 133/2003/NĐ-CP dated November 6, 2003 of the Government supplementing certain substances to the list of narcotic substances and precursors issued together with Decree No. 67/2001/NĐ-CP dated October 1, 2001 of the Government;

Pursuant to Decree No. 163/2007/NĐ-CP dated November 12, 2007 of the Government amending the names, adding, transferring, and removing certain substances from the list of narcotic substances and precursors issued together with Decree No. 67/2001/NĐ-CP dated October 1, 2001 of the Government;

The Ministry of Health guides activities related to psychotropic drugs and precursor substances used as drugs used in Vietnam.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

Article 1. This Circular guides activities related to psychotropic drugs and precursor substances used as drugs (referred to as precursors) used in the medical field and in analysis, testing, and scientific research as specified in the List of Psychotropic Drugs (Annex I, Annex III), the List of Precursor Substances Used as Drugs (Annex II, Annex IV) issued together with this Circular.

Article 2. Finished drug products containing multiple active ingredients, where the formula includes psychotropic active ingredients, precursors combined with other active ingredients (not being addictive drugs, psychotropic drugs, or precursors) with the amount of psychotropic active ingredients, precursors equal to or less than the amount specified in the List of Psychotropic Drugs in combination form (Annex III) and the List of Precursor Substances Used as Drugs in combination form (Annex IV) are exempted from implementing certain clauses of this Circular except for the following clauses: Clause 4, Point b Clause 1 Article 7, Clause 2 Article 9, Clause 1 and Clause 3 Article 11, Clause 2 and Clause 4 Article 12, Article 15, Clause 1 Article 20.

Article 2. Applicability

This Circular applies to individuals and organizations both domestic and foreign engaged in activities related to psychotropic drugs and precursors in the medical field and in analysis, testing, and scientific research in Vietnam.

Article 3. Prescription

The prescription of psychotropic drugs and precursors for outpatients shall be carried out in accordance with the "Regulations on Outpatient Drug Prescriptions" promulgated by the Minister of Health.

Article 4. Drug Labeling

Implementation shall be in accordance with the Circular guiding drug labeling promulgated by the Minister of Health.

Article 5. Delivery and Receipt

When issuing from stock and receiving psychotropic drugs and precursors, a check must be conducted to verify the name of the drug, concentration, quantity, batch number, expiration date, and visual quality; the issuer and recipient must sign and clearly write their names on the stock issuance and receipt documents.

Article 6. Transportation

1. During transportation: Psychotropic substances and precursors must be packaged, sealed, and measures to ensure safety must be taken to prevent loss during transportation; the packaging must clearly indicate the place of origin, destination, name of the substance, and quantity.

2. The head of the entity that has psychotropic substances and precursors must issue a document assigning a person from their own entity to be responsible for transporting psychotropic substances and precursors; the person responsible for transporting psychotropic substances and precursors must have the aforementioned documents, national identity card (or other lawful identification), sales invoice or warehouse release note; they are responsible for the quality of the psychotropic substances and precursors in terms of appearance, quantity, and type during transportation and delivery to the person responsible for storing psychotropic substances and precursors.

3. In cases where an entity dealing with psychotropic substances and precursors needs to hire transportation services for these substances, the hiring party and the transportation service provider must enter into a written contract specifying conditions related to storage and transportation of psychotropic substances and precursors as prescribed. The transportation service provider must meet these conditions during transportation and ensure that the substances are not lost.

The hiring party and the transportation service provider must be responsible for issues related to psychotropic substances and precursors during transportation.

Article 7. Reporting

1. Export and Import Reports:

a) Psychotropic substances and precursors: Within ten days after exporting or importing psychotropic substances and precursors, the importing/exporting entity must report (Form No. 1A, Form No. 1B) to the Ministry of Health (Drug Administration Department) and the Ministry of Public Security (Anti-Narcotics Office);

b) Finished psychotropic substances and precursors in combination as specified in Clause 2 of Article 1 of this Circular: Annually, the entity must report the quantities exported and imported (Form No. 2A, Form No. 2B) to the Ministry of Health (Drug Administration Department); the latest date for submission is January 15 of the following year.

2. Inventory and Usage Reports:

a) Entities dealing with and using psychotropic substances and precursors: Must conduct inventory checks, submit monthly reports, semi-annual reports, and annual reports (Form No. 3A, Form No. 3B) and send them to the authority responsible for approving import/export plans and permits; the reports must be submitted no later than the 15th day of the following month (if it is a monthly report), July 15 (if it is a mid-year report), or January 15 of the following year (if it is an annual report);

b) Provincial Health Departments under the central government: Report on the use of psychotropic substances and precursors by entities within their jurisdiction (Form No. 4); The Military Medical Service of the Ministry of National Defense must report annually on the use of psychotropic substances and precursors in their sector (Form No. 3A) to the Ministry of Health (Drug Administration Department); the reports must be submitted no later than January 30 of the following year.

3. Emergency Reports:

Entities dealing with and using psychotropic substances and precursors must urgently report to the authority responsible for approving import/export plans in case of errors, losses, or suspected losses. Upon receiving urgent reports, the authority responsible for approving import/export plans must conduct audits and take appropriate measures;

Provincial Health Departments under the central government must compile and urgently report to the Ministry of Health (Drug Administration Department).

Article 8. Retention of Records and Ledgers

1. Business establishments engaged in manufacturing, compounding, distributing psychotropic substances and precursor chemicals must record, monitor, and retain documents related to raw materials for psychotropic substances and precursors, finished psychotropic drugs, and precursors after their expiration date for at least two years.

2. Upon expiration of the retention period, the head of the establishment shall convene a committee to destroy, prepare a destruction record, and retain the destruction record at the establishment.

Article 9. Destruction of Drugs

1. Raw materials, finished psychotropic drugs, and precursors that have exceeded their shelf life, are substandard, have reached the end of their sample retention period, returned from treatment departments, or recovered due to patient death must be destroyed. The establishment shall carry out drug destruction as follows:

a) Submit a written request for drug destruction to the authority responsible for budget approval. The request must clearly state the name of the drug, concentration-strength, quantity, reason for destruction, and method of destruction. Drug destruction can only be carried out after approval by the budget approval authority;

b) Form a drug destruction committee as decided by the head of the establishment. The committee must consist of at least three members, including a staff member responsible for the establishment;

c) Prepare a destruction record after the destruction process and retain it at the establishment;

d) After drug destruction, submit a report on the destruction to the budget approval authority (including the destruction record);

2. Residues and waste products generated during the production of psychotropic substances and precursors must be collected and destroyed according to the provisions set forth in points b and c of Clause 1 of this Article.

3. Direct packaging materials for psychotropic substances and precursors that are no longer in use must be collected and destroyed according to the provisions set forth in points b and c of Clause 1 of this Article.

4. The destruction of psychotropic substances and precursors must be conducted separately from other drugs. The destruction process must ensure thoroughness, safety for people and animals, and prevent environmental pollution in accordance with laws on environmental protection.

Article 10. Compounding and Using Psychotropic Substances and Precursors at Research and Training Institutions in Medicine and Pharmacy

1. Research and training institutions in medicine and pharmacy may compound and use psychotropic substances and precursors for teaching and scientific research purposes; they must have a university pharmacist supervise and be responsible for recording compounding ledgers, input-output records, and reporting as stipulated in this Circular.

2. Finished psychotropic substances and precursors must be immediately packaged and labeled to avoid confusion. Labels must contain at least the following information: Name of the institution, name of the drug, concentration-strength (volume), preparer, supervisor, date of preparation.

3. Psychotropic substances and precursors must be stored in separate cabinets equipped with devices and measures to ensure safety and prevent loss.

Chapter II

BUSINESS WITH PSYCHOTROPIC SUBSTANCES AND PRECURSOR CHEMICALS

Article 11. General Principles

1. Establishments involved in producing, exporting, importing, wholesaling, and retailing psychotropic substances and precursors must comply with the conditions for pharmaceutical business as prescribed in Chapter II of the Pharmaceutical Law and Chapter IV of Decree No. 79/2006/NĐ-CP dated August 9, 2006 detailing certain provisions of the Pharmaceutical Law, and adhere to the regulations set forth in this Circular.

2. Establishments dealing with psychotropic substances and precursors must develop and implement standard operating procedures (SOPs) in written form for all specialized activities appropriate to each type of business so that all employees can apply them, at a minimum including the following procedures:

a) Export-import, purchase-sale procedures for psychotropic substances and precursors;

b) Storage procedures for psychotropic substances and precursors;

c) Receipt-delivery and transportation procedures for psychotropic substances and precursors;

d) Destruction procedures for psychotropic substances and precursors (raw materials, precursors, finished psychotropic drugs, precursors, residues, waste products, direct packaging materials).

The development of SOPs must meet the following requirements:

- Ensuring safety, preventing the loss of psychotropic substances and precursors used as drugs;

- Each stage must have handover records, signed confirmations to clearly define the responsibility of each individual in each stage;

3. All employees involved in the business of psychotropic substances and precursors must undergo initial and continuous training on regulatory documents and standard operating procedures related to psychotropic substances and precursors used as drugs; training records must be retained at the establishment.

4. Storage: Production, export, import, wholesale establishments must have warehouses meeting Good Storage Practice (GSP) standards issued by the Ministry of Health; within which, warehouses storing psychotropic substances and precursors must be securely locked, with safety measures in place to prevent loss. If there is no dedicated warehouse, psychotropic substances and precursors must be kept in a separate area within a GSP-compliant warehouse, securely locked, and with safety measures in place to prevent loss.

Article 12. Production

1. Annually, the Ministry of Health (the Drug Administration Department) shall issue a list of facilities permitted to produce psychotropic substances and precursors based on actual circumstances.

2. Facilities producing psychotropic substances and precursors must comply with the following regulations:

a) Meeting Good Manufacturing Practice (GMP) standards appropriate to each formulation for at least two years;

b) Personnel:

- Warehouse manager: a university-level pharmacist or a college-level pharmacist authorized in writing by the unit head (each authorization period does not exceed 12 months);

- Supervisor overseeing research, production, analysis, testing, and responsible for record-keeping and reporting: a university-level pharmacist with at least two years of practice experience at the production facility.

c) Documents and ledgers:

- Ledger for compounding psychotropic substances and precursors (Form No. 5);

- Ledger for tracking the import and export of psychotropic substances and precursors (Form No. 6A);

- Ledger for tracking the export of finished psychotropic substance and precursor products as prescribed in Clause 2, Article 1 of this Circular (Form No. 6B);

- Export warehouse receipt for psychotropic substances and precursors (Form No. 7);

3. Scope of operation of facilities producing psychotropic substances and precursors:

a) Purchase and import raw materials for psychotropic substances and precursors for the production of drugs containing such active ingredients by their own enterprises;

b) Export psychotropic substances and precursors produced by their own enterprises;

c) Sell finished psychotropic substance and precursor products produced by themselves to facilities specified in Clause 1, Article 13 of this Circular.

4. When there is a need for raw materials for psychotropic substances and precursors to research and produce new registered products, the production facility must submit a request to purchase/import raw materials for psychotropic substances and precursors (Form No. 8A); and report in detail the quantity of raw materials for psychotropic substances and precursors used for research and trial production (Form No. 8B).

Article 13. Import and Export - Wholesale Sales

1. Central Pharmaceutical Company 1, Central Pharmaceutical Company 2, Central Pharmaceutical Company 3, Saigon Pharmaceutical Company, Ho Chi Minh City Medical and Pharmaceutical Import-Export Joint Stock Company (YTECO), Hanoi Pharmaceutical and Medical Equipment Joint Stock Company (HAPHARCO) are responsible for supplying raw materials and finished psychotropic substance and precursor products to trading and using facilities nationwide.

2. Personnel: The warehouse manager must be a university-level pharmacist or a college-level pharmacist authorized in writing by the unit head (each authorization period does not exceed 12 months).

3. Documents and ledgers:

a) Ledger for tracking the import and export of psychotropic substances and precursors (Form No. 6A);

b) Export warehouse receipt for psychotropic substances and precursors (Form No. 7);

c) Relevant documents related to the export, import, and sale of psychotropic substances and precursors.

4. Scope of Activities:

a) Export and import of raw materials and finished psychotropic substance and precursor products;

b) Purchase of finished psychotropic substance and precursor products from production facilities;

c) Sale of finished psychotropic substance and precursor products to wholesale facilities, retail facilities selling addictive substances, healthcare facilities, specialized medical and pharmaceutical research and training facilities, detoxification centers nationwide;

d) Sale of raw materials for psychotropic substances and precursors to facilities permitted to produce and compound psychotropic substances and precursors.

5. Provincial and centrally-administered city pharmaceutical companies (including state-owned enterprises and state-owned enterprises after shareholding reform) may purchase finished psychotropic substance and precursor products from the pharmaceutical companies specified in Clause 1 of this Article to supply to healthcare facilities, specialized medical and pharmaceutical research and training facilities, detoxification centers within their jurisdiction.

6. A university-level pharmacist or a college-level pharmacist authorized in writing by the unit head (each authorization period does not exceed 12 months) may directly engage in wholesale sales of psychotropic substances and precursors.

Article 14. Retail Sale

1. Pharmacies, drug counters.

a) Meeting Good Pharmacy Practice (GPP) standards;

b) The pharmacy owner must be a university-level pharmacist and the counter owner must be a college-level pharmacist, directly managing and retailing psychotropic drugs and precursors;

c) Storage: Psychotropic drugs and precursors must be stored in a separate locked cabinet with safety measures to prevent loss;

If the quantity of psychotropic drugs and precursors is small, they may be stored in the same cabinet as narcotic drugs but must be kept in a separate compartment to avoid confusion; the cabinet must be securely locked with safety measures to prevent loss;

d) Records: Finished psychotropic drug and precursor tracking book (Form No. 6A); Outbound warehouse drug psychotropic and precursor delivery note from the supplier;

đ) Scope of operation:

- Purchase and retail sale of finished psychotropic drugs and precursors according to the prescription drug regulation for outpatient treatment;

- Not allowed to purchase or sell raw materials for psychotropic drugs and precursors;

2. Drug retail agents of enterprises, village health station medicine cabinets:

a) Physical facilities: Counters and cabinets must be securely locked; Psychotropic drugs and precursors must be arranged in a safe position to avoid confusion;

b) Records: Finished psychotropic drug and precursor tracking book (Form No. 6A);

c) Scope of operation:

- Enterprise drug retail agents are permitted to sell psychotropic drugs and precursors listed in the Essential Medicines List of Vietnam;

- Village health station medicine cabinets are permitted to sell psychotropic drugs and precursors listed in the essential medicines list for commune-level healthcare in the Essential Medicines List of Vietnam;

Chapter III

PREPARATION, DISPENSING, USE, AND STORAGE OF PSYCHOTROPIC DRUGS AND PRECURSORS AT HEALTHCARE FACILITIES, DEPENDENCY TREATMENT CENTERS

Article 15. Preparation.

1. Healthcare facilities with the function of diagnosing and treating diseases that have the function of preparing psychotropic drugs and precursors must arrange a preparation area meeting the following conditions:

- Having an emergency resuscitation room;

- Preparation room: Must have dust-proof ceiling, easily sanitized floor and walls, capable of sterilization when necessary. The room must be built in a well-ventilated, isolated, safe location away from pollution sources. The minimum floor area is 10 square meters. Equipment must be arranged in a unidirectional flow principle;

- Hand washing facilities and equipment washing facilities;

- Adequate equipment suitable for preparation, storage, and quality testing of drugs;

b) Human resources:

- The person supervising and responsible for record keeping, reporting, and post-preparation drug quality checks: University-level pharmacist;

- The person storing psychotropic drugs and precursors after preparation: College-level pharmacist or higher;

c) Packaging, labeling, storage:

- Prepared psychotropic drugs and precursors must be immediately packaged and labeled to avoid confusion. The label must at least contain the following information: Name of the facility, name of the drug, dosage form, active ingredient, concentration or content, preparer, supervisor, date of preparation;

- Psychotropic drugs and precursors must be stored in a separate cabinet: With safety measures and equipment to ensure security and prevent loss;

d) Files and ledgers:

- Ledger for compounding psychotropic substances and precursors (Form No. 5);

- A quality control ledger;

- A compounding procedure based on prescriptions;

- Standard Operating Procedures (SOPs) for compounding must be established.

2. Scope of activities:

a) Prepared drugs can only be dispensed according to prescriptions for inpatient and outpatient patients of the same facility;

b) Only prepare drugs with formulas, preparation procedures, and quality standards approved by the head of the facility and responsible for the safety and efficacy of the drug;

c) Injectable drugs cannot be compounded.

Article 16. Issuance and Use

1. The pharmacy department shall issue psychotropic drugs and precursors to treatment departments based on the Psychotropic Drugs and Precursor Medication Withdrawal Form (Form No. 9) and directly distribute such medications to outpatients. The head of the pharmacy department or a university-level pharmacist authorized in writing by the head of the pharmacy department shall approve the Psychotropic Drugs and Precursor Medication Withdrawal Forms of the treatment departments.

Upon receiving medication from the pharmacy department, the assigned nursing staff in the treatment departments must verify the name, concentration, dosage, and quantity of the medication before administering it or issuing it to patients.

Any surplus psychotropic drugs and precursors due to unused amounts or patient transfers or deaths must be returned to the pharmacy department by the treatment department with a return document. The head of the pharmacy department shall decide on reusing or destroying these medications according to regulations based on specific circumstances and record this in the pharmacy department's logbook.

The pharmacy department must monitor and fully record the quantities of psychotropic drugs and precursors in stock, received, and issued (Form No. 6A).

2. For direct-use medicine cabinets and emergency medicine cabinets in departments within healthcare facilities that use psychotropic drugs and precursors, nursing staff on duty shall manage and distribute medications according to medical orders. When changing shifts, the on-duty staff member must hand over the medications and monitoring logs to the incoming staff member.

3. Detoxification centers: pharmacists at the intermediate level or higher are responsible for receiving, managing, and distributing psychotropic drugs and precursors.

Article 17. Storage

Storage of psychotropic drugs and precursors in the pharmacy department:

a) Physical infrastructure: Psychotropic drugs and precursors must be stored in warehouses in accordance with good storage practices; warehouses and cabinets storing psychotropic drugs and precursors must have secure locks and be equipped appropriately to ensure safety and prevent loss. If separate warehouses or cabinets are not available, psychotropic drugs and precursors may be stored together with addictive substances but must be arranged separately to avoid confusion.

b) Warehouse manager: a pharmacist at the intermediate level or higher.

2. Storage of psychotropic drugs and precursors in direct-use medicine cabinets and emergency medicine cabinets: Psychotropic drugs and precursors in direct-use medicine cabinets and emergency medicine cabinets must be kept in a separate compartment or drawer with a secure lock. The quantity and types of psychotropic drugs and precursors stored in direct-use medicine cabinets and emergency medicine cabinets shall be specified in writing by the head of the facility.

Chapter IV

RECORDS AND PROCEDURES FOR FORECASTING, PURCHASING, EXPORTING, AND IMPORTING

Article 18. Forecasting.

1. Annually, entities engaged in the business and use of psychotropic drugs and precursors must prepare forecasts for purchasing psychotropic drugs and precursors (Form No. 10). The forecast shall be made in four copies (the approving authority retains two copies, the entity keeps one copy, and the supplier retains one copy).

2. Entities engaged in the business and use of psychotropic drugs and precursors are only permitted to purchase, sell, distribute, and use psychotropic drugs and precursors if they have a forecast approved according to Article 19 of this Circular.

3. The head of the entity is responsible for the quantity of psychotropic drugs and precursors forecasted; the quantity of psychotropic drugs and precursors must match the usage needs of the entity. If the forecasted quantity of psychotropic drugs and precursors exceeds 50% compared to the previous period's usage: the entity must provide a clear explanation for the excess.

In cases where the purchased quantity of psychotropic drugs and precursors according to the forecast does not meet the usage needs, entities may supplement their forecast and provide an explanation.

4. Within seven working days of receiving a valid forecast, the reviewing authority shall examine and approve the forecast or issue a written response stating the reasons for disapproval.

Article 19. Approval of Procurement Plans

1. The Ministry of Health (the Drug Administration Department):

a) Approves procurement plans for psychotropic substances and precursors for pharmaceutical production facilities, healthcare facilities, research institutions, specialized medical and pharmaceutical training institutions, and detoxification centers.

b) Approves procurement plans for finished psychotropic substances and precursors for the entities specified in Clause 1 of Article 13 of this Circular.

c) Approves procurement plans for psychotropic substances and precursors for entities not under the health sector's management but which have a need to purchase such substances and precursors for scientific research purposes. When preparing the procurement plan, the entity must submit a letter explaining the reasons and obtain confirmation from the head of a department or bureau-level agency with direct management authority.

d) Approves procurement plans for finished psychotropic substances and precursors for the Military Medical Service – Ministry of National Defense.

2. Provincial/Municipal Health Departments approve procurement plans for finished psychotropic substances and precursors for wholesale and retail drug outlets, healthcare facilities, research institutions, specialized medical and pharmaceutical training institutions, and detoxification centers within their jurisdiction. Depending on local conditions, the Provincial/Municipal Health Departments may delegate or authorize district or county health departments or district or county health centers (if they have pharmaceutical specialists) to approve procurement plans for finished psychotropic substances and precursors for commune, ward, and town health stations.

3. The Military Medical Service – Ministry of National Defense approves procurement plans for finished psychotropic substances and precursors for hospitals and units under the Ministry of National Defense.

4. The head of the treatment department and the outpatient clinic director sign off on the Prescription for psychotropic substances and precursors for their respective departments (Form No. 9). The head of the pharmacy department signs off on the Prescription for psychotropic substances and precursors for the pharmacy's on-call shifts.

Article 20. Documentation and Procedures for Export and Import

1. Documentation and procedures for exporting and importing psychotropic substances and precursors shall be carried out in accordance with the current Circular guiding the export and import activities of drugs and packaging materials directly contacting drugs issued by the Ministry of Health.

2. Export and import permits for green-colored psychotropic substances and pink-colored precursors are issued for each individual import or export transaction and are valid for a maximum period of one year from the date of issuance.

3. Export and import permits are sent to the enterprise applying for import or export; the Office of the National Anti-Narcotics Committee, the Customs Sub-Department at the border gate where the export or import procedures are conducted; the Ministry of Finance; the International Narcotics Control Board; and the regulatory authority of the importing country (for export permits).

4. Raw materials and finished products of psychotropic substances and precursors can only be exported or imported through international border gates of Vietnam.

Chapter V

INSPECTION - AUDIT - VIOLATION HANDLING

Article 21. Inspection and Audit

1. The Drug Administration Department and the Inspectorate of the Ministry of Health organize inspections and audits of the implementation of this Circular according to their authority over organizations and individuals involved in activities related to psychotropic substances and precursors within the territory of Vietnam.

2. Provincial/Municipal Health Departments are responsible for inspecting and auditing the implementation of this Circular within their jurisdiction.

Article 22. Handling of Violations

Any violation of this Circular will be subject to administrative penalties or suspension of permit issuance, revocation of permits, or criminal prosecution depending on the severity and nature of the violation as stipulated by law.

Chapter VI

IMPLEMENTING PROVISIONS

Article 23. Implementation Schedule

Pharmacies and drug counters shall continue to purchase and sell psychotropic drugs and precursors according to the mandatory implementation schedule for applying the "Good Pharmacy Practice" principles and standards as prescribed by the Ministry of Health.

Article 24. Effective Date

1. This Circular shall take effect 45 days from the date of signature. The following Decisions are hereby repealed: Decision No. 3047/2001/QĐ-BYT dated July 12, 2001 of the Minister of Health on the issuance of the Regulations on Psychotropic Drug Management, List of Psychotropic Drugs and Precursors Used as Medicines, and List of Combined Psychotropic Drugs and Precursors Used as Medicines; Decision No. 1443/2002/QĐ-BYT dated April 25, 2002 of the Minister of Health amending and supplementing certain Articles of the Regulations on Psychotropic Drug Management issued together with Decision No. 3047/2001/QĐ-BYT dated July 12, 2001 of the Minister of Health; Decision No. 71/2004/QĐ-BYT dated January 9, 2004 of the Minister of Health amending and supplementing certain substances to the List of Psychotropic Drugs and Precursors of the Regulations on Psychotropic Drug Management issued together with Decision No. 3047/2001/QĐ-BYT dated July 12, 2001 of the Minister of Health.

2. The Drug Administration Department, units under the Ministry of Health, Provincial Departments of Health, Vietnam Pharmaceutical Corporation; organizations and individuals involved in psychotropic drugs and precursors, foreign organizations and individuals supplying psychotropic drugs and precursors to Vietnam; healthcare facilities, research institutions, and specialized medical-pharmaceutical training centers shall be responsible for implementing this Circular.

In the course of implementation, if there are difficulties or obstacles, units are requested to report to the Ministry of Health (Drug Administration Department) for consideration and resolution./.

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Circular No. 11/2010/TT-BYT guides activities related to psychotropic drugs and precursors used as drugs.

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71/2004/QĐ-BYT Quyết định số 71/2004/QĐ-BYT Về việc bổ sung một số chất vào Danh mục thuốc hướng tâm thần, tiền chất của Quy chế Quản lý thuốc hướng tâm thần ban hành kèm theo Quyết định số 3047/2001/QĐ-BYT ngày 12/7/2001 của Bộ trưởng Bộ Y tế 已失效

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47/2010/TT-BYT Thông tư 47/2010/TT-BYT hướng dẫn hoạt động xuất, nhập khẩu thuốc và bao bì tiếp xúc trực tiếp với thuốc do Bộ Y tế ban hành 生效中

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Tiếng Việt Thông tư số 11/2010/TT-BYT Hướng dẫn các hoạt động liên quan đến thuốc hướng tâm thần và tiền chất dùng làm thuốc 한국어 시행규칙 제 11/2010/TT-BYT 정신향성 약물 및 제조용 전구물질과 관련된 활동 지침 中文通知第11/2010/TT-BYT号关于精神类药物和用作药物的前体物质相关活动的指导

Circular No. 11/2010/TT-BYT guides activities related to psychotropic drugs and precursors used as drugs.

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