Thông tư 10/2010/TT-BYT

CIRCULAR

ON THE ACTIVITIES RELATED TO ADDICTIVE DRUGS

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

Pursuant to the Law on Pharmacy dated June 14, 2005;

Pursuant to the Decree No. 79/2010/ND-CP dated August 09, 2006 elaborating the implementation of a number of articles of the Law on Pharmacy;

Pursuant to the Law on Drug prevention No. 23/2000/QH10 dated December 19, 2000;

Pursuant to the Government's Decree No. 80/2001/ND-CP dated November 05, 2001 on control of legal activities related to narcotic drugs in Vietnam;

Pursuant to the Government's Decree No. 67/2001/ND-CP dated October 01, 2001 promulgating the list of narcotic substances and precursors;

Pursuant to the Government's Decree No. 58/2003/ND-CP dated on controlling the import, export, and transit of narcotic substances, precursors, additive drugs, and psychotropic medicines;

Pursuant to the Government's Decree No.133/2003/ND-CP dated November 06, 2003 on the addition of some substances to the list of narcotic substances and precursors promulgated together with Government's Decree No.67/2001/ND-CP dated October 01, 2001;

Pursuant to the Government's Decree No.163/2007/ND-CP dated November 12, 2007 on changing names, adding, moving, and discarding some substances in the list of narcotic substances and precursor promulgated together with the Government's Decree No. 67/2001/ND-CP dated October 01, 2001;

The Ministry of Health provides guidance on the activities related to addictive drugs.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

1. This Circular provides guidance on activities related to addictive drugs used in medicine, analysis, testing, and scientific research enumerated in the List of addictive drugs (Appendix I and Appendix and Appendix II) promulgated together with this Circular.

2. Finished drugs that contain an addictive substance in combination with other substances (not addictive drugs, psychotropic medicines or drug precursors), contain an amount of addictive substances that is smaller or equal to the amount in the list of addictive substances in combinations (Appendix II) are exempt from some regulations in this Circular, except for Article 4, Point b Clause 1 of Article 7, Clause 2 of Article 9, Clause 1 and Clause 3 of Article 11, Clause 2 and Clause 4 of Article 12, Article 15, Clause 1 of Article 20.

Article 2. Subjects of application

This Circular applies to the Vietnamese and foreign organizations and individuals engaged in activities related to addictive drugs used in medicine, analysis, testing, and scientific research in Vietnam.

Article 3. Prescription

Prescriptions given to outpatients shall comply with the “Regulation on giving prescription to outpatients" promulgated by the Ministers of Health.

Article 4. Drug labels

Drug labels shall comply with the Circulars providing guidance on drug labeling promulgated by the Minister of Health.

Article 5. Delivery

When addictive drugs are delivered, it is required to check the drug names, concentrations, contents, quantity, batch number, expiration dates, and sensory quality of drugs. The deliveryman and the recipient shall sign and write their full names on the delivery note.

Article 6. Transport

1. During the transport, addictive drugs must be packaged, seal, and measures shall be taken to ensure safety and prevent loss during the transport. The exporting, importing locations, drug names, and quantity must be specified on the packages.

2. The head of the facility that has addictive drugs appoint a person in writing to take charge of the transport of addictive drugs. The person in charge of the transport of addictive substances shall carry this written appointment, ID card (or other legal ID papers), sale invoices or delivery note, is responsible for the categories, quantity, and sensory quality of drugs during the transport, and hand them over to the person in charge of keeping addictive drugs.

3. When the seller of addictive drugs hires a courier to deliver addictive drugs, the seller and the courier shall conclude a written contract specifying the conditions on preservation, transport, and receipt of addictive drugs as prescribed. The courier shall comply with such conditions during the transport and prevent loss of drugs.

The seller and the courier are responsible for the issues related to addictive drugs during the transport.

Article 7. Reporting

1. Export and import report:

a) Addictive drugs: within 10 days as from the export or import, the exporter or importer shall send a report (form 1A, form 1B) to the Ministry of Health (the Drug Administration of Vietnam) and the Ministry of Public Security (Narcotic Prevention Office);

b) Addictive finished drugs in combined form defined in Clause 2 Article 1 of this Circular: a report on the quantity of exported and imported drugs (form 2A, form 2B) shall be sent to the Ministry of Health (the Drug Administration of Vietnam) annually by January 15 of the next year.

2. Report on used and unused drugs:

a) Every facility that sells or uses addictive drugs shall check and make and send monthly reports (by the 15^th of the next month), biannual reports (by July 15) and annual reports (by January 15 of the next year) on the quantity of unused addictive drugs to the examining authority or licensing agency.

b) Services of Health shall send annual reports on the use of addictive drugs of the local facilities (form 4); the Military Medicine Department shall send annual reports on the use of addictive drugs in the army (form 3A) to the Ministry of Health (the Drug Administration of Vietnam) by January 30 of the next year.

3. Unscheduled reports:

Every facility that sells or uses addictive drugs shall send an urgent report the confusion, loss, or suspected loss of drugs to the examining authority. When receiving the urgent report, the examining authority shall verify and take appropriate measures;

Services of Health shall aggregate and send urgent reports to the Ministry of Health (the Drug Administration of Vietnam).

Article 8. Retention of documents

1. The facilities that sell, prepare, and dispense addictive drugs shall record, monitor, and keep documents related to the addictive ingredients and addictive finished drugs for at least 02 years after they expire.

2. After the previously mentioned period, the head of the facility shall establish a council to destroy those drugs make and keep the record on the destruction at the facility.

Article 9. Destroying drugs

1. Addictive ingredients and addictive finished drugs that are expired, substandard, the drug samples that passed the retention period, drugs returned from clinical departments, and drugs returned by patients that have died shall be destructed as follows:

a) A written request for drug destruction shall be sent to the examining authority. The written request for drug destruction must specify the names, concentrations, contents, quantity of drugs, reasons, and method of destruction. Drugs shall only be destructed with the approval of the examining authority.

b) A drug destruction council shall be established by the head of the facility. The council consists of at least 03 people, including a manager;

c) A drug destruction record shall be made and kept at the facility;

d) A report on the drug destruction shall be sent to the examining authority (enclosed with the drug destruction record).

2. The redundant products and waste during the production of addictive drugs must be collected and destructed as guided in Point b and Point c Clause 1 of this Article.

3. The packages directly in contact with addictive drugs that are no longer used must be collected and destructed as guided in Point b and Point c Clause 1 of this Article.

4. Addictive drugs shall be destructed separately from other drugs. Measures shall be taken to ensure the complete destruction, safety for humans, animals, and minimize environmental pollution according to legislation on environment protection.

Article 10. Preparing and using addictive drugs at medicine research institutions and training institutions

1. The medicine research institutions and training institutions may prepare and use addictive drugs serving the teaching and scientific research. Bachelor of pharmacy shall supervise the preparation, record the preparation, export and import of addictive drugs, and make reports in accordance with this Circular.

2. Addictive drugs must be immediately packaged and labeled after preparation to avoid confusion. The label must have at least the facility name, drug name, dosage form, ingredients, concentration or contents, volume, preparer, supervisor, and date of preparation.

3. Addictive drugs shall be preserved in separate cabinets with equipment and measures for ensuring safety and preventing loss.

Chapter II

SELLING ADDICTIVE DRUGS

Article 11. General rules

1. The producers, exporters, importers, wholesalers, and retailers of addictive drugs must satisfy the conditions for selling drugs provided in Chapter II of the Law on Pharmacy and Chapter IV of the Government's Decree No. 79/2006/ND-CP dated August 09, 2006 elaborating the implementation of the Law on Pharmacy, and this Circular.

2. The facilities that sell addictive drugs shall establish and follow the standard operating procedure (SOP) for all professional activities, including at least:

a) The procedure for exporting, importing, purchasing and selling addictive drugs;

b) The procedure for preserving addictive drugs;

c) The procedure for delivering, receiving, and transporting addictive drugs;

d) The procedure for destroying addictive drugs (addictive ingredients, addictive finished drugs, redundant products, waste, direct packages).

SOP must:

- Ensure safety and prevent loss of addictive drugs;

- The handover of each stage must be recorded in writing and signed to identify the responsibility of each person in each stage;

3. All persons engaged in the sale of addictive drugs must be provided with initial training by the facility, training in legislative documents, relevant standard operating procedures related to addictive drugs. The training documents must be kept at the facility.

4. Preservation: the producers, exporters, importers, and wholesalers must have warehouse that comply with the standards of good safety practice (GSP) promulgated by the Ministry of Health. The addictive drug warehouses must be firmly locked to ensure safety and prevent loss. If addictive drugs are not stored in separate warehouses, they must be separately placed in a warehouse that meet the standards of GSP is firmly locked to ensure safety and prevent loss.

Article 12. Production

1. Annually, the Ministry of Health (the Drug Administration of Vietnam) shall issue a list of facilities permitted to produce addictive drugs.

2. The facility that produces addictive drugs shall comply with the requirements below:

a) The facility meets the standards of good manufacturing practice (GMP) that suit every dosage form for at least 02 years;

b) Personnel:

- Warehouse-keepers: bachelors of pharmacy;

- The persons that supervises the research, production, analysis, testing, monitoring, and reporting: bachelors of pharmacy that have worked for at least 02 years at the facility;

c) Documents and logbooks:

- Log of addictive drug preparation (form 5);

- Log of export and import of addictive drugs (form 6A);

- Log of sale of addictive finished drugs in combinations defined in Clause 2 Article 1 of this Circular (form 6B);

- Addictive drug delivery note (form 7);

3. Permissible operations of addictive drug producers:

a) Purchasing, importing addictive ingredients to produce drugs that have addictive ingredients of their own;

b) Exporting addictive drugs of their own;

c) Selling addictive finished drugs they produce to the facilities mentioned in Clause 1 Article 13 of this Circular.

4. When addictive ingredients are needed for research into new products, the facility shall submit an application for the purchase/import of addictive ingredients (form 8A), and report the detailed quantity of addictive ingredients used for research and experimental production (form 8B).

Article 13. Export - wholesaling

1. Central Pharmaceutical Company 1, Central Pharmaceutical Company 2, Central Pharmaceutical Company 3, Safaco, Yteco, Hapharco shall supply addictive ingredients and finished addictive drugs to the sellers and users nationwide.

2. Personnel: The warehouse-keepers must be bachelors of pharmacy.

3. c) Documents and logbooks:

a) Logbook for export and import of addictive drugs (form 6A);

b) Logbook for delivery of addictive drugs (form 7);

c) Documents related to the export, import and trade of addictive drugs;

4. Permissible operations:

a) Exporting, importing finished addictive drugs and ingredients;

b) Purchasing addictive drugs from producers;

c) Selling finished addictive drugs to wholesalers and retailers of addictive drugs, medical facilities, medicine research institutions, medicine training institutions, and detoxification centers nationwide;

d) Selling addictive ingredients to the facilities permitted to produce, prepare addictive drugs.

5. Pharmacy companies of central-affiliated cities and provinces (including state-owned companies and equitized state-owned companies) may purchase finished addictive drugs from the pharmacy companies mentioned in Clause 1 of this Article and supply local medical facilities, medicine research institutions, medicine training institutions, and detoxification centers.

6. Addictive drugs shall be sold directly by bachelors of pharmacy.

Article 14. Retailing

1. Services of Health shall direct pharmacies to provide finished addictive drugs to meet demands of local outpatients.

2. The pharmacies that sell addictive drugs must meet the standards of Good pharmacy practice (GPP);

3. Addictive drugs shall be managed and retailed directly by the bachelor of pharmacy who owns the pharmacy.

4. Addictive drugs shall be preserved in separate cabinets that are firmly locked to ensure safety and prevent loss.

A small amount of addictive drugs may be put in the same cabinet with psychotropic medicines and drug precursors but must be separated to avoid confusion. The cabinet must be firmly locked to ensure safety and prevent loss.

5. c) Documents and logbooks:

a) Logbook for export and import of addictive drugs (form 6A);

b) Addictive drugs delivery notes of the supplier;

c) Prescriptions of addictive drugs kept at the facility after selling;

d) Notes of receives of finished addictive drugs submitted by patients’ families.

5. Permissible operations:

a) Purchasing and retailing finished addictive drugs in accordance with the Regulation on giving prescriptions to outpatients;

b) Do not purchase or sell ingredients of addictive drugs.

Chapter III

PREPARING, DISPENSING, USING, PRESERVING ADDICTIVE DRUGS AT MEDICAL FACILITIES AND DETOXIFICATION CENTERS

Article 15. Preparing

1. The medical facility that provides medical examination, treatment and prepares addictive drugs shall prepare a preparation area that meets the conditions below:

a) Facilities:

- A preparation room having an anti-dust ceiling, the floor, and walls must be cleanable. Sterilization shall be carried out where necessary. The room must be built at an airy place, separated, safe, and away from pollution sources. The minimum area is 10 m2. The departments shall be arranged in one-way rules;

- There are places to wash hands and preparation equipment;

- The instruments for preparing, preserving and testing drugs are adequate;

b) Personnel: The supervisor in charge of monitoring, reporting, inspecting drug quality and managing prepared addictive drugs must be a bachelor of pharmacy.

c) Packaging, labeling, preserving:

- Addictive drugs must be immediately packaged and labeled after preparation to avoid confusion. The label must have at least the facility name, drug name, dosage form, ingredients, concentration or contents, volume, preparer, supervisor, and date of preparation;

- Addictive drugs shall be preserved in separate cabinets with equipment and measures for ensuring safety and preventing loss;

d) Documents and logbooks:

- Logbook for addictive drug preparation (form 5);

- Logbook for inspecting and controlling drug quality;

- The procedure for preparing drugs under prescriptions;

- The standard operating procedure for preparing drugs must be established;

2. Permissible operations:

a) The prepared drugs are only sold or dispensed under prescriptions to inpatients and outpatients of the facility;

b) Only prepare the drugs of which the formulae, preparation procedures, and quality standards are approved by the head of the facility, who is responsible for their safety and effectiveness;

c) Do not prepare injection drugs.

Article 16. Dispensing and using

1. The hospital dispensary shall dispense addictive drugs to clinical departments according to addictive drug receipt notes (form 9) and directly dispense drugs to outpatients. The head of the hospital dispensary or the bachelor of pharmacy authorized in writing by the head of the hospital dispensary shall sign the addictive drug receipt notes of clinical departments;

After the clinical department receives drugs from the hospital dispensary, the nurse shall check the drug names, concentrations, contents, and quantity of drugs before injecting or dispensing them to patients;

Addictive drugs that are not used or returned after the patient dies or is moved to another hospital must be returned to the hospital dispensary. The head of the hospital dispensary shall decide the recycling or destruction of such drugs, and keep the records at the hospital dispensary;

The hospital dispensary shall monitor and record the quantity of addictive drugs dispensed, imported, and in stock (form 6A).

2. The drugs in emergency cabinets at the wards and departments in the medical facility that uses addictive drugs shall be kept and dispensed by the nurses on the shift under medical orders. When changing shifts, the drugs and logbook shall be handed over to the next person on the next shift.

3. If the detoxification center does not have a bachelor of pharmacy, the director shall authorize a pharmacy technician in writing (each authorization does not exceed 12 months) to receive, manage, and dispense addictive drugs.

Article 17. Preservation

1. Preserving addictive drugs at the hospital dispensary:

a) Facilities: addictive drugs must be preserved in warehouses that comply with GSP standards; the hospital dispensary shall apply GSP in accordance with the itinerary of the Ministry of Health;

The warehouses and cabinets where addictive drugs are preserved must be firmly locked and provided with equipment to ensure safety and prevent loss. Addictive drugs may be put in the same cabinet with psychotropic medicines and drug precursors but must be separated to avoid confusion.

b) Warehouse-keepers: bachelors of pharmacy or pharmacy technicians (authorized in writing by the head of the facility for no more than 12 months).

2. Preserving addictive drugs in emergency cabinets:

Preserving addictive drugs in emergency cabinets must be put in separate drawers. The cabinets must be firmly locked. The quantity and categories of addictive drugs in emergency cabinets shall be decided in writing by the head of the facility.

Chapter IV

DOCUMENTATION, PROCEDURE FOR ESTIMATING, TRADING, EXPORTING AND IMPORTING

Article 18. Estimating

1. Every year, the facility that sells, uses addictive drugs shall estimate the demand for addictive drugs (form 19). The estimate shall be made into 04 copies (02 copies are kept by the examining authority, 01 copy is kept by the unit, and 01 copy is kept by the seller).

2. The facility that sells, uses addictive drugs shall only purchase, sell, dispense, or use addictive drugs after the estimate is approved as prescribed in Article 19 of this Circular.

3. The head of the facility is responsible for the estimated quantity of addictive drugs. Such quantity must be appropriate for the demand of the facility. If the estimated quantity of addictive drugs is in excess of 50% of the quantity registered in the previous period, the facility must provide explanation;

If the quantity of addictive drugs purchased as estimated is not sufficient, the facility may estimate an additional quantity and provide explanation.

4. Within 07 working days from the day on which the valid estimate is received, the examining authority shall consider approving it or make a written response and explanation if the plan is not approved.

Article 19. Examining estimates

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

a) Examine the estimates of demands for addictive ingredients made by drug producers, medical facility, medicine research institutions and training institutions;

b) Examine the estimates of demands for addictive finished drugs made by the facilities mentioned in Clause 1 Article 13 of this Circular;

c) Examine the estimates of demands for addictive drugs made by the facilities that are not under the management of health authorities but need addictive drugs for scientific research. When making the estimate, the facility shall enclose a written explanation that is certified by the head of a ministerial department;

d) Examine the estimates of demands for finished addictive drugs made by Military Medicine Department - The Ministry of National Defense.

2. Services of Health shall examine the estimates of demands for finished addictive drugs made by local drug wholesalers, drug retailers, medical facilities, medicine research institutions and training institutions, and detoxification centers. The Service of Health may delegate the Health Division of districts and towns, or medical centers of districts and towns (with officials accomplished in pharmacy) to examine estimates of demands for finished addictive drugs made by medical stations of communes, wards and small towns.

3. The Military Medicine Department - The Ministry of National Defense shall examine the estimates of demands for finished addictive drugs made by the hospitals and units affiliated to the Ministry of National Defense. 

4. The heads of clinical departments, the heads of consulting rooms shall sign the addictive drug receipt notes (form 9) given to their staff. The head of the hospital dispensary shall sign the receipt notes given to the staff on shift.

Article 20. Documentation, procedures for export and import

1. The documentation and procedures for exporting and importing addictive drugs shall comply with the current Circulars guiding the export and import of drugs and packages in physical contact with drugs promulgated by the Ministry of Health.

2. The license to export, import addictive ingredients, finished addictive drugs shall be issued to each import, export, and is valid for no more than 01 year from the day on which it is signed.

3. The license to export, import shall be sent to the applicant, the Drug Prevention Office, the sub-department of customs of the border checkpoint where the export, import procedures are completed, the Ministry of Finance, the International Narcotics Control Board, the managing authority of the importing country (for the license to export).

4. Addictive ingredients and finished addictive drugs shall only be exported or imported through international border checkpoints of Vietnam.

Chapter V

INSPECTION AND PENALTIES FOR BREACHES

Article 21. Inspection

1. The Drug administration of Vietnam, Inspectorate of the Ministry of Health shall inspect the compliance with this Circular of the activities related to addictive drugs in Vietnam.

2. Services of Health shall inspect the compliance with this Circular locally.

Article 22. Penalties for violation

Every breach of this Circular, depending on its nature and seriousness, shall carry administrative penalties, or have the license confiscated, or be liable to criminal prosecution as prescribed by law.

Chapter VI

IMPLEMENTATION

Article 23. Implementation

If the pharmacies mentioned in Clause 5 Article 13 of this Circular do not have sufficient bachelors of pharmacy, the head of the pharmacy may authorize pharmacy technicians in writing (each authorization does not exceed 06 months) to retail finished addictive drugs until the end of the period during which the standards of GPP are compulsory.

Article 24. Effect

1. This Circular takes effect after 45 days from the day on which it is signed. The Decision No. 2033/1999/QD-BYT dated July 09, 1999 of the Minister of Health promulgating the Regulation on addictive drug management, the list of addictive drugs and addictive drugs in combinations, the Decision No. 1442/2002/QD-BYT dated April 25, 2002 of the Minister of Health on amendments to the Regulation on addictive drug management promulgated together with the Decision No. 2033/1999/QD-BYT dated July 09, 1999 of the Minister of Health.

2. The Drug Administration of Vietnam, the units affiliated to the Ministry of Health, Services of Health, Vinapharm, organizations and individuals engaged in activities related to addictive drugs, foreign organizations and individuals that export addictive drugs to Vietnam, medical facility, medicine research institutions and training institutions are responsible for the implementation of this Circular.

The difficulties that arise during the implementation should be reported to the Ministry of Health (the Drug Administration of Vietnam) for consideration and settlement./.

APPENDIX I

LIST OF ADDICTIVE DRUGS
(promulgated together with the Circular No. 10/2010/TT-BYT dated April 29, 2010 of the Minister of Health)

APPENDIX II

LIST OF ADDICTIVE DRUGS IN COMBINATIONS
(promulgated together with the Circular No. 10/2010/TT-BYT dated April 29, 2010 of the Minister of Health)