Thông tư 05/2014/TT-BYT

CIRCULAR

DEFINING USE OF HERBAL INGREDIENTS, TRADITIONAL INGREDIENTS IN MEDICAL EXAMINATION AND TREATMENT FACILITIES

Pursuant to the Government's Decree No. 63/2012/NĐ-CP dated August 31, 2012 defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the request of the Director of Traditional Medicine Administration of Vietnam;

The Minister of Health promulgates the Circular defining use of herbal ingredients, traditional ingredients in medical examination and treatment facilities

Chapter 1.

GENERAL PROVISIONS

Article 1. Scope of regulation

This Circular defines the use of herbal ingredients, traditional ingredients (hereinafter referred to as medicine) in medical examination and treatment facilities

Article 2. Interpretation of terms

In this Circular, the following terms shall be interpreted as follows:

1. Herbal ingredients are medicine raw materials derived from animals, plants or mineral.

2. Traditional ingredients (or herb ingredients) are herbal ingredients processed, prepared according to the arguments of traditional medicine used to prevent and cure diseases.

Chapter 2.

QUALITY OF HERBAL INGREDIENTS, TRADITIONAL INGREDIENTS

Article 3. Quality of herbal ingredients, traditional ingredients

1. Herbal ingredients, traditional ingredients must meet quality standards as prescribed: for herbal ingredients under the current pharmacopoeia regulations (if any) or basis standards established by units.

2. Packaging and packaging labels must comply with guidelines on medicine labeling of the Ministry of Health.

Article 4. Quality inspection of herbal ingredients, traditional ingredients

1. Herbal ingredients, traditional ingredients provided for medical examination and treatment facilities must have test papers or notarized copies of test results.

2. Herbal ingredients, traditional ingredients must be inspected through the medicine registry Board of the hospital or registry department of other medical examination and treatment facilities. Herbal ingredients, traditional ingredients shall only provided for medical examination and treatment facilities if they meet the requirements for quality. The test results must be recorded for each batch in the registry in the form prescribed in Appendix 1 enclosed herewith this Circular.

3. The registry board of the Hospital shall comply with the provisions of the Ministry of Health’s Circular 22/2011 / TT-BYT dated June 10, 2011 defining organization and operation of the Pharmacy Department of Hospital; Registry department shall be decided to establish by the heads of other medical examination and treatment facilities including at least the head of the Department of Pharmacy, Accounting, storekeepers and supply staff.

4. Heads of medical examination and treatment facilities shall periodically inspect at least every 03 months and extraordinarily inspect as necessary the quality of herbal ingredients, traditional ingredients in medical examination and treatment facilities. A record must be made after the inspection.

5. Where there is a doubt about the quality of herbal ingredients, traditional ingredients, the head of the medical examination and treatment facility must inspect and (if necessary) send the sample to functional agencies for testing. Herbal ingredients, traditional ingredients shall only be used after the test results meet the quality standards.

Article 5. Provisions of preserving herbal ingredients, traditional ingredients.

1. The storage of herbal ingredients, traditional ingredients must meet the following conditions:

a) It must be large enough, clear, safe and convenient for import and transport;

b) Its ceilings, walls and roof must be designed and built to ensure hygiene and clear, dry, well-lit, warehouse floor must be high enough, even and smooth;

c) The entry of insects and rodents species and other infestation species must be prevented; the growth of mold, termites must be prevented;

d) Appropriate areas must be arranged for work such as: reception areas, storage areas, separate storage area, manufacturing areas of herbal ingredients, traditional ingredients. Herbal ingredients, traditional ingredients that contain oils must be stored in closed containers to prevent absorption into other goods.

2. Equipment must meet the following conditions

a) Herbal ingredients, traditional ingredients must be arranged on shelves, must not be directly contacted with the ground; between the shelves, there must be a distance for convenience of cleaning, loading and uploading;

b) There are appropriate means of transportation;

c) The storage must have enough equipment to preserve herbal ingredients, traditional ingredients such as air ventilation fan, air conditioners, dehumidifier, thermometer, and hygrometer;

d) Equipment used to monitor storage conditions must be calibrated periodically;

dd) the relative humidity must be controlled under 70%;

e) There is enough equipment for fire prevention and fighting as prescribed by law.

3. Preservation must meet the following conditions

Packaging, containers must be labeled and in the right type, must be arranged suitablely to ensure clearness;

b) Cleaning the storage must be ensured;

c) There is a full book system to record and monitor the import, export, processing, basic standards of herbal ingredients, traditional ingredients in the form prescribed in Appendix 2 and Appendix 3 enclosed herewith this Circular;

d) Quality, shelf life of herbal ingredients and traditional ingredients must be monitored regularly; when being detected any signs of no quality assurance, they must be stored in separate areas.

Chapter 3.

INSTRUCTIONS

Article 6. Instructions of medicine

1. Medicine used for patients must meet the following requirements:

a) Prepared in accordance with the regulations of the Ministry of Health;

b) Combined in consistent with theories of traditional medicine in each remedy;

c) Have a preparation process for preparations manufactured in medical examination and treatment facilities; passed the Science Council (if any) and requested the Heads of medical examination and treatment facilities for approval;

d) Cooperate appropriately with the forms of concomitant medication without adverse interaction;

dd) Do not abuse medicine.

2. Recording indications shall comply with provisions on prescription of traditional medicine.

3. Select the administration shall be based on the status of patients, disease extent, characteristics and properties of the medicines to order the appropriate administration.

4. Undesirable effects of medicine (if any) shall be recommended for nurses who take care and monitor the patient (or his or her family).

5. Herbal with medicinal toxicity must meet the following conditions:

a) Be strictly controlled the dose, subjects, administration and be processed in accordance with the regulations of the Ministry of Health; 

b) Be indicated in the treatment which is necessary to have a visit, consultation and monitoring by the physician.

Article 7. Organizations of medicine decoction and distribution

1. Depending on the conditions of each medical examination and treatment facility, Pharmacy Department or traditional Medicine Department or specialized department shall be responsible for in medicine decoction and distribution to patients.

2. Anti-confusion in decocting medicine: the medical prescription, medicine sheet, decocting pot, medicine container must be numbered before and after the decoction; there must be racks, shelves arranged to distinguish medicines that have not decocted or are being decocted or have decocted.

3. Distributing medicine daily and supplemented medicine must comply with the prescription. Medicines must be promptly distributed to ensure that the patient shall take them.

4. Persons who are responsible for the decoction must have expertise in traditional medicine from vocational secondary level or more, constantly updated knowledge about herbal ingredients, traditional ingredients.

5. Daily entry book must be have to record some remedies received and distributed and the rest of the day in the form prescribed in Appendix 4 enclosed herewith this Circular.

6. Decoction place must ensure cleanness and tidy.

7. The decoction way must be complied with Decision 26/2008 / QD-BYT dated July 22, 2008 on the issuance of the technical process of traditional medicine.

8. Decocted medicine must be filtered to remove the residue and coarse sediment.

9. For remedies containing herbal ingredients, traditional ingredients with toxicity: after finishing decoction, the residues must be stored for each patient at least 24 hours after distribution of medicine to patients for retrospective when necessary.

Article 8. Control of medicine distribution and decoction

1. The person in charge of decoction must sign with the medicine distributor the medicines that need decocting and take responsibilities for the number of remedies and the quality of received medicines.

2. The heads of the units shall inspect extraordinarily or periodically the distribution, decoction in medical examination and treatment facilities.

Article 9. Regulations on report

1. Upon the accident, confusion about the use of medicine, medical examination and treatment facilities must handle immediately and report to direct upper management agencies.

2. Medical examination and treatment facilities must report on adverse reactions of the medicines to direct upper management agency and the National Center on medicine information and monitor the adverse reactions of the medicines in accordance with law.

3. Medical examination and treatment facilities under the Ministry of Health, other Ministries ( except the Ministry of National Defense ) and private hospitals shall report the work in traditional medicine annually to the Ministry of Health (Traditional Medicine Administration of Vietnam) before October 15 in the form prescribed in Appendix 5 enclosed herewith this Circular and extraordinarily report when required.

4. Medical examination and treatment facilities in administrative division, except cases prescribed in Paragraph 3 of this Article shall report the work in traditional medicine annually to the Department of Health in central-affiliated cities and provinces before October 15 in the form prescribed in Appendix 5 enclosed herewith this Circular and extraordinarily report when required. The provincial Department of Health shall summarize and report to the Ministry of Health before November 30 annually.

Chapter 4

IMPLEMENTING PROVISIONS

Article 10. Effect

This Circular takes effect from April 01, 2014.

Article 11. Responsibility for implementation

1. the Chief of the Ministry Office, the Director of Traditional Medicine Administration of Vietnam, the Chief Inspector of Ministry, the General Directors, Directors under the Ministry of Health, the Directors of the Department of Health in central-affiliated cities and provinces and the Heads of health sector, the Heads of facilities of medical examination and treatment in traditional medicine shall be responsible for the implementation of this Circular.

2. Traditional Medicine Administration of Vietnam shall be responsible for directing, cooperating with the Department of Health in central-affiliated cities and provinces and other agencies related in inspection and monitoring the implementation of this Circular.

Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health (Traditional Medicine Administration of Vietnam) for guidance, consideration and settlement. /.