Tiếng Việt| THE MINISTRY OF PUBLIC HEALTH | SOCIALIST REPUBLIC OF VIET NAM |
| No: 13/1999/TT-BYT | Hanoi, July 6, 1999 |
Pursuant to October 13, 1993 Ordinance on the Practice of Private Medicine and Pharmacy;
Pursuant to the Government’s Decree No. 6/CP of January 29, 1994 detailing a number of articles of the Ordinance on the Practice of Private Medicine and Pharmacy;
Pursuant to the Government’s Decree No. 2/CP of January 5, 1995 prescribing goods and services banned from commercial business and goods and services subject to conditional business on the domestic market;
This Circular guides in detail the practice of private traditional medicine and pharmacy,
1. General traditional medicine physician is the person with full professional qualification for the traditional medicine and pharmacy to examine and treat general diseases, who is granted the certificate of general traditional medicine physician by the Ministry of Health.
2. Specialized traditional medicine physician is the person with full professional qualification for the traditional medicine and pharmacy to diagnose and treat with traditional medicine ailments relating to specialized branches (internal medicine, surgery, gynaecology, paediatrics, acupuncture or digital massage and pressure…), and is granted the certificate by the Ministry of Health.
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4. Traditional medicine pharmacist is the person who has good theoretical knowledge of the traditional pharmacy, the pharmacological properties, usage, techniques of processing and preparing medicaments, forms of traditional medicines, who is granted the certificate of traditional medicine pharmacist.
5. Trader and preparer of ready-made drugs and traditional medicines are persons who have theoretical knowledge of the traditional pharmacy, understand the properties and usage of and methods of preparing raw drugs (preliminarily prepared or unprepared pharmaceuticals) into ready-made drugs, who are granted the certificate of full qualification for ready-made drug trading and preparation by the Health Services of the provinces and centrally-run cities.
6. Raw drug dealer is the person capable of recognizing and classifying assorted pharmaceuticals and granted the certificate of full qualification for raw drug dealing by the Health Service of the province or centrally-run city.
7. Traditional medicine agent is the person who thoroughly understands the properties and usage of various forms of traditional medicines and is granted the certificate of full qualification for opening the traditional medicine agent by the Health Service of the province or centrally-run city.
8. Assistants to traditional medicine physicians, traditional medicine assistant doctors and doctors are those who have knowledge about traditional medicines but are not qualified for the establishment of private traditional medicine practicing establishments. They include:
- Traditional medicine assistant-doctors and doctors, physicians, pharmacists , who have not got a working seniority long enough for registration of professional practice.
- Modern medicine assistant-doctors and doctors who have studied traditional medicines in their academic curricula.
- Persons who are attending traditional medicine study courses jointly organized by the Health Service and provincial/municipal Traditional Medicine Associations, with lectures and professional assistance given by traditional medicine physicians and pharmacists.
- Primary- and intermediate-level druggist who have knowledge about traditional medicines but are not qualified for the establishment of private traditional medicine practicing establishments.
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- Private traditional medicine clinics.
- Private traditional medicine consultation and treatment rooms.
- Services establishments for treatment, health restoration, functional rehabilitation by method of acupuncture, digital massage and pressure, deep breathing, traditional drug steaming medication.
The traditional medicine production and business establishments with capital lower than the legal capital include:
- Establishments producing and trading in medicinal paste, ointment, nettle-rash, pills and powders (referred for short as traditional medicine products).
- Establishments trading in ready-made drugs, traditional medicine finished products.
- Establishments trading in raw drugs (unprepared pharmaceuticals).
- Traditional medicine products agents.
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DETERMINATION OF PROFESSIONAL QUALIFICATIONS
The certificates of professional qualifications granted by the Health Services of the provinces and centrally-run cities under the guidance in Circular No. 11/BYT-TT of April 23, 1991, Circular No. 05/BYT-TT of May 15, 1993 and Circular No. 08/BYT-TT of May 2, 1994 of the Ministry of Health are valid for registration to practice the profession in localities; if the persons granted the certificates under the above-mentioned Circulars wish to change them for the certificates granted under this Circular, they shall have to file an application therefor, their curriculum vitae and the self-assessment of their professional practice to the provincial/municipal Health Services, which shall make and send lists and CV extracts of the applicants for such change to the Ministry of Health for consideration and settlement.
Persons wishing to sit for such examinations must satisfy the following criteria and conditions:
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2. On the professional qualifications: They must possess all certificates of study subjects according to the materials jointly published by the Ministry of Health and Vietnam Traditional Medicine Association Central Committee and under the training programs organized jointly by the Intermediate Medical School, the traditional medicine clinics and the provincial/municipal Traditional Medicine Association.
a/ Examination criteria for to be general physicians:
- The certificate of the knowledge on fundamental theory of the traditional medicine.
- The certificate of internal medicine pathology and treatment.
- The certificate of surgical pathology and treatment.
- The certificate of paediatric pathology and treatment.
- The certificate of gynaecological pathology and treatment
- The certificate of the five-sense- related pathology and treatment.
- The certificate of non-medicament treatment method.
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- The certificate of pharmacy.
- The certificate of ancient medical prescriptions.
b/ Examination criteria for to be specialized traditional medicine physicians:
- The certificate of the fundamental theory of traditional medicine.
- The certificate of the specialized pathology and treatment registered for the examination.
- The certificate of pharmacology.
- The certificate of pharmacy.
- The certificate of ancient medical prescriptions.
c/ Examination criteria for to be traditional medicine pharmacist:
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- The certificate of pharmacology (physic and chemical properties as well as usage of each kind of traditional drug).
- The certificate of pharmacy.
- The certificate of ancient medical prescriptions.
- The certificate for technical expertise of quality of pharmaceuticals and traditional drugs.
d/ Examination criteria for ready-made drug dealers.
- The certificate of fundamental theories on traditional medicine and pharmacy.
- The certificate of pharmacology.
- The certificate of pharmacy.
- The certificate of ancient medical prescriptions.
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e/ Examination criteria for traditional medicine agency:
- The certificate of fundamental theory on traditional pharmacology.
- The certificate of ancient medical prescriptions.
- The certificate of methods of preservation of traditional drugs.
f/ Examination criteria for raw drug dealers: The certificate of a study course on pharmaceuticals (classification, preliminary preparation, preservation…) which lasted for three months or longer.
- The application for examination for professional-qualification recognition.
- The curriculum vitae.
- The copy of the junior-high school graduation paper or the equivalent (notarized).
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- Two envelops with stamps and two 4 x 6cm photos.
The dossiers for titles with certificates to be granted by the Ministry of Health shall be evaluated by the provincial/municipal Health Services before they are sent together with lists of candidates and their CV extracts to the Ministry of Health (the Traditional Medicine Department).
Article 10.- The examination council.
1. Setting up the examination council: After consulting with the Traditional Medicine Association of the same level, the Ministry of Health or the provincial/municipal Health Service shall issue a decision to set up the examination council.
2. The examination is tasked to:
- Examine dossiers, make lists of candidates and publicly announce qualified ones.
- Organize the examinations:
+ Organize 1 to 2 examinations a year.
+ Announce the examination dates and time.
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- Examination subjects: Written examination (theories) and practice examination (clinical).
Examination questions for general physicians, specialized physicians and pharmacists shall be compiled by the Examination Council of the Ministry of Health, and for other subjects by the provincial/municipal Health Services.
- Organize the marking of examination papers, make records thereon, clearly stating each person�s mark for each examination subject.
- Report to the Health Minister or directors of the provincial/municipal Health Services on the lists of examination passers and failers (if any).
- The Health Minister or directors of the provincial/municipal Health Services shall issue certificates to those who pass the examinations.
1. The applicant for setting up a private traditional medicine clinic must be a traditional medicine doctor or physician, who has practiced the profession at a traditional medicine establishment for 5 years or more and is not subject to any law ban.
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3. A private traditional medicine clinic must have at least the following departments and bureaus:
+ Department for out-patient examination and treatment.
+ Department for in-patient treatment.
+ Pharmaceutical department and facilities, equipment.
+ Technical-administrative-accountancy-supplies bureau.
4. The design of a private traditional medicine clinic shall comply with the "model design of provincial-level traditional medicine hospital" issued together with Decision No. 165/BXD/VTC of July 3, 1995 of the Construction Minister.
5. Being provided with sources of clean water in service of daily life of staff personnel and patients.
6. Scope of operation:
- To give medical examination and treatment, sanatorium and/or functional rehabilitation to in-patients and out-patients by traditional medicine methods and combined methods of traditional medicine and modern medicine.
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- The establishment owners must be traditional medicine assistant-doctors, doctors or physicians (general or specialized), who have practiced the profession for two years or more, have good health and meet other criteria prescribed by law.
- The consultation room must be located separately (from the areas for family’s daily life and other business activities). It must occupy an area of at least 10 m2.
- If medical prescriptions are sold and medical paste, ointment, nettle-rash, pills and powder are prepared in direct service of the patients, there must be the production and preparation establishment equipped adequately with preparation and production facilities, evaluated and certified by the provincial/municipal Health Services.
+ Having medicine cabinet divided into boxes or drug bottles with caps and being put on shelves or racks, with clear marks, being put in airy and clean places.
- Scope of professional practice:
+ To give medical examinations and treatment to out-patients according to their professional qualification stated in the license (excluding clinical beds).
+ To prepare ready-made drugs in direct service of patients.
+ In case of production of medicinal paste, ointment, nettle-rash, pills, powders, the formulas, production process (with full explanation of production facility and equipment enclosed), the usage, doses and anti-prescription thereof must be registered with the provincial/municipal Health Services. The Health Services shall consider the conditions and permit, if such conditions are met, the production of such drugs but only in direct service of its patients, not for circulation on the market.
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+ Traditional medicine assistant-doctors and doctors may combine traditional medicine methods with modern medicine methods in order to raise the quality of diagnoses.
+ Owners of the private practicing establishments shall have to bear full responsibility before law for the safety, effects of their drugs.
1. The establishment owners must be traditional medicine doctors, or traditional medicine physicians for general ailments or specialized in acupuncture, digital massage and pressure, with working seniority of 2 years or more, having good health and meeting other conditions prescribed by law.
2. The establishments’ facilities and equipment must conform with the contents of professional practice.
There must be separate rooms for acupuncture, digital massage and pressure, which must be high and dry, clean and airy, with an average of 4 square meters for each bed.
The bed for acupuncture, digital massage and pressure must be 0.7m high, at least 0.7 m wide and 2 m long.
Acupuncture tools: needle steamer, sterile needle trays, non-sterile needle trays; clean-cotton boxes and dirty-cotton boxes; a separate set of needles is used for each patient; forceps and acupuncture machine (if any).
There is a medicament steaming room and a medicinal steam generating system (if steam medicament service is registered).
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- The establishment owners must have pharmaceutical knowledge recognized by the Ministry of Health or provincial/municipal Health Services.
- Having a definite business address and the business area (store) must at least cover 10 square meters and be airy, clean and qualified for pharmaceutical preservation.
- Having pharmaceutical storage.
- The scope of professional practice: dealing in raw pharmaceuticals.
- The establishment owners must acquire the degree of assistant-pharmacist or higher, having the certificate of traditional medicine study or certificate of eligibility for traditional medicine business granted by the Ministry of Health or the provincial/municipal Health Services; being in good health and meeting other criteria prescribed by law.
- Having a clear business address, the store must at least cover 10 square meters, be clean, high and dry, airy, hygienic, equipped with medicine cabinets or capped bottles put on shelves or racks. The cabinet drawers and bottles must be clearly marked with names of medicines.
- Having place and facilities and equipment for preparation of pharmaceuticals into ready-made drugs.
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1. The establishment owners must acquire the degree of pharmacist, traditional medicine doctor or traditional medicine physician or pharmacist; having good health and meeting other criteria prescribed by law.
2. The preparation, production and trading establishments must have the following sections:
- The raw material (pharmaceuticals and semi-finished products) storehouse which must be airy and clean, equipped with stands to avoid mustiness and moth eating, which must be clearly marked with names of pharmaceuticals to avoid mistakes.
- The traditional medicine preparation and production area must have:
+ A place for preliminary preparation and quality inspection of pharmaceuticals before they are put into production.
+ A room for preliminary processing, preparation and production.
+ A room for quality inspection of finished products.
+ A packaging room.
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- The room for display and sale of medicinal products turned out by the establishment.
The preparation and production area must be arranged according to the one-way principle, airy but closed to keep away pests and dusts. The preparation and production room, the packaging room and the quality inspection room must have their walls pasted with white ceramic tiles for 2m high or more from the floor, their floors paved with enamel bricks and their ceiling painted in white. The finished product storehouse must be large enough and tight close to keep away pests, but airy and clean, equipped with stands and cases to keep medicines away from the floor and walls in order to avoid mustiness, moth and termite eating.
- Having been supplied with clean hygienic water regularly quality-inspected to serve the medicine production.
- Having facilities and equipment compatible to the dossiers of application for medicine production registration already numbered.
- Having the fire prevention and fight system as prescribed.
The scope of professional practice: Being entitled to produce and open store for sale of traditional medicine fished products turned out by the establishment, and given the production and circulation registration numbers by the Ministry of Health; being entitled to sign contracts on the supply thereof to units with consumption demands or with business functions; being entitled to export them to countries having demand therefor.
- The establishment owners must acquire the certificate of professional qualifications for opening the traditional medicine agents, granted by directors of the provincial/municipal Health Services; have good health and meet other criteria prescribed by law.
- Having definite address and a business area of at least 10 square meters; being equipped adequately with facilities for medicine display and preservation.
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+ The application for the establishment of the private traditional medicine clinic.
+ The list of members of the directorate (or the management board) and their curricula vitae.
+ The health examination paper certifying the satisfaction of health criteria.
+ The written certification of having no previous criminal records for every member of the directorate.
+ The hospital’s operation charter.
+ The economic efficiency study report.
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- The application for the setting up of private traditional medicine establishment. If the applicants are working State officials or employees, they shall be only entitled to register the professional practices outside the working hours of their agencies and must acquire the consents of the heads of their agencies. The application must clearly state the form of establishment to be set up, the contents of professional practices and the location for professional practice.
- The curriculum vitae with photo stuck thereon and the certification by the People’s Committee of the ward or commune where the applicant resides or by the head of the agency where the applicant is working.
- Copies (notarized) of all diplomas and/or certificates of professional qualifications.
- The written declaration of material bases, technical equipment and investment capital.
- The operation plan.
- The certificate of the apprentice duration.
- The curricula vitae and copies (notarized) of certificates of professional qualifications of all partners and assistants (if any).
- The health examination papers with certification of meeting health criteria by the applicant, the partners and the assistants.
- The self-criticism paper for the professional practice duration, with comments of the head of the agency or director of a health center or chairman of the Traditional Medicine Association of the district or provincial town.
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Particularly for the dossiers of application for setting up private traditional medicine clinics, before being submitted to the Ministry of Health, the provincial/municipal Health Services shall have to submit them to the People’s Committees of the provinces and centrally-run cities for comments and approval in writing.
Article 21.- Competence to grant certificates of practicing qualifications.
1 The Health Minister shall grant practicing qualification certificates to private traditional medicine clinics and traditional medicine production and business establishments.
The Ministry of Health shall set up an advisory council to assist the minister in scrutiny for granting the practicing qualification certificates to private traditional medicine clinics as well as traditional medicine production and business establishments. Such council shall be composed of:
A Vice Minister in charge of traditional medicine, as chairman.
The Traditional Medicine Department head, the standing vice-chairman.
A leading member of the Clinical Department, member.
A leading member of the Legal Department, member.
A leading member of the Finance - Accountancy Department, member.
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A leading member of Vietnam Pharmaceuticals Department, member.
A leading member of the Medical Equipment- Works Department, member.
A specialist from the Traditional Medicine Department, secretary.
2. The directors of the Health Services of the provinces and centrally-run cities shall grant practicing qualification certificates to other private traditional medicine establishments as defined in Article 2 of this Circular.
The provincial/municipal Health Service shall set up an advisory council to assist its director in the scrutiny for the granting of practicing qualification certificates to other private traditional medicine establishments as defined in Article 2 of this Circular. Such council shall be composed of representatives of concerned bureaus and sections of the provincial/municipal Health Service, of the provincial/municipal Traditional Medicine Association and of the directorate of the traditional medicine clinic, with the deputy-director of the provincial/municipal Health Service in charge of traditional medicine as its chairman.
3. After obtaining the practicing qualification certificate, the establishment owner shall have to fill the procedures applying for the setting up and business registration according to the provisions of law.
The practicing qualification certificate for a traditional medicine preparation, production and business establishment shall be valid for 3 (three) years from the date of granting. Three months before its expiry, if the establishment wishes to continue its operation, its owner shall have to file a dossier to the Ministry of Health through the provincial/municipal Health Service, applying for evaluation, consideration and re-granting.
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- The application for practicing license.
- The professional qualifications and written declaration of practicing duration with certification by the provincial/municipal Traditional Medicine Association.
- The health examination paper with certification of fully meeting health conditions.
To consider the granting of certificate of qualifications for setting up the traditional medicine consultation and treatment establishment to the applicant. The person granted this certificate is only entitled to practice the profession within the mountain commune(s) or islands where his/her professional practice is registered.
A NUMBER OF PROFESSIONAL PROVISIONS
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They shall have to strictly follow the sterilization regulations issued by the Ministry of Health in order to prevent disease transmission and infections in treatment.
2. The prescriptions given to patients must be made according to set form.
3. Traditional medicines must be weighed medicament by medicament according to the order inscribed in the prescription, with ticks given to items already weighed. A kind of medicament can be weighed in one volume which shall later be divided equally for different recipes.
For poisonous medicament of Tables A and B, they must be weighed separately for every recipe and the invoice thereof must be recorded in two copies. One copy shall be kept at the store for at least one year and the other is given to the patient.
4. Traditional medicines must be preserved in medicine cabinets with separate drawers or capped bottles with their names being clearly inscribed thereon. Poisonous medicaments must be preserved in strict accordance with the Ministry of Health’s regulations on poisons. Fake medicines and poor-quality medicines (musty, termite- or moth-eaten…) must not be sold to patients. Street vending of medicines is strictly forbidden.
- The preparation of raw pharmaceuticals into ready-made drugs must be conducted in strict accordance with the methods of traditional medicine preparation.
- The production of traditional medicines in forms of paste, ointment, nettle-rash, pills and powders in direct service of patients (not for circulation on the market) must be carried out in accordance with the process approved by the provincial/municipal Health Services.
5. The private establishments practicing traditional medicines must have books for daily recordings to monitor activities. The situation must be summed up quarterly for report to the provincial/municipal Health Services which shall make sum-up reports to be sent to the Ministry of Health (The Traditional Medicines Department).
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2. The Ministry of Health assigns the provincial/municipal Health Services to directly manage the private traditional medicine establishments in their respective localities.
Article 28.- For the traditional medicine production and business establishments:
1. The production instruments and equipment must be suitable to each kind of product, must not be used interchangeably with household utensils and must not affect the quality of medicines.
2. The preparation of raw pharmaceuticals into ready-made drugs must be conducted in strict accordance with the methods of traditional medicine preparation.
3. The production of medicines in forms of paste, ointment, nettle-rash, pills and powder must comply with the production process and ensure the standard quality, already approved for production and circulation by the Ministry of Health.
4. There must be books to monitor production, medicine quality and operation results:
+ The book for raw materials intakes and release.
+ The book for monitoring the preparation and production process.
+ The book on quality criteria.
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+ The book on finished-products intake and delivery.
+ The book for monitoring purchases and sales.
All books must be fully and clearly recorded.
5. Only material pharmaceuticals and traditional medicine products meeting the quality criteria, which have been approved and given registration numbers for production and circulation in Vietnam, shall be traded on the market.
Article 29.- Regarding signboards :
Contents: uniformly inscribed as follows:
+ Line 1: Name of the practicing form (written in block letters) as prescribed in Article 2 of this Circular.
+ Line 2: The name of the store (if any).
+ Line 3: Name of the person registering the practice.
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+ Line 5: Address of the practicing place Telephone number (if any).
+ Line 6: The serial number of the license- Practicing hours.
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FOR THE HEALTH MINISTER
VICE MINISTER
Le Van Truyen
- 1 Circular No.08-BYT/TT, promulgated by The Ministry of Public Health, guiding the implementation of the Ordinance on private medical and pharmaceutical practice and Decree No. 6-CP on the 29th of January 1994 of the Government concretizing a number of articles of this Ordinance in the area of private practice of traditional national medicine and pharmacy.
- 2 Circular No.08-BYT/TT, promulgated by The Ministry of Public Health, guiding the implementation of the Ordinance on private medical and pharmaceutical practice and Decree No. 6-CP on the 29th of January 1994 of the Government concretizing a number of articles of this Ordinance in the area of private practice of traditional national medicine and pharmacy.
- 1 Decree No. 103/2003/ND-CP of September 12, 2003, detailing the implementation of the ordinance on private medicinal and pharmaceutical practice
- 2 Circular No.08-BYT/TT, promulgated by The Ministry of Public Health, guiding the implementation of the Ordinance on private medical and pharmaceutical practice and Decree No. 6-CP on the 29th of January 1994 of the Government concretizing a number of articles of this Ordinance in the area of private practice of traditional national medicine and pharmacy.
- 1 Decree No. 103/2003/ND-CP of September 12, 2003, detailing the implementation of the ordinance on private medicinal and pharmaceutical practice
- 2 Circular No.08-BYT/TT, promulgated by The Ministry of Public Health, guiding the implementation of the Ordinance on private medical and pharmaceutical practice and Decree No. 6-CP on the 29th of January 1994 of the Government concretizing a number of articles of this Ordinance in the area of private practice of traditional national medicine and pharmacy.