Conditions for granting a license to trade in traditional medicine in Vietnam

To serve the needs of social security: medical examination and treatment, medical examination, and treatment establishments are organized systematically from the central level to the commune, ward, and township levels. The system of medical examination and treatment establishments includes state-owned and private medical examination and treatment establishments and other medical examination and treatment establishments. Traditional medicine diagnosis and treatment rooms are one of the forms of medical examination and treatment in this system. What are the conditions for granting a license to trade in traditional medicine? Today, LSX Lawfirm will give you an article about: “Conditions for granting a license to trade in traditional medicine in Vietnam”, as follows:

Legal grounds

• Law on medical examination and treatment 2009;
• Decree 109/2016/ND-CP stipulating the granting of practice certificates to practitioners and the granting of operation licenses to medical examination and treatment establishments;
• Circular 03/2013/TT-BTC regulating fees for appraisal services; assessment of standards and conditions for medical and pharmaceutical practice; grant operation licenses to medical examination and treatment establishments…;
• Decree 87/2011/ND-CP guiding the Law on Medical Examination and Treatment.

Conditions for granting a license to trade in traditional medicine

To grant a traditional medicine business license, a medical clinic/clinic must meet the following conditions:

Firstly, conditions of facilities

– The clinic/treatment room has an area of ​​at least 10m2 and has a place to receive patients.

– Depending on the registered scope of professional activities, a traditional medicine clinic must satisfy the following additional conditions on facilities:

• In case; there is acupuncture, massage and acupressure, there must be a room or arrangement of beds for acupuncture, massage and acupressure with an area of ​​at least 5m2 per patient bed;
• In case; there is a medicinal sauna, there must be a sauna room with an area of ​​at least 02 m2 and must be closed but with enough light.

Secondly, conditions for medical equipment

If performing a medical examination, prescribing, loading medicine: There is a medicine cabinet, the medicines store in drawers or in glass or white plastic bottles with lids and the names of the drugs are clearly written on the outside;

In the case of performing acupuncture, massage, and acupressure, there must be at least the following equipment:

• Firstly, there are beds for acupuncture, massage, and acupressure;
• Secondly, there enough tools for acupuncture, massage, acupressure;
• Thirdly, there are enough tools and instructions to handle the magnet.

In case of having a medicinal sauna: Must have a vaporizer system, an adjustment valve, a sauna instruction sheet, and an alarm system in case of an emergency.

Thirdly, personnel conditions

• The person in charge of professional and technical expertise of a traditional medicine clinic must be a traditional medicine specialist; or a doctor specializing in traditional medicine or a person who has a certificate of being a physician issued by the Minister of Health. The doctor or the Director of the Department of Health or the person; who has the traditional medicine or has a method of treating traditional diseases and must have a certificate of medical examination and treatment of traditional medicine.
• Having a period of medical examination and treatment; with traditional medicine of at least 54 months, for doctors specializing in traditional medicine;
• Having a period of medical examination and treatment; with traditional medicine of at least 48 months, for doctors specializing in traditional medicine;
• And having a period of medical examination and treatment; with traditional medicine of at least 36 months, for a physician or a person with a traditional remedy or a person with a traditional method of treatment;
• As an organic practitioner in the traditional medicine clinic.

Dossier to apply for a license of a traditional medicine clinic

To carry out procedures for granting a license to operate a traditional medicine clinic. You need to prepare a complete application including the following documents:

• An application for an operation license (made according to the form);
• Certificate of business registration or establishment decision (for organizations);
• Then practicing certificate of the person in charge of the clinic’s professional and technical expertise;
• The list of registered practitioners at the clinic includes the registration of practitioners and people working in medical specialties at the clinic. These people include: cashiers; guard; accountant; receptionist – not subject to a license to practice ;
• Declaration of facilities; medical equipment, organization and personnel of medical examination and treatment establishments (according to form);
• Documents proving that the clinic meets the conditions on facilities; medical equipment; organize personnel suitable; so to the scope of professional activities of the clinic such as: certificate of land use right with house rental contract (if any); to prove that the minimum area requirements are met; contracts, documents on the purchase of equipment at the clinic, etc.
• The list of professional and technical expertise of the clinic proposed on the basis of the list of professional and technical expertise issued by the Minister of Health (the head must make).

Scope of professional activities of traditional medicine

Scope of professional activities means things that a person with a medical examination and treatment practice certificate; can perform within the scope prescribed by law. The scope of traditional medicine professional activities that a traditional medicine practitioner may perform is as follows:

• Firstly, medical examination and treatment with traditional medicine (with drugs and without drugs);
• Secondly, to use ingredients of traditional medicine products licensed by other manufacturers for circulation registration by the Ministry of Health; to serve medical examination and treatment;
• Then prepare raw medicine into cooked medicine, weigh medicine for patients;
• Thirdly, those who practice using traditional remedies or heirloom treatment methods are only entitle to medical examination and treatment by such traditional remedies or methods;
• Finally, in the case where certain prepackaged forms are manufactured; to serve directly to patients of the treatment room (high, single, refund, canopy or other), it must be registered with the provincial Department of Health about the exercise. formulation, manufacturing process (with solution on base substance, equipment), uses, dosage, contraindications and drug labels. The Department of Health will review, appraise and recognize the new conditions for production. Medicines are only for direct service to the patient operator, not stored in the school in accordance with the provisions of the Law on Pharmacy.

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