Procedures for licensing a traditional medicine clinic in Vietnam

by NguyenThiThuTrang

Treatment of diseases by traditional medicine methods is increasingly important. Because people’s medical needs are increasing day by day. Especially, there is a demand for traditional medicine examination and treatment with the advantage of being preferred by the people because the remedies are traditional male remedies of the nation. However, the number of Traditional Medicine clinics is limited. Currently, many people want to open a clinic for treatment to meet the needs of patients, but the legal procedures for licensing a traditional medicine clinic in Vietnam are not clear. Revolving around the above issue, Lawyer X would like to send you the following article:

Law on medical examination and treatment 2009

Decree 109/2016/ND-CP

Decree 158/2018/ND-CP

Consulting content

What is Traditional Medicine?

Traditional medicine is the way folk often refer to the method of medical examination and treatment by traditional methods performed thousands of years ago such as: taking pulse to diagnose diseases, loading medicine, decoction, acupuncture, acupressure, etc., to treat disease.
Traditional medicine today is considered an official method for medical examination and treatment as an independent discipline and has a legal concept mentioned in specialized management documents.

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 (according to the form);
Certificate of business registration or establishment decision (for organizations);
Practicing certificate of the person in charge of professional and technical expertise of the clinic;
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 the form);
Documents proving that the clinic meets the conditions on facilities; medical equipment; organize personnel suitable 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).

Procedures for licensing a traditional medicine clinic

Step 1: Prepare documents

To carry out procedures for granting a license to operate a traditional medicine clinic; You need to prepare documents according to the instructions above

Step 2: Submit your application

Registrants submit 01 set of documents through 3 ways:

Submit your application online through the online public service portal
Submit directly to the Department of Health of the province/city where the clinic is located.
By post to the headquarters of the Department of Health of the province/city directly under the central government.

Step 3: Receipt of application

After receiving the application for an operation license, the Department of Health shall do the following:

In case of online application, after receiving; the online application-receiving agency sends the online application-receiving slip to the applicant;

In case the application is submitted directly at the application-receiving agency, after receiving the application, the receiving agency shall immediately send the application for the operation license a receipt of the application;

If the application is sent by post, within 03 days; calculated from the time of receiving the dossier (calculated according to the arrival postmark); The receiving agency shall send the application for an operation license a receipt of the application.

Step 4: Review the application for appraisal

If the application is valid, the application-receiving agency must consider and issue an operation license within 45 days from the date indicated on the application receipt. In case the operation license is not granted, a written reply must be given clearly stating the reason.

If the application file for an operation license is invalid, the following procedures shall be followed:

Firstly, within 10 working days from the date on which the application is received, the application-receiving agency must send a written notice to the applicant for the operation license to complete the application. . The written notice must specify which documents are supplemented and which contents need to be amended.

Secondly, when receiving a written request to complete the dossier, the medical examination and treatment establishment applying for an operation license must supplement and amend it according to the contents recorded in the document and send it to the medical examination and treatment establishment. application reception.

Thirdly, After 10 working days from the date of receipt of the supplement or modification dossier, if the dossier-receiving agency does not have a written request for amendment or supplementation, it must issue or grant an operation license within 10 working days. 45 days period; If not granted, there must be a written reply clearly stating the reason

Finally, after 60 days from the date the application-receiving agency issues a written request, the applicant establishment fails to supplement, amend, or supplement or amend the dossier but fails to meet the requirements. If required, the procedure for applying for an operating license must be redone from the beginning.

Step 5: Get the result

The Department of Health shall issue an operation license for a traditional medicine clinic to the registrant.

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:

Medical examination and treatment with traditional medicine (with drugs and without drugs);
To use the finished products of traditional medicine produced by other establishments that have been granted circulation registration by the Ministry of Health to serve medical examination and treatment;
Preparation of live drugs into mature drugs (tablets), weighing medicines for patients;
Persons who practice using traditional remedies or heirloom treatment methods may only examine and treat diseases using such traditional remedies or methods;
In case some prepackaged forms are produced to serve directly for patients of the treatment room (high, single, refund, canopy or other forms), it is required to register with the provincial Department of Health about the recipe for the treatment. drugs, manufacturing process (enclosed with an explanation of facilities and equipment), uses, dosages, contraindications and samples of drug labels. The provincial Department of Health will review and approve the new production conditions. Medicines are only for direct service to patients of the clinic, not circulated on the market in accordance with the provisions of the Law on Pharmacy.

Notes when preparing the application for a license of a traditional medicine clinic

– In case there is medical waste to be treated, a contract for medical waste treatment is required; If there is medical wastewater, it is necessary to meet the conditions for having a wastewater drainage system.
– Certificate of professional practice to prove that the medical examination and treatment period is sufficient (form 10, Appendix XI to Decree 109/2016/ND-CP).

– The assignment and appointment of the person responsible for professional and technical expertise or the assignment of medical examination and treatment by a medical examination and treatment establishment must be made in writing.

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Frequently asked questions

What are the conditions for granting a practicing certificate to a Vietnamese traditional medicine doctor?

Having one of the following diplomas or certificates suitable to the form of medical examination and treatment practice:
Professional diplomas related to health are granted or recognized in Vietnam;
Certificate of being a physician;
Certificate of being a person who has a traditional medicine or a method to cure a disease.
Having a written certification of the practice process, except for the case of a physician, a person who has a traditional remedy or a method of treating a disease.
Having a certificate of health enough to practice medical examination and treatment.
Not falling into the case of being banned from practicing medicine or doing jobs related to medical or pharmaceutical expertise according to court judgments or decisions; being prosecuted for penal liability; are in the time of serving a criminal sentence, a court’s criminal decision or a decision on application of administrative handling measures, and consignment to an educational institution or medical treatment establishment; is in the period of being disciplined in the form of warning or higher related to medical examination and treatment; loss or limitation of civil act capacity.

What conditions must be met in order to open a traditional medicine clinic?

To be able to open a clinic specializing in traditional medicine, it is necessary to meet the conditions of personnel; medical equipment and facilities.

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