Circular No. 04/2002/TT-BYT guides the issuance of Practice Certificates for medical and pharmaceutical professions.

This Circular details the procedures for issuing Practice Certificates for medical and pharmaceutical professions for individuals meeting the criteria set forth in the Enterprise Law and related implementing regulations. The certificate is issued only to individuals, not organizations, and each individual may only be granted one type of certificate for one type of practice.

文号04/2002/TT-BYT
文件类型Circular
发布机关Ministry of Health
签署人Đỗ Nguyên Phương — Bộ trưởng
更新30/06/2026
行业Health
领域Uncategorized
发布日期29/05/2002
生效日期13/06/2002
失效日期14/02/2004
状态Expired
✦ 智能摘要

This Circular details the procedures for issuing Practice Certificates for medical and pharmaceutical professions for individuals meeting the criteria set forth in the Enterprise Law and related implementing regulations. The certificate is issued only to individuals, not organizations, and each individual may only be granted one type of certificate for one type of practice.

适用范围

Individuals wishing to engage in medical or pharmaceutical practice

要点

  • Individuals seeking a Practice Certificate for medical examination and treatment must have a degree from universities, colleges, or secondary schools of medicine and provide proof of the required practical experience.
  • Individuals applying for a Practice Certificate for pharmacy must possess a degree or a specialized certification in pharmacy and have completed practical training at a legitimate pharmaceutical establishment.
  • Individuals obtaining a Practice Certificate for traditional medical and pharmaceutical practices must have a degree from universities, colleges, or secondary schools of pharmacy and provide proof of the required practical experience.
  • The validity period of the Practice Certificate is five years. After five years, those holding the certificate (if they wish to renew it) must submit an application for renewal.
  • Practitioners of medicine and pharmacy shall not lend, lease, or allow others to use their Practice Certificates for practice purposes.

🌐 本文件的社会影响

  • Positive impact: Ensuring the quality of healthcare services and enhancing the reputation of private healthcare facilities.
  • Negative impact: The cost for citizens to register for medical and pharmaceutical practice may increase due to requirements for academic qualifications and practical experience.

❓ 常见问题

Who is eligible to obtain a Practice Certificate?

Individuals meeting the criteria stipulated in this Circular and wishing to engage in medical or pharmaceutical practice will be considered for issuance of a Practice Certificate.

What is the validity period of a Practice Certificate?

The validity period of the Practice Certificate is five years. After five years, those holding the certificate (if they wish to renew it) must submit an application for renewal.

What documents are required to apply for a Practice Certificate?

In addition to the application form, applicants must prepare their graduation certificates or certificates of professional qualifications, curriculum vitae, health check-up reports, and a commitment to comply with the provisions of the Law on Protection of People's Health.

What is the scope of validity of a Practice Certificate?

A Practice Certificate issued by the Minister of Health is valid nationwide, while a Practice Certificate issued by the Director of the Provincial Department of Health is valid within the province.

How will violations of the Practice Certificate regulations be handled?

Those violating the provisions of this Circular will be subject to disciplinary action, administrative penalties, or criminal prosecution depending on the severity and nature of the violation, as provided by law.

全文

CIRCULAR

Guidelines for issuing Professional Practice Certificates in Medicine and Pharmacy.

 

Based on the Law on Health Care for the People and related implementing regulations;

Based on the Enterprise Law and related implementing regulations;

Based on the Ordinance on Private Medical and Pharmaceutical Practice and relatedimplementing regulations;

ANDY The following guidelines for issuing Professional Practice Certificates in Medicineand Pharmacy are hereby provided:

 

Chapter I

GENERAL PROVISIONS

Article 1.The Professional Practice Certificate in Medicine and Pharmacy as defined in thisCircular is a document issued by the Ministry of Health, provincial health services(straightforwardly referred to as provinces) for individuals who meet the requiredprofessional qualifications, ethics, and work experience to register for private, semi-public, and self-established medical and pharmaceutical practice (hereinafterreferred to as the Professional Practice Certificate) in accordance with theEnterprise Law and related implementing regulations. Types of Professional Practice Certificates include:

Article 21. Professional Practice Certificate for Diagnosis and Treatment.

2. Professional Practice Certificate for Traditional Medicine:

1. Professional Practice Certificate for Diagnosis and Treatment using TraditionalMedicine;

2.2. Professional Practice Certificate for Traditional Medicine Drugs;

3. Professional Practice Certificate for Pharmacy.

Individuals meeting the criteria stipulated in this Circular and wishing to engage inmedical or pharmaceutical practice shall be considered for issuance of aProfessional Practice Certificate.

Article 3A Professional Practice Certificate is only issued to individuals, not organizations.Each individual can only obtain one type of Professional Practice Certificate toregister for one type of practice and must not exceed the permitted scope ofpractice.

Article 4It is strictly prohibited to lend or rent certificates to others for practice or use themfor other purposes. profession, shall not practice beyond the permitted scope.

Article 5.Strictly prohibited from lending or renting certificates to others for the purposeof practicing or for other purposes. other purposes.

Article 6Practitioners are responsible for complying with regulations concerning medicalspecialty techniques.

During the course of practice, practitioners must continue their education toenhance their professional qualifications, understand relevant industry rules, andkeep up-to-date with national laws and regulations.

Annually, the Ministry of Health and provincial health services organize trainingclasses to improve professional skills, disseminate and update laws andregulations related to healthcare and other relevant provisions. provincial health department shall organize training courses to improveprofessional knowledge, disseminate and update health-related regulatorydocuments and relevant regulations:

, Clause 1, Clause 2 Article 7a of this Regulation.The validity period of the Professional Practice Certificate is five years.

After five years, those holding a Professional Practice Certificate (if they wish torenew it) must submit an application to the issuing authority to process therequest for renewal.

 

Chapter II

CRITERIA FOR ISSUING PROFESSIONAL PRACTICE CERTIFICATES IN MEDICINE ANDPHARMACY

A. PROFESSIONAL PRACTICE CERTIFICATE FOR DIAGNOSIS AND TREATMENT

Article 8: General Standards:

1. Individuals seeking a Professional Practice Certificate for Diagnosis andTreatment must meet the following criteria:

1.1. Must hold a degree from medical or pharmaceutical universities, otheruniversities, colleges, or secondary schools specializing in medicine, and haveaccumulated sufficient time practicing according to the specific requirements for eachtype of practice.

1.2. Must possess professional ethics, full capacity for civil conduct, and sufficienthealth to practice diagnosis and treatment.

1.3. Understanding of the Law on Health Care for the People, the Ordinance onPrivate Medical and Pharmaceutical Practice, and related healthcare regulatorydocuments.

1.4. Understanding of the 12 Provisions on Medical Ethics (annexed to DecisionNo. 2088/QĐ-BYT dated January 6, 1996 of the Minister of Health), HospitalRegulations (annexed to Decision No. 1895/1997/QĐ-BYT dated September 19,1997 of the Minister of Health), and Medical Waste Management Regulations(annexed to Decision No. 3575/1999/QĐ-BYT dated August 27, 1999 of theMinister of Health). Minister of Health), Medical Waste Management Regulations (annexed to DecisionNo. 3575/1999/QĐ-BYT dated August 27, 1999 issued by the Minister of Health).

1.5. Knowledge of national health programs.

1.6. Must commit to comply with the aforementioned regulatory documents(points 1.3 and 1.4), medical specialty technical regulations, and other relatedregulatory documents.

2.There must not occur other diseases listed in the disease declaration list of theMinistry 1.7. Must have full capacity for civil conduct and sufficient health to practice diagnosisand treatment.

3. Not currently under a ban on practice imposed by the Ministry or a court decision,not being pursued for criminal responsibility, not subject to administrative controlmeasures, and not serving a prison sentence or undergoing compulsory educationalor medical treatment measures.

Article 9Specific criteria:

In addition to the general criteria set forth in Article 8 of this Circular, applicantsfor a Professional Practice Certificate for Diagnosis and Treatment must also meetthe following specific criteria:

1. Applicants seeking a Professional Practice Certificate for Diagnosis andTreatment to register at hospitals or multi-specialty clinics must be general orspecialized doctors who have practiced for five years at legally recognized medicalfacilities.

2. Applicants seeking a Professional Practice Certificate for Diagnosis andTreatment for other types of practices except hospitals.

a) Specialized internal medicine clinic:

General or specialized internal medicine doctors who have practiced for fiveyears at legally recognized medical facilities.

At least three years of specialized internal medicine practice in mountainousareas, or a midwife who has practiced for five years at legally recognized medicalfacilities, or a doctor who has practiced for three years at legally recognized medicalfacilities. mountainous areas, a medical assistant who has practiced for five years at alawful healthcare facility or a doctor who has practiced for three years at alawful healthcare facility.

b) Specialized surgery clinic:

General or specialized surgery doctors who have practiced for five years atlegally recognized medical facilities, including at least three years of specializedsurgery practice.

c) Specialized obstetrics-gynecology and family planning clinic:

General or specialized obstetrics-gynecology doctors who have practiced forfive years at legally recognized medical facilities, including at least three years ofspecialized obstetrics-gynecology practice.

ATAt least three years of specialized practice in mountainous areas, or a midwifeor nurse-midwife with secondary education or higher who has practiced forthree years at legally recognized medical facilities.

d) Specialized dental clinic:

General or specialized dental doctors who have practiced for five years atlegally recognized medical facilities, including at least three years of specializeddental practice.

e) Specialized otolaryngology clinic:

General or specialized otolaryngology doctors who have practiced for fiveyears at legally recognized medical facilities, including at least three years ofspecialized otolaryngology practice.

g) Specialized ophthalmology clinic:

General or specialized ophthalmology doctors who have practiced for fiveyears at legally recognized medical facilities, including at least three years ofspecialized ophthalmology practice.

h) Specialized plastic surgery clinic:

Doctors who have practiced for five years at legally recognized medicalfacilities, including at least three years of specialized plastic surgery or aestheticpractice.

i) Specialized rehabilitation and physiotherapy clinic.

Doctors who have practiced for five years at legally recognized medicalfacilities, including at least three years of specialized rehabilitation andphysiotherapy practice.

k) Diagnostic imaging clinic:

General or specialized doctors, radiologists (bachelor's degree in diagnosticimaging from university) who have practiced for five years at legally recognizedmedical facilities. In high mountainous regions, a doctor must have practiced for five years at a legitimate medical facility, including at least three years in radiology specialization.

l) Laboratory Department:

A doctor, pharmacist, biology or chemistry bachelor's degree holder, or laboratory technician (university graduate) who has practiced five years in laboratory specialization at a legitimate medical facility in high mountainous regions, where the person applying to practice is a doctor, pharmacist, biology or chemistry bachelor's degree holder, and has practiced for five years at a legitimate medical facility, including at least three years in specialization.

m) Midwife:

A general practitioner, obstetric specialist, or midwife with a secondary education or higher who has practiced five years in specialization at a legitimate medical facility, including at least three years in obstetrics specialization.

ATIn high mountainous regions: An obstetric specialist or midwife with a secondary education or higher who has practiced three years in specialization at a legitimate medical facility. The person granted a professional practice certificate must be practicing full-time.

B. LICENSE FOR TRADITIONAL MEDICINE PRACTICE

Article 10.General criteria.

1. Must hold a graduation certificate in traditional medicine doctor, traditional medicine assistant doctor, university-level pharmacy, secondary-level pharmacy, primary-level pharmacy, or a Certificate of Recognition as a Traditional Medicine Practitioner, Traditional Medicine Pharmacist, or have a Certificate of Professional Qualification in Traditional Medicine and have practical experience at legitimate traditional medicine facilities according to the requirements of each type of practice.

2.There must not occur other diseases listed in the disease declaration list of theMinistry ethics and professional experience.

3. Having full capacity for civil conduct and sufficient health to practice traditional medicine.

4. Not currently under a court decision prohibiting practice or work related to healthcare, not currently being prosecuted for criminal responsibility or under administrative control measures; not currently serving a prison sentence or administrative decision placing them in educational institutions or compulsory treatment facilities.

5. Understanding and commitment to comply with the provisions of the Law on Protecting People's Health, the Ordinance on Private Medical Practice, the Rules for Traditional Medicine Diagnosis and Treatment Practice, and other guiding documents implementing laws, ordinances, and ethical standards for traditional medicine practitioners according to the Nine Aphorisms of Hai Thuong Lan Oand relevant professional regulations.

Article 11In addition to the general criteria stipulated in Article 10, those granted a traditional medicine practice license must meet the following specific criteria:

1. For those granted a traditional medicine diagnosis and treatment practice license:

1.1. To register at a traditional medicine hospital:

a)Containing content opposing the Socialist Republic of Vietnam, undermining the unity of the entire people; a graduation certificate in traditional medicine doctor or a Certificate of Recognition as a Traditional Medicine Practitioner issued by the Ministry of Health.

b)Containing content inciting violence, propaganda for aggressive war causing hatred among ethnic groups and peoples; inciting obscenity, depravity, crime; at least five years of practical experience at a traditional medicine hospital, traditional medicine department in general hospitals, or specialized hospitals with beds.

1.2. To register for traditional medicine diagnosis and treatment services (excluding the types specified in Clause 1 of this Article):

a)Containing content opposing the Socialist Republic of Vietnam, undermining the unity of the entire people; a graduation certificate: traditional medicine doctor, traditional medicine assistant doctor, Certificate of Recognition as a Traditional Medicine Practitioner, or someone with a family herbal prescription.

b)Containing content inciting violence, propaganda for aggressive war causing hatred among ethnic groups and peoples; inciting obscenity, depravity, crime; at least two years of practical experience at legitimate traditional medicine diagnosis and treatment facilities:

2. For those granted a traditional medicine pharmacy practice license:

2.1. To register for individual business production of finished traditional medicine products (concentrates, decoctions, pills, powders...) or operating a family herbal prescription business:

a)Containing content opposing the Socialist Republic of Vietnam, undermining the unity of the entire people; pharmacy bachelor's degree and having a Certificate of Completion in Traditional Medicine Pharmacy, or a doctor (traditional medicine or holding a Certificate of Recognition as a Traditional Medicine Practitioner or Traditional Medicine Pharmacist issued by the Ministry of Health, or a Certificate of Recognition of Family Herbal Prescription issued by the Provincial Health Department, of the Ministry of Health. 2.2. To register for individual business operation of raw medicinal materials:

b)Containing content inciting violence, propaganda for aggressive war causing hatred among ethnic groups and peoples; inciting obscenity, depravity, crime; a pharmacy technician level or higher who has been trained in Traditional Medicine, or a traditional medicine assistant doctor, traditional medicine doctor, Traditional Medicine Practitioner, Traditional Medicine Pharmacist, or someone recognized by the Provincial Health Department as having the necessary qualifications to operate in traditional medicine pharmacy.

at least two years of practical experience at legitimate traditional medicine pharmacy businesses.

a)Containing content opposing the Socialist Republic of Vietnam, undermining the unity of the entire people; 2.3. To register for individual business operation of live medicinal herbs:Y a) A pharmacy technician level or higher who has been trained in Traditional Medicine, or a traditional medicine assistant doctor, traditional medicine doctor, Traditional Medicine Practitioner, Traditional Medicine Pharmacist, or someone recognized by the Provincial Health Department as having the necessary qualifications to operate in live medicinal herbs.

b)Containing content inciting violence, propaganda for aggressive war causing hatred among ethnic groups and peoples; inciting obscenity, depravity, crime; h) At least two years of practical experience at legitimate live medicinal herb businesses.

2.4. To register for wholesale traditional medicine pharmacy business.

A Certificate of Professional Qualification to open a traditional medicine wholesale pharmacy business issued by the Provincial Health Department.

at least two years of practical experience at legitimate traditional medicine wholesale pharmacy businesses. C. LICENSE FOR MODERN MEDICINE PRACTICE General criteria.

1. Must hold a degree or certificate in pharmacy and have sufficient practical experience at legitimate pharmacy facilities according to the requirements of each type of practice.

a)Containing content opposing the Socialist Republic of Vietnam, undermining the unity of the entire people; 2. Have full capacity for civil conduct and sufficient health to practice pharmacy.

b)Containing content inciting violence, propaganda for aggressive war causing hatred among ethnic groups and peoples; inciting obscenity, depravity, crime; 3. Not currently under a court decision prohibiting practice or work related to healthcare, not currently being prosecuted for criminal responsibility or under administrative control measures; not currently serving a prison sentence or administrative decision placing them in educational institutions or compulsory treatment facilities.

4. Understanding and commitment to comply with the Law on Protecting People's Health, private medical practice laws, pharmacy regulations, and other relevant professional regulations related to pharmacy practice.

Article 121. Individuals registering for pharmaceutical business enterprises and responsible persons for auxiliary units of such enterprises: Hold a university-level degree in pharmacy and have practiced for five years at legitimate pharmacy facilities.

2. Individuals registering for private pharmacies:

2.1. Having civil capacity and sufficient health to practice pharmacy.

3.Not currently under a prohibition on practicing or performing work related tohealthcare pursuant to a court decision, not currently being pursued for criminalresponsibility or subject to administrative supervision measures; not currentlyserving a prison sentence or administrative measure involving placement in aneducational institution or compulsory treatment facility.

4.Understands and commits to implementing the Law on Protecting Public Health,private healthcare laws, pharmaceutical regulations, and other relevant specialregulations pertaining to the practice of pharmacy.

Article 13Specific criteria:

1.Persons registering a pharmaceutical business entity and those responsible forauxiliary units of such entities: Hold a bachelor's degree in a specialized field pharmacy and have five years of practical experience at a lawful pharmacyfacility.

Certificate of Professional Qualification pharmacist, licensed physician, or hold a Certificate of Traditional MedicinePrescription issued by the Ministry of Health and have five years of practicalexperience at a lawful traditional medicine pharmacy or traditional medicalestablishment for persons registering a business entity solely engaged in thesale of traditional medicine.

2.Persons registering a private pharmacy:

2.1.Hold Hold a bachelor's degree in pharmacy and have completed five years of practice at alegal pharmaceutical facility.

2.2.For mountainous regions, highlands, islands, ethnic minority areas, remote andfar-flung areas: hold a bachelor's degree in pharmacy and have completed twoyears of practice at a legal pharmaceutical facility. The person granted aprofessional certificate under this point may only practice within that region.

3.For individuals registering as retail drug agents: hold a secondary school diplomaor vocational training certificate in pharmacy and have completed two years ofpractice at a legal pharmaceutical facility.

 

Chapter III

||| REGISTRATION REQUIREMENTS, PROCEDURES, AND AUTHORITY FOR ISSUING PROFESSIONAL CERTIFICATES IN MEDICINE AND PHARMACY

A. REGISTRATION REQUIREMENTS AND PROCEDURES FOR ISSUING PROFESSIONAL CERTIFICATES IN MEDICINE AND PHARMACY

Article 14.Application APPLICATION PACKAGE FOR THE ISSUE AND RENEWAL OF PROFESSIONAL CERTIFICATES INCLUDES:

1.APPLICATION PACKAGE FOR THE ISSUE OF A PROFESSIONAL CERTIFICATE: a)Application for issuance of a professional certificate.

b)Graduation certificate or Certificate of Professional Qualification (a certified copy).

c)Curriculum vitae with confirmation from the People's Committee of the commune, ward,or town where the applicant has permanent residence registration or the head of theagency where they work.

d)Certificate of practical experience issued and stamped by the head of the practicingsite. e)Health examination report issued by a district, county, or city health center. f)Commitment to comply with the provisions of the Law on Health Protection, Ordinanceon Private Medical and Pharmaceutical Practice, guiding documents implementing thelaw and ordinance, and related professional regulations.

g)Permission to practice outside regular hours issued by the head of the unit if theapplicant is working in state medical or pharmaceutical facilities.

h)Individuals applying for a professional certificate to register hospitals, pharmaceuticalproduction and trading enterprises must provide confirmation that they are notstate civil servants.

i)Three passport-sized photographs (3 cm x 4 cm).

APPLICATION PACKAGE FOR THE RENEWAL OF A PROFESSIONAL CERTIFICATE: a)Application for renewal of a professional certificate. b)Health examination report issued by a district, county, or city health center.

c)Permission to continue practicing outside regular hours issued by the head of theunit if the applicant is working in state medical or pharmaceutical facilities.

d)Confirmation from the Ministry of Health or Provincial Department of Health thatthe applicant has attended training courses and updated knowledge in their specialityand health laws organized by the Ministry of Health or Provincial Department ofHealth. B. PROCEDURES FOR ISSUING PROFESSIONAL CERTIFICATES

a) A letter requesting acceptance of the project from the project proponent. .PROCEDURES:

APPLICATION PACKAGE TO BE SUBMITTED TO THE MINISTER OF HEALTH FOR THEISSUANCE OF A PROFESSIONAL CERTIFICATE:

For those applying for a professional certificate for medical diagnosis and treatment:Hos

pitalization records should be sent to the Treatment Department of the Ministryof Health.

For those applying for a professional certificate for pharmacy: Hospitalizationrecords should be sent to the Vietnam Drug Administration under the Ministry ofHealth. For those applying for a professional certificate for traditional medicine: Hospitalizationrecords should be sent to the Traditional Medicine Department of the Ministry ofHealth. APPLICATION PACKAGE TO BE SUBMITTED TO THE DEPARTMENT OF HEALTH DIRECTOR OF A PROVINCE FOR THE ISSUANCE OF A PROFESSIONAL CERTIFICATE: Send to the ProvincialDepartment of Health where the practice is registered.

C. AUTHORITY FOR ISSUING PROFESSIONAL CERTIFICATES

Article 15.AUTHORITY FOR ISSUING PROFESSIONAL CERTIFICATES:

1.APPLICATION PACKAGE FOR THE ISSUE OF A PROFESSIONAL CERTIFICATE: 1.The Ministry of Health issues professional certificates for hospital registration,pharmaceutical business enterprises (including traditional medicine enterprises), andfacilities producing traditional medicine.

Professional certificates issued by the Ministry of Health are valid nationwide. 2.Provincial Departments of Health issue professional certificates for all types exceptthose specified in Clause 1 of this Article.

Professional certificates issued by Provincial Departments of Health are valid withinthe province. The Ministry of Health establishes a Council to assist the Minister of Health inexamining standards for issuing professional certificates. Health.

a)The Council for issuing professional certificates for medical diagnosis and treatmentis chaired by the Deputy Minister responsible for treatment, with the Vice Chairmanbeing the Director of the Treatment Department, and members includingrepresentatives from the Vietnam Medical Association and other members. b)The Council for issuing professional certificates for traditional medicine is chairedby the Deputy Minister responsible for traditional medicine, with the ViceChairman being the Director of the Traditional Medicine Department, and membersincluding representatives from the Vietnam Association of Traditional Medicine andother members.

a) A letter requesting acceptance of the project from the project proponent. c)The Council for issuing professional certificates for pharmacy is chaired by theDeputy Minister responsible for pharmacy, with the Vice Chairman being theDirector of the Vietnam Drug Administration, and members includingrepresentatives from the Vietnam Pharmaceutical Association and other members.

d)For the issuance of professional certificates for pharmacy for those applying toregister pharmaceutical production enterprises, the Council must include amember who is the Director of the Traditional Medicine Department.

Article 164.Provincial Departments of Health establish a Council to assist the Director of theDepartment of Health in examining standards for issuing professional certificates inmedicine and pharmacy. The Council is chaired by a leader of the Department ofHealth, with the Vice Chairman being the Head of the Medical or PharmacyDivision (depending on the type of professional certificate), and membersincluding representatives from the Traditional Medicine Associations, MedicalAssociations, and Pharmaceutical Associations of the province (depending on thetype of professional certificate) and other members.

5.Within thirty days from the date of receipt of a complete application package for theissuance of a professional certificate, the Ministry of Health or ProvincialDepartment of Health must examine and issue the certificate, if refused, there mustbe a written response stating the reasons. 6.Professional certificates are sent and kept as follows:

Professional certificates issued by the Ministry of Health or Provincial Departmentof Health are made in duplicate: one copy retained by the Ministry of Healthif issued by the Minister of Healthor Provincial Department of Health (ifissued by the Provincial Department of Health Director), one copy for theapplicant.

7.A model of the professional certificate is attached to this Circular*. Those violating the provisions of this Circular will be subject to disciplinary action,administrative penalties, or criminal prosecution according to the law, dependingon the severity and nature of the violation.

1.Professional certificates will be revoked from holders in the following cases:a)Transferring or selling professional certificates;

3.The Ministry of Health shall assign the Planning Department to coordinate with the Financial Accounting Department, International Cooperation Department, and the Project Management Board to be responsible for organizing project evaluations upon completion. b)Lending or renting professional certificates to others; c)Using professional certificates for purposes other than intended;

d)Practicing beyond the permitted scope or violating medical technical regulationscausing serious consequences to patients' health; e)Violating the law or professional ethics in medical or traditional medicine practice;

f)Death of the holder of the professional certificate. 2.Authorities issuing professional certificates have the right to revoke professionalcertificates in cases stipulated in Clause 1 of this Article.

c)The Pharmacy Practice License Issuing Council, chaired by the Deputy Ministerresponsible for pharmaceutical affairs, with the Director General of theVietnamese Drug Administration as Vice-Chairman, and representatives fromthe Vietnam Pharmaceutical Association and other members.

Specifically, when issuing a pharmacy practice license to individuals applyingto establish a traditional medicine manufacturing business, the licensingcommittee must include an additional member from the Department of TraditionalMedicine.traditional medicine.

4.The Provincial Health Department shall establish a council to review and issuepractice licenses to assist the Provincial Health Department Director in reviewing criteria for issuing practice licenses for medicine and pharmacy.The council shall be chaired by a leader of the Provincial Health Department, with the Head of the Medical or Pharmaceutical Department (depending on thetype of practice license) serving as Vice-Chair, and other members includingrepresentatives from the Provincial Traditional Medicine Association, thePharmaceutical Association of the province (depending on the type of practice license) and other members. Y5.Within thirty days from the date of receiving complete application files for aproperly issued practice license,

the Ministry of Health or the Provincial Health Department must review andissue the license; if refusal to issue the license, a written response with clearreasons must be provided. 6.The practice license shall be sent and kept as follows:.

The practice license issued by the Ministry

of Health or authorized by the Provincial Health Department Director shall beprepared in two copies: one copy retained by the Ministry of Health2.The Project Management Board shall provide comments on the adjustmentrequest of the project owner and submit to the Planning Department for thePlanning Department to review or organize an assessment. if issued by the Ministry of Health Minister of Health or the Provincial Health Department (if issued by the Provincial HealthDepartment Director), one copy given to the applicant. 7.A model of the practice license is attached to this Circular*

.Persons violating the provisions of this Circular will be subject to disciplinaryaction, administrative penalties, or criminal prosecution according to the law,depending on the severity and nature of the violation.

 

Chapter IV

HANDLING VIOLATIONS

Article 171.Practice licenses may be revoked in the following cases:

Article 18.

a)Transferring or assigning a practice license;

b)Lending or renting a practice license to others;

c)Using a practice license for unauthorized purposes;

d)Practicing beyond the permitted scope or violating professional medicaltechnical regulations causing serious harm to patient health;

e)Violating the law or professional ethics in the practice of pharmacy ortraditional medicine;

f)The death of the holder of the practice license.

2.Authorities issuing practice licenses have the right to revoke licenses in thecases stipulated in Clause 1 of this Article.

The Ministry of Health shall organize guidance, direction, inspection, andaudits regarding the implementation of this Circular. This Circular takes effect fifteen days after its issuance date and repealsCircular No. 19/2000/TT-BYT dated November 24, 2000 of the Ministry of Healthon guiding the issuance of practice licenses for medical examination andtreatment, Circular No. 20/2000/TT-BYT dated November 28, 2000 of the Ministryof Health on guiding the issuance of traditional medicine practice licenses forregistration of medical examination and treatment services using traditionalmedicine and the sale of traditional medicine, Circular No. 01/2001/TT-BYTdated January 19, 2001 of the Ministry of Health on guiding the issuance ofpharmacy practice licenses, and Circular No. 18/2001/TT-BYT

 

Chapter V

IMPLEMENTING PROVISIONS

Article 19.

1. The practice certificate only has value for registering to conduct pharmaceutical and medical services businesses. Prior to commencing operations, entities must comply with the provisions of the Law on People's Health Protection, the Private Medical and Pharmaceutical Practice Ordinance, and the guiding documents implementing this Ordinance.

2. The Director of the Treatment Department, the Director of the Vietnam Drug Administration, and the Director of the Traditional Medicine Department shall cooperate with the Legal Affairs Department and other relevant departments and the Ministry of Health Inspectorate to organize guidance, direction, and inspection of the implementation of this Circular. 3. This Circular takes effect fifteen days after its date of issuance and revokes Circular No. 19/2000/TT-BYT dated November 24, 2000, issued by the Ministry of Health regarding guidelines for issuing practice certificates for medical examination and treatment; Circular No. 20/2000/TT-BYT dated November 28, 2000, issued by the Ministry of Health regarding guidelines for examining and issuing traditional medicine practice certificates for registering to conduct medical examination and treatment services using traditional medicine and selling traditional medicine drugs; Circular No. 01/2001/TT-BYT dated January 19, 2001, issued by the Ministry of Health regarding guidelines for issuing pharmaceutical practice certificates; and Circular No. 18/2001/TT-BYT dated August 2, 2001, issued by the Ministry of Health amending Article 5 and Article 7 of Circular No. 01/2001/TT-BYT dated January 19, 2001, issued by the Minister of Health, concerning the examination and issuance of pharmaceutical business practice certificates. In the course of implementation, if there are difficulties or obstacles, units and localities must report to the Ministry of Health (Legal Affairs Department) for study and resolution./. dated August 2, 2001 of the Ministry of Health amending Articles 5 and 7 ofCircular No. 01/2001/TT-BYT dated January 19, 2001 of the Minister of Healthguiding the issuance of practice licenses for pharmaceutical businessoperations. During implementation, any difficulties or issues should bereported to the Ministry of Health (Legal Affairs Department) for study andresolution./.

This Circular takes effect fifteen days from the date of issuance andrepeals Circular No. 19/2000/TT-BYT dated November 24, 2000 of the Ministry ofHealth on guiding the issuance of practice certificates for medical and healthservices, Circular No. 20/2000/TT-BYT dated November 28, 2000 of the Ministry ofHealth on guiding the examination and issuance of traditional medicinepractice certificates for registering to operate medical and health servicesservices using traditional medicine and operating traditional medicineproducts, Circular No. 01/2001/TT-BYT dated January 19, 2001 of the Ministryof Health on guiding the issuance of pharmacy practice certificates, andCircular No. 18/2001/TT-BYT dated August 2, 2001 of the Ministry of Healthamending Article 5 and Article 7 of Circular No. 01/2001/TT-BYT dated January19, 2001 of the Minister of Health guiding the examination and issuance ofpharmacy business practice certificates. tế về việc hướng dẫn cấp chứng chỉ hành nghề khám chữa bệnh, Thôngtư số 20/2000/TT-BYT ngày 28/11/2000 của Bộ Y tế về việc hướng dẫn xét cấp giấychứng chỉ hành nghề y dược học cổ truyền để đăng ký kinh doanh dịch vụ khámchữa bệnh bằng y học cổ truyền và kinh doanh thuốc y học cổ truyền, Thông tư số01/2001/TT-BYT ngày 19/1/2001 của Bộ Y tế về việc hướng dẫn cấp chứng chỉ hành nghề dược, Thông tư số18/2001/TT-BYT During implementation, if there are difficulties or obstacles, units andlocalities must report to the Ministry of Health (Legal Department) for studyand resolution./.

 

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