Circular No. 04/2002/TT-BYT dated May 24, 2002 of the Ministry of Health guiding the consideration and granting of medical and pharmaceutical practice certificates

CIRCULAR

GUIDING THE CONSIDERATION AND GRANTING OF MEDICAL AND PHARMACEUTICAL PRACTICE CERTIFICATES

Pursuant to the Law on Protection of People’s Health and the documents guiding the implementation thereof;

Pursuant to the Enterprise Law and the documents guiding the implementation thereof;

Pursuant to the Ordinance on Private Practice of Medical and Pharmaceutical Professions and the documents guiding the implementation thereof;

The Health Ministry hereby guides the consideration and granting of "medical and pharmaceutical practice certificates" as follows:

Chapter I

GENERAL PROVISIONS

Article 1.-The medical and pharmaceutical practice certificate prescribed by this Circular is the document considered and granted by the Health Ministry or the Health Services of the provinces or centrally-run cities (hereinafter referred collectively to as provinces) to individuals who have full professional qualifications, professional ethics and experiences for registration of medical and/or pharmaceutical practices at private, semi-public and people-founded establishments (hereinafter called the professional practice certificates) under the provisions of the Enterprise Law and documents guiding the implementation thereof.

Article 2.-The professional practice certificates shall include the following types:

1. Medical examination and treatment practice certificate.

2. Traditional medicine or pharmacy practice certificate:

2.1. Certificate of practice of medical examination and treatment with traditional medicine;

2.2. Certificate of traditional pharmacy practice.

3. Pharmaceutical practice certificate.

Article 3.-Individuals who fully meet the criteria as prescribed by this Circular and wish to practice medical and/or pharmaceutical profession shall be considered for granting of professional practice certificates.

Article 4.-Professional practice certificates shall be granted only to individuals, not to organizations. Each individual shall be granted only one type of professional practice certificate for registration of one form of professional practice and must not practice his/her profession beyond the permitted scope.

Article 5.-It is strictly forbidden to let other persons borrow, rent certificates for professional practice or use for other purposes.

Article 6.-The professional practitioners shall have to strictly comply with the regulations on medically technical operations. In the course of professional practice, the practitioners must continue their study to raise their professional skills and firmly grasp the branch’s regulations and the State’s laws.

Annually, the Health Ministry and/or provincial Health Services shall organize refresher courses to raise professional qualifications, popularize and update legal documents on health and relevant regulations.

Article 7.-The validity duration of a professional practice certificate shall be 5 years.

After 5 years, the professional practice certificate holders (if wishing to extend them) shall have to file dossiers to the agencies which have issued the professional practice certificates for carrying out the procedures for extension.

Chapter II

CRITERIA FOR THE GRANTING OF MEDICAL, PHARMACEUTICAL PRACTICE CERTIFICATES

A. MEDICAL EXAMINATION AND TREATMENT PRACTICE CERTIFICATES

Article 8.-General criteria:

1. Individuals who wish to be granted the medical examination and treatment practice certificates must satisfy all the following criteria:

1.1. Having diplomas of graduation from medical and/or pharmaceutical universities, other universities, medical colleges or intermediate medical schools and having adequate professional practice time as prescribed for each form of professional practice.

1.2. Having professional ethics, full civil act capacity and good health for medical examination and treatment practice.

1.3. Having knowledge about the Law on Protection of People’s Health, the Ordinance on Private Practice of Medical and Pharmaceutical Professions and the relevant legal documents on health.

1.4. Being knowledgeable about the Twelve-Article Regulation on Physicians’ ethics (issued together with the Health Minister’s Decision No.2088/QD-BYT of January 6, 1996), the Regulation on Hospitals (issued together with the Health Minister’s Decision No.1895/1997/QD-BYT of September 19, 1997), the Regulation on Management of Medical Wastes (issued together with the Health Minister’s Decision No. 3575/1999/QD-BYT of August 27, 1999).

1.5. Being knowledgeable about universal national health programs.

1.6. Committing to observe the above-mentioned legal documents (Points 1.3 and 1.4), the medically technical operation regulations and other relevant legal documents.

2. Having full civil act capacity and good health to practice medical examination and treatment.

3. Not being in the period of being banned from professional practice or banned from doing health-related jobs under court decisions, not being examined for penal liability or being subject to administrative surveillance measures; not being in the period of serving imprisonment sentence or subject to decisions on application of administrative measures of being sent to reformatories or compulsory medical treatment establishments.

Article 9.-Specific criteria

Apart from the general criteria prescribed in Article 8 of this Circular, the applicants for medical examination and treatment practice certificates must also satisfy the following specific criteria:

1. The applicants for medical examination and treatment practice certificates for the registration of hospitals or general consultation clinics must be general or specialized physicians who have practiced their professions for 5 years at lawful medical examination and treatment establishments.

2. The applicants for medical examination and treatment practice certificates for the registration of other forms excluding the form of hospitals:

a/ Internal medicine consultation clinics:

They must be general physicians or specialized internal medicine physicians who have practiced, their profession for 5 years at lawful medical examination and treatment establishments, including at least 3 years for practice of internal medicine.

In highland regions, they must be assistant physicians who have practiced their profession for 5 years at lawful medical examination and treatment establishments or physicians who have practiced profession for at least 3 years at lawful medical examination and treatment establishments.

b/ Specialized surgery consultation clinics:

They must be general physicians or specialized surgeons who have practiced their profession for 5 years at lawful medical examination and treatment establishments, including at least 3 years for surgical practice.

c/ Specialized obstetric clinics, family planning clinics:

They must be general physicians or specialized obstetricians, who have practiced their profession for 5 years at lawful medical examination and treatment establishments, including at least 3 years for obstetric practice.

In highland areas, they must be assistant obstetricians or midwives of intermediate level, who have practiced their specialty for 3 years at lawful medical examination and treatment establishments.

d/ Specialized dento-maxillo-facial consultation clinics:

They must be general physicians or dento-maxillo-facial physicians, who have practiced their profession for 5 years at lawful medical examination and treatment establishments, including at least 3 years for dento-maxillo-and facial practice.

e/ Specialized O.R.L. consultation clinics:

They must be general physicians or specialized O.R.L. physicians, who have practiced their profession for 5 years at lawful medical examination and treatment establishments, including at least 3 years for specialized practice.

f/ Specialized opthalmological consultation clinics:

They must be general physicians or opthalmologists, who have practiced their profession for 5 years at lawful medical examination and treatment establishments, including 3 years for opthalmological practice.

g/ Specialized aesthetic surgery clinics:

The physicians have practiced their profession for 5 years at lawful medical examination and treatment establishments, including at least 3 years for practice of specialized plastic or aesthetic surgery.

h/ Specialized convalescence- Functional Rehabilitation and physical therapy clinics:

The physicians have practiced their profession for 5 years at lawful medical examination and treatment establishments, including at least 3 years for practice of specialized convalescence- functional rehabilitation and physical therapy.

i/ Image diagnose clinics:

They must be general or specialized physicians, bachelor of X-ray (university graduate), of image diagnosis, who have practiced their specialty for 5 years at lawful medical examination and treatment establishments.

In highland areas, they must be physicians who have practiced their profession for 5 years at lawful medical examination and treatment establishments, including at least 3 years for practice of specialized image diagnosis.

j/ Laboratories:

They must be physicians or pharmacists, bachelors of biology or chemistry, test technicians (university graduates) who have practiced their specialty for 5 years at lawful medical examination and treatment establishments.

In highland areas, the professional practice registrants must be physicians, pharmacists, bachelors of biology or chemistry, who have practiced their specialty for 5 years at lawful medical examination and treatment establishments, including at least 3 years for specialized practice.

k/ Maternity homes:

They must be general physicians or specialized obstetricians, midwives of intermediate or higher level, who have practiced their specialty for 5 years at lawful medical examination and treatment establishments, including at least 3 years for obstetric practice.

In highland areas: They must be specialized obstetricians or midwives of intermediate or higher level, who have practiced their specialty for 3 years at lawful medical examination and treatment establishments. Those who are granted the professional practice certificates must be full-time practitioners.

B. TRADITIONAL MEDICINE, PHARMACY PRACTICE CERTIFICATES

Article 10.-General criteria.

1. Having diplomas of traditional medicine physicians or assistant physicians, diplomas of graduation from pharmacy universities, intermediate or primary pharmacy schools, or certificates of galenic physicians, pharmacists, or certificates of traditional medicine or pharmaceutical qualifications, and having time of practice at lawful traditional medicine establishments, depending on the requirements of each form of professional practice.

2. Having professional ethics and experiences.

3. Having full civil act capacity and good health for the practice of traditional medicine or pharmacy.

4. Not being in the period of being banned from professional practice or banned from doing health-related jobs under court decisions, not being examined for penal liability or being subject to administrative surveillance measures; not being in the period of serving imprisonment sentence or subject to decisions on the application of administrative measures of being sent to reformatories or compulsory medical treatment establishments.

5. Having knowledge about and committing to strictly observe the provisions of the Law on Protection of People’s Health, the Ordinance of Private Practice of Medical and Pharmaceutical Professions, the Regulation on practice of medical examination and treatment with traditional medicine and the documents guiding the implementation of the Law and the Ordinance, the traditional medicine and pharmacy practitioners’ ethics according to 9 medical instructions and saying of Hai Thuong Lan Ong, and the relevant professional regulations.

Article 11.-In addition to the general criteria prescribed in Article 10, the grantees of certificates of traditional medicine or pharmacy practice must satisfy all the following specific criteria:

1. For grantees of certificates of practice of medical examination and treatment with traditional medicine:

1.1. For registration of traditional medicine hospitals:

a/ They must have a graduation diploma of traditional medicine physician or a certificate of galenic physician granted by the Health Ministry.

b/ They have practiced their profession for 5 years or more at traditional medicine hospitals, traditional medicine departments of general hospitals or institutes with hospital beds.

1.2. For registration of services on medical examination and treatment with traditional medicine (except for the form prescribed in Clause 1 of this Article):

a/ They must have graduation diploma of traditional medicine physician, traditional medicine assistant physician, a galenic physician certificate, or a family-handed down prescription certificate.

b/ They have a professional practice duration of 2 years or more at lawful establishments for medical examination and treatment with traditional medicine.

2. For grantees of "traditional medicine practice certificates":

2.1. For business registration of private production of traditional medicines (cataplasm, ixora, powder and pill,…) or dealing in family-handed down prescription:

a/ They must have a pharmacist’s diploma and certificate of traditional pharmacy study, or a traditional medicine physician, galenic physician or pharmacist certificate granted by provincial/municipal Heath Services or the Health Ministry.

b/ They have practiced for 2 years or more at lawful traditional medicine trading establishments.

2.2. For registration of individual business households dealing in traditional medicines:

a/ They must be pharmacists of intermediate or higher level and have the certificate of traditional pharmacy study, or be traditional medicine physicians or assistant physicians, galenic physician or pharmacists, or be the grantees of certificates of professional qualifications for traditional medicine business, issued by provincial/municipal Health Services.

b/ They have practiced their profession for 2 years or more at lawful traditional medicine trading establishments.

2.3. For registration of individual business households dealing in raw pharmaceuticals:

a/ They must be pharmacists of primary or higher level, who have been fostered in oriental pharmacy, or be traditional medicine assistant physicians or physicians, galenic physicians or pharmacists, grantees of certificates of professional qualifications for dealing in raw pharmaceutical, issued by provincial/municipal Health Services.

b/ They have practiced for 2 years or more at lawful raw pharmaceutical trading establishments.

2.4. For business registration of traditional medicine agents

a/ Having certificate of professional qualifications for opening traditional medicine agents, granted by Health Services.

b/ Having the practice duration of 2 years or more at lawful traditional medicine agency establishments.

C. PHARMACEUTICAL PRACTICE CERTIFICATES

Article 12.-General criteria

1. Having pharmacy diplomas or certificates and having adequate time of practice at lawful pharmaceutical establishments, depending on each form of professional practice.

2. Having full civil act capacity and good health for pharmaceutical practice.

3. Not being in the period of being banned from professional practice or from doing health-related jobs under court decisions, not being examined for penal liability or being subject to administrative surveillance measure; not being in the period of serving imprisonment sentence or subject to decision on application of administrative measures of being sent to reformatories or compulsory medical treatment establishments.

4. Having knowledge about and committing to observe the Law on Protection of People’s Health, the legislation on private medical and pharmaceutical practice and other professional regulations related to pharmaceutical practice.

Article 13.-Specific criteria:

1. Individuals registering the form of enterprises dealing in pharmaceuticals and persons in charge of dependent units of the enterprises:

- Having university diplomas in pharmacy and having practiced for 5 years at lawful pharmaceutical establishments.

- Having certificates of galenic pharmacist’s or physician’s professional qualifications or certificates of family-handed down prescriptions, granted by the Health Ministry and having practiced for 5 years at lawful traditional medicine or pharmaceutical establishments, for individual registrants of the form of enterprises only dealing in traditional medicines.

2. Individuals registering the form of private drug stores:

2.1. Having university diplomas in pharmacy and having practiced for 5 years at lawful pharmaceutical establishments.

2.2. For mountainous, highland, island regions, areas inhabited by ethnic minority people, deep-lying and far-flung areas: Having university diplomas in pharmacy and having practiced for 2 years at lawful pharmaceutical establishments. Those who are granted certificates of pharmaceutical business practice under the provisions in this point shall only be allowed to conduct professional practice within those areas.

3. Individuals registering the form of drug retail agents: Having intermediate- or primary-level pharmacist diploma and having practiced for 2 years at lawful pharmaceutical establishments.

Chapter III

DOSSIERS, PROCEDURES, COMPETENCE FOR GRANTING OF MEDICAL OR PHARMACEUTICAL PRACTICE CERTIFICATES

Article 14.-Dossiers of application for granting, extension of professional practice certificates shall include:

1. The dossiers of application for granting of professional practice certificate:

a/ The application for granting of professional practice certificate.

b/ The graduation diploma or professional qualification certificate (lawful copies thereof).

c/ Curriculum vitae with certification by the People’s Committee of the commune, ward or district town, where the applicant has registered his/her permanent residence, or by the head of the agency where such person is working.

d/ The written certification of the practice duration, signed and sealed by the head of the unit where he/she has practiced his/her profession.

e/ The health certificate granted by a health center of district, provincial town or higher level.

f/ The written commitment to strictly observe the provisions of the Law on Protection of People’s Health, the Ordinance on Private Practice of Medical and Pharmaceutical Professions, legal documents guiding the implementation of the Law and the Ordinance as well as relevant professional regulations.

g/ The permit for professional practice outside the working hours, issued by the head of the unit if the applicant is working at a State-run medical or pharmaceutical establishment.

h/ Individuals applying for professional practice certificate to register their hospitals, pharmaceutical production and/or business enterprises must get the certification of being not State employees.

i/ 3 portrait photos of 3 x 4 cm size.

2. The dossiers of application for extension of professional practice certificate:

a/ The application for extension of the professional practice certificate.

b/ The health certificate granted by a health center of the district, provincial town or higher level.

c/ The permit to continue professional practice outside the working hours, issued by the unit head if the applicant is working at a State-run medical or pharmaceutical establishment.

d/ The written certification by the Health Ministry or the provincial/municipal Health Service of having gone through training courses for updating professional knowledge and health legislation, organized by the Health Ministry of provincial/municipal Health Services.

B. PROCEDURES FOR GRANTING PROFESSIONAL PRACTICE CERTIFICATES

Article 15.-Procedures:

1. Dossiers proposing the Health Minister to grant professional practice certificates:

- For persons requesting the granting of medical examination and treatment practice certificates: The dossiers shall be sent to the Therapy Department, the Health Ministry.

- For persons requesting the granting of pharmaceutical practice certificates: The dossiers shall be sent to Vietnam Pharmaceutical Management Department of the Health Ministry.

- For persons requesting the granting of traditional medicine or pharmacy practice certificates: The dossiers shall be sent to the Traditional Medicines Department, the Health Ministry.

2. The dossiers proposing the directors of the provincial/municipal Health Services to grant professional practice certificates: To be sent to the provincial/municipal Health Services where professional practice is registered.

C. COMPETENCE TO GRANT PROFESSIONAL PRACTICE CERTIFICATES

Article 16.-Competence to grant professional practice certificates:

1. The Health Ministry shall grant professional practice certificates for registration of hospitals, pharmaceutical business enterprises (including traditional medicines trading enterprises), traditional medicine- producing establishments.

The professional practice certificates granted by the Health Ministry shall be valid nationwide.

2. The provincial/municipal Health Services shall grant professional practice certificates for various forms excluding those prescribed in Clause 1 of this Article.

The professional practice certificates granted by a provincial/municipal Health Service shall be valid within the province.

3. The Health Ministry shall set up Councils for Consideration of the granting of professional practice certificates to assist the Health Minister in considering the criteria for granting of professional practice certificates.

a/ The Council for consideration of the granting of medical examination and treatment practice certificates shall be composed of a vice-minister in charge of therapy as its chairman, the Therapy Department director as its vice-chairman, representatives of the Vietnam Federation of Medical and Pharmaceutical Associations and others as its members.

b/ The Council for consideration of the granting of certificates of traditional medicine or pharmacy practice shall be composed of a vice-minister in charge of traditional medicine and pharmacy as its chairman, the Traditional Medicine Department director as its vice-chairman, representative of Vietnam Oriental Medicine Association and others as its members.

c/ The Council for consideration of the granting of pharmaceutical practice certificates shall be composed of a vice-minister in charge of pharmacy as its chairman, the Vietnam Pharmaceutical Management Department director as its vice-chairman, representatives of Vietnam Pharmacy Association and others as its members.

Particularly for the consideration of the granting of pharmaceutical practice certificates to the applicants for the registration of traditional medicine-producing enterprises, the Council for consideration of certificate granting must also include a member being the director of the Traditional Medicine Department.

4. The provincial/municipal Health Services shall set up Councils for consideration of the granting of professional practice certificates to assist the Service directors in considering the criteria for the granting of medical or pharmaceutical practice certificates. Such a Council shall be composed of a member of the Service’s leadership as its chairman, the head of the Medical or Pharmaceutical Section (depending on type of professional practice certificate) as its vice-chairman, the representatives of the Oriental Medicine Association, the Medicinal Association and the Pharmaceutical Association of the province as well as others as its members.

5. Within 30 days as from the date of receiving complete and valid dossiers of application for the granting of professional practice certificates, the Health Ministry or the provincial/municipal Health Services shall have to consider the granting thereof; if refusing to grant the certificates, they must give written replies and clearly state the reasons therefor.

6. The professional practice certificates shall be sent and kept as follows:

The professional practice certificates granted by the Health Minister or directors of the provincial/municipal Health Services shall be made in 2 copies: 1 copy shall be kept at the Health Ministry (if granted by the Health Minister) or the provincial Health Service (if granted by the director of the provincial/municipal Health Service), and 1 copy given to the applicant.

7. The professional practice certificate forms are attached to this Circular (not printed herewith).

Chapter IV

HANDLING OF VIOLATIONS

Article 17.-The violators of the provisions of this Circular shall, depending on the seriousness and nature of their violations, be disciplined, administratively handled or examined for penal liability according to the provisions of law.

Article 18.-

1. The grantees of professional practice certificates shall have their certificates withdrawn in the following cases:

a/ The certificates are transferred or assigned.

b/ The certificates are lent or leased to other persons.

c/ The certificates are used not for the right purposes.

d/ The professional practice is carried out beyond the permitted scope or in violation of regulations on medically technical operations, causing serious consequences to patients’ health.

e/ The violation(s) of law, the regulations on physicians’ ethics, on morality in pharmaceutical practice, morality in traditional medicine practice is (are) committed.

f/ The professional practice certificate grantee dies.

2. The agencies competent to grant professional practice certificates shall have the right to withdraw such certificates in cases prescribed in Clause 1 of this Article.

Chapter V

IMPLEMENTATION PROVISIONS

Article 19.-

1. The professional practice certificates shall be valid only for business registration of medical and pharmaceutical services. Before commencing their operations, the establishments must implement the provisions of the Law on Protection of People’s Health, the Ordinance on Private Medical and Pharmaceutical Practice and the documents guiding the implementation of this Ordinance.

2. The directors of the Therapy Department, the Vietnam Pharmaceuticals Management Department and of the Traditional Medicine Department shall coordinate with the Legal Department as well as functional Departments, the Inspectorate, of the Health Ministry in guiding, directing, examining and inspecting the implementation of this Circular.

This Circular shall take effect 15 days after its signing for promulgation, annulling Circular No.19/2000/TT-BYT of November 24, 2000 of the Health Ministry on guidance for the granting of medical examination and treatment practice certificates, Circular No.20/2000/TT-BYT of November 28, 2000 of the Health Ministry on guidance for the granting of certificates of traditional medicine and/or pharmacy practice for business registration of services on medical examination and treatment with traditional medicines and on trading in traditional medicines, Circular No.01/2001/TT-BYT of January 19, 2001 of the Health Ministry on guidance for the granting of pharmaceutical practice certificates, Circular No.18/2001/TT-BYT of August 2, 2001 of the Health Ministry amending Articles 5 and 7 of Circular No.01/2001/TT-BYT of January 19, 2001 of the Health Minister guiding the granting of pharmaceutical practice certificates. If any difficulties or problems arise in the course of implementation, units and localities are requested to report them to the Health Ministry (the Legal Department) for study and settlement.