Pháp lệnh 07/2003/PL-UBTVQH11 Về hành nghề y, dược tư nhân năm 2003

ON PRIVATE MEDICAL AND PHARMACEUTICAL PRACTICE
(No. 07/2003/PL-UBTVQH11 of February 25, 2003)

In order to ensure health safety and create favorable conditions for medical examinations and treatments of people; to materialize the policy of socialization and diversification of types of medical and pharmaceutical services; to uniformly manage and put the private medical and pharmaceutical practice into operation according to law;

Pursuant to the 1992 Constitution of the Socialist Republic of Vietnam, which was amended and supplemented under Resolution No.51/2001/QH10 of December 25, 2001 of the Xth National Assembly, the 10th session;

Pursuant to the Law on Protection of People’s Health;

Pursuant to Resolution No. 12/2002/QH11 of December 16, 2002 of the XIth National Assembly, the second session, on law- and ordinance-making programs of the XIth National Assembly, for its whole term (2002-2007) as well as for 2003;

This Ordinance prescribes private medical and pharmaceutical practice,

Chapter I

Article 1.- Domestic and foreign organizations as well as individuals, that meet all the conditions prescribed in this Ordinance, shall be entitled to private medical and pharmaceutical practice.

Article 2.-

1. The private medical and pharmaceutical practice covers:

a) Medical practice;

b) Practice of traditional medicine and pharmacy;

c) Pharmaceutical practice;

d) Practice of vaccines and medical bio-products;

e) Practice of medical equipment and facilities.

2. Private medical and/or pharmaceutical practice establishments include:

a) Private medical or pharmaceutical establishments;

b) People-founded medical or pharmaceutical establishments;

c) Foreign-invested medical or pharmaceutical establishments.

Article 3.- In this Ordinance, the following terms and phrases shall be construed as follows:

1. Private medical or pharmaceutical practice means individuals or organizations register to provide medical examination and/or treatment; to deal in pharmaceuticals, vaccines, medical bio-products, medical equipment, under the provisions of this Ordinance and other relevant law provisions.

2. Private medical or pharmaceutical establishments are those registered for business, managed and administered by individuals, family households or enterprises.

3. People-founded medical or pharmaceutical establishments are those set up by organizations, invested with non-state budget capital contributed by organizations and/or individuals, and self-managed and administered.

4. Private medical or pharmaceutical practice certificates are documents granted by competent State management bodies to individuals who fully meets the practicing conditions as prescribed by this Ordinance.

5. Certificates of eligibility for private medical or pharmaceutical practice are documents granted by competent State management bodies to establishments which satisfy all practicing conditions as prescribed by this Ordinance.

Article 4.-

1. The heads of the traditional- medicine or –pharmacy establishments, pharmaceutical, vaccine or medical bio-product establishments must have private medical or pharmaceutical practice certificates. For enterprises dealing in pharmaceuticals, vaccines and/or medical bio-products, the heads or professional managers thereof must have private medical or pharmaceutical practice certificates.

2. Traditional-medicine or- pharmacy establishments, pharmaceutical, vaccine and/or medical bio-product establishments and enterprises manufacturing medical equipment must have certificates of eligibility for private medical or pharmaceutical practice.

Article 5.-

1. Individuals and organizations engaged in private medical or pharmaceutical practice must abide by the provisions of this Ordinance and other relevant law provisions.

2. The legitimate rights and interests of individuals and organizations engaged in private medical or pharmaceutical practice shall be protected by the State.

Article 6.- The following persons shall not be granted private medical or pharmaceutical practice certificates:

1. Persons who are in the period of being banned from professional practice, from performance of work related to medical or pharmaceutical profession under court judgments or decisions;

2. Persons who are being examined for penal liability;

3. Persons who are serving criminal judgments of courts or decisions on the application of administrative measure of being sent to education camps or medical establishments, or on administrative probation;

4. Persons who are being disciplined for violations in medical or pharmaceutical profession;

5. Persons who lose or are restricted in their civil act capacity.

Article 7.- The following acts are strictly forbidden:

1. Abusing the State-run material and technical foundations for the private medical or pharmaceutical practice;

2. Renting or borrowing private medical or pharmaceutical practice certificates.

Article 8.- The State encourages the development of private medical and/or pharmaceutical establishments and create conditions for private medical or pharmaceutical practitioners to join professional associations.

Chapter II

Section 1. GENERAL CONDITIONS ON PRIVATE MEDICAL OR PHARMACEUTICAL PRACTICE

Article 9.- Persons who are granted certificates of private practice of medicine, traditional medicine and pharmacy, pharmaceutical, vaccines or medical bio-products must satisfy all the following conditions:

1. Having diplomas compatible with the organizational forms and scope of professional practice;

2 Having practiced for a given period of time at medical or pharmaceutical establishments;

3. Having professional ethics;

4. Having good health for professional practice;

5. Satisfying other conditions as prescribed in Articles 17, 22, 27 and 31 of this Ordinance, depending on each organizational form of professional practice;

6. Not being the subjects prescribed in Article 6 of this Ordinance.

Article 10.- Individuals and organizations prescribed in Article 9 of the Enterprise Law must not set up and manage the following forms of private medical or pharmaceutical organizations:

1. Hospitals;

2. Traditional-medicine hospitals;

3. Enterprises dealing in pharmaceuticals, vaccines, medical bio-products or medical equipment;

4. General or specialized consultation clinics, maternity homes, clinics for therapy with traditional medicine, registered for business under the Enterprise Law.

Article 11.- Those who have private medical or pharmaceutical practice certificates may only head or professionally manage a private medical or pharmaceutical establishment in compatibility with the professional scopes prescribed in the certificates of eligibility for private medical or pharmaceutical practice.

Article 12.- Basing itself on the socio-economic conditions, the actual situation of the contingent of the State medical workers and the medical examination and treatment demands of people in regions facing particularly difficult socio-economic conditions, regions facing difficult socio-economic conditions and regions inhabited by ethnic minority people in each given period, and on the provisions in Articles 17, 22, 27 and 31 of this Ordinance, the Health Ministry shall specify the conditions on professional diplomas and practice duration in order to be granted certificates of private medical or pharmaceutical practice in those regions.

Article 13.-

1. Private medical or pharmaceutical establishments must be adequately staffed with professionals, ensure conditions on location, medical equipment and facilities and other necessary conditions as prescribed by law.

2. The professionals in private medical or pharmaceutical establishments must have diplomas, certificates of professional qualifications compatible with their assigned jobs and must observe the provisions of labor legislation.

3. The Health Ministry shall specify the conditions and scope of professional practice for each organizational form of private medical or pharmaceutical practice.

Article 14.-

1. Foreign individuals and organizations engaged in private medical or pharmaceutical practice in Vietnam must comply with the provisions of legislation on foreign investment in Vietnam and the provisions of this Ordinance.

2. Foreigners performing professional work in private medical establishments, traditional-medicine or –pharmacy establishments must obtain the permission of the Health Ministry of Vietnam.

3. Foreigners directly giving medical examination or treatment to Vietnamese must be fluent in Vietnamese language or have interpreters. The interpreters must have the medical degree of intermediate or higher level; for traditional medicine or pharmacy, the interpreters must be the galenic physicians or have the intermediate or higher degree in traditional medicine.

4. The Health Ministry shall specify the private medical or pharmaceutical practice by foreign individuals and/or organizations in Vietnam.

Article 15.-

1. The private medical or pharmaceutical practice certificates shall be withdrawn in the following cases:

a) They are granted ultra vires;

b) The certificate grantees later fall into one of the cases prescribed in Article 6 of this Ordinance;

c) The certificate grantees die;

d) The certificate grantees violate law provisions on medicine, pharmacy;

e) Other cases prescribed by law.

2. The certificates of eligibility for private medical or pharmaceutical practice shall be withdrawn in the following cases:

a) The heads of private medical, traditional-medicine or - pharmacy, pharmaceutical, vaccine or medical bio-product establishments or professional managers of private pharmaceutical, vaccine or medical bio-product establishments have no practice certificates;

b) The certificates of eligibility for private medical or pharmaceutical practice have been granted ultra vires;

c) The private medical or pharmaceutical establishments fail to satisfy the conditions set by the Health Ministry;

d) Within 12 months as from the date of being granted certificates of eligibility for private medical or pharmaceutical practice, the private medical or pharmaceutical establishments still fail to operate;

e) The private medical or pharmaceutical establishments go bankrupt or dissolve;

f) Other cases prescribed by law.

3. The Government shall prescribe the order and competence to withdraw private medical or pharmaceutical practice certificates and certificates of eligibility for private medical or pharmaceutical practice.

Section 2. PRIVATE MEDICAL PRACTICE

Article 16.- Organizational forms of private medical practice shall include:

1. General hospitals, specialized hospitals;

2. General consultation clinics, specialized consultation clinics;

3. Maternity homes;

4. Medical service establishments;

5. Service establishments for domestic and overseas transportation of patients.

Article 17.- Private medical practice certificate grantees must satisfy the following conditions:

1. The conditions prescribed in Article 9 of this Ordinance;

2. Having one of the following diplomas, depending on the requirements of each organizational form and scope of professional practice:

a) Diploma of graduation from medicine university, pharmacy university, university diploma in biology or chemistry;

b) Medical college graduation diploma;

c) Intermediate medical school diploma;

3. Having practiced for 5 years, for organizational forms of professional practice prescribed in Clauses 1, 2, 3 and 5, Article 16 of this Ordinance, at medical examination and treatment establishments; 2 years, for organizational forms of professional practice prescribed in Clause 4, Article 16 of this Ordinance, at medical examination and treatment establishments.

Article 18.-

1. The private medical practitioners being individuals or organizations shall have the following rights:

a) To conduct medical operations within the scope defined in the private medical practice certificates, the private medical practice eligibility certificates;

b) To sign contracts with State-run medical establishments and workers for technical and professional support;

c) To sign contracts with insurance agencies on medical examination and treatment for medically insured persons;

d) To sign contracts with laborers;

e) To reserve the emergency medicine volumes prescribed by the Health Ministry;

f) To receive financial assistance from individuals and organizations according to the provisions of law;

g) To join the Medical Association or other professional associations;

h) To enjoy preferential regimes provided for by law.

2. Private medical practitioners being individuals or organizations shall have the following obligations:

a) To observe the professional and technical regulations of the Health Ministry;

b) To provide emergency treatment to patients according to their respective professional practice capability and scope; where such falls beyond the professional practice scope, to give first-aid and guide the transfer of patients to appropriate medical establishments;

c) To serve the patients attentively, wholeheartedly;

d) To take part in activities of primary healthcare, health protection propagation and guidance; disease prevention and treatment; drug and prostitution prevention and fighting; HIV/AIDS prevention and combat; prevention and combat of sexually transmitted diseases and some other diseases which may cause harms to human health and society; guidance on safe and rational use of medicines;

e) To abide by mobilization decisions of competent State bodies;

f) To promptly report to local medical bodies on detected epidemics, mass poisoning and coordinate with other medical establishments to quickly overcome the consequences;

g) To observe the Health Ministry’s regulations on professional activities, professional fostering;

h) To compile dossiers, books according to law provisions; to supply information in service of medical inspection when so requested; to statistically report to the local medical bodies on professional activities according to the regulations of the Health Ministry and the General Department of Statistics;

i) To put up signboards and post up scope of professional practice and strictly observe the regulations inscribed in the certificates of eligibility for private medical practice;

j) To post up the working time, medical examination and treatment charge rates at private medical establishments and observe the law provisions on prices;

k) To be held responsible before law for their acts of law violation; if causing damage, to pay compensation therefor according to law provisions;

l) To effect professional liability insurance, to fulfill tax and other obligations as provided for by law.

Article 19.- The private medical practitioners may give medical examinations and treatments within their professional practice scopes, may give prescriptions but must not sell medicines.

Article 20.- Private medical practitioners being individuals or organizations are strictly forbidden to perform the following acts:

1. Failing to strictly comply with the regulations in private medical practice certificates, private medical practice eligibility certificates;

2. Applying new professional techniques, using new medicines while giving medical examinations and treatments to patients when not yet so permitted by the Health Ministry.

3. Making advertisements beyond their professional qualifications and practice scopes inscribed in the private medical practice eligibility certificates; making advertisements in contravention of law provisions.

Section 3. PRIVATE PRACTICE OF TRADITIONAL MEDICINE AND/OR PHARMACY

Article 21.- Organizational forms of private practice of traditional medicine and/or pharmacy shall include:

1. Traditional medicine hospitals;

2. Traditional medicine therapy clinics;

3. Service establishments for treatment, convalescence and functional rehabilitation by methods of acupuncture, massage and press on body vital points, light physical exercise, deep-breathing training, medicated inhaling in traditional medicine;

4. Establishments trading in traditional medicines include establishments trading in finished traditional drugs, establishments dealing in loose herbal medicines, establishments trading in unprocessed pharmaceuticals, agents for sale of finished traditional drugs;

5. Centers for traditional-medicine and pharmacy inheritance and application.

Article 22.- Persons granted certificates of practice of traditional medicine or pharmacy must satisfy the following conditions:

1. The conditions prescribed in Article 9 of this Ordinance;

2. Having one of the following diplomas, certificates of professional qualifications, depending on the requirements of each organizational form and scope of professional practice:

a) University or intermediate diploma on traditional medicine;

b) University or intermediate diploma on pharmacy and certificate of training in traditional pharmacy;

c) Certificates of professional qualifications in traditional medicines or pharmacy, granted by the Health Ministry or Health Services of the provinces or centrally-run cities (hereinafter called provincial/municipal Health Services).

3. Having practiced for 5 years, for organizational forms of professional practice prescribed in Clauses 1,2,3 and 5, Article 21 of this Ordinance, at establishments for medical examination and treatment with traditional medicine; 2 years, for the organizational forms of professional practice prescribed in Clause 4, Article 21 of this Ordinance, at traditional-medicine or pharmacy establishments.

Article 23.-

1. Private traditional medicine or pharmacy practitioners being individuals or organizations shall have the following rights:

a) To conduct professional activities in traditional medicine or pharmacy strictly within the scope of private traditional-medicine or-pharmacy practice certificates, private traditional medicine-or-pharmacy practice eligibility certificates;

b) The rights prescribed at Points b, d, f and h, Clause 1, Article 18 of this Ordinance;

c) To sign contracts with insurance agencies on medical examinations and treatments for medically insured persons, except organizational forms of professional practice prescribed in Clause 4, Article 21 of this Ordinance;

d) Private establishments trading in traditional medicines may sell medicines according to prescriptions or refuse to sell medicines according to prescriptions if deeming that the use thereof may adversely affect the users’ health;

e) To join the Eastern Medicine Association or other professional associations.

2. Individuals and organizations practicing traditional medicine or pharmacy shall have the following obligations:

a) The obligations prescribed at Points a, b, c, d, e, f, g, h, k and l of Clause 2, Article 18 of this Ordinance;

b) To put up signboards, post up professional practice scopes and strictly observe the regulations inscribed in the certificates of eligibility for private practice of traditional medicine or pharmacy;

c) To post up the working time, medical examination and treatment charges at their private traditional medicine or pharmacy establishments and observe the law provisions on charges.

Article 24.- Practitioners of medical examination and treatment with traditional medicine and/or pharmacy may give medical examinations, prescriptions and sell traditional medicines to patients at the professional practice establishments.

Article 25.- Private practitioners of traditional medicine or pharmacy, being individuals or organizations are strictly forbidden to perform the following acts:

1. Practicing at variance with the regulations in their private traditional-medicine or pharmacy practice certificates, certificates of eligibility for private practice of traditional medicine or pharmacy;

2. Applying new professional techniques, using new medicines while giving medical examination and/or treatment to patients without permission of the Health Ministry;

3. Employing superstitious practices in medical examination and treatment;

4. Making advertisements beyond their actual professional qualifications and practice scopes inscribed in the certificates of eligibility for private practice of traditional medicine or pharmacy; making advertisements in contravention of law provisions.

Section 4. PRIVATE PHARMACEUTICAL PRACTICE

Article 26.- Organizational forms of private pharmaceutical practice include:

1. Enterprises trading in medicines;

2. Drug stores;

3. Drug sale agents of drug enterprises;

4. Medicine-testing establishments;

5. Medicine preservation establishments.

Article 27.- Private pharmaceutical practice certificate grantees must fully satisfy the following conditions:

1. The conditions prescribed in Article 9 of this Ordinance;

2. Having one of the following diplomas, depending on the requirements of each organizational form and scope of professional practice:

a) University diploma in pharmacy;

b) Intermediate pharmaceutical school diploma;

c) Primary pharmaceutical school diploma;

3. Having practiced for 5 years, for organizational forms of professional practice prescribed in Clauses 1, 2, 4 and 5 of Article 26 of this Ordinance, at pharmaceutical establishments; 2 years, for organizational forms of professional practice prescribed in Clause 3, Article 26 of this Ordinance, at pharmaceutical establishments.

Article 28.-

1. Private pharmaceutical practitioners being individuals or organizations shall have the following rights:

a) To take part in relevant professional and technical activities;

b) To sell medicines according to prescriptions or refuse to sell medicines according to prescriptions if deeming that the use thereof may adversely affect the users’ health;

c) To sign contracts with laborers;

d) To receive financial assistance from individuals and organizations under the provisions of law;

e) To enjoy preferential regimes as provided for by law;

f) To join the Pharmaceutical Association or other professional associations;

2. Private pharmaceutical practitioners being individuals or organizations shall have the following obligations:

a) To comply with the legal documents on pharmacy; only trade in medicines permitted for circulation by the Health Ministry;

b) To abide by the mobilization decisions of competent State bodies;

c) To observe the Health Ministry’s regulations on professional activities, professional fostering;

d) To post up the working time and drug prices at the private pharmaceutical establishments and observe the law provisions on prices;

e) The heads of drug stores, drug sale agents must be present when the establishments are in operation;

f) To reserve common emergency medicine volume prescribed by the Health Ministry;

g) To compile dossiers and books according to law provisions; to supply information in service of medical inspection when so requested; to statistically report to the local medical bodies on their professional activities according to regulations of the Health Ministry and the General Department of Statistics;

h) To be held responsible before law for their acts of violation; to pay compensation for damage, if caused, according to law provisions;

i) To fulfill tax and other obligations according to law provisions.

Article 29.- Private pharmaceutical practitioners being individuals or organizations are strictly forbidden to perform the following acts:

1. Trading in fake medicines, medicines not permitted for circulation by the Health Ministry, having expired use duration, failing to ensure quality, having packages not left intact, having unclear origin;

2. Failing to comply with the provisions in their private pharmaceutical practice certificates, private pharmaceutical practice eligibility certificates;

3. Making advertisements in contravention of law provisions.

Section 5. PRIVATE PRACTICE OF VACCINES, MEDICAL BIO-PRODUCTS

Article 30.- Organizational forms of private practice of vaccine or bio-products include:

1. Enterprises trading in vaccines, medical bio-products;

2. Vaccine, medical bio-product sale agents for enterprises trading in vaccines, medical bio-products;

3. Vaccine, medical bio-product-testing establishments;

4. Vaccine, medical bio-product preservation establishments.

Article 31.- Those who are granted certificates of private practice of vaccines and/or medical bio-products must satisfy all the following conditions:

1. The conditions prescribed in Article 9 of this Ordinance;

2. Having one of the following diplomas, depending on the requirements of each organizational form and scope of professional practice:

a) Medical or pharmaceutical university diploma, university diploma in biology;

b) Medical college diploma;

c) Intermediate medical or pharmaceutical school diploma.

3. Having practiced for 5 years, for the organizational forms of professional practice prescribed in Clause 1, 3 and 4 of Article 30 of this Ordinance, at vaccine, medical bio-product and/or pharmaceutical establishments; 2 years, for the organizational forms of professional practice prescribed in Clause 2 of Article 30 of this Ordinance, at vaccine, medical bio-product and/or pharmaceutical establishments.

Article 32.-

1. Private practitioners of vaccines, medical bio-products being individuals or organizations shall have the following rights:

a) The rights prescribed at Points a, c, d and e of Clause 1, Article 28 of this Ordinance;

b) To join professional associations under the provisions of law.

2. Private practitioners of vaccines and/or medical bio-products being individuals or organizations shall have the following obligations:

a) The obligations prescribed at Point b, c, g, h and i, Clause 2, Article 28 of this Ordinance;

b) To abide by the legal documents on vaccines, medical bio-products. Only to trade in vaccine and/or medical bio-products of the types permitted for circulation by the Health Ministry;

c) To post up the working time and vaccine or medical bio-product prices at the private vaccine and/or medical bio-product establishments and observe the law provisions on prices.

Article 33.- Private practitioners of vaccines and/or medical bio-products being individuals or organizations are strictly forbidden to perform the following acts:

1. Dealing in fake vaccines and/or medical bio-products; vaccines and/or medical bio-products which are not permitted for circulation by the Health Ministry, of expired use duration, of inferior quality, with packages left not intact, or of unidentified origins;

2. Failing to comply with the regulations in their certificates of private practice of vaccines and/or medical bio-products, certificates of eligibility for private practice of vaccines and/or medical bio-products;

3. Advertising vaccines and/or medical bio-products in contravention of law provisions.

Section 6. PRIVATE PRACTICE OF MEDICAL EQUIPMENT

Article 34.- Organizational forms of private practice of medical equipment include:

1. Enterprises dealing in medical equipment;

2. Medical equipment sale agents of medical equipment trading enterprises;

3. Individuals dealing in medical equipment.

Article 35.- The heads or professional managers of private medical equipment trading establishments must satisfy all the following conditions:

1. Having one of the following diplomas, depending on each organizational form of professional practice:

a) Medical or pharmaceutical university diploma, technical university diploma;

b) Medical or technical college diploma;

c) Intermediate medical, pharmaceutical or technical school diploma.

2. Having certificates of professional training in medical equipment, granted by medical equipment training establishments;

3. Having professional ethics;

4. Having good health for professional practice;

5. Not being subjects defined in Clauses 1, 2, 3 and 5, Article 6 of this Ordinance.

Article 36.-

1. Private medical equipment practitioners being individuals or organizations shall have the following rights:

a) The rights prescribed at Points a, c, d and e, Clause 1, Article 28 of this Ordinance;

b) To join professional associations;

2. Private medical equipment practitioners being individuals or organizations shall have the following obligations:

a) The obligations prescribed at Points b, c, g, h and i, Clause 2, Article 28 of this Ordinance;

b) To observe the legal documents on medical equipment. Only to trade in medical equipment of the types permitted for circulation by the Health Ministry;

c) To post up medical equipment prices at the private medical equipment establishment and observe the law provisions on prices.

Article 37.- Private medical equipment practitioners being individuals or organizations are strictly forbidden to perform the following acts:

1. Trading in fake medical equipment; medical equipment not permitted for circulation by the Health Ministry, illegally imported, with expired use duration, of inferior quality, of unidentified origins;

2. Advertising medical equipment in contravention of law provisions.

Chapter III

PROCEDURES AND COMPETENCE FOR GRANTING PRACTICE CERTIFICATES, PRIVATE MEDICAL OR PHARMACEUTICAL PRACTICE ELIGIBILITY CERTIFICATES

Article 38.- The procedures for granting certificates of private practice of medicine, pharmacy, traditional medicine or pharmacy, vaccines or medical bio-products are prescribed as follows:

1. Persons applying for the granting of certificates of private practice of medicine, pharmacy, traditional medicine or pharmacy, vaccines, medical bio-products must forward their dossiers to the Health Ministry or provincial/municipal Health Services;

2. The dossiers of application for the granting of certificates of private practice of medicine, pharmacy, traditional medicine or pharmacy, vaccines or medical bio-products shall include:

a) The application for practice certificate;

b) The lawful copies of professional diplomas, certificates;

c) The curriculum vitae of the practice certificate applicant with certification by the People’s Committee of the commune, ward or district township where he/she resides or by the head of the agency where such person works as a public servant;

d) The health certificate granted by a health center of the rural district, urban district, provincial capital or town;

e) The written certification of having gone through practice at medical examination and/or treatment establishments, traditional medicine or pharmacy establishments, pharmaceutical establishments, or vaccine, medical bio-product establishments;

f) The written consents of the agency head if the applicant for the practice certificate is a public servant or a person working at a State-run medical or pharmaceutical establishment, permitting the private medical or pharmaceutical practice.

Article 39.- The competence to grant certificates of private practice of medicine, pharmacy, traditional medicine or pharmacy, vaccines or medical bio-products is prescribed as follows:

1. The Health Minister shall grant certificates of private practice of medicine, pharmacy, traditional medicine or pharmacy, vaccines or medical bio-products to individuals who register the following organizational forms of professional practice:

a) Hospitals;

b) Foreign-invested medical, pharmaceutical, traditional medicine or pharmacy, vaccine or medical bio-product establishments in Vietnam.

2. The directors of the provincial/municipal Health Services shall grant certificates of private practice of medicine, pharmacy, traditional medicine or pharmacy, vaccines or medical bio-products to individuals who register the other organizational forms of professional practice, except those prescribed in Clause 1 of this Article.

3. Within 30 days as from the date of receiving the complete and valid dossiers, the Health Minister or the Health Service directors shall have to grant the practice certificates; if refusing to grant, they must give written replies, clearly stating the reasons therefor.

4. The practice certificates granted by the Health Minister shall be valid for registration of professional practice nationwide.

The practice certificates granted by Health Service directors shall be valid for registration of professional practice within the provinces or centrally-run cities where such certificates are issued; in cases where professional practice locations are moved to other provinces or centrally-run cities, the Health Ministry’s regulations shall be complied with.

Article 40.- The procedures for granting the private medical or pharmaceutical practice eligibility certificates:

1. A dossier of application for the granting of a private medical or pharmaceutical practice eligibility certificate shall include:

a) The application for granting of certificate of private medical or pharmaceutical practice eligibility certificate;

b) The valid copy of the certificate of private medical or pharmaceutical practice suitable to form of practice registration; the valid copy of the business registration certificate;

c) The list of personnel, professional equipment, material and technical foundations;

d) For enterprises dealing in pharmacy, vaccines and/or medical bio-products, or manufacturing medical equipment, except the private enterprises, apart from the conditions prescribed at Points a, b and c, Clause 1 of this Article, must also have the enterprise charters;

e) For hospitals, in addition to the conditions prescribed at Points a, b and c, Clause 1 of this Article, they must also have the organization and operation charters, the initial operation plans.

2. The dossiers of application for granting of practice eligibility certificates shall be addressed to the Health Ministry or Health Services of the localities where the practice establishments are to be located.

Article 41.- The competence to grant private medical or pharmaceutical practice eligibility certificates is prescribed as follows:

1. The Health Minister shall grant the practice eligibility certificates to the following organizational forms of professional practice:

a) Hospital;

b) Medicine-producing enterprises, medicine-testing establishments, medicine-preserving establishments;

c) Enterprises producing vaccines, medical bio-products; vaccine and/or medical bio-product- testing establishments; vaccine and/or medical bio-product-preserving establishments;

d) Enterprises manufacturing medical equipment;

e) Foreign-invested medical, pharmaceutical, traditional-medicine or-pharmacy, vaccine, medical bio-product or medical equipment establishments.

2. The Health Service directors shall grant private medical or pharmaceutical practice eligibility certificates to other organizational forms of professional practice, except for those prescribed in Clause 1 of this Article and organizational forms of medical equipment practice.

Article 42.-

1. Within 30 days as from the date of receiving the complete and valid dossiers, the Health Ministry shall organize the appraisal with the participation of representatives of the provincial/municipal Health Services in order to grant private medical or pharmaceutical practice eligibility certificates for the organizational forms of professional practices prescribed in Clause 1, Article 41 of this Ordinance; if refusing to grant, the written replies must be given, clearly stating the reasons therefor.

2. Within 30 days as from the date of receiving the complete valid dossiers, the provincial/municipal Heath Services shall organize the appraisals in order to grant private medical or pharmaceutical practice eligibility certificates for organizational forms of professional practice prescribed in Clause 2, Article 41 of this Ordinance; if refusing to grant, the written replies must be given, clearly stating the reasons therefor.

3. If past 12 months after being granted the private medical or pharmaceutical practice eligibility certificates the granted establishments fail to operate, such certificates shall be no longer valid and revoked.

4. The Health Minister shall prescribe the organization of appraisal, the participants therein, the appraisal procedures in order to grant private medical or pharmaceutical practice eligibility certificates.

Article 43.- The private medical or pharmaceutical practice certificates and the private medical or pharmaceutical practice eligibility certificates shall be valid for 5 years as from the date of issuance. 3 months before their expiry, if wishing to continue their professional practice, the individuals and organizations shall have to carry out the procedures for the extension thereof at the medical competent State bodies which have granted such certificates. The extension duration shall be 5 years.

Individuals and organizations applying for the granting of private medical or pharmaceutical practice certificates and/or private medical or pharmaceutical practice eligibility certificates must pay charges and fees therefor as provided for by law.

Article 44.-

1. The business registration of private medical or pharmaceutical establishments shall comply with the provisions of law.

2. Only after being granted the private medical or pharmaceutical practice eligibility certificates can the private medical or pharmaceutical establishments commence their operation.

Chapter IV

Article 45.- The contents of State management over private medical or pharmaceutical practice shall include:

1. To promulgate and direct the implementation of strategies, planning and plans on development of private medical or pharmaceutical practice;

2. To promulgate and organize the implementation of legal documents on private medical or pharmaceutical practice;

3. To grant and withdraw private medical or pharmaceutical practice certificates, private medical or pharmaceutical practice eligibility certificates;

4. To guide the management of private medical or pharmaceutical service charges;

5. To provide professional and technical training and fostering for private medical or pharmaceutical practitioners;

6. To organize and direct the work of emulation and commendation in the private medical and pharmaceutical practice;

7. To inspect and examine the observance of legislation on private medical and pharmaceutical practice; to settle complaints and denunciations and handle violations of law provisions on private medical and pharmaceutical practice.

Article 46.-

1. The Government shall exercise the unified State management over private medical and pharmaceutical practice.

2. The Health Ministry shall be answerable to the Government for the exercise of State management over private medical and pharmaceutical practice.

3. The ministries and ministerial-level agencies shall, within the ambit of their respective tasks and powers, exercise the State management over private medical and pharmaceutical practice.

4. The People’s Committees at all levels shall have to exercise the State management over the private medical and pharmaceutical practice in their respective localities according to the Government’s assignment. The Health Services shall have to help the provincial/municipal People’s Committees in exercising the State management over private medical and pharmaceutical practice.

Article 47.- Vietnam Confederation of Medicine and Pharmacy, Vietnam Eastern Medicine Association and their member associations shall participate, according to their respective functions and tasks, join the health service in educating the professional ethics and providing professional fostering for private medical and pharmaceutical practitioners.

Article 48.- The Private Medical and Pharmaceutical Practice Association is a socio-professional organization and a member of Vietnam Confederation of Medicine and Pharmacy, which is set up from the central to grassroots levels in order to:

1. Rally private medical and pharmaceutical practitioners;

2. Organize training and fostering to raise the professional and legal knowledge and to educate professional ethics for its members;

3. Supervise and help its members to practice in accordance with law provisions;

4. Protect the legitimate rights and interests of its members;

5. Propose to the State management bodies matters related to the private medical and pharmaceutical practice.

Article 49.- The medical State inspectorate shall perform the function of specialized inspection of private medical and pharmaceutical practice.

Article 50.-

1. Individuals and organizations may lodge complaints; individuals may denounce acts of violating the legislation on private medical and pharmaceutical practice.

2. The settlement of complaints and denunciations shall comply with the provisions of the legislation on complaints and denunciations.

Chapter V

Article 51.- Private medical and pharmaceutical practitioners being individuals or organizations, that record achievements in the care for and protection of people’s health, shall be commended and/or rewarded according to law provisions.

Article 52.- Those who violate the provisions of this Ordinance and other relevant law provisions shall, depending on the nature and seriousness of their violations, be disciplined, administratively sanctioned or examined for penal liability; if causing damage, they must pay compensations therefor according to law provisions.

Chapter VI

Article 53.-

1. Individuals and organizations, that are granted private medical or pharmaceutical practice certificates, and/or private medical or pharmaceutical practice eligibility certificates before June 1, 2003, may continue their professional practice till the expiry thereof, prescribed in their private medical or pharmaceutical practice certificates and/or private medical or pharmaceutical practice eligibility certificates, then, if wishing to continue their professional practice, carry out the procedures for the granting of new certificates under the provisions of this Ordinance;

2. The Government shall prescribe the conditions and measures to restrict and to proceed to ban State employees from private medical or pharmaceutical practice as from December 31, 2010.

Article 54.- This Ordinance shall take effect as from June 1, 2003.

This Ordinance shall replace the October 13, 1993 Ordinance on Private Medical and Pharmaceutical Practice.

The previous provisions contrary to this Ordinance shall all be annulled.

Article 55.- The Government shall detail and guide the implementation of this Ordinance.