Ordinance No. 07/2003/PL-UBTVQH11 on Private Medical and Pharmaceutical Practice

ORDINANCE OF THE STANDING COMMITTEE OF THE NATIONAL ASSEMBLY

Private Medical and Pharmaceutical Practice

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To ensure public health safety and facilitate medical examination and treatment for citizens; to implement socialization policies and diversify types of medical and pharmaceutical services; to unify management and incorporate private medical and pharmaceutical practice into lawful operations;

BASED ON THE CONSTITUTION OF THE SOCIALIST REPUBLIC OF VIETNAM IN 1992 AS AMENDED AND COMPLEMENTED BY RESOLUTION NO. 51/2001/QH10 DATED DECEMBER 25, 2001 OF THE TENTH NATIONAL ASSEMBLY SESSION 10;

Based on the Law on Protecting People's Health;

Based on Resolution No. 12/2002/QH11 dated December 16, 2002 of the National Assembly, the 11th term, second session regarding the Program on Legislation and Ordinances of the National Assembly for the 2002-2007 term and 2003;

This Ordinance stipulates private medical and pharmaceutical practice.

 

PART I
General Provisions

Article 1.

Individuals and organizations within the country and foreign individuals and organizations meeting the conditions prescribed by this Ordinance may engage in private medical and pharmaceutical practice.

Article 2.

1. Private medical and pharmaceutical practice includes:

a) Medical practice;

b) Traditional medical and pharmaceutical practice;

c) Pharmaceutical practice;

d) Vaccine and medical biological product practice;

e) Medical equipment practice. 

2. Private medical and pharmaceutical practice establishments include:

a) Private medical and pharmaceutical establishments;

b) Self-established medical and pharmaceutical establishments;

c) Medical and pharmaceutical establishments with foreign investment.

Article 3.

In this Ordinance, the following terms shall be understood as follows:

1. Private Medical and Pharmaceutical Practice This refers to individuals or organizations registering to conduct medical examinations and treatments; pharmaceutical, vaccine, medical biological product, and medical equipment business according to this Ordinance and other relevant laws.

2. Private medical and pharmaceutical establishment is an establishment registered and managed by individuals, households, or enterprises.

3. Self-established medical and pharmaceutical establishment is an establishment established by organizations, funded by non-budgetary capital contributed by organizations and individuals, and self-managed.

4. Private medical and pharmaceutical practice certificate is a document issued by the competent state management agency to individuals who meet the conditions for practicing as prescribed by this Ordinance.

5. Certificate of eligibility for private medical and pharmaceutical practice is a document issued by the competent state management agency to establishments that meet the conditions for practicing as prescribed by this Ordinance.

Article 4.

1. The head of medical, traditional medical, pharmaceutical, vaccine, and medical biological product establishments must hold a private medical and pharmaceutical practice certificate. For pharmaceutical businesses and medical biological product businesses, the head or the professional manager of the business must hold a private medical and pharmaceutical practice certificate.

2. Medical, traditional medical, pharmaceutical, vaccine, and medical biological product establishments; medical equipment manufacturing businesses must have a certificate of eligibility for private medical and pharmaceutical practice.

Article 5.

1. Individuals and organizations engaging in private medical and pharmaceutical practice must comply with this Ordinance and other relevant laws.

2. The rights and legitimate interests of individuals and organizations engaging in private medical and pharmaceutical practice are protected by the State.

Article 6.

The following persons shall not be granted a private medical and pharmaceutical practice certificate:

1. Those currently prohibited from practicing or performing work related to their medical or pharmaceutical specialty according to court judgments or decisions;

2. Those currently under criminal investigation;

3. Those currently serving a criminal sentence or administrative decision to be placed in an educational facility, medical facility, or administrative control;

4. Those currently subject to disciplinary action related to their medical or pharmaceutical specialty;

5. Those lacking or having limited capacity for civil acts.

Article 7.

Strictly prohibit the following acts:

1. Exploiting state-owned facilities and equipment for private medical and pharmaceutical practice;

2. Renting or borrowing a private medical and pharmaceutical practice certificate.

Article 8.

The State encourages the development of private medical and pharmaceutical establishments and creates conditions for private medical and pharmaceutical practitioners to join professional associations.

Chapter II
Private Medical and Pharmaceutical Practice

Section 1
General Conditions for Private Medical and Pharmaceutical Practice

 

Article 9.

Individuals holding a Professional Practice Certificate for private medical, traditional medicine, pharmaceutical, vaccine, and medical product practice must meet the following conditions:

1. Possess a degree appropriate to the form of organization and scope of professional practice;

2. Have had practical experience at a medical or pharmaceutical facility;

3. Demonstrate professional ethics;

4. Be in good health to practice;

5. Meet other conditions specified in Articles 17, 22, 27, and 31 of this Ordinance, depending on the form of practice organization;

6. Not be among those specified in Article 6 of this Ordinance.

Article 10.

Individuals and organizations specified in Article 9 of the Enterprise Law shall not establish and manage the following forms of private medical and pharmaceutical practice organizations:

1. Hospitals;

2. Traditional Medicine Hospitals;

3. Pharmaceutical businesses, vaccine and medical product businesses, and medical equipment businesses;

4. Multi-specialty clinics, specialty clinics, midwifery houses, and traditional medicine treatment rooms registered under the Enterprise Law.

Article 11.

Individuals with a Professional Practice Certificate for private medical and pharmaceutical practice may only head or be responsible for managing the professional activities of a private medical or pharmaceutical facility within the scope of practice specified in their Certificate of Eligibility for Private Medical and Pharmaceutical Practice. Article 12.

Based on economic and social conditions, the current state of the national healthcare workforce, and the need for medical examination and treatment services in areas with particularly difficult economic and social conditions, areas with difficult economic and social conditions, and ethnic minority regions during specific periods, the Ministry of Health will specify the specific conditions regarding academic qualifications and practical experience required to obtain a Professional Practice Certificate for private medical and pharmaceutical practice in those areas, based on the provisions of Articles 17, 22, 27, and 31 of this Ordinance.

Article 13.

1. Private medical and pharmaceutical facilities must have sufficient personnel for professional work, ensuring conditions regarding location, medical equipment, and other necessary conditions as prescribed by law.

2. Personnel engaged in professional work in private medical and pharmaceutical facilities must possess degrees and certificates of professional qualification appropriate to the assigned tasks and must comply with labor laws.

3. The Ministry of Health will specify the conditions and scope of professional practice for each form of private medical and pharmaceutical practice organization.

Article 14.

1. Foreign individuals and organizations practicing private medical and pharmaceutical work in Vietnam must comply with Vietnamese laws on foreign investment and the provisions of this Ordinance.

2. Foreign personnel working in professional positions in private traditional medicine and pharmaceutical facilities must be approved by the Vietnamese Ministry of Health.

3. Foreign individuals directly examining and treating Vietnamese patients must be proficient in Vietnamese or must have an interpreter. Interpreters must have a secondary-level education in medicine; for traditional medicine, interpreters must be licensed traditional doctors or have a secondary-level education in traditional medicine or higher.

4. The Ministry of Health will specify the conditions for foreign individuals and organizations to engage in private medical and pharmaceutical practice in Vietnam.

Article 15.

1. A Professional Practice Certificate for private medical and pharmaceutical practice will be revoked in the following cases:

a) The certificate was issued without proper authority;

b) The individual who obtained the certificate subsequently falls into one of the categories specified in Article 6 of this Ordinance;

c) The individual who obtained the certificate has died;

d) The individual who obtained the certificate violates laws related to medicine and pharmacy;

đ) Other cases as prescribed by law.

2.A Certificate of Eligibility for Private Medical and Pharmaceutical Practice will be revoked in the following cases:

a) The head of a private traditional medicine, pharmaceutical, vaccine, or medical product facility or the professional manager of a private pharmaceutical, vaccine, or medical product facility does not hold a Professional Practice Certificate;

b) The Certificate of Eligibility for Private Medical and Pharmaceutical Practice was issued without proper authority;

c) The private medical or pharmaceutical facility fails to meet the conditions set by the Ministry of Health;

d) Within twelve months from the date of issuance of the Certificate of Eligibility for Private Medical and Pharmaceutical Practice, the private medical or pharmaceutical facility does not operate;

đ) The private medical or pharmaceutical facility is declared bankrupt or dissolved;

f) Other cases as prescribed by law.

3. The Government will stipulate the procedures and authorities for revoking Professional Practice Certificates for private medical and pharmaceutical practice and Certificates of Eligibility for Private Medical and Pharmaceutical Practice.

Section 2
Private Medical Practice

Article 16.

Forms of organization for private medical practice include: 

1. General hospitals, specialized hospitals;

2. Multi-specialty clinics, specialized clinics;

3. Midwifery houses;

4. Healthcare service facilities;

5. Patient transport services within the country and abroad.

Article 17.

Individuals holding a Professional Practice Certificate for private medical practice must meet the following conditions:

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

2. Hold one of the following degrees, depending on the requirements of the form of practice organization and the scope of professional practice:

a) Bachelor's degree in medicine, pharmacy, biology, or chemistry;

b) Associate degree in medicine;

c) Secondary degree in medicine;

3. Have completed five years of practical experience at medical examination and treatment facilities for the forms of practice organization specified in Clauses 1, 2, 3, and 5 of Article 16 of this Ordinance; two years for the form of practice organization specified in Clause 4 of Article 16 of this Ordinance at medical examination and treatment facilities.

Article 18.

1. Individuals and organizations engaging in private medical practice have the following rights:

a) To conduct professional medical activities within the scope of their Professional Practice Certificate for Private Medical Practice and Certificate of Eligibility for Private Medical Practice;

b) To enter into contracts with state healthcare facilities and healthcare workers for technical support;

c) To enter into contracts with insurance agencies for medical examination and treatment services for insured persons;

d) To enter into employment contracts;

đ) To stockpile emergency medicines according to regulations of the Ministry of Health;

e) To receive financial assistance from individuals and organizations in accordance with the law;

g) To participate in medical associations or other professional associations;

h) To enjoy preferential benefits as provided by law.

2. Individuals and organizations engaging in private medical practice have the following obligations:

a) To comply with professional technical regulations of the Ministry of Health;

b) Provide emergency care to patients within the scope of their professional qualifications; if the case does not fall within their professional qualifications, they must provide initial first aid and guide the patient to an appropriate healthcare facility;

c) Serve patients diligently and attentively;

d) Participate in primary health care activities, health promotion, disease prevention and treatment, drug abuse and prostitution prevention, HIV/AIDS prevention, sexually transmitted diseases and other infectious diseases that may harm human health and society, and provide guidance on safe and rational drug use;

đ) Comply with mobilization decisions made by competent state agencies;

e) Report promptly to local health authorities upon discovering epidemics, mass poisoning incidents, and cooperate with other healthcare facilities to quickly address the consequences;

g) Implement regulations on professional activities and continuing education as prescribed by the Ministry of Health;

h) Maintain records and ledgers in accordance with legal provisions; provide information for health investigations when requested; report statistics to local health authorities regarding professional activities as prescribed by the Ministry of Health and the General Statistics Office;

i) Display signs indicating the scope of practice and comply with the provisions recorded in the Certificate of Qualification for Private Medical Practice;

k) Display operating hours, consultation fees, and treatment charges at private healthcare facilities and comply with legal provisions on pricing; 

l) Be legally responsible for any violations of the law committed by themselves; if damage occurs, compensation must be provided according to legal provisions;

m) Implement professional liability insurance, tax obligations, and other legal obligations;

Article 19.

A private medical practitioner may conduct diagnosis and treatment within the scope of their professional qualifications, issue prescriptions but shall not sell drugs;

Article 20.

Strictly prohibited are the following acts by individuals or organizations engaged in private medical practice:

1. Performing activities contrary to the provisions of the Medical Practice Certificate or the Certificate of Qualification for Private Medical Practice;

2. Applying new medical techniques or using new drugs for diagnosis and treatment without permission from the Ministry of Health;

3. Advertising beyond their professional qualifications and scope of practice as recorded in the Certificate of Qualification for Private Medical Practice; advertising in violation of legal provisions;

Section 3
Private Traditional Medicine Practice

Article 21.

The forms of organization for private traditional medicine practice include:

1. Traditional Medicine Hospital;

2. Traditional Medicine Clinic;

3. Service facilities for rehabilitation and functional recovery using acupuncture, massage, moxibustion, breathing exercises, qigong, and herbal steam baths;

4. Traditional Medicine Pharmaceutical Business including finished traditional medicine products, traditional medicine tablets, unprocessed traditional medicinal herbs, and retail outlets for finished traditional medicine products;

5. Centers for Inheriting and Applying Traditional Medicine;

Article 22.

Individuals granted a Certificate of Qualification for Private Traditional Medicine Practice must meet the following conditions:

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

2. Possess one of the following academic degrees or certificates of professional qualification as required by each form of organization and scope of practice:

a) Bachelor's degree or secondary education in traditional medicine;

b) Bachelor's degree in pharmacy or secondary education in pharmacy and a certificate of study in traditional pharmacology;

c) Certificate of Professional Qualification in Traditional Medicine issued by the Ministry of Health or provincial Department of Health;

3. Have completed five years of practical experience in traditional medicine diagnosis and treatment facilities for the forms of organization specified in Clauses 1, 2, 3, and 5 of Article 21 of this Ordinance; two years for the form of organization specified in Clause 4 of Article 21 of this Ordinance;

Article 23.

1. Individuals and organizations engaged in private traditional medicine practice have the following rights:

a) Conduct professional activities in traditional medicine in accordance with the scope of their Certificate of Qualification for Private Traditional Medicine Practice or Certificate of Qualification for Private Traditional Medicine Practice;

b) Rights stipulated in Points b, d, e, and h of Clause 1 of Article 18 of this Ordinance;

c) Enter contracts with insurance agencies for providing medical services to insured patients, except for the forms of organization specified in Clause 4 of Article 21 of this Ordinance;

d) Private traditional medicine pharmaceutical businesses may sell medicines based on prescriptions or refuse to sell medicines if they believe the use could adversely affect the health of the user;

đ) Join the Association of Traditional Medicine or other professional associations;

2. Individuals and organizations engaged in private traditional medicine practice have the following obligations:

a) Obligations stipulated in Points a, b, c, d, đ, e, g, h, l, and m of Clause 2 of Article 18 of this Ordinance;

b) Display signs indicating the scope of practice and comply with the provisions recorded in the Certificate of Qualification for Private Traditional Medicine Practice;

c) Display operating hours, consultation fees, and treatment charges at private traditional medicine facilities and comply with legal provisions on pricing;

Article 24.

A private traditional medicine practitioner may conduct diagnosis, prescribe, and sell traditional medicine to patients at their place of practice;

Article 25.

Strictly prohibited are the following acts by individuals or organizations engaged in private traditional medicine practice:

1. Performing activities contrary to the provisions of the Certificate of Qualification for Private Traditional Medicine Practice or Certificate of Qualification for Private Traditional Medicine Practice;

2. Applying new medical techniques or using new drugs for diagnosis and treatment without permission from the Ministry of Health;

3. Using superstitious methods in diagnosis and treatment;

4. Advertising beyond their professional qualifications and scope of practice as recorded in the Certificate of Qualification for Private Traditional Medicine Practice; advertising in violation of legal provisions;

Section 4
Private Pharmaceutical Practice

Article 26.

Forms of organization for private pharmaceutical practice include:

1. Medicine trading enterprises;

2. Pharmacy;

3. Drug Retailer for Pharmaceutical Businesses;

4. Drug Testing Facility;

5. Drug Storage Facility;

Article 27.

Individuals granted a Certificate of Qualification for Private Pharmaceutical Practice must meet the following conditions:

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

2. Hold one of the following degrees, depending on the requirements of the form of practice organization and the scope of professional practice:

a) Bachelor's degree in pharmacy;

b) A high school diploma in pharmacy;

c) A secondary school diploma in pharmacy;

3. Having practiced for five years under the practice organization forms specified in Clauses 1, 2, 4, and 5 of Article 26 of this Ordinance at a pharmaceutical facility; two years for the practice organization form specified in Clause 3 of Article 26 of this Ordinance at  a pharmaceutical facility.

Article 28.

1. Individual and private pharmacy organizations have the following rights:

a) Participating in related technical and professional activities;

b) Selling medicine based on prescriptions or refusing to sell medicine based on prescriptions if they believe that the use may adversely affect the health of the user;

c) Signing labor contracts;

d) Receiving financial support from individuals or organizations in accordance with the provisions of the law;

đ) Enjoying preferential policies as stipulated by the law;

e) Joining the Pharmaceutical Association or other professional associations;

2. Individual and private pharmacy organizations have the following obligations:

a) Adhering to legal regulatory documents concerning pharmacy; only allowed to trade in types of medicine that have been permitted for circulation by the Ministry of Health;

b) Complying with mobilization decisions made by competent state agencies;

c) Implementing regulations regarding professional activities and professional training provided by the Ministry of Health;

d) Displaying operating hours and drug prices at private pharmaceutical facilities and complying with legal regulations on pricing;

đ) The head of the pharmacy or drug sales agent must be present when the facility is operating;

e) Stocking a basic supply of commonly used emergency medicines as prescribed by the Ministry of Health;

g) Implementing record-keeping requirements as stipulated by law; providing information for medical investigations upon request; reporting statistics on professional activities to local health authorities according to the regulations of the Ministry of Health and the General Statistics Office;

h) Being responsible under the law for their own violations; if causing damage, they must compensate according to the provisions of the law;

i) Fulfilling tax obligations and other obligations as stipulated by the law.

Article 29.

Strictly prohibited for individual and private pharmacy organizations to engage in the following behaviors:

1. Trading counterfeit drugs, drugs not permitted for circulation by the Ministry of Health, expired drugs, drugs not meeting quality standards, drugs without intact packaging, or drugs of unknown origin;

2. Not complying with the provisions in the Private Pharmacy Practice Certificate and the Certificate of Eligibility for Private Pharmacy Practice;

3. Advertising drugs in violation of legal regulations.

Section 5
Private Vaccine and Medical Biological Products Practice

Article 30.

Forms of organization for private vaccine and medical biological products practice include:

1. Enterprises engaged in vaccine and medical biological products trading;

2. Agents selling vaccines and medical biological products to enterprises engaged in vaccine and medical biological products trading;

3. Facilities for testing vaccines and medical biological products;

4. Facilities for storing vaccines and medical biological products.

Article 31.

Individuals granted a Private Vaccine and Medical Biological Products Practice Certificate must meet the following conditions:

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

2. Hold one of the following degrees, depending on the requirements of the form of practice organization and the scope of professional practice:

a) A bachelor's degree in pharmacy, medicine, or a specialized field in biology;

b) Associate degree in medicine;

c) A high school diploma in pharmacy or medicine;

3. Having practiced for five years under the practice organization forms specified in Clauses 1, 3, and 4 of Article 30 of this Ordinance at a vaccine, medical biological products, or pharmaceutical facility; two years for the practice organization form specified in Clause 2 of Article 30 of this Ordinance at a vaccine, medical biological products, or pharmaceutical facility.

Article 32.

1. Individual and private vaccine and medical biological products organizations have the following rights:

a) The rights stipulated in Points a, c, d, and đ of Clause 1 of Article 28 of this Ordinance;

b) Participating in professional associations as prescribed by law;

2. Individual and private vaccine and medical biological products organizations have the following obligations:

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

b) Adhering to legal regulatory documents concerning vaccines and medical biological products; only allowed to trade in types of vaccines and medical biological products that have been permitted for circulation by the Ministry of Health;

c) Displaying operating hours and prices of vaccines and medical biological products at private vaccine and medical biological products facilities and complying with legal regulations on pricing.

Article 33.

Strictly prohibited for individual and private vaccine and medical biological products organizations to engage in the following behaviors:

1. Trading counterfeit vaccines and medical biological products; vaccines and medical biological products not permitted for circulation by the Ministry of Health, expired products, products not meeting quality standards, products without intact packaging, or products of unknown origin;

2. Not complying with the provisions in the Private Vaccine and Medical Biological Products Practice Certificate and the Certificate of Eligibility for Private Vaccine and Medical Biological Products Practice;

3. Advertising vaccines and medical biological products in violation of legal regulations.

Chapter 6
Private Medical Equipment Practice

Article 34.

Forms of organization for private medical equipment practice include:

1. Enterprises engaged in medical equipment trading;

2. Agents selling medical equipment to enterprises engaged in medical equipment trading;

3. Individuals engaged in medical equipment trading.

Article 35.

The head or professional manager of a private medical equipment practice facility must meet the following conditions:

1. Possessing one of the following diplomas depending on the specific organizational form of practice:

a) A bachelor's degree in medicine, pharmacy, or a specialized engineering field;

b) An associate degree in medicine or a specialized field;  Technical Regulations;

c) A high school diploma in medicine, pharmacy, or a specialized engineering field;

2. Holding a specialized training certificate in medical equipment issued by medical equipment technical training institutions;

3. Demonstrate professional ethics;

4. Having sufficient health to practice;

5. Not belonging to the categories specified in Clauses 1, 2, 3, and 5 of Article 6 of this Ordinance.

Article 36.

1. Individual and private medical equipment organizations have the following rights:

a) The rights stipulated in Points a, c, d, and đ of Clause 1 of Article 28 of this Ordinance;

b) Joining professional associations;

2. Individual and private medical equipment organizations have the following obligations:

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

b) Adhering to legal regulatory documents concerning medical equipment; only allowed to trade in types of medical equipment that have been permitted for circulation by the Ministry of Health;

c) Displaying prices of medical equipment at private medical equipment facilities and complying with legal regulations on pricing.

Article 37.

Strictly prohibited for individual and private medical equipment organizations to engage in the following behaviors:

1. Engaging in business with counterfeit medical devices, medical devices not permitted for circulation by the Ministry of Health, illegally imported, expired, not meeting quality standards, or of unknown origin.

2. Advertising medical devices in violation of legal regulations.

Chapter III
Procedures and authority for issuing practice certificates and licenses  to privately practice medicine and pharmacy

Article 38.

Procedures for issuing practice certificates for medicine, traditional medicine, pharmacy, vaccines, and private healthcare products are stipulated as follows:  private medical products shall be regulated as follows:

1. The person applying for a practice certificate for medicine, traditional medicine, pharmacy, vaccines, and private healthcare products must submit the application to the Ministry of Health or the Department of Health.  private medical products must submit applications to the Ministry of Health or the Department of Health;

2. The application for a practice certificate for medicine, traditional medicine, pharmacy, vaccines, and private healthcare products shall include:

a) An application form for a practice certificate;

b) A certified copy of the qualification certificate or proof of professional qualifications;

c) A curriculum vitae confirmed by the People's Committee of the commune, ward, town where the applicant resides, or the head of the agency where the applicant works if they are a civil servant;

d) A health certificate issued by a district-level or higher health center;    

đ) A confirmation of having undergone practical training at a medical examination and treatment facility or a traditional medicine facility or a pharmaceutical facility or a vaccine and healthcare product facility;

e) A written consent from the head of the agency allowing private practice of medicine or pharmacy if the applicant is a civil servant working at state-owned medical or pharmaceutical facilities.

Article 39.

Authority to issue practice certificates for medicine, traditional medicine, pharmacy, vaccines, and private healthcare products is stipulated as follows:  private entities shall be regulated as follows:

1. The Minister of Health shall issue practice certificates for medicine, traditional medicine, pharmacy, vaccines, and private healthcare products to individuals registering under the following forms of practice organization:

a) Hospitals;

b) Medical and pharmaceutical facilities, vaccine and healthcare product facilities with foreign investment in Vietnam.

2. The Director of the Department of Health shall issue practice certificates for medicine, traditional medicine, pharmacy, and vaccine and healthcare product facilities to individuals registering under other forms of practice organization, except those specified in Clause 1 of this Article.  private entities may register other forms of practice for individuals, except for the forms of practice specified in Clause 1 of this Article.

3. Within thirty days from the date of receiving complete and valid applications, the Minister of Health or the Director of the Department of Health must issue the practice certificate; if it is not issued, a written response with detailed reasons must be provided.

4. Practice certificates issued by the Minister of Health are valid nationwide.

Practice certificates issued by the Director of the Department of Health are valid within the province or centrally-administered city where the certificate was issued; in case of transferring the place of practice to another province or centrally-administered city, it shall be carried out according to the regulations of the Ministry of Health.

Article 40.

Procedures for issuing Certificates of Eligibility to Privately Practice Medicine and Pharmacy:

1. The application for a Certificate of Eligibility to Privately Practice Medicine and Pharmacy shall include:                       

a) An application form for a Certificate of Eligibility to Privately Practice Medicine and Pharmacy;

b) A certified copy of the relevant practice certificate for medicine and pharmacy; a certified copy of the business registration certificate;

c) A list of personnel, specialized equipment, and infrastructure;

d) For pharmaceutical businesses, vaccine and healthcare product businesses, and medical device manufacturing businesses, in addition to the conditions specified in points a, b, and c of Clause 1 of this Article, they must also have a company charter;

đ) For hospitals, in addition to the conditions specified in points a, b, and c of Clause 1 of this Article, they must also have a charter on organizational structure and operation, and an initial operational plan.

2. The application for a Certificate of Eligibility to Privately Practice Medicine and Pharmacy shall be submitted to the Ministry of Health or the Department of Health where the headquarters is located.

Article 41.

Authority to issue Certificates of Eligibility to Privately Practice Medicine and Pharmacy is stipulated as follows:

1. The Minister of Health shall issue Certificates of Eligibility to Privately Practice Medicine and Pharmacy for the following forms of practice organization:

a) Hospitals;

b) Pharmaceutical production enterprises, drug testing facilities, drug storage facilities;

c) Vaccine and healthcare product production enterprises, vaccine and healthcare product testing facilities, vaccine and healthcare product storage facilities;

d) Medical device production enterprises;

đ) Medical and pharmaceutical facilities, vaccine and healthcare product facilities, medical device facilities with foreign investment.

2. The Director of the Department of Health shall issue Certificates of Eligibility to Privately Practice Medicine and Pharmacy for other forms of practice organization, except those specified in Clause 1 of this Article and medical device facilities.

Article 42.

1. Within thirty days from the date of receiving complete and valid applications, the Ministry of Health shall organize an assessment with the participation of representatives from the Department of Health to issue Certificates of Eligibility to Privately Practice Medicine and Pharmacy for the forms of practice organization specified in Clause 1 of Article 41 of this Ordinance; if it is not issued, a written response with detailed reasons must be provided.

2. Within thirty days from the date of receiving complete and valid applications, the Department of Health shall organize an assessment to issue Certificates of Eligibility to Privately Practice Medicine and Pharmacy for the forms of practice organization specified in Clause 2 of Article 41 of this Ordinance; if it is not issued, a written response with detailed reasons must be provided.  to establish a review process to issue a Certificate of Eligibility for Private Medical and Pharmaceutical Practice for the forms of organization and operation as stipulated in Clause 2 of Article 41 of this Ordinance; if not issued, a written response with clear reasons must be provided.

3. If the facility does not operate within twelve months from the date of issuance of the Certificate of Eligibility to Privately Practice Medicine and Pharmacy, the certificate will lose its validity and be revoked.

4. The Minister of Health shall stipulate the procedures, participants, and methods for assessing eligibility to issue Certificates of Eligibility to Privately Practice Medicine and Pharmacy.

Article 43.

Practice certificates for medicine and pharmacy, and Certificates of Eligibility to Privately Practice Medicine and Pharmacy are valid for five years from the date of issuance. Three months before the expiration date, if the individual or entity wishes to continue practicing, they must apply for renewal at the competent health authority that issued the certificate. The renewal period is five years.

Individuals and entities applying for practice certificates for medicine and pharmacy, and Certificates of Eligibility to Privately Practice Medicine and Pharmacy must pay fees and charges as prescribed by law.

Article 44.

1. The registration of business for private health and pharmaceutical establishments shall be carried out in accordance with the provisions of the law.

2. Only after obtaining the Certificate of Qualification for Private Health and Pharmaceutical Practice may such private health and pharmaceutical establishments commence operations.  

Chapter IV
State Management of Private Health and Pharmaceutical Practice

Article 45.

The contents of state management over private health and pharmaceutical practice include:

1. Issuing and directing the implementation of strategies, planning, and plans for the development of private health and pharmaceutical practice;

2. Issuing and organizing the implementation of regulatory legal documents on private health and pharmaceutical practice;

3. Issuing and revoking Certificates of Qualification for Private Health and Pharmaceutical Practice and Certificates of Eligibility for Private Health and Pharmaceutical Practice;

4. Guiding price management for private health and pharmaceutical services;

5. Training and enhancing professional skills for practitioners of private health and pharmaceutical practice;

6. Organizing and directing commendation activities within the field of private health and pharmaceutical practice;

7. Inspecting and supervising compliance with laws on private health and pharmaceutical practice; resolving complaints and accusations, and handling violations of laws on private health and pharmaceutical practice.

Article 46.

1. The Government shall uniformly manage state affairs concerning private health and pharmaceutical practice.

2. The Ministry of Health shall be responsible before the Government for managing state affairs concerning private health and pharmaceutical practice.

3. Ministries and agencies at the ministerial level shall implement state management concerning private health and pharmaceutical practice within their respective duties and authorities.

4. People's Committees at all levels shall be responsible for implementing state management concerning private health and pharmaceutical practice within their localities according to the delegation of the Government. The Department of Health shall assist the People's Committee of provinces and centrally-administered cities in implementing state management concerning private health and pharmaceutical practice.

Article 47.

The Vietnam Association of Traditional Medicine, the Vietnam Association of Oriental Medicine, and member associations shall participate in the education of professional ethics and enhancement of expertise for practitioners of private health and pharmaceutical practice in accordance with their functions and tasks.

Article 48.

The Association of Practitioners of Private Health and Pharmaceutical Practice is a social-professional organization, a member of the Vietnam Association of Traditional Medicine, established from central to local levels to:

1. Gather practitioners of private health and pharmaceutical practice;

2. Organize training and improvement of professional knowledge and law, and education of professional ethics for members;

3. Supervise and assist members in practicing in accordance with the provisions of the law;

4. Protect the legitimate rights and interests of members;

5. Propose to state management agencies issues related to private health and pharmaceutical practice.

Article 49.

The State Inspectorate of Health shall perform specialized inspection functions regarding private health and pharmaceutical practice.

Article 50.

1. Individuals and organizations have the right to lodge complaints; individuals have the right to report violations of laws on private health and pharmaceutical practice.

2. The resolution of complaints and reports shall be carried out in accordance with the provisions of the law on complaints and reports.

Chapter V
Commendation and Handling of Violations

Article 51.

Individuals and organizations engaged in private health and pharmaceutical practice who achieve notable results in caring for and protecting public health shall be commended in accordance with the provisions of the law.

Article 52.

Any person violating the provisions of this Ordinance and other relevant laws shall be subject to disciplinary action, administrative penalties, or criminal prosecution depending on the nature and degree of violation; if damage is caused, compensation must be provided in accordance with the provisions of the law.

Chapter VI
Implementation Provisions

Article 53.

1. Individuals and organizations that have been issued Certificates of Qualification for Private Health and Pharmaceutical Practice and Certificates of Eligibility for Private Health and Pharmaceutical Practice prior to June 1, 2003 shall continue to practice until the expiration date specified in these certificates, thereafter wishing to continue practicing must apply for new issuance in accordance with the provisions of this Ordinance;

2. The Government shall stipulate conditions and measures to limit and eventually prohibit civil servants and public officials from engaging in private health and pharmaceutical practice starting December 31, 2010.

Article 54.

This Ordinance takes effect from January  6  2003.

This Ordinance replaces the Ordinance on Private Health and Pharmaceutical Practice dated October 13, 1993.

Previous regulations contrary to this Ordinance are abolished.

Article 55.

The Government shall provide detailed regulations and guidance for the implementation of this Ordinance.