THE GOVERNMENT
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SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
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No: 103/2003/ND-CP
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Hanoi, September 12, 2003
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DECREE
DETAILING THE IMPLEMENTATION OF THE
ORDINANCE ON PRIVATE MEDICINAL AND PHARMACEUTICAL PRACTICE
THE GOVERNMENT
Pursuant to the
December 25, 2001 Law on Organization of the Government;
Pursuant to the February 25, 2003 Ordinance on Private Medicinal and
Pharmaceutical Practice;
At the proposal of the Health Minister,
DECREES:
Chapter
I
GENERAL
PROVISIONS
Article
1.- This Decree details the implementation
of a number of articles of the Ordinance on Private Medicinal and
Pharmaceutical Practice on the conditions for the private practice of medicine
and pharmacy; the rights and obligations of private medicinal and
pharmaceutical practitioners; the procedures and competence to grant the
professional practice certificates, the certificates of satisfaction of all
conditions for private medicinal and pharmaceutical practice; the order and
competence to revoke the certificates of private medicinal and pharmaceutical
practice and the certificates of satisfaction of conditions for private
medicinal and pharmaceutical practice.
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1.
Persons who are fully qualified under the provisions of the Ordinance on
Private Medicinal and Pharmaceutical Practice and this Decree shall be granted
certificates of private medicinal and pharmaceutical practice by the Health
Ministry or the Health Services of the provinces or centrally-run cities
(referred collectively to as the provincial Health Services).
2. The certificates of
private medicinal and pharmaceutical practice shall be granted without
depending on the household registration places of the certificate applicants.
Particularly for Hanoi, Ho Chi Minh City, Hai Phong and Da Nang cities, the
certificates of private medicinal and pharmaceutical practice shall be granted
only to persons who have permanent household registration in such localities for
some forms of professional practice according to the Health Ministry's guidance.
3. The certificates of
private medicinal and pharmaceutical practice shall include:
a) Private medicinal
practice certificates:
- Certificates of
consultation and treatment practice;
- Certificates of
medical service provision.
b) Certificates of
private practice of traditional medicine and pharmacy:
- Certificates of
consultation and treatment practice with traditional medicine;
- Certificates of
traditional pharmacy practice.
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d) Certificates of
vaccine and medical bio-product practice.
Article
3.- Private medicinal and/or
pharmaceutical practice establishments, which are granted certificates of full
satisfaction of conditions for private medicinal and/or pharmaceutical practice
by the Health Ministry or the provincial Health Services shall be allowed to
conduct their professional practice at only one place each and within the
professional scope compatible with each form of professional practice
prescribed in the certificates of satisfaction of conditions for professional
practice.
Chapter
II
CONDITIONS
FOR PRIVATE MEDICINAL AND PHARMACEUTICAL PRACTICE
Article
4.-
1.
The certificates of consultation and treatment practice shall be granted to the
heads of the following establishments:
a) General hospitals
or specialized hospitals;
b) General
consultation clinics or specialized consultation clinics;
c) Maternity homes.
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a) Medical service
establishments;
b) Domestic and
overseas patient transportation service establishments.
3. Certificates of consultation
and treatment practice with traditional medicine shall be granted to the heads
of the following establishments:
a) Traditional
medicine hospitals;
b) Traditional
medicine consultation and therapy clinics;
c) Service
establishments for treatment, convalescence, functional rehabilitation,
respiratory training, medicated inhale;
d) Traditional
medicine and pharmacy inheritance and application centers.
4. The certificates of
traditional pharmacy practice shall be granted to the heads of the following
establishments, which produce and/or trade in traditional medicines (individual
business household registration):
a) Establishments
producing and/or trading in traditional medicine finished products;
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c) Establishments
producing and/or trading in pharmaceuticals not yet prepared;
d) Traditional
medicine finished products sale agents.
5. The pharmaceutical
practice certificates shall be granted to:
a) The heads of the
following establishments:
- Drug stores;
- Agents selling
medicines for drug dealing enterprises;
- Medicine-
expertising establishments;
- Medicine
preservation establishments.
b) The heads or
persons in charge of professional matters of medicine dealing enterprises
(including enterprises dealing in traditional medicines).
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a) The heads of the
following establishments:
- Agents selling
vaccines and medical bio-products for enterprises dealing in vaccines and
medical bio-products.
- Vaccine and medical
bio-product expertizing establishments;
- Vaccine and medical
bio-product preservation establishments.
b) The heads or
persons in charge of professional matters of enterprises dealing in vaccines
and/or medical bio-products.
Article
5.- The private medicinal and
pharmaceutical practice certificate grantees must satisfy the following
conditions:
1. Having professional
degrees suitable to each form of professional practice as provided for in
Clause 2 of Articles 17, 22, 27 and 31 of the Ordinance on Private Medicinal
and Pharmaceutical Practice.
2. Having a duration
for practice at medical and/or pharmaceutical establishments suitable to the
requirements of each form of professional practice as provided for at Clause 3
of Articles 17, 22, 27 and 31 of the Ordinance on Private Medicinal and
Pharmaceutical Practice. Bases for determining the practice duration are
prescribed as follows:
a) For officials and
employees, who have worked at State-run medical or pharmaceutical
establishments and retired or quitted their jobs, the bases shall be the
working duration stated in their retirement decisions or severance decisions,
together with the written certification of the practice duration by the units
which have issued such retirement decisions or severance decisions;
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c) For officials,
employees and persons working in State-run medical or pharmaceutical establishments,
the bases shall be the working duration stated in the written certification of
the agency heads permitting the private medicinal and/or pharmaceutical
practice outside their working hours prescribed by the State. The certification
papers must inscribe clearly the duration of practice at the State-run medical
or pharmaceutical establishments.
3. Having professional
ethics; not being subjects prescribed in Article 6 of the Ordinance on Private
Medicinal and Pharmaceutical Practice.
4. Having certificates
of satisfaction of health conditions for working, granted by medical
examination and/or treatment establishments of district or higher level.
Article
6.- The agency heads shall permit
officials, employees and servants under their management to conduct private
medicinal and/or pharmaceutical practice if the latter fully satisfy the
conditions prescribed by law and commit to ensure their work quality, the
working time and other regulations of the agencies, not to use the material
foundations, equipment and facilities of the agencies for their private
professional practice.
Article
7.-
1.
The certificates of satisfaction of conditions for private medicinal and
pharmaceutical practice shall be granted to professional practice organizations
of the following forms:
a) General hospitals,
specialized hospitals, traditional medicine hospitals;
b) General
consultation clinics, specialized consultation clinics;
c) Maternity homes;
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e) Domestic and
overseas patient transportation service establishments;
f) Traditional
medicine consultation and therapy clinics;
g) Service
establishments for treatment, convalescence, functional rehabilitation by
acupuncture, digital massage, respiratory training, medicated inhale;
h) Establishments
dealing in traditional medicine finished products; establishments dealing in
unprocessed traditional medicines; establishments dealing in pharmaceuticals
not yet prepared; traditional medicines sale agents;
i) Traditional
medicine and pharmacy inheritance and application centers;
j) Drug stores;
k) Medicine sale
agents for medicine-dealing enterprises;
l) Medicine testing
establishments;
m) Medicine
preservation establishments;
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o) Vaccine- and/or
medical bio-product- testing establishments;
p) Vaccine and/or
medical bio-product preservation establishments;
q) Enterprises dealing
in medicines, including traditional medicines;
r) Enterprises dealing
in vaccines, medical bio-products;
s) Enterprises
manufacturing medical equipment and facilities;
t) Foreign-invested
medical, pharmaceutical, traditional medicine or pharmacy, vaccine, medical
bio-product or medical equipment establishments.
2. The Health Ministry
shall specify the conditions for each form of professional practice
organizations under the provisions in Clause 1 of this Article and other forms
of professional practice organizations dealing in medical equipment.
Article
8.-
1.
Outside the working hours prescribed by the labor legislation, officials,
employees and persons working at State-run medical or pharmaceutical
establishments are entitled to sign contracts for overtime work with private
medical or pharmaceutical establishments if the latter so need, but have to
report such in writing to the heads of their agencies.
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Article
9.- Forms of professional practice
organizations where officials, employees and persons working at State-run
medical or pharmaceutical establishments can work:
1. Officials,
employees and persons working at State-run medical or pharmaceutical
establishments can conduct private medicinal or pharmaceutical practices only
in one of the forms of professional practice organization registered as
individual business households as follows:
a) Specialized
consultation clinics; medical service establishments except those providing
medical services on domestic and overseas transportation of patients as
provided for in Clause 5, Article 16 of the Ordinance on Private Medicinal and
Pharmaceutical Practice;
b) Traditional
medicine consultation and treatment clinics; service establishments for treatment,
convalescence, functional rehabilitation by methods of acupuncture, digital
massage, respiratory training, medicated inhale; establishments trading in
traditional medicines except types of traditional medicine finished products;
c) Drug stores, agents
selling drugs for enterprises dealing in medicines;
d) Agents selling
vaccines, medical bio-products for enterprises dealing in vaccines, medical
bio-products.
2. Officials and
employees may conduct private medicinal and pharmaceutical practices only to
the end of December 31, 2010. The certificates of private medicinal or
pharmaceutical practice newly granted or extended for officials and employees
shall only be valid until the end of December 31, 2010.
3. The Health Ministry
shall assume the prime responsibility and coordinate with the Ministry of Home
Affairs and the Ministry of Finance in elaborating and submitting to the Prime
Minister for promulgation the regimes of attraction allowances and professional
preference allowances for medical workers in order to create conditions for
them to work with ease on a long-term basis for State-run medical
establishments.
Article
10.- Validity and time limit of the
professional practice certificates are prescribed as follows:
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2. A certificate of
private medicinal or pharmaceutical practice shall be valid for 5 years. After
5 years, if the private medicinal or pharmaceutical practice certificate
grantees wish to continue their professional practice, they must send dossiers
to the agencies which have granted the professional practice certificates to
carry out the procedures for extension thereof. Certificates granted to
officials and employees as from January 1, 2006 shall be only valid until the
end of December 31, 2010.
3. A dossier of
application for extension of a private medicinal or pharmaceutical practice
certificate shall include:
a) The application for
extension of the private medicinal or pharmaceutical practice certificate;
b) The certificate of
full satisfaction of health conditions for working, granted by a medical
examination and treatment establishment of the district or higher level.
Article
11.- For certificates of full satisfaction
of conditions for private medicinal or pharmaceutical practice, which are still
valid, the professional practice establishments must carry out procedures to
apply for new granting in the following cases:
1. Changing forms of
professional practice organizations.
2. Separation or
merger.
3. Change of
professional practice locations outside the provinces or centrally-run cities; in
case of relocation of professional practice sites within a province, the
private medicinal or pharmaceutical practice establishments must report thereon
to the agencies competent to grant certificates for verification and granting
of new certificates of satisfaction of conditions for private medicinal or
pharmaceutical practice.
Article
12.-
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2. The order for
withdrawal of professional practice certificates, certificates of full
satisfaction of conditions for private medicinal or pharmaceutical practice:
a) Upon the detection
of violation cases where certificates of professional practice and/or
certificates of full satisfaction of conditions for private medicinal or
pharmaceutical practice must be withdrawn under the provisions in Article 15 of
the Ordinance on Private Medicinal and Pharmaceutical Practice, the Health
Ministry or provincial Health Services shall issue withdrawal decisions
according to competence;
b) The Health
Ministry's decisions on withdrawal of certificates of professional practice
and/or certificates of full satisfaction of conditions for private medicinal or
pharmaceutical practice shall be notified to provincial Health Services which shall
have the responsibility to recover them and inspect the execution of the Health
Ministry's decisions on withdrawal of certificates of professional practice
and/or certificates of full satisfaction of conditions for private medicinal or
pharmaceutical practice.
Article
13.- If within 12 months as from the date
of being granted certificates of satisfaction of conditions for private
medicinal or pharmaceutical practice the private medical or pharmaceutical
establishments of domestic or foreign organizations or individuals, or overseas
Vietnamese fail to commence their operation, such certificates shall be no
longer valid and be withdrawn by the Health Ministry or provincial Health
Services.
Article
14.-
1.
Private medicinal or pharmaceutical practitioners shall enjoy the rights
prescribed in Clause 1 of Articles 18, 23, 28, 32 and 36 of the Ordinance on
Private Medicinal and Pharmaceutical Practice.
2. Before recruiting
laborers, the heads of private medicinal or pharmaceutical practice
establishments must sign labor contracts in strict accordance with the law
provisions on labor and must bear responsibility for the professional
qualifications of the practitioners. In cases where State officials and
employees work overtime for private medicinal or pharmaceutical practice
establishments, their labor contracts must clearly state their overtime work
and the overtime work duration at the establishments.
3. Private medicinal
or pharmaceutical practitioners, persons doing professional jobs in private
medical or pharmaceutical establishments may join professional associations.
The Ministry of Home
Affairs, the provincial-level People's Committees shall have to create
favorable conditions for professional Associations of private medicinal or pharmaceutical
practitioners to be set up at different levels and operate according to law
provisions.
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1.
The private medicinal and pharmaceutical practitioners are obliged to implement
the provisions in Clause 2 of Articles 18, 23, 28, 32 and 36 of the Ordinance
on Private Medicinal and Pharmaceutical Practice, the professional and
technical regulations promulgated by the Health Ministry and fulfill other
obligations prescribed by law.
2. The professionals
in private medical or pharmaceutical establishments shall have the
responsibility to strictly observe the medically professional and technical
regulations, to further their study so as to raise their professional
qualifications, and to firmly grasp the branch's regulations and the State's
laws. The Health Ministry and provincial Health Services shall have the
responsibility to organize professional activities, professional fostering and
at the same time create favorable conditions for private medicinal or
pharmaceutical practitioners to be trained or re-trained under the provisions
of law.
Article
16.-
1.
Organizations and individuals applying for the granting of certificates of
private medicinal or pharmaceutical practice or certificates of full
satisfaction of conditions for private medicinal or pharmaceutical practice
must pay charges and/or fees according to law provisions on charges and fees.
2. The Ministry of
Finance shall specify the rates, management and use of charges and fees as prescribed
in Clause 1 of this Article.
Chapter
III
CONDITIONS
FOR PRIVATE MEDICINAL OR PHARMACEUTICAL PRACTICE IN VIETNAM BY FOREIGN
ORGANIZATIONS AND INDIVIDUALS, OVERSEAS VIETNAMESE
Article
17.- Foreign organizations and individuals
and overseas Vietnamese may invest in the fields of medical examination and
treatment (including medical examination and treatment by traditional
medicine), pharmacy, vaccines, medical bio-products and/or medical equipment in
Vietnam in forms prescribed in the Law on Foreign Investment in Vietnam as
follows:
1. Business
cooperation on the basis of business cooperation contracts.
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3. Enterprises with
100% foreign capital.
Article
18.- Overseas Vietnamese, foreign
individuals residing permanently in Vietnam may invest in the fields of medical
examination and treatment (including medical examination and treatment by
traditional medicine), pharmacy, vaccines, medical bio-products, medical
equipment in Vietnam in forms of investment applicable to overseas Vietnamese
and foreigners permanently residing in Vietnam, which are prescribed in the Law
on Domestic Investment Promotion.
Article
19.- Foreign organizations and individuals
and overseas Vietnamese invest in the fields of private medical examination and
treatment, pharmacy, vaccines, medical bio-products and/or medical equipment
and facilities in Vietnam under the provisions in Articles 17 and 18 of this
Decree, the provisions of the Ordinance on Private Medicinal and Pharmaceutical
Practice and legal documents guiding the implementation of this Ordinance.
Article
20.- The Health Ministry shall grant
certificates of full satisfaction of conditions for private medicinal or
pharmaceutical practice to foreign individuals and organizations as well as
overseas Vietnamese, if they fully meet the following conditions:
1. Having the demand
and satisfying the demand of caring for and protecting the health of Vietnamese
and/or foreigners in Vietnam.
2. Having enough
conditions on location, medical equipment and other necessary conditions
according to the Health Ministry's regulations.
3. The heads of
foreign-invested medical examination and treatment establishments, the heads or
the persons performing the professional management of establishments dealing in
pharmacy, vaccines, medical bio-products must satisfy all conditions and be
granted professional practice certificates by Vietnam's Health Ministry
according to the provisions of the Ordinance on Private Medicinal and
Pharmaceutical Practice and this Decree.
Article
21.-
1.
Foreign individuals and overseas Vietnamese doing professional work in private
traditional medicine and pharmacy establishments prescribed in Clause 2,
Article 14 of the Ordinance on Private Medicinal and Pharmaceutical Practice
shall be granted licenses by the Health Ministry if they fully meet the
following conditions:
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b) Having lawful
professional practice certificates or written certification of practicing
profession for more than 3 years (up to the time of application for licenses),
granted by their host countries;
c) Having good health
conditions for professional practice as prescribed;
d) Having legal
records certified by competent bodies of the host countries as not being
subjects defined in Article 6 of the Ordinance on Private Medicinal and
Pharmaceutical Practice;
e) Having work permits
granted by Vietnamese agencies performing the State management over labor.
2. Depending on the
practical situation, the Health Ministry shall specify domains where foreigners
are given priority in, or restricted from, medicinal or pharmaceutical practice
in Vietnam.
Article
22.-
1.
Foreigners directly involved in examination and treatment of patients must be
fluent in Vietnamese or have interpreters. Their prescriptions must be written
in Vietnamese and the language of the foreigners who directly give the medical
examinations and prescriptions.
2. The interpreters
prescribed in Clause 3, Article 14 of the Ordinance on Private Medicinal and
Pharmaceutical Practice must satisfy all the following conditions:
a) Having medical
diploma, traditional medicine or pharmacy diploma of intermediate or higher
level, or being galenic physicians;
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3. For private medical
establishments, private traditional medicine establishments which currently
cannot meet the conditions prescribed at Point b, Clause 2 of this Article, the
directors or heads of such establishments shall be allowed to use interpreters
with certificates of foreign language qualification of C or higher degree until
the end of December 31, 2007. The establishment directors or heads must bear
responsibility for the professional qualifications of such interpreters.
Chapter
IV
IMPLEMENTATION
PROVISIONS
Article
23.- This Decree takes implementation
effect 15 days after its publication in the Official Gazette and replaces the
Government's Decree No.06/CP of January 29, 1994 detailing a number of articles
of the Ordinance on Private Medicinal and Pharmaceutical Practice;
The previous
provisions contrary to this Decree shall all be annulled.
Article
24.- The Health Ministry shall assume the
prime responsibility and coordinate with the concerned ministries and branches
in guiding the implementation of this Decree.
Article
25.- The ministers, the heads of the
ministerial-level agencies, the heads of the agencies attached to the
Government, the presidents of the provincial/municipal People's Committees
shall have to implement this Decree.
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