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THE
MINISTRY OF PUBLIC HEALTH
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SOCIALIST
REPUBLIC OF VIET NAM
Independence - Freedom – Happiness
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No:
01/2001/TT-BYT
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Hanoi
, January 19, 2001
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CIRCULAR
ON
THE CONSIDERATION OF GRANTING OF PHARMACEUTICALS TRADING PRACTICE CERTIFICATES
Pursuant to the Law on
Protection of Peoples Health of July 11, 1989;
Pursuant to Enterprises Law No.13/1999/QH10 of June 12, 1999; the Government’s
Decree No.02/2000/ND-CP of February 3, 2000 on business registration and Decree
No.03/2000/ND-CP of February 3, 2000 guiding the implementation of a number of
articles of the Enterprises Law;
Pursuant to the Government’s Decree No.11/1999/ND-CP of March 3, 1999 on
goods banned from circulation, commercial services banned from provision; goods
and commercial services subject to the restricted or conditional business;
Pursuant to the Ordinance on Private Medical and Pharmaceutical Practice;
the Government’s Decree No.06/CP of January 29, 1994 detailing a number of
articles of the Ordinance on Private Medical and Pharmaceutical Practices;
The Ministry of Health hereby guides the consideration and granting of
pharmaceutical trading practice certificates to individuals who trade in
pharmaceuticals.
Chapter I
GENERAL PROVISIONS
Article 1.- Pharmaceuticals
trading practice certificates (called pharmaceutical practice certificates for
short) are written titles granted by the Health Ministry or the Health Services
of the provinces and centrally-run cities to individuals who are professionally
qualified and have adequate professional experience and practice ethics for
trading in pharmaceuticals according to the provisions of the Enterprises Law
on the Vietnamese territory.
Article 2.-
All individuals who are fully qualified under the provisions of this Circular
and wish to trade in pharmaceuticals shall be granted pharmaceutical practice
certificates.
Article 3.- Subjects
that must hold pharmaceutical practice certificates to make business registration
according to the provisions of the Enterprises Law include:
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2. All partners of a
partnership.
3. The owner or the executive
manager of a private enterprise.
4. Directors or persons in
charge of dependent units of an enterprise (branches, pharmacies, corporated
drugstores).
5. The owner of a private
drugstore.
6. The owner of a drug retail
agent.
Chapter II
CRITERIA FOR BEING GRANTED PHARMACEUTICAL PRACTICE
CERTIFICATES
Article 4.- General
criteria:
- Possessing graduation diploma
in pharmacy specialty;
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- Having good health and full
civil act capacity to conduct pharmaceuticals trading activities;
- Neither being subjects banned
from establishing or managing enterprises prescribed in Article 9 of the
Enterprises Law nor currently subject to disciplines in the pharmaceutical
practice;
- Being knowledgeable about the
Law on Protection of People’s Health, the legislation on private pharmaceutical
and medical practice and the professional regulations relevant to the practice.
Article 5.- Regulations
on professional diplomas and degrees and pharmaceutical practice period
(professional practice period) of individuals to be granted practice
certificates:
1. For individuals conducting
pharmaceuticals trading activities in form of enterprises:
- For enterprises that only
trade in pharmaceuticals: Possessing a diploma of graduation from a pharmacy
university and having practiced for 5 years at a lawful pharmaceutical trading
establishment.
- For enterprises that are
engaged in pharmaceutical production: Possessing a diploma of graduation from a
pharmacy university and having practiced for 5 years at a lawful pharmaceutical
production establishment. Particularly for enterprises producing traditional
medicines with their managers being galenical pharmacists, such managers must
have practiced for 5 years at lawful establishments engaged in production and
preparation of traditional medicines.
- For dependent units of
enterprises: directors or persons in professional charge of such units must
possess diplomas of graduation from a pharmacy university and have practiced
for 5 years at lawful pharmaceutical establishments.
2. For individuals conducting
pharmaceuticals trading activities in form of private drugstores:
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3. For individuals conducting
pharmaceuticals trading activities in form of retail sale agents:
Possessing diplomas of
graduation from a pharmacy intermediate or primary school and having practiced
for 2 years at lawful pharmaceutical establishment.
Chapter III
DOSSIERS, PROCEDURES AND COMPETENCE TO GRANT
PHARMACEUTICAL PRACTICE CERTIFICATES
Article 6.- A
dossier of application for pharmaceutical practice certificate comprises:
- The application for practice
certificate (made according to the set form);
- A valid copy of the diploma of
graduation from a pharmacy tertiary, intermediate or primary school or the
certificate of galenical pharmacist;
- The applicant’s resume (with
his/her photo) containing certification of his/her personal status (not being
examined for penal liability or having his/her imprisonment sentence wiped
out), and that he/she is not disciplined in pharmaceutical practice.
- The written certification of
the period of working at lawful pharmaceutical establishments.
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- Two photos (of size 4 cm x 6
cm);
- The commitment to comply with
the Law on Protection of People’s Health, the legislation on private medical and
pharmaceutical practice and professional regulations related to the
pharmaceutical practice.
Article 7.- Competence
to grant pharmaceutical practice certificates:
1. The Ministry of Health shall
consider and grant practice certificates to individuals having diplomas of
graduation from pharmacy universities or certificates of galenical pharmacists.
Pharmaceutical practice certificates granted by the Ministry of Health are
valid throughout the country.
2. The provincial/municipal
Health Services shall grant pharmaceutical practice certificates to individuals
having diplomas of graduation from pharmacy intermediate or primary schools.
Pharmaceutical practice certificates granted by the provincial/municipal Health
Services are valid in their respective localities.
Article 8.- Each
pharmaceutical practice certificate shall be valid for 5 years.
Article 9.- The
procedures for granting pharmaceutical practice certificates:
Within 30 days for the Ministry
of Health and 15 days for provincial/municipal Health Services after receiving
complete and valid dossiers, such bodies shall consider and grant
pharmaceutical practice certificates to individuals. In case of refusal, they
shall have to notify in writing the reason(s) therefor.
Each pharmaceutical practice
certificate shall be made in 2 copies: One shall be sent to the applicant,
another kept at the practice certificate-granting body. In case of renewal, the
certificate holders shall have to return their old certificates to the granting
bodies.
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HANDLING OF VIOLATIONS
Article 10.-
Individuals granted pharmaceutical practice certificates shall be held
responsible before law for professional pharmaceutical operations in their
business activities. In cases where pharmaceutical practice certificate holders
violate regulations on practice, they shall, depending on the seriousness of
their violations, have their pharmaceutical practice certificates withdrawn
temporarily or permanently.
Article 11.- Bodies
competent to grant pharmaceutical practice certificates may withdraw such
practice certificates from certificate grantees if the latter commit violations
in one of the following cases:
- Hiring out or lending practice
certificates to other people for conducting business activities;
- Trading in fake medicines;
- Repeatedly or seriously
violating the professional regulations;
- Violating the regulations on
professional ethics, thus igniting adverse opinions in the society;
- Failing to conduct business
activities for one year after being granted pharmaceutical practice
certificates.
Chapter V
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Article 12.- This
Circular takes effect 15 days after its signing for promulgation. The previous
documents which are contrary to this Circular are all now annulled.
The Vietnam Pharmaceutical
Management Department, the Health Ministry’s Inspectorate and concerned
departments and sections, the Health Services of the provinces and
centrally-run cities shall have to implement this Circular.
FOR
THE MINISTER OF HEALTH
VICE MINISTER
Le Van Truyen