THE
MINISTRY OF AQUATIC RESOURCES
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SOCIALIST
REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
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No:
03/2002/QD-BTS
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Hanoi,
January 23, 2002
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DECISION
PROMULGATING THE REGULATION ON MANAGEMENT OF AQUATIC
VETERINARY DRUGS
THE MINISTER OF AQUATIC RESOURCES
Pursuant to the Government’s Decree No.50/CP
of June 21, 1994 defining the tasks, powers and organizational apparatus of the
Ministry of Aquatic Resources;
Pursuant to the Government’s Decree No.93/CP of November 27, 1993 guiding the
implementation of the Veterinary Ordinance;
Pursuant to the Government’s Decree No.30/2000/ND-CP of August 11, 2000 on the
annulment of a number of permits and licenses and conversion of some others
into business conditions;
Pursuant to the Government’s Decree No.86/2001/ND-CP of November 16, 2001 on
the conditions for the engagement in aquatic business lines;
Pursuant to Circular No.02-TS/TT of June 25, 1994 of the Ministry of Aquatic
Resources guiding the implementation of the Government’s Decree No.93/CP of
November 27, 1993 on veterinary work for aquatic animals and products thereof;
At the proposal of the director of the Aquatic Resource Protection Department,
DECIDES:
Article 1.- To issue
together with this Decision the Regulation on management of aquatic veterinary
drugs.
Article 2.- This
Decision takes effect 15 days after its signing.
The Regulation issued together with this
Decision shall replace the provisions of Section IV, Circular No.02-TS/TT of
June 25, 1994 of the Ministry of Aquatic Resources.
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FOR THE
MINISTER OF AQUATIC RESOURCES
VICE MINISTER
Nguyen Viet Thang
REGULATION
ON MANAGEMENT OF AQUATIC VETERINARY DRUGS
(Issued together with Decision No. 03/2002/QD-BTS)
Article 1.- This
Regulation prescribes uniform procedures and conditions for the production,
trading, import and test of aquatic veterinary drugs on the Vietnamese
territory.
Article 2.-
Organizations and individuals (hereinafter called establishments) involved in
aquatic veterinary drug activities must strictly abide by the provisions of
this Regulation.
Article 3.- In this
Regulation, the following words and phrases shall be construed as follows:
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a/ Disease prevention and treatment.
b/ Diagnosis of diseases.
c/ Regulation of the reproduction, growth and
development processes.
d/ Environmental improvement and treatment.
2. Test of aquatic veterinary drugs means
determination of the efficiency and safety of those drugs when they are put to
use in aquaculture (their efficacy in epidemic prevention and treatment for
aquatic animals, their safety for men and domestic animals, neither causing
environmental pollution nor destroying the ecological environment).
3. Aquatic veterinary drug-related activities
cover the management, production, trading, import and experimentation of
aquatic veterinary drugs.
Article 4.- State
management agencies in charge of aquatic veterinary drugs:
1. At the central level: The Aquatic Resource
Protection Department shall assist the Minister of Aquatic Resources in
performing the function of State management over aquatic veterinary drugs
throughout the country.
2. At the local level: The Aquatic Resource
Protection Sub-Departments shall assist the directors of the
provincial/municipal Aquatic Resource Services or Agriculture and Rural
Development Services involved in aquatic resource management in performing the
function of State management over aquatic veterinary drugs.
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Chapter II
PROVISIONS ON AQUATIC
VETERINARY DRUG-RELATED ACTIVITIES
Article 5.- Conditions
for aquatic veterinary drug production
Establishments producing aquatic veterinary
drugs must meet all the following conditions:
1. Their locations, workshops, warehouses and
waste treatment systems must satisfy the environmental protection and
veterinary hygiene criteria prescribed by the Ministry of Aquatic Resources.
2. Their facilities and equipment must meet the
requirements of production and preservation of raw materials and products.
3. They have technicians and specialized
technical workers. The persons in charge of technical matters regarding aquatic
veterinary drug production must be veterinarians, aquaculture engineers,
bachelors of biology or biological chemistry, or pharmacists.
4. They have means to inspect the quality of
drugs before they are released from factories.
5. The products released from factories must
ensure the announced quality and stuck with goods labels. The contents
inscribed on goods labels shall comply with Circular No.03/2000/TT-BTS of
September 22, 2000 of the Ministry of Aquatic Resources guiding the
implementation of the Prime Minister’s Circular No.178/1999/QD-TTg of August
30, 1999, which promulgated the Regulation on the labeling of domestically
circulated goods as well as import and export goods.
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7. They are allowed to produce only those kinds
of aquatic veterinary drug, which have been inscribed in the registration
certificates for aquatic veterinary drug production.
Article 6.- Conditions
for aquatic veterinary drug trading
Establishments trading in aquatic veterinary
drugs must meet all the following conditions:
1. Their business locations must ensure the
veterinary hygiene criteria prescribed by the Ministry of Aquatic Resources.
2. They have facilities and equipment for
aquatic veterinary drug preservation.
3. The persons who manage aquatic veterinary
drug stores must obtain, at least, diplomas of intermediate veterinary or
aquacultural schools.
4. They are allowed to trade in only those kinds
of aquatic veterinary drug, which are on the list of those permitted for use promulgated
by the Ministry of Aquatic Resources.
Article 7.- Test of
aquatic veterinary drugs
1. The aquatic veterinary drugs outside the list
of those permitted for use promulgated by the Ministry of Aquatic Resources
must be tested before being imported into Vietnam or produced in the country
for the first time.
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Article 8.- Import of
aquatic veterinary drugs
The import of aquatic veterinary drugs shall
comply with the Ministry of Aquatic Resources�
regulations on the management of specialized aquatic goods import and export.
Chapter III
CONTENTS AND PROCEDURES
FOR THE GRANTING OF AQUATIC VETERINARY DRUG PRODUCTION REGISTRATION
Article 9.- Dossier for
registration of aquatic veterinary drug production
1. An application for registration of aquatic
veterinary drug production, enclosed with a list of drugs to be produced.
2. A disposition on the conditions for aquatic
veterinary drug production.
3. Copies of diplomas of the persons in charge
of technical matters.
4. Technical dossier, including:
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b/ The inspection result card certifying the
satisfaction of the already registered quality standards, granted by the State
inspection agency.
5. Copies of papers related to the founding of
the production establishment such as founding decision, business registration
certificate, investment license.
Article 10.- Procedures
for consideration and granting of registration certificates for aquatic
veterinary drug production
1. When receiving dossiers, the
registration-granting agencies shall base themselves on Article 9 to consider
the dossiers and guide the establishments to supplement incomplete contents.
2. Within 10 working days after receiving the
valid dossiers, the Aquatic Resource Protection Department shall have to
evaluate the production conditions. If all conditions are met, the Aquatic
Resource Protection Department shall grant the registration certificates for
aquatic veterinary drug production to production establishments. If the
evaluation conclusions show that the production establishments fail to meet the
conditions for aquatic veterinary drug production, such establishments may
request the reevaluation after overcoming the shortcomings revealed in the
first evaluation.
Article 11.- Inspection
of conditions for aquatic veterinary drug production
The inspection of conditions for aquatic
veterinary drug production shall be conducted in the following cases:
1. The first-time inspection shall apply to
establishments that have just begun to participate in production and
establishments that have been registered for production but change their
production locations.
2. The re-inspection shall apply to
establishments that have been inspected but fail to meet the production
conditions and establishments that expand their production locations and
production chains.
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4. The extraordinary inspection shall be
conducted when the managing agencies deem it necessary.
Article 12.- Agencies
inspecting conditions for aquatic veterinary drug production
1. The Aquatic Resource Protection Department
shall be the agency inspecting the production conditions for establishments
producing aquatic veterinary drugs throughout the country.
2. The provincial Aquatic Resource Protection Sub-Departments
shall be the agencies inspecting production conditions for establishments
producing aquatic veterinary drugs under the Aquatic Resource Protection
Department’s authorization.
Article 13.- The
effective duration of registration certificates for aquatic veterinary drug
production shall be one year (from the date of issuance). Upon the expiry
thereof, establishments shall have to apply for registration extension if
wishing to continue the production of those aquatic veterinary drugs. The
extension of registration certificates shall be valid for one year.
Article 14.- Extension
of production registration certificates
1. Dossier of application for extension:
a/ The extension application.
b/ The report on the establishment’s production
activities in the effective duration of the granted production registration
certificate.
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2. Extension consideration procedures:
Within 7 working days after receiving the valid
dossiers, the Aquatic Resource Protection Department must consider them and
notify the consideration results.
Chapter IV
RESPONSIBILITIES AND
POWERS OF STATE MANAGEMENT AGENCIES AND RELEVANT ESTABLISHMENTS ENGAGED IN
AQUATIC VETERINARY DRUG ACTIVITIES
Article 15.- Responsibilities
and powers of the Aquatic Resource Protection Department
1. Responsibilities:
a/ To elaborate and submit to the Ministry for
promulgation legal documents on the management of aquatic veterinary drugs.
b/ Annually or periodically, to draw up lists of
aquatic veterinary drugs permitted for use, restricted or banned from use in
Vietnam and submit them to the Ministry’s leaders for decision on the
promulgation thereof.
c/ To settle disputes, complaints and
denunciations related to the management of aquatic veterinary drugs of
establishments, which fall under its competence.
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a/ To grant and withdraw registration
certificates for aquatic veterinary drug production from organizations and
individuals throughout the country.
b/ To examine and inspect aquatic veterinary
drug-related activities.
c/ To request organizations and individuals
producing and trading in aquatic veterinary drugs to supply relevant documents
and materials.
d/ To collect charges as prescribed.
Article 16.-
Responsibilities and powers of Aquatic Resource Protection Sub-Departments or
agencies designated by the provincial/municipal Agriculture and Rural
Development Services to assist the Service directors in exercising the State
management over aquatic veterinary drugs
1. Responsibilities:
a/ To organize the management of aquatic
veterinary drug-related activities in localities.
b/ To receive and settle proposals, complaints
and denunciations regarding the management of aquatic veterinary drugs within
the ambit of their vested powers or transfer them to other competent agencies
for settlement.
2. Powers:
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b/ To request organizations and individuals
producing and trading in aquatic veterinary drugs in localities to supply
relevant documents and materials.
c/ To collect and use charges as prescribed.
Article 17.-
Responsibilities of establishments
To abide by all the provisions of this Regulation
and submit to supervision and inspection by the State agencies managing aquatic
veterinary drugs.
Chapter V
CHARGES AND THE USE
THEREOF
Article 18.- Inspection
agencies are allowed to collect charges for inspection of aquatic veterinary
drug production conditions in cases of first-time inspection, re-inspection and
periodical inspection.
Article 19.- The charge
rates as well as charge management and use shall comply with the Finance
Ministry’s stipulations and guidance.
Chapter VI
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Article 20.-
Organizations and individuals engaged in aquatic veterinary drug-related
activities shall have the right to complain about or denounce conclusions and
handling measures of agencies inspecting and examining aquatic veterinary drugs
in their respective establishments according to the provisions of the Law on
Complaints and Denunciations.
Article 21.-
Organizations and individuals engaged in aquatic veterinary drug-related
activities that fail to observe or breach the provisions of this Regulation
shall be administratively sanctioned according to law provisions.
Article 22.- Persons
responsible for exercising the State management over aquatic veterinary drugs,
who commit acts of violating the provisions of this Regulation, shall,
depending on the seriousness of their violations, be disciplined,
administratively sanctioned or examined for penal liabilities according to law
provisions.
Chapter VII
IMPLEMENTATION PROVISIONS
Article 23.- All
amendments and/or supplements to the contents of this Regulation shall be
considered and decided in writing by the Minister of Aquatic Resources.
Article 24.- The
Aquatic Resource Protection Department shall have to guide, inspect and
organize the implementation of this Regulation.
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