|
THE
MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT
---------
|
SOCIALIST
REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
----------
|
|
No.
02/2009/TT-BNN
|
Hanoi,
January 14, 2009
|
CIRCULAR
GUIDING
THE PROCEDURES FOR WITHDRAWAL AND DISPOSAL OF VETERINARY DRUGS
Pursuant to the Government's
Decree No. 01/ 2008/ND-CP of January 3, 2008, defining the functions, tasks,
powers and organizational structure of the Ministry of Agriculture and Rural
Development;
Pursuant to November 21, 2007 Law No. 05/ 2007/QH12 on Product and Goods
Quality;
Pursuant to the April 29, 2004 Animal Health Ordinance;
Pursuant to the Government's Decree No. 33/ 2005/ND-CP of March 15, 2005,
detailing a number of articles of the Animal Health Ordinance;
The Ministry of Agriculture and
Rural Development guides the procedures for withdrawal and disposal of
veterinary drugs and biological preparations, microorganisms and chemicals used
in animal health (including aquatic veterinary drugs) as follows:
I. GENERAL PROVISIONS
1. Scope of regulation and
subjects of application
a/ This Circular applies to
veterinary drugs and biological preparations, microorganisms and chemicals used
in animal health, including aquatic veterinary drugs (below collectively referred
to as veterinary drugs), specified in Article 50 of the Animal Health Ordinance
and Article 62 of the Government's Decree No. 33/ 2005/ND-CP of March 15, 2005,
detailing a number of articles of the Animal Health Ordinance.
b/ State agencies. Vietnamese and
foreign organizations and individuals engaged in veterinary drug production and
trading activities in the Vietnamese territory shall comply with this Circular.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
The terms referred to in this
Circular are construed as follows:
a/ Use duration means the time
limit for using of a drug lot. Past this time limit, the drug may not be
circulated and used.
b/ Lot means a certain quantity
of products which are manufactured in a given production cycle under a specific
production order and have the same specifications and quality
c/ Poor quality drug means a
drug failing to meet quality standards registered with the Animal Health
Department.
d/ Fake veterinary drug means a
veterinary drug without a production registration certificate granted by a
competent agency, or a product in drug form falling under one of the following
cases:
- Containing no or
insufficiently containing pharmaceutical substances as registered;
- Containing pharmaceutical
substances other than those indicated on the label:
- Using the name, model or
product circulation registration code of another manufacturer;
- Using the name or industrial
design of another manufacturer's product already registered for industrial
property protection.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
f/ Drug of unclear origin means
a drug whose original label fails to specify or insufficiently specifies the
manufacturer's name and address; or fails to specify the country or territory
of manufacture, for an imported drug.
g/ Establishment responsible for
veterinary drugs means a veterinary drug manufacturer, importer or trader.
II. WITHDRAWAL OF VETERINARY
DRUGS
1. Veterinary drugs subject
to withdrawal include:
a/ Those on the list of
veterinary drugs banned from circulation in Vietnam;
b/ Those not on the list of
veterinary drugs permitted for circulation in Vietnam;
c/ Fake veterinary drugs,
veterinary drugs of unclear origin or with expired use duration;
d/ Unlabeled veterinary drugs or
veterinary drugs improperly labeled under law;
e/ Those with changing
appearance (or properties), such as being curdled, turbid, discolored, sedimented, layered or deformed.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
2. Procedures for veterinary
drug withdrawal:
a/ When detecting veterinary
drugs subject to withdrawal under Points a, b. c, d and e. Clause 1, Part II.
competent state agencies shall seal up those drugs and issue withdrawal
decisions.
b/ Veterinary drugs specified at
Point f. Clause 1, Part II shall be withdrawn as follows:
- For a veterinary drug whose
samples are taken at a manufacturer, exporter or importer:
The Animal Health Department
shall notify the drug owner of test results of drug samples and request it to
immediately withdraw the lot of such drug by itself. Within 7 days, for a
pharmaceutical product or chemical, or 45 days, for a vaccine or biological
preparation, from the date of receiving the Animal Health Department's notice,
the enterprise may lodge a complaint about test results with the Animal Health
Department. Past this time limit, if no complaint is lodged, the Animal Health
Department shall issue a decision to withdraw such drug nationwide.
When a complaint is lodged, the
Animal Health Department shall take samples for re-testing. If test results
still show that the drug fails to meet quality standards, the Animal Health
Department shall issue a decision to withdraw the drug nationwide. When test
results show that the drug meet quality standards, the lot of such drug may be
circulated again on the market.
- For a veterinary drug whose
samples are taken in a province or centrally run city:
After having test results, the
sample-taking agency shall immediately seal up the lot of drugs failing to meet
quality standard and issue a decision to withdraw the drug in a province or
centrally run city; and simultaneously notify such to the Animal Health
Department and the manufacturer or importer of the drug lot. Within 7 days, for
a pharmaceutical product or chemical, or 45 days, for a vaccine or biological
preparation, from the date of receiving the Animal Health Department's notice,
an enterprise may lodge a complaint about test results with the Animal Health
Department. Past this time limit, if no complaint is lodged, the Animal Health
Department shall issue a decision to withdraw the drug nationwide.
When a complaint is lodged, the
Animal Health Department shall take samples at the manufacturer or importer for
re-testing. If test results still show that the drug fails to meet quality
standards, the Animal Health Department shall issue a decision to withdraw it
nationwide. When test results show that the drug lot meets quality standards,
the Animal Health Department will not issue a decision for withdrawal nationwide.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
d/ For a veterinary drug subject
to withdrawal nationwide, the Animal Health Department shall issue a withdrawal
decision and publicize it on a central mass media. Provincial-level
Sub-Departments of Animal Health shall supervise the withdrawal in their
localities.
e/ For a veterinary drug subject
to withdrawal in a province or centrally run city, a Sub-Department of Animal
Health shall issue a withdrawal decision and publicize it on a local mass
media.
f/ The Animal Health Department
shall issue a decision for withdrawal nationwide, publicize it on a central
mass media and withdraw the registration number for the following special cases
of violation:
- Veterinary drugs containing
active ingredients on the list of veterinary drugs banned from circulation in
Vietnam.
- Veterinary drugs detected as
failing to meet quality standards in three regular or random examinations in a
year by a competent agency.
- Veterinary drugs with unclear
treatment effects or side effects that may harm human or animal health or pose
risks to humans, animals and the environment.
III. DISPOSAL OF WITHDRAWN
VETERINARY DRUGS
1. Provincial-level
Sub-Departments of Animal Health shall destroy the following veterinary drugs:
a/ Those on the list of
veterinary drugs banned from circulation in Vietnam;
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
c/ Fake veterinary drugs,
veterinary drugs of unclear origin or those with expired use duration;
d/ Veterinary drugs with
changing appearance (or properties), such as being curdled, turbid, discolored,
sedimented, layered or deformed.
e/ Unlabeled veterinary drugs.
A Sub-Department of Animal
Health shall issue a decision to set up a veterinary drug destruction council.
Such a council must have at least three members: a leader of the Sub-Department
of Animal Health, an inspector and a representative of the local environment
agency.
2. For a veterinary drug on the
list of veterinary drugs permitted for circulation in Vietnam, which is being
circulated on the market, but is improperly labeled under law or fails to meet
registered quality standards, the establishment responsible for the drug shall
promptly:
a/ Withdraw and destroy
veterinary drugs violating quality regulations at level 1, including:
- Erroneous contents that may
cause serious consequences;
- Erroneous active ingredients
that may cause serious consequences;
- No active ingredients or lack
of the main active element indicated on the label;
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
- Veterinary drugs subject to
urgent withdrawal under decisions of foreign management agencies (for imported
veterinary drugs).
b/ Withdraw and dispose of
veterinary drugs violating quality regulations at level 2 according to
manufacturers' regulations:
- Veterinary drugs that are
improperly labeled under law;
- Veterinary drugs that fail to
meet one of the registered quality indicators on appearance, physico-chemical properties; microorganisms; or have
contents beyond the 10% limit for the contents indicated on the label; or net
weight (actual volume) beyond the 5% limit for the weight indicated on the
label.
3. In case of destruction, an
establishment responsible for the drug shall cover all expenses for destroying
the drug and take responsibility for the consequences of such destruction under
law.
IV. ORGANIZATION OF
IMPLEMENTATION
1. Responsibilities of
competent agencies
a/The Animal Health Department
shall guide the destruction of veterinary drugs, and forms of documents related
to veterinary drug withdrawal.
b/ The Animal Health Department
and provincial-level Sub-Departments of Animal Health shall organize the
withdrawal and disposal of veterinary drugs under this Circular.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
This Circular takes effect 45
days from the date of its signing.
In the course of implementation,
any arising problems should be reported to the Ministry of Agriculture and
Rural Development (the Animal Health Department) for timely adjustment and
supplementation.
FOR THE MINISTER
OF AGRICULTURE AND RURAL DEVELOPMENT
VICE MINISTER
Diep Kinh Tan