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MINISTRY OF
AGRICULTURE AND RURAL DEVELOPMENT
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No.:
51/2009/TT-BNNPTNT
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Hanoi, August 21,
2009
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CIRCULAR
REGULATIONS
ON INSPECTION AND CERTIFICATION OF ELIGIBILITY FOR PRODUCTION AND SALE OF
VETERINARY DRUGS, BIO-PREPARATIONS, MICROORGANISMS AND CHEMICALS USED IN
VETERINARY MEDICINE AND AQUATIC VETERINARY MEDICINE
Pursuant to the Government’s Decree No. 01/2008/ND-CP
dated January 03, 2008 defining functions, tasks, powers and organizational
structure of Ministry of Agriculture and Rural Development;
Pursuant to the Ordinance on Veterinary Medicine
dated April 29, 2004;
Pursuant to the Government’s Decree No.
33/2005/ND-CP dated March 15, 2005 detailing the implementation of certain
articles of the Ordinance on Veterinary Medicine;
Pursuant to the Government’s Decree No.
59/2006/ND-CP dated June 12, 2008 detailing the implementation of the Law on
Commerce on goods and services banned and restricted from business, and subject
to conditional business;
Ministry of Agriculture and Rural Development
promulgates the following regulations on procedures for the inspection and the
certification of eligibility for production and sale of veterinary drugs,
bio-preparations, microorganisms and chemicals used in veterinary medicine and
aquatic veterinary medicine.
Chapter I
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Article 1. Scope and regulated
entities
1. This Circular provides for requirements and
procedures for the inspection and the certification of eligibility for
production and sale of veterinary drugs, bio-preparations, microorganisms and
chemicals used in veterinary medicine and aquatic veterinary medicine;
ingredients used for producing veterinary drugs and aquatic veterinary
drugs (hereinafter referred to as veterinary drugs).
2. This Circular apply to producers of veterinary
drugs that have not possess GMP Certificates, sellers, importers, exporters and
storage facilities of veterinary drugs that have not possess GSP Certificates;
veterinary drug stores and vendors that have not possess GPP Certificates.
Domestic and foreign organizations and individuals
whose production and sale activities of veterinary drugs are carried out in the
territory of Vietnam must comply with this Circular.
Article 2. Fees and charges
The collection of the inspection fees and charges
for certifying the eligibility for production and sale of veterinary drugs
shall comply with Ministry of Finance’s current regulations and other relevant
legal documents.
Chapter
II
REQUIREMENTS FOR
MANUFACTURING OF VETERINARY DRUGS
Article 3.
General requirements for producers of veterinary drugs
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a) Be not contaminated from the
outside environment;
b) Do not cause adverse impacts
on surrounding environment;
c) Be in distant from
residential areas, schools, office buildings, hospitals, medical testing and
diagnosis facilities;
d) Be convenient for transport,
ensure water and power sources for manufacturing activities.
2. Workshop:
a) The workshop must be built
in a strong and firm manner in conformity with the nature and the scale of
production, avoiding adverse natural impacts such as weather, flood, moisture
and the infiltration of insects or other animals;
b) The workshop must have firm,
dry, flat and non-slip foundation which has to bear the compression of
machinery during the manufacturing of veterinary drugs;
c) Walls and ceiling must be
made of strong and solid materials;
d) The floor must not be
cracked, be designed to prevent the water absorbance or stagnation, easy for
cleaning and suitable for disinfectants;
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e) The planning for construction
must be suitable and conformable to the nature and the scale of production.
g) Each place in the workshop
must meet with the criteria of veterinary hygiene as regulated.
3. Equipment:
a) Machinery and equipment must be arranged and
installed in conformity with intended operations; operational manual and
maintenance plans should be available. There should be the proper industrial
cleaning process to prevent the contamination or cross-contamination between
products.
b) Equipment must be available as regulated in the
Annex No. 1 enclosed with this Circular.
4. Packages:
a) Primary packages must not harm the quality of
veterinary drugs contained inside, and may prevent adverse impacts from the
outside such as light, moisture, and microorganisms during the preservation of
veterinary drugs.
b) Glass packages must be firm and durable kinds in
conformity with the sterilization, transport and preservation.
5. Testing laboratory:
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b) Area of the testing laboratory must be enough
for avoiding the cross-contamination and maintaining samples and titrants.
c) Equipment must be available as regulated in the
Annex No. 2 herein.
d) The testing laboratory manager must possess an
appropriate practice certificate which has been granted by the competent
veterinary agency as regulated.
6. Personal hygiene:
Workers in producers of veterinary drugs must meet
the following requirements:
a) They must be fit for work as regulated by
Ministry of Health; go for periodic check-up once for every year; do not have
any open wounds and dermatological diseases;
b) They must be trained in professional skills,
personal hygiene and industrial cleaning knowledge during the production of
veterinary drugs.
c) Workers in producers of veterinary drugs must
comply with regulations on veterinary hygiene in the production area.
7. Labor safety and hygiene:
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b) Written regulations on the issuance and use of
working equipment and clothing must be promulgated.
c) Fire equipment, and equipment for deodorization,
air ventilation and vacuum must be equipped with suitable capacity. Workers who
use heating, electrical, mechanical, or compressed air equipment must be
provided with safety equipment.
d) Written regulations on labor protection must be
formulated; measures and facilities for preventing and solving problems which
may occur must be available.
8. Waste collection and
treatment system:
a) The wastewater treatment
system must be designed in conformity with the workshop and the scale of
production, ensuring that the wastewater from all sources must be treated in
the appropriate manner and avoiding the pollution in the workshop and
surrounding area.
b) Garbage bins must be placed
in all areas in the producer in the appropriate manner which must be easy for
transport. The wastewater must be treated in conformity with technical
regulations before it can be discharged.
Article 4.
Requirements for producers of medicinal products and chemicals used in
veterinary medicine
1. Warehouse system:
a) Build warehouses and special
areas for storing materials, auxiliary materials, packages and finished
products; the producer must build a warehouse in the outside for storing
explosive and inflammable solvents and materials, and have special areas for
storing discarded materials, semi-finished and finished products.
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c) Necessary equipment and
facilities for ensuring the quality of products must be available and in
conformity with preservation requirements. To be specific:
Storage at normal conditions:
temperature is from 15 to 30 0C, and the humidity shall not exceed
70%;
Cool storage: temperature is
from 8 to 15 0C.
Cold storage: temperature is
from 2 to 8 0C.
Freezing storage: temperature
is ≤-100C.
d) Prevent the direct light and
the contamination from the outside environment;
dd) Products must be arranged
on brackets/shelves in a tidy and scientific way. Brackets/shelves must be at
least 20 cm far away from the foundation surface, and at least 20 cm far away
from the walls; the distance between brackets/shelves or that between items of
products must be at least 30 cm for ensuring the ventilation and facilitating
the warehousing input or delivery of goods, cleaning and sterilization;
e) The producer must promulgate
written regulations on the arrangement and preservation of goods, periodical
inspection, discovery and handling of problems which occur during the
preservation;
g) Equipment for checking
preservation standards and policies on regular recording of technical
parameters must be available.
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a) It must have a place for
practicing mechanical hygiene and chemical hygiene for primary packages,
including ampoule covers, vial covers, bottles, and caps, devices and equipment
for preparation, and personal protective equipment. The floor surface
where the mechanical hygiene is performed must slope about 1.50
towards the drainage ditch and has the rubbing for preventing slip.
b) Ampoules, vials, bottles,
caps, devices and personal protective equipment must be sterilized to meet
requirements on each manufacturing step.
c) Equipment, devices and
chemicals must be suitable for the sterilization;
d) Written regulations on
hygiene and sterilization of primary packages, manufacturing devices and
personal protective equipment must be promulgated.
3. Area for weighing and
delivering materials:
a) Have a separate room for
weighing materials. If a separate room for weighing materials is not available,
measures against the cross-contamination between kinds of materials must be
prepared.
b) Scales and devices for
weighing materials must be available and cleaned after they are used.
4. Area for preparation,
mixture and storage of semi-finished products:
a) The walls and ceiling must be shiny; the
intersection between the foot of the wall and the floor surface, and that
between the wall and the ceiling must be obtuse angles.
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All equipment must be sterilized before they are
moved to the sterile area. They must be stored in sterile conditions with “sterilized”
labels.
Measures against re-contamination before and during
using must be available.
c) The production line for veterinary drugs in the
form of powder: vacuum devices must be equipped.
d) Equipment, devices and
chemicals must be available and suitable for the production process.
dd) It must have special area
for storing semi-finished products whose division is not yet carried.
5. Area for finishing products;
a) This area must be arranged next to the area for division
of drugs for facilitating the receipt of products for packing.
b) Equipment and devices must be available and
suitable for the packing, labeling and transport of products to the warehouse
of finished products.
6. The area for storing
products which fail to meet quality standards must be arranged separately, are
lockable or have a warning sign put up to avoid the confusion with other
products.
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a) Equipment, devices, chemical and the environment
must be in conformity with the procedures for the final inspection of products
before they are released. If the producer fails to meet
requirements for carrying out the inspection, it must contract a qualified
inspection unit to carry out the inspection of products as regulated.
b) Regulations on storage, preservation and
inspection of stored samples must be promulgated.
8. Personal hygiene area and
other areas serving the production.
a) Must be arranged in an
appropriated way and out of contact with the production area.
b) Have necessary equipment,
chemicals and devices for practicing personal hygiene and cleaning such areas.
c) Have air ventilation and
deodorization equipment.
Article 5.
Requirements for producers of vaccines, bio-preparations and microorganisms
Apart from regulations stated
in Article 3 and Article 4 of this Circular, producers of vaccines,
bio-preparations and microorganisms must have separate areas for raising
animals for experimental purpose and treating tested animals; areas and
equipment for keeping breeds of microorganisms to serve the production.
Article 6.
Requirements for producers of hormones used in the veterinary medicine:
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Article 7. Requirements for
processing, dividing and packing veterinary drugs
Regulations in Clauses 1, 2, 4, 5, 6, 7, and 8
Article 3; Clauses 1 and 2, Points a, c, d Clause 4; Clauses 5, 6, 7, 8 Article
4 of this Circular shall apply.
Chapter
III
REQUIREMENTS FOR SALE OF
VETERINARY DRUGS
Article 8.
Wholesalers and retailers of veterinary drugs must satisfy the following
requirements:
1. Have a registered address, signboard indicating
the name of store, establishment or enterprise, and the issued business code;
the board posting the business registration certificate.
2. Minimum area of a veterinary drug store is 10m2
3. Have been equipped with adequate equipment for
showing and selling products; veterinary drugs must be arranged in a scientific
and clean way.
4. Have records for monitoring the input or
delivery of products;
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a) Storage at normal conditions: temperature is
from 15 to 300C.
b) Cool storage: temperature is from 8 to 150C.
c) Cold storage: temperature is from 2 to 80C.
d) Freezing storage:
temperature is ≤-100C.
6. Do not sell veterinary drugs together with other
commodities. If animal breeds and veterinary drugs are allowed to sell in the
same store, they must be arranged separately.
7. A wholesaler of veterinary drugs must have a
warehouse for storing veterinary drugs with suitable area; have equipment and
devices in compliance with requirements for storage of veterinary drugs and
materials which such wholesaler are licensed to sell. Products must be arranged
on brackets/shelves. Brackets/shelves must be at least 20 cm far away from the
foundation surface, and at least 20cm cm far away from the walls; the distance
between brackets/shelves must be at least 30 cm for ensuring the ventilation,
cleaning and sterilization; electric generators must be
available.
8. Veterinary vaccine store must be equipped with
cold storage equipment and standbys for storing vaccines and bio-preparations
in case of the power cut; thermometers for monitoring storage temperature and
taking daily notes.
9. Owners or storekeepers must possess certificates
of practice granted by competent veterinary agencies as regulated.
Article 9.
Importers of veterinary drugs must satisfy the following requirements:
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1. Importers of veterinary vaccines must have
specialized means of transport of vaccines in order that vaccines are stored in
appropriate method during the transport.
2. Owners or technicians must possess certificates
of practice granted by competent veterinary agencies as regulated.
Chapter
IV
PROCEDURES FOR
INSPECTION AND CERTFIICATION OF ELIGIBILITY FOR PRODUCTION AND SALE OF
VETERINARY DRUGS
Article 10. Methods of
inspection
1. The initial inspection shall apply to:
a) Establishments that carry out the first
registration;
b) Establishments that have registered their
production and trading but change location or improve production line;
c) Establishments that have certificates of
eligibility for production and sale of veterinary drugs revoked, production and
trading been suspended, and apply for re-certification.
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3. The periodical inspection
shall be carried out once for every two years for evaluating the maintenance of
production and trading conditions and using as the basis for re-issuance of
certificate of eligibility for production and sale of veterinary drugs.
4. The unscheduled inspection
shall be conducted if the establishment is suspended of committing violations
against the law on veterinary drug production and business or at the request of
competent agencies.
Article 11. Competence to
conduct the inspection and issue certificate of eligibility for production and
sale of veterinary drugs
1. Department of Animal Health
shall inspect the compliance with requirements by producers, sellers, importers
and exporters of veterinary drugs.
2. Sub-departments of animal
health of central-affiliated cities and provinces shall inspect the compliance
with requirements by veterinary drug stores and vendors in their provinces.
Article 12. Application for
certification of eligibility for production of veterinary drugs
1. The application for initial
inspection consists of:
a) The application form for the certification of
eligibility for production of veterinary drugs (Annex 3);
b) Report on production facilities (Annex 5);
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d) Certificate of business registration (certified
copy)
dd) Certificate of practice in production of
veterinary drugs (certified copy).
2. The application for
re-inspection consists of:
a) The application form for re-certification of
eligibility for production of veterinary drugs;
b) Report on the rectification of deficiencies
exposed by the previous inspection.
3. The application for renewal of certificate of
eligibility consists of:
a) The application form for certificate of
eligibility for production of veterinary drugs.
b) The issued Certificate of eligibility for
production of veterinary drugs
Article 13. Application for
inspection and certification of eligibility for sale, importation and
exportation of veterinary drugs
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a) The application form for the certification of
eligibility for sale of veterinary drugs (Annex 4);
b) Report on business conditions (Annex 6);
c) Certificate of business registration (certified
copy)
d) Certificate of practice in sale of veterinary
drugs (certified copy).
2. The application for
re-inspection consists of:
a) The application form for the re-certification of
eligibility for sale of veterinary drugs;
b) Report on the rectification of deficiencies exposed
by the previous inspection.
3. The application for renewal of certificate of
eligibility consists of:
a) The application form for the renewal of
certificate of eligibility for sale of veterinary drugs.
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Article 14. Period, contents
and method of inspection
1. Within 10 (ten) working
days from the receipt of the application, the competent agency shall check the
application and respond in writing to the relevant establishment.
Within 15 (fifteen) working days from the receipt
of the valid application, the competent agency shall conduct the inspection.
2. Contents and method of
inspection:
a) The head of the inspectorate shall inform the
representative of the inspected establishment of the decision and contents of
the inspection.
b) Contents of the inspection: The inspection of
the compliance with requirements for production of veterinary drugs shall
comply with Annex 7; the inspection of the compliance with requirements for
sale of veterinary drugs shall comply with Annex 8 herein. As for direct
producers and importers of veterinary drugs, samples shall be taken and
criteria of veterinary hygiene shall be specified.
c) Upon the completion of the inspection, the
inspectorate shall reach an unanimous agreement on inspection results and
prepare the written record on inspection by using the form stated in Annex No.
7 and Annex No. 8, enclosed to this Circular.
d) Inform the representative of the inspected
establishment of the inspection results. The representative of the
inspected establishment shall state opinions and sign on the written record on
the inspection. If the representative of the inspected establishment
refuses to sign on the written record on inspection, it still remains its legal
effect provided that it is signed by all members of the inspectorate.
dd) The written record on inspection is made into
02 (two) copies of the same legal effect, 01 (one) copy of which shall be sent to
the inspected establishment and 01 (one) other shall be retained at the
inspection agency.
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a) Issue certificate of eligibility for production
and sale of veterinary drugs by using the form stated in Annex No. 9 and Annex
No. 10 of this Circular. Certificate of eligibility shall take effect
within 02 (two) years. Particularly, certificate of eligibility for
production of veterinary drugs shall be valid in conformity with the
implementation progress of GMP which has been approved by Ministry of
Agriculture and Rural Development.
Within 02 months before the certificate of
eligibility expires, the certificate holder must submit the application for
renewal to the competent agency. The application for renewal shall comply
with regulations stated in Clause 2 Article 12 and Article 13 of this Circular.
Renewed certificate of eligibility takes effect within 02 (two) years.
b) If the inspected establishment fails to meet
requirements for certification of eligibility, deficiencies must be announced.
The application for re-certification may be submitted as regulated in Clause 2
Article 12 and Article 13 of this Circular after deficiencies exposed by the
previous inspection are rectified.
Article 15. Unscheduled
inspection
1. The competent veterinary agency shall establish
the inspectorate for conducting the unscheduled inspection if the establishment
is suspended of committing violations against the law on veterinary drug
production and business or at the request of competent agencies.
2. Procedures and contents of the inspection shall
comply with Clause 2, Article 14 of this Circular.
3. The competent veterinary agency shall, on the
basis of the written record on inspection, revoke certificate of eligibility as
per Article 16 of this Circular.
Article 16. Revocation of
certificate of eligibility for production and sale of veterinary drugs
1. Certificate of eligibility for production and
sale of veterinary drugs shall be revoked in the following cases:
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b) The establishment refuses to bear the inspection
at the request of the competent state agency for 02 (two) times or more.
2. Decision on the revocation of certificate of
eligibility for production and sale of veterinary drugs shall be made into 02
(two) copies, 01 (one) copy of which shall be sent to the establishment whose
certificate of eligibility is revoked and 01 (one) other shall be retained at
the inspection agency.
Chapter V
RESPONSIBILITIES AND
RIGHTS OF INVOLVED PARTIES
Article 17. Responsibilities
and rights of producers and sellers of veterinary drugs
1. Responsibilities:
a) Apply for the inspection and certification of
eligibility for production and sale of veterinary drugs and materials, and bear
the inspection as regulated in this Circular.
b) Provide information and relevant documents in
sufficient manner, and facilitate the inspection agencies in performing their
duties.
c) Maintain the compliance with requirements for
production and sale of veterinary drugs as per the issued certificate.
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dd) Attend training courses in production and sale
of veterinary drugs which are organized by state veterinary agencies.
e) Pay fees and charges as regulated.
2. Rights:
Have the right to make complaint against the
conclusion stated in the written record on inspection or inspection results of
criteria of veterinary hygiene.
Article 18. Responsibilities
and rights of inspection agencies
1. Responsibilities:
a) Conduct the inspection and certification of
eligibility for production and sale of veterinary drugs and materials in
compliance with this Circular.
b) Ensure the objectiveness and the impartialness
in the course of inspection and issuance of certificates of eligibility.
c) Conduct the periodical inspection and the
unscheduled inspection of a given establishment that possesses a certificate of
eligibility at the request of the competent state agencies.
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2. Rights:
a) Issue or revoke certificates of eligibility for
production and sale of veterinary drugs as regulated.
b) Supervise and request producers and sellers of
veterinary drugs to rectify their deficiencies in the production and sale of
veterinary drugs.
c) Request relevant establishments to provide
documents and facilitate the inspection of the compliance with regulations
stated in this Circular and other legislative documents relating to the
production and sale of veterinary drugs.
Chapter VI
IMPLEMENTATION
Article 19. Effect
This circular takes effect 45 days from the date on
which it is signed. This Circular shall replace for the Decision
No. 46/1999/QD-BNN dated March 05, 1999 of the Ministry of Agriculture and
Rural Development promulgating Regulations on veterinary hygiene applicable to
producers and sellers of veterinary drugs, and regulations on the inspection of
the compliance with requirements for production of aquatic veterinary drugs
which are stated in the Statute of the management of aquatic veterinary drugs,
enclosed with Decision No. 03/2002/QD-BTS dated January 23, 2002 of Minister of
Aquatic Resources.
Article 20. Implementation
organization
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Any difficulties arisen during the course of
implementation should be promptly submitted to the Ministry of Agriculture and
Rural Development (via the Department of Animal Health) for amendment./.
PP MINISTER
DEPUTY MINISTER
Diep Kinh Tan
ANNEX 1
EQUIPMENT USED IN THE PRODUCTION OF VETERINARY
DRUGS
(Promulgated under the Circular No. 51 /2009/TT-BNNPTNT dated August 21,
2009 of Ministry of Agriculture and Rural Development)
I. VETERINARY DRUGS IN SOLUTION FORM FOR ORAL
ADMINISTRATION, INJECTION AND MIXING WITH ANIMAL BREEDS
1. Technical balance
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3. Dissolution flasks.
4. Filtration equipment:
purification filter, bacteria filter
5. Homogenization devices
(colloid mill or homogenizer) used for producing injectable suspensions and
emulsions.
6. Equipment for testing
semi-finished products: turbidimeter, pH-meter, graduated cylinders or
technical balance.
7. Sterilization equipment:
steam sterilizer or steam sterilization chamber (used in the production of
injectable solutions)
8. Packing equipment: vial
filling machine, ampoule sealer
9. Batch coding machine
10. Other equipment: machines
for washing vials, ampoules, plastic and aluminum caps, vial and cap drying
oven or tunnel, autoclave for plastic caps.
II. INJECTABLE DRUGS IN THE FORM OF POWDER
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2. Moisture balance
3. Sterilization equipment
4. Equipment for dividing drug
dosage: powder filling machine
5. Batch coding machine
6. Other equipment: machines for
washing vials, ampoules, plastic and aluminum caps, vial and cap drying oven or
tunnel, autoclave for plastic caps.
III. VETERINARY DRUGS IN THE FORM OF POWDER OR
GRANULE FOR ORAL ADMINISTRATION OR MIXING WITH ANIMAL FEEDS
1. Technical balance
2. Moisture balance
3. Mill or grinding machine
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5. Mixing equipment (batch
mixer)
6. Granulation equipment
7. Drying equipment: stationary
dryer or fluidized-bed dryer.
8. Tablet press machine
(applicable to the production of veterinary tablets)
9. Machine for dividing drug
dosage or packing machine (bag packing machine)
10. Batch coding machine
Note: In case of production
of effervescent tablets, other than the tablet press machine, a separate drying
system must be available for maintaining the humanity of below 25% in the
preparation, pressing and packing area.
ANNEX 2
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No.
Required
equipments of a producer of bio-preparations or vaccines
No.
Required
equipments of a producer of pharmaceuticals or chemicals
1
Incubator
1
Analytical balance
2
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2
Technical balance
3
Optical microscope
3
Moisture balance; pH meter
4
pH meter
4
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5
Colony counter
5
Water still - double distillation
6
Sterile autoclave
6
Ultraviolet-visible spectrophotometer or thin-layer
chromatography machine
7
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7
Glass devices and other necessary equipment to serve
the qualitative analysis made at the inspected establishment
ANNEX 3
APPLICATION FOR CERTIFICATION OF ELIGIBILITY FOR
PRODUCTION OF VETERINARY DRUGS
(Promulgated under the Circular No. 51 /2009/TT-BNNPTNT dated August 21,
2009 of Ministry of Agriculture and Rural Development)
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
-----------------------
APPLICATION FOR
CERTIFICATION OF ELIGIBILITY FOR PRODUCTION OF VETERINARY DRUGS
To: Department of
Animal Health
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Name of the producer of veterinary drugs:
Address:
Telephone:………..
Fax:………………….
Name of the owner:
Permanent residence:
Types of products:
o Pharmaceuticals
o Vaccines, bio-preparations
o
Chemicals
o Other
types
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Enclosed documents (if this is the initial
inspection):
a) The application form for
the certification of eligibility for production and sale of veterinary drugs;
b) Report on production and
business facilities;
c) List of kinds of veterinary
drugs and materials.
d) Certificate of business
registration (certified copy)
dd) Certificate of practice in
production and sale of veterinary drugs (certified copy).
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Representative
of the inspected establishment
(Signature and
seal, if any)
ANNEX 4
APPLICATION FOR CERTIFICATION OF ELIGIBILITY FOR
SALE OF VETERINARY DRUGS
(Promulgated under the Circular No. 51 /2009/TT-BNNPTNT dated August 21,
2009 of Ministry of Agriculture and Rural Development)
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
-----------------------
APPLICATION FOR
CERTIFICATION OF ELIGIBILITY FOR SALE OF VETERINARY DRUGS
To: (1)
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Name of the seller of veterinary drugs:
Address:
Telephone:………..
Fax:………………….
Name of the owner:
Permanent residence:
Type of products which shall
be sold:
o Pharmaceuticals
o Vaccines, bio-preparations
o
Chemicals
o Other
types
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Enclosed documents (if this is the initial
inspection):
a) The application form for
the certification of eligibility for sale of veterinary drugs;
b) Report on business
facilities;
c) Certificate of business
registration (certified copy)
d) Certificate of practice in
sale of veterinary drugs (certified copy).
……[place],
on………………..[date]
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(Signature and
seal, if any)
Notes:
(1) Submit the application to the sub-department of
animal health if the applicant is the seller of veterinary drugs.
Submit the application to
Department of Animal Health if the applicant is the importer of veterinary
drugs.
ANNEX 5
REPORT ON THE COMPLIANCE WITH REQUIREMENTS FOR
PRODUCTION OF VETERINARY DRUGS
(Promulgated under the Circular No. 51/2009/TT-BNNPTNT dated August 21, 2009
of Ministry of Agriculture and Rural Development)
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
-----------------------
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To: Department of
Animal Health
Name of the inspected establishment:
…………………………………………………………….
Address: ……………………………………………………………..
Telephone:………………….. Fax………………………………… Email:……………..
Type of products:
o
Pharmaceuticals
o Vaccines, bio-preparations
o
Chemicals
o Other types
We hereby explain about our facilities for
producing veterinary drugs. To be specific:
1. Production location
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3. Equipment and devices used in the production
4. Warehouse system
5. Sterilization area
6. Area for weighing and delivering materials
7. Area for preparing, dividing and storing
semi-finished products
8. Area for finishing products
9. Hygienic area
10. Waste and sewage collection and treatment
system
11. Packing
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13. Disinfection and decontamination
14. Human resource
15. Personal hygiene
16. Labor safety and hygiene
17. Industrial water
18. The implementation of regulations on
batch-related documents
19. The implementation of regulations on quality
management:
- Testing laboratory
- The staff of the testing laboratory
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- Regulations on inspection of materials, finished
products, sample storage and inspection of stored sample
…….[place],
on………[date]
Owner of the
inspected establishment
(Signature and
seal)
Note: The applicant must explain about contents
stated from item 1 to item 19 according to the contents of inspection stated in
the List of inspected items, enclosed with the written record on inspection of
the compliance with requirements for production of veterinary drugs in Annex 7
herein.
ANNEX 6
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
-----------------------
REPORT ON THE
COMPLIANCE WITH REQUIREMENTS FOR SALE OF VETERINARY DRUGS
To: (*)
………………………………………..
Name of the inspected establishment:
…………………………………………………………….
Address: ……………………………………………………………..
Telephone:………………….. Fax………………………………… Email:……………..
Type of business:………………………………………………….
We hereby explain about our conditions for sale of
veterinary drugs. To be specific:
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2. Equipment: (specify name, quantity of equipment
serving the storage of veterinary drugs such as cabinets, shelves, hygrometers,
thermometers, refrigerators, etc.)
3. Records: (certificate of business registration,
certificate of practice, records for following selling activities, etc.)
4. The list of types of veterinary drugs which
shall be sold
…….[place],
on………[date]
Owner of the
inspected establishment
(Signature and
seal, if any)
Note: (*) Submit the report
to Department of Animal Health if the applicant is the importer or exporter of
veterinary drugs; or the sub-department of animal health if the applicant is
the veterinary drug store or vendor.
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ANNEX 7
WRITTEN RECORD ON INSPECTION OF THE COMPLIANCE WITH
REQUIREMENTS FOR PRODUCTION OF VETERINARY DRUGS
(Promulgated under the Circular No. 51 /2009/TT-BNNPTNT dated August 21,
2009 of Ministry of Agriculture and Rural Development)
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
----------------
No.:
/…………………
………….. ……..[place], on………………….[date]
WRITTEN RECORD ON
INSPECTION OF THE COMPLIANCE WITH REQUIREMENTS FOR PRODUCTION OF VETERINARY
DRUGS
Today, on………………..[date], at……………………………………………
-
Address:……………………………………………………………........................................
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We, consisting
of:
Representative of the inspection agency:
1. Mr. (Mrs.):………………………………………..
Position:………………………… ...........
2. Mr. (Mrs.):………………………………………..
Position:………………………… ...........
3. Mr.
(Mrs.):……………………………………….. Position:………………………… ...........
4. Mr. (Mrs.):………………………………………..
Position:………………………… ..........
5. Mr. (Mrs.):………………………………………..
Position:………………………… ...........
Representatives of the producer of veterinary
drugs:
1. Mr.
(Mrs.):……………………………………….. Position:………………………… ...........
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- Pursuant to the Ordinance on
veterinary medicine in 2004 and the Government’s Decree No. 33/2005/ND-CP dated
March 15, 2005 detailing the implementation of certain articles of the
Ordinance on veterinary medicine;
- Pursuant to the Circular
No.
/2009/TT-BNNPTNT dated…………………….. of Ministry of Agriculture and Rural
Development promulgates regulations on the inspection and the certification of
the eligibility for production and sale of veterinary drugs, bio-preparations,
microorganisms and chemicals used in veterinary medicine and aquatic veterinary
medicine;
- Pursuant to Decision
No…………….dated…………….of Director of Department of Animal Health on the
establishment of the Inspectorate in charge of conducting the inspection of the
compliance with requirements for production of veterinary drugs
1. Name of inspected producer of
veterinary drugs:……………………………
...............................................................................................................................
2. Production
location:…………………………………………………………………….
3. Date of
establishment: ................/............/……………………………...............
4. Operating production lines
o
Pharmaceuticals
o Vaccines, bio-preparations
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5. The quantity of products
which are permitted for free
sale:
product(s)
In which:
- The quantity of products
which are produced and
sold:
product(s)
- The quantity of products
which are not
produced:
product(s)
6. Inspection results: As per
enclosed list
7. Conclusion of the
Inspectorate:
………………………………………………………………………………………………….
……...…………………………………………………………………………………………..
……...…………………………………………………………………………………………..
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………………………………………………………………………………………………….
8. Opinions of the producer of
veterinary drugs:
…………………………………………………………………………………………………
……...………………………………………………………………………………………….
……...…………………………………………………………………………………………..
………………………………………………………………………………………………….
This record has been re-read to the
inspectorate and representative of the producer of veterinary drugs who have
unanimously agreed and signed this record. This record is made into 02 copies
of the same effect.. The inspectorate shall keep 01 copy and the other is kept
at the producer of veterinary drugs for implementation.
Representative
of the producer of veterinary drugs
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Representative
of the inspection agency
LIST OF INSPECTED
ITEMS
(Enclosed to the Written record on inspection of the compliance with requirements
for production of veterinary drugs)
1. Name of the inspected
establishment: …………………………………………………………….
2. Address:
…………………………………………….
Telephone:…………………..
Fax………………………………………………
3. Inspection results
Part 1. General evaluation of the producer of
veterinary drugs: 40 marks
No.
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Yes
No
Standard mark
Mark granted
(1)
(2)
(3)
(4)
(5)
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1.
Production location
4.0
1.1. Be in distant from residential areas, public
works, etc.
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1.2. Do not cause adverse impacts on surrounding
environment
2.
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5.0
2.1. The workshop is designed and built in
conformity with GMP standards
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2.2. Have areas for production
2.3. Areas are designed in an appropriate way for
minimizing mistake or cross-contamination in course of production
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2.4. The production is carried out according to
one-way production line
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2.6. Be convenient for inspection
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2.7. Comply with regulations on environmental
hygiene
2.8. Be easy for disinfection and decontamination
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2.9. Be proof against dust and the infiltration
of harmful animals
3.
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5.0
3.1. The quantity, types and capacity of each
type of equipment are in conformity with each production line.
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3.2. Be convenient for operation, cleaning and
maintenance
3.3. Equipment and devices are made of suitable
materials
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3.4. Have regulations on operation, inspection
and maintenance
4.
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2.0
4.1. Have suitable structure and materials
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4.2. The warehouse’s capacity must be in
conformity with the scale of production
4.3. Have equipment for checking technical
criteria (temperature, humidity, etc.), records.
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4.4. Have regulations on the arrangement and
inspection of stored materials and products
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- By records
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- With computer aid
5.
Sterilization area
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1.0
5.1. Have separate area for treating packing and
devices
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5.3. Have adequate and appropriate equipment,
devices and chemicals
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5.4. Have regulations on sterilization
6.
Area for weighing and delivering materials
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1.0
7.
Area for preparing, dividing and storing
semi-finished products
5.0
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7.2. Have adequate and appropriate equipment and
devices
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7.3. Comply with regulations on hygiene and
sterilization
8.
Area for finishing products
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1.0
8.1. Have suitable structure and materials
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9.
Hygienic area
1.0
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9.1. Have suitable structure and materials
9.2. Have necessary equipment for practicing
personal hygiene
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10.
Waste and sewage collection and treatment
system
2.0
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10.2. Have regulations on inspection of sewage
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10.3. Have regulations on waste collection and
treatment
11.
Packing
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1.0
11.1. Made of suitable materials
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12.
Labeling
2.0
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a. Be in conformity with the approved labels
b. Specify all contents as regulated.
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13.
Disinfection and decontamination
2.0
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13.2. Equipped with suitable devices and chemicals
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13.3. Have measures for distinguishing sterilized
devices
14.
Human resource
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3.0
14.1. Production manager has qualified
professional knowledge, and possesses certificate of practice
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14.3. Workers have certificates of health
examination as regulated
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14.4. Workers are trained in regular and periodical
basis.
15.
Personal hygiene
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1.0
15.1. Have regulations on personal hygiene in
production;
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16.
Labor safety and hygiene
1.0
...
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16.1. Have regulations on delivery and use of
personal protective equipment.
16.2. Change and sterilize personal protective
equipment after production shift;
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16.3. Equipment for air ventilation, vacuum, and
fire prevention and fighting is suitable.
17.
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3.0
17.1. Have clear water for production and
hygiene.
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17.2. Analyze water samples as regulated.
No.
Yes
Standard mark
...
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1
Prepare documents for each type of products
5
2
Have adequate documents and monitoring sheets
...
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5
3.
Have test report of each batch
10
...
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20
No.
Yes
Standard mark
Mark granted
1
Establish a quality control department in regular
way
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9
2
Managers and staff of the quality control
department have obtained certificates of practice
3
...
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Equipment:
3.1
Required equipment of a producer of
pharmaceuticals or chemicals
...
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- Ultraviolet-visible spectrophotometer
8
- Analytical balance
...
...
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2
- Moisture meter
3
...
...
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- Technical balance
1
- Water still - double distillation
...
...
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- Drying oven (50 - 250 oC)
3
- Glass devices and other necessary equipment to
serve the testing
...
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2
3.2
Required equipment of a producer of
bio-preparations or vaccines
...
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Incubator
3
Sterile laminar flow cabinet
...
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Optical microscope
3
pH meter
...
...
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1
Colony counter
2
...
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Sterile autoclave
3
Glass devices and other necessary equipment to
serve the testing
...
...
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3.3
Inspection of materials
1
3.4
Inspection of semi-finished products
...
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1
3.5
Inspection of finished products
3
...
...
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Store samples and inspect stored samples as
regulated
2
Total
...
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Note: With regard to the
producer of both pharmaceuticals, chemicals and bio-preparations, vaccines, the
mark of equipment stated in Part 3 is calculated by arithmetic mean of Item 3.1
and Item 3.2 of Part 3.
Ranking of inspected establishment:
1. Failed: below 50 marks
2. If the criteria of veterinary
hygiene are satisfactory as assessed by the National Center for Veterinary
Hygiene Inspection I or the National Center for Veterinary Hygiene Inspection
II, the inspected establishment shall be ranked as follows:
- Excellent: from 90 to 100 marks
- Good: from 70 to below 90 marks
- Satisfactory: from 50 to below 70 marks
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(Signature and
seal)
REPRESENTATIVE
OF THE INSPECTION AGENCY
ANNEX 8
WRITTEN RECORD ON INSPECTION OF THE COMPLIANCE WITH
REQUIREMENTS FOR SALE OF VETERINARY DRUGS
(Promulgated under the Circular No. 51 /2009/TT-BNNPTNT dated August 21,
2009 of Ministry of Agriculture and Rural Development)
Department…………
……..SUB-DEPARTMENT OF ANIMAL HEALTH
--------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
----------------
No.:
/…….
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WRITTEN RECORD ON
INSPECTION OF THE COMPLIANCE WITH REQUIREMENTS FOR SALE OF VETERINARY
DRUGS
Today, on………………..[date], at……………………………………………
- Address:……………………………………………………………........................................
- Telephone:…………… Fax:…………………….. E-mail:
……………...............................
We, consisting
of:
Representatives of the inspection agency:
1. Mr. (Mrs.):....................................................................
Position:……………………….
2. Mr.
(Mrs.):..........................................................................
Position:…………………
3. Mr.
(Mrs.):.........................Position:………………… ..
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5. Mr.
(Mrs.):..................................................................................
Position:……………
Representatives of the seller of veterinary
drugs:
1. Mr.
(Mrs.):..........................................................................
Position:………………….
2. Mr.
(Mrs.):..........................................Position:………………………………………
......
- Pursuant to the Ordinance on
veterinary medicine in 2004 and the Government’s Decree No. 33/2005/ND-CP dated
March 15, 2005 detailing the implementation of certain articles of the
Ordinance on veterinary medicine;
- Pursuant to the Circular
No.
/2009/TT-BNNPTNT dated…………………….. of Ministry of Agriculture and Rural
Development promulgates regulations on the inspection and the certification of
the eligibility for production and sale of veterinary drugs, bio-preparations,
microorganisms and chemicals used in veterinary medicine and aquatic veterinary
medicine;
- Pursuant to Decision
No……………dated……………..on the establishment of the Inspectorate
to conduct the inspection of the
compliance with requirements for sale of veterinary drugs
I. Inspection results: As per
enclosed list
...
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..................................................................................................................................
..................................................................................................................................
..................................................................................................................................
..................................................................................................................................
..................................................................................................................................
..................................................................................................................................
..................................................................................................................................
..................................................................................................................................
..................................................................................................................................
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..................................................................................................................................
..................................................................................................................................
This record is finished at
................ hour(s), on................[date], and has been re-read to the
Inspectorate and representative(s) of the inspected establishment who have
simultaneously signed on this record. This record is made into 02
copies of the same effect, and each party shall keep 01 copy.
REPRESENTATIVE OF
THE SELLER OF VETERINARY DRUGS
REPRESENTATIVE
OF THE INSPECTION AGENCY
LIST OF INSPECTED
ITEMS
(Enclosed to the
written record on inspection of the compliance with requirements for sale of
veterinary drugs)
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Address: ……………………………………………………………..
Telephone:………………….. Fax………………………………… Email:……………..
Type of business registration:………………………………………………….
No.
CONTENTS
INSPECTION
RESULTS
Yes
No
Standard mark
...
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I
Facilities (35
marks)
1
Construction and design
1.1
...
...
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4
1.2
Built at a safe, high and dry place, far away
from sources of pollution
3
...
...
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1.3
Built of firm and solid materials
5
1.4
Ceiling is proof against dust
...
...
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2
1.5
Walls and ceiling must be smooth, and be cleaned
easily
2
2
...
...
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6
3
Have area for showing products
5
...
...
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4
Have area for storing veterinary drugs
5
5
Have separate area for showing animal feeds for
sale
...
...
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3
II
Equipment (25
marks)
1
Equipment for storing veterinary drugs may
prevent adverse effects of light, temperature, moisture, pollution and the
infiltration of insects.
...
...
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1.1
Have cabinets for storing veterinary drugs
5
1.2
Cabinets and shelves for storing veterinary drugs
are easily cleaned and arranged aesthetically
...
...
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2
1.3
Have thermometer and hygrometer, and take notes
5
1.4
...
...
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2
1.5
The area for selling veterinary drugs is bright
for facilitating selling activities and avoiding mistakes
2
...
...
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2
Storage equipment can meet requirements for
storage stated in labels of relevant drugs, including: refrigerators, air conditioners,
dehumidifiers
6
3
The area for selling veterinary drugs has ambient
temperature (temperature is below 300c, humidity is equal or below
75%)
...
...
...
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3
III
Records (10
marks)
1
Legal documents
...
...
...
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1.1
Have certificate of business registration
1
1.2
Have certificate of practice in sale of
veterinary drugs
...
...
...
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3
1.3
Have adequate records of employees
2
2
...
...
...
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2.1
Records of input and delivery of each type of
veterinary drugs
2
...
...
...
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2.2
Records of batch number and expiry date
2
IV
Origin of veterinary
drugs (20 marks)
1
...
...
...
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18
2
Have the list of types of veterinary drugs for
sale
2
...
...
...
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V
Performance of
professional regulations (10 marks)
1
Have a separate area or cabinet for storing drugs
or insecticides
2
2
...
...
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2
3
The label and instruction sheet are to indicate
and matched with the type of drug contained inside.
3
...
...
...
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4
All types of veterinary drugs are tidily arranged
for avoiding mistake
1
5
Veterinary drugs are arranged in conformity with
storage requirements specified in their labels
...
...
...
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2
Ranking of inspected establishment:
I. The seller of veterinary drugs:
- Excellent: from 90 to 100 marks
- Good: from 70 to below 90 marks
- Satisfactory: from 50 to below 70 marks
- Failed: below 50 marks
II. The import or export of veterinary drugs:
...
...
...
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2. If the criteria of veterinary
hygiene are satisfactory as assessed by the National Center for Veterinary
Hygiene Inspection I or the National Center for Veterinary Hygiene Inspection
II, the inspected establishment shall be ranked as follows:
- Excellent: from 90 to 100 marks
- Good: from 70 to below 90 marks
- Satisfactory: from 50 to below 70 marks
REPRESENTATIVE
OF THE INSPECTED ESTABLISHMENT
(Signature and
seal)
REPRESENTATIVE
OF THE INSPECTION AGENCY
...
...
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CERTIFICATE OF ELIGIBILITY FOR PRODUCTION OF
VETERINARY DRUGS
(Promulgated under the Circular No. 51 /2009/TT-BNNPTNT dated August 21,
2009 of Ministry of Agriculture and Rural Development)
MINSITRY OF
AGRICULTURE AND RURAL DEVELOPMENT
DEPARTMENT OF ANIMAL HEALTH
----------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
----------------
CERTIFICATE OF
ELIGIBILITY FOR PRODUCTION OF VETERINARY DRUGS
No.: …….../
GCN-SXT
Name of producer of veterinary drugs:
……………………………………………………………..
Address:
……………………………………………………………..
Telephone:…..
..
Fax:……….
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
…………………………………………………………………………………………...
…………………………………………………………………………………………...
………………………………………………………………………………...................
…………………………………………………………………………………………..
…………………………………………………………………………………………..
This Certificate of eligibility shall remain
validity until………………………………..[date].
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
DIRECTOR
Note: (*) specify production
lines such as the production line for drugs in the form of powder, the
production line for injectable solutions, etc.
ANNEX 10
CERTIFICATE OF ELIGIBILITY FOR SALE OF VETERINARY
DRUGS
(Promulgated under the Circular No. 51 /2009/TT-BNNPTNT dated August 21,
2009 of Ministry of Agriculture and Rural Development)
FORM
1
DEPARTMENT OF
AGRICULTURE AND RURAL DEVELOPMENT
PROVINCE………….
SUB-DEPARTMENT OF ANIMAL HEALTH
----------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
----------------
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
OF ELIGIBILITY FOR SALE
OF VETERINARY DRUGS
No.:
…….../GCN-KDT
Name of the seller of veterinary drugs:
…………………………………………………………….
Address:
……………………………………………………………..
Telephone:…..
..
Fax:……….
Name of the owner:
…………………………………………………………….
Permanent residence:
……………………………………………………………..
Is eligible for sale of
veterinary drugs, including the following products: (*)
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
…………………………………………………………………………………………...
………………………………………………………………………………...................
…………………………………………………………………………………………..
…………………………………………………………………………………………..
This Certificate of eligibility shall remain validity
until………………………………..[date].
... ...
...[place], on…………………………[date]
DIRECTOR
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
FORM
2
MINISTRY OF
AGRICULTURE AND RURAL DEVELOPMENT
DEPARTMENT OF ANIMAL HEALTH
----------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
----------------
CERTIFICATE
OF ELIGIBILITY FOR SALE OF VETERINARY DRUGS
No.:
…….../GCN-KDT
Name of the seller of veterinary drugs:
…………………………………………………………….
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
Telephone:…..
..
Fax:……….
Name of the owner:
…………………………………………………………….
Permanent residence:
……………………………………………………………..
Is eligible for sale of
veterinary drugs, including the following products: (*)
…………………………………………………………………………………………...
…………………………………………………………………………………………...
………………………………………………………………………………...................
…………………………………………………………………………………………..
…………………………………………………………………………………………..
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
This Certificate of eligibility shall remain
validity until………………………………..[date].
... ...
...[place], on…………………………[date]
DIRECTOR
Note: (*) specify types of products
such as vaccines, pharmaceuticals, chemicals, etc.