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THE MINISTRY OF
AGRICULTURE AND RURAL DEVELOPMENT
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THE SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No.
13/2022/TT-BNNPTNT
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Hanoi, September
28, 2022
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CIRCULAR
ON AMENDMENTS TO
CIRCULARS ON MANAGEMENT OF VETERINARY DRUGS
Pursuant to the Government’s Decree No.
15/2017/ND-CP dated February 17, 2017 defining the functions, tasks, powers and
organizational structure of the Ministry of Agriculture and Rural Development;
Pursuant to the Law on Veterinary Medicine;
Pursuant to the Law on Animal Husbandry;
Pursuant to the Law on Drug Prevention and
Control 2021;
Pursuant to the Government's Decree No.
105/2021/ND-CP dated December 4, 2021 on elaboration of and guidelines for the
Law on Drug Prevention and Control;
Pursuant to the Government's Decree No.
113/2017/ND-CP dated October 9, 2017 on elaboration of and guidelines for the
Law on Chemicals;
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The Minister of Agriculture and Rural
Development promulgates a Circular on amendments to the Circulars on management
of veterinary drugs.
Article 1. Amendments to Circular No.
12/2020/TT-BNNPTNT dated November 9, 2020 of the Minister of Agriculture and
Rural Development on management of veterinary drugs containing narcotic
substances and precursors; veterinary prescribing, prescriptions of veterinary
drugs; amendments to Circular No. 18/2018/TT-BNNPTNT.
1. Clause 1 Article 1 shall be amended as follows:
“1. Import, export, transit through Vietnam,
production, trading in, use, delivery, transport and storage of veterinary
drugs and veterinary drug materials containing narcotic substances and
precursors; veterinary prescribing, prescriptions of veterinary drugs within
the territory of Vietnam.”
2. Clause 4 shall be added to clause 3 Article 1 as
follows:
“4. List of veterinary drugs containing
narcotic substances and precursors; List of narcotic substances and precursors
being veterinary drug materials containing narcotic substances and precursors.”
3. Clause 1 Article 2 shall be amended as follows:
“1. Domestic and foreign organizations and
individuals related to import, export, transit through Vietnam, production,
trading in, use, delivery, transport and storage of veterinary drugs and
veterinary drug materials containing narcotic substances and precursors;
veterinary prescribing and use of veterinary prescriptions within the territory
of Vietnam.”
4. Clause 1 Article 3 shall be amended as follows:
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5. Clause 1a shall be added to clause 1 Article 3
as follows:
“1a. Veterinary drug materials containing
narcotic substances, precursors mean addictive substances, psychotropic
ingredients and veterinary drug precursors containing narcotic substances and
precursors specified in Clause 1 of this Article.”
6. The name of Chapter II shall be amended as
follows:
“Chapter II
MANAGEMENT OF
NARCOTIC SUBSTANCE- AND PRECURSOR-CONTAINING VETERINARY DRUGS AND VETERINARY
DRUG MATERIALS”
7. Article 3a shall be added to Article 4 as
follows:
“Article 3a. List of veterinary drugs
containing narcotic substances and precursors; List of narcotic substances and
precursors being veterinary drug materials containing narcotic substances and
precursors
1. List of veterinary drugs containing narcotic
substances and precursors in Appendix XI issued herewith.
2. List of narcotic substances and precursors being
veterinary drug materials containing narcotic substances and precursors in
Appendix XII issued herewith.”
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“Article 4. Import of narcotic substance-
and precursor-containing veterinary drugs and veterinary drug materials”
1. Organizations and individuals entitled to apply
for the license to import narcotic substance- and precursor-containing
veterinary drugs include:
a) Organizations and individuals that have the
certificate of eligibility to import veterinary drugs or certificate of
eligibility to produce veterinary drugs containing narcotic substances and
precursors;
b) Organizations and individuals that apply for
import of narcotic substance- and precursor-containing veterinary drugs for the
first time for the purposes of scientific search, precious and rare animal
disease prevention and treatment and have the business registration certificate
or enterprise registration certificate or investment license or establishment
decision issued by a competent authority.
2. Organizations and individuals that import
veterinary drugs stipulated in clause 1 Article 3
This Circular shall comply with Points a and d,
Clause 1 and Clause 2, Article 20 of Decree No. 105/2021/ND-CP dated December
4, 2021 of the Government on elaboration of and guidelines for the Law on Drug
Prevention and Control (hereinafter referred to as Decree No. 105/2021/ND-CP).
3. Regulations on import of narcotic
substance-containing and precursor-containing veterinary drugs materials.
a) The permission for import of narcotic
substance-containing veterinary drug materials is only granted to a veterinary
drug producer that imports materials to serve its production activities;
b) If imported narcotic substance-containing
veterinary drug materials are not used up, the importer is permitted to
transfer them to the producer that complies with the regulation set out in
Clause 1 Article 7 hereof and a written notification shall be sent to the
Department of Animal Health before the transfer;
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4. The Department of Animal Health has the power to
issue licenses to import narcotic substance- and precursor-containing
veterinary drugs, and narcotic substance- and precursor-containing veterinary
drug materials.
5. The license to import narcotic substance- and
precursor-containing veterinary drugs or narcotic-containing and
precursor-containing veterinary drug materials shall use the form No. 02A, form
No. 02B in the Appendix issued together with Decree No. 105/2021/ND-CP.
6. The license to import narcotic substance- and
precursor-containing veterinary drugs or narcotic-containing and
precursor-containing veterinary drug materials is issued for each import and
valid for 12 months from the date of issue. In case the permit expires but the
import has not yet been carried out, the enterprise shall apply to the
Department of Animal Health for the extension of permit, with unlimited number
of times of extension.
7. The issuance, modification and re-issuance of
the license to import veterinary drugs or veterinary drug materials containing
narcotic substances or precursors due to loss, misplacement or errors shall
comply with the provisions of Point d, Clause 3 of Article 20 of Decree No.
105/2021/ND-CP”
9. Clause 2 Article 5 shall be amended as follows:
“2. An application and procedures for export
of narcotic substance-containing veterinary drugs shall comply with Point a,
point d Clause 1 and Clause 2 Article 20 of Decree No. 105/2021/ND-CP.”
10. Clause 3a shall be added to clause 3 Article 5
as follows:
“3a. The license to export narcotic
substance- and precursor-containing veterinary drugs shall use the form No.
02A, form No. 02B in the Appendix issued together with Decree No.
105/2021/ND-CP”.
11. Clause 4 Article 5 shall be amended as follows:
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12. Clause 4a shall be added to clause 4 Article 5
as follows:
“4a. The issuance, modification and
re-issuance of the license to export veterinary drugs containing narcotic
substances or precursors due to loss, misplacement or errors shall comply with
Point d, Clause 3 of Article 20 of Decree No. 105/2021/ND-CP.”
13. Article 5a shall be added to Article 6 as
follows:
“Article 5a. Exemption, revocation of
export license, import license of veterinary drugs, veterinary drug materials
containing precursors
1. Exemption from issuance of export licenses and
import licenses for veterinary drugs containing precursors as prescribed in
Clause 1, Article 13 of Decree No. 113/2017/ND-CP dated October 9, 2017 on
guidelines for the Law on Chemicals (hereinafter referred to as Decree No.
113/2017/ND-CP).
2. The revocation of the license to export and
import veterinary drugs and veterinary drug materials containing precursors shall
comply with Clause 2, Article 13 of Decree No. 113/2017/ND-CP.
3. The Department of Animal Health has the power to
revoke export licenses and import licenses for precursor-containing veterinary
drugs and veterinary drug materials. Organizations and individuals whose
licenses are revoked are responsible for sending these licenses to the
Department of Animal Health within 05 working days from the date of receiving
the decision on revocation.”
14. Article 6 shall be amended as follows:
“Article 6. Transit of substance- and
precursor-containing veterinary drugs and veterinary drug materials through
Vietnam”
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15. Clause 1 Article 7 shall be amended as follows:
“1. Production of substance- and
precursor-containing veterinary drugs
a) Domestic production of substance- and
precursor-containing veterinary drugs shall be only carried out by producers
having an effective certificate of eligibility to produce veterinary drugs
issued by the Department of Animal Health;
b) Application and procedures for issuance of the
Certificate of eligibility to manufacture veterinary drugs containing narcotic
substances and precursors along with the production line of veterinary drugs
that have been granted the Certificate of eligibility for production comply
with Points a and c, Clause 2, Article 16 of Decree No. 105/2021/ND-CP;
c) Application and procedures for re-issuance of
the Certificate of eligibility to manufacture veterinary drugs containing
narcotic substances or precursors in case the Certificate is lost, misstated,
damaged or changed as to information of organizations and individuals in the
Certificate shall comply with Clause 3, Article 16 of Decree No.
105/2021/ND-CP;
d) Application and procedures for amending the
Certificate of eligibility for production of veterinary drugs containing
narcotics or precursors in case of changes in scale, location or product
category shall comply with Clause 4, Article 16 of Decree No. 105/2021/ND-CP.”
16. Article 9 shall be amended as follows:
“Article 9. Use of substance-containing
veterinary drugs for animal disease treatment
1. A person having the veterinary practice
certificate covering animal diagnosis, examination, surgery, testing,
immunization is permitted to use substance-containing veterinary drugs to treat
animal diseases by prescription; the substance- and precursor-containing
veterinary drugs that are not used or are underused must be returned to the
veterinary drug selling establishment within 10 days.
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17. Article 11 shall be amended as follows:
“Article 11. Transport of narcotic
substance- and precursor-containing veterinary drugs and veterinary drug
materials
1. During transport of narcotic substance- and
precursor-containing veterinary drugs and veterinary drug materials, they must
be packaged and labeled with full contents according to regulations of law,
clearly stating the name of the substance, concentration, content, weight,
origin and origin.
2. Individuals, agencies and organizations that
have narcotic substance- and precursor-containing veterinary drugs and
veterinary drug materials shall be responsible for the safety and loss of goods
during transportation.”
18. Add active ingredients “Toltrazuril, Amprolium,
Clopidol” at the end of Clause 1, Article 14.
19. Clause 7 shall be added to clause 6 Article 14
as follows:
“7. Veterinary drugs that contain active
ingredients belonging to the group of drugs for the prevention and treatment of
internal and external parasites.”
20. Article 20 shall be amended as follows:
“Article 20. Prescribing veterinary drugs
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2. The quantity of drugs in a prescription shall
not exceed a 07 (seven)-day supply or shall follow the manufacturer’s
instructions and comply with Articles 13, 17 and 18 hereof.
3. The establishment or individual in charge of
examination, diagnosis, surgery and testing shall send a list of practice
registration numbers of prescribers for narcotic substance- and
precursor-containing veterinary drugs to the veterinary authority of province
where the operation is registered.”
21. Point dd Clause 4 Article 23 shall be amended
as follows:
“dd) Send a 6-month report (data from
December 15 of the previous year to June 14 of the reporting period), annual report
(data from December 15 of the previous year to December 14 of the reporting
period) to the Department of Animal Health and the Sub-Department of Animal
Health in the area under its management according to the form in Appendix II
issued with this Circular.”
22. Point dd shall be added to point d Clause 3
Article 24 as follows:
“dd) Provide the practice certificate number
and the name of the authority issuing the practice certificate of the
prescriber to the veterinary authority of the province where the practice is
performed if the practice certificate is issued by a veterinary authority of
another province or city.”
Article 2. Annulment, replacement,
supplementation of certain Appendices to Circular No. 12/2020/TT-BNNPTNT dated
November 9, 2020 of the Minister of Agriculture and Rural Development on
management of veterinary drugs containing narcotic substances and precursors;
veterinary prescribing, prescriptions of veterinary drugs; amendments to
Circular No. 18/2018/TT-BNNPTNT
1. Annul Appendix I. Application form for
registration of export and import of veterinary drugs containing narcotic
substances, precursors and veterinary drug materials containing narcotic
substances.
2. Replace Appendix VII with Appendix VII in
Appendix I issued together with this Circular.
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4. Add Appendix XI. List of veterinary drugs
containing narcotic substances and precursors in Appendix I issued herewith.
5. Add Appendix XII. List of narcotic substances
and precursors being veterinary drug materials containing narcotic substances
and precursors in Appendix I issued herewith.
Article 3. Amendments to Circular No.
13/2016/TT-BNNPTNT dated June 2, 2016 of the Minister of Agriculture and Rural
Development on management of veterinary drugs
1. Annul phrase “antibody” at point g, Clause 3,
Article 3.
2. Add the phrase "information and
characteristics of the original microorganism strains used to produce vaccines
and antibodies for domestically produced products" before the phrase
“documents relevant to the copyright and the application of the certificate of
manufacture of vaccines/antibodies (if any)” at Point n, Clause 3, Article 3.
3. Annul Point p, Clause 3, Article 3.
4. Annul Point d and dd Clause 6 Article 3.
5. Add the phrase “for application submission via
postal service or in person” after the phrase “drug registration application”
at Point a, Clause 2, Article 6.
6. Clause 3 shall be added to clause 2 Article 6 as
follows:
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7. Add the phrase “up to the date of application
submission” after the phrase “within 12 months” in Clause 4, Article 10.
8. Clause 6 shall be added to clause 5 Article 20
as follows:
“6. Carry out an online assessment, in case,
due to natural disasters or regulations on prevention and control of dangerous
epidemics, the on-site assessment cannot be carried out to issue a certificate
of eligibility for production of veterinary drugs. The on-site assessment will
be carried out after the localities controlled natural disasters and epidemics
according to regulations; immediately revoke the certificate in case the
organization or individual violates the law and handle the violation according
to the regulations of law.”
9. Clause 5 shall be added to clause 4 Article 21
as follows:
“5. Carry out an online assessment, in case,
due to natural disasters or regulations on prevention and control of dangerous
epidemics, the on-site assessment cannot be carried out to issue a certificate
of eligibility for trading and import of veterinary drugs. The on-site
assessment will be carried out after the localities controlled natural
disasters and epidemics according to regulations; immediately revoke the
certificate in case the organization or individual violates the law and handle
the violation according to the regulations of law.”
10. Add the phrase "For veterinary drugs that
must be prescribed, write the symbol Rx in the left corner of the drug name and
the words "Prescription drug" at the end of point e, Clause 1,
Article 27.
11. Replace the phrase “Within 10 days for
pharmaceuticals, chemicals and biological products” with the phrase “Within 15
days for pharmaceuticals, chemicals and biological products” at point a, Point
b, Clause 2, Article 39.
Article 3. Amendments to, replacement of certain
Appendices of Circular No. 13/2016/TT-BNNPTNT dated June 2, 2016 of the
Minister of Agriculture and Rural Development on management of veterinary drugs
1. Replace Appendix X. Application for registration
of sale of processed and portioned veterinary drugs with Appendix X.
Application for registration of sale of processed and portioned veterinary
drugs in Appendix II enclosed herewith.
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3. Add the phrase “Part 1. General criteria” after
the phrase “II. GROUP OF ASSESSMENT CRITERIA” in Appendix XXIII.
4. Replace Appendix XXVIII. Application form for registration,
extension of registration for GMP inspection with Appendix XXVIII. The
application form for registration and extension of GMP inspection registration
provided in Appendix II to this Circular.
Article 5. Transitional provisions
1. For applications for licensing import of
veterinary drugs, veterinary drug materials containing narcotic substances,
precursors; applications for the Certificate of eligibility to manufacture
veterinary drugs; applications for the Certificate of eligibility to trade and
import veterinary drugs; applications for registration of sale of veterinary
drugs received before the effective date of this Circular shall comply with
laws at the time of application submission.
2. Veterinary drug products that have been
manufactured or imported before the effective date of this Circular may
continue to be sold with the registered product label until the expiry date of
the product. Veterinary drug products manufactured or imported after the
effective date of this Circular must have information about prescription drugs
on the product's original label or on the supplementary label or on the product
manual.
Article 6. Implementation.
1. This Circular comes into force as of November
12, 2022.
2. The Director of the Department of Animal Health,
the heads of units affiliated to Ministries and relevant entities shall
implement this Circular.
Difficulties that arise during the implementation
of this Circular should be reported to the Ministry of Agriculture and Rural
development (via Department of Animal Health) for consideration./.
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PP. MINISTER
DEPUTY MINISTER
Phung Duc Tien
APPENDIX I
REPLACEMENT,
SUPPLEMENTATION OF CERTAIN APPENDICES OF CIRCULAR NO. 12/2020/TT-BNNPTNT
(Issued together with Circular No. 13/2022/TT-BNNPTNT dated September 28,
2022 of the Minister of Agriculture and Rural Development)
1. Appendix VII.
2. Appendix X. List of veterinary drug active
ingredients belonging to the group of important antibiotics.
3. Appendix XI. List of substance- and
precursor-containing veterinary drugs.
4. Appendix XII. List of narcotic substances and
precursors being veterinary drug materials containing narcotic substances and
precursors.
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APPENDIX VII
FORM 1. PRESCRIPTION
USED IN VETERINARY DRUG PRESCRIPING PRACTICES FOR THE TREATMENT AND PROTECTION
OF ANIMALS
Name, address, phone number of health facility
(if any):
Practicing certificate code of prescriber:
Address of prescriber:
Phone number of prescriber:
PRESCRIPTION
Full name of animal husbandry/aquaculture owner:
………………........…....
Name of farm/animal husbandry/aquaculture
facility (if any): …………………….
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Phone:………………FAX: (if any) …………………….
Animal species (2): …Number of animals
(individuals) (3):……………
Number of ponds/tanks/lakes/barns with sick
animals given prescription: …………………………………………………….
Ages (4):……………… Breed (if needed):……………………
Diagnose: …………………………………......……………
……………………………………………….....……………
Drugs for treatment (5): …..
………………………….......................
Time to stop using the drugs: ………………….........…
Instructions (6): …………………………………………….........
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Follow-up
appointment date:
INSTRUCTIONS ON HOW TO WRITE ITEMS IN A
PRESCRIPTION
Veterinary prescription is clearly written on
white paper
1. Address: Input the name and address of the
farm, place where the animals are raised: house number, street, residential
group or village/hamlet, commune/ward/township,
district/town/town/province-affiliated city, province/city.
2. Animal species: Input the name of the animal
species.
3. Number of animals (individuals): Input the
number of animals given prescription
4. Age: Age: Input the stage, age or weight of
the animal or input the breeding and commercial stage for aquatic animals.
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6. Instructions:
- Nutrition regime for the animal.
FORM 2. PRESCRIPTION
USED FOR VETERIANARY DRUG PRESCRIPTION PRACTICES AT ANIMAL FEED PRODUCERS FOR
ANIMAL PREVENTIVE HEALTHCARE
Name, address, phone number of health facility
(if any):
Practicing certificate code of prescriber:
Address of prescriber:
Phone number of prescriber:
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Preventive drugs (1): …………………………………......
......................................................................................
Purposes of use (2):……………………..…………..
Animal species (3):………… Breed (if
needed):…………………….
Age (4):…………………….……………………..
Description of animal feed: .................
Weight (5):..........
Instructions (6): ……………………………………………………
…………………………………………………………………
Applied at feed production establishment (7):
………..
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[Date]…………………….
Prescriber/Veterinarian
(Signature, full name)
INSTRUCTIONS ON HOW TO WRITE ITEMS IN A
PRESCRIPTION
Veterinary prescription is clearly written on
white paper
1. Preventive drugs: Input full information as
prescribed in Article 18 of Circular No. 12/2020/TT-BNNPTNT.
2. Purposes: Specify what disease that the drug
aims to prevent <0}
3. Animal species: Input the name of the animal
species.
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5. Volume: Input the volume of the batch of
manufactured animal feed containing prescription drugs.
6. Instructions: Additional instructions, other
notes (if any).
7. Applied at feed production establishment:
input the full name, address and phone number of the animal feed producer
using the prescription.
APPENDIX X
LIST OF VETERINARY
DRUG ACTIVE INGREDIENTS BELONGING TO THE GROUP OF IMPORTANT ANTIBIOTICS
NO.
Group
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1.
Aminocyclitols
Spectinomycin
2.
Cyclic polypeptides
Bacitracin, Enramycin
3.
Pleuromutilins
Tiamulin, Valnemulin
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APPENDIX XI
LIST OF VETERINARY
DRUGS CONTAINING NARCOTIC SUBSTANCES AND PRECURSORS
(Obtaining Certificate of free sale in Vietnam)
I. LIST OF
VETERINARY DRUGS CONTAINING NARCOTIC SUBSTANCES AND PRECURSORS PRODUCED
DOMESTICALLY
No.
Description
Main active
ingredient
Packing form
Mass/Volume
Uses
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VB PHARMA JOINT STOCK COMPANY
1.
MULTICID
Formic Acid, Amonium Formiate, Lactic Acid,
Propionic Acid, Amonium propionate
Bottles, jars
10ml, 20ml, 50ml, 100ml, 500ml, 1000ml
Lower the pH of the water, affect directly on the
stomach to lower the pH and help in the correct functioning of digestive
enzymes.
VBP-78
2.
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Acetic acid, Formic acid, Lactic acid, Propionic
acid, Citric acid
Bottles, jars, cans
10ml, 20ml, 50ml, 100ml, 200ml, 250ml, 500ml, 1l,
2l, 5l.
Inhibit pathogenic bacteria, enhance the growth
of intestinal microflora, increase food absorption for animals
VBP-216
3.
A Folaccit C
Vitamin C, Citric acid, Formic acid, Lactic acid,
extract
Packages, boxes
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Prevent vitamin C deficiency, strengthen
resistance, reduce stress, limit intestinal diseases in fish
BN.TS4-20
VIET ANH VETERINARY DRUG INVESTMENT JOINT
STOCK COMPANY
4.
ALLCID LIQUID
Formic Acid, Propionic Acid, Ammonium Formate,
Lactic Acid
Bottles
10, 100, 250, 500ml; 1, 5, 10, 20l
Inhibit the growth of yeast, microorganisms in
water, animal feed to help animals easily absorb, prevent flatulence,
indigestion on buffaloes, cows, horses, pigs, goats, sheep, chickens, ducks,
geese, birds
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A.S.T.A. MANUFACTURING-TRADE LIMITED COMPANY
5.
Chelatox
Propionic acid, Formic acid, Lactic acid, Malic
acid, Tartaric acid, Phosphoric acid, Ctric acid, Sorbitol, Copper sulphate
Bottles, cans
5, 10, 20, 50, 100, 250, 500ml; 1; 2; 5, 10 l
Prevent the formation of toxins of intestinal
pathogens, improve the immune system, increase resistance in buffaloes, cows,
goats, sheep, pigs, poultry
ASTA-125
6.
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Vitamins B1, B2, B6, Aspartic acid, Citric acid,
Malic acid, Phosphoric acid, Tartaric acid, Copper sulfate, Potassium
chloride, Yeast
Bottles, cans
1; 2; 5, 10, 20, 50, 100, 250, 280, 500ml; 1;
1,1; 2; 5; 10l
Provide vitamins and minerals; stimulate the
production of enzymes, strengthen the immune system in cows, goats, sheep,
pigs, poultry
ASTA-138
GAU VANG VETERINARY MANUFACTURING AND TRADING
LIMITED COMPANY
7.
Tracheal ventilation
Bromhexine, Tartaric acid
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5, 3, 10, 30, 50, 100, 200, 250, 500 g; 1, 2, 5,
10, 15, 25 kg
Combined with antibiotics to enhance the
effectiveness of treatment of respiratory diseases.
HCM-X17-27
NAM THAI VETERINARY DRUG LIMITED COMPANY
8.
Digicofin-NT
Caffeine, Sodium Salicylate, Ephedrine
Hydrochloride, Digitoxin
Tubes, jars
2; 5, 10, 20, 50, 100ml
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NT-81
NAPHA VETERINARY DRUG TRADING &
MANUFACTURING LIMITED COMPANY
9.
A.C.F
Formic acid
Bottles
5, 10, 20, 50, 100, 250, 500ml; 1; 2; 5 l
Treat Nosema, diarrhea, powdery mildew, Varoa
mites, tracheamites on honey bees
HCM-X24-101
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BIOTONIC LIQUID
Citric acid; Lactic acid; Formic acid;
Methionine; Lysine; Vitamins B1, B5, B6, PP, C
Bottles, cans
5, 10, 20, 50, 100, 250, 500ml; 1; 2; 5, 10, 20 l
Detoxify the liver, treat diseases caused by
vitamin deficiency in shrimp and fish.
HCM.TS34-51
THINH A VETERINARY DRUG TRADING AND PRODUCTION
JOINT STOCK COMPANY
11.
Ox Virin- F
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Bottles, cans
10, 20, 50, 100, 200, 250, 500ml; 1; 2,5; 10, 20
l
Disinfect barns, slaughterhouses, food storage
areas, transport vehicles, tools, livestock equipment, disinfect water pipes
and sterilize air of cages, disinfect breeding environment.
HCM-X11-305
II. LIST OF
VETERINARY DRUGS CONTAINING IMPORTED NARCOTIC SUBSTANCES AND PRECURSORS
No.
Description
Main active
ingredient
Packing form
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Uses
Registration
number
VIRBAC COMPANY (FRANCE)
1.
Zoletil 50
Tiletamine base, Zolazepam
Jars
5g
Anesthesia in veterinary medicine
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VIC-ANIMAL HEALTH CO., LTD (BELARUS)
2.
Productive Acid SE
Formic Acid, Lactic Acid, Acetic Acid, Citric
Acid, Propionic Acid
Bottles, cans, barrels
30; 50; 100, 250, 300, 500ml, 1, 2, 5, 10; 20;
25; 50; 100; 200l
Inhibit the growth of pathogenic microorganisms
in food, drinking water and gastrointestinal tract to prevent diarrhea in
buffaloes, cows, goats, sheep, pigs and poultry
VAH-18
INTRACARE B.V. COMPANY (NETHERLANDS)
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Intra Aqua Acid Mineral
Zinc, Copper, Lactic acid, Formic acid, Propionic
acid
Jars, barrels, cans
1, 2, 5, 10, 20, 25, 200 l
Treat gastrointestinal infections caused by
pathogenic microorganisms causing sensitivity to acids. Indicated in case of
mineral deficiency (copper and zinc), increase immunity in buffaloes, cows,
calves, horses, goats, sheep, pigs and poultry.
IBV-13
INTERCHEME WERKEN "DE ADELAAR" B.V
COMPANY (NETHERLANDS)
4.
Stimosol Oral
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Boxes, Bottles
50, 500ml, 1l
Prevent and treat vitamin B deficiency disease,
stimulate the immune system in calves, goats, sheep, pigs and poultry.
ICW-76
5.
Intrasan pH Oral
Acetic acid, Formic acid, Lactic acid, Citric
acid, Propionic acid
Bottles, cans
100ml, 500ml, 1l, 5l
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ICW-148
ANTEC INTERNATIONAL/GLOBAL-TALKE COMPANY, S.L.
(ENGLAND)
6.
Farm Fluid S
Acetic acid, Tar acid, Dodecyl benzene, Sulphonic
acid
Jars, bottles, barrels
10; 20; 25, 50, 100, 250, 500ml, 1, 2, 2,5; 5;
10; 25; 50; 200l
Antiseptics
ATI-4
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7.
Fam-30®
Iodine, Sulfuric acid, Phosphoric acid
Bottles, barrels
1; 5; 25; 250l
Antiseptics used in animal husbandry and
veterinary medicine
PFU-70
TROY LABORATORIES PTY COMPANY (AUSTRALIA)
8.
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Ketamine HCL
Jars
10, 50ml
Anesthesia on buffaloes, cows, horses, pigs,
goats, dogs, cats
TROY-3
PHARMADIX CORP (PERU)
9.
Ket-A-100®
Ketamine (as hydrochloride)
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10; 20, 30, 100, 250, 500ml
Anesthesia on buffaloes, cows, horses, sheep,
pigs, dogs, cats, poultry
PCP-10
Y.S.P INDUSTRIES (M) SDN. BHD COMPANY
(MALAYSIA)
10.
COUGHLIN Injection
Sulpyrine, Dl-Methyl Ephedrine, Chlorpheniramine
Maleate
Jars
100ml
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YSPM-21
PT. BIOPLAGEN INDONESIA COMPANY (INDONESIA)
11.
Bioplagen Perox®
Hydrogen Peroxide, Acetic Acid
Bottles, jars, cans
1, 2, 5, 10, 20l
Disinfect breeding surfaces and the environment, transportation
vehicles, water tanks, water distribution systems, livestock and poultry
barns
INDO.TY07-01
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12.
MERATM CID
Formic acid, Propionic acid, Silicic acid,
Amonium formate, Amonium propionate
ags, boxes, buckets, barrels
500g; 1, 2, 5, 10, 20, 25, 40, 50kg
Add organic acids, inhibit the growth of bacteria
and molds and fungi in food.
GER.TS1-1
APPENDIX XII
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I. List of narcotic substances being veterinary
drug materials
1. Ketamine
2. Tiletamine
3. Zolazepam
II. List of precursors being veterinary drug
materials
1. Acetic acid
2. Formic acid
3. Ammonium formate
4. Tartaric acid
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6. Sulfuric acid
7. Acetone
8. Acetyl chloride
APPENDIX II
REPLACEMENT OF
CERTAIN APPENDICES OF CIRCULAR NO. 13/2016/TT-BNNPTNT
(Issued together with Circular No. 13/2022/TT-BNNPTNT dated September 28,
2022 of the Minister of Agriculture and Rural Development)
1. Appendix X. Application for registration of sale
of veterinary drugs that are processed and portioned.
2. Appendix XXVIII. Application form for
registration, extension of registration for GMP inspection.
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APPLICATION FOR
REGISTRATION OF SALE OF PROCESSED AND PORTIONED VETERINARY DRUGS
NAME OF
ORDERING FACILITY
THE SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No:……/DK-CT
(Location)….(date)…….
APPLICATION FOR
REGISTRATION OF SALE OF PROCESSED AND PORTIONED VETERINARY DRUGS
To: Department of
Animal Health
Pursuant to Circular No. 13/2016/TT-BNNPTNT dated
June 2, 2016 of the Minister of Agriculture and Rural Development on veterinary
drug management
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Name: …………………………………………………..........
Address :……………………………………………………..........
Phone number:…………Fax number……………
Email:........................................................
Certificate of sale of products of the ordering
facility, issued by the Department of Animal Health (No.:…………date of
issue:……..)
RECEIVING FACILITY:
Name: …………………………………………………..........
Address :……………………………………………………..........
Phone number:…………Fax number……………
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Certificate of eligibility for production of the
processing and portioning facility (number:…………date of issue:…….)
We hereby apply for registration of sale of
processed and portioned veterinary drugs below:
……..… (product name)……………, registration number:
………..
Processing stages: …….
When allowed to be sold, we undertake to comply
with Vietnamese law on veterinary drugs and other relevant laws.
REPRESENTATIVE
OF FACILITY
(Signature, full name and stamp/digital signature, if any)
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APPLICATION FORM FOR
REGISTRATION, EXTENSION OF REGISTRATION FOR GMP INSPECTION
APPLICANT’S
NAME
-------
THE SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No:……/DK-CT
(Location)….(date)…….
APPLICATION FORM
FOR REGISTRATION, EXTENSION OF REGISTRATION FOR GMP INSPECTION
To: Department of
Animal Health
Pursuant to Circular No. 13/2016/TT-BNNPTNT dated
June 2, 2016 of the Minister of Agriculture and Rural Development on veterinary
drug management
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2. Factory address:
3. Certificate of enterprise registration:
4. Veterinary practice certificate:
a) Of the technician in charge: number:…….date of
issue:……
b) Of the person in charge of the veterinary drug
testing laboratory: number:…….date of issue:……
5. Phone number:
Fax:
Email:
Request the Department of Animal Health to
undertake inspection and re-inspection visit to our facility to issue the
certificate of good manufacturing practice according to GMP-WHO (ASEAN) for the
following veterinary drug production lines:
- Oral liquid drugs
- Powder for injection, solution for injection,
suspension for injection...
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Attached documents:
- ……..;
REPRESENTATIVE
OF APPLICANT
(Signature, full name and stamp/digital signature, if any)