Thông tư 13/2022/TT-BNNPTNT của Bộ Nông nghiệp và Phát triển nông thôn về việc sửa đổi, bổ sung một số điều của các Thông tư về quản lý thuốc thú y

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. MINISTERDEPUTY MINISTERPhung 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: …………………………………......……………

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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): …………………………………......

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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 VIETNAMIndependence - Freedom - Happiness---------------

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 VIETNAMIndependence - Freedom - Happiness---------------

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:

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REPRESENTATIVE OF APPLICANT (Signature, full name and stamp/digital signature, if any)