Circular No. 13/2022/TT-BNNPTNT Amending and supplementing certain articles of Circulars on veterinary drug management

CIRCULAR
Amending and supplementing certain provisions of circulars on veterinary drug management

Pursuant to Decree No. 15/2017/NĐ-CP dated February 17, 2017 of the Government stipulating 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 Livestock Breeding;

Pursuant to the Law on Prevention and Control of Narcotics 2021;

Pursuant to Decree No. 105/2021/NĐ-CP dated December 4, 2021 of the Government detailing and guiding the implementation of certain provisions of the Law on Prevention and Control of Narcotics;

Pursuant to Decree No. 113/2017/NĐ-CP dated October 9, 2017 of the Government detailing and guiding the implementation of certain provisions of the Chemicals Law;

1. The List of veterinary drugs permitted for circulation in Vietnam (Annex I).

The Minister of Agriculture and Rural Development promulgates this Circular amending and supplementing certain provisions of circulars on veterinary drug management.

Article 1. Amending and supplementing certain provisions of Circular No. 12/2020/TT-BNNPTNT dated November 9, 2020 of the Minister of Agriculture and Rural Development on the management of veterinary drugs containing narcotic substances and precursors; prescriptions and veterinary drug orders; amending and supplementing certain provisions of Circular No. 18/2018/TT-BNNPTNT.

1. Amending and supplementing Clause 1 of Article 1 as follows:

"1. Importing, exporting, transiting through Vietnam's territory, producing, trading, using, delivering, transporting, storing veterinary drugs and raw materials for veterinary drugs containing narcotic substances and precursors; issuing prescriptions and veterinary drug orders within Vietnam."

2. Supplementing Clause 4 after Clause 3 of Article 1 as follows:

"4. List of veterinary drugs containing narcotic substances and precursors; List of narcotic substances and precursors as raw materials for veterinary drugs containing narcotic substances and precursors."

3. Amending and supplementing Clause 1 of Article 2 as follows:

"1. Organizations and individuals inside and outside Vietnam related to importing, exporting, transiting through Vietnam's territory, producing, trading, using, delivering, transporting, storing veterinary drugs and raw materials for veterinary drugs containing narcotic substances and precursors; issuing prescriptions and veterinary drug orders within Vietnam."

4. Amending and supplementing Clause 1 of Article 3 as follows:

"1. Veterinary drugs containing narcotic substances and precursors are veterinary drugs containing narcotic substances and precursors listed in the Catalogue of Narcotic Substances and Precursors prescribed by the Government."

5. Supplementing Clause 1a after Clause 1 of Article 3 as follows:

"1a. Raw materials for veterinary drugs containing narcotic substances and precursors are addictive drugs, psychotropic drugs, and precursors used to produce veterinary drugs containing narcotic substances and precursors as prescribed in Clause 1 of this Article."

6. Amend and supplement the name of Chapter II as follows:

"Chapter II"

MANAGEMENT OF VETERINARY DRUGS CONTAINING NARCOTIC SUBSTANCES AND PRECURSORS, RAW MATERIALS FOR VETERINARY DRUGS CONTAINING NARCOTIC SUBSTANCES AND PRECURSORS

DRUGS, ANIMAL HEALTH MATERIALS CONTAINING DRUGS

AND PRECURSOR SUBSTANCES"

7. Supplementing Article 3a before Article 4 as follows:

"Article 3a. List of veterinary drugs containing narcotic substances and precursors; List of narcotic substances and precursors as raw materials for veterinary drugs containing narcotic substances and precursors

1. The list of veterinary drugs containing narcotic substances and precursors at Appendix XI attached hereto.

2. The list of narcotic substances and precursors as raw materials for veterinary drugs containing narcotic substances and precursors at Appendix XII attached hereto."

8. Amending and supplementing Article 4 as follows:

"Article 4. Importing veterinary drugs containing narcotic substances and precursors, raw materials for veterinary drugs containing narcotic substances and precursors"

1. Organizations and individuals eligible to apply for import permits for veterinary drugs containing narcotic substances and precursors include:

a) Organizations and individuals holding a Certificate of Eligibility for Importation of Veterinary Drugs or a Certificate of Eligibility for Production of Veterinary Drugs Containing Narcotic Substances and Precursors;

b) Organizations and individuals applying for the first-time import of veterinary drugs containing narcotic substances and precursors for scientific research, prevention, and treatment of diseases in rare animals with business registration certificates or enterprise registration certificates or investment licenses or establishment decisions issued by state management agencies.

2. Organizations and individuals importing veterinary drugs as prescribed in Clause 1 of Article 3 of this Circular shall implement according to the provisions of point a, point d Clause 1 and Clause 2 of Article 20 of Decree No. 105/2021/NĐ-CP dated December 4, 2021 of the Government detailing and guiding certain provisions of the Law on Prevention and Control of Narcotics (hereinafter referred to as Decree No. 105/2021/NĐ-CP).

3. Provisions on importing raw materials for veterinary drugs containing narcotic substances and precursors.

a) Importing raw materials for veterinary drugs containing narcotic substances is only allowed for production facilities importing raw materials for their own production activities;

b) In cases where unused raw materials for veterinary drugs containing narcotic substances have been imported, the importing entity is permitted to transfer them to production facilities meeting the requirements set out in Clause 1 of Article 7 of this Circular and must notify the Department of Animal Health in writing before transferring;

c) Documents, procedures, and formalities for importing raw materials for veterinary drugs containing narcotic substances and precursors shall be implemented according to the provisions of point a, point d Clause 1 and Clause 2 of Article 20 of Decree No. 105/2021/NĐ-CP.

4. The Department of Animal Health is the competent authority to issue import permits for veterinary drugs and raw materials for veterinary drugs containing narcotic substances and precursors.

5. Import permits for veterinary drugs and raw materials for veterinary drugs containing narcotic substances and precursors are in Form No. 02A, Form No. 02B attached to Decree No. 105/2021/NĐ-CP.

6. Import permits for veterinary drugs and raw materials for veterinary drugs containing narcotic substances and precursors are valid for each importation and have a validity period as stated on the permit but not exceeding 12 months from the date of issuance. In case the validity period stated on the permit has expired but the importation has not been completed, the enterprise may request the Department of Animal Health to extend the permit without limitation on the number of extensions.

7. Issuing, adjusting, reissuing import permits for veterinary drugs and raw materials for veterinary drugs containing narcotic substances and precursors due to loss, misplacement, or errors shall be carried out according to the provisions of point d Clause 3 of Article 20 of Decree No. 105/2021/NĐ-CP."

9. Amending and supplementing Clause 2 of Article 5 as follows:

"2. Documents, procedures, and formalities for exporting veterinary drugs containing narcotic substances and precursors shall be implemented according to the provisions of point a, point d Clause 1 and Clause 2 of Article 20 of Decree No. 105/2021/NĐ-CP."

10. Supplementing Clause 3a after Clause 3 of Article 5 as follows:

"3a. Export permits for veterinary drugs containing narcotic substances and precursors are in Form No. 02A, Form No. 02B attached to Decree No. 105/2021/NĐ-CP."

11. Amending and supplementing Clause 4 of Article 5 as follows:

11. AMEND AND SUPPLEMENT Clause 4 of Article 5 as follows:

"4. The export permit for veterinary drugs containing narcotic substances or precursors shall be issued for each exportation and shall be valid within the period specified on the permit but not exceeding twelve months. In case the term specified on the permit expires but the exportation has not been carried out, the enterprise may request the Department of Animal Health to extend the validity of the permit without limitation on the number of extensions."

12. Add Clause 4a following Clause 4 of Article 5 as follows:

"4a. The issuance, adjustment, reissuance of the Export Permit for veterinary drugs containing narcotic substances or precursors due to loss, misplacement, or errors shall be implemented according to the provisions at Point d, Clause 3, Article 20 of Decree No. 105/2021/NĐ-CP."

13. Add Article 5a before Article 6 as follows:

"Article 5a. Exemption, Revocation of Export Permits, Import Permits for Veterinary Drugs, Raw Materials for Veterinary Drugs Containing Precursors

1. Exemption from issuing Export Permits, Import Permits for veterinary drugs containing precursors shall be conducted according to the provisions at Clause 1, Article 13 of Decree No. 113/2017/NĐ-CP dated October 9, 2017 detailing and guiding the implementation of certain articles of the Chemical Law (hereinafter referred to as Decree No. 113/2017/NĐ-CP).

2. The revocation of Export Permits, Import Permits for veterinary drugs, raw materials for veterinary drugs containing precursors shall be conducted according to the provisions at Clause 2, Article 13 of Decree No. 113/2017/NĐ-CP.

3. The Department of Animal Health is the authority responsible for revoking Export Permits, Import Permits for veterinary drugs, raw materials for veterinary drugs containing precursors. Organizations and individuals whose permits are revoked shall have the responsibility to send the permits to be revoked to the Department of Animal Health within five working days from the date of receipt of the decision to revoke."

14. Amend and supplement Article 6 as follows:

"Article 6. Transit through Vietnam's Territory for Veterinary Drugs Containing Narcotic Substances or Precursors, Raw Materials for Veterinary Drugs Containing Narcotic Substances or Precursors

The dossier, procedures, and formalities for issuing transit permits through Vietnam's territory for veterinary drugs containing narcotic substances or precursors, raw materials for veterinary drugs containing narcotic substances or precursors shall be implemented according to the provisions at Article 22 of Decree No. 105/2021/NĐ-CP."

15. Amend and supplement Clause 1 of Article 7 as follows:

"1. Production of Veterinary Drugs Containing Narcotic Substances or Precursors

a) The production of various types of veterinary drugs containing narcotic substances or precursors within the country can only be carried out at facilities that have been granted a Certificate of Compliance with Conditions for Veterinary Drug Production by the Department of Animal Health and which remain valid;

b) The dossier, procedures, and formalities for issuing a Certificate of Compliance with Conditions for Veterinary Drug Production containing narcotic substances or precursors on the same production line as veterinary drugs already granted a Certificate of Compliance with Conditions for Production shall be implemented according to the provisions at Point a and Point c, Clause 2, Article 16 of Decree No. 105/2021/NĐ-CP;

c) The dossier, procedures, and formalities for reissuing a Certificate of Compliance with Conditions for Veterinary Drug Production containing narcotic substances or precursors in cases where the certificate is lost, erroneous, damaged, or there is a change in information of organizations or individuals recorded in the certificate shall be implemented according to the provisions at Clause 3, Article 16 of Decree No. 105/2021/NĐ-CP;

d) The dossier, procedures, and formalities for amending a Certificate of Compliance with Conditions for Veterinary Drug Production containing narcotic substances or precursors in cases where there is a change in scale, location, or type of product produced shall be implemented according to the provisions at Clause 4, Article 16 of Decree No. 105/2021/NĐ-CP."

16. Amend and supplement Article 9 as follows:

"Article 9. Use of Veterinary Drugs Containing Narcotic Substances to Treat Animals

1. Individuals holding a veterinary practice certificate for diagnosis, treatment, surgery, laboratory testing, and vaccination of animals are permitted to use veterinary drugs containing narcotic substances to treat animals according to prescriptions; in cases where they do not use or do not use up the drugs, they must return them to the drug-selling facility within ten days.

2. Drug-selling facilities receiving and recording the return of veterinary drugs containing narcotic substances that were not used or not fully used from users as stipulated in Clause 1 of this Article shall follow the model set forth in Appendix VI attached to this Circular. The record shall be made in two copies (one copy retained by the drug-selling facility, one copy handed over to the person returning the drugs). The store owner shall decide based on specific conditions whether to reuse or destroy the drugs according to the provisions at Clause 3 and Clause 4, Article 40 of Circular No. 13/2016/TT-BNNPTNT dated June 2, 2016 issued by the Minister of Agriculture and Rural Development on the management of veterinary drugs."

17. Amend and supplement Article 11 as follows:

"Article 11. Transport of Veterinary Drugs Containing Narcotic Substances or Precursors, Raw Materials for Veterinary Drugs Containing Narcotic Substances or Precursors.

1. During transportation, veterinary drugs containing narcotic substances or precursors, raw materials for veterinary drugs containing narcotic substances or precursors must be packaged and labeled with complete content as required by law, including clearly stating the name of the substance, concentration, quantity, weight, origin, and place of manufacture.

2. Individuals, agencies, organizations possessing veterinary drugs containing narcotic substances or precursors, raw materials for veterinary drugs containing narcotic substances or precursors shall bear responsibility for the safety and loss of goods during transportation."

18. Add the active ingredients "Toltrazuril, Amprolium, Clopidol" at the end of Clause 1 of Article 14.

19. Add Clause 7 following Clause 6 of Article 14 as follows:

"7. Veterinary drugs containing active ingredients belonging to the group of drugs for preventing and treating internal and external parasites."

20. Amend and supplement Article 20 as follows:

"Article 20. Prescription of Veterinary Drugs

1. A prescription for veterinary drugs shall be made in three copies: one copy retained by the animal health care, surgical, diagnostic facility; one copy sent to the animal breeding facility; one copy retained by the veterinary drug dispensing facility. In cases where the prescription is written and sold by the animal health care, surgical, diagnostic facility itself, the prescription shall be made in two copies: one copy retained by the prescribing facility; one copy sent to the animal breeding facility.

2. Prescriptions for veterinary drugs shall be written for quantities not exceeding seven (7) days' usage or according to the manufacturer's instructions and the provisions of Articles 13, 17, and 18 of this Circular.

3. Facilities and individuals engaged in animal health care, surgical, diagnostic services must submit a list of registration numbers of veterinary drug prescribers containing narcotic substances or precursors to the specialized animal health management agency at the provincial level where they operate."

21. Amend and supplement Point d Clause 4 Article 23 as follows:

"d) Submit periodic reports every six months (data from December 15 of the year prior to the reporting period to June 14 of the reporting period), annual reports (data from December 15 of the year prior to the reporting period to December 14 of the reporting period) to the Animal Health Department and Regional Animal Health Sub-department under their jurisdiction according to the form set out in Appendix II issued together with this Circular."

22. Supplement Point d after Point c Clause 3 Article 24 as follows:

"d) Provide the registration number of the practice certificate and the name of the issuing entity for the practice certificate of the prescribing person to the specialized animal health management agency of the province where the practice takes place if the practice certificate is issued by a specialized animal health management agency of another province or city."

Article 2. Repeal, replace, and supplement some Appendices of Circular No. 12/2020/TT-BNNPTNT dated November 9, 2020, of the Minister of Agriculture and Rural Development on the management of veterinary drugs containing narcotic substances and precursors; prescriptions and veterinary drug orders; amend and supplement some provisions of Circular No. 18/2018/TT-BNNPTNT.

1. Repeal Appendix I. Form for registering the import and export of veterinary drugs containing narcotic substances and precursors, raw materials for veterinary drugs containing narcotic substances.

2. Replace Appendix VII with Appendix VII at Appendix I issued together with this Circular.

3. Replace Appendix X. List of active ingredients of important antibiotic veterinary drugs with Appendix X. List of active ingredients of important antibiotic veterinary drugs at Appendix I issued together with this Circular.

4. Supplement Appendix XI. List of veterinary drugs containing narcotic substances and precursors at Appendix I issued together with this Circular.

5. Supplement Appendix XII. List of narcotic substances and precursors as raw materials for veterinary drugs containing narcotic substances and precursors at Appendix I issued together with this Circular.

Article 3. Amend and supplement some provisions of Circular No. 13/2016/TT-BNNPTNT dated June 2, 2016, of the Minister of Agriculture and Rural Development on the management of veterinary drugs.

1. Repeal the term "antibody" at Point g Clause 3 Article 3.

2. Supplement the phrase "information and characteristics of the original microorganism strain used to produce vaccines and antibodies for domestically produced products" before the phrase "documents related to copyright and application of vaccine and antibody production certificates (if any)" at Point n Clause 3 Article 3.

3. Repeal Point p Clause 3 Article 3.

4. Repeal Points d and f Clause 6 Article 3.

5. Supplement the phrase "for submission through postal service or direct submission" after the phrase "registration dossier" at Point a Clause 2 Article 6.

6. Supplement Clause 3 after Clause 2 Article 6 as follows:

"3. Submission methods include online, through postal service, or direct submission."

7. Supplement the phrase "as of the date of submission" after the phrase "within twelve months" at Clause 4 Article 10.

8. Supplement Clause 6 after Clause 5 Article 20 as follows:

"6. Conduct online inspection and evaluation in cases where natural disasters occur or regulations on prevention and control of dangerous diseases must be applied, making it impossible to conduct on-site inspections and evaluations to issue certificates of compliance for veterinary drug production. On-site inspections will be conducted once localities have controlled natural disasters and diseases according to regulations; immediately revoke certificates for organizations and individuals who violate laws and handle violations according to legal provisions."

9. Supplement Clause 5 after Clause 4 Article 21 as follows:

"5. Conduct online inspection and evaluation in cases where natural disasters occur or regulations on prevention and control of dangerous diseases must be applied, making it impossible to conduct on-site inspections and evaluations to issue certificates of compliance for veterinary drug trading and import. On-site inspections will be conducted once localities have controlled natural disasters and diseases according to regulations; immediately revoke certificates for organizations and individuals who violate laws and handle violations according to legal provisions."

10. Supplement the phrase "For veterinary drugs that require a prescription, the symbol Rx shall be marked at the top left corner of the drug name and the phrase 'Prescription Drug' at the end of Point e Clause 1 Article 27."

11. Replace the phrase "Within ten days for pharmaceuticals, chemicals, and biological preparations" with the phrase "Within fifteen days for pharmaceuticals, chemicals, and biological preparations" at Point a and Point b Clause 2 Article 39.

Article 4. Amend, supplement, and replace some Appendices of Circular No. 13/2016/TT-BNNPTNT dated June 2, 2016, issued by the Minister of Agriculture and Rural Development on veterinary drug management.

1. Replace Appendix X. Application for Registration of Circulation of Veterinary Drugs Produced Through Processing and Dividing with Appendix X. Application for Registration of Circulation of Veterinary Drugs Produced Through Processing and Dividing at Appendix II promulgated together with this Circular.

2. Amend and supplement the name of Appendix XX and the form at Appendix XX to read: "Application for Issuance and Extension of Certificate of Eligibility for Sale and Importation of Veterinary Drugs."

3. Add the phrase "Part I. General Indicators" after the phrase "II. GROUP OF EVALUATION INDICATORS" at Appendix XXIII.

4. Replace Appendix XXVIII. Form for Registration and Extension of Registration for GMP Inspection with Appendix XXVIII. Form for Registration and Extension of Registration for GMP Inspection at Appendix II promulgated together with this Circular.

Article 5. Transitional Provisions

1. For import permit applications for veterinary drugs, raw materials for veterinary drugs containing narcotic substances, precursors; applications for issuance of Certificate of Eligibility for Production of Veterinary Drugs; applications for issuance of Certificate of Eligibility for Sale and Importation of Veterinary Drugs; and applications for registration of circulation of veterinary drugs received before this Circular takes effect shall be processed according to the laws in force at the time of submission of the application.

2. Veterinary drugs that have been produced and imported before this Circular takes effect may continue to circulate with their registered product labels until the expiration date of the products. Veterinary drugs produced and imported after this Circular takes effect must include information about prescription drugs on the original product label or on the secondary label or on the Product Usage Instructions.

Article 6. Implementation Clauses.

1. This Circular takes effect from November 12, 2022.

2. The Director of the Animal Health Department, Heads of units under the Ministry, and related organizations and individuals are responsible for implementing this Circular.

During the implementation of this Circular, if there are any difficulties or need for amendments and supplements, please promptly report to the Ministry of Agriculture and Rural Development (through the Animal Health Department) for consideration and resolution./.

Appendix I
AMEND AND SUPPLEMENT SOME APPENDICES
OF CIRCULAR NO. 12/2020/TT-BNNPTNT

(Issued together with Circular No. /2022/TT-BNNPTNT dated  month  year 2022

of the Minister of Agriculture and Rural Development)

1. Appendix VII.

2. Appendix X. List of active ingredients of veterinary drugs belonging to the important antibiotic group.

3. Appendix XI. List of veterinary drugs containing narcotic substances, precursors.

4. Appendix XII. List of narcotic substances, precursors as raw materials for veterinary drugs containing narcotic substances, precursors.

Appendix VII
MODEL 1. PRESCRIPTION FOR VETERINARY DRUGS
FOR TREATMENT AND PREVENTIVE TREATMENT OF ANIMALS

GUIDELINES FOR RECORDING ITEMS IN THE PRESCRIPTION

The veterinary prescription should be written on white paper, with clear handwriting.

1. Address: Record the name and address of the farm where the animals are kept: house number, street, residential ward or village/commune/ward, district/city/district/provincial city, province/city.

2. Species of animals: Record the name of the species of animals.

3. Number of animals (heads): Record the number of animals prescribed.

4. Age: Record the stage, age, or weight of the animals or record the breeding or commercial stage for aquatic animals.

5. Treatment drug: Record all information as stipulated in Article 18 of Circular No. 12/2020/TT-BNNPTNT.

6. Instructions:

- Dietary regimen for animals.

MODEL 2. PRESCRIPTION FOR VETERINARY DRUGS
AT FEED PRODUCTION FACILITIES TO PREVENT DISEASES IN ANIMALS

GUIDELINES FOR RECORDING ITEMS IN THE PRESCRIPTION

The veterinary prescription is presented on white paper with clear handwriting.

1. Disease prevention drugs: fully record information as prescribed in Article 18 of Circular No. 12/2020/TT-BNNPTNT.

2. Purpose of use: Clearly state which disease it is for preventing.

3. Animal species: Record the name of the animal species.

4. Age group: Record the stage, age, or weight of the animals using the animal feed containing veterinary drugs.

5. Quantity: Record the quantity of the batch of animal feed produced containing the drug according to the prescription.

6. Instructions: Add any additional instructions or notes (if any).

7. Animal feed production facility: Fully record the name, address, and phone number of the animal feed production facility using the prescription.

ANNEX X

LIST OF ACTIVE SUBSTANCES OF VETERINARY DRUGS BELONGING TO
THE IMPORTANT ANTIBIOTIC GROUP

ANNEX XI
LIST OF VETERINARY DRUGS CONTAINING NARCOTIC SUBSTANCES AND PRECURSOR CHEMICALS
(Licensed for circulation in Vietnam)

I. LIST OF VETERINARY DRUGS CONTAINING NARCOTIC SUBSTANCES AND PRECURSOR CHEMICALS PRODUCED DOMESTICALLY

JOINT STOCK COMPANY NAM THAI VETERINARY DRUGS

II. LIST OF VETERINARY DRUGS CONTAINING NARCOTIC SUBSTANCES AND PRECURSOR CHEMICALS IMPORTED

Appendix XII

VETERINARY DRUGS CONTAINING DRUGS AND PRECURSOR SUBSTANCES
I. List of drugs used as raw materials for veterinary drugs

1. Ketamine

2. Tiletamine

3. Zolazepam

II. List of precursor substances used as raw materials for veterinary drugs

1. Acetic acid

2. Formic acid

3. Ammonium formate

4. Tartaric acid

5. Ephedrine

6. Sulfuric acid

7. Acetone

8. Acetyl chloride

REPLACEMENT OF SOME ANNEXES

Seal Registration Certificate
TO THE CIRCULAR NUMBER 13/2016/TT-BNNPTNT
(Issued together with Circular number /2022/TT-BNNPTNT dated month year 2022

1. Annex X. Application for registration of veterinary drug production, processing, and repackaging.
of the Minister of Agriculture and Rural Development)

2. Annex XXVIII. Sample application for registration and extension of Good Manufacturing Practice (GMP) inspection.

SAMPLE APPLICATION FOR REGISTRATION OF VETERINARY DRUG PRODUCTION

ANNEX X

PROCESSING, REPACKAGING
NAME OF THE COMMISSIONING PARTY

PRODUCTION BY COMMISSIONING, PROCESSING, REPACKAGING
To: Department of Animal Health

Pursuant to Circular No. 13/2016/TT-BNNPTNT dated June 2, 2016 issued by the Minister of Agriculture and Rural Development on the management of veterinary drugs

COMMISSIONING PARTY:

Name:…

Address:…

Phone number:…Fax number…

Email:…

Product registration certificate of the commissioning party issued by the Department of Animal Health (number:…date of issue)

PARTY RECEIVING COMMISSIONING, REPACKAGING:

Name:…

Address:…

Phone number:…Fax number…

Email:…

Production facility certification of the receiving party (number:…date of issue)

We hereby apply for the registration of the following veterinary drugs produced through commissioning and repackaging:

…(product name)…, registration number: …

Processing steps:…….

Upon approval for circulation, we commit to comply strictly with all relevant laws and regulations of Vietnam regarding veterinary drugs.

(Signature, full name, stamp/

SAMPLE APPLICATION FOR REGISTRATION AND EXTENSION OF GMP REGISTRATION

Number:…/DK-CT

2. Factory address:

Pursuant to Circular No. 13/2016/TT-BNNPTNT dated June 2, 2016 issued by the Minister of Agriculture and Rural Development on the management of veterinary drugs

COMMISSIONING PARTY:

1. Name of the entity:

3. Business registration certificate:

4. Veterinary practice certificate:

a) Of the technical supervisor: number…date…month…year…issued

b) Of the head of the veterinary drug testing laboratory: number…date…month…year…issued

5. Telephone:

- Oral liquid medication

- Injectable powder, injectable solution, injectable suspension…

(Specify: non-beta lactam or beta-lactam)

REPRESENTATIVE OF THE ORGANIZATION

The accompanying documents include:

- ........;