Thông tư 13/2022/TT-BNNPTNT ngày 28/09/2022 sửa đổi Thông tư về quản lý thuốc thú y do Bộ trưởng Bộ Nông nghiệp và Phát triển nông thôn ban hành

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;

At the request of the Director of the Department of Animal Health;

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:

 “1. Narcotic substance- and precursor-containing veterinary drugs mean veterinary drugs that contain narcotic substances and precursors stated in the List of narcotic substances and precursors stipulated by the Government.”

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.”

8. Article 4 shall be amended as follows:

 “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;

c) An application and procedures for import of narcotic substance-containing veterinary drug materials shall comply with Point a, point d Clause 1 and Clause 2 Article 20 of Decree No. 105/2021/ND-CP.

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:

 “4. The license to export narcotic substance- and precursor-containing veterinary drugs is issued for each export and is valid for the period stated in the license but not exceeding 12 months. In case the license expires but the export has not yet been carried out, the enterprise shall apply to the Department of Animal Health for the extension of license, with unlimited number of times of extension”

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”

Applications and procedures for licensing transit of substance- and precursor-containing veterinary drugs and veterinary drug materials through Vietnam are specified in Article 22 of the Decree No. 105/2021/ND-CP.”

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.

2. The veterinary drug selling establishment shall receive and make a record on receipt of the substance-containing veterinary drugs that are not used or are underused from the user specified in Clause 1 of this Article using the form in the Appendix VI hereof. The record shall be made into 02 copies (01 archived at the veterinary drug selling establishment, 01 issued to the user). Shop owners shall, based on specific conditions, decide to reuse or destroy it according to Clauses 3 and 4, Article 40 of Circular No. 13/2016/TT-BNNPTNT dated June 2, 2016 of the Minister of Agriculture and Rural Development on veterinary drug management”.

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

1. A prescription for veterinary drugs shall be made into 03 copies: 01 archived at the examination, diagnosis, surgery and testing establishment; 01 archived at the animal raising establishment; 01 archived at the veterinary drug supplying and selling establishment. If the prescription is made up and the veterinary drugs are sold by the examination, diagnosis, surgery and testing establishment itself, the prescription shall be made into 02 copies: 01 archived by the prescriber; 01 archived at the animal raising establishment.

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.

3. Replace Appendix X. List of veterinary active ingredients belonging to group of important antibiotics with Appendix X. List of veterinary active ingredients belonging to group of important antibiotics with Appendix I issued herewith.

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:

 “3. The form of application submission is any of the following: online or by postal service or in person.”

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 4. 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.

2. Amend the name of Appendix XX and the name of the application form in Appendix XX to: “Application for issuance and renewal of certificate of eligibility to trade and import veterinary drugs”.

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./.

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.

APPENDIX VII

FORM 1. PRESCRIPTION USED IN VETERINARY DRUG PRESCRIPING PRACTICES FOR THE TREATMENT AND PROTECTION OF ANIMALS

FORM 2. PRESCRIPTION USED FOR VETERIANARY DRUG PRESCRIPTION PRACTICES AT ANIMAL FEED PRODUCERS FOR ANIMAL PREVENTIVE HEALTHCARE

APPENDIX X

LIST OF VETERINARY DRUG ACTIVE INGREDIENTS BELONGING TO THE GROUP OF IMPORTANT ANTIBIOTICS

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

II. LIST OF VETERINARY DRUGS CONTAINING IMPORTED NARCOTIC SUBSTANCES AND PRECURSORS

APPENDIX XII

LIST OF NARCOTIC SUBSTANCES AND PRECURSORS BEING VETERINARY DRUG MATERIALS CONTAINING NARCOTIC SUBSTANCES AND PRECURSORS

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

5. Ephedrine

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.

APPENDIX X

APPLICATION FOR REGISTRATION OF SALE OF PROCESSED AND PORTIONED VETERINARY DRUGS

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

ORDERING FACILITY:

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……………

Email:........................................................

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.

APPENDIX XXVIII

APPLICATION FORM FOR REGISTRATION, EXTENSION OF REGISTRATION FOR GMP INSPECTION

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

1. Facility name:

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...

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

Attached documents:

- ……..;

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