Circular No. 12/2020/TT-BNNPTNT on the management of veterinary drugs containing narcotic substances and precursors; prescriptions and veterinary prescriptions; amending and supplementing some articles of Circular No. 18/2018/TT-BNNPTNT.

CIRCULAR

Regulations on the management of veterinary drugs containing narcotic substances, precursor substances; prescription, veterinary prescriptions; amendment and supplementation of certain provisions

veterinary prescription, veterinary prescription form; amend and supplement some articles

Amending and supplementing some provisions of Circular No. 18/2018/TT-BNNPTNT

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 Animal Health dated June 19, 2015;

Pursuant to the Law on Livestock Raising dated November 19, 2018;

Pursuant to Decree No. 80/2001/NĐ-CP dated November 5, 2001 of the Government guiding the lawful control activities related to narcotics within the country;

Pursuant to Decree No. 58/2003/NĐ-CP dated May 29, 2003 of the Government stipulating the import, export, and transit through Vietnam's territory of narcotic substances, precursor substances, addictive drugs, and psychotropic drugs;

Pursuant to Decree No. 73/2018/NĐ-CP dated May 15, 2018 of the Government stipulating lists of narcotic substances and precursor substances;

Pursuant to Decree No. 13/2020/NĐ-CP dated January 21, 2020 of the Government detailing the Law on Livestock Raising;

Pursuant to Decree No. 60/2020/NĐ-CP dated May 29, 2020 of the Government amending and supplementing the list of narcotic substances and precursor substances issued together with Decree No. 73/2018/NĐ-CP dated May 15, 2018 of the Government stipulating lists of narcotic substances and precursor substances;

At the proposal of the Director of the Animal Health Department,

The Minister of Agriculture and Rural Development issues this Circular regulating the management of veterinary drugs containing narcotic substances, precursor substances; prescription, veterinary prescriptions; amending and supplementing some provisions of Circular No. 18/2018/TT-BNNPTNT.

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates on:

2. List of antibiotics as prescribed in Clause 4, Article 12 of Decree No. 13/2020/NĐ-CP dated January 21, 2020 of the Government detailing the Law on Livestock Raising (hereinafter referred to as Decree No. 13/2020/NĐ-CP).

Article 2. Applicability

This Circular applies to:

2. Organizations and individuals producing, importing veterinary drugs within Vietnam.

In this Circular, the following terms shall be understood as follows:

2. Using veterinary drugs containing antibiotics to prevent disease in animals means using veterinary drugs containing antibiotics for terrestrial animals in the early stages according to Clause 1, Article 12 of Decree No. 13/2020/NĐ-CP, which have a risk of contracting disease but show no clinical signs of disease.

3. Using veterinary drugs containing antibiotics for prophylactic treatment of animals means using veterinary drugs for a group of animals at risk of contracting disease when one or more animals in the group are diagnosed, tested, and concluded to be infected, suspected of being infected, or to prevent and treat infections before and after surgery in animals.

4. Using veterinary drugs to treat diseases in animals means using veterinary drugs for animals showing clinical signs of disease or diagnosed, tested, and concluded to be infected.

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

a) Organizations and individuals holding a Certificate of Eligibility for Importing Veterinary Drugs or a Certificate of Eligibility for Producing Veterinary Drugs in accordance with laws on animal husbandry;

b) Organizations and individuals applying for the first-time import of veterinary drugs containing narcotic substances, precursors for participation in exhibitions, fairs, scientific research, and treatment of rare animals, provided they have a business registration certificate, enterprise registration certificate, investment permit, or establishment decision issued by a state management agency.

2. The dossier, procedures, and formalities for importing veterinary drugs containing narcotic substances, precursors with a Certificate of Circulation in Vietnam, and raw materials for veterinary drugs containing narcotic substances are stipulated as follows:

a) The dossier includes: An application form for importing veterinary drugs containing narcotic substances, precursors, and raw materials for veterinary drugs containing narcotic substances according to the model prescribed in Appendix I attached to this Circular, and the dossier components specified in point a, Clause 1, Article 6 of Decree No. 58/2003/ND-CP dated May 29, 2003 of the Government on controlling imports, exports, and transits of narcotic substances, precursors, addictive drugs, and psychotropic drugs through Vietnam's territory (hereinafter referred to as Decree No. 58/2003/ND-CP). Documents in foreign languages must be translated into Vietnamese and certified regarding the legality of the translation. Organizations and individuals submit one dossier directly, via postal service, or through an online environment (national single window mechanism, online public services).

b) The procedures and formalities for importation are implemented in accordance with the provisions of Clause 3, Article 6 of Decree No. 58/2003/ND-CP.

3. The dossier, procedures, and formalities for importing veterinary drugs containing narcotic substances, precursors without a Certificate of Circulation in Vietnam are stipulated as follows:

a) The dossier includes: The documents specified in point a, Clause 2 of this Article; in cases of emergency disease control, disaster relief, and supplementary documents specified in points b, c, d, and đ, Clause 1, Article 22 of Circular No. 13/2016/TT-BNNPTNT dated June 2, 2016 of the Minister of Agriculture and Rural Development on managing veterinary drugs (hereinafter referred to as Circular No. 13/2016/TT-BNNPTNT); in cases of participation in exhibitions, fairs, scientific research, and treatment of rare animals, supplementary documents specified in points c, d, đ, and e, Clause 3, Article 22 of Circular No. 13/2016/TT-BNNPTNT. Organizations and individuals submit one dossier directly, via postal service, or through an online environment (national single window mechanism, online public services).

b) The procedures and formalities for importation are implemented in accordance with the provisions of point b, Clause 2 of this Article.

4. Regulations on importing raw materials for veterinary drugs containing narcotic substances:

a) The importation of raw materials for veterinary drugs containing narcotic substances is only permitted for production facilities to serve their own drug production activities;

b) In cases where imported raw materials are not fully utilized, the importing facility is allowed to transfer them to other production facilities meeting the requirements stipulated in Clause 1, Article 7 of this Circular and must notify the Department of Animal Health in writing before transferring;

c) The dossier for importing raw materials for veterinary drugs containing narcotic substances includes: The documents specified in point a, Clause 2 of this Article and points b, c, and d, Clause 7, Article 22 of Circular No. 13/2016/TT-BNNPTNT. Organizations and individuals submit one dossier directly, via postal service, or through an online environment (national single window mechanism, online public services).

d) The procedures and formalities for importing raw materials for veterinary drugs containing narcotic substances are implemented in accordance with the provisions of point b, Clause 2 of this Article.

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

6. Import permits for veterinary drugs containing narcotic substances, precursors, and raw materials for veterinary drugs containing narcotic substances are issued for each importation and are valid for 12 months from the date of issuance.

7. Importing facilities must retain importation dossiers for veterinary drugs containing narcotic substances, precursors, and raw materials for veterinary drugs containing narcotic substances in paper or electronic form including:

a) A record book for tracking the import, export, and stock of veterinary drugs containing narcotic substances, precursors, and raw materials for veterinary drugs containing narcotic substances according to the model prescribed in Appendix III attached to this Circular;

b) An export warehouse receipt for veterinary drugs containing narcotic substances, precursors, and raw materials for veterinary drugs containing narcotic substances according to the model prescribed in Appendix IV attached to this Circular;

c) Certificates and documents related to the importation, sale, and transfer of veterinary drugs containing narcotic substances, precursors, and raw materials for veterinary drugs containing narcotic substances.

1. Veterinary drugs containing narcotic substances or precursors for export must have a Certificate of Circulation in Vietnam.

a) The dossier includes: An application form for exporting veterinary drugs containing narcotic substances or precursors according to the model prescribed in Appendix I attached to this Circular and the dossier components stipulated in point a, Clause 1, Article 6 of Decree No. 58/2003/ND-CP. If these documents are in a foreign language, they must be translated into Vietnamese and certified regarding the legality of the translation. Organizations and individuals submit one dossier directly, through postal services, or via the online environment (national single window mechanism, online public service).

b) The procedures and formalities for exporting veterinary drugs containing narcotic substances or precursors shall be implemented in accordance with the provisions of Clause 3, Article 6 of Decree No. 58/2003/ND-CP.

5. The exporting entity must store the export dossier for veterinary drugs containing narcotic substances or precursors in paper or electronic form including:

a) Documents specified in points a and b of Clause 7, Article 4 of this Circular;

b) Documents and materials related to the export and sale of veterinary drugs containing narcotic substances or precursors.

The dossier, procedures, and formalities for issuing transit permits through Vietnam's territory for veterinary drugs and raw materials for veterinary drugs containing narcotic substances or precursors shall be implemented in accordance with the provisions of Articles 12 and 13 of Decree No. 58/2003/ND-CP.

Article 7. Production and registration for circulation of veterinary drugs containing narcotic substances and precursors

2. The procedures and formalities for registering the circulation of veterinary drugs containing narcotic substances and precursors shall be carried out in accordance with the provisions of Articles 3 and 8 of Circular No. 13/2016/TT-BNNPTNT.

3. The production facility must store the production records of veterinary drugs, raw materials for veterinary drugs containing narcotic substances and precursors in paper or electronic form, including:

a) A record book tracking the preparation and production of veterinary drugs containing narcotic substances and precursors according to the model attached as Appendix V to this Circular;

b) Documents specified in points a and b of Clause 7, Article 4 of this Circular;

c) Receipts and documents related to the purchase and sale of veterinary drugs containing narcotic substances and precursors; raw materials for veterinary drugs containing narcotic substances and precursors.

Article 8. Trading in veterinary drugs containing narcotic substances and precursors permitted to circulate in Vietnam

1. The trading facility for veterinary drugs containing narcotic substances and precursors must have a Certificate of Eligibility for Trading in Veterinary Drugs as prescribed by the laws on veterinary medicine.

2. The trading facility may only sell veterinary drugs containing narcotic substances and precursors to users who have prescriptions as stipulated in this Circular and other trading facilities for veterinary drugs that have been issued a Certificate of Eligibility for Trading in Veterinary Drugs by the provincial specialized management agency for veterinary medicine.

3. The trading facility must store the trading records of veterinary drugs containing narcotic substances and precursors in paper or electronic form, including:

a) Documents specified in points a and b of Clause 7, Article 4 of this Circular;

b) Contracts, invoices, and receipts related to the purchase and sale of veterinary drugs containing narcotic substances and precursors;

c) Prescriptions for veterinary drugs containing narcotic substances and precursors kept at the facility after sale; a receipt for receiving veterinary drugs containing narcotic substances and precursors according to the model provided in Appendix VI attached to this Circular.

1. Persons holding a veterinary practice certificate for diagnosing, treating, operating on, and testing animal diseases are permitted to use veterinary drugs containing narcotic substances or precursors for treatment according to prescriptions; in cases where unused or partially used drugs are returned within ten days to the selling entity.

2. The selling entity receiving and recording the return of veterinary drugs containing narcotic substances or precursors due to non-use or partial use from users as specified in Clause 1 of this Article shall follow the model prescribed in Appendix VI attached to this Circular. The record is made in two copies (one copy retained by the selling entity, one copy handed over to the person returning the drug).

Article 10. Storage of veterinary drugs and raw materials for veterinary drugs containing narcotic substances and precursors

1. Importing and production facilities must store veterinary drugs and raw materials for veterinary drugs containing narcotic substances and precursors in separate warehouses or cabinets, marked with clear labels, securely locked, and not mixed with other drugs, raw materials for drugs, animal feed, fish feed, raw materials for producing animal feed, fish feed, and other products.

2. Trading facilities for veterinary drugs must separately store and keep veterinary drugs containing narcotic substances and precursors in locked cabinets with clear labels.

3. For individuals and facilities using veterinary drugs: Veterinary drugs containing narcotic substances and precursors must be stored separately and not lost during use.

1. The delivery and receipt of veterinary drugs and raw materials for veterinary drugs containing narcotic substances or precursors shall be carried out in accordance with the provisions of Clauses 2 and 3, Article 6 of Decree No. 80/2001/ND-CP dated November 5, 2001, guiding the legal control activities related to narcotics within the country (hereinafter referred to as Decree No. 80/2001/ND-CP).

2. The transportation of veterinary drugs and raw materials for veterinary drugs containing narcotic substances or precursors shall be carried out in accordance with the provisions of Clause 1, Article 8 of Decree No. 80/2001/ND-CP.

Article 12. Retention period for records of veterinary drugs and raw materials for veterinary drugs containing narcotic substances and precursors

1. Importing, exporting, producing, trading, and using facilities for veterinary drugs and raw materials for veterinary drugs containing narcotic substances and precursors must retain relevant records in paper or electronic form for at least two years from the date the drugs or raw materials expire; prescriptions for veterinary drugs containing narcotic substances and precursors must be retained in accordance with Article 22 of this Circular.

2. Upon expiration of the retention period for records, the head of the importing, exporting, producing, and trading facilities for veterinary drugs as stipulated in Clause 1 of this Article shall establish a committee to destroy the records, prepare a destruction record, and retain it at the facility.

Chapter III
APPLICATION FORM AND PRESCRIPTION FOR VETERINARY DRUGS

Article 13. Principles for Prescribing Veterinary Medicines

1. All types of veterinary medicines must be prescribed when used, except for those types of veterinary medicines specified in Article 14 of this Circular.

2. The prescription of veterinary medicines must be based on the results of medical examination or diagnosis or disease testing, except in cases stipulated in Clause 1, Article 19 of this Circular; ensuring rationality, safety, effectiveness, and suitability with the degree of illness.

3. The prescriber may only prescribe veterinary medicines that are permitted to circulate and be used in Vietnam.

Article 14. Types of Veterinary Medicines Not Requiring Prescription Types of veterinary medicines not requiring prescription include:

1. Veterinary medicines containing active ingredients belonging to the group of anticoccidial drugs including: Decoquinate, Diclazuril, Halofuginone hydrobromide, Lasalocid A sodium, Maduramicin ammonium alpha, Monensin sodium, Narasin, Nicarbazin, Robenidine hydrochloride, Salinomycin sodium, Semduramicin sodium.

3. Vaccines and antibodies used in veterinary purposes.

4. Hormones used in aquaculture.

5. Veterinary medicines used for the purpose of enhancing resistance and supporting treatment of diseases.

6. Herbal medicines used in veterinary purposes.

1. The list of active ingredients of veterinary medicines belonging to the category of critically important antibiotics as set out in Appendix VIII attached to this Circular. 2. The list of active ingredients of veterinary medicines belonging to the category of highly important antibiotics as set out in Appendix IX attached to this Circular.

3. The list of active ingredients of veterinary medicines belonging to the category of important antibiotics as set out in Appendix X attached to this Circular.

4. The period of use of veterinary medicines containing antibiotics specified in Clauses 1, 2, and 3 of this Article for disease prevention in young animals shall be implemented according to the provisions of Clause 3, Article 12 of Decree No. 13/2020/NĐ-CP.

Article 16. Types of Medicines Directly Used by Individuals with Professional Certificates for Diagnosis, Examination, Treatment, Surgery, and Disease Testing of Animals

1. Injectable medicines for pain relief, except anti-inflammatory medicines without steroid components.

2. Inhalation or injection medicines for anesthesia.

3. Pain-relieving medicines (opioids, opiates), anticonvulsants, sedatives, hypnotics (barbiturates), tranquilizers (benzodiazepines), and psychotropic medicines.

4. Injectable medicines containing selenium.

5. Medicines affecting the sympathetic and parasympathetic nervous systems.

6. Stimulants and hormones for injection, including adrenal hormones; Adrenal cortex steroids; Sex hormones containing anabolic steroids.

7. Intravenous veterinary medicines.

Article 17. Individuals Authorized to Prescribe Veterinary Medicines

The following individuals are authorized to prescribe veterinary medicines:

1. Individuals holding a professional certificate for diagnosis, examination, treatment, surgery, and disease testing of animals.

2. Veterinarians or individuals with a university degree in veterinary science or animal husbandry-veterinary science and a professional certificate for diagnosis, examination, treatment, surgery, and disease testing of animals when prescribing veterinary medicines containing narcotic substances or precursors.

1. Hold a practice certificate for animal diagnosis, disease examination, treatment, surgery, and laboratory testing.

2. Be a veterinarian or have a university degree in veterinary science or livestock-veterinary science and hold a practice certificate for animal diagnosis, disease examination, treatment, surgery, and laboratory testing when issuing a veterinary prescription containing narcotic substances or precursors.

Article 18. Content of veterinary prescriptions

1. Record all contents of the prescription according to the model attached as Appendix VII of this Circular clearly and accurately.

2. Prescription for veterinary drugs as follows:

a) Veterinary drug with one active ingredient

Record according to the international nonproprietary name (INN, generic). For example, for a drug with the active ingredient Amoxicillin at a concentration of 500mg, record the name as follows: Amoxicillin 500mg. Record according to the international nonproprietary name and trade name. For example, for a drug with the active ingredient Amoxicillin at a concentration of 500mg, the trade name is A, record the name as follows: Amoxicillin (A) 500mg.

Veterinary drug with multiple active ingredients: record according to the trade name and the names of the main active ingredients.

b) 3. Record the name of the drug, the concentration or amount of the active ingredient, the quantity or volume of the drug, dosage, route of administration, time of administration if necessary, and the cessation period for each type of drug.

4. Write the number 0 (zero) before the quantity of the drug if it consists of only one digit (less than 10).

5. Any corrections to the veterinary prescription must be signed by the prescriber next to the corrected content.

6. Cross out any blank space on the paper from below the prescription content to the signature area of the prescriber in a direction from top to bottom and left to right; sign and write (or stamp) the prescriber's full name.

7. Contraindications and warnings when using veterinary drugs.

8. The veterinary prescription has a single-use value and must have a recognizable mark immediately after use.

Article 19. Prescription of veterinary drugs in animal feed production

1. Prescription of veterinary drugs containing antibiotics for disease prevention in animals

a) The prescription of veterinary drugs containing antibiotics for disease prevention in animals shall only apply to young animals. Determination of young animals is regulated in Clause 1, Article 12 of Decree No. 13/2020/NĐ-CP.

b) The prescription shall be carried out according to the provisions of Clause 3, Article 13, Article 17, and Article 18 of this Circular and ensure rationality, safety, and effectiveness. The prescription follows Model 2 attached as Appendix VII of this Circular.

2. Prescription of veterinary drugs for treatment and prophylactic treatment of animals shall be carried out according to the provisions of Article 13, Article 17, and Article 18 of this Circular. The prescription follows Model 1 attached as Appendix VII of this Circular.

Article 20. Prescription of veterinary drugs containing narcotic substances and precursors

2. The prescription of veterinary drugs shall not exceed a seven-day supply or as directed by the manufacturer and in accordance with the provisions of Article 13, Article 17, and Article 18 of this Circular.

3. Animal health examination, treatment, surgery, and laboratory testing facilities must establish and send a list of sample signatures of those who issue veterinary prescriptions containing narcotic substances and precursors to the provincial specialized animal husbandry management agency in their locality.

3. Veterinary examination, treatment, surgery facilities, and laboratories must establish and submit a list of specimen signatures of individuals issuing veterinary prescriptions containing narcotic substances or precursors from their facility to the provincial specialized veterinary management agency at their location.

Article 21. Prescription of veterinary drugs using information technology

1. Veterinary prescriptions shall be made on computers, electronic devices, and stored in software at animal health examination, treatment, surgery, and disease testing facilities. For prescriptions containing narcotic substances or precursors, a copy must be printed for the animal owner to keep one copy and another copy retained at the facility issuing or selling the prescription.

2. Facilities and individuals engaged in animal health examinations, treatments, surgeries, and disease tests must ensure the storage of veterinary prescriptions for management purposes and data extraction when necessary.

Article 22. Storage of veterinary prescriptions

1. Organizations and individuals practicing animal health examinations, treatments, surgeries, and disease tests, livestock feed production facilities, veterinary drug trading facilities, breeding farms, and aquaculture facilities must store prescriptions for two years from the date of issuance.

2. The storage of prescriptions shall be carried out in one of the following forms:

a) Storing original or copied prescriptions;

b) Storing prescriptions in software that ensures accessibility. Information includes: name and address of the animal health examination and treatment facility (if applicable); name of the prescriber; name and address of the livestock feed production facility using the prescription; name and address of the animal owner, species of animal; name of the drug, dosage, quantity, dose, route of administration.

Chapter IV
IMPLEMENTATION

Article 23. Responsibilities of specialized management agencies

1. Responsibilities of the Animal Health Department

a) Organizing the implementation, guidance, supervision, evaluation, inspection, and audit of this Circular;

b) Organizing information dissemination and propaganda regarding the import, export, transit, production, trade, use, receipt, transportation, and storage of veterinary drugs containing narcotic substances or precursors; veterinary prescriptions and rational, effective use of veterinary drugs;

c) Organizing inspections of the prescription of veterinary drugs containing antibiotics in livestock feed;

d) Guiding the training of new and supplementary content on veterinary prescriptions and prescription writing for those holding veterinary practice certificates;

đ) Submitting proposals to the Ministry of Agriculture and Rural Development for amendments and supplements to the list of active ingredients of veterinary drugs belonging to the special, very important, and important antibiotic groups specified in Appendices VIII, IX, X issued together with this Circular.

2. Responsibilities of the Livestock Production Department

a) Organizing the implementation, guidance, supervision, inspection, and audit of livestock feed production facilities containing veterinary drugs;

b) Organizing training, information dissemination, and propaganda on veterinary prescriptions and rational, effective use of livestock feed containing veterinary drugs.

3. Responsibilities of the Fisheries General Department

a) Organizing information dissemination and propaganda on the use of veterinary drugs for aquaculture facilities;

b) Cooperating with the Animal Health Department to organize inspections and audits of the use of veterinary drugs at aquaculture facilities.

4. Responsibilities of the Departments of Agriculture and Rural Development of provinces and centrally-administered cities directing functional units:

a) Organizing the implementation, guidance, supervision, and inspection of this Circular within their jurisdiction;

b) Managing lists and samples of signatures of those prescribing veterinary drugs containing narcotic substances or precursors;

c) Organizing training, information dissemination, and propaganda on the management of veterinary drugs containing narcotic substances or precursors in trade, use, receipt, transportation, and storage; veterinary prescriptions within their jurisdiction;

d) Inspecting and auditing the trade, use, storage, receipt, and transportation of veterinary drugs containing narcotic substances or precursors as stipulated in this Circular within their jurisdiction;

e) Organizing training on specialized content about veterinary prescriptions and prescription writing for those holding veterinary practice certificates;

g) Developing a roadmap for managing databases of veterinary prescriptions within their jurisdiction.

Article 24. Responsibilities of organizations and individuals related to the matter

1. Responsibilities of establishments producing and importing veterinary drugs containing narcotic substances and precursors:

a) Shall only sell veterinary drugs containing narcotic substances and precursors to establishments selling veterinary drugs that have obtained a certificate of eligibility for selling veterinary drugs as prescribed, and to establishments permitted to practice animal examination, diagnosis, surgery, and animal disease testing;

b) Shall keep records in accordance with this Circular; report periodically on the 25th day of the last month of each quarter and on December 20th of each year, or upon urgent request, the results of production and importation of veterinary drugs containing narcotic substances and precursors to the Department of Animal Health and the Regional Animal Health Service under their jurisdiction according to the form set out in Appendix II issued together with this Circular.

2. Responsibilities of establishments selling veterinary drugs:

a) Shall only resell veterinary drugs to other establishments selling veterinary drugs that have been granted a certificate of eligibility for selling veterinary drugs, and sell to users when there is a prescription as prescribed by this Circular;

b) Shall accept returns of unused veterinary drugs containing narcotic substances and precursors from the owner of the animal or the representative of the owner of the animal in accordance with Clause 2, Article 9 of this Circular;

c) Shall keep prescriptions in accordance with Article 22 of this Circular;

d) Shall keep records in accordance with this Circular; report periodically on the 20th of each month, or upon urgent request, to the provincial specialized animal health management agency regarding the quantity, purpose of use, address of the purchasing establishment, and the quantity of recovered veterinary drugs containing narcotic substances and precursors according to the form set out in Appendix II issued together with this Circular.

3. Responsibilities of establishments examining, treating, operating on animals, and testing animal diseases:

a) Shall only issue and sell veterinary drugs when there is a prescription as prescribed by this Circular;

b) Shall accept returns of veterinary drugs containing narcotic substances and precursors from the owner of the animal or the representative of the owner of the animal;

c) Shall keep veterinary drug prescriptions in accordance with Article 22 of this Circular;

4. Responsibilities of prescribers of veterinary drug prescriptions:

a) Shall decide and be responsible for the dosage, method of use, and duration of use for the types of veterinary drugs listed in the prescription;

b) Shall guide the use of drugs for the owner of the animal or the representative of the owner of the animal;

c) Shall participate in training courses organized by educational institutions or authorized animal health agencies on the content of veterinary prescriptions and prescription writing.

5. Responsibilities of establishments producing animal feed containing veterinary drugs:

a) Shall only mix veterinary drugs requiring prescriptions into animal feed when there is a prescription from a prescriber as prescribed by this Circular;

b) Shall keep veterinary drug prescriptions in accordance with Article 22 of this Circular.

6. Responsibilities of users of veterinary drugs:

a) Shall use veterinary drugs strictly in accordance with the prescription; return unused or partially used veterinary drugs containing narcotic substances and precursors in accordance with this Circular;

b) Shall record the use of veterinary drugs containing narcotic substances and precursors, antibiotics for animals at the facility;

c) Shall promptly notify the prescriber of the veterinary drug and the nearest specialized animal health management agency if the animal shows abnormal signs after using the drug;

d) Shall keep veterinary drug prescriptions in accordance with Article 22 of this Circular.

7. Organizations and individuals providing technical advice and guidance in animal health work, livestock breeding, aquaculture, processing, preservation of animals and animal products shall be responsible for implementing the use of veterinary drugs in accordance with this Circular.

8. Educational institutions teaching livestock breeding, animal health, aquaculture, and aquatic animal pathology shall be responsible for training students and trainees on regulations related to prescription writing and veterinary prescriptions.

Article 25. Implementation timeline for veterinary drug prescriptions

1. Veterinary drug prescriptions containing narcotic substances and precursors shall be implemented from the date this Circular takes effect.

2. Veterinary drug prescriptions not containing narcotic substances and precursors for treating diseases and preventive treatment of terrestrial animals shall be implemented as follows:

a) Large-scale farm livestock operations shall implement from the date this Circular takes effect;

b) Medium-scale farm livestock operations shall implement from January 1, 2022;

c) Small-scale farm livestock operations shall implement from January 1, 2023;

d) Household livestock operations shall implement from January 1, 2025.

The determination of large-scale, medium-scale, small-scale farms, and household livestock operations shall be in accordance with Article 21 of Decree No. 13/2020/NĐ-CP.

3. Veterinary drug prescriptions not containing narcotic substances and precursors for treating diseases in aquaculture shall be implemented as follows:

a) Intensive breeding facilities for key aquatic species shall implement from the date this Circular takes effect;

b) Intensive breeding facilities for non-key aquatic species and semi-intensive breeding facilities shall implement from January 1, 2023;

c) Other types of aquaculture shall implement from January 1, 2025;

d) In cases where importing countries or consignees require different veterinary drug prescriptions than those stipulated in this Circular, such requirements shall be followed.

4. Veterinary drug prescriptions in animal feed production shall be implemented from the date this Circular takes effect.

5. It is encouraged that livestock and aquaculture facilities implement prescription requirements earlier than those specified in Clause 2 and Clause 3 of this Article.

Article 26. Amending and supplementing certain provisions of Circular No. 18/2018/TT-BNNPTNT

Amend and supplement Clause 21 of Article 1 of Circular No. 18/2018/TT-BNNPTNT as follows:

"5. The announcement of conformity of veterinary drug products shall be carried out in accordance with the law from February 14, 2024."

Article 27. Transitional Provisions

Animal feed containing veterinary drugs that require prescriptions may continue to be produced, imported, and circulated for use until their expiration date as indicated on the packaging before the effective date of this Circular.

Article 28. Implementation Provisions

1. This Circular shall take effect from December 25, 2020.

2. The Department of Animal Health, the Department of Livestock Production, the General Department of Fisheries, provincial Departments of Agriculture and Rural Development under central cities, and related organizations and individuals shall be responsible for implementing this Circular.

3. During implementation, if there are difficulties or need for amendments and supplements, relevant agencies, organizations, and individuals are requested to promptly report to the Ministry of Agriculture and Rural Development (through the Department of Animal Health) for consideration and resolution./.

Appendix I

MODEL APPLICATION FOR EXPORTING AND IMPORTING VETERINARY DRUGS CONTAINING NARCOTIC SUBSTANCES AND PRECURSORS, RAW MATERIALS FOR VETERINARY DRUGS CONTAINING NARCOTIC SUBSTANCES

(Annexed to Circular No. 12/2020/TT-BNNPTNT dated November 9, 2020

of the Minister of Agriculture and Rural Development)

Number:...EX/IM

CONTAINING NARCOTIC SUBSTANCES AND PRECURSORS, RAW MATERIALS

FOR VETERINARY DRUGS CONTAINING NARCOTIC SUBSTANCES

Based on the need for exporting/importing veterinary drugs containing narcotic substances and precursors, raw materials for veterinary drugs containing narcotic substances, for the purpose of:

□ Usage

Composition, concentration

(In words) Means of transport and conditions ensuring safe transportation:...:..........................................................................................................................................................................

Port of export/import:...

Expected import time:...

Company commits to comply with the law.

REPRESENTATIVE OF ORGANIZATION/INDIVIDUAL

Seal Registration Certificate

CONTAINING NARCOTIC SUBSTANCES AND PRECURSORS

Number.../Tel:...Fax:...

of the Minister of Agriculture and Rural Development)

Number:...EX/IM

(Batch No)

Date of sale, use

ANNEX III

CONTAINING NARCOTIC SUBSTANCES AND PRECURSORS

RECORD OF EXPORT, IMPORT, INVENTORY OF VETERINARY DRUGS, RAW MATERIALS FOR VETERINARY DRUGS CONTAINING NARCOTIC SUBSTANCES AND PRECURSORS
of the Minister of Agriculture and Rural Development)

Number:...EX/IM

Name of entity:...

Address:…

Telephone: ...

(Start using from...to...)

RECORD OF EXPORT, IMPORT, INVENTORY OF VETERINARY DRUGS, RAW MATERIALS

CONTAINING NARCOTIC SUBSTANCES AND PRECURSORS

Name of raw material/Name of drug, concentration/concentration:...

Place of export/import

Unit of measurement:...

* Each drug must have its own separate pages, the number of pages varying according to the quantity of drugs exported/imported.

MODEL WAREHOUSE EXPORT DOCUMENT FOR VETERINARY DRUGS, RAW MATERIALS

REGULATIONS ON THE CERTIFICATE DESIGN FOR OUTSTANDING RURAL INDUSTRIAL PRODUCTS

WAREHOUSE EXPORT DOCUMENT FOR VETERINARY DRUGS, RAW MATERIALS

Number.../Tel:...Fax:...
of the Minister of Agriculture and Rural Development)

Number:...EX/IM

Name of entity:...

Address:…

Exported to facility*:

Number.../Tel:...Fax:...

Name of drug, concentration/concentration

Fax:

1. Internal facility export.

2. Export to another facility:

- Clearly state the name of the recipient, ID number/Identity card/Passport/Personal identification number/Equivalent documents

- The facility may use financial invoices instead of this form but must include all information required in this form or attach a batch report.

** Legal representative or authorized person in charge or deputy authorized by the legal representative

MODEL RECORD OF PRODUCTION AND COMPOUNDING OF VETERINARY DRUGS CONTAINING

Appendix V

NARCOTIC SUBSTANCES AND PRECURSORS

RECORD OF PRODUCTION AND COMPOUNDING OF VETERINARY DRUGS CONTAINING
of the Minister of Agriculture and Rural Development)

Number:...EX/IM

Name of entity:...

(Start using from...to...)

RECORD OF PRODUCTION AND COMPOUNDING OF VETERINARY DRUGS CONTAINING
RECORD OF PRODUCTION AND COMPOUNDING OF VETERINARY DRUGS CONTAINING

Name of drug - concentration, concentration

RECORD OF PRODUCTION AND COMPOUNDING OF VETERINARY DRUGS CONTAINING

The book is numbered from page 01 to the end, and stamped with a cross-stamp between pages.

Appendix VI

MODEL OF THE RECORD FOR RECEIVING ANIMAL MEDICINES CONTAINING DRUG SUBSTANCES AT ANIMAL MEDICINE SELLING ESTABLISHMENTS
of the Minister of Agriculture and Rural Development)

Number:...EX/IM

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
---------------

RECORD FOR RECEIVING ANIMAL MEDICINES CONTAINING DRUG SUBSTANCES

1. Name of the person delivering:

- Address:

- ID number/Identity card number/Passport number/Personal identification number/Equivalent documents:

Issuing authority: Date of issue:

2. Name of the selling establishment:

- Owner of the selling establishment:

- Address:

3. List of items received:

4. Delivery time: The above items were delivered and received at...hours...minutes on...day...month...year...

5. Delivery location (Detail the actual delivery address):

This record is agreed upon and established in two copies, each party keeps one copy/

Appendix VII

FORM 1

PRESCRIPTION FOR ANIMAL MEDICINES APPLICABLE TO ANIMAL MEDICINE PRESCRIPTIONS

FOR TREATMENT AND PREVENTIVE TREATMENT OF ANIMALS

of the Minister of Agriculture and Rural Development)

Number:...EX/IM

FORM 2

PRESCRIPTION FOR ANIMAL MEDICINES APPLICABLE TO ANIMAL MEDICINE PRESCRIPTIONS

AT FEED PRODUCTION FACILITIES FOR ANIMAL HEALTH PROTECTION

of the Minister of Agriculture and Rural Development)

Number:...EX/IM

Appendix VIII

LIST OF ACTIVE SUBSTANCES OF ANIMAL MEDICINES

BELONGING TO THE CRITICAL ANTIBIOTICS GROUP

of the Minister of Agriculture and Rural Development)

Number:...EX/IM

Appendix IX

LIST OF ACTIVE SUBSTANCES OF ANIMAL MEDICINES BELONGING TO THE

VERY IMPORTANT ANTIBIOTICS GROUP

of the Minister of Agriculture and Rural Development)

Number:...EX/IM

ANNEX X

LIST OF ACTIVE SUBSTANCES OF ANIMAL MEDICINES

BELONGING TO THE IMPORTANT ANTIBIOTICS GROUP

(Annexed to Circular No. 12/2020/TT-BNNPTNT dated November 9, 2020

Number:...EX/IM