Circular No. 03/2009/TT-BNN on labeling of veterinary drugs

CIRCULAR

Regulations on labeling veterinary drugs

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Based on the Animal Health Ordinance dated April 29, 2004 and Decree No. 33/2005/NĐ-CP dated March 15, 2005 of the Government detailing implementation of certain provisions of the Animal Health Ordinance;

Based on Decree No. 01/2008/NĐ-CP dated January 3, 2008 of the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development;

Based on Decree No. 89/2006/NĐ-CP dated August 30, 2006 of the Government stipulating contents, methods of labeling, and state management of labels for goods circulating in Vietnam, exported and imported goods (hereinafter referred to as Decree No. 89/2006/NĐ-CP);

Based on Circular No. 09/2007/TT-BKHCN dated April 6, 2007 of the Ministry of Science and Technology guiding implementation of certain provisions of Decree No. 89/2006/NĐ-CP dated August 30, 2006 of the Government on product labeling;

The Ministry of Agriculture and Rural Development stipulates the labeling of veterinary drugs, raw materials for veterinary drugs, biological preparations, microorganisms, chemicals used in veterinary medicine, including aquatic veterinary drugs (hereinafter referred to as veterinary drugs) as follows:

I. GENERAL PROVISIONS

Thông tư này quy định chi tiết khoản 4 Điều 38 Luật Thủy sản số 18/2017/QH14 đã được sửa đổi, bổ sung tại điểm c khoản 21 Điều 14 Luật số 146/2025/QH15.

a) This circular stipulates the contents and methods of labeling for exported, imported, and domestically circulated veterinary drugs.

b) The following cases are not within the scope of this circular:

- Veterinary drugs temporarily imported for re-export or temporarily imported for participation in exhibitions and then re-exported; goods in transit, goods transferred at border gates, non-commercially imported veterinary drugs, donated veterinary drugs, veterinary drugs currently under research at research and production facilities;

- Imported veterinary drugs for testing or trial purposes;

- Imported veterinary drugs for emergency disease control or other special cases;

- Veterinary drugs given as gifts or presented as personal luggage when entering or leaving the country.

Thông tư này áp dụng đối với tổ chức, cá nhân có liên quan đến hoạt động kinh doanh đối tượng thủy sản nuôi chủ lực trên lãnh thổ Việt Nam.

Domestic and foreign organizations and individuals engaged in manufacturing, manufacturing under license, processing, dividing, repackaging (hereinafter referred to as manufacturing), trading, importing, and exporting veterinary drugs must comply with these regulations, intellectual property laws, and relevant legal documents.

In this technical regulation, the following terms are understood as follows:

In this regulation, the following terms are understood as follows:

a) Veterinary drug is a substance or compound derived from animals, plants, microorganisms, minerals, chemicals used to prevent, diagnose, treat diseases, or to restore, adjust, improve animal body functions, including pharmaceutical products, chemicals, vaccines, hormones, some biological preparations, and some microorganisms used in veterinary medicine.

b) Brand name is a trade name established by the drug manufacturer, different from the generic name or international common name.

c) Drug label is a written, printed, or drawn text, picture, image, or symbol embossed or raised directly on the commercial packaging of the drug or firmly attached to the commercial packaging of the drug to provide essential and main information about the drug to assist users in selecting and using it correctly and serve as a basis for competent authorities to conduct inspections, supervision, and management.

d) Labeling of drugs is the act of displaying basic and necessary information about the drug on the drug label so that consumers can recognize, select, consume, and use it properly; to promote the product by manufacturers and traders; and to enable competent authorities to carry out inspection and control.

đ) Original label of the drug is the label first printed or firmly attached to the commercial packaging of the drug after completing the final packaging process in the production line.

e) Supplementary label is a label showing mandatory information translated from the original label into Vietnamese and supplementing mandatory information in Vietnamese according to the law that is missing from the original label of the drug.

f) Commercial packaging of the drug is packaging containing the drug, circulating together with the drug, and includes two types:

- Direct packaging is packaging that comes into direct contact with the drug;

- Outer packaging is packaging used to package one or more units of the drug with direct packaging.

g) Name and address of the organization or individual responsible for the drug is the name and address of the organization or individual producing, exporting-importing, or entrusting export-import of the drug.

h) Packaging specification of the drug is the quantity of the drug expressed by net weight, actual volume, or counted number.

i) Production batch number is a code consisting of numbers, letters, or a combination of both to identify a batch of drugs and allow tracing the entire history of that batch, including all stages of the production process, quality control, and distribution.

k) Date of manufacture is the time point marking the completion of the production, processing, bottling, packaging, or other final steps of a batch of drugs.

m) Expiry date of the drug is the time limit set for a batch of drugs beyond which the drug may not be used.

n) Country of origin of the drug is the country or territory where the entire drug was produced or where the final basic processing stage was carried out in the case of multiple countries or territories involved in the production process.

o) "Instructions for use and storage of drugs" is information related to usage methods, necessary conditions for use and storage, warnings of hazards, procedures for handling hazardous incidents, and guidance for users to effectively, safely, and reasonably use the drug.

The "Instructions for use and storage of drugs" leaflet is a document accompanying the commercial packaging of the drug, recording usage instructions and other required information.

4. Types of veterinary drugs that must be labeled

a) Drugs circulating domestically; exported and imported drugs must be labeled according to the provisions of this circular, except for the cases specified in point b of this clause.

b) In cases where foreign organizations or individuals importing Vietnamese drugs request labeling according to the sales contract and bear responsibility for their requirements, the exporting organizations or individuals may implement according to the contract provided that these requirements do not alter the nature of the drug, do not violate Vietnamese law, and the law of the importing country.

5. Position of veterinary drug labels

The label of veterinary drugs must be displayed (printed, affixed, attached, or mounted) on the commercial packaging of the drug at a position that can be easily observed and clearly identified without having to disassemble any parts of the drug, in accordance with Clause 1 of Article 6 of Decree 89/2006/NĐ-CP.

6. Size of the veterinary drug label

Organizations and individuals responsible for labeling the drug shall determine the size of the label but must ensure that all mandatory contents as prescribed in Part II of this Circular are fully recorded.

7. Color of characters, symbols, and images on the veterinary drug label

The color of letters, numbers, drawings, images, signs, and markings on the label must be clear. For mandatory contents as prescribed, letters and numbers must have contrasting colors compared to the background of the label, according to Article 8 of Decree 89/2006/NĐ-CP.

8. Language presented on the veterinary drug label

a) Mandatory contents to be shown on the veterinary drug label must be recorded in Vietnamese, except in cases provided for in point d of this clause.

b) Veterinary drugs produced and circulated domestically, in addition to complying with the provisions of point a of this clause, may also be recorded simultaneously in another language. The size of the text in another language must not exceed the size of the text in Vietnamese.

c) Imported veterinary drugs into Vietnam where the original label does not show or inadequately shows the mandatory contents in Vietnamese must have an additional label showing the mandatory contents in Vietnamese while retaining the original label of the drug.

d) The following contents may be recorded in other languages based on Latin alphabets:

- Trade name, generic name, or international nonproprietary name of the drug;

- International nonproprietary name or scientific name of the components, quantified components of the drug when they cannot be translated into Vietnamese or can be translated but do not make sense in Vietnamese;

- Name and address of foreign enterprises producing or holding production rights for the drug.

đ) Contents recorded on the veterinary drug label, including additional labels and usage instructions, must ensure truthfulness, clarity, accuracy, and reflect the true nature of the drug.

9. Responsibility for labeling veterinary drugs

a) For veterinary drugs produced in Vietnam for domestic circulation, the organization or individual producing the drug must be responsible for the labeling.

b) For veterinary drugs produced in Vietnam for export, the organization or individual producing or exporting the drug must be responsible for the labeling.

c) In the case where exported veterinary drugs cannot be sold abroad and are returned for domestic circulation, the organization or individual bringing the drug into circulation must label it in accordance with Clause 8, Part I of this Circular.

when circulating within the country, organizations and individuals bringing drugs into circulation must label them in accordance with the provisions of Clause 8, Part I of this Circular.

d) In the case where the organization or individual responsible for labeling the drug according to Article 10 of Decree 89/2006/NĐ-CP requests another organization or individual to perform the labeling, they still bear responsibility for the label of their drug.

đ) For imported veterinary drugs where the original label does not comply with the provisions of this Circular, the importing organization or individual must record an additional label in accordance with point c of Clause 8, Part I of this Circular before circulating the drug and must retain the original label.

e) Organizations and individuals producing and trading in drugs must comply with intellectual property laws and bear legal responsibility for intellectual property issues related to the contents recorded on the drug label.

II. CONTENTS AND METHODS OF LABELING VETERINARY DRUGS

Section A

CONTENTS TO BE RECORDED ON THE VETERINARY DRUG LABEL

1. Mandatory contents to be recorded on the veterinary drug label

The veterinary drug label must include the following contents:

a) Drug name;

b) Active ingredient, quantified active ingredient (concentration or dosage);

c) Packaging specifications;

d) Indications, usage, contraindications; Time to stop using the drug (if applicable) for harvesting eggs, meat, milk from the designated animal species;

designated;

đ) Formulation, registration number, batch number, date of manufacture, expiration date, phrase "For veterinary use only";

e) Warning signs

- For highly toxic veterinary drugs in List A, the phrase (in black font): "Do not exceed the prescribed dose" must be added.

- For moderately toxic veterinary drugs in List B, the phrase (in red font): "Do not exceed the prescribed dose" must be added.

f) Name and address of the organization or individual responsible for the drug;

g) Origin of the drug;

(For drugs produced in Vietnam for domestic circulation, if the address of the place of production is already recorded, it is not mandatory to record the origin).

h) Usage instructions, storage instructions.

If it is not possible to display all the above contents, the label must include the contents specified in points a, b, c, đ, e, f, and g of this clause. Other mandatory contents must be recorded in an additional label or in the drug usage instructions, and the label must indicate where these contents are recorded.

2. Additional contents recorded on the veterinary drug label

In addition to the mandatory contents prescribed in Clause 1, Section A, Part II of this Circular, other contents may be recorded on the label, such as quality standard code. These contents must ensure truthfulness, accuracy, and not mislead about the nature or efficacy of the drug, nor mislead about other label contents.

3. Contents recorded on the label of raw materials for veterinary drugs

The label of raw materials for veterinary drugs must include the following contents:

a) Raw material name;

b) Concentration or dosage (if applicable);

c) Raw material standards;

đ) Net weight or volume;

e) Batch number, date of manufacture;

f) Expiration date, storage conditions;

g) Registration number (if applicable);

h) Name and address of the manufacturing facility;

i) Origin of the raw material;

(For raw materials produced in Vietnam for domestic circulation, if the address of the place of production is already recorded, it is not mandatory to record the origin).

j) Name and address of the importing facility (for imported raw materials);

k) Warning signs.

4. Contents recorded on the label of veterinary drug blister packs

The label on the veterinary drug blister pack must minimally include the following contents:

a) Drug name;

b) Active ingredient, concentration: for combined veterinary drugs containing three or fewer active ingredients, the active ingredients and concentrations of each must be fully recorded.

c) Production batch number, expiry date, registration number for circulation;

d) Name of the production facility. The name of the production facility may be abbreviated but must ensure that the name of the production facility can be recognized.

Blister packs of drugs must be contained within outer packaging bearing a label displaying all the contents prescribed in Clause 1, Section A, Part II of this Circular.

5. Content of labels on direct packaging with small size

a) For veterinary drug labels on direct packaging with small size and special design that cannot display all mandatory contents as prescribed in Clause 1, Section A, Part II of this Circular, the following minimum contents must be included:

- Veterinary drug name;

- Active ingredient(s), concentration: if the veterinary drug contains three or fewer active ingredients, all active ingredients and their concentrations must be listed;

- Volume or weight;

- Production batch number, expiry date, registration number for circulation;

- Name of the production facility which may be abbreviated but must ensure recognizability.

b) Direct packaging containing various types of veterinary drugs must be contained within outer packaging bearing a label displaying all the contents prescribed in Clause 1, Section A, Part II of this Circular.

Section B

LABELING OF VETERINARY DRUGS

1. Veterinary drug name

a) The veterinary drug name is set by organizations or individuals producing and trading veterinary drugs. The name of the drug shall not mislead about its nature and efficacy.

The drug name on the label must be bold and prominent.

In cases where the brand name is a single substance, the generic name or international nonproprietary name (INN) must be immediately stated after the brand name.

b) The drug name may be based on:

- Generic name;

- International nonproprietary name (INN);

- Brand name.

2. Active ingredients, concentration or strength

a) List all active ingredients and excipients used to produce and present in the finished product, including cases where the form of raw materials has been changed during production as stipulated in Clause 1, Article 18 of Decree 89/2006/NĐ-CP.

b) List all active ingredients and their concentrations or strengths for the smallest unit of dosage or smallest unit of packaging. The name of the active ingredient should be listed according to the generic name or INN.

c) If the name of a component is listed on the veterinary drug label to attract attention to the product, the quantity of that component must be specified.

d) In addition to the above contents, for aquatic veterinary drugs, the formula or composition must also be listed.

đ) Units of measurement

Indicate units of measurement on the veterinary drug label using either full names or symbols of units of measurement. For example: "grams" or "g"; "milliliters" or "ml".

- Weight units: kilograms (kg), grams (g), milligrams (mg). Below 1 kg, use the unit "g" (for example: write 500g instead of 0.5 kg); Below 1g, use the unit "mg" (for example: write 500mg instead of 0.5g).

- Volume units: liters (l), milliliters (ml). Below one liter, use the unit "ml" (for example: write 500ml instead of 0.5 liters).

- International activity units may be used for certain specific active ingredients.

3. Packaging specifications

a) Packaging specifications of drugs refer to the quantity, net weight, actual volume of drugs contained in commercial packaging.

b) Drug packaging specifications must be indicated in natural counting units.

c) Specific labeling methods for some types and forms of veterinary drugs are as follows:

- Veterinary drug tablets: Indicate the number of tablets and the concentration of active ingredient per tablet;

- Veterinary drug powders: Indicate the net weight;

- Veterinary drug liquids: Indicate the actual volume;

- Fish breeding stimulants and other substances: Indicate the International Unit (IU or UI).

d) When there are multiple units of packaging in one commercial package of drugs, the quantity of each unit of packaging and the total number of units must be indicated.

4. Indications, usage, contraindications, and withdrawal period (if applicable)

a) Treatment indications for each animal species listed on the label must correspond to the drug's efficacy.

b) Usage must clearly indicate the route of administration, dose, and duration of treatment.

c) If the drug has contraindications, they must be clearly stated.

d) Indications, usage, and contraindications may be indicated in one of the following ways:

- Directly on the commercial packaging of the drug;

- In cases where the label on the outer packaging does not have enough space to list the content of indications, usage, and contraindications, the label must include the phrase "Indications, usage, contraindications: please read in the instructions for use" and must include an instruction leaflet attached to the commercial packaging of the drug.

đ) Withdrawal period (if applicable) of the drug: Clearly state the withdrawal period for each animal species designated for use.

The withdrawal period of the drug must correspond to the time recorded in the Registration Circulation File.

5. Formulation, registration number for circulation, production batch number, production date, expiry date, storage conditions

a) The formulation of veterinary drugs is listed as: tablets, powder, injectable solution, injectable suspension, powder for injection, oral solution...

b) The registration number for circulation is a code issued by the Department of Animal Health to certify that a veterinary drug product has been registered for circulation in Vietnam. It is marked as SĐK: XX-XXXX-XX

c) Production batch number, listed as follows:

- Production batch number: XXXX; or Production batch number: SX: XXXX. The structure of the production batch number is determined by the production facility.

d) The way to write day, month, year for production date, expiry date, and specific storage period is as follows:

- The production date and expiry date on the label can be fully written or abbreviated in uppercase letters as: NSX, HSD, in the order of day, month, year of the Gregorian calendar. Each digit for day, month, and year is written in two digits, and the year can be written in four digits. All digits for a particular date must be written on the same line.

- The method of writing day, month, year for production date and expiry date is stipulated in Article 16 of Decree 89/2006/NĐ-CP as follows:

Example: If the production date is February 4, 2006, and the expiry date is October 2, 2008, then the label must display one of the following formats:

+ NSX: 020406 - HSD: 021008; or

+ NSX 02 04 06 - HSD 02 10 08; or

+ NSX: 02042006 - HSD: 02102008; or

+ NSX: 02 04 2006 - HSD: 02 10 2008; or

+ NSX: 02/04/06 - HSD: 02/10/08; or

+ NSX: 020406 - HSD: 30 months; or

+ NSX: 020406 - HSD: 30 months from NSX.

+ NSX: 020406 - HSD: 30 months from NSX.

- In the case where it is not possible to write the characters "NSX", "HSD" together with the digits indicating day, month, year, such information must be directed on the label.

Example: If the production time and expiration date are marked at the bottom of the package as "020406 021008", then the label must state: See NSX, HSD at the bottom of the package.

- In the case where the production time "NSX" and expiration date "HSD" are written in a foreign language on the label, such information must be directed on the label.

Example: If the production date and expiration date are marked on the package as "MFG 020406 EXP 021008", then the label must state: NSX, HSD see "MFG" "EXP" on the package.

- In the case where the production date and expiration date are written in a foreign language on the label, the secondary label must indicate: production date, expiration date or abbreviated as "NSX", "HSD" see “Mfg Date” “Exp Date” on the package.

d) Storage conditions are climate factors to prevent changes in the quality of the drug. The necessary storage conditions for the drug must be clearly stated on the drug label. For example: Store in a dry, well-ventilated place, temperature not exceeding 30°C.

6. Warning signs to note

a) Injectable drugs and injectable powder drugs must clearly indicate the route of administration. The route of administration can be abbreviated as follows: intramuscular injection (tb), subcutaneous injection (tdd), intravenous injection (tm).

b) Eye drops and eye ointments must have the line of text "Eye Drops".

c) Topical drugs must have the line of text "For External Use Only".

d) Oral drugs packed in vials must have the line of text "Not for Injection".

e) For certain veterinary chemicals that require attention, specific quality indicators must be marked, and if they are flammable, explosive, toxic, or corrosive, corresponding warnings must also be included. If these chemicals are contained in pressure vessels, additional markings such as the tank number, filling capacity, and hazard warnings must be added.

f) On the label of veterinary drugs, any warnings (if applicable) must be noted to ensure safety for people when using them to treat livestock and poultry.

g) Methods of marking warning signs:

- All letters and warning signs must be printed clearly and prominently so that they can be easily recognized;

- In cases where a veterinary drug has multiple warning signs, all such signs must be fully marked.

7. Name and address of the organization or individual responsible for the drug

a) The name and address of the organization or individual responsible for the drug

shall not be abbreviated.

b) The method of recording the name and address of the organization or individual responsible for the drug is as follows:

- For domestically produced veterinary drugs, the name and address of the drug manufacturing facility should be recorded;

- For imported veterinary drugs circulating in Vietnam, the following should be recorded:

+ The name and address of the organization or individual producing the drug, the country of production;

+ The name and address of the organization or individual importing the drug.

The name of the manufacturing facility must not be smaller than the name of the importing facility.

- For veterinary drugs packaged from semi-finished products of another manufacturer, the name and address of the packaging facility and the name of the semi-finished product manufacturing facility should be recorded.

The name of the packaging facility must be recorded in the same location and have the same size as the name of the semi-finished product manufacturing facility.

- For veterinary drugs manufactured under license or permission from another organization or individual, the following must be recorded:

“Produced under license from: (record the name of the licensing entity) at: (record the name of the licensee)” and the address of the licensee;

The name of the licensee must not be smaller than the name of the licensing entity.

- For veterinary drugs manufactured under contract, the following must be recorded: “Produced at: (record the name of the contractor) pursuant to a contract with: (record the name of the contracting party)” and the address of the contractor;

The name of the contractor must not be smaller than the name of the contracting party.

- In cases where veterinary drugs are produced directly at the registered business location, the label must record the name and address of the manufacturing facility according to the business registration.

Example: Produced at Company A, Song Than Industrial Zone, Binh Duong Province

- In cases where veterinary drugs are produced at locations other than the registered business location, the label must record the address of the production location of the product or goods.

Example: Vitamin B1 products of Company A are produced in multiple locations, then it should be recorded as follows:

If produced at the factory in Hung Yen, it should be recorded as "produced at Factory X, Town Nhu Quynh, Van Lam, Hung Yen" or "product of Company A, produced at Town Nhu Quynh, Van Lam, Hung Yen". If produced at the factory in Binh Duong, it should be recorded as "produced at Factory Y, An Phu Commune, Thuan An, Binh Duong" or "product of Company A, produced at An Phu Commune, Thuan An, Binh Duong".

c) In cases where the distributor's name and address are marked on the label, the distributor's name and address must be recorded in the same location as the manufacturer's name and address and must not be larger than the manufacturer's name.

d) The name of the organization or individual responsible for the drug must be recorded with the full name of the entity as recorded in relevant legal documents related to the establishment of the entity. A trading name may be added but must not be larger than the full name.

đ) Address of the manufacturing facility, packaging facility, licensee, and contractor: Record the house number, street (village, hamlet), commune (ward, town), district (city district, provincial city), province (central city).

8. Origin of veterinary drugs

The origin of the drug is recorded as follows

a) For imported drugs: Record "produced in" or "origin" followed by the name of the country or territory where the drug was produced.

b) For drugs produced in Vietnam for domestic circulation and already marked with the address of the production location, there is no need to record the origin of the drug.

c) The origin of the drug must be recorded on the outer packaging and direct packaging of the drug.

9. Instructions for using veterinary drugs

a) Drugs labeled in accordance with this Circular must have a Vietnamese instruction leaflet. The content of the instruction leaflet can be printed on the packaging or intermediate label instead of being provided separately.

The size and color of the text on the instruction leaflet must be large enough and clear to be easily readable by the naked eye.

b) The instruction leaflet for the drug must include the following contents:

- Ingredients, formula for the smallest unit dose or the smallest unit packaging. In the formula, all active ingredients and excipients must be listed by their generic or international non-proprietary names. Clearly state the amount or concentration of each active ingredient, without necessarily stating the amount or concentration of excipients;

- Veterinary drug name;

- Ingredients, formula for the smallest dosage unit or for the smallest packaging unit. In the formula, all active ingredients and excipients must be listed by their generic name or international non-proprietary name. The concentration or amount of each active ingredient must be clearly stated, it is not mandatory to state the concentration or amount of excipients;

For veterinary drug ingredients imported without a Vietnamese name, the ingredient name shall be recorded according to the exporting country and the Latin name.

- Formulation of the drug;

- Packaging specifications;

- Indications;

- Dosage, method of administration, route of administration:

+ Clearly state the amount of drug for one single administration into the animal's body as prescribed or the amount of drug used in one day;

+ Clearly state the dosage for each species and age group of animals as prescribed;

+ Clearly state the route of administration, time of administration, and method of administration to achieve the highest efficacy.

- Contraindications (if any): must clearly state the cases where the drug should not be used for each species and age group of animals;

- Precautions when using veterinary drugs: must clearly state preventive measures and precautions when using the drug; special recommendations for the environment, drug users, and animals intended to use the drug;

- Drug interactions with other drugs and other types of interactions (if any) that may affect the drug's efficacy;

- Adverse reactions (if any): must clearly state the adverse reactions that may occur when using the drug ”.

Clearly state the situations where the use of the drug must be stopped and the situations where a veterinarian must be notified.

- Summary of pharmacodynamic and pharmacokinetic characteristics (for new drugs and brand-name drugs);

- Overdose and treatment (if any): symptoms of overdose and methods of treatment and emergency care;

- Warning signs and recommendations: must record warning signs as specified in Clause 6, Section B, Part II of this Circular;

- Storage conditions: clearly state the necessary conditions for storing the drug;

- Expiry date of the drug: record as specified in Clause 5, Section B, Part II of this Circular or indicate the period from the date of production (example: Expiry date: 24 months from the date of production).

Record the usage period of the drug from the date the direct packaging is opened for undosed drugs.

- Name and address of the organization or individual responsible for the drug.

10. Method of recording supplementary labels

Supplementary labels must be attached to the outer packaging of veterinary drugs and must not obscure the content of the original label. The content recorded on the supplementary label must not mislead the content of the original label, and the organization or individual recording the label must bear legal responsibility for the accuracy and truthfulness of the additional content. The method of recording supplementary labels is as follows:

a) In cases where the supplementary label has sufficient space, record all mandatory content as stipulated in Clause 1, Section A, Part II of this Circular.

b) In cases where the supplementary label has limited space and cannot fully record all mandatory content, at least the following contents must be recorded:

- Drug name;

- Active substance, concentration or strength;

- Name of the organization or individual responsible for the drug;

- Registration number;

- Packaging specifications;

- Production date, expiry date, batch number.

- Origin of the drug.

Other mandatory contents that are missing must be recorded in the Instructions for Use sheet. In such cases, the supplementary label must include the statement: "Other information please refer to the Instructions for Use sheet provided" and consider the part recorded on the Instructions for Use sheet as part of the supplementary label.

c) In cases where the original label uses Latin-based alphabets and the following contents are already on the original label, it is permissible not to translate them into Vietnamese and they do not need to be shown on the supplementary label:

- Trade name, generic name, or international nonproprietary name of the drug;

- International non-proprietary name or scientific name of each component of the drug in cases where it cannot be translated into Vietnamese or can be translated but does not make sense in Vietnamese.

- Name and address of foreign enterprises producing or holding production rights for the drug.

III. IMPLEMENTATION

1. The Department of Animal Health, Provincial Departments of Agriculture and Rural Development, domestic and foreign organizations and individuals engaged in the production, business, import, export of veterinary drugs, and organizations and individuals involved in the circulation of veterinary drugs in Vietnam are responsible for implementing Decree No. 89/2006/ND-CP dated August 30, 2006 of the Government on product labeling, Circular No. 09/2007/TT-BKHCN dated April 6, 2007 of the Ministry of Science and Technology, and the guidance of this Circular.

2. Veterinary drugs with labels recorded according to Circular No. 75/2000/TT-BNN-KHCN dated July 17, 2000 of the Minister of Agriculture and Rural Development that were put into circulation on the market before the effective date of this Circular may continue to circulate until the expiry date of the drug.

3. This Circular takes effect 45 days from the date of signature. During implementation, if there are any issues, organizations and individuals are requested to promptly report to the Ministry of Agriculture and Rural Development (Department of Animal Health) for consideration and resolution./.