Circular No. 04/2008/TT-BYT guiding the labeling of medicines

 

 

 

 

 CIRCULAR

Guidelines for Drug Labeling

Based on the Medicine Law number 34/2005-QH11 dated June 14, 2005;

Based on Decree number 89/2006/NĐ-CP dated August 30 2006 of the Government regarding product labels;

Based on Decree number 188/2007/NĐ-CP dated December 27 2007 of the Government defining functions, tasks, authorities, and organizational structure of the Ministry of Health;

Based on Circular number 09/2007/TT-BKHCN dated April 6, 2007 of the Ministry of Science and Technology guiding the implementation of some provisions of Decree number 89/2006/NĐ-CP dated August 30 2006 of the Government regarding product labels;

The Ministry of Health guides drug labeling as follows:

Part 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 guides the content and method of labeling for drugs circulating in Vietnam, exported, and imported.

b) Labels for temporarily imported and re-exported drugs, labels for non-commercially imported drugs, aid drug labels, and labels for research and production purposes within production facilities not covered by this Circular.

c) Labels for emergency imported drugs or other special cases shall be subject to specific regulations by the Ministry of Health according to each case.

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.

This Circular applies to organizations and individuals producing, trading, exporting, and importing drugs in Vietnam.

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

a) Drugs are substances or mixtures of substances intended for human use to prevent, treat, diagnose diseases, or adjust physiological functions including finished products, raw materials for drugs, vaccines, medical products, except functional foods.

b) Drug label is a written, printed, or drawn text, picture, image, or symbol imprinted or firmly attached to the drug's commercial packaging to provide essential 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.

c) Drug labeling is the act of displaying basic and necessary information about the drug on the label.

d) Original drug label is the label first imprinted or firmly attached to the drug's commercial packaging after completing the packaging process in the production line.

đ) Supplementary label is the label that translates mandatory contents from the original label into Vietnamese and supplements mandatory contents in Vietnamese according to the law if the original label lacks such contents.

e) Commercial packaging of drugs is the packaging containing and circulating with the drugs. Commercial packaging of drugs includes two types:

- Direct packaging is the packaging directly containing the drugs;

- Outer packaging is the packaging used to package one or several units of drugs with direct packaging.

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

h) Drug circulation is the activity of displaying, transporting, storing drugs during the buying and selling process.

i) Name and address of the organization or individual responsible for the drug are the name and address of the organization or individual producing, exporting, or importing the drug.

k) Packaging specification of drugs is the quantity of drugs expressed by net weight, actual volume, or count.

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

m) Date of manufacture is the time mark indicating the completion of manufacturing, processing, bottling, packaging, or other final steps of a batch of drugs.

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

o) Country of origin of drugs is the country or territory where the drugs were entirely produced or where the final substantial processing was carried out when multiple countries or territories participated in the production process.

p) Usage instructions are necessary information to guide users to use drugs effectively, safely, and reasonably.

The usage instruction leaflet is a document accompanying the drug's commercial packaging containing usage instructions and other required information.

4. Drugs must be labeled

a) Drugs circulating domestically; exported and imported drugs must be labeled according to the provisions of this Circular, except as provided 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 comply with the contract provided that these requirements do not alter the nature of the drugs, do not violate Vietnamese laws, and the laws of the importing country.

5. Position of drug labels

Drug labels must be affixed to the drug's commercial packaging at a position easily visible upon observation without having to disassemble parts of the drug.

6. Size of drug labels

Organizations and individuals responsible for labeling drugs must determine the size of the label but ensure that all mandatory contents are fully displayed and easily recognizable by the naked eye.

7. Color of text, symbols, and images on drug labels

The color of text, numbers, drawings, images, symbols, and markings on drug labels must be clear. For mandatory contents, text and numbers must contrast with the background color of the label.

8. Language presented on drug labels

a) Mandatory contents on drug labels must be written in Vietnamese, except as provided in point d of this clause.

b) Drugs produced and circulated domestically, in addition to complying with the provisions of point a of this clause, the contents on the label can also be written in another language. Contents in another language must correspond to the Vietnamese content. The font size of the text in another language must not be larger than the font size of the text in Vietnamese.

c) For medicines imported into Vietnam where the original label does not display or insufficiently displays mandatory contents in Vietnamese, a supplementary label must be affixed to show the mandatory contents in Vietnamese while retaining the original label of the medicine.

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

- The brand name, generic name, or international nonproprietary name of the medicine;

- The international nonproprietary name or scientific name of the components or quantified components of the medicine when they cannot be translated into Vietnamese or can be translated but have no meaning in Vietnamese;

- The name and address of foreign enterprises producing or holding the right to produce the medicine.

9. Labeling responsibility for medicines

a) Medicines produced for domestic circulation shall be the responsibility of the organizations or individuals producing the medicines for labeling.

b) Medicines produced in Vietnam for export shall be the responsibility of the organizations or individuals producing or exporting the medicines for labeling.

In cases where exported medicines are not sold abroad and are returned to domestic circulation, the organizations or individuals bringing the medicines into circulation must label them according to the provisions of this Circular.

c) For medicines imported into Vietnam where the original label does not comply with the provisions of this Circular, the organizations or individuals importing the medicines must affix a supplementary label according to the provisions of point c, Clause 8, Part I of this Circular before circulating them and must retain the original label.

d) The contents recorded on the labels of medicines, including supplementary labels and usage instructions, must ensure truthfulness, clarity, accuracy, and reflect the true nature of the medicines.

10. Implementation of intellectual property regulations

Organizations and individuals producing and trading in medicines must comply with the laws on intellectual property and bear legal responsibility for intellectual property issues concerning the contents recorded on the labels of medicines.

Part II

CONTENTS OF THE MEDICINE LABEL

Section A. General Medicine Labels

1. Mandatory contents to be displayed on the medicine label

The medicine label must fully display the following mandatory contents:

a) Medicine name;

b) Active ingredients, dosage, or concentration;

c) Packaging specifications;

d) Indications, usage methods, contraindications;

đ) Formulation, registration number or import permit number, production batch number, date of manufacture, expiration date, storage conditions;

e) Warning signs;

g) Name and address of the organization or individual responsible for the medicine;

h) Origin of the medicine;

i) Usage instructions for the medicine.

In cases where it is impossible to display all of the above mandatory contents, the medicine label must display the contents of points a, b, đ, and h of this clause. Other mandatory contents must be recorded in supplementary labels or in the usage instructions for the medicine, and the label must indicate where these contents are recorded.

2. Additional contents displayed on the medicine label

In addition to the mandatory contents prescribed in Clause 1, Section A, Part II of this Circular, additional contents may be recorded on the medicine label. These contents must ensure truthfulness, accuracy, and must not mislead about the nature, efficacy of the medicine, or other label contents.

 Section B. Special Medicine Labels

1. Raw material labels

a) Raw material labels for medicines must include the following contents:

- Raw material name;

- Dosage or concentration (if applicable);

- Raw material standards;

- Net weight or volume;

- Production batch number, date of manufacture;

- Expiration date, storage conditions;

- Registration number (if applicable);

- Name and address of the manufacturing facility, origin of the medicine;

- Name and address of the importing facility (for imported raw materials).

b) Raw material labels for medicines classified as addictive substances must include the word "Addictive." Raw material labels for medicines classified as psychotropic substances must include the word "Psychotropic." Raw material labels for medicines classified as precursor substances must include the phrase "Precursor substance for medicinal use."

The words "Addictive," "Psychotropic," and "Precursor substance for medicinal use" must be printed in bold within a circular frame at the top right corner of the label.

2. Labels on blister packs

a) Labels on blister packs must at least include the following contents:

- Medicine name;

- Active ingredient, dosage: if the medicine is a combination product containing three or fewer active ingredients, the name and dosage of each active ingredient must be listed;

- Production batch number, expiration date;

- Name of the manufacturing facility. The name of the manufacturing facility may be abbreviated but must be recognizable.

b) Blister packs must be contained within outer packaging that displays all the contents prescribed in Clause 1, Section A, Part II of this Circular.

3. Labels on small direct contact packaging

a) Labels on small direct contact packaging with special designs that cannot fully display the mandatory contents prescribed in Clause 1, Section A, Part II of this Circular must at least include the following contents:

- Medicine name;

- Active ingredient, dosage: if the medicine is a combination product containing three or fewer active ingredients, the name and dosage of each active ingredient must be listed;

- Volume or weight;

- Production batch number, expiration date;

- Name of the manufacturing facility. The name of the manufacturing facility may be abbreviated but must be recognizable.

b) Small direct contact packaging containing medicines must be contained within outer packaging that displays all the contents prescribed in Clause 1, Section A, Part II of this Circular.

4. Labels on compounded medicines must include the following contents:

a) Medicine name, formulation;

b) Active ingredient, concentration or dosage;

c) Compounding date, expiration date;

d) Route of administration;

đ) Patient's name;

e) Compounder's name;

g) Name and address of the compounding facility.

5. Labels on medicines for national health programs

a) Labels on medicines for national health programs must include all mandatory contents prescribed in Clause 1, Section A, Part II of this Circular.

b) For medicines from programs that are not allowed to be sold, the phrase "Medicine from program not for sale" must be recorded.

Part III

METHODS FOR LABELING MEDICINES

1. Medicine name

a) The medicine name is self-assigned by organizations or individuals producing or trading in medicines. The medicine name must not mislead about the nature and efficacy of the medicine.

The font used to write the medicine name on the label must be bold and prominent.

If the brand name is a single active ingredient, the generic name or international nonproprietary name must be immediately listed after the brand name.

b) Types of medicine naming may include:

- Generic name;

- International nonproprietary name (INN);

- Brand name.

2. Active ingredient, dosage, or concentration

a) Record the active ingredient and dosage or concentration of each active ingredient for the smallest unit of dose division or smallest unit of packaging. The name of the active ingredient should be recorded using the generic name or international nonproprietary name.

For drugs made from medicinal herbs: record the names of the herbal ingredients in Vietnamese. In cases where imported drugs do not have Vietnamese names, record them according to the name of the exporting country followed by the Latin name.

b) Units of measurement.

- Weight units: use grams (abbreviation is g), milligrams (abbreviation is mg), micrograms (abbreviation is mcg) or kilograms (abbreviation is kg) if the drug has a large weight;

- Volume units: use milliliters (abbreviation is ml), or liters (abbreviation is l) if the drug has a large volume;

- If the weight is less than 1mg, or the volume is less than 1ml, write it in decimal form (for example: 0.25mg; 0.5ml);

- International activity units may be used for certain special active substances as prescribed.

3. Packaging specifications

a) Recording packaging specifications of drugs involves recording the quantity, net weight, and actual volume of the drug contained in the commercial packaging.

b) Drug packaging specifications must be recorded using natural counting numbers.

c) Specific recording methods for each type of drug:

- For tablet forms: record the number of tablets. For hard gelatin capsules: record the net weight;

- For powder, granule, and ointment forms: record the net weight;

- For liquid forms: record the actual volume.

d) In cases where there are multiple units of packaging within a single commercial package, the dosage of each unit of packaging and the number of units must be recorded.

đ) The outer packaging of the drug should contain sufficient direct packages to meet the usual treatment dose.

For drugs supplied to hospitals, this point does not apply, but the outer packaging must bear the phrase "For Hospital Use Only."

4. Indications, usage, contraindications (if any) of the drug

a) Treatment indications on the label must correspond to the drug's efficacy.

b) Usage must clearly state the route of administration, dosage, and duration of use.

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

d) Indications, usage, contraindications can be recorded in one of the following two ways:

- Directly on the commercial packaging of the drug;

- In cases where the outer label does not have enough space to record 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 accompanying instruction leaflet with the commercial packaging of the drug.

5. Formulation type, registration number, import permit number, production batch number, date of manufacture, expiration date, storage conditions

a) The formulation type of the drug: record as compressed tablets, capsules, injectable, suppository...

b) The registration number is the symbol issued by the Ministry of Health of Vietnam (Drug Administration Department) for a drug to certify that it has been registered for circulation in Vietnam. It is recorded as SĐK: XX-XXXX-XX

c) The import permit number is the number issued by the Drug Administration Department to allow the importation of drugs without a registration number. It is recorded as GPNK: XXXX/QLD-XX.

d) The production batch number is recorded as follows:

- Production batch number: XXXX; or Production batch number: XXXX.

The structure of the production batch number is determined by the manufacturing facility.

đ) The date of manufacture and expiration date are recorded in the order of day, month, year of the Gregorian calendar. Each digit representing day, month, or year is recorded in two digits, and the year may be recorded in four digits. The digits representing day, month, and year of a specific time point must be recorded on the same line.

- The date of manufacture and expiration date on the label can be fully recorded or abbreviated as NSX, HD.

Example: NSX: 050706; or NSX: 05072006; or NSX: 05/07/06;

or NSX: 05/07/2006.

- HD: 050708; or HD: 05072008; or HD: 05/07/08;

or HD: 05/07/2008.

- In cases where the date of manufacture and expiration date are recorded in a foreign language on the label, the label must also include the following: date of manufacture, expiration date or abbreviations NSX, HD, see "Mfg Date" "Exp Date" on the packaging.

e) Storage conditions are climate factors to prevent changes in drug quality. The necessary conditions for storing the drug must be clearly stated on the drug label.

Example: Store in a dry place, temperature not exceeding 30°C.

6. Warning signs

a) Prescription drugs must have the Rx symbol in the upper left corner of the drug name and the phrase "Prescription Only Medicine."

b) Injectable drugs must clearly state the route of administration. Abbreviations for routes of administration may be used: intramuscular injection (IM), subcutaneous injection (SC), intravenous injection (IV).

c) Eye drops must have the phrase "Eye Drops."

d) Nasal drops must have the phrase "Nasal Drops."

đ) Topical drugs must have the phrase "For External Use Only."

e) Drugs packaged in vials for oral use must have the phrase "Do Not Inject."

f) The drug label must include the phrases "Keep Out of Reach of Children," "Read Instructions Before Use."

g) Methods for recording warning signs:

- Warning signs and letters must be printed clearly and prominently so they can be easily recognized;

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

7. Name and address of organizations or individuals responsible for the drug

a) Record the name and address of the organization or individual responsible for the drug in the following specific cases:

- For domestically produced drugs, record the name and address of the drug manufacturer;

- For imported drugs circulating in Vietnam, record:

+ Name and address of the producing organization or individual, country of production;

+ Name and address (province, city) of the importing organization or individual.

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

- For drugs packaged from semi-finished products of another manufacturer, record the name and address of the packaging facility and the name of the semi-finished product manufacturer;

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

- For drugs manufactured under license or permission from another organization or individual, record: "Produced under License from: (name of licensing entity) at: (name of licensee)" and the address of the licensee;

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

- For drugs manufactured under contract, record: "Produced at: (name of contractor) pursuant to contract with: (name of client)" and the address of the contractor;

The name of the contractor must not be smaller than the name of the client.

b) In the case where the distributor's name and address are indicated on the label, the name and address of the distributor must be printed in the same location as those of the manufacturer, and the size must not exceed that of the manufacturer's name.

c) The name of the organization or individual responsible for the drug mentioned in point a of this clause must be printed with the full name of the entity recorded in relevant legal documents concerning the establishment of such entity. A trade name may also be included but its size must not exceed that of the full name.

d) The address of the production facility, packaging facility, franchised facility, and contract manufacturing facility shall include the house number, street (village, hamlet), commune (ward, town), district (city district, provincial city, provincial capital), province (central city).

đ) The names of organizations, individuals, and place names must not be abbreviated.

8. Origin of the drug

a) The origin of the drug shall be indicated as follows: "produced at" or "manufactured at" 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 bearing the address of the production site, it is not mandatory to indicate the origin of the drug.

c) The origin of the drug must be printed on both the outer packaging and the immediate packaging of the drug.

9. Instructions for use of the drug

a) Drugs that must be labeled according to this Circular must have a Vietnamese instruction leaflet attached to the commercial packaging (except for raw material labels and compounded drug labels based on prescriptions).

The font size and color of the text on the instruction leaflet must be large enough and clear to easily read the contents with the naked eye.

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

- Medicine name;

- Ingredients, formula for the smallest dosage unit or the smallest packaging unit. In the formula, all active ingredients and excipients must be listed by their generic names or international nonproprietary names. The concentration or amount of each active ingredient must be clearly stated, while the concentration or amount of excipients need not be specified;

For drugs derived from herbal medicines: list the names of the medicinal herbs in Vietnamese and Latin. For imported herbal medicines without Vietnamese names, list the names of the herbs according to the exporting country and in Latin.

- Formulation of the drug;

- Packaging specifications;

- Indications;

- Dosage, method of administration, route of administration: clearly state the amount of drug for a single dose or daily dose; specify the dosage for adults, children, and elderly if applicable;

Clearly state the route of administration, when to take the drug (e.g., before or after meals...), and the method of administration to achieve maximum efficacy (e.g., drink plenty of water...).

- Contraindications: clearly state the situations in which the drug should not be used;

- Precautions when using the drug: clearly state the precautions and warnings when using the drug; special recommendations for pregnant women, nursing mothers, children, patients with chronic diseases, and effects on work (e.g., operating machinery, driving vehicles...);

- Drug interactions with other drugs and other types of interactions (e.g., alcohol, food) that may affect the drug's efficacy;

- Adverse reactions: clearly state the adverse reactions that may occur when using the drug and include the statement "Report any adverse reactions experienced when using the drug to your doctor."

Clearly state the situations requiring discontinuation of drug use and the situations requiring notification to a doctor.

- Pharmacodynamic and pharmacokinetic characteristics (for modern drugs);

- Overdosage and treatment: symptoms of overdose and methods of treatment and emergency care;

- Warning signs and recommendations: must include warning signs as stipulated in Clause 6, Part III of this Circular.

Include the recommendation: "Read the instructions carefully before use. If more information is needed, consult a doctor."

For prescription drugs, include the statement "This drug can only be used according to a doctor's prescription."

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

- Expiry date of the drug: as prescribed in Point đ, Clause 5, Part III of this Circular or as a period from the date of manufacture (e.g., Expiry Date: 24 months from the date of manufacture).

State the shelf life of the drug from the date the immediate packaging is opened for undivided doses (if applicable).

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

10. Supplementary Labels for Drugs

Supplementary labels must be affixed to the outer packaging of the drug and must not obscure the content of the original label. The content printed on supplementary labels must not mislead the content of the original label, and the organization or individual printing the label must bear legal responsibility for the accuracy and truthfulness of the additional content. The printing of supplementary labels shall be as follows:

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

b) In cases where the supplementary label has insufficient space to print all mandatory content, at least the following must be printed:

- Medicine name;

- Active ingredient, concentration or amount;

- Name of the organization or individual responsible for the drug (as prescribed in Clause 7, Part III of this Circular);

- Registration number or import permit number;

- Packaging specifications;

- Production date, expiry date, batch number.

- Origin of the drug.

Any other mandatory content missing must be printed in the instruction leaflet. In such cases, the supplementary label must include the statement: "Other information is available in the instruction leaflet provided," and consider the part printed on the instruction leaflet as part of the supplementary label.

c) In cases where the original label uses Latin-based characters and the following information is already present on the original label, it is permissible not to translate into Vietnamese and not to display on the supplementary label:

- The brand name, generic name, or international nonproprietary name of the medicine;

- International nonproprietary 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.

- The name and address of foreign enterprises producing or holding the right to produce the medicine.

Part IV

INSPECTION, AUDIT AND VIOLATION HANDLING

1. Inspection and Supervision

a) The Department of Medicine Management and the Inspectorate of the Ministry of Health organize inspections and supervision of the implementation of this Circular within their authority over pharmaceutical production and trading units nationwide.

b) Provincial Departments of Health under central cities are responsible for inspecting and supervising the implementation of this Circular within their jurisdiction.

2. Disciplinary Actions

a) Organizations and individuals producing, trading, exporting, and importing drugs in Vietnam must comply with the provisions of Decree No. 89/2006/NĐ-CP dated August 30, 2006, and the guidance provided in this Circular.

b) Organizations and individuals violating the regulations on drug labels under the law shall be subject to administrative penalties or criminal liability depending on the nature and extent of the violation, and if damage is caused, they must compensate according to the law.

Part V

IMPLEMENTING PROVISIONS

1. This Circular takes effect ninety days from the date of publication in the Official Gazette. The Circular No. 14/2001/TT-BYT dated June 26, 2001, issued by the Ministry of Health on guidelines for labeling drugs and cosmetics directly affecting human health, and the Circular No. 14/2000/TT-BYT dated June 22, 2000, issued by the Ministry of Health on implementing Decision No. 178/1999/QĐ-TTg dated August 30, 1999, of the Prime Minister regarding the labeling of vaccine and immunological products, are hereby repealed.

2. Drugs labeled in accordance with Circular No. 14/2001/TT-BYT dated June 26, 2001, and Circular No. 14/2000/TT-BYT dated June 22, 2000, issued by the Minister of Health, which were put into circulation on the market before the effective date of this Circular, may continue to circulate until their expiration date.

3. The Drug Administration Department, subordinate units of the Ministry of Health, Provincial Departments of Health, the Vietnam Pharmaceutical Corporation, pharmaceutical production and trading enterprises, and foreign companies licensed to operate in the pharmaceutical sector are responsible for implementing this Circular.

4. In case of any difficulties during implementation, organizations and individuals are requested to promptly report to the Ministry of Health (Drug Administration Department) for consideration and resolution.