Circular No. 14/2001/TT-BYT

CIRCULAR

ISSUED BY THE MINISTRY OF HEALTH DECREE NO. 14/2001/TT-BYT ON JUNE 26, 2001
GUIDELINES FOR LABELING DRUGS AND COSMETICS DIRECTLY AFFECTING HUMAN HEALTH

- BASED ON THE LAW ON PROTECTING PUBLIC HEALTH;

- BASED ON DECISION NO. 178/1999/QĐ-TTg OF AUGUST 30, 1999, ISSUED BY THE PRIME MINISTER, ESTABLISHING THE REGULATIONS ON PRODUCT LABELING FOR DOMESTIC CIRCULATION AND EXPORT AND IMPORT GOODS; DECISION NO. 95/2000/QĐ-TTg OF AUGUST 15, 2000, ISSUED BY THE PRIME MINISTER, REGARDING AMENDMENTS AND SUPPLEMENTS TO CERTAIN CONTENTS OF THE REGULATIONS ON PRODUCT LABELING FOR DOMESTIC CIRCULATION AND EXPORT AND IMPORT GOODS ESTABLISHED IN ACCORDANCE WITH DECISION NO. 178/1999/QĐ-TTg OF AUGUST 30, 1999, ISSUED BY THE PRIME MINISTER; AND CIRCULAR NO. 34/1999/TT-BTM OF DECEMBER 15, 1999, ISSUED BY THE MINISTRY OF TRADE, GUIDING THE IMPLEMENTATION OF DECISION NO. 178/1999/QĐ-TTg OF AUGUST 30, 1999, ISSUED BY THE PRIME MINISTER, ESTABLISHING THE REGULATIONS ON PRODUCT LABELING FOR DOMESTIC CIRCULATION AND EXPORT AND IMPORT GOODS;

IMPLEMENTING THE GUIDANCE OF THE PRIME MINISTER AS STATED IN OFFICIAL LETTER NO. 304/CP-KTQĐ OF APRIL 18, 2001, REGARDING THE ISSUE OF GUIDING DOCUMENTS TO IMPLEMENT THE REGULATIONS ON PRODUCT LABELING, THE MINISTRY OF HEALTH GUIDES THE LABELING OF DRUGS AND COSMETICS DIRECTLY AFFECTING HUMAN HEALTH AS FOLLOWS:

PART I
GENERAL PROVISIONS

Article 1. APPLICANTS AND SCOPE OF APPLICATION:

1. Scope of application:

The applicants of this Circular are organizations, individuals, and traders engaged in the production, import, and domestic circulation of drugs and cosmetics in Vietnam.

Article 2. Scope of Regulation

a) This Circular guides the labeling of domestically produced drugs and cosmetics for domestic circulation and export; and drugs and cosmetics produced abroad that are imported for consumption in the Vietnamese market.

b) Drugs and cosmetics temporarily imported for re-export; drugs and cosmetics manufactured for foreign countries; labels used during the production process of drugs and cosmetics within factories are not covered by this Circular.

Emergency imported drug labels or other special cases shall be regulated according to specific conditions set forth by the Ministry of Health.

Article 2. Livestock for slaughter includes: cattle, buffalo, goats, sheep, pigs, horses, donkeys, camels, and other livestock used for food;

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

1. Drug and cosmetic labels are printed, drawn, or imprinted images directly on the product packaging or firmly affixed to the product packaging to provide essential and primary information about the drugs and cosmetics, aiding consumers in selecting and using them correctly, and serving as a basis for competent authorities to conduct inspections, supervision, and management. use drugs and cosmetics correctly, and serve as a basis for competent authorities to conduct inspections, supervision, and management.

2. Product packaging for drugs and cosmetics refers to packaging directly attached to the drugs and cosmetics and sold together with them to end-users, including direct packaging and outer packaging.

a) Direct packaging for drugs and cosmetics is packaging that directly contacts and contains the drugs and cosmetics, forming their shape and size, or wrapping them tightly according to their shape and size.

b) Outer packaging for drugs and cosmetics is packaging containing one or more direct packaging units of drugs and cosmetics. number of packaging containers for drugs and cosmetics.

3. Non-retail packaging for drugs and cosmetics includes various types of packaging used for transportation and storage of drugs on transport vehicles or in warehouses.

4. Mandatory content of drug and cosmetic labels includes the most important information about the drugs and cosmetics that must be displayed on the labels.

5. Non-mandatory content of drug and cosmetic labels consists of additional information beyond the mandatory content that must be displayed on the labels.

6. The main part of the label for drugs and cosmetics is the section where mandatory label content is recorded, designed to be easily visible and clear under normal display conditions, and should not be located at the bottom of the packaging.

7. Additional information section is the continuation of the main part of the label, recording non-mandatory content of the drug and cosmetic labels, or some mandatory content when the main part of the label does not have enough space.

8. The drug usage guide is an accompanying document provided with the product packaging of the drug, containing necessary information to guide users on safe and rational drug use (as stipulated in Chapter III of this Circular).

Article 3. BASIC REQUIREMENTS FOR DRUG AND COSMETIC LABELS:

All letters, numbers, drawings, images, symbols, and signs recorded on drug and cosmetic labels must be clear, legible, accurate, and not cause confusion with other drugs, cosmetics, or goods.

Article 4. LANGUAGE USED ON DRUG LABELS:

1. Labels for domestically circulated drugs must be written in Vietnamese. Depending on the type of drug, they may also include foreign language translations, but the size of the foreign language text must be smaller.

2. Labels for domestically produced drugs intended for export can be written in the language of the importing country if agreed upon in the purchase and sale contract or as required by the importing country.

3. For foreign drugs registered and imported for consumption in the Vietnamese market, the language on the labels must be either Vietnamese or English, with the possibility of adding another language. There must be a Vietnamese drug usage guide accompanying the product packaging.

4. For imported drugs without registration numbers for consumption in the Vietnamese market, the language on the labels must comply with one of the following methods:

a) When signing the import contract, the importing enterprise requests the supplier to agree to record mandatory information in Vietnamese on the original label.

b) If agreement cannot be reached as stated above, the importing enterprise must prepare a Vietnamese drug usage guide to accompany the product packaging before selling or circulating it in the market.

The drug usage guide must comply with the provisions of Chapter III of this Circular.

PART II
CONTENT OF DRUG LABELS

PART 1. REGULAR DRUG LABELS

SECTION 1. MANDATORY CONTENT

Article 5. The general label of drugs must fully include the mandatory content prescribed in Articles 6, 7, 8, 9, 10, 11, and 12 of this Circular. For special drug labels, labeling shall be carried out according to the provisions in Part 2 of Chapter II of this Circular.

Article 6. Drug Name:

The drug name may be:

- International Nonproprietary Name (INN).

- Scientific name.

- Name established by the manufacturer.

The writing of the drug name must be bold, prominent, and have a height not less than 2mm (two millimeters).

Article 7. Name and address of the production facility:

1. The name of the production facility is the full name of the production facility recorded in legal documents related to the establishment of that production facility. A trade name may also be included but with a smaller size than the full name.

2. If the drug is completely produced at one production facility, the name of that production facility must be indicated.

3. If the drug is packaged from semi-finished products of other manufacturers, the name and address of the packaging facility and the name and address of the production facility producing the semi-finished products must be indicated.

4. For licensed production of foreign drugs in Vietnam or other Vietnamese manufacturers, the label must include the Vietnamese phrase "Produced under license of: (Name of licensing entity) at: (Name of licensee entity)". The name of the licensee entity must be larger than the name of the licensing entity.

5. For imported drugs, the importer must affix a supplementary label with the name and address of the importer on the original label without obscuring the main information on the original label.

6. The address includes: house number (if applicable), street (village, hamlet), commune (ward, town), district (city district, provincial city), province, (central city directly under the central government), country name (for exported and imported drugs).

Article 8. Composition of the drug:

1. List the components that determine the effect of the drug as stated on the drug label.

2. Units of measurement for the drug.

- Mass: Use units such as gram (g), milligram (mg), microgram (mcg), or kilogram (kg) if the mass is large.

- Volume: Use units such as milliliter (ml) or liter (l) if the volume is large. - If the mass is less than 1 mg or the volume is less than 1 ml, it should be written in decimal form (e.g., 0.25 mg; 0.5 ml) rather than as a fraction.

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

Quantity of goods (packaging specifications), and dosage form: 1. The packaging specifications of the drug are the net quantity or mass, volume, actual dimensions of the drug contained in the commercial packaging.

Article 9. 2. The dosage form of the drug is recorded according to the dosage form in the packaging container.

Indications, usage, contraindications (if any):

1. The therapeutic indications on the label must be consistent with the drug's function. Regarding usage, the route of administration, dose, method of dose division, and duration of use must be clearly stated. If there are contraindications, they must be clearly stated along with situations requiring caution.

Article 10. 2. In this section, only essential information sufficient for users to use the drug reasonably and safely is required. Information can be recorded in one of the following ways:

- Directly on the commercial packaging.

- If the commercial label does not have enough space to record this section, the phrase "Please read the instructions for use" must be printed and a Vietnamese language instruction leaflet must accompany the commercial packaging.

Registration number (SĐK) - Production batch number (SX) - Expiry date (HD) - Storage conditions - Date of manufacture (SX) - Quality standards applied:

1. The registration number is a symbol issued by the Ministry of Health (Vietnam Drug Administration) for a drug to certify that it has been registered in Vietnam.

Article 11. 2. The production batch number is determined by the production facility. If the structure of the production batch number does not indicate the date of manufacture, the production facility must additionally print the date of manufacture on the label (Date of manufacture: day, month, year when the batch of drugs was completed).

3. Expiry date: is the time limit beyond which the drug is not allowed to circulate or be used. The expiry date is recorded in numbers (or letters) indicating the month and year.

4. Storage conditions for the drug: are environmental factors for storage to prevent changes in the quality of the drug. These conditions must be clearly stated on the drug label.

5. Quality standards for the drug: are the quality standards applied by the manufacturer (e.g., Vietnamese Pharmacopoeia, British Pharmacopoeia, Corporate Standards...).

6. Recording the date of manufacture, expiry date:

- Recorded according to the Gregorian calendar.

- Date of manufacture: The day consists of two digits; the month consists of two digits or the name of the month in letters; the year consists of the last two digits of the year (e.g., Date of manufacture: 01/03/00).

- Expiry date: The month consists of two digits or the name of the month in letters; the year consists of the last two digits of the year (e.g., Expiry date: 03/99).

- In cases where equipment and production technology cannot be overcome, the date of manufacture, expiry date, and production batch number may be recorded at the bottom of the packaging.

Warning signs: 1. For prescription drugs listed in the prescription drug list, the label must include the phrase "Prescription drug" and the Rx symbol must be placed in the upper left corner of the main part of the label.

2. Finished product labels of toxic drugs must include the phrase "Do not exceed the prescribed dose".

Article 12. 3. Finished product labels of addictive drugs and psychotropic drugs must include the phrase "Use as directed by a physician".

4. Finished product labels of eye drops must include the phrase "Eye drops".

5. Finished product labels of nasal drops must include the phrase "Nasal drops".

6. If the drug requires special warnings to ensure user safety, these must be clearly stated (e.g., do not administer intravenously).

7. If the drug can cause serious harm to people and the environment when improperly disposed of, clear warnings about disposal must be provided (e.g., do not burn).

8. If the drug is only for adults, the phrase "Prohibited for children" must be printed. If there are specific age contraindications, they must be specified (e.g., Not for children under 2 years old).

9. On the outer packaging label of the drug, the phrases "Keep out of reach of children" and "Read the instructions carefully before use" must be printed.

10. Method of recording warning signs:

8. If the drug is only for adults, the phrase "Prohibited for children" must be printed. If there are specific contraindications for certain ages, they must be specified (for example: Not to be used by children under 2 years old).

9. On the label of the outer commercial packaging of the drug, the phrases "Keep out of reach of children" and "Read the instructions carefully before use" must be printed.

10. Method of marking warning signs:

a) The letters and warning signs must be printed clearly, with a minimum size of 1.5mm and a maximum size equal to the name of the drug.

b) If a drug requires multiple warning signs, all such signs must be fully recorded. Warning signs must be recorded on the main part of the label.

c) If the drug is both a prescription drug and also falls under the category of toxic drugs, addictive drugs, psychotropic drugs, or all these categories, only the warning sign for over-the-counter drugs "Prescription Drug" and the Rx symbol should be marked at the top left corner of the main part of the label.

If the drug does not fall under the category of prescription drugs, the warning signs shall be recorded according to Clause 2 and 3 of Article 12 of this Circular.

List of prescription drugs, toxic drugs, addictive drugs, and psychotropic drugs according to the regulations on these types of drugs issued by the Ministry of Health of Vietnam.

d) For imported drugs, if the original commercial packaging does not contain all the required warning signs as stipulated in this Circular, they may be recorded in one of the following two ways:

+ Directly marking on the original commercial packaging.

+ In cases where the original label cannot be changed, an additional label containing all the required warning signs must be affixed next to the original label on the commercial packaging without obscuring the main information on the original label.

SECTION 2. NON-MANDATORY CONTENT

Article 13. Besides the mandatory content that must be displayed on the drug label, additional necessary information can be added based on the requirements of each type of drug, but it must not conflict with the laws and this Circular, nor obscure or mislead the mandatory content on the label. Non-mandatory content may include: code number, barcode, logo, trademark, name and address of the importer, distributor, company registration, etc., but their size must be smaller than the manufacturer's name.

PART 2. SPECIAL DRUG LABELS

Article 14. Raw material labels:

Raw material drug labels must include the following contents:

1. Name and address of the production facility;

2. Name of raw material and standards of raw material;

3. Packaging weight or volume;

4. Concentration or content;

5. Production batch number; date of production;

6. Registration number (if applicable);

7. Expiry date, storage conditions.

Raw material labels for Class A toxic drugs must have the word "Toxic A" printed in bold within a circular frame at the top left corner of the main part of the label. The size of the word "Toxic A" must be at least the same as the size of the raw material name. Raw material labels for Class B toxic drugs must have the word "Toxic B" printed in bold within a circular frame at the top left corner of the main part of the label. The size of the word "Toxic B" must be at least the same as the size of the raw material name.

Raw material labels for addictive drugs must have the word "Addictive". Raw material labels for psychotropic drugs must have the word "Psychotropic". The words "Addictive" and "Psychotropic" must be at least the same size as the raw material name and printed in bold within a circular frame at the top right corner of the main part of the label.

For raw material labels of foreign toxic, addictive, or psychotropic drugs that do not meet the above requirements, the importer must affix an additional label with the warning signs "Toxic A", "Toxic B", "Addictive", "Psychotropic" when importing them into the warehouse.

Labels on blister packs:

Article 15. Labels on blister packs must minimally include the following contents:

1. Name of the production facility;

2. Drug name (if the drug name is based on a trade name and contains only one active ingredient, then the generic name of the active ingredient must be recorded); content;

3. Production batch number;

4. Expiry date;

The name of the manufacturer may be abbreviated (ensuring the manufacturer's name is recognizable) but the trading name cannot be used as a substitute.

Imported and exported drugs must record the country of the manufacturer.

Blister packs must be contained in the outer commercial packaging of the drug with all the contents specified in Part 1 of Chapter II of this Circular.

Labels printed or affixed on injection vials or syringe tubes with small label areas (insufficient to record all mandatory content) must minimally include the following information:

Article 16. 2. Drug name, concentration or content;

2. Drug name (if the drug name is based on a trade name and contains only one active ingredient, then the generic name of the active ingredient must be recorded); content;

3. Volume or weight;

4. Production batch number, expiry date;

5. Route of administration: intramuscular (IM), subcutaneous (SC), intravenous (IV).

Injection vials or syringe tubes must be contained in the outer commercial packaging of the drug with all the contents specified in Part 1 of Chapter II of this Circular.

Imported and exported drugs must record the country of the manufacturer.

Blister packs must be contained in the outer commercial packaging of the drug with all the contents specified in Part 1 of Chapter II of this Circular.

VIETNAM TOBACCO ASSOCIATIONLabels printed or affixed on bottles or syringes containing oral solutions or other small packages that do not contain all the mandatory content specified in Part 1 of Chapter II of this Circular must minimally include the following information:

Article 17. 1. Name of the production facility

5. Route of administration;

3. Volume or weight;

4. Production batch number, expiry date;

5. Route of administration: intramuscular (IM), subcutaneous (SC), intravenous (IV).

6. Add a bold statement "Not for Injection" (applicable to oral solution syringes).

The name of the production facility may be abbreviated but must ensure the manufacturer's name is recognizable and the trading name cannot be used as a substitute.

These packages must be contained in the outer commercial packaging of the drug with all the contents specified in Part 1 of Chapter II of this Circular.

Blister packs must be contained in the outer commercial packaging of the drug with all the contents specified in Part 1 of Chapter II of this Circular.

DRUG USAGE GUIDANCE SHEET

CHAPTER III
Drugs within the scope of this Circular must be accompanied by a drug usage guidance sheet in Vietnamese along with the commercial packaging if the label on the commercial packaging does not fully display the contents specified in Article 19 of this Circular.

Article 18. The drug usage guidance sheet must include the following contents:

Article 19. 1. Drug name.

2. Formula for the smallest unit of packaging (e.g., tablet, capsule...).

In the formula, all active ingredients and excipients (using international common names) and the content or concentration of active ingredients (excipient content or concentration need not be recorded).

3. Formulation of the drug.

4. Packaging specifications: clearly state the packaging specifications applied for circulation.

5. Indications: clearly state specific treatment indications of the drug.

6. Information needed before using the drug:

a) Contraindications, precautions when using the drug: Clearly state situations where the drug should not be used. Clearly state preventive measures and precautions for using the drug. Special recommendations when using the drug must be clearly stated for each group (e.g., children, pregnant women), impact on work (e.g., driving vehicles, operating machinery).

b) Interactions of the drug with other drugs and other types of interactions (e.g., alcohol, tobacco, food) that may affect the efficacy of the drug.

b) Interactions between drugs and other drugs and other types of interactions (such as alcohol, tobacco, food) that may affect the efficacy of the drug.

7. Adverse effects: clearly state the adverse effects of the drug. Note: "Report any adverse effects encountered when using the drug to the physician."

8. Usage instructions:

- Dosage: may be stated according to body weight or specific dosage, depending on the type of drug. Clearly distinguish dosages for adults, children, and elderly if applicable.

- Method of use: State the route of administration, how to divide the dose, number of times to use, when to use (before, after meals...), and the method of using the drug to achieve the highest efficacy (for example: take with plenty of water...).

- Situations where the use of the drug must be discontinued.

- Situations where the physician must be notified.

9. Warnings:

- "Read the usage instructions carefully before use. If more information is needed, consult a physician."

- For prescription drugs, add: "This drug can only be used according to a physician's prescription."

10. Expiry date, storage conditions, and applicable standards:

- Storage conditions for the drug.

- Clearly state which quality standard the drug meets.

- Expiry date: State the period of use for the drug (for example, 24 months...).

11. Name of the manufacturing entity, address, phone number, fax number, email (if available).

PART IV
COSMETIC PRODUCTS DIRECTLY AFFECTING
HUMAN HEALTH

Article 20. Entities producing and trading cosmetic products directly affecting human health must comply with Decision No. 178/1999/QĐ-TTg dated August 30, 1999; Decision No. 95/2000/QĐ-TTg dated August 15, 2000 issued by the Prime Minister regarding the Labeling Regulations for goods circulating domestically and imported/exported goods (referred to as the Government Regulations); and Circular No. 34/1999/TT-BTM dated December 15, 1999 issued by the Ministry of Trade guiding the implementation of Decision No. 178/1999/QĐ-TTg dated August 30, 1999 issued by the Prime Minister regarding the Labeling Regulations for goods circulating domestically and exported/imported goods (referred to as the Ministry of Trade Guidance Circular). In addition to the provisions in the aforementioned documents, labels of cosmetic products directly affecting human health must ensure the following requirements: 1) Main quality criteria:

At the main part of the cosmetic product label, state the skin irritation index (according to the skin irritation criteria specified in the product quality standards, for example: "Does not cause skin irritation," "Mild skin irritation"...).

2) Functionality, usage instructions, and storage conditions:

- The cosmetic product label must include functionality, usage instructions, and storage conditions.

- If the direct packaging label of a small cosmetic product does not contain all the required information, there must be outer packaging containing the direct packaging or an accompanying usage instruction sheet detailing functionality and storage conditions.

REVIEW OF DRUG LABELS AND BRAND MARKS

CHAPTER V
OF DRUGS
The drug label registration dossier is part of the drug registration application dossier. Entities applying to change the drug label must submit the new label along with a sample of the previously approved drug label.

Article 21. The Ministry of Health (Vietnam Drug Administration) reviews the content of drug labels within the scope regulated by this Regulation.

Article 22. Manufacturing entities wishing to apply for a new label or to change the drug label must submit their application at the Vietnam Drug Administration.

Manufacturing entities must comply with national regulations on industrial property rights and register for industrial property protection at the National Office of Industrial Property (Ministry of Science, Technology, and Environment).

Article 23. Entities with drug labels that have been granted trademark registration certificates or design patents must submit copies of these certificates together with the drug label registration dossier.

INSPECTION, AUDIT, AND VIOLATION HANDLING

Chapter VI
Inspection - Audit:

Article 24. 1) The Vietnam Drug Administration leads and coordinates with relevant departments and the Ministry of Health’s Inspectorate to organize inspections and audits of the implementation of this Circular by drug and cosmetic product manufacturing and trading entities nationwide.

2) Provincial Health Departments under central cities are responsible for inspecting and auditing the implementation of this Circular by drug and cosmetic product manufacturing and trading entities within their jurisdiction.

Violations of laws concerning the labeling of goods for drugs and cosmetics will be handled according to the law.

Article 25. Handling Violations:

This Circular takes effect 15 days from the date of issuance and replaces Decision No. 416/2000/QĐ-BYT dated February 18, 2000 issued by the Minister of Health regarding the Labeling Regulations for drugs and cosmetics directly affecting human health.

Chapter VII
IMPLEMENTING PROVISIONS

Article 26: During the implementation process, if there are any issues, entities should report them to the Ministry of Health for consideration and resolution.

In case of any difficulties during implementation, units shall report to the Ministry of Health for consideration and resolution.