Circular No. 01/2018/TT-BYT stipulates the labeling of drugs, raw materials for drugs, and drug user instructions.

CIRCULAR

Regulations on drug labeling and drug usage instructions and the drug usage guide

 

Pursuant to Law No. 105/2016/QH13 dated November 16, 2016 on pharmaceuticals 06 the 04 Pursuant to Decree No. 32/2019/NĐ-CP dated April 10, 2019 of the Government on assigning tasks, procurement or tendering for the supply of products and services using state budget from regular operating expenses;Article 16 on pharmaceuticals;

Pursuant to Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing certain provisions and implementing mechanisms of the Pharmaceutical Law;

Pursuant to Decree No. 43/2017/NĐ-CP dated April 14, 2017 of the Government on product labeling; covering product labeling;

Pursuant to Decree No. 75/2017/NĐ-CP dated June 20, 2017 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health; 0Decree No. 6/2017/ND-CP of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Department trThe Minister of Health issues this Circular on drug labeling and drug usage instructions,

The Minister of Health issues the Circular prescribing the labeling of drugs, raw materials for drugs, and the drug usage guide.

 PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

Article 1. This Circular prescribes the content and method of labeling for drugs and drug ingredients, and drug usage instructions circulating in the market; changing the expiration date on drug labels in cases of national defense, security, disease prevention and control, disaster relief, and mitigation of catastrophic consequences.

Article 2. Drugs and drug ingredients not subject to the scope of regulation of this Circular include:

a) Drugs and drug ingredients intended for export without registration for circulation in Vietnam;

b) Imported drugs under non-commercial purposes as prescribed in Clause 1, Article 75 of Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing certain provisions and implementing mechanisms of the Pharmaceutical Law (hereinafter referred to as Decree No. 54/2017/NĐ-CP);

c) Imported drugs used to meet urgent needs for national defense, security, disease prevention and control, disaster relief, and mitigation of catastrophic consequences as prescribed in Clause 1, Article 67 of Decree No. 54/2017/NĐ-CP.

Article 2. Interpretation of Terms

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

1. Commercial packaging of drugs refers to packaging containing drugs and drug usage instructions circulated together with the drugs; commercial packaging of drugs includes direct contact packaging with drugs, outer packaging, or intermediate packaging (if any).

2. Intermediate packaging refers to packaging used to package one or several units of drugs with direct contact packaging and located within the outer packaging of the drugs.

3. Production batch number is a symbol by number or letter, or a combination of both, used to identify a batch of drugs or drug ingredients and allow tracing the entire history of that batch of drugs or drug ingredients including all stages of production, quality inspection activities, and circulation of that batch of drugs or drug ingredients.

4. Primary label of drugs or drug ingredients is the label initially affixed by the manufacturer on the commercial packaging of drugs or drug ingredients.

Article 3. Position of drug labels and drug usage instructions

1. The position of drug labels shall be implemented according to the provisions of Article 4 of Decree No. 43/2017/NĐ-CP dated April 14, 2017 of the Government on product labeling (hereinafter referred to as Decree No. 43/2017/NĐ-CP).

Article 4. Size of labels, size of characters and numbers on labels, color of characters, symbols, and images on labels, language presentation of labels and drug usage instructions

1. The size of labels, size of characters and numbers on labels, color of characters, symbols, and images on drug labels and drug usage instructions shall be implemented according to the provisions of Article 5 (except for the content prescribed in Point b, Clause 2, Article 5) and Article 6 of Decree No. 43/2017/NĐ-CP.

2. Compulsory contents to be displayed on drug labels and drug usage instructions must be written in Vietnamese, except for some contents permitted to be written in other languages with Latin script according to the provisions of Clause 4, Article 7 of Decree No. 43/2017/NĐ-CP.

Article 5. Supplementing additional labels and replacing drug usage instructions in Vietnam

a) Imported drugs that have been registered for circulation in Vietnam but whose commercial packaging already contains Vietnamese drug usage instructions without updating the content according to the requirements of the Ministry of Health, except where the drug does not require such instructions as stipulated in points a, b, c, and d of Clause 1, Article 13 of this Circular;

b) Imported drugs that have not yet obtained registration for circulation in Vietnam and whose commercial packaging lacks Vietnamese drug usage instructions, except where the drug does not require such instructions as stipulated in points a, b, c, d, and e of Clause 1, Article 13 of this Circular.

3. Principles and locations for supplementing additional labels and replacing or supplementing drug usage instructions in Vietnamese:

After clearing customs, imported drugs and medicinal ingredients as specified in Clauses 1 and 2 of this Article must be supplemented with additional labels and Vietnamese drug usage instructions according to the following principles:

a) Additional labels shall be supplemented at storage warehouses for drugs and medicinal ingredients that meet the Good Storage Practice (GSP) standards of the importing entity;

4. In the case of replacing or supplementing drug usage instructions as specified in point b of Clause 3 of this Article, the secondary packaging entity that has performed the replacement or supplementation of drug usage instructions must strictly adhere to the Good Manufacturing Practice standards during the implementation of the provisions of point b of Clause 3 of this Article and must report to the Ministry of Health for management, inspection, and audit purposes, specifically:

a) The report must be submitted within one (01) month from the date of completion of the replacement or supplementation of drug usage instructions in Vietnam;

b) The report must include the following information: name of the importing entity; name of the drug; registration number or import permit number; production batch number; production date; expiration date; quantity of drugs that have had their usage instructions replaced or supplemented.

5. Entities responsible for labeling drugs are responsible for supervising and coordinating with entities performing the supplementation of additional labels and replacement or supplementation of drug usage instructions and must bear responsibility for the quality of the drugs and medicinal ingredients throughout the process of supplementing additional labels and replacing or supplementing drug usage instructions.

Article 6. Liability for labeling of drugs, drug ingredients, and drug usage instructions

1. Organizations responsible for labeling drugs, drug ingredients including secondary labels and drug usage instructions must ensure truthful, clear, and accurate labeling that reflects the true nature of the drugs and drug ingredients.

2. For domestically produced drugs and drug ingredients:

a) Production facilities and registration organizations for drugs and drug ingredients must be responsible for implementing the labeling of drugs and drug ingredients, and drug usage instructions issued by the production facility or registration organization.

b) Medical examination and treatment establishments permitted to prepare, compound, weigh (dispense) traditional medicine according to Clause 1 and Clause 2, Article 70 of the Drug Law; and produce, compound drugs according to Clause 2 and Clause 3, Article 85 of the Drug Law must be responsible for implementing the labeling of drugs prepared, compounded, weighed (dispensed), produced, or compounded by such establishment.

c) Pharmacies that compound drugs according to prescriptions sold at the pharmacy according to Point b, Clause 1, Article 47 of the Drug Law must be responsible for implementing the labeling of drugs compounded by such pharmacy.

3. For imported drugs and drug ingredients:

a) Importing organizations and registration organizations for drugs must be responsible for labeling drugs and drug usage instructions issued by the importing organization for drugs with circulation registration certificates.

b) Importing organizations and registration organizations for drug ingredients must be responsible for labeling drug ingredients imported by such organizations.

c) Importing organizations must be responsible for labeling drugs and drug usage instructions issued by the importing organization for drugs without circulation registration certificates.

4. For drug ingredients divided or separated into smaller packaged units during wholesale or retail sales: pharmaceutical business establishments that separate drugs must be responsible for affixing secondary labels in accordance with the provisions of Clause 2 and Clause 3, Article 7 of this Circular.

Chapter II

CONTENT OF LABELS AND DRUG USAGE INSTRUCTIONS

Section 1

REQUIRED CONTENT TO BE DISPLAYED ON THE LABEL

Article 7. Outer packaging label of drugs and drug ingredients

1. The outer packaging label of drugs must display the following contents:

a) Medicine name;

b) Formulation type;

c) Composition, dosage, weight, or concentration of active substances and medicinal materials in the drug formula;

d) Packaging specifications;

d) Indications, usage methods, contraindications of the drug;

e) Circulation registration certificate number or import permit number (if applicable);

g) Batch number, production date, expiration date of the drug, quality standards, storage conditions of the drug;

h) Warning signs and usage recommendations for the drug;

i) Name and address of the drug manufacturing facility;

k) Name and address of the importing organization (for imported drugs);

l) Origin of the drug.

2. The outer packaging label of drug ingredients (including medicinal materials, traditional herbal medicines, semi-finished herbal materials, semi-finished drugs) must display the following contents:

a) Name of the drug ingredient;

b) Weight or volume of the drug ingredient in the smallest unit of packaging;

c) Quality standards of the drug ingredient;

d) Circulation registration certificate number or import permit number (if applicable);

đ) Batch number, production date, expiration date, storage conditions of the drug ingredient;

e) Name and address of the drug ingredient manufacturing facility;

g) Name and address of the drug ingredient importing organization (for imported drug ingredients);

h) Origin of the drug ingredient.

3. Label of drug ingredients subject to special control (including semi-finished drugs):

In addition to the contents prescribed in Clause 2 of this Article, drug ingredients that are active substances, medicinal materials, or semi-finished drugs containing active substances or medicinal materials listed in the Schedule of Addictive Drugs, Psychotropic Drugs, Precursors for Drugs, Toxic Raw Materials for Drugs, Toxic Medicinal Materials, Radioactive Raw Materials for Drugs, must have the corresponding phrases printed on the outer packaging label as follows: "Addictive Ingredient", "Psychotropic Ingredient", "Precursor Ingredient for Drugs", "Toxic Ingredient", "Toxic Medicinal Material", "Radioactive Ingredient".

The phrases "Addictive Ingredient", "Psychotropic Ingredient", "Precursor Ingredient for Drugs", "Toxic Ingredient", "Toxic Medicinal Material", "Radioactive Ingredient" must be bolded within a frame and printed on the main face of the label bearing the name of the ingredient.

4. In cases where the outer packaging label of drugs cannot fully display the contents prescribed in Clause 1 of this Article, the contents prescribed in Point đ, Clause 1 of this Article may be summarized as follows: "Indications, usage methods, contraindications and other information: see the drug usage instruction sheet attached."

Article 8. Labels on Intermediate Pharmaceutical Packaging

1. The labels on intermediate pharmaceutical packaging must include at least the following information:

a) Medicine name;

b) Production batch number;

c) Expiry date.

2. In cases where the intermediate packaging material is transparent and allows the information on the direct contact packaging label to be visible, the intermediate packaging label does not need to include the information specified in Clause 1 of this Article.

Article 9. Labels on Direct Contact Pharmaceutical Packaging and Raw Materials for Medicines

1. The labels on direct contact pharmaceutical packaging must include all of the following mandatory information:

a) Medicine name;

b) Quantitative ingredients, concentration, or weight of active pharmaceutical ingredients or medicinal substances in the formula;

c) Production batch number;

d) Expiry date;

đ) Name of the medicine manufacturing facility;

2. Labels on direct contact packaging for raw materials for medicines. In cases where raw materials for medicines already have outer packaging that includes all the information required under Clause 2 and Clause 3 of Article 7 of this Circular, if they are not sold individually, there is no requirement to label the direct contact packaging.

3. For medicines and raw materials for medicines without outer packaging, the direct contact packaging must include all the information required for the outer label as stipulated in Article 7 of this Circular.

Article 10. Supplementary Labeling

1. Supplementary labels must fully include all mandatory information in Vietnamese as prescribed in Article 7 of this Circular, which is missing from the original label.

2. In cases where the supplementary label is too small to include all mandatory information as prescribed in Clause 1 of this Article, some information may be recorded as follows:

a) Indications, usage, contraindications, and other information: see the accompanying drug user guide;

b) Clearly indicate how to view the production date, expiry date, and production batch number printed on the original label;

c) Registration certificate number or import permit number: may remain blank but before releasing the medicine onto the market, the registration certificate number or import permit number (if applicable) must be clearly marked.

Article 11. Medicine Labels in Certain Other Cases

1. Traditional medicines processed, compounded, weighed (dispensed) according to Clause 1 and Clause 2 of Article 70 of the Pharmacy Law and medicines produced, compounded according to Clause 2 and Clause 3 of Article 85 of the Pharmacy Law must bear labels with the following mandatory information, except as provided in Clause 3 of this Article:

a) Outer labels of traditional medicines and compounded medicines must include the following information:

- Information prescribed in Points a, b, c, d, đ, g, and h of Clause 1 of Article 7 of this Circular;

- Name and address of the healthcare facility producing, compounding, processing, dispensing traditional medicines.

b) Direct contact packaging labels for traditional medicines must include the following mandatory information:

- Information prescribed in Points a, b, c, and d of Clause 1 of Article 9 of this Circular;

- Name of the healthcare facility producing, compounding, processing, dispensing traditional medicines.

c) In cases where traditional medicines and compounded medicines do not have outer packaging, the direct contact packaging must include the information required for the outer label as prescribed in Point a of Clause 1 of this Article.

2. Compounded medicines dispensed according to prescriptions at pharmacies as prescribed in Point b of Clause 1 of Article 47 of the Pharmacy Law must have outer labels or direct contact packaging labels and must include the following mandatory information:

a) Medicine name, dosage form;

b) Active ingredient, concentration, or content;

c) Date of compounding, expiry date, storage conditions;

d) Name and address of the pharmacy compounding the medicine;

đ) Patient's name from the prescription;

e) Warning signs for special control medicines.

3. Traditional medicines weighed, dispensed according to prescriptions as prescribed in Clause 1 of Article 70 of the Pharmacy Law are not required to comply with labeling requirements set out in this Circular but must have outer packaging containing the medicine and must include the patient's name and age on the outer packaging to avoid confusion during distribution.

4. Medicines not registered for circulation in Vietnam but permitted for importation for purposes such as bioequivalence testing, bioavailability assessment, sample registration, sample testing, scientific research, exhibition at trade fairs, and exhibitions are not required to include mandatory labeling information as prescribed in Articles 7 and 8 of this Circular, but must retain the original imported medicine label and must supplement with a supplementary label as follows:

a) Medicines used for bioequivalence testing, bioavailability assessment, sample testing, and scientific research: must include the phrase "Medicine for Research Purposes";

b) Medicines used for sample registration: must include the phrase "Sample Registration Medicine";

c) Medicines used for exhibition at trade fairs and exhibitions: must include the phrase "Exhibition Sample Medicine".

5. Raw materials for medicines, including active pharmaceutical ingredients not registered for circulation in Vietnam but permitted for importation for sample registration, sample testing, drug research, and exhibition at trade fairs and exhibitions as prescribed in Clause 3 of Article 60 of the Pharmacy Law are not required to include mandatory labeling information as prescribed in Articles 7 and 8 of this Circular, but must retain the original label.

6. Raw materials for medicines, including active pharmaceutical ingredients, excipients, and unfinished pharmaceutical products not registered for circulation in Vietnam imported for the production of medicines based on registration files already approved for circulation in Vietnam must include supplementary labels indicating the information prescribed in Clause 2 and Clause 3 of Article 7 of this Circular (excluding the name and address of the importing entity). If the original label already includes this mandatory information in languages using Latin script, there is no requirement to supplement with a supplementary label.

7. Imported medicines as prescribed in Point b of Clause 1 of Decree 54/2017/NĐ-CP are not required to include Vietnamese labeling as prescribed in this Circular but must retain the original label.

Section 2

CONTENT OF THE DRUG USER GUIDE

Article 12. Content of the drug usage guide

The drug usage guide includes the following contents:

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

2. Warning signs and recommendations when using the drug.

3. Drug formula components.

4. Formulation type.

5. Indications.

6. Usage method and dosage.

7. Contraindications.

8. Warnings and precautions when using the drug.

9. Drug use for pregnant women and nursing mothers.

10. Impact of the drug on driving ability and operating machinery.

11. Drug interactions and contraindications.

12. Adverse effects of the drug.

13. Overdose and treatment methods.

14. Pharmacological characteristics (not mandatory for over-the-counter drugs, herbal medicines, traditional medicines).

15. Pharmacokinetic characteristics (not mandatory for over-the-counter drugs, herbal medicines, traditional medicines).

16. Packaging specifications.

17. Storage conditions, expiration date, and quality standards of the drug.

18. Name and address of the drug manufacturing facility.

Article 13. General requirements for the drug usage guide

1. Drugs circulating in the market, produced, compounded, and processed in medical facilities as stipulated in Clause 1, Article 11 of this Circular must have a drug usage guide in Vietnamese, except for the following cases:

a) Drugs compounded, processed, and formulated according to prescriptions and formulas as stipulated in Clause 1, Article 70 and Clause 2, Article 85 of the Medicine Law solely for direct use and sale based on prescriptions at the same medical facility;

b) Compounded drugs sold directly at pharmacies as stipulated in Point b, Clause 1, Article 47 of the Medicine Law;

c) Drugs without a drug circulation registration certificate in Vietnam but permitted for importation under the following circumstances: bioequivalence testing, bioavailability assessment, sample registration, sample testing, scientific research, participation in exhibitions and trade fairs;

d) Imported drugs as stipulated in Point b, Clause 1, Decree 54/2017/NĐ-CP;

đ) Over-the-counter drugs with labels fully displaying all required information as specified in Article 12 of this Circular.

2. For drugs as stipulated in Point d, Clause 1 of this Article, the original foreign language drug usage guide must be retained.

3. Drugs with the same name, active ingredient, medicinal herb, formulation type, route of administration, indication, and manufacturer but with different volumes, concentrations, or packaging specifications and allowed to circulate may be included in a single drug usage guide. If there are differences in content among various concentrations, specific details must be provided for each concentration, volume, and packaging specification.

4. Each outer package of the drug must include at least one drug usage guide in Vietnamese. In cases where the drug does not have an outer package, each direct contact package with the drug must contain at least one drug usage guide.

Chapter III

LABELING AND DRUG USAGE GUIDE WRITING METHODS

Article 14. Methods for writing drug names and raw material names

1. Drug names and raw material names must be placed in a visible and readable position and must be the largest in size compared to other mandatory contents on the label and drug usage guide.

2. Drug names and raw material names should be written in Latin letters and can also be supplemented with numbers in Arabic numerals, Roman numerals, or other symbols from the Greek alphabet (for example: alpha, beta).

3. Drug names should be written according to the trade name or international nonproprietary name. For traditional medicines listed in the Traditional Medicine Catalog recognized by the Ministry of Health, they can be written according to the trade name or traditional prescription name recognized by the Ministry of Health, except for individual traditional herbs. Trade names of drugs must comply with the following principles:

a) Not having promotional characteristics;

b) Not causing misunderstanding about the composition or origin of the drug. In cases where the drug contains multiple active ingredients or medicinal herbs, the name of each component cannot be used as the drug name;

c) Not misleading or excessively describing the effects, efficacy, or indications of the drug;

d) Not violating Vietnamese customs, traditions, and aesthetics;

đ) Not conflicting with intellectual property rights of other individuals or organizations that are protected;

g) Not using the same name for drugs with different active ingredients;

h) Not using different names for drugs that meet all the following criteria: active ingredient, medicinal herb, formulation type, route of administration, concentration, dosage, and manufacturer. This regulation does not apply to contract-manufactured drugs and contract manufacturing of such drugs shall be carried out in accordance with the regulations of the Minister of Health on contract manufacturing of drugs;

i) For drugs with the same name, same manufacturer, same formulation type, and same active ingredient but with different dosages or concentrations, the drug name may be accompanied by the corresponding dosage or concentration immediately adjacent to the drug name for identification and differentiation.

4. Raw material names (excluding medicinal herbs and semi-finished drug products) shall be written in accordance with Clause 2, Article 16 of this Circular.

5. Names of traditional herbs shall be written according to the name of the medicinal herb as stipulated in Clause 3, Article 16 of this Circular and the phrase "traditional herb" shall be added before the Vietnamese name of the medicinal herb.

6. Names of medicinal herbs shall be written in accordance with Clause 3, Article 16 of this Circular.

7. Names of semi-finished medicinal herbs shall be written in accordance with Clauses 4 and 5, Article 16 of this Circular.

8. Names of semi-finished drug products (excluding semi-finished medicinal herbs) shall be written in accordance with Clause 6, Article 16 of this Circular.

Article 15. Warning Signs and Recommendations for Medication Use

1. Warning signs and recommendations for medication use must be printed on the label, the drug usage instructions sheet, including:

a) The phrases: "Keep out of reach of children," "Read the instructions carefully before use;"

b) For prescription drugs:

- On the outer packaging label: the symbol "Rx" must be marked at the top left corner of the drug name and the phrase "Prescription Drug;"

- The drug usage instructions sheet: the symbol "Rx" must be marked at the top left corner of the drug name; the phrase "This drug can only be used according to a prescription" must be included.

- Radioactive drugs: the phrase "RADIOACTIVE DRUGS" must be printed in bold, uppercase letters;- Drugs listed in the toxic drug directory as prescribed by the Ministry of Health: the warning phrase "TOXIC DRUGS" must be included;- Drugs for national health programs: the phrase "Program Drug, Not for Sale" must be included;

- Donated drugs or humanitarian aid drugs: the phrase "Donated Drug, Not for Sale" must be included;- Drugs for clinical trial purposes: the phrase "For Clinical Trial Use Only. Prohibited for Other Purposes" must be printed on the label;- Drugs for national health programs: the phrase "Program Drug, Not for Sale" must be included;

- For similar bioproducts: the phrase "Similar Bioproduct Name" must clearly state that it is a similar bioproduct to the reference bioproduct "Reference Bioproduct Name."

d) Additional warning signs and recommendations for specific types of drugs as follows:

- Injectable drugs: The label of injectable or infusion drugs must clearly specify or abbreviate the route of administration such as intramuscular injection (IM), subcutaneous injection (SC), intravenous injection (IV), intravenous infusion (IVI) or other specific methods of administration;

- Eye drops, eye ointments: The phrase "Eye Drops" or "Eye Ointment" must be included. For nasal drops, the phrase "Nasal Drops" must be included; for ear drops, the phrase "Ear Drops" must be included;

- Topical drugs must include the phrase "For External Use Only." Oral syringes must include the phrase "Not for Injection;"

- For drugs requiring thorough shaking before use (e.g., suspensions, powders, multi-dose granules intended for oral consumption that may settle, precipitate, or separate upon mixing), the phrase "Shake Well Before Use" must be clearly stated.

2. Methods of printing warning signs and recommendations for medication use:

a) Warning phrases and signs must be clearly printed on the outer packaging label or secondary labels and the drug usage instructions sheet. The content must be easily recognizable under normal observation conditions;

b) For the drug usage instructions sheet: immediately below the drug name, the warning signs and recommendations for medication use as specified in points a, b, and c of Clause 1 of this Article must be included, except for the Rx symbol;

c) In cases where a drug has multiple warning signs, all warning signs of the drug must be fully included.

Article 16. Drug Formula Components and Semi-finished Drug Products

a) Outer Packaging Label of Drugs and Semi-finished Drug Products:

- Fully list the name and concentration, weight, or volume of each active ingredient or herbal component in the drug formula or semi-finished drug product for the smallest unit of dosage or smallest unit of packaging;

- For vaccines: Clearly indicate the active ingredient corresponding to each dose unit;

1. General provisions:

- For traditional medicine drugs, herbal drugs, semi-finished traditional medicine products, and semi-finished herbal drug products: The name of each herbal component must be listed in Vietnamese, without the need to include the scientific name of the herbal component;

- It is not mandatory to list the excipient components, their concentrations, weights, volumes, or concentrations;

- Specifically, for state-secret traditional medicine drugs and family-hereditary traditional medicine drugs permitted by the Ministry of Health, certain herbal components, their quantities, or concentrations in the drug formula do not have to be displayed on the commercial packaging label. In such cases, the outer packaging label must include the phrase "The drug production formula is a state secret" or "The drug production formula is a family-hereditary secret."

b) Inner Packaging Label Directly Contacting with Drugs and Semi-finished Drug Products:

- Single-component drugs or drug combinations containing three or fewer active ingredients or herbal components: Fully list the active ingredients or herbal components in the drug formula or semi-finished drug product as stipulated in point a of this clause;

- Drug combinations containing more than three active ingredients or herbal components: There is no requirement to list the active ingredients or herbal components in the drug formula or semi-finished drug product. If listed, they must comply with the provisions of point a of this clause;

- For liquid drugs, the volume for the smallest unit of packaging must be indicated on the label.

c) Drug Usage Instructions Sheet:

- Fully list the name and concentration, weight, or volume of each active ingredient or herbal component in the drug formula for the smallest unit of dosage or smallest unit of packaging, and include the phrase "Active Ingredients:" or "Drug Ingredients:" before listing the names of the active ingredients or herbal components in the drug formula;

- Fully list the names of excipients in the drug formula and include the phrase "Excipients:" before listing the names of the excipients in the drug formula. It is not mandatory to list excipients that evaporate or are lost during production, nor is it mandatory to list the weight, volume, concentration, or volume of each excipient in the drug formula;

- For bioproducts: The quantity of the bioproduct must be expressed in units of weight, biological activity units, or international units for each bioproduct;

- For traditional medicine drugs and herbal drugs: The name of each herbal component must be listed in Vietnamese followed by the scientific name of the component in parentheses immediately after the Vietnamese name, with the scientific name italicized.

- Fully list the excipient ingredients in the drug formula and include the phrase "Excipient Ingredients:" before listing the names of the excipient ingredients in the drug formula. It is not mandatory to list excipients that have evaporated or disappeared during production, nor is it mandatory to specify the quantity, volume, concentration, or amount of each excipient ingredient in the drug formula;

- It is not mandatory to list the excipient components, their concentrations, weights, volumes, or concentrations;

- For biologics: The content of biologics is expressed in units of mass, biological activity units, or international units for each biologic;

- For traditional medicine, herbal drugs: The name of each herbal ingredient is recorded in Vietnamese followed by the scientific name of each herbal ingredient, with the scientific name of the herbals italicized within parentheses immediately following the Vietnamese name of the herbals;

- In cases involving traditional medicines listed in the State Secrets Directory and family-inherited traditional medicines as prescribed by the Ministry of Health, it is permissible not to disclose certain herbal ingredients, their quantities, or the weight of the herbs in the medicine formula. In such cases, the formula must include the corresponding statement: "The production formula of the medicine is a state secret" or "The production formula of the medicine is a family-inherited secret."

2. Method of recording drug substances and excipients:

a) The name of the drug substance and excipient shall be recorded according to the international common name or scientific name of the drug substance or excipient;

b) The name of the drug substance and excipient components does not need to be translated into Vietnamese.

3. Method of recording herbal materials and traditional medicinal ingredients:

a) Vietnamese name:

- The name of the herbal material and traditional medicinal ingredient shall be recorded according to the Vietnamese conventional name specified in the Vietnamese Pharmacopoeia or the name recorded in the drug and raw material lists issued by the Minister of Health;

- In cases where the Vietnamese name of the herbal material is not included in the Vietnamese Pharmacopoeia or in the drug and raw material lists issued by the Ministry of Health: record according to the Vietnamese name of the herbal material in the book "Herbs and Traditional Medicines in Vietnam" by Do Tat Loi; the book "1000 Herbs and Medicinal Animals" by the Institute of Pharmacy; the name of the herbal material in this case must be advised by the Advisory Council for the issuance of the Drug Circulation Registration Certificate by the Minister of Health;

- In cases where the imported herbal material name cannot be translated into Vietnamese, record according to the name of the herbal material from the exporting country (or manufacturing country) along with the scientific name of the herbal material;

- In cases where different parts of the herbal material and traditional medicinal ingredient are used as medicine: specify the part of the herbal material used as medicine or record according to the name indicating the part used as medicine of the herbal material. For example: Lotus heart, Mulberry flower, Forsythia flower.

b) Scientific name (Latin name):

- The scientific name of the herbal material and traditional medicinal ingredient shall be recorded according to the scientific name of the herbal material in italicized style as recorded in the Vietnamese Pharmacopoeia or in the herbal material and traditional medicinal ingredient lists issued by the Minister of Health;

- In cases where the scientific name of the herbal material and traditional medicinal ingredient is not included in the Vietnamese Pharmacopoeia or in the lists issued by the Minister of Health, record the scientific name of the herbal material as recorded in foreign pharmacopoeias.

4. Method of recording names of herbal extract, types of extract, and herbal extract formula:

a) Recording method for herbal extract:

- Must fully record: the name of the extract, type of extract, and the composition, concentration, quantity, or weight of each herbal component in the herbal extract;

- For herbal extracts with trade names, the trade name of the herbal extract may be recorded, while clearly stating the name of each herbal component in the herbal extract according to Clause 3 of this Article;

- In cases where the herbal extract does not have a trade name, record the word "extract" (for single-component herbal extract) before the name of the herbal material or the phrase "mixed herbal extract" (for multi-component herbal extract) before the names of the components;

b) Recording method for types of herbal extract:

- Herbal extracts must clearly indicate the type of extract, which includes three types: liquid extract, thick extract, or dry extract as defined in the Vietnamese Pharmacopoeia;

- In cases where the type of herbal extract is not clearly indicated, clearly record the moisture limit along with the name of the herbal extract or clearly record the ratio of the extract to the initial herbal material quantity;

c) Recording method for herbal extract formula:

- In cases where the monograph in the Vietnamese Pharmacopoeia or recognized foreign pharmacopoeia specifies quantitative standards for the content of active ingredients or groups of compounds, record the herbal extract along with the percentage content of the active ingredient or group of compounds determined for each herbal material;

- In cases where the monograph in the Vietnamese Pharmacopoeia or recognized foreign pharmacopoeia does not specify quantitative standards for the content of active ingredients or groups of compounds, the herbal extract must be recorded along with the initial quantity of herbal material or clearly record the ratio of the extract to the initial herbal material (the initial herbal material is herbal material meeting the standard for medicinal use);

- When using a solvent other than ethanol, water, or an ethanol-water mixture for extracting herbal material to produce the extract, the herbal extract must be recorded along with the name of the solvent used for extraction.

5. Method of recording semi-finished herbal products (excluding herbal extracts) in the medicine formula:

a) Must fully record: the name of the semi-finished herbal product and the composition, concentration, quantity, or weight of each herbal component in the semi-finished product;

b) Recording method for the name of semi-finished herbal products:

- For semi-finished products with trade names, the trade name of the semi-finished herbal product may be recorded, while clearly stating the name of each herbal component in the semi-finished herbal product according to Clause 3 of this Article;

- In cases where the semi-finished herbal product does not have a trade name, record according to the name of the herbal material specified in Clause 3 of this Article (for semi-finished herbal products containing only one type of herbal material) or record as "mixed herbal material" (for semi-finished herbal products containing multiple types of herbal materials), while clearly indicating the type of semi-finished herbal product (e.g., powder, granules) before the name of the herbal material or before the phrase "mixed herbal material";

c) Recording method for the formula of semi-finished herbal products:

- In cases where the monograph in the Vietnamese Pharmacopoeia or recognized foreign pharmacopoeia specifies quantitative standards for the content of active ingredients or groups of compounds, record the semi-finished herbal product along with the percentage content of the active ingredient or group of compounds determined for each herbal material;

- In cases where the monograph in the Vietnamese Pharmacopoeia or recognized foreign pharmacopoeia does not specify quantitative standards for the content of active ingredients or groups of compounds, the semi-finished herbal product must be recorded along with the initial quantity of herbal material or clearly record the ratio of the semi-finished herbal product to the initial herbal material (the initial herbal material is herbal material meeting the standard for medicinal use);

6. Method of recording names of semi-finished medicines (excluding semi-finished herbal products) in the medicine formula:

a) Must fully record: the name of the pharmaceutical intermediate and the components, concentration, content, or weight of each active ingredient in the pharmaceutical intermediate.

b) The method of recording the name of the pharmaceutical intermediate:

- For pharmaceutical intermediates with a trade name, it is permissible to record the trade name of the pharmaceutical intermediate, while clearly stating the name of each active ingredient contained in the pharmaceutical intermediate as stipulated in Clause 2 of this Article;

- In cases where the pharmaceutical intermediate does not have a trade name, it shall be recorded according to the name of the active ingredient specified in Clause 2 of this Article (for pharmaceutical intermediates containing only one active ingredient) or recorded as "active ingredient mixture" (for pharmaceutical intermediates containing multiple active ingredients), while clearly indicating the type of pharmaceutical intermediate (e.g., powder, granules) before the name of the active ingredient or the phrase "active ingredient mixture."

c) The method of recording the formula of the pharmaceutical intermediate: carried out according to the provisions for pharmaceutical intermediates in Clause 1 of this Article.

7. Units of measurement for expressing content, concentration, weight, volume:

Content, concentration, weight, and volume are calculated based on units of mass, volume units, activity units, or other commonly used units, as follows:

a) Mass measurement units: use grams (abbreviated as g), milligrams (abbreviated as mg), micrograms (abbreviated as μg or mcg), or kilograms (abbreviated as kg). If the mass is less than 1 mg, it should be written in decimal form (e.g., 0.25mg);

b) Volume measurement units: use milliliters (abbreviated as ml), microliters (abbreviated as μl or mcl), or liters (abbreviated as l or L). When the volume of the drug is less than 1 ml, it should be written in decimal form (e.g., 0.5ml);

c) Other measurement units:

- International activity units may be used for certain special active ingredients as prescribed;

- Internationalized measurement units commonly used in the healthcare sector, such as IU and other international activity units, when translated into Vietnamese may cause confusion in usage, can retain the original international unit notation without requiring translation into Vietnamese.

d) In cases where the active ingredient's form in the drug formula differs from its dosage form, the content, concentration, and weight must be converted to the dosage form on the outer packaging label and the user guide. The form of the active ingredient includes base form, salt form, hydrated form, or other forms of the active ingredient.

Article 17. Formulations

1. The formulation of the drug must be specifically recorded as: tablets, capsules, hard gelatin capsules, injectable solutions, powder for injection, suppositories (specify the placement site), powders, granules, or other formulations as prescribed by the Vietnamese Pharmacopoeia or other commonly used international pharmacopoeias.

2. For the drug user guide, in addition to the contents stipulated in Clause 1 of this Article, the following information must be supplemented:

a) Must describe the external characteristics of the drug regarding color, size, physical state, shape, or external signs of the drug (if applicable);

b) For drugs in tablet form with grooves designed, it must specify whether the drug can be broken in half;

c) Clearly indicate information about pH and osmolality (if applicable).

Article 18. Indications

The indications of the drug must correspond to the purpose, formulation, and route of administration of the drug. Information about indications must be clear and specific, and must include the following contents:

1. Purpose of drug use: clearly record the purpose of drug use, such as: treatment, supportive treatment, prevention (prophylaxis), symptom relief.

2. Drug use population (if applicable): clearly record the indication or limitation of indication for each specific user group, which may be classified by age group or age range or specific age limit.

3. Additional conditions for safe and effective drug use (if applicable).

Example: during treatment, it is necessary to combine with other drugs or methods to enhance treatment efficacy or reduce unwanted side effects of the drug.

Article 19. Dosage and Administration

1. Dosage:

a) The dosage must be clearly stated for each route of administration or according to each indication and method of drug use.

- Clearly state the time interval and timing between doses within a day, and the method of drug use to achieve maximum efficacy (for example: drink with plenty of water, take before meals);

- Clearly state the minimum total dosage recommended, the maximum total dosage recommended, and the duration of drug use limit (if applicable).

b) Clearly state the dosage and method of administration for adults and children (if applicable). The dosage for children must be clearly stated for each age group or based on weight;

c) Clearly state the dosage adjustments required for special user groups (if applicable) such as: children, elderly people, patients with renal insufficiency, patients with hepatic insufficiency, or other cases.

2. Administration:

a) The method of drug administration must clearly state the route of administration, duration of use, and the method of drug use to achieve maximum efficacy:

- For injectable drugs, clearly state the preparation or reconstitution method for injection, clearly state the route of injection and injection method: intramuscular injection, intravenous injection, intravenous infusion, subcutaneous injection, deep subcutaneous injection, deep intramuscular injection, and other injection methods; clearly state the information about the injection or infusion rate (if required);

- Clearly state the method of drug use for certain cases that require attention or recommendations as specified in Point d Clause 1 Article 15 of this Circular;

- For decoctions: clearly state the method of drug use, method of consumption (water used for decoction, decoction utensils, decoction method, alcohol soaking method, temperature and decoction or soaking time), information about contraindications and precautions when using decoctions.

b) For prescription drugs:

In addition to the provisions in Point a Clause 2 of this Article, additional information about the method of drug use for children, special groups, and other necessary recommendations (if applicable) must be provided as follows:

- The dosage must be clearly stated for each age group. The dosage is calculated based on weight or body surface area (mg/kg or mg/m2) or divided into corresponding dose intervals. Drugs are used for children with similar indications as adults, the dosage and method of drug use for children must be clearly stated;

- If there is no pediatric formulation available, provide information on preparing the drug form for children from what age after preparation according to the manufacturer's recommendation;

- If the drug does not have an indication for one or all age groups of children, the dosage and method of use must be clearly stated in one of the following presentation methods:

+ The safety and efficacy of the drug for children of a specific age (measured in months or years), or suitable patient groups (such as gender, weight) have not been proven;

+ The drug is not recommended for children of a specific age (measured in months or years), or suitable patient groups (such as gender, weight) due to issues related to drug safety and efficacy;

+ It is not advisable to use the drug on children of a specific age (measured in months or years), (or suitable patient groups, such as gender, weight) with a specific drug indication.

- Necessary recommendations regarding dosage and method of drug use (if applicable):

+ When stopping drug use, forgetting to take a dose, using the drug with food and drink, resuming drug use after a treatment course;

+ Adjusting the dosage when using other drugs simultaneously, adjusting the dosage appropriately based on the patient's condition (dependent on clinical signs and symptoms and/or test results evaluating renal function, liver function corresponding to the adjusted dosage level);

+ Preventive measures for some specific adverse reactions (for example, taking anti-nausea medication before using cancer treatment drugs), mild but common adverse reactions at the initial dosage;

+ Special recommendations about handling or administering the drug for healthcare workers or patients when using the drug (if applicable), information about other administration methods, especially gastric lavage (if there is information), for drugs administered via non-gastrointestinal routes, clearly state the information about the drug injection or infusion rate.

3. Some special notes on drug handling before and after drug use:

Supplement information on drug use in certain cases requiring drug handling before and after drug use, specifically as follows:

a) Drug handling before use (if applicable):

- Clearly state the method of preparing the drug before use (reconstitution or dilution);

- Describe measures to protect the person preparing the drug;

- Clearly state the external characteristics of the drug before reconstitution or dilution, the characteristics of the drug after reconstitution for drug forms that require reconstitution before use.

b) Drug handling after use (if applicable):

- Clearly state the cautious disposal of the drug after use for certain specific cases such as: cytotoxic drugs, preparations containing live organisms, and other cases with specific regulations;

- In cases where there are no special usage or handling instructions, clearly state "No special requirements for drug handling after use" for healthcare workers.

Article 20. Contraindications

1. Medicines with contraindications must clearly specify the cases where the medicine should not be used.

2. Medicines with contraindications for children must clearly indicate specific age groups of children (in months or years) or other appropriate patient groups (such as by gender, weight) corresponding to each contraindication of the medicine.

Article 21. Warnings and Precautions when Using Medicines

1. Must clearly state preventive measures, precautions when using medicines, conditions requiring caution when using medicines, special recommendations when using medicines for children, patients with chronic diseases (if available information).

2. Conditions requiring caution when using medicines:

a) Tests or conditions of the patient that need to be evaluated before using the medicine, necessary measures to minimize the risk of adverse reactions to the patient during the use of the medicine;

b) Severe adverse reactions that need to be warned to healthcare personnel;

c) Measures to prevent and detect early signs of severe adverse reactions;

d) Risks related to starting or temporarily stopping treatment;

đ) Special groups at high risk of experiencing severe adverse reactions related to the drug group (these reactions are often serious or common);

e) Clinical signs, symptoms, or tests that need to be monitored during treatment. Tests affected by the use of the medicine;

g) Warnings and precautions for children regarding the safety of long-term use of the medicine (for example, effects on child development, neurodevelopment, reproductive development, and other cases);

h) Warnings related to excipients or residual substances with known adverse effects. The content of the warning to this excipient component must be clearly stated in this section or recorded in the warnings and precautions when using the medicine;

i) Warning about the presence of ethanol in the formula of the medicine;

k) Risks related to errors that may occur during the use of the medicine.

3. For biosimilar products:

Must clearly state the warnings regarding risks associated with switching between reference biologics and biosimilar products during treatment.

Article 22. Use of Medicines for Pregnant Women and Nursing Mothers

1. Use of medicines for pregnant women:

a) Provide information on the risks of medicines for pregnant women. In cases where there is insufficient information about the impact of medicines on pregnant women, it must clearly state "No data on the use of medicines in pregnant women, only use if the benefits outweigh the risks";

b) Recommendations for the use of medicines for pregnant women must include content on the use of medicines in women who are capable of becoming pregnant or are using contraceptive methods, and the use of medicines at different stages of pregnancy;

c) Supplement information on the impact of medicines on the fetus, including providing key information on the potential impact of medicines on the fetus. If there is no information on fetal toxicity, it must be clearly stated in this case;

d) Provide recommendations on monitoring the fetus and newborns whose mothers used medicines during pregnancy (if available information).

2. Use of medicines for nursing mothers:

Clearly specify each case such as stopping or continuing breastfeeding, stopping or continuing treatment (if full information is available).

Article 23. Impact of Medications on Driving Ability and Operating Machinery

1. Clearly indicate the impact of medications on driving ability and operating machinery at one of the following levels: no impact or negligible impact, slight impact, moderate impact, severe impact.

In cases where there is no evidence of the impact of medications on driving ability and operating machinery, it must be clearly stated: "No evidence of the impact of medications on driving ability and operating machinery."

2. Provide additional important information (if applicable) such as the duration for which these impacts diminish and the tolerance to continued medication use.

Article 24. Drug Interactions and Incompatibilities

1. Drug Interactions:

a) Fully record all drug interactions with other drugs and other types of interactions (for example: alcohol, food) that may affect the efficacy and therapeutic effect of the drug, specifically as follows:

- Clearly state drug interactions when they have clinical significance based on pharmacodynamic characteristics and pharmacokinetic studies of the drug;

- Clearly state the consequences of drug interactions: clinical manifestations (if any), the impact of drug interactions on blood drug concentration, pharmacokinetic parameters of active substances or metabolites with activity, the impact of drug interactions on test results. Clearly state the methods to mitigate the consequences of interactions;

- Clearly state the mechanism of interaction if it is clear. If there are no studies on drug interactions, this must be clearly stated in this section;

- Other serious drug interactions such as: drug absorption into packaging, injection equipment.

b) For herbal medicines and traditional medicines, clearly state contraindications when using the medicine (if any). For example: if taking warm-natured medicine, avoid cold raw foods; if taking cool-natured medicine, avoid spicy and stimulating foods.

2. Drug Incompatibilities:

a) Record information about chemical and physical incompatibilities of the drug with other drugs when mixed or used simultaneously, especially those drugs that are reconstituted or diluted before intravenous administration;

b) In cases where there is insufficient information about drug incompatibilities, add the statement: "Due to lack of studies on drug incompatibility, do not mix this drug with other drugs."

Article 25. Adverse Reactions of Medications

1. Clearly state situations where medication use should be discontinued, situations where adverse reactions must be reported to a physician or pharmacist, and reporting of adverse reactions of the drug to the National Center for Drug Information and Adverse Reaction Monitoring.

2. In addition to the contents stipulated in Clause 1 of this Article, supplementary information must be added according to the summary table of adverse reactions as prescribed (if applicable):

a) Summary Table of Adverse Reactions: categorized by frequency: very common (ADR ≥ 1/10), common (1/100 ≤ ADR < 1/10), uncommon (1/1000 ≤ ADR < 1/100), rare (1/1000 ≤ ADR < 1/10000) and very rare (ADR < 1/10000); For herbal medicines and traditional medicines: only list adverse reactions, without requiring categorization of adverse reactions by frequency.

b) For patients who are children, describe: characteristics regarding age and severity of adverse reactions in pediatric patients (if any); clinically significant differences between adults and children (or specific age groups) regarding drug safety (if any). If this information has been mentioned in another section of the usage guide, a reference to the section containing the information must be provided.

c) Any clinically significant differences (regarding frequency of occurrence, severity, recovery potential, and monitoring requirements) in special populations (such as elderly individuals, patients with liver or kidney failure, patients with comorbidities) must be clearly stated.

3. In cases where adverse reactions of the drug have not been recorded or there is no evidence, add the statement: "No reports of adverse reactions of the drug have been recorded" and the statement "Report any adverse reactions experienced during medication use immediately to a physician or pharmacist."

Article 26. Overdose and Management Measures

1. Overdose:

a) Specify the symptoms and manifestations when using an overdose of the drug: Specifically record acute poisoning symptoms and signs, and the potential to cause congenital malformations (if applicable);

b) In cases where there is no information on drug overdose usage: specifically record the statement "No data on drug overdose usage, do not exceed the prescribed dose of the drug."

2. Management measures for drug overdose:

a) Specify the measures or management methods for overdose, including monitoring measures, the use of agonists, antagonists, detoxification, and methods to enhance drug excretion from the body. In cases where there is no information or incomplete information, record the phrase "Actively monitor to implement timely management measures";

b) Provide specialized information for specific groups such as elderly people, pregnant women and nursing mothers, children, patients with liver or kidney failure, and patients with chronic diseases (if applicable).

Article 27. Information on Pharmacology and Clinical Data

1. Pharmacodynamic characteristics: Include the following contents:

a) The pharmacological group and ATC code of the drug (if available);

b) Description of the mechanism of action of the drug corresponding to the approved indications;

2. Pharmacokinetic characteristics: Include the following contents:

a) Pharmacokinetic characteristics of the drug (absorption, distribution, metabolism, excretion, and other characteristics) corresponding to the recommended dose, concentration, and dosage form of the drug;

b) Description of differences between factors (such as age, gender, weight, smoking status, patients with liver or kidney failure) that affect pharmacokinetic parameters. If these effects have clinical significance, clearly specify them with quantitative parameters;

c) Relationship between dose, concentration, pharmacokinetic parameters (including primary criteria, secondary criteria, adverse reactions) and the characteristics of the patient population studied;

d) For pediatric patients: Summarize the results from pharmacokinetic studies on different age groups of children and compare them with adults (if available). Clearly specify the dosage forms used in pediatric pharmacokinetic studies and highlight any uncertainties due to the limitations of using the drug on pediatric patients.

3. Data from clinical and non-clinical trials (if available):

a) Summarize the main results recorded from large-scale clinical trials supporting the approved indication of the drug (if available), including at least the following information:

- Description of the main features of the study sample;

- Primary criteria;

- Secondary criteria (if applicable);

- Study results related to the primary criteria.

b) Provide key information related to non-clinical studies (if available).

Article 28. Smallest Unit of Packaging and Packaging Specifications

1. The smallest unit of packaging is typically defined as follows:

a) For solid dosage forms such as tablets, the smallest unit of packaging is the tablet. In cases of small capsules, the smallest unit of packaging is the package, bottle, vial, or pouch;

b) For liquid dosage forms, the smallest unit of packaging is the vial, bottle, vial, pouch, syringe, prefilled syringe;

c) For powder for injection dosage forms, the smallest unit of packaging is the vial, bottle, vial, pouch, syringe, prefilled syringe;

d) For powder or effervescent granules for oral suspension dosage forms, the smallest unit of packaging is the package, bottle, vial, pouch;

đ) For topical dosage forms such as creams, ointments, gels, the smallest unit of packaging is the tube, bottle, pouch;

e) For transdermal patch dosage forms, the smallest unit of packaging is the patch;

g) For aerosol or inhalation dosage forms, the smallest unit of packaging is the spray can, spray bottle, inhaler, spray dose, or container for use with a nebulizer;

h) For combination kit dosage forms, the smallest unit of packaging is the kit;

i) For decoction dosage forms, the smallest unit of packaging is the pouch, package, or box;

k) For raw materials for drugs, the smallest unit of packaging is the bag, pouch, package, crate, box, bottle, vial.

2. Method of recording packaging specifications:

a) Packaging specifications are recorded according to the natural count of the quantity, mass, or volume of the drug contained in the commercial packaging;

b) In cases where there are multiple units of packaging in a single commercial package of the drug, the number of each unit of packaging must be specified along with the total number of units of packaging;

c) Clearly specify any accompanying components with the drug, such as needles, syringes, measuring spoons, measuring cups, nebulizers, and other auxiliary equipment included in the commercial packaging of the drug (if applicable).

3. For drugs listed under special control categories such as addictive drugs, psychotropic drugs, and precursor substances for drug manufacture, the outer packaging of the drug shall not contain more than 100 smallest units of packaging.

Article 29. Production batch number, production date, expiration date

1. Production batch number:

The production batch number may be fully written as "Production batch number" or abbreviated using one of the following phrases: "Production batch SX", "Batch SX", "LSX" or "SLSX" followed by information about the production batch number symbol. The information and structure of the production batch number symbol shall be determined by the manufacturer.

2. Production date, expiration date (or usage period):

a) The production date, expiration date (or usage period) may be fully written as "Production date", "Expiration date" or "Usage period" or abbreviated in uppercase letters as "NSX", "HD" or "HSD", followed by information on the production date and expiration date of the drug;

b) The production date and expiration date shall be recorded in the order of day, month, year of the Gregorian calendar. Each digit for day, month, and year shall be written with two digits, except for the year which may also be written with four digits.

The digits for day, month, and year of a time point must be recorded on the same line and separated between day, month, and year by a "/" (day/month/year), "." (day.month.year), "-" (day-month-year), space (day month year), or the digits for day, month, and year may be written consecutively;

c) In cases where the outer packaging of the drug contains tubes, vials of solvent for injection, or other components accompanying the drug, the label of the outer packaging must be displayed as follows:

- If the production date and expiration date of all components of the product are the same, the production date and expiration date shall be jointly recorded on the label of the outer packaging of the product;

- If the production date and expiration date of each component within the product are different, the expiration date of the product set on the label of the outer packaging shall be recorded according to the shortest expiration date among the components or specifically record the expiration date of each component in the product set;

3. Recording method for production date, expiration date (or usage period), production batch number:

- If the label records the production date, expiration date, and production batch number in a foreign language, then the supplementary label must record as follows: production date (NSX), expiration date (HD/HSD), production batch number (LSX/SLSX) see the information recorded in the foreign language on the original label of the product.

Example: NSX, HD, SLSX see "Mfg Date", "Exp Date", "Lot.No." printed on the packaging.

- If the label directly contacting the drug records the expiration date in the format "month/year", while the outer packaging label records the full expiration date in the format "day/month/year", the drug's expiration date shall be calculated based on the expiration date recorded on the outer packaging label;

- If both the label directly contacting the drug and the outer packaging label record the expiration date in the format "month/year" but the production date is recorded on the label as follows:

+ If the original label records the production date in the format "day/month/year", the expiration date recorded on the supplementary label shall be calculated and recorded based on the production date on the original label;

+ If the original label records the production date in the format "month/year", the expiration date shall be calculated as the last day of the month of expiration, and the supplementary label must include the phrase: "expiration date is the last day of the month of expiration";

b) In cases where the direct packaging label has a small size that does not have enough space to record the production batch number, expiration date, or corresponding symbols "Production batch SX" and "HD" as stipulated in Clause 1 and Clause 2 of this Article, the series of numbers representing the production batch number and expiration date may be recorded on the direct packaging label, but the outer packaging label must fully record these pieces of information as required;

- Clearly state the time period starting from the production date;

- Expiration date after opening the direct packaging for the first time for drugs that have not been divided into doses such as eye drops, nasal sprays, ear drops, ointments, gels used multiple times, and liquid multi-dose preparations for oral consumption or tablets packed in large containers (if applicable);

- Expiration date after preparation for use for powdered drugs or effervescent drugs that require mixing into a solution or suspension before use such as: powdered drugs, effervescent drugs mixed into a suspension, solutions for injection or oral consumption.

Article 30. Changing the expiration date on drug labels for reasons of national defense, security, disease prevention and control, disaster relief, and mitigation

In cases of national defense, security, disease prevention and control, disaster relief, and mitigation, the Minister of Health shall decide on changing the expiration date on drug labels and specify the method of recording the expiration date for each specific case based on the quality of the drugs, the actual situation between benefits and risks, or severe shortages of domestic drug supplies.

Article 31. Recording storage conditions for drugs and raw materials, and quality standards

1. Drug labels, raw material labels, and user instructions:

Clearly record necessary temperature conditions (recorded in degrees Celsius, abbreviated as °C, and must be recorded with specific numbers). Any notes regarding humidity, light, or other special storage requirements at the storage location or during transportation to ensure drug quality during storage and circulation (if applicable).

2. Record storage conditions for drugs clearly in the user instructions for cases specified in items 2 and 3 of point c, Clause 3, Article 29 of this Circular.

3. Method of recording quality standards:

On outer packaging labels and drug user instructions, quality standards for drugs and raw materials must be recorded as follows:

a) For drugs and raw materials applying Vietnamese Pharmacopoeia or foreign Pharmacopoeia recognized by the Ministry of Health: quality standards should be recorded according to the full name in Vietnamese of the Pharmacopoeia or abbreviated name in Vietnamese for the Vietnamese Pharmacopoeia, or abbreviated name in English for foreign Pharmacopoeia. It is not mandatory to record the version number or publication year of the Pharmacopoeia;

b) Drugs and raw materials applying basic standards, record fully as "Basic Standards" or abbreviated as: "BS".

Article 32. Registration Number for Circulation, Import Permit Number

1. Registration Number for Circulation in Vietnam.

Record fully as "Registration Number for Circulation:" or abbreviated as "SĐK:" and leave blank when submitting registration application documents. Before circulating drugs on the market, supplement the registration number issued by the Ministry of Health for drugs and raw materials that have been granted circulation registration.

2. Import Permit Number:

Record fully as "Import Permit Number:" or abbreviated on the label as "GPNK:" and leave this section blank when submitting import application documents. Before circulating drugs on the market, supplement the import permit number issued by the Ministry of Health for drugs and raw materials without circulation registration.

Article 33. Name and Address of Production, Compounding, Processing, Importing Entities and Other Related Entities (if applicable)

1. General rules for recording the name and address of production entities and importing entities on drug labels and user instructions:

a) Outer packaging labels of drugs and raw materials:

- For domestically produced drugs: record fully the role, name, and address of the drug production entities;

- For domestically produced or imported raw materials: record fully the name and address of the raw material production entity;

- For imported drugs: record fully the role, name, and address of the drug production entity; name and address of the importing entity.

b) Direct contact packaging labels: The name of the production entity can be recorded in full or trade name but must ensure the identification of the production entity.

In cases where multiple entities participate in the production of finished drugs, it may be recorded in one of the following two ways:

- Record fully all participating production entities;

- Record the name of the entity responsible for releasing the batch of drugs.

c) For traditional medicine as stipulated in Clause 1 and Clause 2, Article 70 of the Medicine Law and drug labels produced, compounded in medical examination and treatment facilities as stipulated in Clause 2 and Clause 3, Article 85 of the Medicine Law:

- Outer packaging labels: record fully the name and address of the medical examination and treatment facility performing compounding, preparation, mixing, and production of drugs;

- Direct contact packaging labels: record the full name or trade name of the medical examination and treatment facility.

d) Drug labels compounded according to prescriptions sold at pharmacies as stipulated in item b, Clause 1, Article 47 of the Medicine Law: record fully the name and address of the pharmacy compounding the drug;

đ) User instructions: must record fully the role, name, and address of the drug production entities. For imported drugs, the country of production must be translated into Vietnamese unless it cannot be translated or has no meaning in Vietnamese;

e) In addition to production entities and importing entities, the roles, names, and addresses of other related entities (such as registration entities, drug distribution companies, brand owners, product owners, and other cases) may also be recorded on the labels and user instructions.

2. Recording the role of related entities before the entity's name, specifically:

a) For production entities:

- If only one production entity participates in the production process: record the role as "Production Entity:";

- If multiple production entities participate in the production process: clearly record the role of each production entity, such as: "Intermediate Product Production Entity"; "Primary Packaging Entity"; "Entity Responsible for Batch Release";

- The name of the drug and raw material production entity is the name recorded in the business license for pharmaceutical activities issued by the competent authority.

b) For importing entities: record the role as "Importing Enterprise";

c) For other entities: record the role as "Distribution Entity", "Product Owner", "Brand Owner", and other entities related to drugs (if applicable).

3. Recording the name and address of the production entity:

a) For drugs produced with the participation of different production facilities, the names of all participating production facilities must be recorded along with their addresses, which are the locations of drug production according to the regulations on recording the names and addresses of production facilities. The names of the participating production facilities must be in the same font size and on the same label surface (same plane).

b) For drugs produced under contract manufacturing, record: "Produced at: (name and address of the contract manufacturer) pursuant to a contract with: (name and address of the contract entruster)". The name and address of the contract manufacturer must be in the same font size and recorded on the same label surface (same plane) as those of the contract entruster.

c) For drugs produced under technology transfer, record: "Produced at: (name and address of the technology recipient) transferred from: (name and address of the technology provider)". The name and address of the technology provider must be in the same font size and recorded on the same label surface (same plane) as those of the technology recipient.

4. Method of recording the name and address of the importing entity: Record according to one of the following methods:

a) Fully record "Importing enterprise: name and address of the drug importing entity" on the label;

b) Abbreviate to "DNNK: full name and address of the drug importing entity".

Record "Importing enterprise:" or "DNNK:" and leave the space for the name of the importing entity blank, but before releasing the drug onto the market, fully supplement the name and address of the importing entity in this section.

5. Other provisions regarding the method of recording the name and address:

a) Method of recording the name of the entity:

- Name of domestic entities: record according to the name of the entity recorded in the certificate of business registration for pharmaceuticals, business registration certificate, or investment certificate issued by the competent authority;

Specifically, for healthcare facilities: record the name according to the medical practice permit issued in accordance with the Law on Medical Examination and Treatment.

- Name of foreign entities: record according to the name recorded in the drug product certificate or Good Manufacturing Practice (GMP) certificate for pharmaceutical products issued by the competent authority of the country of origin, or the name recorded on other relevant certificates.

Specifically, for the name of the production facility, it must be recorded according to the name recorded in the drug product certificate or GMP certificate for pharmaceutical products issued by the competent authority of the country of origin.

b) Method of recording the address of the entity:

- Address of domestic production facilities: the address of domestic production facilities must be recorded according to the business location for pharmaceuticals recorded in the certificate of business registration for pharmaceuticals that corresponds to the pharmaceutical business entity, and may also include the main office address of the enterprise;

- Address of production facilities: Record according to house number, street (village, hamlet), commune (ward, town), district (city district, provincial city), province (central city);

Specifically, the address of healthcare facilities: Record the correct production location of the healthcare facility according to the medical practice permit issued in accordance with the Law on Medical Examination and Treatment.

- For imported drugs:

Record the address of the production facility as the production location recorded in the drug product certificate or GMP certificate for pharmaceutical products issued by the competent authority of the country of origin.

c) The name, address, and logo (if any) of organizations and individuals related to the drugs specified in this clause, when recorded on the label or instructions for use, must not exceed the size of the name, address, or logo (logo) of the production facility, except where such organization can prove itself to be the owner of the product.

d) If the label records the name, address, and logo (logo) of the drug distributor, then the name, address, and logo (logo) of the distributor must not be larger than those of the production facility.

e) If the drug production facility is a member or subsidiary of an organization such as a company, corporation, group, association, or other organizations, it has the right to record the name or name and address, trademark, brand, and other contents of such organization on the label upon permission from these organizations, but still must record the production location of the drug.

Example: If a drug is produced at a branch of Company B located at Address A, then on the label, it can record "Company B, Branch of Company, Produced at Address A".

Article 34. Origin of Medicines and Raw Materials for Medicines

1. Method of Determining the Origin of Medicines and Raw Materials for Medicines:

a) The origin of medicines and raw materials for medicines shall be determined in accordance with the provisions of the Commercial Law, guiding documents of the Commercial Law on the origin of goods, and related legal documents;

b) Organizations and individuals responsible for labeling medicines as stipulated in Article 6 of this Circular shall determine and record the origin of their medicines and raw materials for medicines truthfully, accurately, and in compliance with legal regulations on the origin of goods or Agreements to which Vietnam has acceded.

2. Method of Recording the Origin of Imported Medicines and Raw Materials for Medicines:

The origin of medicines and raw materials for medicines shall be recorded on the outer packaging of the medicines and raw materials for medicines as follows:

a) Record the phrase "origin:", "produced in:" or "produced by:" followed by the name of the country or territory that produces the medicines and raw materials for medicines;

The name of the country or territory producing the medicines and raw materials for medicines shall not be abbreviated.

b) In cases where the medicines and raw materials for medicines have the same origin as the country or territory producing them, only the name of the producing country in Vietnamese or English must be recorded when translating into Vietnamese does not convey meaning or cannot be translated;

c) In cases where the medicines and raw materials for medicines have a different origin from the country or territory producing them, full information on the origin of the medicines must be recorded in accordance with point a, Clause 2 of this Article.

3. For medicines and raw materials for medicines produced in Vietnam for circulation domestically, if the label already records the address of the place of production, there is no need to record the origin of the medicines and raw materials for medicines on the label.

Article 35. Other Contents Displayed on Medicine Labels

1. In addition to mandatory contents prescribed in this Circular, the model labels and user guide of medicines proposed in the registration dossier of medicines, import dossier of medicines without a registration certificate, or labels of medicines as specified in Clause 1 and Clause 2 of Article 11 of this Circular may include additional contents but must comply with the provisions of Clause 3 of this Article.

2. In addition to mandatory contents prescribed in this Circular, before putting medicines into circulation on the market, organizations and individuals responsible for medicines are allowed to record additional contents on the labels and user guides of medicines compared to the contents approved by the competent authority, provided they comply with the provisions of Clause 3 of this Article, without the need to notify or obtain approval from the competent authority, but the entity responsible for labeling must bear responsibility for the accuracy of the additional information, including:

a) Supplementing or modifying anti-counterfeiting stickers and other contents related to product anti-counterfeiting on medicine labels to prevent counterfeits or make it easier to identify products;

b) Changing the format and color of the user guide; changing the size of the outer packaging label or direct packaging of medicines and raw materials for medicines;

c) Supplementing or modifying telephone numbers, area code, website addresses, email addresses of entities related to medicines; trademark owners;

d) Supplementing or modifying the ® symbol after the name of the medicine, after the name or company logo; changing the company logo related to medicines;

đ) Changing the position of recording the registration certificate number or import permit number, the position of affixing supplementary labels, the position of recording batch number, expiration date, production date on the label;

3. Provisions for Other Contents Displayed on Labels:

a) They must not contravene the law, must not be promotional in nature, and must ensure truthfulness, accuracy, reflecting the true nature and efficacy of the medicines, not obscuring or distorting mandatory contents on medicine labels, and must ensure that mandatory contents are consistent with the labels approved by relevant units of the Ministry of Health;

b) They must not contain the following information or images:

- Information and images prohibited from use in advertising activities as stipulated in Article 8 of the Advertising Law;

- Contents as stipulated in Clauses 2, 3, 4, 5, 6, 10, 11, 12, 13, 14, 15, and 16 of Article 126 of Decree No. 54/2017/ND-CP;

- Contents and images as stipulated in Clause 2 of Article 18 of Decree No. 43/2017/ND-CP.

- Information and images about similar biological products being bioequivalent or clinically equivalent to reference biological products.

c) Contents in another language as stipulated in point e, Clause 2 of this Article must correspond fully to the Vietnamese content. The font size of the text and numbers in another language must not obscure or be larger than the font size of the Vietnamese text and numbers;

d) Medicines and raw materials for medicines intended for export may be labeled and user guides in another language according to the purchase and sale contract of the importing country, but the content of the labels and user guides must not distort the information and nature of the medicines and raw materials for medicines.

Chapter IV

IMPLEMENTING PROVISIONS

Article 36. Effective Date

1. This Circular takes effect from June 1, 2018.

2. Circular No. 06/2016/TT-BYT dated March 8, 2016 of the Minister of Health on labeling medicines ceases to be effective from the date this Circular takes effect, except for the contents regulating labeling of in vitro diagnostic products which continue to be effective until replaced by another regulatory document.

Article 37. Transitional Provisions

1. Medicines and raw materials for medicines that have been granted a registration certificate or import permit before the effective date of this Circular shall be handled as follows:

a) Continue to circulate and use the label and drug usage instructions that have been approved by the Ministry of Health until the expiration date of the batch of drugs or raw materials for drugs produced or imported during the validity period of the registration certificate for circulation or import permit issued before this Circular takes effect, except in the cases provided for in point b, Clause 1 of this Article and in Clause 5 of Article 6 of this Circular;

b) For drugs and raw materials for drugs listed in the Catalogue of Toxic Drugs and Raw Materials for Toxic Drugs as prescribed in Circular No. 06/2017/TT-BYT dated May 3, 2017 issued by the Minister of Health on the Catalogue of Toxic Drugs and Raw Materials for Toxic Drugs; and drugs listed in the Catalogue of Over-the-Counter Drugs as prescribed in Circular No. 23/2014/TT-BYT dated June 30, 2014 issued by the Minister of Health on the Catalogue of Over-the-Counter Drugs but not included in the Catalogue of Over-the-Counter Drugs issued together with Circular No. 07/2017/TT-BYT dated May 3, 2017 issued by the Minister of Health on the Catalogue of Over-the-Counter Drugs (hereinafter referred to as Circular No. 07/2017/TT-BYT), the drug registration entities and drug importers must classify, update, and supplement information related to the classification of drugs and raw materials for drugs as follows:

- Drugs and raw materials for drugs produced before the effective date of this Circular: shall comply with the provisions of point a, Clause 1 of this Article;

- Drugs and raw materials for drugs produced from the effective date of this Circular: the entity must independently update information related to the classification of drugs and raw materials for drugs on the label and drug usage instructions in accordance with this Circular before circulating them on the market within twelve months from the effective date of this Circular without needing to notify the Ministry of Health, except in cases where the entity implements procedures to change or supplement the drug registration certificate related to the usage instructions of the drug already registered under the regulations on drug and raw material registration of the Ministry of Health;

2. Drug registration applications or drug import applications without a registration certificate submitted to competent units under the Ministry of Health before the effective date of this Circular but not yet granted a registration certificate or import permit, except for drugs and raw materials for drugs specified in Clause 3 of this Article, shall be considered as follows:

a) The drug registration entity or drug importer is permitted to submit supplementary documents to the Ministry of Health requesting updates to the information on the label and drug usage instructions in accordance with this Circular to be reviewed and granted a registration certificate or import permit for drugs without a registration certificate;

b) In case the entity does not submit supplementary documents as prescribed in point a of this clause, the Ministry of Health will review the contents of the label and drug usage instructions according to Circular No. 06/2016/TT-BYT dated March 8, 2016 issued by the Minister of Health on labeling of drugs, except in the cases provided for in point b, Clause 1 of this Article;

Within six (6) months from the date of issuance of the registration certificate for drugs or raw materials for drugs, the entity responsible for labeling the drug must update the label and usage instructions according to the provisions of this Circular through the procedure for changing or supplementing the drug registration certificate as prescribed in the Circular on drug and raw material registration of the Ministry of Health, except in the cases provided for in point b, Clause 3 of Article 6 of Circular No. 07/2017/TT-BYT;

3. Before the effective date of this Circular, for drug registration applications or raw material registration applications for drugs in the form of changes or supplements to the drug registration certificate related to changes in the label or drug usage instructions that have been submitted to competent units under the Ministry of Health but not yet approved, the drug registration entity or drug importer must supplement the label and drug usage instructions in accordance with this Circular.

Article 38. Publication of Content of the Drug Usage Guide

1. The Drug Administration Department shall be responsible for reviewing, updating, and publishing the drug usage guide for medicines that have been granted registration certificates under the List of Original Brand Name Drugs and Reference Biological Products announced by the Minister of Health on the Drug Administration Department's electronic information website for medicine producers and registrants to refer to during the preparation of registration files for similar generic drugs and biological products.

2. The drug usage guide for original brand name drugs and reference biological products listed in the said list, which has changes or supplements during circulation, must be published and uploaded on the Drug Administration Department's electronic information website within 45 days from the date of signing the approval document for the content supplement or change of the drug usage guide.

a) The drug usage guide for generic drugs and similar biological products must ensure consistency with the drug usage guide of the original brand name drugs and reference biological products corresponding to the concentration, dosage form, route of administration, and active substance of the drug, except for unavoidable differences (such as shelf life, excipient components, quality standards, bioavailability parameters, pharmacokinetic data, adverse effects, clinical trial results). Information about adverse effects in the drug usage guide for generic drugs and similar biological products must not be less than that of the original brand name drugs and reference biological products, except for adverse effects related to excipients that are not present in the composition of the generic drugs and similar biological products.

b) Within twelve months from the date the Drug Administration Department publishes and uploads the drug usage guide for original brand name drugs and reference biological products on its electronic information website as stipulated in Clause 1 and Clause 2 of this Article, the medicine registrants and manufacturers of generic drugs and similar biological products shall be responsible for independently updating the label and usage guide content in accordance with the drug usage guide of the original brand name drugs and reference biological products for the information specified in Point a of Clause 2 of this Article, without the need to notify the Ministry of Health, except in cases where the Ministry of Health requires otherwise.

Article 39. Referential Provisions

In case the regulatory legal documents and provisions cited in this Circular are amended, supplemented, or replaced, they shall be implemented according to the new regulatory legal documents.

Article 40. Responsibility for Implementation

The Drug Administration Department, the Traditional Medicine Management Department, units under the Ministry of Health, provincial and municipal health departments, Vietnam Pharmaceutical Corporation - Joint Stock Company, domestic and foreign medicine producers and registrants, medicine importers and exporters, raw material suppliers, medical examination and treatment facilities, and compounding pharmacies shall be responsible for implementing this Circular.

In the course of implementation, if there are any difficulties, organizations and individuals are requested to promptly reflect them to the Ministry of Health (Drug Administration Department, Traditional Medicine Management Department) for consideration and resolution./.