Chương III Thông tư 01/2018/TT-BYT: Cách ghi nhãn và tờ hướng dẫn sử dụng thuốc

Chapter III

PRESENTATION OF INFORMATION ON DRUG LABELS AND PACKAGE INSERTS

Article 14. Names of drugs and medicinal ingredients

1. The name of drug or medicinal ingredient must be easily recognizable and of a size bigger than that of other compulsory information on the label or package insert.

2. The name of drug or medicinal ingredient must be written in a Romance language and may contain digits, Roman numbers or other symbols written in Greek alphabet (e.g. alpha, beta).

3. The drug name shall be its trade name or international nonproprietary name. Names of traditional drugs on the List of traditional drugs recognized by the Ministry of Health shall be trade names or names of traditional remedies approved by the Ministry of Health, except traditional ingredients. The trade name of drug should not:

a) Provide any advertising information;

b) Provide any misleading information about the composition or origin of the drug. If the drug contains multiple active ingredients or herbal ingredients, the name of any ingredient is not used as the drug name;

c) Cause misinterpretation or provide exaggerated description of effects or indications of the drug;

d) Show any disrespect to Vietnamese traditional values and customs;

dd) Cause conflicts with protected products of other intellectual property rights holders;

e) Be identical or similar to the name of drugs granted certificate of registration of another facility;

g) Use the same name for drugs containing different active ingredients;

h) Use different names for the drugs that have same active ingredients or herbal ingredients, dosage form, administration route, concentrations or contents and manufacturer. This provision shall not apply to processed drugs which shall be governed by specific regulations on domestic processing of drugs announced by the Minister of Health;

i) If multiple drugs share the same name, manufacturer, dosage form and active ingredients but the concentrations or contents are different, corresponding concentrations or contents may be written next to the drug name in a recognizable way.

4. The name of medicinal ingredients (excluding herbal ingredients and semi-finished drugs) shall be written in accordance with regulations in Clause 2 Article 16 herein.

5. The name of traditional ingredients shall be the name of herbal ingredients which are written in accordance with regulations in Clause 3 Article 16 herein and have the phrase “vị thuốc cổ truyền” (“traditional ingredients”) added before the Vietnamese name of herbal ingredients.

6. The name of herbal ingredients shall be written in accordance with regulations in Clause 3 Article 16 herein.

7. The name of semi-finished herbal medicines shall be written in accordance with regulations in Clause 4 and Clause 5 Article 16 herein.

8. The name of semi-finished drugs (excluding semi-finished herbal medicines) shall be written in accordance with regulations in Clause 6 Article 16 herein.

Article 15. Precautions and recommendations

1. The following precautions and recommendations must be written on labels and package inserts of drugs:

a) The text ““Để xa tầm tay trẻ em” ("Keep away from children") and “Đọc kỹ hướng dẫn sử dụng trước khi dùng” ("Read instructions carefully before use");

b) For prescription drugs:

- On the label of the secondary package: On the upper left corner of the drug name must have the symbol "Rx" and the text “Thuốc kê đơn" (“Prescription drugs”);

- On the package insert: On the upper left corner of the drug name must have the symbol "Rx" and the text “Thuốc này chỉ dùng theo đơn thuốc” (“This drug is taken with prescription only").

c) For controlled drugs or other drugs:

- Radioactive drugs must have the text “THUỐC PHÓNG XẠ” (“RADIOACTIVE DRUG”) written in a bold and uppercase type;

- Drugs on the list of toxic drugs announced by the Ministry of Health must have the text “THUỐC ĐỘC” (“TOXIC DRUG”) written in a bold and uppercase type;

- Drugs used to serve a health program of the State must have the text “Thuốc chương trình, không được bán” (“For a health program, not for sale”);

- Drugs used as emergency aid or humanitarian aid must have the text “Thuốc viện trợ, không được bán” (“As emergency aid or humanitarian aid, not for sale”);

- The label of drugs used for clinical testing purpose must have the text “Thuốc dùng cho thử lâm sàng. Cấm dùng cho mục đích khác” (“Do not use for any purposes other than the clinical testing”);

- Biosimilars must have both name of the biosimilar and name of the reference biologic.

d) Other precautions and recommendations for each type of drug:

- The administration route of injectable drug must be written briefly or in full on the label, including: "tiêm bắp" ("intramuscular injection"), "tiêm dưới da" ("subcutaneous injection"), "tiêm tĩnh mạch" ("intravenous injection"), "tiêm truyền tĩnh mạch" ("intravenous infusion"), etc.

- The text “Thuốc nhỏ mắt” and “Thuốc tra mắt” shall be written on labels of eye drops and eye ointment respectively; “Thuốc nhỏ mũi” on labels of nose drops; “Thuốc nhỏ tai” on labels of ear drops;

- The text “Thuốc dùng ngoài” shall be written on labels of topical drugs; “Không được tiêm” ("No injection") on bottles of oral drugs;
- Drugs that must be shaken well before use (E.g.: multi-dose packages of drugs in the form of blends, powder and granule that must be reconstituted before use or easily deposited or separated into layers after being dissolved) must have the text “Lắc kỹ trước khi dùng” ("Shake well before use").

2. Format of precautions and recommendations:

a) The text and symbols must be clearly printed on secondary packages or secondary labels and package inserts. Contents must be clear enough to be read in normal conditions;

b) On package inserts: Precautions and recommendations prescribed in Points a, b and c Clause 1 of this Article, except for the symbol “Rx”, must be written right below the drug name;

c) All the precautions of the drug must be written.

Article 16. Composition of drugs and semi-finished drugs

1. General provisions:

a) Secondary package labels of drugs and semi-finished drugs:

- The names of active ingredients or herbal ingredients and concentrations or contents thereof in a smallest dose or package of drugs or semi-finished drugs shall be specified;

- For vaccine: Active ingredients in a dose unit shall be specified;

- For biologics: Contents of the biologic shall be expressed according to the weight unit, the unit of biologic activity or the international unit of each biologic;
- For traditional drugs, herbal drugs, semi-finished traditional rugs and semi-finished herbal drugs: Names of herbal ingredients shall be Vietnamese names. Their scientific names are not required on the labels;

- Composition, contents, weights, volumes or concentration of excipients is not required on the labels;

- Labels of traditional drugs on the list of State secrets and labels of family remedies as recognized by the Ministry of Health are allowed to omit certain herbal ingredients and contents or weights thereof. In such case, secondary package labels must have the text “Công thức sản xuất thuốc là bí mật nhà nước” (“The formula is state secret”) or “Công thức sản xuất thuốc là bí mật gia truyền” (“The formula is family secret”).

b) Primary package labels of drugs and semi-finished drugs:

- If the drug or semi-finished drug contains from one to three active ingredients or herbal ingredients, all active ingredients or herbal ingredients shall be specified in accordance with regulations in Point a of this Clause;

- If the drug or semi-finished drug contains more than three active ingredients or herbal ingredients, names of active ingredients or herbal ingredients are not required on primary package labels. Active ingredients or herbal ingredients and contents thereof may be also specified on labels in accordance with regulations in Point a of this Clause;

- If drug is in a liquid form, the drug labels must have the volume in a smallest package unit.

c) Package inserts:

- The names of active ingredients or herbal ingredients and concentrations, weights or contents thereof in a smallest dose or smallest package unit must be specified on package inserts. The text “Thành phần dược chất:” or “Thành phần hoạt chất:” (“Active ingredients:”) must be specified before names of active ingredients or herbal ingredients;

- All excipients in the drug formula must be specified and the text “Thành phần tá dược:” (“Excipients:”) must be also specified before names of excipients. The excipients that evaporate or disappear during the manufacturing process may be omitted. The weights, volumes, contents or concentrations of excipients are not required;

- The package insert of vaccines must have all active ingredients in a dose unit;

- For biologics: Contents of the biologic shall be expressed according to the weight unit, the unit of biologic activity or the international unit of each biologic;

- For traditional drugs and herbal drugs: Both Vietnamese name and scientific name of each herbal ingredient shall be specified. The scientific name of herbal ingredient shall be italicized in the brackets right after its Vietnamese name;

- Package inserts of traditional drugs on the list of State secrets and labels of family remedies as recognized by the Ministry of Health are allowed to omit certain herbal ingredients and contents or weights thereof. In such case, package inserts must have the text “Công thức sản xuất thuốc là bí mật nhà nước” or “Công thức sản xuất thuốc là bí mật gia truyền”.

2. Expression of active ingredients and excipients:

a) Name of an active ingredient or excipient shall be its international nonproprietary name or scientific name;

b) It is not required to translate names of active ingredients and excipients into Vietnamese language.

3. Expression of herbal ingredients and traditional ingredients:

a) Vietnamese name:

- Names of herbal ingredients and traditional ingredients shall be conventional names in Vietnamese language as specified in the Pharmacopoeia of Vietnam or in the lists of drugs and medicinal ingredients announced by the Minister of Health;

- If Vietnamese names of herbal ingredients are not available in the Pharmacopoeia of Vietnam or the lists of drugs and medicinal ingredients announced by the Minister of Health, Vietnamese names of these herbal ingredients as specified in the book “Những cây thuốc và vị thuốc Việt Nam" (“Traditional plants and ingredients of Vietnam”) of Mr. Do Tat Loi, or the book “1000 Cây thuốc và động vật làm thuốc" (“1000 medicinal plants and animals”) of the National Institute of Medicinal Materials. In such cases, names of herbal ingredients shall be decided by the Minister of Health according to the counseling of the Advisory Council for drug registration certification affiliated to the Ministry of Health.

- If the names of imported herbal ingredients cannot be translated into Vietnamese language, the names in the exporting country (or the country of origin) and their scientific names shall be written;

- If more than one part of the plant is used as herbal ingredients of traditional ingredients, the parts must be specified. Example: Tam sen, Hoa hoe, Kim ngan hoa.

b) Scientific names (Latin names):

- Scientific names of herbal ingredients or traditional ingredients shall be their scientific names in italics in the Pharmacopoeia of Vietnam or in the lists of herbal ingredients and traditional ingredients announced by the Minister of Health;

- If scientific names of herbal ingredients and traditional ingredients are not available in the Pharmacopoeia of Vietnam or in the Minister of Health’s lists of herbal ingredients and traditional ingredients, their scientific names in foreign pharmacopoeias shall be written.

4. Expression of bone glue, type and formula of bone glue:

a) Expression of the bone glue:

- Name of the bone glue, type and composition of the bone glue, concentrations, contents or weights of herbal ingredients in the bone glue must be specified;

- If the bone glue has a trade name, this trade name and names of herbal ingredients in the bone glue shall be specified in accordance with regulations in Clause 3 of this Article;

- In case there is no trade name, the word “cao” (“bone glue”) shall be specified right before the name of herbal ingredient (if the bone glue contains the only ingredient) or the phrase “cao hỗn hợp dược liệu” (“bone glue mixture”) shall be specified right before names of herbal ingredients (if the bone glue contains multiple ingredients).

b) Expression of type of the bone glue:

- Type of the bone glue must be clearly specified. There are three types of the bone glue, liquid, solid and dried glue according to Vietnam’s pharmacopoeia;

- If the type of the bone glue is not identified, the moisture content limit and name of the bone glue or the ratio of bone glue and initial herbal ingredients must be specified.

c) Expression of formula of the bone glue:

- If the treatise of Vietnam’s pharmacopoeia or a foreign pharmacopoeia recognized by the Ministry of Health provides criteria for quantifying contents of active ingredients or compounds, name of the bone glue must be written together with the contents (%) of active ingredients or compounds quantified in each herbal ingredient;

- If the treatise of Vietnam’s pharmacopoeia or foreign pharmacopoeias recognized by the Ministry of Health does not provide criteria for quantifying contents of active ingredients or compounds, name of the bone glue must be written together with the weight of corresponding initial herbal ingredients or the ratio of the bone glue and the initial herbal ingredients (initial herbal ingredients are herbal ingredients qualified for medicinal use);

- If the solvent used for extracting herbal ingredients to manufacture bone glue is not ethanol, water or a mixture of ethanol and water, the name of the bone glue must be written together with that of the solvent.

5. Expression of name of semi-finished herbal medicines (excluding bone glue):

a) The name of semi-finished herbal medicine and the composition, concentrations, contents or quantities of herbal ingredients contained in the semi-finished herbal medicine must be fully specified;

b) Expression of the name of semi-finished herbal medicine:

- If the semi-finished herbal medicine has a trade name, this trade name shall be written together with the name of every herbal ingredient contained in the semi-finished herbal medicine in accordance with regulations in Clause 3 of this Article;

- If there is no trade name, the name of herbal ingredient shall be written according to regulations in Clause 3 of this Article (if the semi-finished herbal medicine contains the one herbal ingredient) or the text “hỗn hợp dược liệu” (“mixture of herbal ingredients”) shall be written (if the semi-finished herbal medicine contains multiple herbal ingredients). The form of the semi-finished herbal medicine (such as powder or granule) must be also written right before the name of herbal ingredient or the text " hỗn hợp dược liệu”.

c) Expression of formula of the semi-finished herbal medicine:

- If the treatise of Vietnam’s pharmacopoeia or a foreign pharmacopoeia recognized by the Ministry of Health provides criteria for quantifying contents of active ingredients or compounds, name of the semi-finished herbal medicine shall be written together with the contents (%) of active ingredients or compounds quantified in each herbal ingredient;

- If the treatise of Vietnam’s pharmacopoeia or foreign pharmacopoeias recognized by the Ministry of Health does not provide criteria for quantifying contents of active ingredients or compounds, name of the semi-finished herbal medicine must be written together with the weights of corresponding initial herbal ingredients or the ratio of the semi-finished herbal medicine and the initial herbal ingredients (initial herbal ingredients are herbal ingredients qualified for medicinal use).

6. Expression of name of semi-finished drugs (excluding semi-finished herbal medicines):

a) The name of semi-finished drug and the composition, contents, concentrations or weights of active ingredients contained in the semi-finished drug must be sufficiently specified; b) Expression of the name of semi-finished drug:

- If the semi-finished drug has a trade name, this trade name shall be written together with the name of every active ingredient contained in the semi-finished drug in accordance with regulations in Clause 2 of this Article;

- If there is no trade name, the name of active ingredient shall be written according to regulations in Clause 2 of this Article (if the semi-finished drug contains the one active ingredient) or the text “hỗn hợp dược chất” (“mixture of active ingredients”) shall be written (if the semi-finished drug contains multiple active ingredients). The form of the semi-finished drug (such as powder or granule) must be also written right before the name of active ingredient or the text " hỗn hợp dược chất”.

c) Expression of formula of the semi-finished drug: Regulations on semi-finished drugs in Clause 1 of this Article shall be applied.

7. Measurement units:

Contents, concentrations, weights and volumes are expressed as weight units, volume units, activity units or other common measurement units. To be specific:

a) Weight units: gram (g), milligram (mg), microgram (μg or mcg), or kilogram (kg). The weight below 1 mg shall be expressed as a decimal fraction (e.g. 0.25 mg);

b) Volume units: Mililiter (ml), microliter (μl or mcl), or liter (l or L). The volume below 1 ml shall be expressed as a decimal fraction (e.g. 0.5 ml);

c) Other measurement units:

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

- If internationalized medical measurement units such as IU and other conventional units of activity of certain special active ingredients may cause misinterpretation if translated into Vietnamese language, they may be kept unchanged.

d) Where the form of an active ingredient is different from the form used for dose determination, the secondary package label and package insert must have the conversion of the concentration, content or weight of that active ingredient to the form used for dose determination. The form of an active ingredient is either base, salt, hydrate or another form.

Article 17. Dosage form

1. The dosage form must be clearly specified and might be: tablets, hard capsules, solution for injection, powder for solution for injection, suppositories (specify inserting positions), powders, granules and other types of drugs according to the Pharmacopoeia of Vietnam or common International Pharmacopoeias.

2. In addition to the information specified in Clause 1 of this Article, package inserts must have the additional information below:

a) External features such as color, size, form, shape or other external signs (if any);

b) Whether scored tablets should be split in half or not;

c) Information about pH and osmotic concentration (if any).

Article 18. Indications

Indications of a drug must be conformable with its dosage form and administration route. The indications must be clear, particular, and must specify:

1. Purposes of the drug: whether the drug is used for curative, supportive care, preventive or symptom relief purpose.

2. Drug users (if any): specify the drug indications applied to each type of drug users; drug users may be sorted by age or group of age.

3. Additional conditions for safe and effective use of drugs (if any), e.g. the drug must be combined with other drugs or methods to improve the effectiveness or reduce side effects during the course of treatment.

Article 19. Dose and usage instructions

1. Dose:

a) Specify the recommended dose for each administration route or/and each indication or method for drug use.

- Specify the interval between drug uses in a day, method to achieve best result (e.g. drink a lot of water or take before eating);

- Specify the recommended minimum and maximum total dose; specify the limited use duration of drugs (if any).

b) Specify the doses and directions applied to adults and children (if any). Doses for children must be sorted by age group or body weight;

c) Specify the doses for special users such as children, elderly people, patients suffering from renal failure, liver failure, etc.

2. Usage instructions:

a) Specify the administration route, administration time, and directions in order to achieve best results:

- If the drug is injectable, the preparation or reconstitution for injection and injection method must be specified e.g. intramuscular injection, intravenous injection, infusion, subcutaneous injection, deep subcutaneous injection, deep intramuscular injection, or other method; injection or infusion rate shall be specified if required;

- Directions for drug use in special cases of precautions or recommendations as mentioned in Point d Clause 1 Article 15 herein must be specified;

- Herbal drugs: specify the usage instructions (water, tools, method, temperature, and time), contraindications and cautions.

b) For prescription drugs:

In addition to directions in Point a Clause 2 of this Article, directions for children or special drug users and recommendations (if any) must be specified as follows:

- Doses shall be specified by group of age. A dose is calculated according to body weight or body surface area (mg/kg or mg/m2) or divided into intervals. If a drug is used for children with similar indications as those applied to adults, the dose and usage applied to children must be specified;

- If there is no indication for one or all age group of children, the dose and usage must be specified in either of the following manners:

+ The safety and effectiveness of drugs for children at certain ages (expressed as months or years) or group of patients (e.g. by gender, body weight) is not proven;

+ The drug is not recommended for children at certain ages (express as months or years) or group of patients (e.g. by gender, body weight) due to its safety and effectiveness;

+ The drug should not be used for infant patients (from age x to y), (or other groups of patients e.g. by gender, body weight) with regard to certain indications.

- Recommendations with regard to dose and usage (if any):

+ When to stop using drugs? What to do when forgetting to take a dose? What foods and drinks to use with drugs? When to reuse drugs after a course of treatment?;

+ Adjustment of dose when combining with other drugs; adjustment of dose to the patient’s conditions (depending on the clinical symptoms and signs and/or kidney or liver function test results);

+ Preventive measures for some specific adverse reactions (e.g. taking antiemetics before using antineoplastic drugs); mild adverse reactions that are common when taking the first dose;

+ Recommendations about drug administration for health officials or patients (if any); information about other routes of administration, especially through gastric sonde (if information is available). If the administration route is other than the gastrointestinal tract, the injection or infusion rate must be specified.

3. Special notes for treatment of drugs before and after use:

Instructions for treatment of drugs before and after use must be specified as follows:

a) Treatment of drugs before use (if any):

- Specify the preparation of drugs before use (reconstitution or dilution);

- Specify measures for protecting drug preparer;

- Specify external features of drug before being reconstituted or diluted, and features of reconstituted drug.

b) Treatment of drugs after use (if any):

- Specify precautions for discarding drugs after use in certain cases such as cytotoxic drugs, preparations that contain live bacteria and other cases where specific regulations apply;
- If there is no usage instruction or special treatment precaution for health officials, the text “Không có yêu cầu đặc biệt về xử lý thuốc sau khi sử dụng” (“No precaution for treatment for drugs after use”) shall be written.

Article 20. Contraindications

1. If there are contraindications, the cases in which drugs must not be used must be specified.

2. If the contraindications involve children, the ages of children (expressed as months or years) or other group of patients (e.g. by gender or body weight) must be specified.

Article 21. Warnings and cautions

1. Specify the cautions when using drugs and recommendations about use of drugs for children and chronic disease patients (if any).

2. Conditions that need cautions:

a) The test results or conditions of the patients that need assessing before using drugs; necessary measures for minimizing the risk of adverse reactions while using drugs;

b) Serious adverse reactions that need to be reported to health officials;

c) The preventive measures and early detections of symptoms of serious adverse reactions;

d) The risks related to the beginning or suspension of treatment;

dd) The subjects likely to have adverse reactions to the group of drugs (usually serious or common);

e) The clinical symptoms, signs, or test results that need monitoring during the course of treatment. The tests affected by drug use;

g) The warnings and cautions for infant patients related to safety of long-term drug administration (such as influence on the child’s growth, mental development, sexual development, etc.);

h) Warnings related to excipients or drug residues that cause adverse drug reactions or influences as proven. Warnings related o these excipients must be specified in this part or in the part of warnings and cautions when using drugs;

i) Warnings related to ethanol in the drugs;

k) The risks related to inaccurate administration route.

3. For biosimilars:

Specify warnings about risks related to replacement or conversion between reference preparations and biosimilars during the treatment.

Article 22. Using drugs during pregnancy and breastfeeding

1. Using drugs during pregnancy:

a) Provide information about the influence of drugs on pregnant women. If such information is not available, the text “Không có dữ liệu về sử dụng thuốc trên phụ nữ có thai, chỉ nên dùng thuốc nếu lợi ích vượt trội so với nguy cơ” (“There is no controlled data in human pregnancy. The drug is only recommended for use during pregnancy when benefit outweighs risk”) must be specified;

b) The recommendations for pregnant women must include recommendations about the use of drugs by women suspected of pregnancy, women practicing birth control, and the use of drugs in various stages of pregnancy;

c) Provide additional information about the influence of drugs on the fetus, including information about possible influence of drugs on the fetus. The unavailability of information about toxicity of drugs upon the fetus must be specified;

d) Provide recommendations about monitoring of the fetus and newborn babies whose mother uses drugs during pregnancy (if information is available).

2. Using drugs during breastfeeding:

Recommendations for breastfeeding must specify whether the breastfeeding must be stopped or may be carried on, whether the treatment must be stopped or may be carried on (if sufficient information is available).

Article 23. Influence of the drug on ability to drive or operate machinery

1. The level of influence must be specified: no influence or inconsiderable influence, mild influence, medium influence, or serious influence.

The text “Chưa có bằng chứng về ảnh hưởng của thuốc lên khả năng lái xe, vận hành máy móc" (“There is no proven influence of the drug on ability to drive or operate machinery”) must be written.

2. Additional important information (if any) must be specified such as the time the effects decreases and the effectiveness of drugs when resuming the drug use.

Article 24. Drug interactions and incompatibilities

1. Drug interactions:

a) Specify the reactions of the drug with other drugs and other reactions (e.g. with alcohol, foods, etc.) that may affect the effectiveness of the drug. To be specific:

- Specify information about drug interactions with clinical significance based on their pharmacodynamic properties and pharmacokinetic studies;

- Specify consequences of drug interactions such as: clinical signs (if any), influence of drug interactions on drug concentration in blood, pharmacokinetic data of drugs or active metabolites of drugs; influence of drug interactions on test results. Treatment for minimizing consequences of drug interactions must be also specified;

- Specify the mechanism of interaction if the mechanism is clear. The unavailability of drug interaction studies must be specified;

- Other serious drug interactions such as the adsorption of the drug onto its package or syringe.

b) The contraindications of herbal drugs or traditional drugs must be specified (if any). E.g.: if the drug tends to cause damp-heat, raw, cold and frozen foods should be abstained; if the drug tends to cause damp-cold, hot and spicy foods should be abstained.

2. Drug incompatibilities:

a) Specify information about chemical and physical incompatibilities with other drugs when they are mixed or used simultaneously, especially drugs reconstituted or diluted before use for intravenous infusion;

b) If the information about drug incompatibilities is unavailable, the text ““Do không có các nghiên cứu về tính tương kỵ của thuốc, không trộn lẫn thuốc này với các thuốc khác” (“There is no study on drug incompatibilities. Do not mix this drug with other drugs") shall be specified.

Article 25. Adverse drug reactions

1. Specify the cases in which drug use must be suspended, the cases in which adverse drug reactions must be reported to the physician or pharmacist, or reported to the National Center of Drug Information & Adverse Drug Reactions.

2. Apart from the information specified in Clause 1 of this Article, information about adverse drug reactions according to the summary (if any) must be added as follows:

a) Adverse reactions shall be sorted by frequency: very common (ADR ≥ 1/10), common (1/100 ≤ ADR < 1/10), not common (1/1000 ≤ ADR < 1/100), rare (1/1000 ≤ ADR < 1/10000) and very rare (ADR < 1/10000);

Classification of adverse reactions of herbal drugs or traditional drugs by frequency is not required.

b) If the users are children, it is required to describe the children’s ages and seriousness of adverse reactions (if any); clinical differences in drug safety between adults and children (or between certain age groups). If such information is already mentioned in another part of the package insert, it must be referred to;

c) Every clinical difference in frequency, seriousness of reactions, ability to recover, and the cases that need monitoring in special users (e.g. elderly people, patients suffering from liver failure, renal failure, and other diseases) must be specified.

3. If there is no record or evidence about drug adverse reactions, the text "Chưa ghi nhận được báo cáo về phản ứng có hại của thuốc" (“There is no reported case of adverse drug reactions”) and “Thông báo ngay cho bác sỹ hoặc dược sỹ những phản ứng có hại gặp phải khi sử dụng thuốc” (“Any adverse drug reactions should be immediately reported to the physician or pharmacist”) shall be specified.

Article 26. Overdose and treatment

1. Overdose:

a) Specify the symptoms and signs of overdose: Symptoms and signs of acute poisoning and possibility to cause permanent injuries (if any);

b) If the information about drug overdose is unavailable, the text “Không có dữ liệu về sử dụng thuốc quá liều, không dùng quá liều chỉ định của thuốc” (“There is no record of drug overdose. Do not use this medicine in larger mounts than recommended”) shall be specified.
2. Treatment for overdose:

a) Specify the measures or treatment for overdose, including monitoring and using adrenergic agonists, antagonists, antidotes, or enhanced drug excretion. If such information is not available or not sufficient, there must be the text “Tích cực theo dõi để có biện pháp xử trí kịp thời” ("Keep monitoring to respond in time");

b) Provide information for special users such as: elderly people, pregnant and breastfeeding women, children, patients having kidney failure, liver failure, or other diseases (if any).

Article 27. Pharmacological and clinical effects

1. Pharmacodynamics: The following information about pharmacodynamics must be specified:

a) Pharmacological group and ATC number (if any);

b) Description of the reaction mechanism corresponding to the approved indications;

2. Pharmacokinetics: The following information about pharmacokinetics must be specified:

a) Pharmacokinetic properties of drugs (absorption, distribution, metabolism, elimination, and other properties) corresponding to the recommended dose, concentration, and dosage form;

b) Description of the differences between the factors (such as ages, genders, body weights, smokers and non-smokers, patients suffering from kidney failure or liver failure) that influence the pharmacokinetics. If such influences are clinical, they must be quantified;

c) The relationship between the dose, concentration, pharmacodynamics (including primary and secondary criteria, and side effects) and characteristics of the test subjects;

d) With regard to infant patients: summarize results of pharmacokinetics study on children at various ages and comparison to adults (if any). Specify the dosage form used for pharmacokinetics study on children, the uncertainties due to limited use of drugs on children.

3. Results of clinical and non-clinical tests (if any):

a) Summary of primary results of major clinical tests that support the approved indications (if any), including:

- Description of primary characteristics of the sample;

- Primary criteria;

- Secondary criteria (if any);

- Study results related to primary criteria.

b) Provide basic information concerning non-clinical studies (if any).

Article 28. Smallest package unit and package contents

1. Common smallest package units are as follows:

a) Drugs in the form of tablets: The smallest package unit shall be tablet. With regard to drugs in the form of Chinese tablets, the smallest package unit shall be pack, jar, bottle or bag;

b) Drugs in liquid form: The smallest package unit shall be jar, bottle, vial, pack, prefilled syringe or injection device;

c) Drugs in form of powder that have to be reconstituted before use: The smallest package unit shall be jar, bottle, vial, pack, prefilled syringe or injection device;

d) Drugs in the form of powder or granule: The smallest package unit shall be jack, bottle, jar or pack;

dd) Drugs in the form of cream, ointment or gel for external use: The smallest package unit shall be tube, jar or pack;

e) Drugs in the form of transdermal patches: The smallest package unit shall be patch;

g) Drugs in the form of spray or aerosol: The smallest package unit shall be spray bottle, metered dose inhaler or drug jar of aerosol nebulizer;

h) Drugs in the form of kits: The smallest package unit shall be the kit;

i) Herbal drugs: The smallest package unit shall be pack, bag or box;

k) Medicinal ingredients: The smallest package unit shall be bag, pack, box, bottle, jar, or vial.

2. Expression of package contents:

a) The package contents of a drug must be expressed as natural numbers of the quantity, net weight, or true volume of drugs contained in a commercial package;

b) If a commercial package contains multiple package units, the content of each package and quantity of packages must be specified;

c) Every equipment accompanied to the drug such as injection needle, syringe, measuring spoon, measuring cup, aerosol device and other supportive tools contained in the commercial package (if any) must be specified.

3. If the drug is on the list of controlled drugs which are narcotic drugs, psychotropic drugs, or drug precursors, the secondary package shall not contain more than 100 smallest package units.

Article 29. Batch number, manufacturing date and expiry date

1. Batch number:

Batch number shall be expressed fully as “Số lô sản xuất” or briefly as “Số lô SX”, “Lô SX”, “LSX” or “SLSX” and information about the batch number. The information and composition of the batch number is decided by the manufacturer.

2. Manufacturing date and expiry date:

a) The manufacturing date and expiry date shall be written fully as “Ngày sản xuất”, “Hạn dùng” or “Hạn sử dụng”, or briefly as “NSX”, “HD” or "HSD" before information about the manufacturing date and expiry date;

b) The manufacturing date and expiry date shall be expressed in any of the following format: [dd/mm/yy], [dd. mm. yy], [dd-mm-yy], [dd mm yy], or [ddmmyy];c) Where the secondary package contains diluent vials or reconstitution kit:

- If the drug and its component parts share the same manufacturing date and expiry date, that manufacturing date and expiry date shall be specified on the label of the secondary package;

- If the expiry dates of the drug and its component parts are different, the shortest expiry date or the expiry date of every component part shall be specified.

3. Expression of manufacturing date, expiry date and batch number:

a) Where the manufacturing date, expiry date and batch number are written on in a foreign language:

- If the manufacturing date, expiry date and batch number on the original label are written in a foreign language, the secondary label must contain the text: “ngày sản xuất (NSX), hạn dùng (HD/HSD), số lô sản xuất (LSX/SLSX) xem thông tin ghi ngày sản xuất, hạn dùng, số lô sản xuất bằng tiếng nước ngoài được in trên nhãn gốc sản phẩm”.

E.g.: NSX, HD, SLSX: see “Mfg Date”, “Exp Date”, “Lot.No.” on the original label.

- If the expiry date on the primary package label is expressed as “mm/yy” and the expiry date on the secondary package label is fully expressed as “dd/mm/yy”, the expiry date expressed on the secondary package label shall apply;

- If the expiry date on both the primary package label and secondary package label is expressed as “mm/yy” but:

+ the manufacturing date on the original label is fully expressed as “dd/mm/yy”, the expiry date on the secondary label shall be calculated and expressed according to the manufacturing date on the original label;

+ the manufacturing date on the original label is expressed as “mm/yy”, the expiry date shall be the last day of the expiry month and the secondary label must have the text ““hạn dùng là ngày cuối cùng của tháng hết hạn” (“expiry date is the last day of the expiry month”).b) If the primary package label is so small that the batch number or expiry date has to be written in series of numbers instead of with the text “Số lô SX” and “HD” as prescribed in Clause 1, Clause 2 of this Article, such information must be fully written on the secondary package as prescribed;

c) The package insert must contain the following information:

- Expiry date of the drug as a period from the manufacturing date;

- The useful life after opening the primary package for the first time for drugs without divided dose such as eye drops, nose drops, ear drops, ointment, gel and orally administered multi-dose liquid drugs or tablets bottled in large quantities (if any);

- The useful life after preparation for drugs in the form of powder, granule that must be reconstituted before use (e.g. injection or oral administration).

Article 30. Change of expiry dates of labeled drugs because of national defense and security, epidemic control or disaster recovery need

Because of national defense and security, epidemic control or disaster recovery need, Minister of Health may decide to change the expiry dates of labeled drugs and stipulate the way to express the expiry date in each specific case on the basis of drug quality, comparison between benefits and risks or lack of domestic supply of drugs.

Article 31. Storage conditions and quality standards

1. The label of drugs or medicinal ingredients and package inserts must:

Specify the storage conditions in terms of temperature (expressed as ⁰C), humidity, and lighting or other special storage conditions in order to avoid affecting the drug quality during storage and transport (if any).

2. The package insert must specify storage requirements with regard to the cases mentioned in Paragraph 2 and 3 Point c Clause 3 Article 29 herein.

3. Expression of quality standards:

The secondary package label and package insert must have quality standard of the drug or medicinal ingredient. To be specific:

a) If the drug or medicinal ingredient follows quality standards of the Pharmacopoeia of Vietnam or a foreign pharmacopoeia recognized by the Ministry of Health, the quality standard shall be specified according to the full name in Vietnamese language of the pharmacopoeia or the abbreviated name in Vietnamese language of the Pharmacopoeia of Vietnam or the abbreviated name in English of the foreign pharmacopoeia. The version or publishing year is not required;

b) If the drug or medicinal ingredient follows a basic standard, the text “Tiêu chuẩn cơ sở” or “TCCS” shall be specified.

Article 32. Registration number and import license number

1. Registration number in Vietnam:

Specify “Số giấy đăng ký lưu hành:” (“Registration number:”) or “SĐK:” without information specified when applying for the registration number. Before selling drugs on the market, the registration number issued by the Ministry of Health to the drug or medicinal ingredient granted the Certificate of registration must be added.
2. Import license number:

Specify “Số giấy phép nhập khẩu:” ("Import license number") or “GPNK:” without information specified when submitting the application for license to import drugs. Before selling drugs on the market, the import license number issued by the Ministry of Health to the drug or medicinal ingredient without the Certificate of registration must be added.

Article 33. Names and addresses of manufacturer, preparation and processing factory, importer and relevant entities (if any)

1. General provisions on name and address of manufacturer and importer on the drug label and package insert:

a) Secondary package labels of drugs and medicinal ingredients:

- If drugs are manufactured in Vietnam: write the role, name and address of the drug manufacturer;

- If medicinal ingredients manufactured in Vietnam or imported: write the name and address of manufacturer of medicinal ingredients;

- If drugs are imported: write the role, name and address of the drug manufacturer; the name and address of the drug importer.

b) Primary package labels: Full name or business name of the manufacturer shall be specified as long as the manufacturer is identified.

If a drug has more than one manufacturer:

- Specify every manufacturer of the commercial drug; or

- Specify the name of the manufacturer responsible for the release of the batch.

c) With regard to traditional drugs prescribed in Clause 1 and Clause 2 Article 70 of the Law on Pharmacy and drugs produced or prepared within health facilities as prescribed in Clause 2 and Clause 3 Article 85 of the Law on Pharmacy:

- On the secondary package label: write the name and address of the health facility that prepare or produce drugs;

- On the primary package label: write the full name or business name of the health facility. d) Labels of drugs prepared according to prescriptions for sale at drugstores in accordance with regulations in Point b Clause 1 Article 47 of the Law on Pharmacy must have the name and address of the drugstore;

dd) Package inserts: write the role, name and address of manufacturers. If drugs are imported, the name of manufacturing country must be translated into Vietnamese unless Vietnamese name is not available;

e) Apart from the name and address of the manufacturer and importer, the drug label and package insert may contain the roles, names and addresses of relevant entities such as the registrant, distributor, brand owner, drug owner or relevant entities.

2. Expression of role of entities responsible for the drug:

a) Manufacturer:

- If a drug has the one manufacturer: the role shall specified by the text “Cơ sở sản xuất:”
- If a drug has more than one manufacturer: the role of each manufacturer must be specified either as “Cơ sở sản xuất bán thành phẩm” (“Manufacturer of semi-finished drugs”), “Cơ sở đóng gói cấp 1” ("Primary packaging facility”) or “Cơ sở chịu trách nhiệm xuất xưởng lô” (“The entity responsible for release of the batch”);

- The name of manufacturer shall be the name specified in the Certificate of eligibility for pharmacy business issued by a regulatory authority.

b) Importer: write the role as “Doanh nghiệp nhập khẩu” (“Importer”);

c) Other entities: specify the role as “Cơ sở phân phối” (“Distributor”), “Chủ sở hữu sản phẩm” (“Drug owner”), “Chủ sở hữu nhãn hiệu hàng hóa” (“Brand owner") or other entities (if any).

3. Expression of name and address of manufacturer:

a) If a drug has more than one manufacturer, names and addresses of all manufacturers must be written. Their names must be of the same size and on the same plane;

b) If drugs are processed by another entity, the label shall have the text “Sản xuất tại ... theo hợp đồng với ... “ ("Manufactured by [processor's name and address] under contract with [hirer's name and address]”). The processor's name and address must be on the same plane of the label and have the same size as the hirer's;

c) Labels of drugs manufactured under technology transfer must have the text “Sản xuất tại … được chuyển giao công nghệ từ …” (“Manufactured by [transferee’s name and address] by adopting the technology transferred from [transferor’s name and address]”). The transferor's name and address must be on the same plane of the label and have the same size as the transferee’s.

4. Expression of name and address of importer: a) Fully specify the text là “Doanh nghiệp nhập khẩu: tên, địa chỉ của cơ sở nhập khẩu thuốc, nguyên liệu làm thuốc” (“Importer: name and address”) on the label; or

b) Briefly specify “DNNK: tên, địa chỉ đầy đủ cơ sở nhập khẩu” (“Importer: name and address”).

Specify “Doanh nghiệp nhập khẩu:” or “DNNK:” without the importer's name. The importer's name and address must be added before selling drugs on the market.

5. Other provisions on expression of name and address:

a) Expression of names of relevant establishments:

- Name of a domestic establishment: write the name specified in the Certificate of eligibility for pharmacy business, the certificate of enterprise registration or the investment certificate issued by a regulatory authority;

Names of health facilities shall be the names specified in the license to provide healthcare services in accordance with regulations of the Law on medical examination and treatment.
- Name of a foreign establishment: write the name specified in the drug certificate or GMP certificate, or relevant legal document issued by the competent authority in the home country.

Particularly, name of a foreign manufacturer shall be the same as the name specified in the drug certificate or GMP certificate issued by the competent authority in the home country.

b) Expression of addresses of relevant establishments:

- Address of a domestic manufacturer: specify the address which is the business location specified in the Certificate of eligibility for pharmacy business. The address of the enterprise’s head office may be also specified;

- Address of a manufacturer must include the house number, name of the street or neighborhood, commune or ward, district, province or centrally-affiliated city;

Particularly, the address of a health facility shall be the address of its manufacturing factory as specified in the License to provide healthcare services in accordance with regulations of the Law on medical examination and treatment.

- For imported drugs:

The address of the manufacturer shall be the address of its manufacturing factory as specified in the drug certificate or GMP certificate issued by the competent authority in the home country.

c) The names, addresses, logos of relevant entities specified in the label or package insert as regulated in this Clause must not be larger in size than those of the manufacturer, unless it is the drug owner as proven;

d) If the label contains the name, address, and/or logo of the distributor, the distributor’s name, address, and logo must not be larger in size than the manufacturer’s;

dd) If the manufacturer is a member or dependent unit of an organization such as a company, general company, corporation, association, or another organization, its name, address, brand, trademark, and other contents may be written on the label if permitted by such organization as long as the address of the factory where drugs are manufactured is specified.

E.g.: Drugs are manufactured at factory A of company B, the label may have the text “Công ty B, Chi nhánh công ty, sản xuất tại địa chỉ A” ("Company B, branch, manufactured at A”).

Article 34. Origins of drugs and medicinal ingredients

1. Determination of origins of drugs and medicinal ingredients:

a) Origins of drugs and medicinal ingredients shall be determined in accordance with the Law on Commerce, legislative documents on guidelines for the Law on Commerce with regard to goods origins and relevant legislative documents;

b) The entities responsible for labeling as prescribed in Article 6 herein shall determine and specify origins of their drugs and medicinal ingredients in honest and genuine manner and in conformity with the law regulations on good origins or international treaties to which Vietnam is a signatory.

2. Expression of origins of imported drugs and medicinal ingredients:

Origins of drugs or medicinal ingredients shall be written on secondary packages as follows:

a) The phrase “xuất xứ:” ("origin:") or “sản xuất tại:” ("manufactured in:") or “sản xuất bởi:” (“manufactured by:”) and the name of the country or territory in which the drug or medicinal ingredient is manufactured;

The name of the country or territory in which the drug or medicinal ingredient is manufactured must be the full name.

b) If the drug or medicinal ingredient origin is the same as the country or territory in which it is manufactured, only the country's name in Vietnamese (or English if Vietnamese name is not available) is required;

c) If the drug or medicinal ingredient origin is different from the country or territory in which it is manufactured, full information about drug or medicinal ingredient origin as set out in Point a Clause 2 of this Article must be written.

3. For drugs or medicinal ingredients manufactured in Vietnam for domestic sale, if the manufacturer’s address is already written, the drug or medicinal ingredient origin may be omitted.

Article 35. Other contents on labels

1. In addition to the compulsory information prescribed in this Circular, other information may be written on the label and package insert included in the application for registration or license to import the drug without registration number or the drug label in the case prescribed in Clause 1 or Clause 2 Article 11 herein provided it must satisfy regulations in Clause 3 of this Article.

2. In addition to the compulsory information prescribed in this Circular and before selling drugs on the market, the responsible entity may write other information on the drug label and/or package insert which has been approved by a regulatory authority without giving a notification and obtaining the approval from a regulatory authority provided that it must satisfy the requirements in Clause 3 of this Article. In such case, the responsible entity shall ensure the accuracy of additional information. To be specific:

a) Affix or alter anti-fraud stamps as well as other security warnings and anti-counterfeit contents on drug labels to help fight against counterfeit products or recognize their products;

b) Change the form or color of the package insert; the size of the secondary package label or the primary package label;

c) Add or alter the telephone number, zip code, web address or email address of any relevant entity responsible for the drug or of the brand owner;

d) Add or alter the symbol ® behind the drug name or behind the company’s name or logo; change logo of any relevant entity responsible for the drug;

dd) Change the position of the registration number or import license number, the position of the secondary label, or the position of batch number, expiry date or manufacturing date on the label;

e) Add information in another language which is translated from the information in Vietnamese language as approved by the Ministry of Health according to the application for drug registration or the application for the license to import drugs without registration number.

3. Provisions on additional information on the label:

a) Additional information must be lawful, truthful, and accurate, and reflect the true nature and effects of drugs, must not be advertising information and must not block or falsify compulsory information on the label, and ensure that the compulsory information is conformable with the label approved by a functional unit of the Ministry of Health;

b) Additional information must not be:

- Information or images prohibited in advertising as regulated in Article 8 of the Law on Advertising;

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

- Information and images prescribed in Clause 2 Article 18 of the Decree No. 43/2017/ND-CP;

- Information or images about the bioequivalence or clinical equivalence between biosimilars and reference biologics.

c) The information in another language as prescribed in Point e Clause 2 of this Article must be conformable with the information in Vietnamese language. The text or numbers in another language must not block or be larger in size than those in Vietnamese language;

d) The label and package insert of drugs or medicinal ingredients manufactured in Vietnam and exported may have the information written in the language of the importer’s country as requested under the sale contract provided that it shall not falsify the information and the nature of drugs or medicinal ingredients.

Bài viết liên quan