Chương II Thông tư 01/2018/TT-BYT: Nội dung của nhãn, tờ hướng dẫn sử dụng thuốc

Chapter II

INFORMATION ON DRUG LABELS AND PACKAGE INSERTS

Section 1. COMPULSORY INFORMATION ON LABELS

Article 7. Secondary package labels of drugs and medicinal ingredients

1. The secondary package label of drugs must contain the compulsory information below:

a) The drug name;

b) Dosage form;

c) The composition of the drugs, contents, weights or concentrations of active ingredients or herbal ingredients;

d) Package contents;

dd) Indications, usage instructions and contraindications;

e) Registration number or import license number (if any);

g) Batch number, manufacturing date, expiry date, quality standards and storage conditions;

h) Precautions and recommendations;

i) Name and address of manufacturer;

k) Name and address of importer (for imported drugs);

l) Drug origin.

2. The secondary package label of medicinal ingredients (including herbal ingredients, traditional ingredients, semi-finished drugs and semi-finished herbal medicines) must contain the compulsory information below:

a) Name of medicinal ingredients;

b) Weight or volume of medicinal ingredients contained in a smallest package unit;

c) Quality standards of medicinal ingredients;

d) Registration number or import license number (if any);

dd) Batch number, manufacturing date, expiry date and storage conditions;

e) Name and address of manufacturer of medicinal ingredients;

g) Name and address of importer (for imported medicinal ingredients);

h) Origin of medicinal ingredients.

3. Labels of controlled medicinal ingredients (including controlled semi-finished drugs):

In addition to compulsory information specified in Clause 2 of this Article, the following texts must be specified on secondary labels of medicinal ingredients which are active ingredients, herbal ingredients or semi-finished drugs containing active ingredients or herbal ingredients on the Lists of narcotic active ingredients, psychotropic ingredients, drug precursors, toxic medicinal ingredients, toxic herbal ingredients and radioactive medicinal ingredients: “Nguyên liệu gây nghiện” (“Narcotic active ingredients”), “Nguyên liệu hướng thần” (“Psychotropic ingredients”), “Nguyên liệu tiền chất làm thuốc” (“Drug precursors"), “Nguyên liệu độc” (“Toxic medicinal ingredients”), “Dược liệu độc” (“Toxic herbal ingredients”) or “Nguyên liệu phóng xạ” (“Radioactive medicinal ingredients”).

The text “Nguyên liệu gây nghiện”, “Nguyên liệu hướng thần”, “Nguyên liệu tiền chất làm thuốc”, “Nguyên liệu độc”, “Dược liệu độc”, “Nguyên liệu phóng xạ” must be printed bold type in box and on the main side of the label on which the name of medicinal ingredients is specified.

4. If the secondary package label cannot contain all compulsory information prescribed in Clause 1 of this Article, the information specified in Point dd Clause 1 of this Article may be briefly summarized by the following text: “Chỉ định, cách dùng, chống chỉ định và các thông tin khác: xem trong tờ hướng dẫn sử dụng thuốc kèm theo” (“Please refer to the package insert for indications, usage instructions, contraindications and other information”).

Article 8. Intermediate package labels

1. The intermediate package label of drugs must contain the compulsory information below:

a) The drug name;

b) Batch number;

c) Expiry date.

2. If the intermediate package is made of transparent materials through which information on the primary package label may be revealed, it is not required to have the information specified in Clause 1 of this Article.

Article 9. Primary package labels of drugs and medicinal ingredients

1. The primary package label of drugs must contain the compulsory information below:

a) The drug name;

b) The composition of the drugs, contents, weights or concentrations of active ingredients or herbal ingredients;

c) Batch number;

d) Expiry date;

dd) Name of manufacturer.

2. Primary package labels of medicinal ingredients:

If the secondary package label of medicinal ingredients contains sufficient compulsory information as regulated in Clause 2 and Clause 3 Article 7 herein, the primary package label may be exempted provided that the medicinal ingredients are not divided for retail.

3. If there is no secondary package, primary package labels of drugs and medicinal ingredients must contain sufficient information of secondary package labels as regulated in Article 7 herein.

Article 10. Secondary labels

1. The secondary label shall contain every compulsory information which is not written on the original label in Vietnamese language as prescribed in Article 7 of this Circular.

2. If the secondary label is so small that it cannot contain compulsory information as specified in Clause 1 of this Article 7, certain compulsory information may be written as follows:

a) Indications, usage instructions, contraindications and other information: Please refer to the package insert;

b) The way to find out the information about manufacturing date, expiry date and batch number printed on the original label must be available;

c) Registration number or import license number may not be specified but the information about registration number or import license number (if any) must be specified before drugs are sold on the market.

Article 11. Drug labels in other cases

1. Traditional drugs prepared according to regulations in Clause 1 and Clause 2 Article 70 of the Law on Pharmacy and drugs produced and prepared according to regulations in Clause 2 and Clause 3 Article 85 of the Law on Pharmacy must have labels containing the following compulsory information, except for the cases mentioned in Clause 3 of this Article:

a) The secondary package label of traditional drugs and prepared drugs must contain the following information:

- The information prescribed in Points a, b, c, d, dd, g and h Clause 1 Article 7 herein;

- Name and address of health facility producing or preparing drugs.

b) The primary package label of traditional drugs must contain the compulsory information below:

- The information prescribed in Points a, b, c and d Clause 1 Article 9 herein;

- Name of health facility producing or preparing drugs.

c) If there is no secondary package, the primary package label of traditional drugs and prepared drugs must contain sufficient compulsory information of the secondary package label as prescribed in Point a Clause 1 of this Article.

2. Drugs prepared according to prescriptions and sold at drugstores in accordance with regulations in Point b Clause 1 Article 47 of the Law on Pharmacy must have secondary package labels or primary package labels containing the compulsory information below:

a) Drug name, dosage form;

b) Active ingredients and concentrations or contents thereof;

c) Preparation date, expiry date, storage conditions;

d) Name and address of drugstore preparing drugs;

dd) Name of patient presenting the prescription;

e) Precautions for controlled drugs.

3. Traditional drugs prepared according to prescriptions in accordance with regulations in Clause 1 Article 70 of the Law on Pharmacy are exempted from labeling as prescribed in this Circular but must have the secondary package on which full name and age of patient are specified to avoid mistake while delivering drugs.

4. Drugs which have been not yet granted the Certificate of registration in Vietnam but are imported to serve the purpose of bioequivalence study, bioavailability assessment, use as specimens for registration, testing or scientific research, or display at a fair or exhibition shall be exempted from labeling with compulsory information prescribed in Article 7 and Article 8 herein but must have their original labels unchanged and affixed with secondary labels as follows:

a) The secondary label of drugs used for bioequivalence study, bioavailability assessment or as specimens for testing or scientific research must have the text “Thuốc dùng cho mục đích nghiên cứu” (“Drugs used for research purpose”);

b) The secondary label of drugs used as specimens for registration must have the text “Thuốc làm mẫu đăng ký” (“Drugs used as registration specimens”);

c) The secondary label of drugs used for display at a fair or exhibition must have the text “Thuốc làm mẫu trưng bày” (“Drugs for display”).

5. Medicinal ingredients which are active ingredients and have been not yet granted the Certificate of registration in Vietnam but are imported to use as specimens for registration, testing or research, or for display at a fair or exhibition in accordance with regulations in Clause 3 Article 60 of the Law on Pharmacy shall be exempted from labeling with compulsory information prescribed in Article 7 and Article 8 herein but must have their original labels unchanged.

6. Medicinal ingredients which are active ingredients, excipients or semi-finished drugs and have been not yet granted the Certificate of registration in Vietnam but are imported to produce drugs according to registration documents of drugs granted the Certificate of registration in Vietnam must have secondary labels containing compulsory information prescribed in Clause 2 and Clause 3 Article 7 herein (except for name and address of importer). The secondary label may be exempted if the original label contains all this compulsory information in other Romance languages.

7. Drugs imported in accordance with regulations in Point b Clause 1 Article 68 of the Decree No. 54/2017/ND-CP shall be exempted from labeling in Vietnamese language as regulated herein provided that their original labels must be kept unchanged.

Section 2. INFORMATION ON PACKAGE INSERTS

Article 12. Information on package inserts

The package insert of drugs must contain the compulsory information below:

1. The drug name.

2. Precautions and recommendations.

3. Composition of the drug.

4. Dosage form.

5. Indications.

6. Usage instructions and dose.

7. Contraindications.

8. Warnings and cautions.

9. Warnings for the use of drugs during pregnancy and breastfeeding.

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

11. Drug interactions and incompatibilities.

12. Adverse drug reactions.

13. Overdose and treatment.

14. Information about pharmacodynamics (not applicable to OTC drugs, herbal drugs and traditional drugs).

15. Information about pharmacokinetics (not applicable to OTC drugs, herbal drugs and traditional drugs).

16. Package contents.

17. Storage conditions, expiry date and quality standards.

18. Name and address of manufacturer.

Article 13. Requirements of a package insert

1. Every drug sold on the market, or produced or prepared by a health facility as regulated in Clause 1 Article 11 herein, must have a package insert written in Vietnamese language, except for the following cases:

a) Drugs produced or prepared according to traditional remedies or prescriptions as regulated in Clause 1 Article 70 and Clause 2 Article 85 of the Law on Pharmacy for use or retail according to prescriptions at health facilities;

b) Drugs prepared and retailed at drugstores in accordance with regulations in Point b Clause 1 Article 47 of the Law on Pharmacy;

c) Drugs which have been not yet granted the Certificate of registration in Vietnam but are imported to serve the purpose of bioequivalence study, bioavailability assessment, use as specimens for registration, testing or scientific research, or display at a fair or exhibition;
d) Drugs imported in accordance with regulations in Point b Clause 1 Article 68 of the Decree No. 54/2017/ND-CP;

dd) OTC drugs having labels containing all compulsory information of the package insert as prescribed in Article 12 herein.

2. Package inserts in foreign languages of the drugs mentioned in Point d Clause 1 of this Article must be kept unchanged.

3. If multiple drugs share the same name, active ingredients, herbal ingredients, dosage form, administration route, indications and manufacturer but the volume, contents, concentrations, weights or package contents are different and all of them are permitted for free sale, they may be written on the same package insert.

If there are differences in concentrations or contents, it is required to specify the concentrations, contents, volumes or package contents.
4. At least one package insert in Vietnamese language must be contained in the secondary package of drugs. If there is no secondary package, at least one package insert must be contained in the primary package of drugs.