Thông tư 06/2016/TT-BYT về quy định ghi nhãn thuốc

THE MINISTRY OF HEALTH

Circular No.06/2016/TT-BYTdated March 08, 2016 of the Ministry of Health on drug labeling

Pursuant to the Law on Pharmacy No. 34/2005-QH11 dated June 14, 2005;

Pursuant to the Government s Decree No. 89/2006/ND-CP dated August 30, 2006 on goods labels;

Pursuant to the Government s Decree No. 63/2012/ND-CP dated August 31st 2012 defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the request of Director of Drug Administration of Vietnam;

The Minister of Health promulgates a Circular on drug labeling.

Chapter I

GENERAL PROVISIONS

Article 1. Scopeof adjustment

1.This Circular provides for contents of drug labels and methods for labeling drugs sold on the market.

2.This Circular does not apply to labels of:

a) Drugs serving bioavailability testing, bioequivalence testing, testing and experimental manufacture of drugs at drug-manufacturing facilities or other research facilities of the manufacturers;

b) Drugs without registration number imported within a limited quantity specified in Point b, d, dd, e, and g Clause 2 Article 20 of the Law on Pharmacy;

c) Prescription oriental medicines sold directly at medical facilities exempt from registration and not widely sold on the market.

3.Labels of drugs specified in Point b and Point c Clause 2 of this Article shall comply with Clause 2 Article 36 of the Law on Pharmacy.

Article 2. Definitions

In this Circular, the terms below are construed as follows:

1.Drug label means a print or drawing of text, pictures, or symbols directly printed or pressed on the commercial packages of drugs, or firmly affixed on the commercial packages of drugs, including the instruction sheet and secondary label.

2.Drug labeling means the expression of basic, necessary, and primary information about the drug on the label in order to help users recognize, select, and use drugs properly, and to facilitate the inspection, control, and management of regulatory bodies.

3.Original label means the label that express the information that are first printed or firmly affixed on the commercial packages of the drug after the packaging stage in the production line is completed.

4.Commercial package of a drug means the package that envelops the drugs and the instruction sheet and is sold together with drugs.Commercial packages of drugs include primary package, secondary package, and probably intermediate package.

5.Primary package means the package that envelops drugs and is in direct contact with drugs.

6.Secondary package means the package used to envelop one or some units of drugs that already have primary packages.

7.Intermediate package means the package which is used to wrap one or some units of drugs that already have primary packages and contained in the secondary package.

8.Name and address of responsible entity means the name and address of the entity that registers, manufactures, exports, imports of drugs, or entrusts the export or import of drugs.

9.Package contents means the quantity of drugs expressed as net weight, true volume, or pcs (pieces) in a package unit.

10.Batch number means a series of numbers of letters or both that helps recognize the batch of drug and permits the trace of history of a batch of drugs, including all production stages, quality inspections and sale of that batch.

11.Instruction sheet means the document enclosed in the commercial package of drugs, which contain necessary information about the use and conditions of drugs in order to for physicians and/or users to use drugs safely, effectively, and rationally.

12.Registration number means a series of characters and digits granted by a unit of the Ministry of Health to a drug or in vitrodiagnostic reagents in order to certified that it is permitted for free sale in Vietnam.

13.Import license number means a series of characters and digits written on the license for import drugs without registration numbers.

Article 3. Responsibilities for labeling

1.With regard to drugs manufactured in Vietnam:

a) The registrant and/or manufacturer of drugs sold in Vietnam is responsible for drug labeling;

b) The manufacturer of drugs for export and/or exporter of drugs is responsible for drug labeling;

2.With regard to drugs manufactured overseas and imported for sale in Vietnam:

a) The registrant and/or manufacturer of drugs is responsible for labeling of drugs having registration numbers;

b) The importer and/or manufacturer of drugs is responsible for labeling of drugs without registration numbers;

3.Contents of goods labels must be truthful, clear, and accurate, and reflect the nature of drugs in accordance with the drug registration and drug import documents approved by the Ministry of Health.

Article 4. Label position

Drug labels must be affixed on the commercial packages of drugs where their contents can be recognized easily with bare eyes without having to remove any part of the package.

Article 5. Sizes of labels, colors of text, symbols, and pictures on the labels

1.The entity responsible for labeling shall decide the sizes of the labels.

2.The sizes, color of text, numbers, pictures, symbols, and signs on the label must be clear, legible, and recognizable in normal conditions. To be specific:

a) Colors of the compulsory text must be contrast to the background.

b) The minimum height of text of compulsory information is 1.2 mm. On the secondary label, the minimum text height is 0.9 mm.

Article 6. Languages on drug labels and secondary labels

1.Compulsory information on a drug label must be written in Vietnamese language, except for the following information which may be written in other Romance languages:

a) Drug name: proprietary name, generic name, or international nonproprietary name of the drug;

b) The international nonproprietary names or scientific names with chemical formulae or structural formulae of active ingredients, excipients, and other contents of drugs;

c) The name and address of the foreign company that registers, manufactures, grants franchise, or processes drugs.

2.Every drug sold domestically market must have an instructions sheet written in Vietnamese language in accordance with this Circular. If certain information has to be written in another language, the content written in the foreign language must match the content written in Vietnamese language and its size must not exceed that of the Vietnamese content.

3.Imported drugs for sale in Vietnam shall be labeled in either of the following manners:

a) An original label in Vietnamese language with adequate compulsory information specified in this Circular. Apart from that, other languages may be concurrently used. On the original label, the size of text in foreign language of the same content must not exceed that of the Vietnamese content.

b) Secondary label containing compulsory information in Vietnamese language that is not written on the primary label. The original label must be kept unchanged.

4.If the original label of imported drugs does not contain sufficient compulsory information in Vietnamese language, the importer shall be granted customs clearance in order to affix the secondary labels. Secondary labels shall be affixed within a facility that has GMP certificate or in a drug storage facility that has GSP certificate of the importer permitted to import finished drugs or provide drug storage services before drugs are sold on the market.

5.Where a foreign entity that imports drugs manufactured in Vietnam requests that drugs be labeled under the sale contract and takes responsibility for their request, the drug manufacturer and exporter may adhere to the contract as long as such request does contravene the nature of drugs and does not contravene Vietnam’s law or the importing country’s law.

Chapter II

CONTENTS OF DRUG LABELS

Section 1. COMPULSORY INFORMATION ON COMMERCIAL PACKAGES AND SECONDARY LABELS

Article 7. Secondary package label

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

1.With regard to commercial drugs, vaccines, serums containing antibodies, curative reagents:

a) The drug name;

b) The composition of the drugs: active ingredients and concentrations thereof (including salts of active ingredients, if any); excipients and concentrations thereof are not required;

c) Dosage form (except for in vitro diagnostic reagents), packaging contents;

d) Indications (or effects if the drug is an oriental medicine or herbal medicine), directions, and contraindications;

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

e) Registration number or import license number;

g) Notes;

h) Name and address of the responsible entity;

i) Drug origin.

2.With regard to in vitro diagnostic reagents:

a) Name of the reagent;

b) The composition of the drugs: active ingredients and concentrations thereof or content of active ingredients in smallest package unit; excipients and concentrations thereof are not required;

c) Package contents;

d) Purposes and directions;

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

e) Registration number or import license number;

g) Notes;

h) Name and address of the entity responsible for the reagent;

i) Origin of the reagent.

3.If the secondary label is so small that it cannot contain all the compulsory information, at least the information below must be specified:

a) The information specified in Point a, b, c, dd, e, h and I Clause 1 of this Article shall be written on the secondary package labels of commercial drugs, vaccines, serums containing antibodies, and curative regents, and information in Point a, b, c, dd, e, h, and I Clause 2 of this Article of in vitro diagnostic reagents;

b) The secondary label must contain all the compulsory information prescribed n Article 10 of this Circular that is not written on the original label.

Article 8. Intermediate package label

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

a) The drug name;

b) Manufacturer s name

c) Batch number, expiry date.

2.If the intermediate package is made of a transparent information which reveals information on the primary package label, it is not required to have the information specified in Clause 1 of this Article.

Article 9. Primary package label of commercial drugs

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

a) The drug name;

b) Composition of drugs:

-If the composition of the drugs has more than 03 active ingredients, it is not required to specify the active ingredients, excipients, and concentrations thereof. If active ingredients and concentrations thereof are specified, it is required to specify the concentration of each active ingredient, including their salts (if any);

-For drugs containing not more than 03 active ingredients: It is required to specify active ingredients and concentrations of each active ingredients, including their salts (if any);

-For in vitro diagnostic reagents, it is not required to specify active ingredients and excipients.

c) Net weight or volume (not applied to blister packs);

d) Batch number, expiry date;

dd) Name of manufacturer:: abbreviated name or English business name is permitted 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.

2.If there is no secondary package, the primary package must contain the information prescribed in Article 7 of this Circular.

Article 10. Secondary label

1.The secondary label shall contain every compulsory information which is not written on the original label in Vietnamese as prescribed in Clause 1 or Clause 2 Article 7 of this Circular. If the secondary label is so small that it cannot contain every compulsory information which is not written on the original label in Vietnamese, the information specified in Point a, dd, e, h and I Clause 1 or Clause 2 Article 7 of this goods is required. Other compulsory information shall be written on the instructions sheet. The secondary label must have the text ("Please refer to the instructions sheet for other information”). The part that contains such compulsory information on the instructions sheet is considered part of the secondary label.

2.The secondary label must be firmly affixed on the secondary package (or primary package if there is no secondary package) and must not block the contents of the original label.

Article 11. Labels of ingredients and semi-finished products to be registered

1.The label of ingredients and semi-finished products must contain the information below:

a) The name of the ingredient or semi-finished product;

b) Concentration (if any);

c) Net weight or volume;

d) Quality standards of the ingredient or semi-finished product;

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

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

g) Name and address of the manufacturer of the ingredient or semi-finished product;

h) Name of the importer (if the ingredient or semi-finished product is imported).

i) Origin of the imported ingredient.

2. The labels of ingredients classified as narcotic drugs, psychotropic drugs, or precursors must contain the text"narcotic drugs", "psychotropic drugs", or"precursor" respectively.

The text"narcotic drugs", "psychotropic drugs", or"precursor" must be printed bold type on the upper right corner of the label.

3.The label of herbal ingredients or bone glue used as medicinal ingredients must contain the following information:

a) Name of the herbal ingredient or bone glue extracted from herbal ingredients (including the Vietnamese name and Latin scientific name);

b) Concentration (if any);

c) Net weight or volume;

d) Quality standards, humidity, batch number, manufacturing date, expiry date, storage conditions;

dd) Registration number (if any); import license number (if any);

e) Name and address of the manufacturer;

g) Name and address of the importer (if the herbal ingredient or bone glue is imported).

h) Origin of the imported herbal ingredient.

Article 12. Drug labels in other cases

1.Labels of drugs prepared according to prescriptions and used in medical facilities must contain:

a) Drug name, dosage form;

b) Active ingredients and concentrations thereof;

c) Name of the preparers, preparation date, expiry date;

d) Directions, dose;

dd) Name of the patient; ward (if any);

e) Name and address of the medical facility.

2.The label of herbal drugs being sold on the market must contain the information below:

a) Name of the herbal remedy;

b) Composition of the remedy: the herbal ingredients and amount thereof;

c) Package contents, net weight.

d) Effects, dose, directions, contraindications;

dd) Registration number of import license number (if any), batch number, manufacturing date, expiry date, storage conditions;

e) Notes;

g) Name and address of the entity responsible for the drug;

h) Origin of the imported herbal drugs.

Section 2. INFORMATION ON THE ISNTRUCTIONS SHEETS

Article 13. Requirements of an instructions sheet

1.Every drug sold on the market must have an instructions sheet written in Vietnamese language. Each commercial package must contain at least 01 instruction sheet in Vietnamese language, except for the following cases:

a) Ingredients, semi-finished products, herbal ingredients, bone glues, drugs prepared according to prescriptions and used within a medical facility.

b) If the product is an in vitro diagnostic reagent used with testing machines, the instruction sheet may be attached to the testing machine instead of the commercial package (as a printed copy or soft copy) or posted on the manufacturer s website.

2.The instruction sheets must contain sufficient information for health officials or patients. The content of the instruction sheet shall be extracted from instructions on the use of drugs for health officials and expressed in a way that is simple and understandable to patients. Jargons should be avoided.

3.If multiple drugs share the same name, active ingredients, dosage form, indications, and manufacturer but the concentrations are different and all of them are permitted for free sale, they may be written on the same instruction sheet. If there are differences in concentrations, it is required to specify the concentrations.

4.The size and color of text on the instructions sheet must be large and clear enough to be read in normal conditions.

5.The content of an instruction sheet of a modern medicine, oriental medicine, or herbal medicine has two parts: instructions for patients and instructions for health officials. The content may be written on the same sheet or two separate sheets as follows:

a) If they are written on the same sheet, the instructions for patients shall comply with Article 14 of this in; instructions for health officials are not required to contain information in Clause  1, 2, 3, 5, 12, 13, 14 Article 15 of this Circular.

b) If they are written on two separate sheets, the instructions for patients and health officials shall contain sufficient information specified in Article 14 and Article 15 of this Circular.

6.The content of instructions sheets of vaccines and curative reagents shall contain sufficient information specified in Article 15 of this Circular.

7.The content of instructions sheets of in vitro diagnostic reagents shall contain sufficient information specified in Article 16 of this Circular.

Article 14. Instructions for patients

The instruction sheet for patients shall contain the following information in the correct order:

1. Drug name.

2. The following warning text shall be written right below the drug name:

a) “Read the instructions carefully before use", "Keep away from children", “Inform the physician or pharmacist of adverse effects encountered during use".

b) For prescription drug, the phrases “Medicines with the prescription”, “Medicine for prescription”, and “This medicine used under  doctor’s prescription” are interchangeable.

3. Drug composition and concentrations.

a) Specify every active ingredient, percipient and their concentrations (including their salts or hydrates , if any), herbal ingredients, bone glues in a smallest dose or pack. The concentrations of percipients are not required. The percipients that evaporate or disappear during the manufacturing process may be omitted.

b) For oriental medicines and herbal medicines: write the Vietnamese name and Latin (scientific) name of the herbal ingredients and bone glues.

4. Dosage form and description thereof.

5. Description of package contents.

6. Indications: specify information about the drug indications.

7. Directions, dose and administration route of the drug.

8. Contraindications.

9. Adverse effects (if any).

10. What drugs or foods should be avoided when using this drug?

Specify the reactions of the drug with other drugs and other reactions.

11. What to do when forgetting to take drugs: Specify necessary acts or measures when the patient forgets to take drugs;

12. Storage conditions and temperature.

13. Signs and symptoms and manifestations of overdose.

14. What to do when having an overdose: specify methods for dealing with overdose.

15. Cautions.

16. The cases that need consultation with a physician or pharmacist and the text "Ask a physician or pharmacist for more information".

17. Expiration date: specify the expiration date from the date of manufacture and expiration date from the first date on which the primary package is open or after preparation (drugs that need to be reconstituted before use).

18. Name, address, symbol (if any) of the manufacturer.

19. Date for update: the date of issue of the registration number on by a unit of the Ministry of Finance or the day on which latest updates to the instruction sheet are approved.

Article 15. Instructions for health officials

The instruction sheet for health officials shall contain the following information in the correct order:

1. Drug name.

2. Composition of drugs.

a) Specify every active ingredient, percipient and their concentrations (including their salts or hydrates , if any), herbal ingredients, bone glues in a smallest dose or pack. The concentrations of percipients are not required. The percipients that evaporate or disappear during the manufacturing process may be omitted.

b) For oriental medicines and herbal medicines: write the Vietnamese name and Latin (scientific) name of the herbal ingredients and bone glues.

3. Dosage form.

4. Information about pharmacodynamics and pharmacokinetics of modern medicines or curative reagents.

5. Package contents.

6. Indications (or effects if the drug is an oriental medicine or herbal medicine), contraindications, dose, and directions.

7. Cautions.

8. Reactions of the drug with other drugs and other reactions.

9. Adverse effects

10. Overdose and treatment.

11. Notes and cautions.

Specify the notes and other warnings (if any), except for the warnings specified in Clause 2 Article 14 hereof.

12. Storage conditions and expiry date.

13. Manufacturer s name and address.

14. Date for update: the date of issue of the registration number on by a unit of the Ministry of Finance or the day on which latest updates to the instruction sheet are approved.

Article 16. Instructions for in vitro diagnostic reagents

Instructions for using in vitro diagnostic reagents include:

1. Name of the reagent.

The text "Keep away from children" and "Read instructions carefully before use" after the reagent name.

2. Composition of the reagent.

Specify the contents of the smallest package unit. Specify the concentration of each active ingredient. The concentrations of percipients may be omitted.

3. Package contents.

4. Purposes and directions

Specify the principles, testing procedures, and result interpretation.

5. Sensitivity, effectiveness, accuracy, detection limit (not applied to biological used for machine calibration or test result verification);

6. Cautions and warnings.

7. Notes and recommendations.

8. Storage conditions, expiry date, and elements affecting the expiry date (if any).

9. Manufacturer s name and address.

10. Date for update: the date of issue of the registration number on by a unit of the Ministry of Finance or the day on which latest updates to the instruction sheet are approved.

Chapter III

DRUG LABELLING

Article 17. Drug names

1. The drug name on labels is created by the manufacturer, seller, or registrant. If the drug name is different from the international nonproprietary name and contains a single substance, the generic name or international nonproprietary name must be specified.

2. A drug name consists of letters and may have digits, regardless of case. If multiple drugs share the same name, manufacturer, dosage form but the concentrations are different, corresponding concentrations may be written next to the drug name in a recognizable way.

3. The drug name must be bold and recognizable in a way that the nature and effects of drugs are not misinterpreted or exaggerated.

Article 18. Composition of drugs

1. Names of active ingredients and excipients

a) Names of active ingredients and excipients shall be their generic names or international nonproprietary names. Where the chemical form of an active ingredient is different from the form used for dose determination, the concentration of that active ingredient must be converted to the form used for dose determination.

b) For oriental medicines and herbal medicines:

-If the drug is derived from bone glue (single-substance bone glue or standardized bone glue according to the pharmacopoeia) or bone glue mixture, the composition of the glue or mixture, herbal ingredients and their quantities must be specified.

-For herbal medicines: the names of herbal ingredients shall be Vietnamese names. If an imported drug contains ingredients that do not have Vietnamese names, the names in the exporting country (country of origin) and their Latin names (scientific names) shall be written;

-For a herbal medicine whose ingredients are in various forms such as glue, granule, powder, etc., the composition and concentrations shall be specified according to the corresponding initial forms.

c) Name of herbal ingredients:

-Names of herbal ingredients shall be common Vietnamese names (their Latin names may be written in addition thereto). Conventional names or original names of the plants or animals from which herbal ingredients are derived may be used.

-Conventional names of herbal ingredients are their proper names in traditional medicines. Example: Phu Binh, Bach Gioi Tu, Huong Phu.

-If more than one part of the plant are used as medicinal ingredients, the parts must be specified.

-Where names of herbal ingredients and bone glues in Vietnamese language are written as composition of the drug in the instruction sheet, Latin names (scientific names) of herbal ingredients and bone glues must also be written; Latin names of composition of herbal ingredients and bone glues are not required on the drug label.

d) Name of the bone glue:

-Bone glue names shall be Vietnamese names (their Latin names may be written in addition thereto). If the names of an imported bone glue cannot be translated into Vietnamese language, its foreign name in the exporting country (or country of origin) and its Latin name shall be written;

-Specify the form of the bone glue according to Vietnam’s pharmacopoeia, which is either liquid, solid, or dried glue. If solid or dried glue contains any excipient or preservative, the excipients or preservatives and concentrations (%) thereof must be specified on the label.

-If active ingredients in a herbal ingredient have been identified, the concentrations of bone glue and active ingredients must be specified;

-If active ingredients in a herbal ingredient are not identified, the initial ratio of herbal ingredients and bone glue must be specified.

-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.

2. Drug composition

a) The active ingredients and concentrations thereof, including their salts (if any), in a smallest dose or package shall be specified as follows:

-Divided dose: concentrations of active ingredients in a dose unit. A dose might be a table, a pack, or a volume of drug (if drug is in liquid form), or a certain weight of drug (if drug is solid). If drug is a solution (including medicinal syrup, medicinal alcohol and similar forms), the concentrations of active ingredients may be expressed as percentage (weight/volume). If the active ingredient is in liquid form and their accurate concentrations are not required, the concentrations shall be expressed as percentage (volume/volume) e.g. accurate concentrations essential oils in a drug is not required when inspecting drug quality.

-With regard to drugs without divided dose (it is not required to determine the exact dose before use: cream, ointment, transdermal patch and similar forms): determine the concentrations of drug in a certain weight of drugs if the drug is in solid form or semi-solid form, or in a certain volume of drug if drug is in liquid form, or in a certain area if drug is in the form of transdermal patches. Example: every 1 g/ml, 10 mg/ml, 100 mg/ml, each patch (cm2) contains a specific amount active ingredients (g or mg).

b) With regard to multi-dose drugs: specify the active ingredients and concentrations thereof.

3. Measurement units

Concentrations are expressed as:

a) gram (g), milligram (mg), microgram (μg or mcg), or kilogram (kg) if the weight of drug is significant;

b) Milliliter (ml), micro liter (μl), or liter (l or L) if the drug volume is significant. The weight below 1 mg or the volume below 1 ml shall be expressed as a decimal fraction e.g. 0.25 mg or 0.5 ml.

c) Other measurement units:

-Activity unit may be used for special active ingredients;

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

Article 19. Package contents

1. Package contents mean the quantity, net weight, or true volume of drugs contained in a commercial package. The package contents of a drug must be expressed as natural numbers, in particular:

a) Drugs in the form of tablets: number of tables. With regard to drugs in the form of Chinese tablets, the net weight of a divided dose or a smallest packaged may be written;

b) Drugs in the form of ointment, gel, powder, granule, herbal drugs, herbal ingredients, medicinal ingredients: specify the net weight;

c) Drugs in the form of powder or multi-dose granule, lyophilized powder that have to be reconstituted before use: specify the net weight.

d) Drugs in liquid form: specify the true volume;

dd) In vitro diagnostic reagents: specify the total quantity of tests and volume of each package.

2. Maximum quantity of commercial drugs in a package:

a) For tablets: Not more than 200 tablets in a jar or bottle or a container of blister packs. If the drug contains addictive ingredients, psychotropic ingredients, or drug precursors containing single or multiple ingredients, the secondary package shall not contain more than 100 tablets;

b) For single-dose injectable solution: not more than 25 vials or pipes or prefilled syringes;

c) For multi-dose injectable solution: not more than 10 doses in a vial or jar;

d) For liquid preparations for oral use: not more than 50 divided doses;

dd) For sprayer or aerosol: not more than 200 doses;

e) For other forms: not more than 50 divided doses.

3. The maximum package content specified in Clause 2 of this Article does not apply to:

a) In vitro diagnostic reagents;

b) Medicinal ingredients and semi-finished products;

c) Chinese round pills;

d) Drugs supplied for hospitals (except for commercial drugs containing addictive ingredients, psychotropic ingredients, or drug precursors containing single or multiple ingredients), the secondary packages of which must have the "For hospitals only";

4. If a commercial package contains multiple packages, the content of each package and quantity of packages must be specified.

Article 20. Indications, directions, doses, and contraindications

1. Indications

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

a) Purposes of the drug: whether the drug is used for preventive, diagnostic, or curative purpose;

b) Drug users: specify the drug indications applied to each type of drug users; drug users may be sorted by age or group of age;

c) 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.

2. Indications and dose

Specify the administration route, dose, administration time, and other notes when using drugs (if any).

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

-If the drug is injectable, the preparation 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.

-On the bottle of liquid drugs for oral use must have the text “No injection”;

-On the package of multi-dose drugs in the form of powder of granules that must be dissolved before oral use must have the text “Shake well before use”;

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

b) Dose

-Dose: Specify the recommended dose for each indication, administration route, and method, the interval between drug uses in a day, method to achieve best result e.g. drink a lot of water, take before eating;

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

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

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

c) Prescription modern medicines

Information about the dose, directions for children, special users, and recommendations of prescription modern medicines shall 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 the dosage form for children is not available, it is required to provide information about how to prepare a dose for children and the minimum age recommended by the manufacturer;

-If there is no indications 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 (express 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 some specific adverse reactions e.g. taking antiemetic 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. Contraindications

If there are contraindications, the cases in which drugs must not be used must be specified. The contraindications involving children, the ages of children or other group of patients e.g. by gender or body weight must be specified.

Article 21. Cautions, reactions, and adverse effects

1. Cautions

Specify the cautions when using drugs, recommendations about use of drugs for pregnant and breastfeeding women, children, chronic disease patients, and influences of drugs upon people’s life (if any).  To be specific:

a) Conditions that need cautions

-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;

-Serious adverse reactions that need to be reported to the Ministry of Health;

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

-The risks related to the beginning or suspension of treatment;

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

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

-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.);

-Warnings and risks related to excipients and ethanol in the drugs (applied to herbal medicines);

-The risks related to inaccurate administration route.

b) Recommendations for pregnant women and breastfeeding women

-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. Recommendations about monitoring of the fetus and newborn babies whose mother uses drugs during pregnancy (if information is available);

-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);

-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.

c) The influence of the drug on work (machine operators, vehicle operators, people working at height, etc.):

-The level of influence must be specified: no influence or inconsiderable influence, mild influence, medium influence, or serious influence. Write the text “No reported influence of the drug on working ability of machine operators, vehicle operators, people working at height, etc.";

-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.

2. 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.

b) The contraindications of herbal drugs, oriental medicines, or herbal medicines must be specified (if any).

c) Prescription modern medicines

Apart from the information specified in Point a Clause 2 of this Article, information about drug interaction must be added as follows:

-Specify information about drug interactions 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;

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

-Specify information about chemical and physical incompatibility with other drugs when they are mixed or used simultaneously, especially drugs reconstituted before use. Other serious drug interactions such as the adsorption of the drug onto its package or syringe.

3. Adverse effects

a) Specify the cases in which drug use must be suspension, the cases in which adverse effects must be reported to the physician or pharmacist.

b) With regard to prescription modern drugs

Apart from the information specified in Point a Clause 3 of this Article, information about adverse effects according to the summary (if any) must be added as follows:

-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);

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

-Specify 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.

Article 22. Pharmacodynamics, pharmacokinetics, overdose, and treatment

1.Pharmacodynamics and pharmacokinetics

Only information about pharmacodynamics and pharmacokinetics of modern medicines is required.

a) Pharmacodynamics

The following information about pharmacodynamics must be specified:

-Pharmacological group and ATC number;

-Description of the reaction mechanism corresponding to the approved indications and possible adverse reactions during use;

-Summary of primary results of major clinical tests that support the approved indications (if any). For new modern medicines, the description of primary characteristics of the sample and study result includes: primary criteria (mandatory), secondary criteria (as the case may be), subgroup analysis or post-hoc analysis (in special cases).

b) Pharmacokinetics

The following information about pharmacokinetics must be specified:

-Pharmacokinetic properties of drugs (absorption, distribution, metabolism, elimination, whether linear or non-linear) corresponding to the recommended dose, concentration, and dosage form. If such information is not available, corresponding information of other administration routes, dosage forms, or dosages may be used;

-Describe 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;

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

-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.

2.Overdose and treatment

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

c) Specify the measures or treatment for overdose, including monitoring, using stimulants, antidotes, enhancement of drug excretion. If such information is not available or not sufficient, there must be the text “keep monitoring to respond in time";

c) Provide information for special users such as: elderly people, patients having kidney failure, liver failure, or other diseases (if any);

d) With regard to infant patients: Specify the notes, the concentration of drug that can cause fatal toxicity with only one dose (if any).

Article 23. Dosage form, registration number, import license number, manufacturing date, expiry date, storage conditions

1. Dosage form

Write the dosage form according to the registration documents or drug import documents of drugs without registrations approved by the Ministry of Health. The dosage form might be: tablets, film coated tablets, sugar coated tablets; hard capsules, soft capsules; solution for injection; powder for solution for injection, blend for injection, oral solution or blend; suppositories, oral powders, granules and other types of drugs according to Pharmacopoeia of Vietnam and/or common International Pharmacopoeia.

2. Registration number, import license number

a) Registration number: the text “Registration number" or “SDK” and the number issued by the Ministry of Health.

b) Import license number: the text "Import license number") or “GPNK” and the license number issued by a unit of the Ministry of Health.

3. Batch number, manufacturing date, expiry date

Batch number shall be expressed as “SX” Lot, “SX” Lot, “LSX” or “SLSX” and information about the batch number. The information and composition of the batch number is decided by the manufacturer.

4. Manufacturing date and expiry date:

a) The manufacturing date and expiry date shall be written as “Production date”, “Date” or “Using term”, or “Production date”, “Instruction” or "Using term" before information about the manufacturing date and expiry date. On the secondary package, the expiry date may be replaced with a period from the manufacturing dates (months or years).

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], [ddmmyy].

Example: A batch is manufactured on July 05, 2014 and has a shelf life of 24 months (02 years), the manufacturing date and expiry date shall be expressed as follows:

-NSX: 050713, 05/07/13, 05.07.13, 05-07-13; or NSX: 05072013, 05/07/2013, 05.07.2013, 05-07-2013;

-HD: 050715, 05/07/15, 05.07.15, 05-07-15; or HD: 05072015, 05/07/2015, 05.07.2015, 05-07-2015.

c) Where the secondary package contains diluent vials or reconstitution kit:

-If the manufacturing dates and expiry dates of the drug containing diluent vials or reconstitution kits are the same, they shall be specified on the label of the secondary package;

-If the manufacturing dates and expiry dates of the drug containing diluent vials or reconstitution kits are different, the manufacturing dates and expiry dates of the drug containing diluent vials or reconstitution kits shall be specified.

5) Expression of manufacturing date and expiry date in some special cases:

a) Where the manufacturing date and expiry date are written in a foreign language:

-If the manufacturing date and expiry date on the original label are written in a foreign language, the secondary label must contain the text: “Production date,Using date)  xem “Mfg Date” “Exp Date” (Mfg Date and Exp Date are manufacturing dates and expiry date) or corresponding manufacturing date and expiry date according to the original label;

-If the manufacturing date and expiry date on the original label are expressed as mm/yy or mm/yyyy, the expiry date on the secondary date shall be the 1stof the expiry month. This does not apply to in vitro diagnostic reagents.

Example: On the original label, the manufacturing date is 09/2013, shelf life 24 months, and expiry date 08/2015, then the expiry date on the secondary label shall be 01/08/2015.

-If the manufacturing date on the original label is expressed as dd/mm/yy or mm/dd/yy and the expiry date is expressed as mm/yy, the expiry date on the secondary label shall contain the text "expiry day is the 1stof the expiry month" or ("expiry date is 01/mm/yy");

Example: On the original label, the manufacturing date is 18/01/2012; the expiry date is 01/2015, and the shelf life is 36 months, then the expiry date on the secondary label shall be 01/01/2015.

-If the manufacturing date and expiry date on the original label are expressed as mm/yy or mm/yyyy, the expiry date on the secondary label shall be the 1st of the expiry month.

Example: On the original label, the manufacturing date is Jan/2008 or 01/2008, the shelf life is 24 months, and expiry date is 01/2010, then the expiry date on the secondary label shall be 01/01/2010.

b) If the primary package is so small that the batch number or expiry date has to be written in series of numbers instead of with the text “Number of production lot” and “HD” as prescribed in Clause 3 of this Article, such information must be fully written on the secondary package as prescribed.

c) The instructions sheet must contain the following information:

-Expiry date of the drug in the same manner as that on the label or 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, and orally administered multi-dose liquid drugs (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);

-The useful life after opening the package for the first time for orally administered multi-dose liquid drugs or tablets bottled in large quantities (if any).

6.Storage conditions

The drug label and instruction sheet must specify the storage conditions in terms of temperature (expressed as0C), humidity, and lighting in order to avoid affecting the drug quality during storage and transport (if any). Example: "Store in a dry place, protect from light, temperature not exceeding 30°C".

Specify in the instruction sheet the requirements with regard to useful life and storage conditions after opening the package for the first time, after diluting, or reconstituting (if required).

Article 24. Precautions and recommendations

1. On the drug label must have the text"Keep away from children" and “"Read instructions carefully before use". For prescription drugs (except for in vitro diagnostic reagents):

2. On the upper left corner of secondary packages of prescription drugs must have the symbol "Rx". On the label of the secondary package and the instructions sheet must have the text "Thuốc bán theo Dơn”. If the symbol "Rx" and information about prescription drug is not available on the original label, they must appear on the secondary label.

The text “Medicines with the prescription”, “Medicine for prescription”, and “This medicine used under  doctor’s prescription” are interchangeable.

3. Other notes and recommendations.

The notes (except for in vitro diagnostic reagents) must be written as follows:

a) The administration route of injectable drug must be written briefly or in full on the label, including: "intramuscular injection", "subcutaneous injection", "intravenous injection", "intravenous infusion", etc.;

b) The text “Eyes drops” shall be written on labels of eye drops and eye ointment respectively; “nose drops” on labels of nose drops; “Ear drops” on labels of ear drops;

c) The text “Outside medicine” shall be written on labels of topical drugs; "No injection" on bottles of oral drugs;

d) The multi-dose package of drugs in the form of blends, powder, and granule that must be reconstituted before use must have the text "Shake well before use".

4. Format of notes:

a) The text and symbols must be printed bold and clear enough to be read in normal conditions on secondary packages and instructions sheets.

b) All the notes of the drug must be written.

c) If the original label of an imported drug for sale in Vietnam does not have notes and recommendations specified in Clause 1, 2, or 3 of this Article, they must be available on the secondary label and instruction sheets.

d) Notes and recommendations specified in Clause 3 of this Article should be written on labels of primary packages.

Article 25. Name and address of the entity responsible for the drug

1. The name and address of the responsible entity shall be written on a case-by-case basis. To be specific:

a) If drugs are manufactured in Vietnam: write the name and address of the drug manufacturer.

b) If drugs are imported for sale in Vietnam.

-Name and address of the drug manufacturer;

-Name and address of the drug importer or the entity that entrusts the import (if any).

The manufacturer’s name must not be smaller in size than the name of the drug importer or distributor ((if any).

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

d) Labels of drugs manufactured under franchise must have the text” ("Manufactured under franchise of [franchisor s name] at [franchisee s name]") and address of the franchisee. The franchisor s name must be on the same plane of the label and have the same size as the franchisee s.

dd) If drugs are processed by another entity, the label shall have the text "Manufactured by [processor s name] under contract with [hirer s name]) and address of the processor. The processor s name must be on the same plane of the label and have the same size as the hirer s.

2. Expression of name and address of the responsible entity specified in Clause 1 of this Article:

a) The name and address of the responsible entity shall be written in full according to the legal documents about the establishment of such entity. The business name of the responsible entity may be written next to its full name, provided the business name is not larger than the full name in size.

b) Names and addresses on the label and instructions sheet must not be abbreviated except for the case in Point dd Clause 1 Article 9 of this Circular;

c) The address of the manufacturer, packaging facility, facility responsible for the batch, franchisee, processor, or distributor must include the house number, name of the street or neighborhood, commune or ward, district, province, and country of origin (for imported drugs).  For imported drugs, the address of the manufacturer or other related foreign facilities shall be the same as the address specified in relevant legal documents such as drug certificate, certificate of free sale, GMP certificate, etc.

3. Names and addresses of relevant entities

a) Apart from the name and address of the responsible entity prescribed in Clause 1 of this Article, the drug label may contain the names, addresses, logos of relevant entities such as the registrant, distributor, brand owner, or relevant entities, provided their roles and responsibility for the drug are specified.

b) The names, addresses, logos of relevant entities mentioned in Point a Clause 3 of this Article must not be larger in size than those of the manufacturer and must be legible in normal conditions.

c) 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;

d) If the manufacturer is a member of 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 facility where drugs are manufactured is specified.

Example: Drugs are manufactured at facility A of company B, the label may have the text "Company B, branch, manufactured at A".

Article 26. Drug origins

1. Determination of drug origins

Drug origins shall be determined in accordance with Clause 1 Article 3 the Government s Decree No. 19/2006/ND-CP dated February 20, 2006 on guidelines for the Law on Commerce with regard to goods origins and relevant legislative documents.

2. Expression of drug origins

The drug origin shall be written on the primary package and secondary package as follows:

a) The phrase "origin:" or "manufactured in" and the country s name in Vietnamese (or English if Vietnamese name is not available).

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

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

Article 27. Other contents on drug labels

1. Responsible entities are recommended to print bar codes or affix 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.

2. The responsible entity may write other information on the drug label in addition to the compulsory information prescribed in this Circular. Additional information must be lawful, truthful, accurate, and reflects the true nature and effects of drugs, must not block or falsify compulsory information on the label, and ensure that the compulsory information is conformable with the label approved by the Ministry of Health.

Chapter IV

IMPLEMENTATIONPROVISIONS

Article 28. Effect

1. This Circular takes effect on July 01, 2016. Circular No. 04/2008/TT-BYT dated May 12, 2008 of the Minister of Health on drug labeling is annulled from the effective date of this Circular.

2. It is recommended that this Circular be implemented before its effective date.

Article 29. Transition

1. With regard to drugs granted registration numbers and drugs granted import licenses without registration numbers under Circular No. 04/2008/TT-BYT before this Circular comes into force, they may be sold with the labels and instruction sheets approved by units affiliated to the Ministry of Health until their expiry dates.

2. Applications for certificate of free sale or permission for import of drug registration numbers submitted to units affiliated to the Ministry of Health and have not been granted before the effective date of this Circular shall be considered as follows:

a) The registrant or importer may submit additional documents about the label and instruction sheet of the drug in accordance with this Circular in order to be granted the registration number of license for import of drug without registration number.

b) If no additional documents are submitted, the label and instruction sheet may be considered under Circular No. 04/2008/TT-BYT. Within 06 months from the day on which the certificate of free sale is issued, the facility responsible for drug labeling shall update the label and instruction sheets in accordance with this Circular in the form of registration of changes according to Circular No. 44/2014/TT-BYT.

Article 30. Reference

In case the legislative documents and regulations cited in this Circular are changed or replaced, the newer ones shall apply.

Article 31. Implementationresponsibilities

Drug Administration of Vietnam, units affiliated to the Ministry of Health, Services of Health of provinces, Vinapharm, Vietnamese and foreign drug registrants and drug manufacturers are responsible for the implementation of this Circular.

Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health (Drug Administration of Vietnam, Medical Equipment and Work Administration, Traditional Medicine Administration) for consideration./.

For the Minister

The Deputy Minister

Pham Le Tuan