Consolidated Document number 01/VBHN-BYT stipulates the quality of medicines, raw materials for medicines, and the instructions for use of medicines.

 

CIRCULAR

REGULATIONS ON DRUG LABELING, DRUG RAW MATERIALS LABELING AND DRUG USE INSTRUCTIONS SHEET

Circular No. 01/2018/TT-BYT dated January 18, 2018 on drug labeling, raw materials for drugs labeling and drug use instructions sheet, effective from June 1, 2018, has been amended and supplemented by:

Circular No. 08/2022/TT-BYT dated September 5, 2022 on drug registration and circulation, raw materials for drugs, effective from October 20, 2022;

Circular No. 23/2023/TT-BYT dated November 30, 2023 amending and supplementing some articles of Circular No. 01/2018/TT-BYT dated January 18, 2018 on drug labeling, raw materials for drugs labeling and drug use instructions sheet, effective from January 15, 2024.

Pursuant to Law No. 105/2016/QH13 dated April 6, 2016 on pharmaceuticals;

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

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

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

At the proposal of the Director of the Drug Administration Department.

The Minister of Health issues this Circular on drug labeling, raw materials for drugs labeling and drug use instructions sheet

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

1. This Circular stipulates the content and method of drug labeling, raw materials for drugs labeling and drug use instructions sheet circulating in the market; changing the expiration date of drugs already labeled on the drug label in cases of national defense, security, disease prevention and control, disaster relief, and catastrophe mitigation.

2. Drugs and raw materials for drugs listed below are not within the scope of regulation of this Circular:

a) Drugs and raw materials for drugs intended for export without a registration certificate for circulation in Vietnam;

b) Imported drugs in cases not for commercial purposes as provided for in Clause 1, Article 75 of Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing some provisions and implementing measures of the Pharmaceutical Law (hereinafter referred to as Decree No. 54/2017/NĐ-CP);

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

Article 2. Interpretation of Terms

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

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

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

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

4. Original label of drugs, raw materials for drugs is the label first affixed by the production facility on the commercial packaging of drugs, raw materials for drugs.

Article 3. Position of drug labels, raw materials for drugs labels and drug use instructions sheet

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

2. The drug use instructions sheet is an inseparable part of the drug label and is contained in the outer packaging of the drugs. In case the drugs do not have outer packaging, the drug use instructions must be printed or affixed on the direct contact packaging with the drugs.

3.2 Labels and drug use instructions sheets of radioactive drugs are not required to accompany commercial packaging but may be provided to treatment facilities along with the drug delivery and receipt documents or affixed to packaging used for storage, transportation, and preservation of the drugs.

4.3 For imported drugs that have been granted a registration certificate for urgent purposes for national defense, security, disease prevention and control, disaster relief, and catastrophe mitigation, the drug use instructions sheet may be affixed to the outer packaging.

Article 4. The size of labels, the size of letters and numbers on labels, the color of letters, symbols and images on labels, and the language used for labels and drug usage instructions

1. The size of labels, the size of letters and numbers on labels, the color of letters, symbols and images on drug labels, raw materials for drugs, and drug usage instructions shall be implemented according to the provisions of Article 5 (excluding the contents prescribed in point b, Clause 2, Article 5) and Article 6 of Decree No. 43/2017/NĐ-CP.

2. Compulsory contents that must be displayed on drug labels, raw material labels for drugs, and drug usage instructions must be recorded in Vietnamese, except for certain contents that may be recorded in other languages with Latin alphabets as prescribed in Clause 4, Article 7 of Decree No. 43/2017/NĐ-CP.

Article 5. Supplementing additional labels, supplementing or replacing drug usage instructions in Vietnam

1.4 Imported drugs and raw materials for drugs into Vietnam whose original labels do not fully display all required contents compared to the labels approved by the Ministry of Health, the importing entity shall implement the supplementation of Vietnamese additional labels after customs clearance. The supplemented additional labels must ensure consistency with the drug labels already approved by the Ministry of Health and must be completed before the drugs are put into circulation on the market while retaining the original label.

2.5 The following cases are allowed to supplement or replace drug usage instructions in Vietnamese after customs clearance:

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

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

c) Imported drugs that have been granted registration for circulation by the Ministry of Health in emergency situations for national defense, security, disease prevention and control, disaster relief, and which do not have drug usage instructions in Vietnamese in their commercial packaging.

3. Principles and locations for implementing the supplementation of additional labels, or the supplementation or replacement of drug usage instructions in Vietnam:

After customs clearance, imported drugs and raw materials for drugs as prescribed in Clauses 1 and 2 of this Article must implement the supplementation of additional labels or the supplementation or replacement of drug usage instructions in Vietnamese according to the following principles:

a) The supplementation of additional labels shall be carried out at warehouses for storing drugs and raw materials for drugs that meet the Good Storage Practices (GSP) standards of the importing entity;

b) 6 The supplementation or replacement of drug usage instructions in Vietnamese shall be carried out at the secondary packaging department (secondary packaging) of entities that meet the Good Manufacturing Practices (GMP) standards within the scope of the Drug Business Qualification Certificate;

In cases where drug usage instructions are attached directly to the drug packaging as prescribed in Clause 2, Article 3 of this Circular, the supplementation or replacement of drug usage instructions shall be carried out at the packaging department of entities that meet GMP standards or at warehouses for storing drugs and raw materials for drugs that meet GSP standards before the drugs are put into circulation on the market;

c) The process of supplementing additional labels, replacing or supplementing drug usage instructions in Vietnamese in Vietnam must ensure that it does not affect the quality of drugs and raw materials for drugs;

d) 7 The supplementary or replaced drug usage instructions in Vietnamese must be consistent with the drug usage instructions already approved by the Ministry of Health and must be completed before the drugs are put into circulation on the market.

4. For cases of supplementing or replacing drug usage instructions as prescribed in point b, Clause 3 of this Article, the secondary packaging entity that has implemented the supplementation or replacement of drug usage instructions must ensure full compliance with GMP standards during the implementation of the provisions of point b, Clause 3 of this Article and must report to the Ministry of Health to serve management, inspection, and supervision of drug business activities, specifically:

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

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

5. Entities responsible for labeling drugs are responsible for monitoring and coordinating with entities implementing the supplementation of additional labels, or the supplementation or replacement of drug usage instructions, and must bear responsibility for the quality of drugs and raw materials for drugs throughout the process of supplementing additional labels, replacing or supplementing drug usage instructions.

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

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

2. For domestically produced drugs and drug ingredients:

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

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

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

3. For imported drugs and drug ingredients:

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

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

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

4. For drug ingredients divided or separated into smaller packaged units during wholesale or retail sales: pharmaceutical business entities performing such division or separation must be responsible for affixing secondary labels in accordance with the provisions of Clauses 2 and 3, Article 7 of this Circular.

Chapter II

CONTENT OF LABELS AND DRUG USAGE INSTRUCTIONS

Section 1. REQUIRED CONTENT ON LABELS

Article 7. Outer packaging labels of drugs and drug ingredients

1. The outer packaging label of drugs must include the following information:

a) Medicine name;

b) Formulation type;

c) Active ingredient(s), dosage, weight, or concentration of active substance(s) or medicinal material(s) in the drug formula;

d) Packaging specifications;

d) Indications, usage, contraindications of the drug;

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

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

h) Warning signs and recommendations when using the drug;

i) Name and address of the drug manufacturing facility;

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

l) Origin of the drug.

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

a) Name of the drug ingredient;

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

c) Quality standards of the drug ingredient;

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

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

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

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

h) Origin of the drug ingredient.

3. Labels of drug ingredients requiring special control (including semi-finished drugs):

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

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

4. In cases where the outer packaging label of a drug cannot fully display the contents specified in Clause 1 of this Article, the content specified in Point đ, Clause 1 of this Article may be summarized as follows: "Indications, usage, contraindications and other information: see the drug usage instructions accompanying the drug."

Article 8. Labels of intermediate packaging for medicines

1. The label of intermediate packaging for medicines must include at least the following information:

a) Medicine name;

b) Production batch number;

c) Expiry date.

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

Article 9. Labels of direct contact packaging with medicines and raw materials for medicines

1. The label of direct contact packaging with medicines must include all of the following mandatory information:

a) Medicine name;

b) Quantitative components, concentrations, or quantities of active pharmaceutical ingredients and medicinal substances in the formula;

c) Production batch number;

d) Expiry date;

đ) Name of the medicine manufacturing facility;

2. Label of direct contact packaging with raw materials for medicines.

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

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

Article 10. Methods of affixing supplementary labels

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

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

a) Indications, usage, contraindications, and other information: see the drug usage instructions provided separately;

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

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

Article 11. Labels of medicines in certain other cases

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

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

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

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

b) Direct contact packaging label of traditional medicines must include the following mandatory information:

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

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

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

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

a) Name of the medicine, dosage form;

b) Active ingredient, concentration, or quantity;

c) Preparation date, expiry date, storage conditions;

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

đ) Patient's name;

e) Warning signs for special control medicines.

3. Traditional medicines weighed and dispensed according to prescriptions as prescribed in Clause 1 of Article 70 of the Medicine Law are not required to bear labels as prescribed in this Circular but must have outer packaging containing the medicine and must include the patient's name and age on the outer packaging to avoid confusion when distributing.

4. Medicines not yet registered for circulation in Vietnam but permitted for importation for purposes such as bioequivalence testing, bioavailability assessment, sample registration, sample testing, scientific research, participation in exhibitions and trade fairs do not need to bear labels with the mandatory information prescribed in Articles 7 and 8 of this Circular, but must retain the original imported label and must supplement a supplementary label as follows:

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

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

c) Medicines used for participation in exhibitions and trade fairs: must include the phrase "Exhibition display sample".

5. Raw materials for medicines, including active pharmaceutical ingredients not yet registered for circulation in Vietnam but permitted for importation for purposes such as sample registration, sample testing, drug research, and participation in exhibitions and trade fairs as prescribed in Clause 3 of Article 60 of the Medicine Law do not need to bear labels with the mandatory information prescribed in Articles 7 and 8 of this Circular, but must retain the original label.

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

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

Section 2. CONTENTS OF THE DRUG USE INSTRUCTIONS SHEET

Article 12. Contents of the Drug Use Instructions Sheet

The drug use instructions sheet includes the following contents:

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

2. Warning signs and recommendations when using the drug.

3. Formula components.

4. Formulation type.

5. Indications.

6. Usage method and dosage.

7. Contraindications.

8. Warnings and precautions when using the drug.

9. Use of drugs for pregnant women and nursing mothers.

10. Impact of drugs on driving ability and operating machinery.

11. Interactions and contraindications of drugs.

12. Adverse effects of drugs.

13. Overdose and treatment methods.

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

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

16. Packaging specifications.

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

18. Name and address of the drug manufacturing facility.

Article 13. General Requirements for the Drug Use Instructions Sheet

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

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

b) Drugs compounded according to prescriptions and sold at pharmacies as stipulated in Point b, Clause 1, Article 47 of the Medicine Law;

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

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

đ) Over-the-counter drugs with labels fully displaying all contents of the drug use instructions sheet as prescribed in Article 12 of this Circular.

2. For drugs as stipulated in Point d, Clause 1 of this Article, the original drug use instructions sheet in a foreign language must be retained.

3. Drugs with the same name, active ingredient, medicinal herb, formulation type, route of administration, indication, and manufacturer but with different volumes, concentrations, or packaging specifications and allowed to circulate concurrently may be recorded in a single drug use instructions sheet. In cases where there are differences in contents among various concentrations of the drug, specific details must be provided for each concentration, volume, and packaging specification.

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

Chapter III

LABELING AND DRUG USE INSTRUCTIONS SHEET RECORDING METHODS

Article 14. Methods of Recording Drug Names and Raw Material Names

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

2. Drug names and raw material names shall be recorded in Latin characters and may also include numbers written in Arabic numerals, Roman numerals, or other symbols according to the Greek alphabet (for example: alpha, beta).

3. Drug names shall be recorded either by brand name or by international nonproprietary name. For traditional medicines listed in the Traditional Medicine Catalogue recognized by the Ministry of Health, they can be recorded by brand name or by the recognized traditional prescription name, except for individual traditional herbs. Brand names of drugs must comply with the following principles:

a) Not having promotional nature;

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

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

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

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

e) Not being identical or similar to the names of drugs already registered for circulation by other registrants, except for drugs specified in Point a, Clause 1, Article 6 and Point a, Clause 1, Decision 16/2023/TT-BYT dated August 15, 2023 of the Minister of Health regarding the registration for circulation of processed drugs and technology transfer drugs in Vietnam;

g) Not naming drugs with the same name if they have different active ingredients;

h) (abolished);

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

4. Raw material names (excluding medicinal herbs and semi-finished pharmaceutical products) shall be recorded as prescribed in Clause 2, Article 16 of this Circular.

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

6. Medicinal herb names shall be recorded as prescribed in Clause 3, Article 16 of this Circular.

7. Semi-finished medicinal product names shall be recorded as prescribed in Clauses 4 and 5, Article 16 of this Circular.

8. Semi-finished drug product names (excluding semi-finished medicinal products) shall be recorded as prescribed in Clause 6, Article 16 of this Circular.

Article 15. Warning and advisory signs when using medicine

1. Warning and advisory signs when using medicine must be recorded on the label, user guide, including:

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

b) For prescription medicines:

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

- User guide: the symbol "Rx" must be marked at the top left corner of the drug name; the line of text "This medicine can only be used according to a prescription" must be recorded.

c) For special controlled medicines or other medicines:

- Radioactive drugs: the line of text "RADIOACTIVE DRUG"must be printed in bold, uppercase letters;

"Medicine listed in the toxic medicine catalog as prescribed by the Ministry of Health: the advisory line of text must be recorded: "TOXIC DRUG"must be printed in bold, uppercase letters;

- Medicine for state health programs: record the line of text: "Program medicine, not for sale";

- Aid medicine, humanitarian aid medicine: record the line of text: "Aid medicine, not for sale";

- Medicine for clinical trial purposes: on the label, the line of text "For clinical testing use only, prohibited for other purposes" must be recorded;

- 10 (abolished).

d) Other warning and advisory signs for each type of medicine as follows:

- Injectable medicine: On the label of injectable or infusion medicine, the specific route of administration of the injectable medicine must be clearly recorded or abbreviated as follows: intramuscular injection (IM), subcutaneous injection (SC), intravenous injection (IV), intravenous infusion (IVI) or other specific injection methods;

- Eye drops, eye ointment: Record the line of text: "Eye drops" or "Eye ointment". Nasal drops record the line of text: "Nasal drops"; ear drops record the line of text "Ear drops";

- Topical medicine must record the line of text: "For external use only"; Medicine in tube form for oral use must record the line of text: "Do not inject";

- For medicines that require thorough shaking before use (e.g., suspensions, powders, multi-dose granules intended for oral use that require mixing into a suspension or a formulation prone to settling, depositing, or layering), the line of text "Shake well before use" must be clearly recorded.

2. Recording method for warning and advisory signs when using medicine:

a) The lines of text, warning signs must be clearly printed on the outer packaging label or secondary label and the user guide. The content must be easily recognizable under normal observation conditions;

b) For the user guide: Record immediately below the drug name the warning and advisory signs when using medicine as specified in points a, b, and c of Clause 1 of this Article, except for the Rx symbol;

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

Article 16. Composition formula of medicine, semi-finished medicine

1. General provisions:

a) Outer packaging label of medicine, semi-finished medicine:

- Fully record the name and quantity, weight, or concentration of each active ingredient, herbal ingredient in the medicine formula, semi-finished medicine for the smallest unit of dosage division or the smallest unit of packaging. For liquid and semi-solid medicines with multi-dose packaging specifications: Active ingredient quantity is recorded as a percentage (% weight/weight or weight/volume);

- For vaccines: The active ingredient corresponding to each dose unit must be clearly recorded;

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

- For traditional medicine, herbal medicine, semi-finished traditional medicine, semi-finished herbal medicine: The name of each herbal ingredient is recorded in Vietnamese, scientific names of herbal ingredients are not necessarily required;

- It is not mandatory to record the composition, quantity, weight, volume, or concentration of excipients;

- Specifically, for traditional medicine listed in the State Secret Catalog and family traditional medicine as prescribed by the Ministry of Health, it is allowed not to display some herbal ingredients, quantities, and weights of herbal ingredients in the medicine formula on the commercial packaging label of the medicine. In such cases, the outer packaging label must record the corresponding line of text: "The production formula of the medicine is a state secret" or "The production formula of the medicine is a family secret".

b) Direct contact packaging label of medicine, semi-finished medicine:

- Medicine, semi-finished medicine in single active ingredient, herbal ingredient form or combination with less than or equal to three (3) active ingredients, herbal ingredients: Fully record the active ingredient, herbal ingredient in the medicine formula, semi-finished medicine as stipulated in point a of this clause;

- Medicine, semi-finished medicine combined with more than three (3) active ingredients, herbal ingredients: There is no requirement to record the active ingredient, herbal ingredient in the medicine formula, semi-finished medicine. If recorded, the active ingredient, herbal ingredient must be recorded according to the provisions of point a of this clause;

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

c) User guide:

- Fully record the name and quantity, weight, or concentration of each active ingredient, herbal ingredient in the medicine formula for the smallest unit of dosage division or the smallest unit of packaging and must include the line of text "Active ingredients:" or "Active components:" before recording the names of the active ingredients, herbal ingredients in the medicine formula;

- Fully record the name of the excipient in the medicine formula and the line of text "Excipients:" before recording the names of the excipients in the medicine formula. It is not mandatory to record evaporated or lost excipients during production and it is not mandatory to record the weight, volume, quantity, or concentration of each excipient in the medicine formula;

- For vaccines: The active ingredient corresponding to each dose unit must be clearly recorded;

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

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

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

2. Method of recording drug substances and excipients:

a) The name of drug substances and excipients shall be recorded according to their international common names or scientific names.

b) The names of drug substance and excipient components do not need to be translated into Vietnamese.

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

a) Vietnamese name:

- The names of herbal ingredients and traditional medicinal herbs shall be recorded according to the Vietnamese conventional names specified in the Vietnamese Pharmacopoeia or those listed in the drug and raw material directories issued by the Minister of Health;

- In cases where the Vietnamese name of the herbal ingredient is not included in the Vietnamese Pharmacopoeia or in the drug and raw material directories issued by the Ministry of Health, it shall be recorded according to the Vietnamese name of the herbal ingredient in the book "Vietnamese Medicinal Plants" by Do Tat Loi; or in the book "1000 Medicinal Plants and Animals" by the Institute of Pharmacy; the name of the herbal ingredient in this case must be advised by the Advisory Council for the Minister of Health to issue a registration certificate for the circulation of drugs.

- In cases where imported herbal ingredients cannot be translated into Vietnamese, they shall be recorded according to the name of the herbal ingredient from the exporting country (or the producing country) along with the scientific name of the herbal ingredient;

- In cases where different parts of the herbal ingredient or traditional medicinal herb are used for medicinal purposes: the specific part used for medicinal purposes must be clearly stated or recorded according to the name indicating the part used for medicinal purposes. For example: Lotus heart, Mulberry flower, Silver Bells flower.

b) Scientific name (Latin name):

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

- In cases where the scientific name of the herbal ingredient or traditional medicinal herb is not included in the Vietnamese Pharmacopoeia or in the directories issued by the Minister of Health, the scientific name of the herbal ingredient shall be recorded according to foreign pharmacopoeias.

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

a) Recording method for herbal extracts:

- It is necessary to fully record the name of the extract, type of extract, and the components, concentration, quantity, or weight of each herbal ingredient in the herbal extract;

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

- In cases where the herbal extract does not have a trade name, the word "extract" (for extracts containing only one herbal ingredient) should be recorded before the name of the herbal ingredient or the phrase "mixed herbal extract" (for extracts containing multiple herbal ingredients) should be recorded before the names of the herbal ingredients.

b) Recording method for types of herbal extracts:

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

- In cases where the type of herbal extract is not clearly specified, the moisture content limit must be clearly stated along with the name of the herbal extract or the ratio of the extract to the initial amount of herbal ingredients must be clearly stated.

c) Recording method for herbal extract formulas:

- If the monograph in the Vietnamese Pharmacopoeia or recognized foreign pharmacopoeia specifies quantitative standards for the content of drug substances or groups of compounds, the herbal extract must be recorded along with the percentage content of the drug substance or group of compounds according to each herbal ingredient;

- If the monograph in the Vietnamese Pharmacopoeia or recognized foreign pharmacopoeia does not specify quantitative standards for the content of drug substances or groups of compounds, the herbal extract must be recorded along with the initial weight of the herbal ingredients or the ratio of the extract to the initial herbal ingredients (the initial herbal ingredients are those meeting the standards for medicinal use);

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

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

a) It is necessary to fully record the name of the semi-finished herbal product and the components, concentration, quantity, or weight of each herbal ingredient in the semi-finished product;

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

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

- In cases where the semi-finished herbal product does not have a trade name, it shall be recorded according to the name of the herbal ingredient specified in Clause 3 of this Article (for semi-finished herbal products containing only one type of herbal ingredient) or recorded as "mixed herbal ingredients" (for semi-finished herbal products containing multiple types of herbal ingredients), while also clearly stating the type of semi-finished herbal product (e.g., powder, granules) before the name of the herbal ingredient or before the term "mixed herbal ingredients".

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

- If the monograph in the Vietnamese Pharmacopoeia or recognized foreign pharmacopoeia specifies quantitative standards for the content of drug substances or groups of compounds, the semi-finished herbal product must be recorded along with the percentage content of the drug substance or group of compounds according to each herbal ingredient;

- If the monograph in the Vietnamese Pharmacopoeia or recognized foreign pharmacopoeia does not specify quantitative standards for the content of drug substances or groups of compounds, the semi-finished herbal product must be recorded along with the initial weight of the herbal ingredients or the ratio of the semi-finished herbal product to the initial herbal ingredients (the initial herbal ingredients are those meeting the standards for medicinal use).

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

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

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

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

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

c) The method of recording the formula of the pharmaceutical intermediate: carried out according to the regulations for pharmaceutical intermediates as stipulated in Clause 1 of this Article;

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

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

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

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

c) Other units of measurement:

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

- International units of measurement such as IU and other international units of activity for certain special active ingredients, when translated into Vietnamese may cause misunderstanding in usage, can retain the original international unit notation without requiring translation into Vietnamese;

d) When the form of the active ingredient used in the drug formula differs from the form used for dosage calculation, the content, concentration, and weight must be converted to the dosage form on the outer packaging label and the user guide. The form of the active ingredient includes base form, salt form, hydrated form, or other forms of the active ingredient;

Article 17. Formulations

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

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

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

b) For tablet formulations with grooves, it must specify whether the tablet can be broken in half;

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

Article 18. Indications

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

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

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

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

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

Article 19. Dosage and Administration

1. Dosage:

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

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

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

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

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

2. Administration:

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

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

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

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

b) For prescription medicines:

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

- The dosage must be clearly stated for each age group. The dosage is calculated based on weight or body surface area (mg/kg or mg/m²) or divided into corresponding dosage intervals. Drugs are used for children with similar indications as adults, the dosage and method of drug administration for children must be clearly stated;²- In cases where there is no pediatric formulation available, provide information on preparing a pediatric formulation from what age after mixing according to the manufacturer's recommendation;

- In cases where the drug does not have an indication for one or all age groups of children, the dosage and method of administration must be clearly stated in one of the following ways:

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

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

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

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

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

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

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

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

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

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

a) Drug handling before use (if applicable):

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

- Describe measures to protect the person preparing the drug;

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

b) Drug handling after use (if applicable):

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

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

- In the case where there is no usage or special handling instruction to be noted for healthcare workers, it shall be clearly stated "No special requirements for drug disposal after use".

Article 20. Contraindications

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

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

Article 21. Warnings and Precautions when Using Medicines

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

2. Conditions requiring caution when using medicines:

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

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

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

d) Risks related to starting or temporarily stopping treatment;

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

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

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

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

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

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

3. For biosimilar products:

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

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

1. Use of medicines for pregnant women:

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

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

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

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

2. Use of medicines for nursing mothers:

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

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

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

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

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

Article 24. Drug Interactions and Incompatibilities

1. Drug Interactions:

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

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

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

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

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

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

2. Drug Incompatibilities:

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

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

Article 25. Adverse Reactions of Medications

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

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

a) Summary Table of Adverse Reactions: categorized by frequency: very common (ADR ≥ 1/10), common (1/100 ≤ ADR < 1/10), uncommon (1/1000 ≤ ADR < 1/100), rare (1/1000 ≤ ADR < 1/10000), and very rare (ADR < 1/10000);

For herbal medicines and traditional medicines: only list adverse reactions without requiring categorization of adverse reactions by frequency.

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

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

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

Article 26. Overdose and Management

1. Overdose:

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

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

2. Management when using an overdose:

a) Specify the measures or methods for managing an overdose, including monitoring measures, using agonists, antagonists, detoxification methods, and techniques to enhance drug excretion from the body. If there is no information or incomplete information, record the statement "Actively monitor to implement timely management measures";

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

Article 27. Information on Pharmacology and Clinical Data

1. Pharmacodynamic characteristics: Include the following contents:

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

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

2. Pharmacokinetic characteristics: Include the following contents:

a) The pharmacokinetic characteristics of the drug (absorption, distribution, metabolism, excretion, and other characteristics) corresponding to the recommended dose, concentration, and formulation of the drug;

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

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

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

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

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

- Description of the main characteristics of the study sample;

- Primary evaluation criteria;

- Secondary evaluation criteria (if applicable);

- Study results related to the primary criteria.

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

Article 28. Smallest Unit of Packaging and Packaging Specifications

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

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

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

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

d) For oral suspension powder or granule dosage forms, the smallest unit of packaging is the packet, bottle, pouch;

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

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

g) For aerosol or inhalation dosage forms, the smallest unit of packaging is the spray can, inhaler bottle, vial, or dose inhaler;

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

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

k) For raw materials, the smallest unit of packaging is the bag, pouch, packet, crate, box, bottle, or vial.

2. Method of recording packaging specifications:

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

b) In cases where a single commercial package contains multiple units of packaging, the number of each unit of packaging and the total number of units must be specified;

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

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

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

1. Production batch number:

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

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

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

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

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

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

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

- If the production date and expiration date of each component within the product are different, the label of the outer packaging of the set of products shall indicate the expiration date of the component with the shortest expiration date or specify the expiration date of each component in the set of products.

3. Method of recording production date, expiration date (or usage period), production batch number:

a) In cases where the original label records the production date, expiration date, and production batch number:

- If the production date, expiration date, and production batch number are recorded in a foreign language on the label, then on the secondary label, it must be recorded as follows: production date (NSX), expiration date (HD/HSD), production batch number (LSX/SLSX), referring to the information recorded in a foreign language on the original label of the product.

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

- If the direct contact label records the expiration date in the format "month/year" while the outer packaging label records the expiration date in full format "day/month/year", the expiration date of the drug shall be calculated based on the expiration date recorded on the outer packaging label.

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

+ If the original label records the production date in full format "day/month/year", the expiration date recorded on the secondary label shall be calculated and recorded according to the production date recorded on the original label.

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

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

c) Method of recording the expiration date of the drug in the user guide:

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

- The expiration date after opening the direct contact packaging for the first time for drugs that have not been pre-dosed such as eye drops, nasal sprays, ear drops, ointments, gels for multiple uses, and liquid multi-dose preparations for oral administration.

- The expiration date after preparation for use for powdered drugs, effervescent drugs that require preparation into a solution or suspension before use, such as powdered suspensions, solutions for injection or oral administration.

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

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

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

1. Drug labels, raw material labels, and user instruction sheets:

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

2. Clearly record storage conditions for drugs in the user instruction sheet for cases specified in Section 2 and 3, Point c, Clause 3 of Article 29 of this Circular.

3. Method of recording quality standards:

On outer packaging labels and user instruction sheets, clearly record the quality standards for drugs and raw materials as follows:

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

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

Article 32. Circulation registration number, import permit number

1. Domestic circulation registration number.

Record fully as “Circulation Registration Number:” or abbreviate as “SĐK:” and leave blank when submitting the application for circulation registration. Before releasing the drug onto the market, supplement the circulation registration number issued by the Ministry of Health for drugs and raw materials that have been granted circulation registration.

2. Import permit number:

Record fully as “Import Permit Number:” or abbreviate on the label as “GPNK:” and leave this section blank when submitting the application for drug importation. Before releasing the drug onto the market, supplement the import permit number issued by the Ministry of Health for drugs and raw materials without circulation registration.

Article 33. Name and address of production facilities, compounding facilities, processing facilities, importing facilities, and other related facilities (if applicable)

1. General rules for recording the name and address of production facilities and importing facilities on drug labels and user instruction sheets:

a) Outer packaging labels of drugs and raw materials:

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

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

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

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

In cases where multiple facilities participate in the production of finished drugs, they may be recorded in either of the following ways:

- Record fully all participating production facilities;

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

c) For traditional medicine as stipulated in Clause 1 and Clause 2 of Article 70 of the Medicine Law and for drugs compounded, prepared, or manufactured in medical examination and treatment facilities as stipulated in Clause 2 and Clause 3 of Article 85 of the Medicine Law:

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

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

d) Labels of compounded drugs sold at pharmacies as stipulated in Point b, Clause 1 of Article 47 of the Medicine Law: record fully the name and address of the pharmacy compounding the drugs;

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

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

2. Recording the role of related facilities before the name of the facility, specifically:

a) For production facilities:

- If only one production facility participates in the production process: record the role as “Production Facility:”.

- If multiple production facilities participate in the production process: clearly record the role of each production facility, such as: “Intermediate Production Facility”; “Primary Packaging Facility”; “Facility Responsible for Batch Release”;

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

b) For importing facilities: record the role as “Importing Enterprise”;

c) For other facilities: record the role as “Distributor”, “Product Owner”, “Brand Owner”, and other related roles to the drug (if applicable).

3. Method of recording the name and address of the production facility:

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

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

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

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

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

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

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

5. Other provisions regarding the format for recording the name and address:

a) Format for recording the name of the entity:

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

Specifically, for healthcare examination and treatment establishments: record the name according to the permit for healthcare examination and treatment activities as stipulated by the Law on Healthcare Examination and Treatment.

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

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

b) Format for recording the address of the entity:

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

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

Specifically, for the address of healthcare examination and treatment establishments: Record the correct location of drug production of the healthcare examination and treatment establishment according to the permit for healthcare examination and treatment activities as stipulated by the Law on Healthcare Examination and Treatment.

- For imported drugs:

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

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

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

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

Example: Drugs produced at a branch of Company B located at address A, the label may record "Company B, Branch of Company, Produced at Address A."

Article 34. Origin of Medicines and Raw Materials for Medicines

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

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

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

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

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

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

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

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

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

3. For medicines and raw materials for medicines produced in Vietnam for circulation within the country and already labeled with the address of the production location, there is no requirement to record the origin of the medicines and raw materials for medicines on the label.

Article 35. Other Contents Displayed on Medicine Labels

1. In addition to mandatory contents as prescribed in this Circular, the model labels and user guide sheets included in the drug registration dossier, importation dossier without a circulation registration certificate, or medicine labels as specified in Clause 1 and Clause 2 of Article 11 of this Circular may include additional contents provided they comply with the provisions of Clause 3 of this Article.

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

a) Supplementing or modifying counterfeit prevention stickers and other anti-counterfeiting contents related to the product on the medicine label to prevent counterfeits or make the product easily identifiable;

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

c) Supplementing or modifying telephone numbers, area codes, website addresses, email addresses of entities related to the medicines; brand owners;

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

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

e) Content recorded in another language translated from Vietnamese contents already approved by the Ministry of Health according to the drug registration dossier or importation dossier without a circulation registration certificate;

g)14 Supplementing barcode, QR code, DataMatrix Code (DMC) or suitable codes on the medicine label to implement electronic usage guidance retrieval and electronic product labeling according to the roadmap of the Minister of Health.

3. Provisions for Other Contents Displayed on Labels:

a) They must not contravene the law, must not be promotional in nature, and must ensure truthfulness, accuracy, and reflect the true nature and efficacy of the medicines, without obscuring or distorting mandatory label contents, and must ensure that mandatory contents are consistent with the labels approved by relevant health authorities;

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

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

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

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

- Information and images about bioequivalence or clinical equivalence of biosimilar products compared to reference products.

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

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

Chapter IV

IMPLEMENTING PROVISIONS

Article 36. Effective Date 15

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

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

Article 37. Transitional Provisions

1. Medicines and raw materials for medicines that have been granted circulation registration certificates or import permits before the effective date of this Circular shall be implemented as follows:

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

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

- Drugs and drug raw materials produced before this Circular takes effect: shall comply with the provisions of point a of Clause 1 of this Article;

- Drugs and drug raw materials produced from the day this Circular takes effect: the entity must independently update information related to the classification of drugs and drug raw materials on the label and drug usage instructions according to the provisions of this Circular before circulating them on the market within twelve months from the date this Circular takes effect, without needing to notify the Ministry of Health, except in cases where the entity implements procedures to change or supplement the drug circulation registration certificate related to the usage instructions of the drug already registered as prescribed in the Circular on the registration of drugs and drug raw materials of the Ministry of Health.

2. Drug circulation registration files or drug importation files without a circulation registration certificate submitted to competent units under the Ministry of Health before this Circular takes effect but have not yet been granted a circulation registration certificate or import permit, except for cases of drugs and drug raw materials prescribed in Clause 3 of this Article, shall be considered as follows:

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

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

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

3. Before this Circular takes effect, drug registration files or drug raw material registration files for changes or supplements to the drug circulation registration certificate related to changes in the label and drug usage instructions that have been submitted to competent units under the Ministry of Health but have not yet been approved, the drug registration entity or drug importer must supplement the label and drug usage instructions according to the provisions of this Circular.

Article 38. Publication of Content of the Drug Usage Guide

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

2. Any changes or additions to the drug usage guide for original brand name drugs and reference biological products listed in the List must be published and uploaded on the Department of Medicines Administration's electronic information website within forty-five days from the date of signing the approval letter for the updated or changed content of the drug usage guide.

3.16 Drug registrants and manufacturers shall be responsible for updating and supplementing the content of the drug usage guide for generic drugs in accordance with the usage instructions of corresponding original brand name drugs as stipulated as follows:

a) The drug usage guide for generic drugs (having the same active ingredient, concentration, dosage form, and route of administration as the original brand name drug) must ensure consistency with the usage instructions of the corresponding original brand name drug. For other information in the drug usage guide for generic drugs such as shelf life, excipient components, quality standards, bioavailability parameters, pharmacokinetic data, adverse drug reactions, and clinical trial results may differ from those of the original brand name drug. Information about adverse drug reactions in the drug usage guide for generic drugs must not be less than that of the corresponding original brand name drug, except for adverse reactions related to excipients that are not present in the composition of the generic drug.

b) Within twelve months from the date the Department of Medicines Administration publishes and uploads the drug usage guide for original brand name drugs on its electronic information website as stipulated in Clause 1 and Clause 2 of this Article, drug registrants and manufacturers of generic drugs shall be responsible for self-reviewing and updating the label and usage instructions to align with the drug usage guide of the original brand name drug for the information specified in Clause 2 of this Article without needing to report to the Ministry of Health, unless otherwise required by the Ministry of Health.

Article 39. Reference Provisions

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

Article 40. Responsibility for Implementation

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

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

 

 

 

1 Circular No. 08/2022/TT-BYT dated September 5, 2022, regulating the circulation registration of drugs and raw materials for drugs is based on the following grounds:

"Pursuant to the Law on Medicines No. 105/2016/QH13 dated April 6, 2016;

Pursuant to Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing some provisions and measures to implement the Law on Medicines;

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

Pursuant to the Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain regulations related to investment and business conditions within the scope of management of the Ministry of Health;

At the proposal of the Director of the Drug Administration Department.

The Minister of Health promulgates this Circular regulating the circulation registration of drugs and raw materials for drugs"

Circular No. 23/2023/TT-BYT dated November 30, 2023 amending and supplementing certain articles of Circular No. 01/2018/TT-BYT dated January 18, 2018, regulating labeling of drugs and raw materials for drugs and the drug usage guide is based on the following grounds:

"Pursuant to the Law on Medicines No. 105/2016/QH13 dated April 6, 2016;

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

Pursuant to Decree No. 111/2021/NĐ-CP dated December 9, 2021 of the Government amending and supplementing certain articles of Decree No. 43/2017/NĐ-CP dated April 14, 2017 of the Government on product labels;

Pursuant to Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing some provisions and measures to implement the Law on Medicines;

Pursuant to the Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain regulations related to investment and business conditions within the scope of management of the Ministry of Health;

Pursuant to Decree No. 95/2022/NĐ-CP dated November 15, 2022 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Drug Administration Department.

The Minister of Health promulgates this Circular amending and supplementing certain articles of Circular No. 01/2018/TT-BYT dated January 18, 2018, regulating labeling of drugs and raw materials for drugs and the drug usage guide."

2 This clause was added at Clause 1 of Article 1 of Circular No. 23/2023/TT-BYT, effective from January 15, 2024

3 This clause was added at Clause 1 of Article 1 of Circular No. 23/2023/TT-BYT, effective from January 15, 2024

4 This clause was amended and supplemented at Clause 2 of Article 1 of Circular No. 23/2023/TT-BYT, effective from January 15, 2024

5 This clause was amended and supplemented according to Clause 3 of Article 1 of Circular No. 23/2023/TT-BYT, effective from January 15, 2024

6 This point was amended and supplemented according to Clause 4 of Article 1 of Circular No. 23/2023/TT-BYT, effective from January 15, 2024

7 This point was added according to Clause 5 of Article 1 of Circular No. 23/2023/TT-BYT, effective from January 15, 2024

8 This point was amended and supplemented according to Clause 6 of Article 1 of Circular No. 23/2023/TT-BYT, effective from January 15, 2024

9 This paragraph was abolished according to Point d Clause 2 of Article 44 of Circular No. 08/2022/TT-BYT, effective from October 20, 2022

10 This paragraph was abolished according to Clause 7 of Article 1 of Circular No. 23/2023/TT-BYT, effective from January 15, 2024

11 This paragraph was amended and supplemented according to Clause 8 of Article 1 of Circular No. 23/2023/TT-BYT, effective from January 15, 2024

12 The title of this clause was amended according to Clause 9 of Article 1 of Circular No. 23/2023/TT-BYT, effective from January 15, 2024

13 This paragraph was amended according to Clause 10 of Article 1 of Circular No. 23/2023/TT-BYT, effective from January 15, 2024

14 This point was added according to Clause 11 of Article 1 of Circular No. 23/2023/TT-BYT, effective from January 15, 2024

Article 15, Article 2, Article 3, and Article 4 of Circular No. 23/2023/TT-BYT dated November 30, 2023, amending and supplementing certain provisions of Circular No. 01/2018/TT-BYT dated January 18, 2018, on labeling of drugs and drug ingredients and instructions for use of drugs are hereby stipulated as follows:

“Article 2. Effective Date

This Circular shall take effect from January 15, 2024.

Article 3. Transitional Provisions

1. Drugs and drug ingredients produced or imported before January 1, 2025 may continue to circulate and be used with labels and instructions for use that have been approved by the Ministry of Health until the expiration date of the drug or drug ingredient batch.

2. Labels and instructions for use of drugs included in applications for issuance, extension, change, or supplementation of registration certificates submitted to the receiving authority before this Circular takes effect but are still under processing shall be implemented according to the regulations at the time of application submission, except where the registrant voluntarily implements the provisions of this Circular from the date it becomes effective.

By no later than January 1, 2025, labels and instructions for use of drugs must comply with the provisions of this Circular before being put on the market.

Article 4. Responsibilities for Implementation

1. The Drug Administration Department shall be responsible for:

a) Develop regulations and implementation timelines for electronic product labeling for drugs circulating on the market to be promulgated by the Minister of Health.

b) Organize guidance and implementation of the provisions of this Circular.

2. The Director of the Ministry's Office; the Director of the Drug Administration Department; the Inspector General of the Ministry; the Heads of units under and affiliated with the Ministry of Health; the Directors of Provincial Health Services; the Heads of health sector institutions; organizations and individuals engaged in drug registration activities are responsible for implementing this Circular.

3. During the implementation process, if there are difficulties or obstacles, agencies, organizations, and individuals are requested to report to the Ministry of Health (Drug Administration Department) for consideration and resolution.

Article 44, Article 46 of Circular No. 08/2022/TT-BYT dated September 5, 2022, on the registration of drugs and drug ingredients are stipulated as follows:

Article 44. Effective Date

1. This Circular shall take effect from October 20, 2022.

2. The following regulations are abolished:

a) Circular No. 32/2018/TT-BYT dated November 12, 2018, of the Minister of Health on drug registration;

b) Clause 3, Article 1 of Circular No. 23/2021/TT-BYT dated December 9, 2021, of the Minister of Health amending and supplementing certain legal normative documents issued by the Minister of Health;

c) Clause 5, Article 1 of Circular No. 29/2020/TT-BYT dated December 31, 2020, of the Minister of Health amending, supplementing, and abolishing certain legal normative documents issued by the Minister of Health, jointly issued;

d) Point h, Clause 3, Article 14 of Circular No. 01/2018/TT-BYT dated January 18, 2018, of the Minister of Health on labeling of drugs and drug ingredients and instructions for use of drugs.

Article 46. Implementation Timeline

1. From the date this Circular takes effect, production facilities that have more than two drugs with the same active substance or medicinal plant component, dosage form, route of administration, dose, or concentration in a single unit dose already registered for circulation, when submitting applications for renewal of registration certificates, the production facility will cooperate with the drug registrant to select and apply for renewal of registration certificates for two drugs in accordance with Clause 6, Article 8 of this Circular. The remaining drugs already registered for circulation will have their registration certificate validity extended until December 31, 2025.

2. For domestically produced drugs and drug ingredients that have been granted registration certificates before this Circular takes effect and the facility has a need to import excipients or capsules into Vietnam: Before the first importation into Vietnam, the registrant updates all information about the imported excipients or capsules in the previously approved dossier onto the online service system of the Drug Administration Department. Within five working days from the date of information update, the Drug Administration Department must complete the announcement. The registrant is responsible for the accuracy of the updated information compared to the information in the previously approved dossier and is not required to update the information again at subsequent imports.

3. The application of registration numbers according to the structure specified in Appendix VI attached to this Circular for new issuance and renewal of registration certificates shall be implemented from January 1, 2023. For drugs that have been granted registration numbers before January 1, 2023 and whose registration certificates are renewed, they may continue to use the previously granted registration numbers for up to a maximum of twelve months from the date of issuance of the registration number according to the structure specified in Appendix VI attached to this Circular.

This paragraph was amended pursuant to Clause 12, Article 1 of Circular No. 23/2023/TT-BYT, and shall take effect from January 15, 2024.