Circular No. 13/2009/TT-BYT guiding the activities of drug information and advertising

CIRCULAR

Guidelines for drug information and advertising activities

__________________

Pursuant to Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government on the functions, tasks, powers, and organizational structure of the Ministry of Health;

Based on the Drug Law No. 34/2005-QH11 dated June 14, 2005;

Based on the Advertising Ordinance No. 39/2001/PL-UBTVQH dated November 16, 2001;

Based on the Government Decree No. 24/2003/NĐ-CP dated March 13, 2003 detailing the implementation of the Advertising Ordinance;

The Ministry of Health guides drug information and advertising activities as follows:

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

1.Scope of Regulation:

This Circular stipulates conditions for drug information and advertising; registration files and procedures for drug information and advertising; inspection, supervision, and handling of violations related to drug information and advertising in Vietnam.

第二条 组织和实施奖励工作的支出水平，如政府第152/2025/NĐ-CP号决定关于分级授权和奖励领域的分权规定

This Circular applies to agencies, organizations (hereinafter referred to as units), and individuals involved in drug information and advertising activities within the territory of Vietnam.

Article 2. Interpretation of Terms

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

1. Drugs are substances or mixtures of substances intended for human use for disease prevention, treatment, diagnosis, or adjustment of physiological functions of the body, including finished drugs, raw materials for drugs, vaccines, medical products, except functional foods.

2. Drug information refers to the collection and/or provision of relevant information about drugs such as indications, contraindications, dosage, administration methods, adverse reactions of drugs, precautions when using drugs for specific groups of people (children, pregnant women, nursing mothers, elderly people, and other groups) by responsible entities or individuals providing drug information to meet the information needs of healthcare professionals or drug users directly engaged in medical or pharmaceutical practices.

3. Drug advertising is an activity introducing drugs conducted directly by drug business units or through collaboration, sponsorship, or delegation to another unit to promote prescription, supply, sale, and/or use of drugs based on rational, safe, and effective drug use.

4. Drug advertising on other advertising media refers to advertising activities transmitted through media not mentioned in this Circular.

5. Drug introduction seminars specified in this Circular are product introduction sessions or scientific topic discussions for healthcare staff related to drugs organized and sponsored by drug business units.

6. Drug introducers are representatives of drug business units operating in Vietnam assigned by their units to introduce drugs to healthcare staff.

Article 3.General Conditions for Drug Information and Advertising

1. Only registered units may submit registration files for drug information and advertising they have registered. In cases where a registered unit wishes to delegate another unit to submit registration files for drug information and advertising, a written authorization must be provided. The delegated unit must be a legally recognized entity.

2. Drugs that have been granted registration numbers for circulation in Vietnam may be advertised according to the provisions of this Circular. Drugs that have not yet been granted registration numbers for circulation in Vietnam but are permitted to circulate in other countries can only be communicated to healthcare staff through drug introduction seminars.

3. The content of drug information and advertising must ensure scientific accuracy, objectivity, truthfulness, clarity, and must not cause misunderstanding.

4. The language used in drug information and advertising must be Vietnamese, except in cases where terms have been internationalized or where trademarks or terms cannot be replaced by Vietnamese.

5. The smallest font size in drug information and advertising must be large enough to be visible under normal conditions but must not be smaller than the equivalent size of 11 VnTime.

6. Units engaging in drug information and advertising must bear responsibility for the content and legality of the information provided in their drug information and advertising activities.

Article 4. Fees for the examination of registration dossier for drug information and advertising

1. Units registering drug information and advertising in accordance with this Circular must pay the examination fee for the registration dossier at the agency receiving the registration dossier for drug information and advertising in accordance with current laws. A sample of drug information and advertising corresponding to one registration dossier for drug information and advertising must pay the examination fee as follows:

2. a) The case where it is considered as one registration dossier for drug information and advertising when meeting one of the following cases:

- One sample of drug information and advertising for one target group of a drug with one dosage form and one strength;

- One sample of drug information and advertising for one target group of two or more drugs with the same active ingredient but different strengths, dosage forms, and routes of administration from the same manufacturer;

- One sample of drug information and advertising for one target group on multiple formats (for example: leaflets, posters, books, newspapers, etc.);

b) The case where it is not considered as one registration dossier for drug information and advertising:

- One drug being advertised for one target group but having multiple samples of drug information and advertising. In this case, each sample of drug information and advertising is considered as one registration dossier for drug information and advertising.

- One sample of drug information and advertising for one target group but including multiple drugs. In this case, each drug is considered as one registration dossier for drug information and advertising.

Article 5. Prohibited Acts

1. Advertising prescription drugs; vaccines, medical products used for disease prevention; non-prescription drugs that have been recommended by competent state management agencies through written notices to be used restrictively or under the supervision of healthcare professionals.

2. Providing information or advertising cosmetics, health supplements, and other products that are not drugs with unclear content that may mislead consumers into believing these products are drugs.

3. Using material benefits or financial incentives in any form to influence healthcare professionals or drug users to promote the prescription or use of drugs.

4. Misusing the registration number granted by the Drug Administration Department or another country's drug regulatory authority to advertise drugs.

5. Using the name, symbol, image, status, reputation, letters of appreciation from patients of medical or pharmaceutical organizations, or healthcare staff to advertise or recommend drugs.

6. Misusing the format of healthcare professionals guiding disease prevention, treatment, or drug usage through articles in newspapers, radio programs, or television broadcasts to advertise drugs.

7. Using clinical research results that lack sufficient scientific basis or medical evidence to provide information or advertise drugs.

8. Misusing test results, certifications issued by competent authorities, or medals awarded by trade fairs for products and/or units to advertise drugs.

9. Providing information or advertising drugs with content that is inconsistent with Vietnamese customs and traditions; overusing animal images or other unrelated images to provide information or advertise drugs, leading to misunderstandings among users.

10. Distributing to the public informational materials intended for healthcare staff.

11. Using phrases, words, images, sounds that create the following impressions for the public:

a) This drug is number one, better than all others;

b) Using this drug is the best method;

c) Using this drug does not require a doctor's opinion;

d) This drug is completely harmless, has no side effects, and has no contraindications.

12. Comparing one's own drug advertising with that of other organizations or individuals with the intent of promoting one's own drug.

13. Advertising or providing information (except in cases specified in Clause 3, Article 9 of this Circular) about drugs that have not yet been granted a registration number or whose registration number has expired.

14. Providing information (except in cases specified in Clause 2, Article 10 of this Circular) or advertising drugs before submitting the registration dossier for drug information and advertising to the competent state management agency; providing or advertising drug information that does not match the registered content; providing or advertising drug information during the period when the dossier is being reviewed and processed according to regulations.

DRUG INFORMATION AND ADVERTISING

Chapter II

INFORMATION, ADVERTISING OF DRUGS

Section I. DRUG INFORMATION

Article 6. General Responsibilities for Drug Information

1. The Ministry of Health, provincial and municipal health departments under the central government, health sectors, and medical examination and treatment facilities (hereinafter referred to collectively as healthcare facilities) shall be responsible for organizing drug information and monitoring adverse drug reactions; promptly informing prescribers and users to ensure rational, safe, and effective drug use.

2. The National Center for Drug Information and Adverse Reaction Monitoring shall be responsible for assisting the Ministry of Health in collecting, compiling, analyzing, reporting, and providing relevant drug information and adverse drug reaction data.

Article 7. Drug Information in Hospitals

1. The hospital director shall be responsible for managing and directing drug information activities within the hospital. This responsibility is carried out through the hospital's drug information unit.

2. The tasks of the hospital's drug information unit include:

a) Collecting and receiving drug information;

b) Providing drug information to ensure safe and rational drug use within the hospital. Providing processed feedback information to lower-level hospitals (for regional and provincial hospitals);

c) Directing, guiding, and inspecting the drug information units of lower-level hospitals (for regional and provincial hospitals);

d) Collecting, compiling, and reporting adverse drug reactions to the Hospital Pharmacy and Treatment Council, the National/Central Center for Drug Information and Adverse Reaction Monitoring;

e) Other issues related to drug information.

3. Medical staff shall be responsible for:

a) Providing relevant drug information to users during medical examinations and treatments;

b) Monitoring and reporting adverse drug reactions to the hospital's drug information unit.

Article 8. Drug Information of Pharmaceutical Business Units

1. Pharmaceutical business entities and individuals have the right and responsibility to provide drug information they register, produce, import, and distribute to medical staff and drug users.

2. Only scientific data that has been proven can be provided as drug information. The source, origin of the information, the provider of the information, and the time of provision must be accurate, objective, truthful, scientific, and clear.

3. During the circulation of drugs, pharmaceutical business entities and drug registration entities shall be responsible for monitoring and promptly reporting new drug information, adverse drug reactions, and signs of drug quality degradation discovered by the business entity to the Drug Administration and the National Center for Drug Information and Adverse Reaction Monitoring.

4. Retail pharmacies shall provide relevant information and usage guidance when selling drugs to customers; collect and report adverse drug reactions and signs of drug quality degradation to the competent authority. Retail pharmacies shall be responsible for the origin of displayed and introduced drug information/promotional materials; only allowing authorized pharmaceutical business entities/or persons authorized to distribute approved drug information/promotional materials from the Drug Administration.

Section II. INFORMATION FOR INTRODUCING MEDICINES TO HEALTH WORKERS

Article 9. Forms of information for introducing medicines to health workers

1. Through "Medicine Promoters".

2. Distributing informational materials about medicines to health workers.

3. Seminars for introducing medicines to health workers.

4. Displaying and introducing medicines at specialized healthcare conferences and seminars.

Article 10. Responsibilities and limits on information for introducing medicines to health workers

1. Medicine business units or authorized units may only provide information to introduce medicines within the scope regulated by this Circular to health workers.

2. The content of medicine information provided to health workers does not need to be registered with the Drug Administration Department: Information about medicines that have been accepted by the Drug Administration Department in the drug registration dossier, including the medicine label and the drug usage instructions.

3. The content of medicine information must be submitted for registration to the Drug Administration Department:

a) Information about medicines already included in the label and drug usage instructions but with changes in ratio, shape, size, color, image, or layout arrangement;

b) Information about medicines already included in the label and drug usage instructions with additional details;

c) Information about medicines not included in the label and drug usage instructions;

d) Information about medicines collected through market product monitoring;

đ) Independent studies, new studies related to medicines.

Units may only introduce medicines to health workers according to the forms prescribed in Article 9 of this Circular.

Article 11. Medicine Promoters

1. Only those who have been issued a "Medicine Promoter" card may provide information and introduce medicines to health workers.

2. Medicine Promoters must meet the following conditions:

a) They must be health or pharmaceutical staff with a minimum of a college degree. In cases where Medicine Promoters have a college degree in health or pharmaceuticals, they must also meet the following conditions:

- Having worked for at least two years at a legitimate health or pharmaceutical facility;

- Undergoing training according to the framework training program for Medicine Promoters stipulated by the Ministry of Health

b) They must have been trained and educated by the recruiting unit;

c) They must possess sufficient knowledge about the medicines assigned to them and understand relevant pharmaceutical regulatory documents.

3. The following individuals are not allowed to participate in promoting medicines:

a) Those prohibited from practicing medicine or pharmacy according to court judgments and/or currently under criminal investigation and/or subject to administrative control measures;

b) Those lacking civil capacity;

c) Current civil servants or public officials.

4. Responsibilities of Medicine Promoters:

a) They can only promote medicines that have been permitted for circulation in Vietnam as assigned by the recruiting unit and can only provide information about medicines consistent with the registration dossier at the Drug Administration Department;

b) They can only promote medicines to health workers;

c) When promoting medicines, they must wear the "Medicine Promoter" card and must obtain the consent of the facility receiving the medicine information before proceeding with the promotion;

d) Collect adverse reaction reports of medicines, quality-related reports to enable the unit to promptly compile and report to the Ministry of Health (Drug Administration Department); National Center for Medicines Information and Adverse Reaction Monitoring.

Article 12. Responsibilities of the Hospital Director when there is a Drug Promoter Operating

1. Only allow individuals with a Drug Promoter card to participate in drug promotion activities, and check on the implementation of the responsibilities of drug promoters as stipulated in Clause 4, Article 11 of this Circular.

2. Establish internal regulations specifying the components, location, time, and organization for Drug Promoters to interact and exchange information with healthcare staff within the unit.

3. Implement measures to prevent employees within the unit from prescribing or guiding the use of drugs for profit influenced by material, financial, or any other form of inducement from drug promoters.

4. Immediately suspend the operation of a drug promoter within their own unit if the drug promoter engages in any violation of this Circular.

5. Be responsible for the origin of informational materials and drug advertisements being disseminated within their own unit, only allowing pharmaceutical business units or persons authorized to distribute informational materials and advertisements that have been registered with the Drug Administration Department.

Article 13. Informational Materials for Drug Promotion to Healthcare Staff

1. Informational materials for promoting drugs to healthcare staff must be prepared according to the provisions of Article 14 of this Circular.

2. The sections of the materials providing proof and citations illustrating the content must be truthful, up-to-date, and clearly state the name of the material, author's name, and publication date of the material.

3. New information discovered through scientific research or market product monitoring must be provided in the form of updated scientific information accompanied by proof materials. The new information section must include the phrase: "This information is for reference purposes only."

4. Informational materials for promoting drugs to healthcare staff must have the phrase "Informational Material for Healthcare Staff" at the top of all pages. For multi-page materials, page numbers must be included, and the first page must clearly indicate detailed information about the product on specific pages and print: (a) the Drug Registration File Acceptance Number issued by the Drug Administration Department - Ministry of Health XXXX/XX/QLD-TT, dated ..., (b) the printing date ..., ...

5. Informational drug materials may only provide information related to the drug and should not include unrelated information.

Article 14. Content of Informational Drug Materials for Healthcare Staff

1. Drug Name: May use either the brand name or generic name.

2. Active Ingredients.

a) For synthetic drugs: Use the international nomenclature.

b) For drugs derived from herbal sources: Use the Vietnamese name (except for Vietnamese medicinal herbs that do not yet have a Vietnamese name, then use the original name from the country of origin along with the Latin name).

3. Formulation.

4. Indications and Uses.

5. Dosage.

6. Method of Administration.

7. Side Effects and Adverse Reactions.

8. Contraindications and Precautions.

9. Drug Interactions.

10. Name and Address of the Main Manufacturer and Distributor.

11. New information for reference and the materials proving the source of such information.

12. List of cited references.

Article 15. Information Documents on Vaccines and Medical Products for Disease Prevention

In addition to the contents prescribed in Article 14 of this Circular, information documents on vaccines and medical products for disease prevention must also include the following contents:

1. Usage Objectives (related to age, health status...):

a) Persons who can use;

b) Persons who cannot use.

2. Usage Regimen: when to use, how many times to use, and repeat interval.

3. Vaccine and Medical Product Storage Conditions: clearly state storage equipment, storage temperature, and other storage conditions (if applicable).

4. Drug Interaction Notes:

a) Drug Interactions: which types of drugs should not be used simultaneously during vaccination (or administration) of vaccines and medical products for disease prevention; which types of drugs should not be used after using vaccines and medical products for disease prevention;

b) Administration Method: injection site (intramuscular, subcutaneous, intradermal).

5. Possible Adverse Events and Handling Methods: early adverse events, late adverse events.

6. Other Notes.

Article 16. Seminars Introducing Medicines to Healthcare Staff

1. Medicine trading units, representative offices registered to operate in the pharmaceutical field in Vietnam have the right to organize seminars to introduce medicines that have been permitted for production and circulation in other countries to healthcare staff.

Foreign entities wishing to organize medicine introduction seminars in Vietnam must cooperate with a Vietnamese medicine trading unit or a Vietnamese healthcare facility such as hospitals, specialized healthcare institutes, healthcare staff training facilities, professional healthcare associations, or professional pharmaceutical associations.

2. The content of medicine introduction at seminars includes:

a) Medicine Name: may use brand name or generic name;

b) Active Ingredient:

- For synthetic medicines: use the international nomenclature;

- For medicines derived from herbal sources: use Vietnamese names (except for medicinal herbs not yet named in Vietnam, use the original name from the country of origin along with the Latin name).

c) Active Ingredient Content/Concentration;

d) Formulation;

đ) Information and Research Results on:

- Pharmacokinetics;

- Pharmacodynamics;

- Clinical Information: Indications, dosage, administration method, contraindications, precautions, usage notes, side effects, harmful reactions and handling methods, drug interactions, overdose cases and handling methods;

- Information about formulation, formula, storage method, expiration date, packaging specifications;

- Information on drug classification: addictive drugs, psychotropic drugs, prescription drugs, over-the-counter drugs;

- Other related information;

- Manufacturer's and main distributor's name and address.

3. Seminar speakers must be professionals with extensive knowledge and experience regarding the introduced medicines.

Article 17. Displaying Medicines at Health Conferences and Seminars

1. Units organizing and hosting specialized health conferences and seminars wishing to display and introduce medicines at these events must notify the Health Department of the location where the conference or seminar will be held in writing before the event.

2. All advertising activities accompanying the display of medicines at conferences and seminars must comply with the regulations on medicine advertising stipulated in this Circular and other relevant laws.

Article 18. Activities of promoting and advertising medicines by sponsors

1. Units and individuals have the right to sponsor funds and materials for medical staff conferences on a voluntary, open, and unconditional basis.

2. The activities of introducing medicines to medical staff by sponsors at specialized health conferences must comply with the regulations on providing medicine information to medical staff stipulated in this Circular and other relevant laws.

3. The activities of promoting and advertising medicines by sponsors at other conferences, radio programs, television programs must comply with the regulations on advertising medicines to the public stipulated in this Circular and other relevant laws.

Section III. ADVERTISING OF MEDICINES

Article 19. Types of medicines that can be advertised

1. Medicines listed in the Over-the-Counter Medicine List issued by the Ministry of Health and having valid registration numbers may be advertised in books, newspapers, magazines, leaflets, online newspapers, websites of enterprises, advertising service units' websites, billboards, posters, neon signs, illuminated objects, objects in the air, underwater, transportation means, mobile objects, and other advertising media.

2. Medicines registered for circulation in Vietnam by the Ministry of Health, with active ingredients included in the list of active ingredients for registering advertisements on radio and television issued by the Ministry of Health, may be advertised on radio and television.

Article 20. Forms of advertising medicines

1. Advertising in books, newspapers, magazines, leaflets, posters.

2. Advertising on boards, signs, billboards, banners, illuminated objects, objects in the air, underwater, transportation means, mobile objects.

3. Advertising on radio and television.

4. Advertising on online newspapers, enterprise websites, advertising service unit websites.

5. Advertising on other information dissemination media.

Article 21. Content of advertising medicines

1. The content of drug advertisements must be consistent with the following documents:

a) The drug usage guide approved by the Ministry of Health (Drug Administration Department).

b) Special articles about the drug recorded in the National Pharmacopoeia or recognized international drug literature.

2. The content of advertising medicines in books, newspapers, magazines, leaflets, boards, signs, billboards, banners, illuminated objects, objects in the air, underwater, transportation means, mobile objects must include the following information:

a) Drug name: the name in the decision granting the registration number for circulation in Vietnam;

b) Active Ingredient:

- For synthetic medicines: use the international nomenclature;

- For medicines derived from herbal sources: use Vietnamese names (except for medicinal herbs not yet named in Vietnam, use the original name from the country of origin along with the Latin name).

c) Indications;

d) Usage method;

đ) Dosage;

e) Contraindications and/or recommendations for special groups such as pregnant women, nursing mothers, children, elderly people, patients with chronic diseases;

g) Side effects and adverse reactions;

h) Things to avoid and precautions when using the drug;

i) Name and address of the drug manufacturing facility. (The distributor's name and address may also be added);

k) Warning "Read the usage instructions carefully before use";

l) At the top of the first page of the drug advertisement material, print:

- The number of the Drug Advertisement Registration Acceptance Certificate of the Drug Administration Department: XXXX/XX/QLD-TT, date ... month ... year;

- Date ... month ... year ... printed material.

For multi-page materials, pages must be numbered, and the first page must clearly state how many pages the material has and where detailed product information can be found.

Article 22. Advertising of medicines on radio and television

1. Medicines that meet the following conditions may be advertised on radio and television:

a) The active ingredient of the medicine must be included in the list of active ingredients of medicines registered for advertising on radio and television;

b) The medicine must not contain any active ingredient listed in the current regulations under the categories of addictive substances, psychotropic substances, precursors, and radioactive substances.

2. The list of active ingredients of medicines registered for advertising on radio and television shall be issued by the Minister of Health. This list will be updated to supplement and adjust as necessary.

3. The content of medicine advertisements must comply with the information requirements set out in points a, b, c, e, i, and k of Clause 2, Article 21 of this Circular; specifically, points a, b, c, e, and k of Clause 2, Article 21 must be read clearly and loudly. If the medicine contains three or more active ingredients, the main active ingredient or the common name of vitamins, minerals, and herbal medicines may be read depending on the broadcast duration.

4. In cases where an entity wishes to advertise on local radio and television stations, it must notify the local Department of Health in writing along with the receipt of the application for registration of medicine advertisements from the Drug Administration and the advertisement content or script confirmed by the Drug Administration.

Article 23. Advertising of medicines on online newspapers, company websites, and advertising service provider websites

1. A medicine business entity may only advertise the medicines it sells on its own legitimate website. It is not permitted to advertise medicines that it does not sell.

2. A medicine business entity or an authorized entity may only advertise medicines on the website of an advertising service provider if the advertising service provider has an Internet Content Provider (ICP) license from the Ministry of Information and Communications and a business registration certificate for advertising services as stipulated by law.

3. Medicine advertisements on online newspapers, company websites, and advertising service provider websites must be conducted in a separate section. This section must clearly state "Special Section for Medicine Advertisements" and this statement must be bolded with a larger font size than normal and continuously displayed at the top of the page.

4. Content of advertisements on online newspapers, company websites, and advertising service provider websites:

a) Medicine advertisements on websites must comply with the provisions of Clause 2, Article 21 of this Circular. Such advertisements must be distinct and not overlap or interweave multiple medicines at the same time to avoid confusion.

b) Medicine advertisements on websites in video clip form must comply with the provisions of Article 22 of this Circular.

5. Entities that have been granted a receipt for the application for registration of medicine advertisements according to the forms prescribed in Clauses 1, 2, and 3, Article 20 of this Circular may use the approved advertisement content to advertise on Websites, consistent with the content already registered with the Drug Administration.

Article 24. Advertising of medicines on other advertising media

Entities may only advertise medicines on other advertising media when such media convey sufficient information in accordance with points a, b, c, e, and k of Clause 2, Article 21 of this Circular and must comply with current relevant regulations.

Article 25. Prohibitions on Indications in Drug Advertising Content

The following indications shall not be included in drug advertising content:

1. Indication for treating tuberculosis and leprosy.

2. Indication for treating sexually transmitted diseases.

3. Indication for treating chronic insomnia.

4. Indications with stimulative effects.

5. Indication for treating cancer and tumors.

6. Indication for treating diabetes or other similar metabolic disorders.

Article 26. Displaying Drugs at Trade Fairs and Exhibitions

1. Drugs that have been registered for circulation by the Ministry of Health may be displayed at trade fairs and exhibitions, except for addictive drugs, psychotropic drugs, precursor substances used to make drugs, and radioactive drugs.

2. Drugs that have not yet been registered for circulation by the Ministry of Health must obtain a permit from the Ministry of Health (Drug Administration Department) to import such drugs for display at trade fairs and exhibitions if they wish to exhibit them.

Chapter III

REGISTRATION PROCEDURES FOR DRUG INFORMATION AND ADVERTISING

Article 27. Authorities Receiving and Processing Drug Information and Advertising Registration Files

1. The Ministry of Health (Drug Administration Department): Receives and processes registration files for drug advertising and information registration files to introduce drugs to healthcare staff.

2. Provincial Health Departments: Receive and process registration files for seminars introducing drugs to healthcare staff and issue certificates to Drug Introducers.

Article 28. Drug Introducer Certificate Application Documents and Procedures

1. The application documents for a Drug Introducer certificate with a bachelor's degree include:

a) A Drug Introducer certificate application form (Form 1a-QC);

b) A curriculum vitae (with confirmation from the management authority or local government);

c) A certified copy of a valid graduation certificate as stipulated in Point a, Clause 2, Article 11 of this Circular;

d) A health certificate;

đ) A list of products assigned to introduce;

e) A commitment letter from the recruited and assigned Drug Introducer stating that they have thoroughly understood and will comply with all relevant pharmaceutical regulations.

2. The application documents for a Drug Introducer certificate with an associate degree:

Must meet the requirements set out in Clause 1 of this Article and also meet the following specific requirements:

a) A training certificate for Drug Introducers issued by a training institution designated by the Ministry of Health;

b) A confirmation of at least two years of work experience at a legitimate medical or pharmaceutical facility.

3. Procedure for Issuing a Drug Introducer Certificate:

a) The employing entity sends the application documents as prescribed to the provincial health department where the entity has its headquarters or representative office;

b) Within twenty working days from the date of receipt of complete and valid application documents, the provincial health department will issue the Drug Introducer certificate (Form 1b-QC) based on the application documents. If the certificate is not issued, a written response with the reasons must be provided.

4. The Drug Introducer certificate is valid for two years from the date of issuance. To renew the Drug Introducer certificate, the employing entity must submit the application documents one month before the certificate expires.

5. The employing entity must retrieve and return the Drug Introducer certificate to the provincial health department that issued it in the following cases:

a) The Drug Introducer changes their place of employment;

b) The Drug Promoter ceases to perform the role of Drug Promoter;

c) The Drug Introducer certificate has expired.

6. The provincial health department will revoke the Drug Introducer certificate when the Drug Introducer violates any of the provisions set out in Article 5 of this Circular.

7. In case the Drug Introducer operates in another province, the employing entity must send a notification letter detailing the time, location, and plan of activities to the provincial health department of that province.

Article 29. Documents and Procedures for Processing Registration of Seminars to Introduce Medicines to Health Workers

1. Prior to organizing seminars to introduce medicines to health workers in any locality, the unit must prepare and submit a registration dossier to the Department of Health of that locality. The registration dossier for seminars to introduce medicines to health workers shall include:

a) A seminar registration form for introducing medicines to health workers (in accordance with Form 2a-QC);

b) The location and program of the seminar (tentative);

c) The content of each report and the name and scientific title of the presenter;

d) Materials intended to be displayed or distributed at the seminar;

đ) Materials related to the medicines being introduced at the seminar;

e) Reference materials (if any).

2. All documents within the dossier must bear the stamp of the unit preparing the dossier.

3. Upon receiving a complete and valid registration dossier in accordance with this Circular, the Department of Health shall issue a receipt for the dossier (in accordance with Form 2b-QC) to the submitting unit. The date on the receipt is the date when the Department of Health received the complete and valid dossier. Within fifteen working days from the date of receipt of the dossier, if the Department of Health does not issue a letter requesting amendments or supplements, the unit may organize the seminar as registered.

4. In case the registration dossier for the seminar to introduce medicines is incomplete or invalid according to this Circular, within fifteen working days, the Department of Health shall notify the registering unit to amend or supplement the dossier.

5. If the Department of Health issues a letter requesting amendments or supplements:

a) The letter requesting amendments or supplements must clearly specify which additional documents are required, what contents need to be amended, and what additional contents are needed.

b) The unit must amend or supplement the dossier in accordance with the contents specified in the letter requesting amendments or supplements and resubmit the amended or supplemented dossier to the Department of Health. When the unit amends or supplements the dossier in accordance with the requirements, the Department of Health shall issue a receipt for the dossier, with the date on the receipt being the date when the Department of Health received the supplementary dossier. Within five working days from the date of receipt of the amended or supplemented registration dossier, if the Department of Health does not issue a letter requesting further amendments or supplements, the unit may organize the seminar as amended.

6. The unit submitting the registration dossier for the seminar has the responsibility to notify the Department of Health receiving the registration dossier at least one day in advance about the specific location and official time of the seminar.

Article 30. Documents and Procedures for Processing Registration of Information and Advertising of Medicines

1. Prior to disseminating or advertising medicines, units must submit a registration dossier for information and advertising of medicines to the Ministry of Health (Drug Administration Department).

2. Contents of the registration documents

a) A registration form for information and advertising of medicines (in accordance with Form 3a-QC);

b) The format and content of the planned information and advertising;

c) Reference materials to verify the content of the information and advertising;

d) A copy of the Drug Usage Guide approved by the Drug Administration Department;

đ) A copy of the Product Circulation Permit issued by the Drug Administration Department or a copy of the Decision on Drug Registration Number issued by the Drug Administration Department;

e) A copy of the Certificate of Eligibility for Medicine Business or the license for foreign companies operating in Vietnam;

g) If advertising through radio or television, scripts and audiovisual materials must be submitted. The script must clearly describe the visual elements, dialogue, and music;

3. All documents within the dossier must bear the stamp of the unit preparing the dossier. Copies of the documents specified in Points d, đ, and e of Clause 2 of this Article only need to be stamped by the unit registering the information and advertising.

4. The proposed content for information and advertising or the script description must be submitted in two copies. After completion, one copy will be retained by the regulatory authority, and one copy will be stamped with confirmation by the Drug Administration Department and handed over to the unit registering the information and advertising.

5. The Drug Administration Department will not consider information and advertising content unrelated to medicines as stipulated in this Circular.

6. Upon receiving a complete and valid registration dossier in accordance with this Circular, the Drug Administration Department shall issue a receipt for the dossier (in accordance with Form 3b-QC) to the submitting unit. The date on the receipt is the date when the Drug Administration Department received the complete and valid dossier. Within ten working days from the date on the receipt, if the Drug Administration Department does not issue a letter requesting amendments or supplements, the unit may disseminate or advertise as registered.

7. In case the registration dossier for information and advertising of medicines is incomplete or invalid according to this Circular, within ten working days, the Drug Administration Department shall notify the registering unit to supplement or complete the dossier.

8. If the Drug Administration Department issues a letter requesting amendments or supplements:

a) The letter requesting amendments or supplements must clearly specify which additional documents are required, what contents need to be amended, and what additional contents are needed;

b) The unit must amend or supplement the dossier in accordance with the contents specified in the letter requesting amendments or supplements and resubmit the amended or supplemented dossier to the Drug Administration Department. When the unit amends or supplements the dossier in accordance with the requirements, the Drug Administration Department shall issue a receipt for the dossier, with the date on the receipt being the date when the Drug Administration Department received the supplementary dossier. Within ten working days from the date of receipt of the amended or supplemented information and advertising content, if the Drug Administration Department does not issue a letter requesting further amendments or supplements, the unit may disseminate or advertise as amended;

c) Within three months from the date the Drug Administration Department issues a letter requesting amendments or supplements, if the unit registering the information and advertising does not amend or supplement the dossier, the dossier will lose its validity.

9. The registration and review procedures for information and advertising dossiers shall be restarted in the following cases:

- The unit disseminating or advertising medicines must amend or supplement the dossier but does not follow the contents specified in the letter requesting amendments.

- The content of the information and advertising registered at the Drug Administration Department and acknowledged with a receipt, but the unit disseminates or advertises without complying with Article 5 of this Circular.

In these cases, the Drug Administration will issue a letter notifying the registering entity that it may not disseminate information or advertise according to the registered content.

10. If the entity has a registration dossier for drug information and advertising that does not comply with Clause 14, Article 5 of this Circular, the Drug Administration will issue a warning letter to the entity and suspend acceptance and examination of its drug information and advertising registration dossiers for 3 to 12 months depending on the specific circumstances as follows:

a) Suspend acceptance and examination of the entity's drug information and advertising registration dossiers for 3 months in the case of non-compliance with Clause 14, Article 5 of this Circular.

b) Suspend acceptance and examination of the entity's drug information and advertising registration dossiers from 3 to 6 months in the case of non-compliance with Clause 14, Article 5 of this Circular twice within a year.

c) Suspend acceptance and examination of the entity's drug information and advertising registration dossiers from 6 to 12 months in the case of non-compliance with this Circular three times or more within a year.

In addition to the above measures, the Drug Administration will publicize the content of the violations on its website; notify the Inspection Agency and other competent authorities to examine and handle the matter in accordance with the law.

Article 31. Effectiveness of drug information and advertising materials

Drug information and advertising materials registered with the Drug Administration shall cease to be valid in the following cases:

1. The drug registration number has expired.

2. The drug has been withdrawn from registration or has been recommended by the competent state management agency to limit its use.

3. There have been changes in the information about the drug.

Chapter IV

INSPECTION, AUDIT AND VIOLATION HANDLING

Article 32. Inspection and Audit

1. The Drug Administration and the Ministry of Health’s Inspectorate shall organize inspections and audits of the implementation of this Circular within their respective jurisdictions for entities and individuals involved in drug information and advertising activities on Vietnamese territory.

2. Provincial Health Departments shall be responsible for inspecting and auditing the implementation of this Circular within their jurisdiction.

Article 33. Handling of Violations and Complaints and Reports

1. Entities and individuals who violate the provisions shall be subject to administrative penalties, suspension of advertising, withdrawal of the registration number of the violating drug product, or criminal liability as prescribed by law, depending on the severity of the violation.

2. Entities and individuals have the right to file complaints and reports regarding information and advertising activities in accordance with the law on complaints and reports.

Chapter V

IMPLEMENTING PROVISIONS

Article 34. Effective Date

1. This Circular shall take effect 45 days from the date of signature. Decree No. 2557/2002/QĐ-BYT dated July 4, 2002, issued by the Minister of Health on the issuance of regulations on information and advertising of drugs for human use and cosmetics directly affecting human health, and Circular No. 12/2002/TT-BYT dated August 23, 2002, issued by the Minister of Health on guidelines for advertising vaccines and immunobiological products for human use, are hereby repealed.

2. The agency receiving and processing drug information and advertising registration dossiers shall be responsible for publishing the contents of registered information and advertising and cases of violations of drug information and advertising regulations on its website to serve monitoring, inspection, and audit work.

3. Entities that have submitted drug information and advertising registration dossiers and received acceptance certificates from competent state management agencies before the effective date of this Circular may continue to disseminate information and advertise until the information and advertising materials become invalid.

4. The Drug Administration, subordinate units under the Ministry of Health, Provincial Health Departments, Vietnam Pharmaceutical Corporation, pharmaceutical production and trading enterprises, foreign companies operating in the pharmaceutical sector, and related entities and individuals shall be responsible for implementing this Circular.

5. During the implementation process, if there are any issues, entities and individuals are requested to promptly report them to the Ministry of Health (Drug Administration) for consideration and resolution./.