Circular No. 13/2009/TT-BYT of September 01, 2009, guiding drug information provision and advertising

• Official number: 13/2009/TT-BYT
• Legislation Type: Circular
• Organization: The Ministry of Health
• Signer: Cao Minh Quang
• Issued Date: 01/09/2009

THE MINISTRY OF HEALTH -------	SOCIALIST REPUBLIC OF VIET NAM Independence - Freedom – Happiness ---------
No. 13/2009/TT-BYT	Hanoi, September 01, 2009

CIRCULAR

GUIDING DRUG INFORMATION PROVISION AND ADVERTISING

Pursuant to the Government's Decree No. 188/2007/ND-CP of December 27, 2007, defining the functions, tasks, powers and organizational structure of the Ministry of Health;
Pursuant to Pharmacy Law No. 34/2005/QH11 of June 14, 2005;
Pursuant to Advertising Ordinance No. 39/2001/PL-UBTVQH of November 16, 2001;
Pursuant to the Government's Decree No. 24/2003/ND-CP of March 13, 2003, detailing the Advertising Ordinance;
The Ministry of Health guides drug information provision and advertising as follows:

THE MINISTRY OF HEALTH

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation and subjects of application

1. Scope of regulation:

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2. Subjects of application:

This Circular applies to agencies and organizations (below referred to as units) and individuals engaged in drug information provision and advertising in the Vietnamese territory.

Article 2. Interpretation of terms

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

1. Drug means a substance or a mixture of substances for human use in prevention, treatment and diagnosis of diseases or adjustment of physiological functions of human body. Drugs include end-products and materials for production of drugs, vaccines, and medical biologicals, except functional foods.

2. Drug information provision means the collection and/or provision of drug-related information such as indications, contraindications, dosage, methods of administration and harmful reactions of drugs and precautions for special groups of users (children, pregnant women, breast­feeding women, elderly people and other users) by units and individuals responsible for providing drug information to meet information needs of medical or pharmaceutical practitioners or drug users.

3. Drug advertising means the introduction of drugs by a drug trader itself or in collaboration with, sponsorship or authorization for another unit to promote the prescription, supply, sale and/ or use of drugs in a proper, safe and effective manner.

4. Drug advertising on other advertising media means advertising on media other than those specified in this Circular.

5. Drug introduction seminar under this Circular means meetings held or sponsored by drug traders to introduce drug products or discuss scientific themes for medical workers engaged in drug-related activities.

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Article 3. General conditions on drug information provision and advertising

1. Only drug registering units may register dossiers to provide information on and advertise their registered drugs. When such a unit wishes to authorize another unit to make registration, it must produce a letter of authorization. The authorized unit must have the legal entity status.

2. Information on drugs with registration numbers for circulation in Vietnam may be provided or advertised under this Circular Information on drugs without registration numbers for circulation in Vietnam which have been licensed for circulation in other countries may be provided to medical workers only through drug introduction seminars.

3. Contents of drug information provision and advertising must be scientific, objective, accurate, truthful and clear and must not lead to misunderstanding.

4. The spoken and written language used in drug information provision and advertising is Vietnamese, except internationalized words or trademarks or wordings without synonyms in Vietnamese.

5. The smallest font size of characters in information and advertisements must be big enough to be readable in normal conditions and must not be smaller than those equivalent to size 11 of VnTime font.

6. Drug information providers and advertisers shall be held responsible for the contents and legality of the information they have provided.

Article 4. Charges for examination of registration dossiers of drug information provision and advertising

1. Drug information providers and advertisers defined in this Circular shall pay charges for dossier examination at agencies receiving registration dossiers of drug information provision and advertising under current law.

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a/ The following cases are regarded as one registration dossier of drug information provision and advertising:

- One form of information provision and advertisement for a certain subject on a drug with single content and mode of preparation:

- One form of information provision and advertisement for a certain subject on two or more drugs of the same manufacturer with the same active ingredient but with different contents, modes of preparation and routes of administration;

- One form of information provision and advertisement for a certain subject on a drug in different means (for instance, leaflets, posters, books, newspapers, etc);

b/ The following cases are not regarded as one registration dossier of drug information provision and advertising:

- Information on or advertisement for a drug for a certain subject in different forms. In this case, each form of drug information provision and advertisement is regarded as one registration dossier of drug information provision and advertising.

- One form of drug information provision and advertisement for a certain subject but on different drugs. In this case, each drug is regarded as one registration dossier of drug information provision and advertising.

Article 5. Prohibited acts

1. Advertising prescription drugs; vaccines and medical biologicals for disease prevention: and drugs other than prescription ones, which are subject to limited use or use under the supervision of physicians according to written recommendations issued by competent state management agencies.

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3. Using material or financial benefits in any form to affect physicians and drug users in order to promote the prescription and use of drugs.

4. Making use of drug circulation registration numbers granted by the Drug Administration of Vietnam or drug management agencies of other countries to advertise drugs.

5. Using the names, symbols, images, positions, prestige and mails of medical and pharmaceutical organizations and medical workers and thank-you letters of patients to advertise or recommend drugs.

6. Advertising drugs in the form of physicians' instruction on disease prevention and treatment or drug use instruction in newspaper articles and radio or television broadcast programs.

7. Using clinical research results which lack scientific grounds and medical evidences for drug information provision and advertising.

8. Making use of test results and certifications issued by competent agencies and medals granted to products and/or units in exhibitions and fairs to advertise drugs.

9. Providing information on and advertising drugs with contents irrelevant to Vietnam's fine traditions and customs; making use of animal images or other irrelevant images to provide information on and advertise drugs, leading to users' misunderstanding.

10. Making public drug information documents for medical workers.

11. Using sentences, words, images and sounds giving the following impressions to the public:

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c/ This drug may be used without physicians' advice;

d/ This drug is harmless and has no side effects and no contraindications.

12. Making comparisons for the purpose of advertising that one's drugs are better than those of other organizations and individuals.

13. Advertising and providing information on drugs without registration numbers or with expired registration numbers (except the case specified in Clause 3, Article 9 of this Circular).

14. Providing information on (except the case specified in Clause 2, Article 10 of this Circular) and advertising drugs before submitting registration dossiers of drug information provision and advertisings to competent state management agencies; providing information on and advertising drugs at variance with registered contents; providing information on and advertising drugs whose dossiers are being considered and processed under regulations.

Chapter II

DRUG INFORMATION PROVISION AND ADVERTISING

Section 1. DRUG INFORMATION PROVISION

Article 6. General responsibilities for drug information provision

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2. The National Center for Drug Information and Control of Harmful Reactions of Drugs shall assist the Ministry of Health in collecting, summing up, analyzing, reporting and providing information on drugs and their harmful reactions.

Article 7. Drug information provision in hospitals

1. Directors of hospitals shall manage and direct drug information provision in hospitals through their hospitals' drug information units.

2. Tasks of a hospital's drug information unit include:

a/ To collect and receive drug information;

b/ To provide drug information to ensure safe and proper use of drugs within the hospital. To provide processed feedback information to lower-level hospitals (for regional and provincial hospitals);

c/ To guide, direct and inspect drug information units of lower-level hospitals (for regional and provincial hospitals);

d/ To collect, sum up and report on harmful reactions of drugs to drug and treatment councils of hospitals and the national/regional Center for Drug Information and Control of Harmful Reactions of Drugs;

e/ To deal with other issues related to drug information provision.

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a/ Provide information on related drugs for drug users during medical examination and treatment;

b/ Supervise and report on harmful reactions of drugs to drug information units of hospitals.

Article 8. Drug information provision by drug traders

1. Drug traders have the right and responsibility to provide information on drugs they have registered, manufactured, imported and distributed to medical administrators and workers and drug users.

2. Drug traders may provide information on drugs only when proven scientific data are fully available. The source and origin of information, information providers and time of information provision must be accurate, objective, truthful, scientific and clear.

3. In the course of drug circulation, drug traders and drug registering units shall supervise and promptly report to the Drug Administration of Vietnam and the National Center for Drug Information and Control of Harmful reactions of Drugs on latest information on drugs and their harmful reactions and signs of their quality reduction.

4. Drug retailers shall provide relevant information and instructions on use of drugs when retailing drugs to buyers; and collect and report on harmful reactions of drugs and signs of drug quality reduction to immediate professional management agencies. Drug retailers shall be responsible for the source of drug information/advertisement documents which are being displayed and introduced at their establishments; and may allow drug traders or authorized persons to distribute only drug information and advertisement documents already approved by the Drug Administration of Vietnam.

Section II. INFORMATION PROVISION FOR INTRODUCTION OF DRUGS TO MEDICAL WORKERS

Article 9. Forms of providing information for introduction of drugs to medical workers

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2. Distribution of drug information documents to medical workers.

3. Drug introduction seminars for medical workers.

4. Display and introduction of drugs at specialized health conferences and seminars.

Article 10. Responsibilities and limits of information provision for introduction of drugs to medical workers

1. Drug traders or authorized units may only provide information to introduce drugs governed by this Circular to medical workers.

2. Information on drugs to be introduced to medical workers without having to register with the Drug Administration of Vietnam is the one already accepted by the Drug Administration of Vietnam in drug registration dossiers, including drug labels and use instruction inserts.

3. Drug information subject to submission of registration dossiers of drug information provision and advertising at the Drug Administration of Vietnam:

a/ Drug information already included in labels and use instruction inserts but with changes in proportion, shape, size, color, image or layout;

b/ Drug information already included in labels and use instruction inserts but with any additional details;

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d/ Drug information collected through supervision of products on the market;

e/ Independent and new studies related to drugs.

Units may only introduce information to medical workers in the forms specified in Article 9 of this Circular.

Article 11. Drug introducers

1. Only those having obtained drug introducer cards may provide information on and introduce drugs to medical workers.

2. A drug introducer must satisfy all the following criteria:

a/ Being a medical or pharmaceutical worker with professional secondary-level qualifications or higher. A medical or pharmaceutical worker with a professional secondary-level qualifications must meet two additional conditions as follows:

- Having worked for at least two years at a lawful medical or pharmaceutical establishment;

- Having been trained under the framework training program for drug introducers under the Ministry of Health's regulations.

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c/ Completely knowledgeable about the drugs he/she is assigned to introduce and relevant legal documents on pharmacy.

3. The following persons may not introduce drugs:

a/ Those banned from conducting medical or pharmaceutical practices under court judgments or rulings and/or being examined for penal liability and/or being subject to administrative probation measures.

b/ Those without full civil act capacity;

c/ Civil servants or public employees.

4. Responsibilities of drug introducers:

a/ To introduce only drugs already licensed for circulation in Vietnam which are assigned to them and to provide only drug information relevant to dossiers registered at the Drug Administration of Vietnam;

b/ To introduce drugs only to medical workers;

c/ To wear drug introducer cards when introducing drugs and to introduce drugs only at the approval of information recipients;

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Article 12. Responsibilities of directors of hospitals where drug introducers operate

1. To allow only those with drug introducer cards to introduce drugs and to examine drug introducers in performing their responsibilities specified in Clause 4, Article 11 of this Circular.

2. To set rules specifying participants, places and times for, and organize, meetings for information exchange between drug introducers and medical workers of their hospitals.

3. To adopt measures to prevent the prescription and instruction on use of drugs by their hospitals' staff for profit purposes as affected by drug introducers materially, financially or otherwise.

4. To promptly stop activities of drug introducers within their hospitals when drug introducers violate this Circular.

5. To be responsible for the source of drug information and advertisement documents which are being distributed in their hospitals, to allow drug traders or authorized persons to distribute only drug information and advertisement documents already registered at the Drug Administration of Vietnam.

Article 13. Drug information documents for introduction to medical workers

1. Drug information documents for introduction to medical workers must be compiled under Article 14 of this Circular.

2. The part providing proofs and excerpts to illustrate information must be truthful and updated and must specify titles of documents, names of authors and time of publication.

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4. A drug information document for introduction to medical workers must have a header which reads "information document for medical workers" on every page. A multi-page document must have its pages numbered and the first page must specify the number of the page providing details on the product and indicate (a) the number of the slip on receipt of the registration dossier of drug information provision and advertising of the Drug Administration of Vietnam - the Ministry of Health XXXX/XX/QLD-TT, date.... month... year...., (b) date.... month.... year of printing the document.

5. Drug information documents may provide only drug information, not information irrelevant to drugs.

Article 14. Contents of a drug information document for medical workers

1. Drug name, which can be proprietary or original name.

2. Active ingredients

a/ For a western medicine: To use international nomenclature.

b/ For a herbal medicament: To use Vietnamese name (except materia medica whose names in Vietnamese are unavailable. In this case, to use the original name of the country of origin together with Latin name).

3. Form of preparation.

4. Effect and indications.

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6. Method of administration.

7. Side effects and harmful reactions.

8. Contraindications and precautions.

9. Drug interactions.

10. Names and addresses of manufacturer and main distributor.

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

12. List of extracted documents.

Article 15. Information documents on vaccines and medical biologicals for disease prevention

Apart from the contents specified in Article 14 of this Circular, the information document on a vaccine or medical biological for disease prevention must include the following contents:

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a/ Eligible users;

b/ Ineligible users.

2. Administration chart: use time and interval and time for booster injection or oral use.

3. Preservation of the vaccine or medical biological: To specify preservation tools and temperature and other preservation conditions (if any).

4. Notes on drug interactions:

a/ Drug interactions: To specify drugs disallowed for concurrent use during the time of injection (or oral use) of the vaccine or medical biological for disease prevention; and drugs disallowed for use after use of the vaccine or medical biological for disease prevention;

b/ Injection methods: positions of injection (intramuscular, hypodermic or intracutaneous injection).

5. Possible accidents and handling methods: early and late accidents.

6. Other notes.

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1. Drug traders and representative offices having registered pharmaceutical activities in Vietnam may organize seminars to introduce drugs which have been licensed for manufacture and circulation in other countries to medical workers.

A foreign unit wishing to hold a drug introduction seminar in Vietnam shall coordinate with a Vietnamese drug trader or health establishment such as hospital, medical specialty institute, medical worker training establishment and professional medical workers' or pharmacists' association.

2. Contents of a drug introduction seminar include:

a/ Name of the drug: To use proprietary name or original name;

b/ Active ingredients:

- For a western medicine: To use international nomenclature;

- For a herbal medicament: To use Vietnamese name (except materia medica whose names in Vietnamese are not available. In this case, to use the original name of the country of origin together with Latin name).

c/ Content/concentration of active ingredients;

d/ Form of preparation;

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- Pharmacokinetics;

- Pharmacodynamics;

- Clinical information: indications, dosage, method of administration, contraindications, precautions, notes on use, side effects, harmful reactions and handling methods, drug interactions, overdoses and handling methods;

- Information on preparation, preparation formula, preservation methods, expiry date, packings specifications;

- Information on drug classification: addictive drugs, psychotropic drugs, prescription drugs and non-prescription drugs;

- Other relevant information;

- Names and addresses of manufacturer and main distributor.

3. Rapporteurs of seminars must be professionals conversant with drugs to be introduced.

Article 17. Display of drugs at specialized health conferences and seminars

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2. All advertising activities together with the display of drugs at conferences or seminars must comply with regulations on drug advertising under this Circular and other relevant laws.

Article 18. Drug introduction and advertising by sponsors

1. Units and individuals may provide financial and material assistance for conferences of medical workers voluntarily, publicly and unconditionally.

2. Sponsors shall introduce drugs to medical workers at specialized health conferences according to this Circular's provisions on drug information provision for medical workers and other relevant laws.

3. Sponsors shall introduce and advertise drugs at other conferences and on radio or television broadcasts according to this Circular's provisions on drug advertising to the public and other relevant laws.

Section III. DRUG ADVERTISING

Article 19. Drugs permitted for advertising

1. Drugs on the list of non-prescription drugs promulgated by the Ministry of Health with valid registration numbers may be advertised on books, newspapers, magazines, leaflets, online newspapers, websites of enterprises and advertising service providers, panels, posters, banners, illuminative objects, aerial or underwater objects, means of transport, other movable objects and other advertising media.

2. Drugs with registration numbers for circulation in Vietnam granted by the Ministry of Health and having main active ingredients on the Ministry of Health "s list of active ingredients permitted for registration of advertising on radio and television may be advertised on radio and television.

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1. Advertising on books, newspapers, magazines, leaflets and posters.

2. Advertising on billboards, signs, panels, banners, illuminative objects, aerial or underwater objects, means of transport and other movable objects.

3. Advertising on radio and television.

4. Advertising on online newspapers and websites of enterprises and advertising service providers.

5. Advertising on other advertising media.

Article 21. Contents of drug advertising

1. Advertising of a drug must comply with the following documents:

a/ Use instruction insert already approved by the Ministry of Health (the Drug Administration of Vietnam).

b/ Thesis on the drug already included in the National Pharmacopoeia record or in internationally recognized drug documents.

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a/ Name of the drug, which is the name specified in the decision on the drug's registration number of circulation in Vietnam;

b/ Active ingredients:

- For a western medicine: To use international nomenclature:

- For a herbal medicament: To use Vietnamese name (except materia medica whose names in Vietnamese are unavailable. In this case, to use the original name of the country of origin together with Latin name).

c/ Indications;

d/ Method of administration;

e/ Dosage;

f/ Contraindications and/or recommendations for special users such as pregnant women, breast­feeding women, children, elderly people and sufferers of chronic diseases;

g/ Side effects and harmful reactions;

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i/ Name and address of drug manufacturer. (Name and address of distributor may be added);

j/ The phrase "Carefully read instructions before use;"

k/ At the end of the first page of the drug advertising document, to print:

- Number of the slip on receipt of the registration dossier of drug advertising of the Drug Administration of Vietnam: XXXX/XX/QLD-TT, date... month.... year....; Date... month... year... of printing the document.

- For multiple-page documents, to number the pages and indicate on the first page the number of pages of the document and the number of the page providing detailed information on the drug.

Article 22. Drug advertising on radio and television

1. Drugs fully meeting the following conditions may be advertised on radio and television:

a/ Having main active ingredients on the list of active ingredients of drugs permitted for registration of advertising on radio and television;

b/ Having no active ingredients on the lists of addictive drugs, psychotropic drugs, pre-substances and radioactive drugs under current regulations;

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3. A drug advertisement must provide all information specified at Points a, b, c, f, i and j, Clause 2. Article 21 of this Circular. Information specified at Points a, b, c, f and j must be loudly and clearly read. For a drug with 3 or more active ingredients, to read the main active ingredient or generic names of vitamins, minerals and materia medica, depending on the broadcasting time.

4. A unit wishing to advertise drugs on a local radio or television station shall report such in writing to the provincial-level Health Department of the concerned locality, enclosed with the slip on receipt of the registration dossier of drug information provision and advertising of the Drug Administration of Vietnam and advertising contents or screenplay certified and stamped by the Drug Administration of Vietnam.

Article 23. Drug advertising on online newspapers and websites of enterprises and advertising service providers

1. Drug traders may only advertise their traded drugs on their lawfully set up websites and may not advertise drugs they are not trading in.

2. Drug traders or authorized units may only advertise drugs on websites of advertising service providers when these service providers possess Internet Content Provider (ICP) licenses granted by the Ministry of Information and Communications and advertising service business registration certificates under law.

3. Drugs shall be advertised on online newspapers and websites of enterprises and advertising service providers in a separate section which must clearly read "For drug advertising only" in bold letters with a font size bigger than the normal one. This phrase must constantly appear at the head of the section.

4. Contents of drug advertising on online newspapers and websites of enterprises and advertising service providers:

a/ Drug advertising on websites must comply with Clause 2, Article 21 of this Circular. Drugs must be advertised on websites separately without being included in or mixed with advertising of other drugs at the same time to avoid misunderstanding.

b/ Drug advertising on websites in a video clip must comply with Article 22 of this Circular.

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Article 24. Drug advertising on other advertising media

Units may only advertise drugs on other advertising media when these media can fully convey the information specified at Points a. b, c, f and j, Clause 2, Article 21 of this Circular and shall comply with relevant regulations.

Article 25. Indications banned from drug advertising

When advertising drugs, the following indications must not be included:

1. Treatment of tuberculosis and leprosy.

2. Treatment of sexually transmitted diseases.

3. Treatment of chronic insomnia.

4. Of aphrodisiac nature.

5. Treatment of cancers and tumors.

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Article 26. Drug display at exhibitions and fairs

1. Drugs with circulation registration numbers granted by the Ministry of Health may be displayed at fairs and exhibitions except addictive, psychotropic and radioactive drugs and presubtances for drug manufacture.

2. Drugs without circulation registration numbers granted by the Ministry of Health may be displayed at fairs and exhibitions only when they are granted drug import permits for display at exhibitions and fairs by the Ministry of Health (the Drug Administration of Vietnam).

Chapter III

DOSSIERS, ORDER AND PROCEDURES FOR RECEIPT OF DOSSIERS OF DRUG INFORMATION PROVISION AND ADVERTISING

Article 27. Agencies receiving and processing dossiers of drug information provision and advertising

1. The Ministry of Health (the Drug Administration of Vietnam) shall receive and process drug advertising registration dossiers and registration dossiers of drug information provision for medical workers.

2. Provincial-level Health Departments shall receive and process registration dossiers of drug introduction seminars for medical workers and grant cards to drug introducers.

Article 28. Dossiers, order and procedures for grant of drug introducer cards

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a/ An application for a drug introducer card (made according to a set form);

b/ Resume (certified by the applicant-managing agency or local administration);

c/ Valid copy of diploma under Point a. Clause 2. Article 11 of this Circular;

d/ Health certificate;

e/ List of products to be introduced by the applicant;

f/ Written commitment of the applicant on his/her conversance and compliance with relevant legal documents on pharmacy.

2. A dossier of application for a drug introducer card for holders of professional secondary degree comprises the papers specified in Clause I of this Article and the following:

a/ Certificate of drug introducer training granted by a training institution under the Ministry of Health's regulations:

b/ Certificate of the applicant's seniority of working at a lawful medical or pharmaceutical establishment for at least two years;

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a/ Employers of drug introducers shall submit dossiers under regulations to provincial-level Health Departments of localities where their headquarters or representative offices are based;

b/ Within 20 working days after receiving complete and valid dossiers, provincial-level Health Departments shall, based on these dossiers, grant drug introducer cards (made according to a set form). In case of refusal, they shall reply in writing clearly stating the reason.

4. A drug introducer card is valid for two years from the date of grant. To obtain new cards, employers of drug introducers shall submit dossiers again one month before the expiry of drug introducer cards.

5. Employers of drug introducers shall revoke and return drug introducer cards to card-granting provincial-level Health Departments in the following cases:

a/ Drug introducers work for other employers:

b/ Drug introducers are no longer tasked to introduce drugs;

c/ Drug introducer cards have expired.

6. Provincial-level Health Departments shall revoke drug introducer cards when drug introducers violate one of the provisions of Article 5 of this Circular.

7. When drug introducers operate in other provinces, their employers shall report in writing to provincial-level Health Departments of concerned localities on the time, places and work plans of drug introducers.

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1. Before holding a drug introduction seminar for medical workers of a locality, a unit shall submit a registration dossier to the Health Department of that locality. Such a dossier comprises:

a/ Registration form of a drug introduction seminar for medical workers (made according to a set form);

b/ (Tentative) venue and agenda of the seminar ;

c/ Contents of each report, names and scientific titles of rapporteurs;

d/ Documents planned for display and distribution at the seminar;

e/ Documents on drugs to be introduced at the seminar;

f/ Reference documents (if any).

2. All documents in a dossier must be appended with the dossier compiler's seal.

3. When receiving complete and valid dossiers under this Circular, provincial-level Health Departments shall give a dossier receipt slip (made according to a set form) to dossier submitting units. The date of the receipt slip is the date provincial-level Health Departments receive full and valid dossiers. Fifteen working days after provincial-level Health Departments receive dossiers, units may hold seminars according to registered contents if provincial-level Health Departments make no written request for modification and supplementation of dossiers.

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5. When a provincial-level Health Department makes a written request for a unit to modify and supplement a dossier:

a/ Its request must specify and detail documents to be added or contents to be modified or supplemented.

b/ The unit shall modify and supplement contents as requested and submit revised contents to the provincial-level Health Department. When the unit makes modifications and supplements as requested, the provincial-level Health Department shall give the unit a dossier receipt slip. The date of this slip is the date the provincial-level Health Department receives the supplemented dossier. Five working days alter the provincial-level Health Department receives revised contents of seminar registration, the unit may hold the seminar according to the revised contents if the provincial-level Health Department makes no written request for further modification and supplementation.

6. Units submitting seminar registration dossiers shall report in advance (for at least one day) on specific venues and times of seminars to provincial-level Health Departments receiving their dossiers.

Article 30. Dossiers, order and procedures for processing registration dossiers of drug information provision and advertising

1. Before providing information on and advertising drugs, units shall submit registration dossiers of drug information provision and advertising to the Ministry of Health (the Drug Administration of Vietnam).

2. Such a dossier comprises:

a/ Registration form for drug information provision and advertising (made according to a set form);

b/ Expected form, contents of drug information provision and advertising;

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d/ Copy of the use instructions insert already approved by the Drug Administration of Vietnam;

e/ Copy of the production circulation permit granted by the Drug Administration of Vietnam or the decision on drug registration number of the Drug Administration of Vietnam;

f/ Copy of the certificate of satisfaction of drug trading conditions or license for operation in Vietnam of foreign companies;

g/ For advertising on radio or television, screenplay and video or audio tape. The screenplay must clearly describe images, words and music;

3. All documents in the dossier must be appended with the dossier compiler's seal. For the documents specified at Points d. e and f, Clause 2 of this Article, only their copies appended with seal of drug information and advertisement registering units are required.

4. Planned drug information and advertisement and screenplays shall be submitted in two copies. After they are completed, one copy shall be kept at managing agencies and the other shall be certified and stamped by the Drug Administration of Vietnam and handed to the units registering drug information provision and advertising.

5. The Drug Administration of Vietnam will not consider registration of drug information provision and advertising irrelevant to drugs under this Circular.

6. When receiving complete and valid registration dossiers under this Circular, the Drug Administration of Vietnam shall send dossier submitting units a dossier receipt slip (made according to a set form). The date of this slip is the date the Drug Administration of Vietnam receives complete and valid dossiers. Fifteen working days after the date of the receipt slip, units may provide information on and advertise drugs according to registered contents if the Drug Administration of Vietnam make no written request for modification and supplementation of dossiers.

7. When registration dossiers of drug information provision and advertising are incomplete or invalid under this Circular, within 15 working days, the Drug Administration of Vietnam shall make a written request for registering units to modify and complete their dossiers.

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a/ Such request must specify and detail documents to be added or contents to be modified or supplemented.

b/ The unit shall modify and supplement contents as requested and submit revised drug information and advertisement to the Drug Administration of Vietnam. When the unit makes modifications and supplements as requested, the Drug Administration of Vietnam shall send the unit a dossier receipt slip. The date of this slip is the date the Drug Administration of Vietnam receives the revised dossier. Five working days after the Drug Administration of Vietnam receives revised drug information and advertisement contents, the unit may provide information on and advertise drugs according to the revised contents if the Drug Administration of Vietnam makes no written request for further modification and supplementation.

c/ Within 3 months after the Drug Administration of Vietnam makes a written request for supplementation and modification, if a drug information and advertisement registering unit fails to modify and supplement the dossier, such dossier is invalidated.

9. Order and procedures for registration and examination of dossiers of drug information provision and advertising eligible for dossier examination shall be carried out again in the following cases:

- Drug information providers or advertisers subject to dossier modification and supplementation fail to modify and supplement dossiers as requested.

- Drug information providers or advertisers have registered drug information and advertisement contents at the Drug Administration of Vietnam and obtained receipt slips, but fail to comply with Article 5 of this Circular.

In this case, the Drug Administration of Vietnam shall issue a notice to drug information and advertisement registering units disallowing them to provide information on and advertise drugs according to registered contents.

10. When units having registration dossiers of drug information provision and advertising fail to comply with Clause 14, Article 5 of this Circular, the Drug Administration of Vietnam shall issue written warnings to these units and stop receiving and examining their registration dossiers of drug information provision and advertising for between 3 and 12 months, specifically as follows:

a/ To stop receiving and examining for 3 months registration dossiers of drug information provision and advertising of units which fail to comply with Clause 14. Article 5 of this Circular.

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c/ To stop receiving and examining for between 6 and 12 months registration dossiers of drug information provision and advertising of units which fail to comply with this Circular three times or more in a year.

In addition to the above measures, the Drug Administration of Vietnam shall publish violations of violators on its website; and report such to inspection agencies and competent functional agencies for consideration and handling under law.

Article 31. Validity of drug information documents

Drug information documents already registered at the Drug Administration of Vietnam are invalidated in the following cases:

1. Drug registration numbers have expired.

2. Drug registration numbers are withdrawn or drugs are subject to limited use under recommendations by competent state management agencies.

3. There are changes in drug information.

Chapter IV

EXAMINATION, INSPECTION, AND HANDLING OF VIOLATIONS

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1. The Drug Administration of Vietnam and the Inspectorate of the Ministry of Health shall examine and inspect according to their competence the implementation of this Circular by units and individuals engaged in drug information provision and advertising in the Vietnamese territory.

2. Provincial-level Health Departments shall examine and inspect the implementation of this Circular within their localities.

Article 33. Handling of violations, complaints and denunciations

1. Violating units and individuals shall, depending on the severity of their violations, be administratively sanctioned or have their advertising stopped or have registration numbers of drugs with violation withdrawn or be examined for penal liability under law.

2. Units and individuals may lodge complaints and denunciations about drug information provision and advertising under the law on complaints and denunciations.

Chapter V

IMPLEMENTATION PROVISIONS

Article 34. Effect

This Circular takes effect 45 days from the date of its signing. To annul the Health Minister's Decision No. 2557/2002/QD-BYT of July 4, 2002, promulgating the Regulation on providing information on and advertising drugs for human use and cosmetics directly affecting human health; and the Minister of Health's Circular No. 12/2002/TT-BYT of August 23, 2002, guiding advertising of vaccines and immune biological preparations for human use.

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3. Units having registered dossiers of drug information provision and advertising and obtained receipt slips before the effective date of this Circular may provide information on and advertise drugs until drug information documents are invalidated.

4. The Drug Administration of Vietnam, the Ministry of Health-attached units, provincial-level Health Departments, Vietnam Pharmacy Corporation, pharmaceuticals manufacturers and traders, foreign companies licensed to operate in the pharmacy domain and concerned units and individuals shall implement this Circular.

5. In the course of implementation, any arising problems should be promptly reported to the Ministry of Health (the Drug Administration of Vietnam) for consideration and settlement.

FOR THE MINISTER OF HEALTH
DEPUTY MINISTER




Cao Minh Quang