Chương II Thông tư 13/2009/TT-BYT: Thông tin, quảng cáo thuốc

Chapter II

DRUG INFORMATION PROVISION AND ADVERTISING

Section 1. DRUG INFORMATION PROVISION

Article 6. General responsibilities for drug information provision

1. The Ministry of Health, provincial-level Health Departments, health agencies of branches and medical examination and treatment establishments (below referred to as health establishments) shall provide information on drugs and supervise harmful reactions of drugs and promptly notify such to prescribers and drug users to ensure proper, safe and effective use of drugs.

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.

3. Medical administrators and workers shall:

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

1. Through drug introducers.

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;

c/ Drug information not included in labels and use instruction inserts;

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.

b/ Having been trained by his/her employer;

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;

d/ To collect reports on harmful reactions of drugs and those related to drug quality for their employers to promptly sum up and report to the Ministry of Health (the Drug Administration of Vietnam) and the National Center for Drug Information and Control of Harmful Reactions of Drugs.

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.

3. Information on new inventions and discoveries through scientific researches or supervision of products on the market must be provided with updated scientific information enclosed with supporting materials. Such information must be accompanied with the disclaimer: "This information is for reference only."

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.

5. Dosage.

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:

1. Target users (related to age, health status, etc):

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.

Article 16. Drug introduction seminars for medical workers

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;

e/ Information and research results on:

- 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

1. Organizers or hosts of specialized health conferences or seminars wishing to display and introduce drugs at these conferences or seminars shall notify such in writing to provincial-level Health Departments of the localities where the conferences or seminars are to be held before they are held.

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.

Article 20. Forms of drug advertising

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.

2. Advertising of a drug on newspapers, magazines, leaflets, billboards, signs, panels, posters, banners, illuminative objects, aerial or underwater objects, means of transport and other movable objects must include the following information:

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;

h/ Notes on use of drug;

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;

2. The Minister of Health shall promulgate the list of active ingredients of drugs permitted for registration of advertising on radio and television. This list shall be updated for appropriate supplementation and amendment.

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.

5. Units having obtained slips on receipt of registration dossiers of drug information provision and advertising in the forms specified in Clauses 1, 2 and 3. Article 20 of this Circular may use approved advertising contents for advertising on websites in accordance with advertising contents registered with the Drug Administration of Vietnam.

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.

6. Treatment of diabetes or similar metabolic disorder diseases.

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).