Chương I Thông tư 13/2009/TT-BYT: Những quy định chung

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation and subjects of application

1. Scope of regulation:

This Circular guides conditions on drug information provision and advertising; dossiers and procedures for registration of drug information provision and advertising; and inspection, examination, and handling of violations in drug information provision and advertising in Vietnam.

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.

6. Drug introducer means a staff member of a drug trader operating in the Vietnamese territory who is assigned by this trader to introduce drugs to medical workers.

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.

2. One form of drug information provision or advertisement corresponding to one registration dossier is subject to examination charges as follows:

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.

2. Providing information on and advertising cosmetics, functional foods and non-drug products with unclear contents which may lead to consumers' misunderstanding of those products as drugs.

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:

a/ This drug is number one or best of all; b/ Using this drug is the best method;

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.