Circular No. 13/2009/TT-BYT of September 01, 2009, guiding drug information provision and advertising
THE MINISTRY OF HEALTH
SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom – Happiness
Hanoi, September 01, 2009
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
Article 1. Scope of regulation and subjects of application
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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.
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