Quyết định 45/2007/QĐ-BYT của Bộ Y tế về việc ban hành Danh mục hoạt chất thuốc được đăng ký quảng cáo trên truyền thanh, truyền hình

DECISION

PROMULGATING THE LIST OF ACTIVE INGREDIENTS OF MEDICINES PERMITTED TO BE REGISTERED FOR RADIO AND TELEVISION ADVERTISEMENT

THE MINISTER OF HEALTH

Pursuant to the Law on Pharmacy of June 14, 2005;

Pursuant to November 16, 2001 Ordinance No. 39/2001/PL-UBTVQH-10 on Advertisement of the National Assembly Standing Committee;

Pursuant to the Governments Decree No. 59/2002/ND-CP of June 4, 2002, cancelling a number of permits and licenses and replacing some others with other management forms;

Pursuant to the Governments Decree No. 24/2003/ND-CP of March 13, 2003, detailing the implementation of the Ordinance on Advertisement;

Pursuant to the Governments Decree No. 49/2003/ND-CP of May 15, 2003, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to Joint Circular No. 01/2004/TTLT-BVHTT-BYT of January 12, 2004, of the Ministry of Culture and Information and the Ministry of Health, guiding advertising activities in the domain of health;

At the proposal of the director of the Drug Administration of Vietnam,

DECIDES:

Article 1. To promulgate together with this Decision the List of active ingredients of medicines permitted to be registered for radio and television advertisement.

Article 2. This Decision takes effect 15 days after its publication in CONG BAO and replaces the Minister of Healths Decision No. 815/2003/QD-BYT of March 12, 2003, promulgating the List of active ingredients of medicines permitted to be registered for radio and television advertisement.

Article 3. The director of the Office and the chief inspector of the Ministry of Health, the director of the Drug Administration of Vietnam, the director of the Therapy Department, the directors of the Traditional Medicine Department and concerned Departments and Bureaus, the heads of units under the Ministry of Health, directors of provincial/ municipal Health Services, heads of healthcare sections of branches, and domestic and foreign organizations and individuals engaged in advertising medicines on radio and television in Vietnam shall implement this Decision.

LIST OF ACTIVE INGREDIENTS
OF MEDICINES PERMITTED TO BE REGISTERED FOR RADIO AND TELEVISION ADVERTISEMENT
(Promulgated together with the Minister of Healths Decision No. 45/2007/QD-BYT of December 18, 2007)

I. PRINCIPLES FOR SELECTION AND CONSIDERATION

1. List of active ingredients

Principles for selection of active ingredients of medicines to be permitted for registration for radio and television advertisement include:

1.1. They are on the list of medicines with valid registration numbers for circulation in Vietnam.

1.2. They can be taken orally or applied on skin, in the form of ear, eye or nasal drops or suppositories, taken and held in the mouth or administered through sprayers or inhalers.

1.3. They are indicated for treatment of common diseases and can be taken by patients for self-treatment without medical examination, consultation and surveillance by medical doctors.

1.4. They do not fall into medicine groups requiring prescriptions specified in the current Regulation on medicine prescription and sale of prescribed medicines.

1.5. They have no known severe harmful effects (i.e., harmful effects that may cause death or danger to life of patients, worsen the illness situation to the extent that patients are hospitalized or undergo a prolonged treatment, cause permanent or severe disabilities, or inborn deformities in patients children and similar consequences) and/or have these effects cautioned.

2. Medicines having two or more active ingredients, traditional medications and medicines prepared from materia medica

Medicines having two or more active ingredients, traditional medicines and medicines prepared from materia medica may be considered to be permitted for registration for radio and television advertisement when they fully satisfy the following conditions:

2.1. For medicines having two or more active ingredients:

- Having valid registration numbers for circulation in Vietnam.

- Having in their ingredients at least one active ingredient that produces their principal effects and is on the list of active ingredients of medicines permitted for registration for radio and television advertisement.

- Being on lists of over-the-counter (OTC) medicines of countries of origin (countries that manufacture finished medicines and/or ex-workshop medicine lots or where medicine products are transported before arriving at the importing country), for imported medicines.

- Having their ingredients proved to be on the lists of OTC medicines published in the countries where these ingredients originate, for domestically manufactured medicines.

- Being not novel medicines under the Law on Pharmacy.

2.2. For traditional medicines and medicines prepared from materia medica:

- Having valid registration numbers for circulation in Vietnam.

- Being indicated for treatment of common diseases and use by patients for self-treatment without medical examination, consultation and surveillance by medical doctors.

- Containing no highly toxic materia medica ingredients.

- Having no known severe harmful effects and/or having these effects cautioned.