Circular No. 42/2010/TT-BYT Issuing the List of Active Pharmaceutical Ingredients and Herbal Medicines for Advertising Registration on Radio and Television

CIRCULAR

Issuing the List of Active Ingredients of Medicines and Herbal Materials for Registration for Advertising on Radio and Television

and pharmaceuticals and medicinal herbs registered for advertising on radio and television

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Pursuant to Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to the Medicine Law No. 34/2005/QH11 dated June 14, 2005;

The Ministry of Health hereby issues and guides the implementation of the "List of Active Ingredients of Medicines and Herbal Materials for Registration for Advertising on Radio and Television" as follows:

Article 1. Attached herewith is the "List of Active Ingredients of Medicines and Herbal Materials for Registration for Advertising on Radio and Television," including:

1. List of active ingredients of medicines;

2. Provisions concerning herbal materials

Article 2. Interpretation of Terms

1. Active ingredient of medicine (also known as drug substance): Is a substance or mixture of substances with therapeutic activity used in the production of medicines.

2. Medicine derived from herbal materials : Is medicine produced from natural raw materials of animal, plant, or mineral origin.

Medicine containing purified active ingredients extracted from herbal materials, or medicine combining herbal materials with synthetic chemical active ingredients, shall not be considered as medicine derived from herbal materials.

Article 3. Principles for Establishing the List:

1. The List of Active Ingredients of Medicines and Herbal Materials for Registration for Advertising on Radio and Television is established based on the List of Over-the-Counter Medicines and specific criteria regarding pharmacological properties and safety of medicines.

2. The List of Active Ingredients of Medicines and Herbal Materials for Registration for Advertising on Radio and Television must be consistent with the actual use and supply of medicines in Vietnam and harmonize with current regulations on drug advertising information.

3. The List of Active Ingredients of Medicines and Herbal Materials for Registration for Advertising on Radio and Television will be amended and supplemented to align with the List of Over-the-Counter Medicines when there are changes in the List of Prescription Medicines. In cases where necessary, to ensure user safety, certain types of medicines may be removed from the List of Active Ingredients of Medicines for Registration for Advertising on Radio and Television if serious adverse effects are discovered.

Article 4. Criteria for Selecting Active Ingredients of Medicines:

1. Included in the List of Over-the-Counter Medicines issued by the Ministry of Health that remains valid.

2. Active ingredients of medicines meet the criteria of the List of Over-the-Counter Medicines but will not be selected if they have at least one of the following characteristics:

- For external use, local action, but with an uncontrolled risk of absorption through the skin.

- Indicated for the treatment of common diseases but these diseases have symptoms easily confused with those requiring medical examination.

- Requires strict adherence to dosage regimen/treatment schedule/time, otherwise antibiotic resistance may occur.

- Safe for short-term use but may pose risks if used long-term.

Article 5. Application of the List

The List of Active Ingredients of Medicines and Herbal Materials for Advertising on Radio and Television is one of the legal bases for registering and reviewing applications for advertising medicines on radio and television.

Article 6. Implementation Provisions

1. This Circular takes effect 45 days from the date of issuance. The Decision No. 45/2007/QĐ-BYT dated December 18, 2007 of the Minister of Health on issuing the List of Active Ingredients of Medicines and Herbal Materials for Registration for Advertising on Radio and Television is hereby repealed.

2. Contents of advertisements for medicines already accepted for registration for advertising by the Drug Administration before this Circular takes effect may continue to be advertised until the advertisement content expires.

3. The Drug Administration, units under the Ministry of Health, Provincial Departments of Health, Vietnam Pharmaceutical Corporation, pharmaceutical manufacturing and trading enterprises, foreign companies licensed to operate in the pharmaceutical sector are responsible for implementing this Circular.

4. During the implementation process, if there are any difficulties, organizations and individuals are requested to promptly report to the Ministry of Health (Drug Administration) for consideration and resolution./.