Circular No. 42/2010/TT-BYT dated December 15, 2010 of the Ministry of Health promulgating the list of pharmaceutical active substances and medicinal herbs permitted to be registered for advertisement on radio and television

CIRCULAR

PROMULGATING THE LIST OF PHARMACEUTICAL ACTIVE SUBSTANCES AND MEDICINAL HERBS PERMITTED TO BE REGISTERED FOR ADVERTISEMENT ON RADIO AND TELEVISION

Pursuant to the Decree No. 188/2007/ND-CP dated December 27, 2007 of Government regulating functions, tasks, powers and organizational structure of Ministry of Health;
Pursuant to the Pharmacy Law No. 34/2005/QH11 dated June 14, 2005;
The Ministry of Health issues and guides to implement “The list of pharmaceutical active substances and medicinal herbs permitted to be registered for advertisement on radio and television” as follows:

Article 1.Issue together with this Circular “The list of pharmaceutical active substances and medicinal herbs permitted to be registered for advertisement on radio and television, including:

1. The List of pharmaceutical active substances;

2. Regulations for medicinal herbs

Article 2. Interpretation of terms

1.Pharmaceutical active substances(also known as drugs) means: a substance or a mixture of substances which is active in treatment used for drug production

2. Drugs derived from medicinal plants mean: drug is produced from raw materials derived from nature of animal, vegetable or mineral.

Drugs with pure active substances extracted from medicinal herbs, drugs with combination of medicinal herbs and synthetic chemical active substances are not called drugs from medicinal herbs

Article 3. The principle to set up list:

1. List of pharmaceutical active substances and medicinal herbs permitted to be registered for advertisement on radio and television is set up on basis of no prescription drug list and specific criterions on pharmacological properties and safety of drug.

2. List of pharmaceutical active substances and medicinal herbs permitted to be registered for advertising on radio and television in accordance with actual of Vietnam s drug using, supplying and consistent with regulations on current drug advertisement information.

3. List of pharmaceutical active substances and medicinal herbs permitted to be registered for advertising on radio and television will be amended and supplemented in accordance with list of no-prescription in case where list of prescription is changed. When it is necessary, to ensure safety for user, some drugs that can be removed from list of active substances and medicinal herbs permitted to be registered for advertising on radio and television if there are detected seriously harmful effects.

Article 4. Selective criteria for pharmaceutical active substances

1. On the list of drugs without writing a prescription issued by the Ministry of Health are still valid.

2. Pharmaceutical active substance meets criteria of list of drugs without writing a prescription but it will not be selected if it includes at least one of the following characteristics:

- Topical, stay-in effect but are likely not control the amount of drug absorbed through skin.

- Appointed in treatment of common diseases, but these diseases include symptoms that easily confused with disease need to be a doctor’s visit.

- Having using dose / regimen / duration should be strictly obeyed if not, shall happen status of drug resistance.

-Safe to use short term but may be at risk in case of prolonged use.

Article 5. Application to list

List of pharmaceutical active substances and medicinal herbs permitted to be advertised on radio and television is one of the legal bases for registration, consideration of drug advertising dossier on radio and television.

Article 6. Provisions for implementation

1. This Circular takes effect 45 days after date of its signing. To annul the Decision No. 45/2007/QD-BYT of December 18, 2007 of the Minister of Health on promulgating list of pharmaceutical active elements and drugs registered for advertising on radio and television.

2. The content of drug advertisement on radio and television that had the receipt of advertisement registration dossier by the Department of Drug Administration before the effective date of this Circular will be continued advertising until the content of that drug advertisement unvalued.

3. Department of Drug Administration, units under the Ministry of Health, Departments of Health of provinces and cities directly under Central Government, Vietnam Pharmaceutical Corporation, pharmaceutical business-manufacturing enterprises, foreign company licensed activities in line of pharmacy is responsible for implementation of this Circular.

4. In the process of implementation, if problems arising to propose organizations and individuals to promptly inform to the Ministry of Health (Department of Drug Administration) for consideration and settlement. /.