The Regulation of Herbal Medicinal Products in Armenia

Abstract

Herbal medicinal products have been licensed in Armenia since 1992, through the Drug and Medical Technology Agency of the Ministry of Health of the Republic of Armenia. To date, 112 herbal medicinal products have been registered. Of all the nonprescription drugs in the Armenian pharmaceutical market, 23% consist of herbal medicinal products which, according to 2001 data, represent $50,000 to $60,000 in sales volume. During the last decade, 15 local manufacturers of herbal medicinal products were licensed.

The legislative basis for herbal medicinal products is the 1998 Law of the Republic of Armenia on Drugs. The basic authorization for herbal medicinal products in Armenia is the Republic of Armenia's decision On the State Registration Procedure of Pharmaceutical Products and Payments for Their State Expertise of April 25, 2001. The experts of the Drug and Medical Technology Agency of the Ministry of Health of the Republic of Armenia published The Armenian National Formulary for Medicinal Plants and they are preparing to publish a list of essential medicinal plants.

The tasks to be solved by the drug regulatory bodies are as follows: improving the control system for the quality of the herbal medicinal products of local manufacturers, which will make it possible to produce standardized and safe products; and improving legislation concerning the manufacturing and distribution of herbal medicinal products in Armenia. It is also necessary to improve postmarketing efforts on Adverse Drug Reactions monitoring, including for herbal medicinal products.

Keywords

Herbal medicinal products Drug law Regulatory status Local market Licensing

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