The Regulation of Herbal Medicinal Products in Armenia
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The Regulation of Herbal Medicinal Products in Armenia
Entil Gabrielyon, MD, DSc Director
Elmira Amroyan, MD, DSc Professor and Head. The Pharmacological Committee Annet Zakaryan, PhD Senior Expert Gagik Grigoryan, PhD Head. The Inspection Department Drug and Medical Technologv Agency of Armenia, Yerevan, The Republic ofArmenia
Key Words Herbal medicinal products; Drug law; Regulatory status; Local market; Licensing
Correspondence Address Elmira Amroyan, MD, Dsc, 15 Moskovyan Street, 375001, Yerevan, Armenia. (e-mail: [email protected]).
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 ofArmenia. 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 $50,000to $60,000in sales volume. During the last decade, U local manufacturers of herbal medicinal products were licensed. The legislative basis for herbal medicinal products is the 1998Law 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 PharmaceuticalProducts
INTRODUCTION Armenian traditional medicine, with its rather long history, has a rich depository of drugs at its disposal, including many specimens of flora, fauna, and the inorganic world. In ancient times, the herbal drugs of the Armenian Highlands were especially well known. They were exported to many countries of the East and West and included in the worlds most ancient "pharmacopoeias." Ancient authors such as Herodotus (490-425 B.C.), Xenophon (430-354 B.C.), Strabo (64-24 B.C.), Tacitus (58-117 A.D.), and others often mentioned the herbal medications of Armenian flora in their descriptions (1). An Armenian physician and scientist of the fifteenth century Amirdovlat of Amasia (Amirdovlat Amasyaci),had his particular place within the well-known assembly of "Chief Doctors," that is, within the most able physicians of Armenian traditional medicine (Heratsi, Magistrus, Grigorus, and Ishokh). His work Needless for Ignoramus, in which more than 3500 drug herbals were described, was the peak of Armen-
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 medicinalplants. The tasks to be solved by the drug regulatory bodies are as follows: improving the control system for the quality of the herbal medicinalproducts of local manufacturers, which will make it possible to produce standardized and safe products; and improving legislation concerning the manufacturing and disfn'bution of herbal medicinalproducts in Armenia. It is also necessary to improve postmarketing efforts on Adverse Drug Reac
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