The Regulation of Dietary Supplements in the Republic of Armenia
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Drug hfonnariorr Jmnral. Vol. 36, pp. 889-897. 2001Printed in the USA. All rights reherved.
Copyright 0 2002 Drug Information Association Inc.
THE REGULATION OF DIETARY SUPPLEMENTS IN THE REPUBLIC OF ARMENIA EMII,GABRIELYAN, MD, DSc Ilirector, Drug and Medical Technology Agency of Armenia. Yerevan, The Republic of Armenia
ELMIRAAMROYAN,MD, DSc Professor. Head. The Pharmacological Committee. Drug and Medical Technology Agency of Armenia, Yerevan. The Republic of Armenia
ALEXANDER PANOSYAN, PHD, DSc Professor, Head. Guelbenkian Research Laboratory, Yerevan, The Republic of Armenia
ANNETZAKARYAN, PHD Senior Expert, Drug and Medical Technology Agency of Armenia, Yerevan. The Republic of Armenia
Sixty-one dietary supplements are currently registered in Armenia and interest in these products has been growing. In 1996, the Armeninn Drug and Medical Technology Agency of the Ministry of Heeilth adopted the “Resolution of Licensing of Dietary supplement Products. *’ This resolution is based upon the Drug Law of Armenia of 1998. which excludes from registration in Armenia any drugs that are detrimental to public health due to the uncontrolled sale of such prodircts and the lack of information about them. The I>rug and Medical Technology Agency created a product database with information about registered dietary supplenients ’ rnanufiicturers, ingredients, and claims. The resolution and the database demonstrate the Drug and Medical Technology Agency ’s dietury supplement expertise nnd evaluation criteria. The parameters for rejected dietury supplement applications are included and the requirements for dietary supplement labels are described. To prevent cididterated or counterfeit dietary supplements from being marketed in Arrnenici, special controls were introduced for some categories of dietar-y supplements (sedeitives, hypoglwernic supplements, tonics, and arthritis supplements). Key Words: Dietary supplements; Drug law; Regulatory status; Label; Licensing
INTRODUCTION
the Drug Law of 2002 as “products which, when taken into mouth, contain ‘dietary inDIETARY SUPPLEMENTS HAVE become gredients’ intended to supplement the diet.” more widespread worldwide in the last 10 to The “dietary ingredients” in these products 15 years. They appeared in Armenia in 1994. include vitamins, minerals, herbs or other The National Assembly of the Republic of botanicals, amino acids, and substances such Armenia defines “dietary supplements” in as enzymes, organ tissues, glandular ingredients, and metabolites. Dietary supplements can also be extracts or concentrates, and may Reprint address: Elmira Amroyan. MD. DSc. 15 Mosbe found in many forms, such as tablets, capkovyan s~..375001. Yerevan. Armenia (e-mail: elmira sules, liquids, or powders (1). Recently, herbal @phm.am). 889
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E. Gobrirlycin. E. Amrowrr, A. Pmnoswn. and A. ZukaTon
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dietary supplements, those consisting entirely of plants, were separated out from dietary supplements (23).
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