Kısaltmalar
CTD
Common
Technical Document
DHEA
Dihydroepiandrosteron
DSHEA
Dietary Supplement Health and Education Acts
EC
European Community
EEC
European Economic Community
EMEA
European Medicines Agency
EP
European Pharmacopoeia
ESCOP
European Scientific
Cooperative on Phytotherapy
EU
European Union
FDA
Federal Drug Administration
GACP
Good Agricultural and Collection Practice
GCP
Good Clinical Practice
GMP
Good Manufacturing Practice
HMPC
Committee
on Herbal Medicinal Products
HMPWP
Herbal Medicinal Products Working Party
ICDRA
International Conference on Drug Regulatory Authorities
ICH
International Conference on Harmaonization
OTC
Over-the-Counter Drugs
SPC
Summary of Product Characteristics
SR
Sustained
Release
TRIPS
Trade Related Intellectual Property Rights
WHO
World Health Organization
Kaynaklar
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Busse W. The significance of quality for efficacy and safety of herbal medicinal products. Drug Inform
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Chang HM, But PPH (Eds.). Pharmacology and Applications of Chinese Materia Medica, Vols. I and
II,
World Scientific, Philadelphia, 2001.
EMEA. Guideline on Specifications: Test Procedures and Acceptance Criteria for Herbal
Drugs,Herbal Drug Preparations and Herbal Medicinal Products/Traditional Herbal Medicinal Pro-
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Eudralex-The Rules Governing Medicinal Products in the European Union. http://ec.europa.eu/en-
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Gaedcke F, Steinhoff B. Herbal medicinal products, Medpharm Scientific Publishers, CRC Press, Stutt-
gart, 2003.
Guidelines for the Assessment of Herbal Medicines. Geneva, World Health Organization, 1991
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Bitkilerle Tedavi Sempozyumu
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inghamton, NY, 2004.
JSHM. Japanese Standards for Herbal Medicines, Yakuji Nippo, Tokyo,1993.
Keller K, Legal Requirements for the use of phytopharmaceutical drugs in the Federal Republic of Ger-
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Mosihuzzaman M, Choudhary MI,
Protocols on Safety, Efficacy, Standardization and Documentation
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Sezik, E., Yeşilada, E., V. Bitkisel İlaç Hammaddeleri Toplantısı Bildiri Kitabı, Sanem Matbaacılık, A.Ş.,
Ankara, 1987
Talbott S.M. A Guide to Understanding Dietary Supplements, The Haworth Press, Inc., Binghamton,
NY, 2003, pp. 1-47.
Vlietinck A, Pieters L, Apers S, Legal Requirements for the quality of herbal substances and herbal
preparations for the manufacturing of herbal medicinal products in the European Union, Planta Med.
2009; 75: 683-688.
WHO Pharmaceuticals Newsletter, No. 1, World Health Organization Press, Geneva, 2009.
WHO. WHO Monographs of Selected Medicinal Plants, Vol. 1, 2 World Health