Herbal medicinal products in the European Union - AESGP

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[CAN 5] Policy Issues: Indications for Use – Multi-ingredient Low Dilution Homeopathic Preparations, Bureau of Programme, March 1997. Pharmaceutical Assessment, Therapeutic Products [CAN 6] Guideline for Low Dilution Multi-ingredient – Homeopathic Products with Indications for Use, Bureau of Pharmaceutical Assessment, Therapeutic Products Programme, March 1997. [CAN 7] Good Manufacturing Practices, Supplementary Guidelines for the Manufacture of Herbal Medicinal Products, Final Version, Drugs Directorate, Canada, 1996. (1998 version to be available in the near future.) [CAN 8] Policy Issues: Herbs Used as Non-medicinal Ingredients in Nonprescription Drugs for Human Use, Bureau of Nonprescription Drugs, The Drugs Directorate, Health Canada, September 1995. [MEX 1] Bylaws of the General Health Law, 4 February 1998. [MEX 2] Labeling Norm for Medicinal Products. [USA 1] Dietary Supplement Health and Education Act. 1994. Public Law 103-417. [USA 2] Office the Federal Register. 1997. Code of Federal Regulations. Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded, and for establishing monographs. Title 21: Food and drugs, part 330.10 rev. Washington, DC: U.S. Government Printing Office. [USA 3] Office of the Federal Register. 1997. Code of Federal Regulations. Adequate and well-controlled studies. Title 21: Food and drugs, part 314.126 rev. Washington, DC: U.S. Government Printing Office. [USA 4] Federal Register. May 11, 1972. 37:9464. [USA 5] Commission on Dietary Supplement Labels. 1997. Report on the Commission on Dietary Supplement Labels. [USA 6] Quote from Prevention Magazine survey. 1997. In: HerbalGram 40. [USA 7] Tom Simone citing data from Information Resources Inc., Chicago. In: [USA 8] Drugstores largest mass-market channel for supplement sales, Natural Business, March 1998. Richman, A. and J.P. Witkowski. 1997. Whole Foods, October. In: Herbalgram 41:53. [USA 9] Office of the Federal Register. 1997. Code of Federal Regulations. Current good manufacturing practice in manufacturing, packing or holding human food. Title 21: Food and drugs, part 110 rev. Washington, DC: U.S. Government Printing Office. [USA 10] Keller, K. 1992. Results of the revision of herbal drugs in the Federal Republic of Germany with a special focus on risk aspects. Zeitschrift für Phytotherapie 116:118. [USA 11] Henry A. Waxman in Hearing of the Subcommittee on Health and [USA 12] Environment, Committee on Energy and Commerce, House of Representatives, 29 July 1993. Tyler, Varro. 1997. When will there come a savior? HerbalGram 41:27-28. [USA 13] Nutrition Labeling and Education Act. 1990. Public Law 101-535. [USA 14] Food and Drug Administration Modernization Act of 1997. Public Law 105-115. [USA 15] Foster, S. ed. 1992. Herbs of Commerce. American Herbal Products Association, Bethesda, MD. [USA 16] Federal Trade Commission Act, 5 U.S.C. 45. [USA 17] Federal Trade Commission. 1994. Enforcement policy statement on food advertising. Federal Register 59:28388-28396. 140
[USA 18] Federal Trade Commission. 1983. Advertising substantiation program; request for comment. Policy statement regarding advertising substantiation. Federal Register 48:10471-10475. 141
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Herbal medicinal products in the Eu
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VII.5 P OST M ARKETING S URVEILLANC
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ESCOP and WHO monographs ESCOP as w
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For instance, Garlic (Allium sativu
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delineated in Council Directive 75/
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V. ATTEMPTS TO HARMONISE SCIENTIFIC
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and Member States recommend that bo
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Country National legislation Austri
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tinctures, coctions or any other ga
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There is for the time being no spec
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18 Medicinal products (“Medicamen
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Greece Herbal products that make th
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advertisements and the form (tablet
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the fight against charlatans, in pa
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United Kingdom Peppermint and camom
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12(2) Those restrictions also do no
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Ireland Yes Normal procedure Italy
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32 Country Applied Austria Yes Belg
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Germany In 1994, the Federal Instit
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Spain Registration requirements are
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Denmark Bibliographic applications
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Products referred to in Section 68,
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ibliographic registration dossier f
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France According to the French Medi
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VII.2.5 ESCOP and WHO Monographs an
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Germany • Commission E monographs
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50 Flos Arnicae Flos Calendulae Fol
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According to the Agency Instruction
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1978. The regulation is not specifi
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Indication Plants Medicinal plants
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vegetable or animal kingdom, bacter
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Preparations from Indications St. J
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Greece No Yes Yes Ireland N o (Yes)
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is justified. Certain combinations
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The MCA would follow the CPMP Guide
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Spain Magisterial and officinal pre
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Luxembourg The Division of Pharmacy
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Ireland The case has not been encou
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74 • Mild diuretic effect • Mil
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Product Active ingredient Bekunis S
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Senna - constipation Capsicum - mus
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Almost all countries perform GMP in
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Italy In the pharmacovigilance syst
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ecause of defective quality. There
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United Kingdom In early 1997, the M
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Country National legislation Remark
Page 94 and 95: products. So-called “old” medic
Page 96 and 97: United Kingdom The major problem wi
Page 98 and 99: VII.6.4 Application of Council Dire
Page 100 and 101: Germany According to Section 18 Art
Page 102 and 103: Luxembourg Council Directive 92/25/
Page 104 and 105: Italy The sale of medicinal product
Page 106 and 107: Country Status of distance selling
Page 108 and 109: IX. LEGAL REQUIREMENTS AND THE ASSE
Page 110 and 111: and minerals may be recommended for
Page 112 and 113: submit clinical studies and other s
Page 114 and 115: IX.1.4 Post-marketing surveillance
Page 116 and 117: materials that have well recognised
Page 118 and 119: The Department of Herbal Medicinal
Page 120 and 121: Ingredients Indications Senna fruit
Page 122 and 123: c ) Are distance selling and telesh
Page 124 and 125: e ) Are there “combination produc
Page 126 and 127: Section 4 of the Dietary Supplement
Page 128 and 129: homeopathic products are regulated
Page 130 and 131: Finally, FDA suggested that the pri
Page 132 and 133: IX.3.5 Labelling and advertising of
Page 134 and 135: As mentioned under question 5.1, th
Page 136 and 137: Germany Dr Konstantin Keller Federa
Page 138 and 139: Yale University, New Haven, Connect
Page 140 and 141: [DK 3] Bekendtgørelse om mærkning
Page 142 and 143: [I 17] D.M. 16 aprile 1998 "Approva
Page 146 and 147: XII. ANNEXES XII.1 List of Acronyms
Page 148 and 149: XII.2 List of Tables Table 1: Docum
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Herbal medicinal products in the European Union - AESGP

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