Herbal medicinal products in the European Union - AESGP

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74 • Mild diuretic effect • Mild relaxing effect, sleep aid, temporary insomnia • Mild cardiac troubles • Intestinal flora stabiliser Table 21: Main indications for herbal medicinal products in Finland Echinacea purpurea , E. pallida , E. angustifolia (14) Ginkgo biloba (11) Crataegus oxycantha (9) Jecoris aselli oleum (8) Sabal serrulata (6) Melissae folium (5) Valerianae radix (4) Equiseti herba (4) Ginseng radix (4) Solidaginis herba (4) Strobuli lupuli (4) Taraxaci radix (4) Violae tricoloris herba (4) Anisi fructus (3) Betulae folium (3) Chrysanthemum parthenium (3) Equisethum arvense (3) Hyperici herba (3) Passiflorae herba (3) Ubidecarenonum (10) Natural bicarbonate (3) Magnesium hydroxide (2) Table 22: Main ingredients for herbal medicinal products in Finland (number of products)
France There are approximately 530 proprietary medicinal products containing only plant-based preparations. The major indications are: diet aids, laxatives, improving blood circulation and light sedatives. The major ingredients are Fucus, Orthosiphon, Plantago ovata, Senna, Aesculus hippocastanum, Vitis vinifera, Valeriana, Crataegus, Passiflora and others. Some older products that contain a combination of active chemicals and plant extracts are still on the market (e.g., cough syrup containing pholcodine and drosera extract). Germany About 800 herbal medicinal products have successfully completed review or been granted a new marketing authorisation. The most important preparations contain Crataegus sp., Hypericum perforatum, Ginkgo biloba, Valeriana officinalis, Senna, Matricaria chamomilla, Urtica dioica, Echinacea purpurea, Allium sativum, etc. About 3 700 old herbal medicinal products are still under review. The exact number of herbal medicinal products covered by standard marketing authorisations is not known as products that can be distributed outside pharmacy are not reported to the Federal Institute for Drugs and Medical Devices (BfArM). Greece 44 herbal medicinal products were authorised as of May 1998. These products were approved under the EC Directives as well as the specific regulation in the Ministerial Decree of 1994 [GR 1]. Examples include Senna and Ginseng products. Ireland No information available. Italy The estimation is that there are about 100 products on the market with about 180 marketing authorisations granted. See also the data from the Institute for Medical Statistics (IMS) 1996 [I 4-5]. Main indications are laxatives, sedatives, digestive products and cough and cold products. Most herbal products on the market are not registered as medicinal products. Luxembourg There is no information available from the Division of Pharmacy and Medicinal Products about the number of herbal medicinal products that have been authorised. In total, there are about 11 000 medicinal products on the market. The Netherlands The following examples were given by the Medicines Evaluation Board (MEB). Except Crataegutt and Hametum, these products are registered according to Council Directive 65/65/EEC. They all have indication claims. 75
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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
Page 28 and 29: the fight against charlatans, in pa
Page 30 and 31: United Kingdom Peppermint and camom
Page 32 and 33: 12(2) Those restrictions also do no
Page 34 and 35: Ireland Yes Normal procedure Italy
Page 36 and 37: 32 Country Applied Austria Yes Belg
Page 38 and 39: Germany In 1994, the Federal Instit
Page 40 and 41: Spain Registration requirements are
Page 42 and 43: Denmark Bibliographic applications
Page 44 and 45: Products referred to in Section 68,
Page 46 and 47: ibliographic registration dossier f
Page 48 and 49: France According to the French Medi
Page 50 and 51: VII.2.5 ESCOP and WHO Monographs an
Page 52 and 53: Germany • Commission E monographs
Page 54 and 55: 50 Flos Arnicae Flos Calendulae Fol
Page 56 and 57: According to the Agency Instruction
Page 58 and 59: 1978. The regulation is not specifi
Page 60 and 61: Indication Plants Medicinal plants
Page 62 and 63: vegetable or animal kingdom, bacter
Page 64 and 65: Preparations from Indications St. J
Page 66 and 67: Greece No Yes Yes Ireland N o (Yes)
Page 68 and 69: is justified. Certain combinations
Page 70 and 71: The MCA would follow the CPMP Guide
Page 72 and 73: Spain Magisterial and officinal pre
Page 74 and 75: Luxembourg The Division of Pharmacy
Page 76 and 77: Ireland The case has not been encou
Page 80 and 81: Product Active ingredient Bekunis S
Page 82 and 83: Senna - constipation Capsicum - mus
Page 84 and 85: Almost all countries perform GMP in
Page 86 and 87: Italy In the pharmacovigilance syst
Page 88 and 89: ecause of defective quality. There
Page 90 and 91: United Kingdom In early 1997, the M
Page 92 and 93: 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
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homeopathic products are regulated
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Finally, FDA suggested that the pri
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IX.3.5 Labelling and advertising of
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As mentioned under question 5.1, th
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Germany Dr Konstantin Keller Federa
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Yale University, New Haven, Connect
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[DK 3] Bekendtgørelse om mærkning
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[I 17] D.M. 16 aprile 1998 "Approva
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[CAN 5] Policy Issues: Indications
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XII. ANNEXES XII.1 List of Acronyms
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XII.2 List of Tables Table 1: Docum
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