Herbal medicinal products in the European Union - AESGP

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Preparations from Indications St. John's Wort (herb) Slight transient depressive disorders Saw palmetto (fruit) Micturition disorders in benign prostate hyperplasia stages I and II Nettle (root) Micturition disorders in benign prostate hyperplasia stages I and II Hawthorn (flowering tops) Decreasing cardiac function (NYHA* stage II) Kava Kava (rhizome) Nervous tension, anxiety and restlessness Ginkgo biloba (leaf) Symptomatic treatment of disturbed performance in organic brain syndrome... * Classification according to New York Heart Association 60 Table 19: “Modern” herbal medicinal products in the German market Greece There are no “modern” products as such on the market. Ireland There are no “modern” products as such on the market. Italy There are highly processed extracts on the market which are standardised by their active principles and are considered by the Ministry of Health as “modern”. Examples are bilberry, silymarin, and laxatives (i.e., sennosides and cascarosides). Marketing authorisations for such products have usually been based on bibliographic applications. However, in the absence of a specific legal framework for plant-based medicinal products, it is not appropriate to ask whether such products should be considered as herbal or regular medicinal products. The Ministry of Health will follow any guidance from the European Commission or the EMEA Ad hoc Working Group on Herbal Medicinal Products that might bring some clarification. Luxembourg In light of the systematic mutual recognition of other Member States’ marketing authorisations in Luxembourg, it is supposed that such products exist on the market. The Netherlands For example, products from Cassia (Senna), Rhamnus frangula, Valeriana officinalis, Plantago ovata, Hamamelis virginiana, Ginkgo biloba, some of them also as combinations, were fully registered in 1996. A product containing Crataegus and a combination of Hamamelis virginiana and Aesculus hippocastanum are for the moment “licensed”, that means not (yet) fully registered. For example, Hypericum and garlic products were not registered as medicinal products even after assessment, and therefore these products tend not to be developed from their traditional use status. An application for Hypericum has not yet been submitted. One Ginkgo biloba extract was registered in 1996 after a full assessment. Several Valerianae, Senna and Psyllium products had been registered earlier as medicinal products. Portugal In cases of “modern” herbal medicinal products, full proof of quality, safety and efficacy is required like for any other medicinal product.
Spain For new indications and new dosage forms, a new application is required (whether or not it is a herbal medicinal product). In case of old products which are being further developed from their traditional use, the dossiers will be checked by the authorities. Sweden If any of the parameters (e.g., indication or content) do not have a long tradition, the indication may not contain the wording “Traditionally used for …”. If the herbal medicinal products are too highly processed (e.g., pure substances isolated from plant material), they are not classified as herbal medicinal products but rather as ordinary medicinal products. In that case, of course, the indication does not begin with the wording mentioned above. There is no general rule concerning the time-limit when “traditionally” is discussed. The MPA has been reluctant to set any specific time-limit. Instead, this has to be decided for each product on a case-by-case basis. United Kingdom — Hypericum: “depression” would be a new clinical indication. No product has been licensed yet. There are food supplements supplied with indications of anti-depressive effects but MCA is trying to stop this. — Gingko biloba: there have been some applications but the MCA has not agreed on delivering a marketing authorisation. This would be an NCE (New Chemical Entity) which would require a full application and would be assessed in the same way as a synthetic drug. — Crataegus: this would be an NCE. — Valerian: the United Kingdom was the Reference Member State in a Mutual Recognition Procedure for a Valerian-containing medicinal product. — Garlic: There are licensed garlic products for colds, flu, etc. There is no garlic product licensed for, e.g., cardiovascular usage. Numerous unlicensed food supplements claim cholesterol and heart benefits. A licence application would be considered as an abridged application. The problem with “new” indications is that they usually fail to satisfy requirements on efficacy. However, some valuable examples of the contrary are: — Isphagula husk, which is a bulk forming laxative but now has an indication for lowering cholesterol. It is available OTC — Evening primrose oil, which is widely sold as a food supplement but is also licensed for eczema and breast pain. — Peppermint oil, which is sold OTC for irritable bowel syndrome. Summary For herbal medicinal products which are further developed from their traditional use, e.g. further processed extracts and/or products with “high level” indications, a full licence is required in most cases, and efficacy has to be proven by clinical studies. In several countries however, such products do not exist. VII.2.10 Comparison of the Requirements for Proof of Efficacy in the Member States Country Simplified Proof Bibliographic proof Full clinical proof Austria Yes Only supportive Yes Belgium Yes (Yes) Yes Denmark N o Yes N o Finland N o Yes N o France Yes (Yes) Yes Germany Yes Yes Yes 61
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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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Page 16 and 17: Country National legislation Austri
Page 18 and 19: tinctures, coctions or any other ga
Page 20 and 21: There is for the time being no spec
Page 22 and 23: 18 Medicinal products (“Medicamen
Page 24 and 25: Greece Herbal products that make th
Page 26 and 27: 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 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 78 and 79: 74 • Mild diuretic effect • Mil
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
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Page 112 and 113: submit clinical studies and other s
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IX.1.4 Post-marketing surveillance
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materials that have well recognised
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The Department of Herbal Medicinal
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Ingredients Indications Senna fruit
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c ) Are distance selling and telesh
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e ) Are there “combination produc
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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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