Herbal medicinal products in the European Union - AESGP

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Country Status of distance selling Status of teleshopping Austria Not permitted Not permitted Belgium Not permitted Not permitted Denmark Allowed Allowed Finland Allowed for pharmacies Not permitted France Not permitted Not permitted Germany Allowed for non-pharmacy- Not permitted 102 bound products Greece Not permitted Not permitted Ireland Not permitted Not permitted Italy Not permitted Not permitted Luxembourg Not used Not used The Netherlands Allowed *1) Not used *1) Portugal Not permitted Not permitted Spain Not permitted Not permitted Sweden Allowed Allowed United Kingdom *2) *2) Table 29: Distance selling and teleshopping Notes: 1) The Netherlands: Some health insurers in the Netherlands have begun dispatching prescribed medication by mail. This has led to concern in pharmacy circles. One company (James Telesuper) sells OTCs by mail catalogue. This practice is legal because OTCs can officially be supplied by a druggist. Druggists are currently requesting the right to dispense prescribed OTCs. Teleshopping of non-prescription medicinal products is not found in the Netherlands. 2) United Kingdom: The Medicines Control Agency (MCA) is not aware of evidence of supply by teleshopping. It is aware of some supply of herbal medicinal products by mail order and is considering whether there is a need to clarify the legal position. Summary It can be concluded that both distance selling and teleshopping are not permitted for herbal medicinal products in most countries; in several cases however they are allowed under certain conditions.
VIII. CONCLUSIONS AND RECOMMENDATIONS Council Directive 65/65/EEC defines the basic criteria for medicinal products. Herbal preparations are considered as medicinal products if they meet the definition of this Directive. Herbal medicinal products can be found in all Member States of the European Union although the relative size of their markets varies considerably. According to Council Directive 65/65/EEC, herbal medicinal products – like all other medicinal products – need to obtain a marketing authorisation before they can be placed on the market. This guarantees a high level of consumer protection through the fact that proof of quality, safety and efficacy has to be provided. The Ad hoc Working Group on Herbal Medicinal Products established in 1997 at the European Agency for the Evaluation of Medicinal Products (EMEA) has carried out a comprehensive review of existing guidelines and updated/adapted them to the particular needs of herbal medicinal products. This work is highly appreciated by all parties involved because it helps to provide specific guidance in the assessment of the quality, safety and efficacy of herbal medicinal products. It is therefore recommended to strengthen the Ad hoc Working Group. This should help to further develop and update guidelines to clarify the situation for herbal medicinal products, with the final objective of allowing their free circulation throughout the European Union. This work should also include the verification of monographs proposed by the European Scientific Co-operative on Phytotherapy (ESCOP) and the World Health Organisation (WHO) in order to come to generally accepted European Summaries of Product Characteristics for widely used medicinal plants. To carry out this work, it would seem appropriate to endow the Ad hoc Working Group on Herbal Medicinal Products with an enlarged budget and an improved infrastructure. Consideration should also be given to turning the Ad Hoc Working Group into a committee with a permanent structure, and eventually into a Committee on Herbal Medicinal Products (CHMP) which would co-ordinate the assessment of herbal medicinal products within the EMEA and consequently for the European Union. Although herbal medicinal products are covered by the requirements of Council Directive 65/65/EEC, several EU Member States seem to face problems in applying identical rules to all medicinal products in a uniform manner. It is therefore recommended that some clarification of Council Directive 75/318/EEC be incorporated into the existing EC legislation on pharmaceuticals for those herbal medicinal products which are safe, of appropriate quality and whose indications are exclusively based on adequate proof of efficacy through documented traditional use. This might include the incorporation of a statement relating to this traditional use in the approved indication, e.g. in the form of a prefix. In this way, communication on such medicines would become identifiable, e.g. through the label/leaflet and through advertising. 103
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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
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 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 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 144 and 145: [CAN 5] Policy Issues: Indications
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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