Herbal medicinal products in the European Union - AESGP

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ESCOP and WHO monographs ESCOP as well as WHO monographs may be used in many Member States as a summary of bibliographic data. Further clarification concerning the efficacy and safety documentation, e.g., from the EMEA Ad Hoc Working Group on Herbal Medicinal Products, is regarded as desirable by many regulatory authorities. Simplified proof of efficacy Beside the category of fully licensed herbal medicinal products, a range of national/traditional herbal medicinal products exists in many Member States. For these products, national authorities usually verify the safety and ensure a sufficient level of quality. For proof of efficacy, the level of requirements is sometimes adjusted to take into account the long-term experience and in a certain sense simplified. A specific simplified procedure exists in Austria, Belgium, France and Germany, and is proposed in Spain. The indications often refer to the traditional use of the product, and a specific statement “traditionally used in ...” is at present added to the indication claims in France and Germany. Further developed products 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 such products do not exist. Different requirements for proof of efficacy It has been demonstrated that different requirements exist for herbal medicinal products i n terms of proof of efficacy: 1. The option exists to provide simplified proof of efficacy in Austria, Belgium, Germany, France and (is proposed) in Spain. 2. The option exists to provide bibliographic proof of efficacy in almost all countries, although it is in practice sometimes unknown or difficult to provide, or can be only supportive of clinical data in Austria. 3. The option exists to provide full clinical proof in all countries except Denmark and Finland (which allow only bibliographic applications) and Luxembourg (unknown i n practice). Individual supply In many cases, herbal medicinal products (like other medicinal products) are made up and/or supplied to individual patients following a one-to-one consultation between patient and practitioner. A number of herbal medicinal products are magisterial formulas, which are prepared by the pharmacist. For magisterial formulas, a marketing authorisation is not needed according to Article 2.4 of Council Directive 65/65/EEC. A specific situation exists in the United Kingdom, where a practitioner – according to Section 12(1) of the Medicines Act – may supply products without a licence to a customer. Intermediate products Intermediate products of herbal origin intended for further processing by an authorised manufacturer or for the preparation of a magisterial or officinal formula do not fall under the definition of a medicinal product according to Council Directive 65/65/EEC, and are therefore not subject to marketing authorisation as such. Intermediate products of herbal origin are mostly handled like any other raw material used for the production of medicinal products, and are therefore regulated according to the applicable EC rules, e.g. on Good Manufacturing Practice. 2
Products from foreign countries The quality of imported medicinal plants and their preparations is assessed differently. Finished products are often treated as new chemical entities with full proof of quality, safety and efficacy being required. There are however in several cases no specific regulations concerning the control of raw materials or crude drugs, particularly not for those products that enter the market as foodstuffs or other products not controlled in the same way as medicinal products. Good Manufacturing Practice and quality control All Member States also apply the manufacturing requirements of Council Directive 75/319/EEC to herbal medicinal products. Starting materials of herbal medicinal products are in principle controlled in accordance with the European Pharmacopoeia in all Member States. Inspections concerning GMP are carried out in practically all Member States. Inspections in third countries are performed as well, but not by all Member States. Post marketing surveillance The adverse reaction reporting systems of the Member States also monitor herbal medicinal products insofar as they are authorised medicinal products. The effectiveness of existing pharmacovigilance systems can be demonstrated by several withdrawals of marketing authorisations for herbal medicinal products due to safety concerns in connection with certain plants. Consumer reports could give an improved picture of the spectrum of adverse reactions to herbal medicinal products. The degree of acceptance of reports obtained from consumers in the national pharmacovigilance systems varies from one country to another. Labelling Council Directive 92/27/EEC on labelling and leaflets has been implemented by all Member States. In principle, the national requirements on labelling also apply to herbal medicinal products insofar as they are authorised medicinal products. No specific problems seem to occur except in cases where there is no prior control of labels or where promotional material is included in the label. Advertising All Member States have implemented Council Directive 92/28/EEC on advertising into national law. This directive also covers herbal products as far as they are authorised as medicinal products. The specific problems encountered are particularly due to health products not licensed as medicines claiming “indications” which they are not allowed to claim. Distribution and retail sale Council Directive 92/25/EEC on the wholesale of medicinal products in principle applies to all medicinal products and therefore also to all authorised herbal medicinal products. The retail sale of herbal medicinal products is restricted to pharmacies in Belgium, France, Greece, Ireland, Italy, Luxembourg, Portugal and Spain. It is permitted in other outlets – at least for certain herbal medicinal products – in Austria, Denmark, Finland, Germany, the Netherlands, Sweden and the United Kingdom. Distance selling and teleshopping Both distance selling and teleshopping are not permitted for herbal medicinal products i n most countries. In several cases they are allowed under certain conditions. Herbal medicinal products in the single market Herbal medicinal products are regarded as medicinal products in more or less all Member States and therefore have – at least in theory – the option to obtain a marketing authorisation in the same way as all other medicinal products. There are however large differences in the legal systems of the Member States, in particular concerning: the classification of herbal products, the possibility to receive a marketing authorisation based on a full application, bibliographic application or simplified proof of efficacy; and retail distribution. Furthermore there are different traditions regarding the therapeutic use of medicinal plant preparations. 3
Page 1: Herbal medicinal products in the Eu
Page 4 and 5: VII.5 P OST M ARKETING S URVEILLANC
Page 8 and 9: For instance, Garlic (Allium sativu
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Page 24 and 25: Greece Herbal products that make th
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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
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Page 42 and 43: Denmark Bibliographic applications
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Page 48 and 49: France According to the French Medi
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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
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products. So-called “old” medic
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United Kingdom The major problem wi
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VII.6.4 Application of Council Dire
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Germany According to Section 18 Art
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Luxembourg Council Directive 92/25/
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Italy The sale of medicinal product
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Country Status of distance selling
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IX. LEGAL REQUIREMENTS AND THE ASSE
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and minerals may be recommended for
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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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