Herbal medicinal products in the European Union - AESGP

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12(2) Those restrictions also do not apply to the sale, supply, manufacture or assembly of any herbal remedy where the process to which the plant or plants are subjected in producing the remedy consists only of drying, crushing or comminuting, and the remedy is, or is to be, sold or supplied. (a) under a designation which only specifies the plant or plants and the process and does not apply any other name to the remedy, and (b) without any written recommendation (whether by means of a labelled container or package or a leaflet or in any other way) as to the use of the remedy. Sections 7 and 8 of the Medicines Act relate to the requirement to hold licences for the sale, supply and manufacture of, and wholesale dealing in, medicinal products. The Medicines Order 1971 [UK 4], as amended, sets out exclusions from some of the requirements of Section 7 of the Medicines Act where: (i) the product is sold or supplied to, among others, a person, in the course of whose business herbal remedies are sold, where that medicinal product being a herbal remedy is to be sold or supplied in circumstances to which Section 12(1)(b) of the Act relates, Provided that (ii) no advertisement is made for it, and sale or supply is in response to an unsolicited order; (iii) manufacture/assembly is under the supervision of staff qualified to ensure the product is of the character/specification required by the person at (i); (iv) written records to manufacture and sale are kept; (v) a manufacturers licence is held. The categories of products above are medicinal products but exempt from marketing authorisation if they fulfil the requirements above. The two exemptions are specifically intended to allow herbalists to continue to make up tailored herbal remedies and for suppliers of basic unprocessed herbal products through any retail outlet to continue to do so. Summary In Ireland, Spain and the United Kingdom, there are preparations defined as medicinal products which are exempt from licensing under specific conditions. VII.1.5 Combinations of Herbs and Combinations with Other Groups of Substances Questions were asked as to whether there are “combination products” on the market including combinations of herbal ingredients with homeopathics and food supplements such as vitamins, etc. Inquiries were also made as to how authorities assess these products. For the assessment of criteria for combinations of herbs, see point VII.3.1. 28
Country Combinations of herbal ingredients in the market Combinations of herbal ingredients with homeopathics in the market Assessment of combinations with homeopathics Austria Yes Yes Full application, Section 13 Belgium Yes No Not allowed Denmark Yes - - Finland Yes Yes Homeopathic product as non-active ingredient France Yes No Not allowed Germany Yes Yes These are “old” products (a new application would be refused) Greece Yes No Not allowed Ireland Yes Yes Full application Italy Yes No Not allowed *1) Luxembourg - No - The Netherlands Yes Yes Normal procedure *2) Portugal Yes - - Spain Yes - - Sweden Yes - - United Kingdom Yes - - Table 4: Combinations of herbal ingredients and combinations of herbal and homeopathic ingredients Notes: 1) Italy: The Italian legislation on homeopathy began with Legislative Decree (“Decreto legislativo”) 17 March 1995 No. 185 (G.U. 117 of 22 May 1995) [I 9] and was modified by Law (“Legge”) 8 October 1997 No. 347 (G.U. No. 241 of 15 October 1997) [I 10]. It reproduces the exact terms of Council Directive 92/73/EEC and does not consider this type of combination. 2) The Netherlands: There are various combination products on the market. They fall into the category of foodstuffs and are therefore not assessed by any authority as long as they do not make medicinal claims. There are, however, several products on the market which do not yet fulfil the requirements of a full marketing authorisation while they are in the review process. Combinations with homeopathics seem to pose a major problem. With the implementation of Council Directive 92/73/EEC by the Homeopathic Act, any medicinal product containing homoeopathically prepared substances falls under this Homeopathic Act and may not contain any substance that is not manufactured according to a homeopathic pharmacopoeia. Therefore, combinations with homeopathic ingredients must be approved prior to marketing. There are “old” products on the market that are neither fully registered nor purely herbal medicinal products but that are partly old homeopathic preparations or mixtures. Country Combination with vitamins in the market Assessment Austria Yes Full application, Section 13 Belgium Yes *1) Denmark Yes Pharmaceutical specialties Finland Yes *2) Vitamin as non-active ingredient France Yes *3) - Germany Yes *4) Justification needed Greece - - 29
Page 1: Herbal medicinal products in the Eu
Page 4 and 5: VII.5 P OST M ARKETING S URVEILLANC
Page 6 and 7: ESCOP and WHO monographs ESCOP as w
Page 8 and 9: For instance, Garlic (Allium sativu
Page 10 and 11: delineated in Council Directive 75/
Page 12 and 13: V. ATTEMPTS TO HARMONISE SCIENTIFIC
Page 14 and 15: and Member States recommend that bo
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 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 78 and 79: 74 • Mild diuretic effect • Mil
Page 80 and 81: 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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