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The Future of Herbal Medicinal Products: is there a need for scientific assessment? The Italian situation Anna Rita Bilia Department of Pharmaceutical Sciences, via Ugo Schiff, 6 50019 Sesto Fiorentino (FI) Italy ESCOP Symposium 18th June 2009 Cologne, Germany 20th Anniversary of the European Scientific Cooperative on Phytotherapy “Prodotto Erboristico” Herbal Medicinal Products FOODS COSMETICS Medical devices ESCOP Symposium 18th June 2009 Cologne, Germany 20th Anniversary of the European Scientific Cooperative on Phytotherapy 2 Food for special purposes Dir. 89/398/EEC Fortified Foods Reg. 1925/06 FOOD or FOOD INGREDIENT Reg. (EC) No. 178/2002 Functional Foods Reg. 1924/06 Food Supplements Directive 2002/46/EC 3 Novel foods Reg. (EC) No. 258/97 ESCOP Symposium 18th June 2009 Cologne, Germany 20th Anniversary of the European Scientific Cooperative on Phytotherapy LIST OF PLANTS CAN BE USED IN FOOD : http://www.ministerosalute.it/alimenti/resources/documenti/dietetica/ListaErbeNomeBotanicoaprile2009.pdf RESTRICTIONS: Dosages, age of patients, controindications, interactions Cimicifuga racemosa (Nota Min.Salute n. 600.12/I.5.i.h./4160 del 1 febbraio 2007) Citrus aurantium ssp. amara (Nota Min.Salute n. 600.12/AG45.1/2688 del 20 ottobre 1999) Ginkgo biloba (Nota Min.Salute n. 600/AG45.1/9113 del 21 novembre 2001) Hypericum perforatum (Nota Min.Salute n. 600/12/AG45.1/2688 come modificata dalle attuali Linee Guida del Ministero della Salute) Etc… LIST OF PLANTS CANNOT BE USED IN FOOD : http://www.ministerosalute.it/alimenti/resources/documenti/dietetica/elenco_di_piante_e_derivati_giugno2006.pdf Species no longer included Arnica Arnica montana All the plant parts Grindelia Grindelia camporum Leaf and flowering tops 4 LIST OF FOOD SUPPLEMENTS: http://www.ministerosalute.it/alimenti/resources/documenti/dietetica/prodotto_luglio2008.pdf ESCOP Symposium 18th June 2009 Cologne, Germany 20th Anniversary of the European Scientific Cooperative on Phytotherapy Herbal Medicinal Products registered by full or simplified registration procedures are automatically linked to pharmacy-only status. Traditional HMP Homeopathics HERBAL MEDICINAL PRODUCTS 1-over-the-counter drugs (OTC) available without special restrictions 2-prescription only medicine (POM), which must be prescribed by a licensed medical practitioner. 3- medicines which can only be sold in registered pharmacies, by or under the supervision of a pharmacist. HERBAL DRUG Hamamelidis aqua and folium Cardus fructus HERBAL MEDICINAL PRODUCT Derminiol Optrex Ananase Cerotto Bertelli Dolpyc Legalon Hyppocastani semen Ipecacuana New Fadem Nervaxon Proserem Quiens Remotive Flebostasin R PHARMACEUTICAL FORM (COMPANY) Cream (Marvecspharma Services) Eye drops and eye bath (Boots Healthcare) Tablets (Rottapharm) Plasters (Kelemata) Gel (Teofarma) Syrup, coated tablets, eff. granulate in packets (Madaus) Coated tablets (Germed Pliva Pharma) Capsules (Biohealth Pharmaceutical srl) Ointment (Pharbenia) Tablets (Pharbenia) Syrup (New Fadem) Coated tablets (Fidia Farmaceutici) Capsules (Arkofarm) Coated tablets (Marco Antonetto) Coated tablets (Aboca) Capsules (Daiiki Sankio Italia) Centella Silimarin Silmar Centellase Psilli semen Fibrolax Granulate in packets (Giuliani) OTC Myrtilli fructus Mirtilene forte Tegens Pigenil Falquilax Pursennid Tisana Kelemata Soft capsules (SIFI) Capsules and packets (Sanofi-Aventis) Soft capsules (Pharmaphar) Coated tablets (Falqui SpA) Coated tablets (Novartis) Coated tablets, granulate, tea bags, powered herbal drug (Kelemata srl) liquid preparation (Asta medica) Soft capsules (Pierre Fabre Pharma) Soft capsules (Cornelli Cons.) Soft capsules (Guidotti) Soft capsules (Lampugnani) Soft capsules (Lisapharma) PO OTC PO OTC OTC OTC OTC Ananas Capsicum Ipecac radix Hyperici herba Pygeum cortex Senna folium, senna fructus acutifoliae and senna fructus angustifoliae Serenoa repentis fructus Sterculia Valeriana radix Xprep Permixon Prosteren Rilaprost Saba Serpens Normacol Arkocapsule valeriana Ticalma Valeriana Alfa Valeriana Dispert Valeriana Farmades Medicine in packets (Norgine Italia) Capsules (Arkocapsule) Drug in packets and sugar coated pills (Kelemata) Coated tablets (Alfa Wasserman) Coated tablets (Solvay Pharma) Tablets (Farmades) CATEGORY No PO OTC PO OTC OTC PO PO PO OTC No PO PO PO PO PO PO No PO PO PO PO PO PO 6 OTC OTC OTC OTC OTC OTC HERBAL MEDICINAL PRODUCTS AS SINGLE COMPONENT MARKETED IN ITALY, SITUATION END 2008 FORMA FARMACEUTICA (COMPANY) HERBAL MEDICINAL PRODUCT (HERBAL DRUGS IN COMBINATIONS) Fitosonno (hawthorn, passionflower, willow) Lenicalm (hawthorn, asperula, tilia) Passiflorine (hawthorn, passionflower, willow) Biocalm (valerian, passionflower, mint) Dormiplant (valerian, melissa) Reve (valerian, passionflower) Capsules (Pharbenia) Tablets (Dolisos) Syrup (Teofarma) Drops (Lizofarm) Coated tablets (Marvecspharma Services) Capsules (Vaillant) (I.M.O.) OTC OTC OTC OTC OTC OTC Capsolin (capsicum, camphor, eucalyptus, trementina) Ointment (Warner Lambert) OTC Midro (caraway, senna, liquorice, mint) Amaro medicinale Giuliani (rhamnus, rheum, gentian, boldo) Confetti lassativi Giuliani C.M. (rhamnus, senna, boldo) Digelax (rhamnus, boldo, rheum, artichoke, cascarilla) Eparema (rhamnus, boldo, rheum) Eparema levul (rhamnus, boldo, rheum) Hepatos (rhamnus, boldo) Mepalax (rhamnus, boldo, rheum) Tamarine (rhamnus, senna) Fave di fuca (fucus, rhamnus, frangula) Agiolax (ispaghula, senna) Fibrolax complex (ispaghula, senna) Powder, drug in packets (Vaillant) Oral solution (Giuliani) OTC OTC Sugar coated pills (Giuliani) Syrup (Poli) (Pharmacia Italia) Sugar coated pills and syrup (Lab.Farm.S.I.T.) Syrup (Lab.Farm.S.I.T.) Syrup (Teofarma) Sugar coated pills and syrup (ABC Farmaceutici) Syrup and Jam (Serono) Sugar coated pills (Roche) (Pharbenia) Oral granulate (Madaus) Granulate in packets (Giuliani) OTC OTC OTC OTC OTC OTC OTC OTC OTC OTC Tussamag (chestnut, thyme) Syrup (Teofarma) OTC Soluzione Schoum (fumaria, ononidis, piscidia) Soluzione Schoum forte (fumaria, ononidis, piscidia) Solution (Rhone-Poulenc Rorer) (Sanofi-Aventis) Liquid preparation (Rhone-Poulenc Rorer) (SanofiAventis) Solution (Farmatre) Solution (Iema) Capsules (Marvecspharma Services) OTC OTC Gengivario (myrrh, ratania) Prostaplant (nettle, saw palmetto) CATEGORY 7 No PO No PO PO HERBAL MEDICINAL PRODUCTS IN COMBINATION MARKETED IN ITALY, SITUATION END 2008 TRADITIONAL HERBAL MEDICINAL PRODUCTS SUBMITTED TO EVALUATION IN ITALY SINGLE COMPONENTS St. John’s wort Devil’s claw Saw palmetto Coneflower Pelargonium sidoides DC. (Unckaloabo, South African geranium) COMBINATIONS 8 Rhodiola rosea L. St. John’s wort+passionflower+valerian (Golden root or roseroot) ESCOP Symposium 18th June 2009 Cologne, Germany 20th Anniversary of the European Scientific Cooperative on Phytotherapy CONCLUDING REMARKS -A few number of applications for registration of THMPs have been submitted to the Italian Ministry of Health: Coneflower, Devil’s Claw, and Saw Palmetto, Pelargonium sidoides, Rhodiola rosea and St. John’s wort and a combination of St. John’s wort plus passionflower and valerian. -Foods for specified health use hold the largest share of the whole Italian botanical market and the OTC and POM status plays a minor role, in contrast with the situation of the majority of the European countries -Italy has a list of admitted (positive list) and another list of herbals banned from food (negative list). There is also a list of notified herbal food supplement products. 9 ESCOP Symposium 18th June 2009 Cologne, Germany 20th Anniversary of the European Scientific Cooperative on Phytotherapy