Download The Future of Herbal Medicinal Products: is there a need for

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
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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
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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
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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
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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
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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.
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ESCOP
Symposium
18th June 2009
Cologne, Germany
20th Anniversary of the European Scientific Cooperative on Phytotherapy