Regulatory Situation of Herbal Medicines - A Worldwide Review
(1998; 49 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentFOREWORD
Open this folder and view contentsI. INTRODUCTION
Open this folder and view contentsAfrica
Open this folder and view contentsThe Americas
Open this folder and view contentsEastern Mediterranean
Close this folderEurope
View the documentGeneral aspects
View the documentAttempts to Meet the Need for Harmonization
View the documentAustria
View the documentBelgium
View the documentBulgaria
View the documentDenmark
View the documentEstonia
View the documentFinland
View the documentFrance
View the documentGermany
View the documentGreece
View the documentHungary
View the documentIceland
View the documentIreland
View the documentItaly
View the documentNetherlands
View the documentNorway
View the documentPortugal
View the documentSpain
View the documentSweden
View the documentSwitzerland
View the documentTurkey
View the documentUnited Kingdom
Open this folder and view contentsSouth East Asia
Open this folder and view contentsWestern Pacific
View the documentIII. CONCLUSION
View the documentIV. REFERENCES


On 8 January 1981, a guideline was issued by the Italian Health Authority classifying herbal products as medicines or health food products respectively [83].

The first type of herbal product covers plants traditionally used as food or flavour. They serve for nutritional purposes and are not allowed to claim therapeutic indications. They are classified as dietetic products and do not need an approval, but the authority has to be notified of the label. These products are allowed to be sold outside pharmacies, in so-called "erboristerias" which are also regulated in this guideline. The responsible person for the "erboristeria", the "erborista", is not allowed to give recommendations on the use of herbal products. The "erborista" can sell herbal products which are not pharmacy-bound, but is not allowed to prepare mixtures of these products.

Herbal products that make therapeutic claims, that have a particular pharmacological activity or that might be toxic, are considered as medicines and are only allowed to be sold through pharmacies. Mixtures of herbs, such as herbal teas or similar preparations, with a brand name and/or therapeutic indications have to be registered as medicinal products. They are only allowed to be sold by a pharmacist in a pharmacy. The "erborista" is not allowed to sell medicinal plants for therapeutic purposes, whereas the pharmacist is allowed to prepare and to sell mixtures of medicinal plants to the public.

The guideline contains two annex lists, one for medicinal plants which may only be sold in pharmacies, and a second list of plants that may be sold outside pharmacies.

When registered as a medicine, a herbal product needs a leaflet which gives information on indication claims, risk, dosage, etc. According to this guideline, the application dossier must contain a technical-analytical documentation. With respect to the pharmacological, toxicological, and clinical documentation, a bibliographic application in accordance with the Directive 65/65/EEC is possible [83].

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