- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Quality and Safety: Medicines > Regulatory Support
(1998; 49 pages) [French] [Spanish]
On 8 January 1981, a guideline was issued by the Italian Health Authority classifying herbal products as medicines or health food products respectively .
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 .