Herbal medicinal product

Any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations [DIR 2001/83/EC Art 1(30)].

Herbal substances are all mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried, form, but sometimes fresh. Certain exudates that have not been subjected to a specific treatment are also considered to be herbal substances. Herbal substances are precisely defined by the plant part used and the botanical name according to the binominal system [DIR 2001/83/EC Art 1(31)].

Herbal preparations are preparations obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. These include comminuted or powered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates [DIR 2001/83/EC Art 1(32)].