Herbal Medicinal Products and Patients' Needs in Europe

Identical or very similar herbal products with different legal status are available in the European Union. Parallel to registered herbal medicinal products there are many plant species or processed products used for health purposes without licenses because they are not considered to be medicinal products. Herbal products, however, should be evaluated in the same way as all medicinal products: their expected benefit should be balanced against their potential risks. As a basic approach to the assessment of herbal medicinal products, the Association of the European Self-Medication Industry (AESGP) developed a model which should meet the requirements of patients, authorities, and producers. This proposal aims at clarifying the position of herbal medicinal products in the European Union under the scope of community legislation in the pharmaceutical sector.