Article 1
Directive 2001/83/EC is hereby amended as follows: 1. in Article 1 the following is added: "29. Traditional herbal medicinal product: a herbal medicinal product that fulfils the conditions laid down in Article 16a(1); 30. 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; 31. Herbal substances: 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 binomial system (genus, species, variety and author); 32. Herbal preparations: preparations obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. These include comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates." 2. The following chapter is inserted in Title III: "CHAPTER 2a Specific provisions applicable to traditional herbal medicinal products