S.L. 458.44 Art. 2Interpretation. S.L. 458.34

For the purposes of these regulations -

"the Committee" means the Committee for Herbal Medicinal Products set up within the European Medicines Agency, established by Regulation (EC) 726/2004; "corresponding product" as referred to in regulation 5(1)(c), means a product which is characterised by having the same active ingredients, irrespective of the excipients used, the same or similar intended purpose, equivalent strength and posology and the same or similar route of administration as the medicinal product applied for; "the Directive" means Directive 2001/83/EC as amended by Directive 2004/24/EC; "herbal medicinal product" means 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; "herbal preparations" means 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;

"herbal substances" means all mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed but 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); "the Medicines Regulations" means the Medicines (Marketing Authorisation) Regulations;

"traditional herbal medicinal product" means a herbal medicinal product that fulfils the conditions laid down in regulation 3.