Europska regulativa biljnih i tradicionalnih biljnih lijekova

Medicinal products, which contain only herbal substances or herbal preparations as active ingredients, can be approved, in line with European legislation, and legislation of Republic of Croatia, as herbal medicines after marketing authorization procedure, or as traditional herbal medicines after simplified registration procedure. Differences between the above stated categories of herbal and traditional herbal medicinal products are often unknown to health professionals and patients. It is important to point out specific differences upon which marketing authorization far herbal medicines or registration of traditional herbal medicine is granted. The application documentation far herbal and traditional herbal medicinal products, as well as its assessment, are quite complex. Each product which is intended to be placed on the market in medicinal product category must fulfill all applicable requirements according to regulations in Republic of Croatia and European Union in the field of medicinal products, in order to ensure its quality, efficacy and safe use. Also, it is important to encourage health professionals to inform patients that there are other categories of products besides the medicinal products, such as medical devices, cosmetics and food supplements, which may contain similar or same herbal substances. Since medicinal products are subject to the most rigorous requirements, which ensure the best quality, it is important to distinguish them from other categories of products