O leku roślinnym: krótka historia pojęcia i związanych z nim regulacjach prawnych

Abstract

In Antiquity, the term “medicine” meant a substance used for medicinal purposes, of plant, mineral or animal origin. Nowadays, in addition to the term “medicine”, the legal term “medicinal product” is used more and more often. According to the tradition of galenic pharmacy, the term plant medicine (or medicinal product of plant origin) meant whole medicinal plants, their specific parts (herb, flowers, leaf, inflorescences, roots, tubers, rhizomes, etc.) used for medicinal purposes, or their various formulations obtained from fresh or dried plants. Nowadays, the term medicinal product is reserved for substances with documented effects, confirmed by safety studies and clinical trials. Among products of plant origin, there are many other categories of products that do not constitute medicinal products, i.e. do not have “the ability to prevent or treat diseases occurring in humans or animals, or are administered for the purpose of making a diagnosis or for the purpose of restoring, improving or modifying physiological functions of the body through pharmacological, immunological or metabolic action”, according to the definition of a medicinal product defined in the Pharmaceutical Law in Poland. The differentiation of plant-based products is based on their properties and the purpose of their use, not on the source of origin.