Plasma zur Fraktionierung: Wirkstoff oder Arzneimittel?

Abstract

Source Plasma: Active Pharmacentical Ingredient or Medicinal Product? The question whether source plasma is already a medicinal product or still an active pharmaceutical ingredient is of high legal importance because the legal requirements for active pharmaceutical ingredients (active substances) are lower than those for medicinal products. The majority of the competent authorities in the individual federal states do not take this legally necessary differentiation into consideration. The consequence is that an applicant for a manufacturing authorization for source plasma regularly has to comply with the more stringent legal prerequisites for medicinal products. The court rulings until now have qualified source plasma as medicinal product. In the literature this opinion has partly been taken over without any examination. Partly however source plasma is qualified as raw material, as active pharmaceutical ingredient, or as starting material. Therefore, for legal certainty it is fundamental to clarify the legal situation. The definition of an active pharmaceutical ingredient as defined in § 4 subp. 19 of the German Drug Law (Arzneimittelgesetz; AMG) has been introduced by the 4th amendment to the AMG of 1990. Since then the AMG includes for the first time a definition of a preliminary stage of a medicinal product which contains medically active constituents without being a medicinal product itself. The Transfusion Law (Transfusionsgesetz) also qualifies source plasma as active pharmaceutical ingredient. This definition is also confirmed by the European Drug Law. Consequently, in the sphere of blood products the competent authorities pursuant to § 13 subp. 4 AMG are legally bound to differentiate unmistakably and clearly between an authorization to manufacture medicinal products (blood preparations) and an authorization to manufacture active pharmaceutical ingredients (source plasma).