In a dispute regarding eligibility in accordance with health insurance law, the Swiss Federal Supreme Court ruled on the remuneration payable for the reconstitution of cytostatics under aseptic conditions, inter alia by interpreting the rules of Good Manufacturing Practice for medicinal products in small quanti-ties as stated in the Swiss Pharmacopoeia (Decision of the Federal Supreme Court 150 V 210). This judgment highlighted uncertainty regarding the distinction under therapeutic products legislation be-tween the manufacture and reconstitution of medicinal products. To clarify the requirements under ther-apeutic products law, Swissmedic has elucidated the Good Manufacturing Practice rules applicable to medicinal products in small quantities as stated in the Swiss Pharmacopoeia (Ph. Helv.). To this end, the scope and definitions in Chapters 20.1.A.2, 20.1.B, 20.2.A.2, 20.2.B, 20.3.A.2 and 20.3.B, as well as the associated explanations in Chapters 21.1.A.2 and 21.1.B of the Ph. Helv., have been revised. Moreover, the concept of “preparation for administration” has been introduced as a general term. Preparation for administration refers to any processing subsequent to production that is required for making a medicinal product ready to use. This can include both simple actions (such as dissolving, diluting, etc.) and more complex actions (e.g. aseptic preparation of sterile medicinal products, labelling of radio-pharmaceuticals, etc.). The amended text also explains that preparation of an approved medicinal product for administration, as carried out in accordance with the Information for healthcare professionals and the Patient information, is referred to as “reconstitution” according to the international terminology.
This revision enters into effect as an urgent amendment on 1 June 2025. From the point of view of therapeutic products legislation, the Decision of the Federal Supreme Court with regard to remuneration is not called into question.
Chapters 20 and 21 of the Ph. Helv. (valid from 1 June 2025)
