16 May 2025
Swissmedic: Urgent amendment to the Swiss Pharmacopoeia
Swissmedic has decided, with effect from 1 June 2025, to make an urgent amendment to the Good Manufacturing Practice rules for medicinal products in small quantities as stated in the Swiss Pharmacopoeia. The amendment clarifies the distinction under therapeutic products legislation between manufacture and reconstitution.
The amendment follows a judgement of the Swiss Federal Supreme Court, which 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 quantities as stated in the Swiss Pharmacopoeia (Decision of the Federal Supreme Court 150 V 210). This judgement highlighted ambiguity in therapeutic products legislation concerning the difference between the manufacturing and the reconstitution of medicinal products.
For more information, see here.
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