Swissmedic Clarifies GMP Scope for Drug Preparation vs. Manufacturing

Effective 1 June 2025, Swissmedic is revising Good Manufacturing Practice (GMP) guidelines in the Swiss Pharmacopoeia (Ph. Helv.) to clarify the distinction between "manufacturing" and "preparation for administration." This follows a Federal Supreme Court ruling (BGE 150 V 210) concerning reimbursement for aseptically reconstituted cytostatics, which raised legal uncertainties.

The update introduces the term "preparation for administration"—covering all post-manufacturing steps to make a drug ready for use, from simple dilution to complex aseptic handling or radiolabelling.

Critically, Swissmedic confirms these activities, including reconstitution of authorised medicines, are not subject to GMP requirements for small-scale manufacturing. Relevant revisions affect Ph. Helv. Chapters 20 and 21, now available on the Swissmedic website in German, French, and Italian.

18-06-2025