Swissmedic differentiates GMP Scope for Manufacturing and Preparation for Administration

Swissmedic has published an urgent revision of the regulations of Good Manufacturing Practice for medicinal products in small quantities in the Swiss Pharmacopoeia (Ph. Helv.). The revision will enter into force on 1 June 2025 and relates in particular to the distinction under therapeutic products legislation between manufacturing and preparation for administration.

The background to this is a ruling by the Swiss Federal Supreme Court (BGE 150 V 210), which was made in connection with the reimbursement of aseptically reconstituted cytostatics. The judgement had created uncertainties regarding the legal classification of reconstitution - in particular with regard to the distinction from manufacturing subject to GMP.

In response, Swissmedic has amended several chapters of the Ph. Helv. (including 20.1.A.2, 20.1.B, 20.2, 20.3 and the associated explanations in Chapter 21) and introduced the new generic term 'preparation for administration'. This includes all handling steps after manufacture to convert a medicinal product into a ready-to-use form. This includes simple measures such as dissolution or dilution as well as complex activities such as aseptic preparation or radiolabelling.

It is important to note: The revised regulation explicitly clarifies that preparation for administration - including the reconstitution of authorised medicinal products - does not fall under the scope of the GMP regulations for medicinal products in small quantities. The amendment comes into force on 1 June 2025.

The revised Chapters 20 and 21 of the Ph. Helv. can be viewed on the Swissmedic website in German, French and Italian.