Changes to SwissPAR HMV4 guidance document

Section 5, Clinical Assessment, of the Public Assessment Report is not part of the SwissPAR


The current section 3, Data and Extracts from Studies and Pooled Analyses, of the Public Assessment Report (PAR) will in future be labelled section 5, Clinical Assessor’s notes on submitted studies and pooled analyses – Swissmedic’s internal notes. This new section 5 of the PAR is solely an internal administrative working tool and does not form part of the SwissPAR (see also article in Swissmedic Journal 12/2022). Section 6 of guidance document SwissPAR HMV4 has been revised accordingly.

Other editorial changes have also been made as part of the update to the guidance document.

The revised guidance document SwissPAR HMV4 is valid with effect from 1 January 2023.