Changes to Guidance Document Authorization Procedures for COVID-19 Medicinal Products During a Pandemic HMV4

1 August 2022 — Swissmedic published the revised guidance document effective 1 August 2022.

The marketing authorization holder must continuously monitor the efficacy of medicinal products used to prevent and/or treat COVID-19 against current SARS-CoV-2 variants according to the conditions imposed. In the present revision of the Guidance document, Swissmedic clarifies what information it needs once WHO classifies a SARS-CoV-2 variant as a variant of interest, variant of concern or lineage under monitoring (section 8).