The marketing authorisation 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).
As part of the revision, Annex 1 and 2 of the Access position papers have been deleted and the explanatory notes in section 9 have been updated. In place of the Annexes, reference is now made to the availability of the Access position papers on the Swissmedic website.
The revised Guidance document Authorisation procedures for COVID-19 medicinal products during a pandemic HMV4 is valid with effect from 1 August 2022.