In the extraordinary situation presented by the pandemic, Swissmedic was empowered under Ordinance 3 on Measures to Combat the Coronavirus (COVID-19) (COVID-19 Ordinance 3; SR 818.101.24) to grant certain exceptions for medicinal products intended for the treatment of patients with COVID-19 or for preventing COVID-19 infection. Among other things, a rolling authorisation procedure was introduced and certain requirements relating to medicinal product information could be met by means of QR codes rather than on paper.
In accordance with Art. 29 para. 8 of COVID-19 Ordinance 3, the Ordinance’s extended validity period expires on 30 June 2024. This means that there is no longer any basis permitting Swissmedic to grant exceptions in respect of medicinal products for the treatment or prevention of COVID-19.
Those medicinal products for which exceptions were originally granted under COVID-19 Ordinance 3 have in the meantime met the requirements of therapeutic products legislation.