Swissmedic clarifies in the authorisation forms how to describe the indication of the medicinal product and simplifies the standardised consents for sharing information with partner authorities
As there will no longer be any legal basis for doing so, Swissmedic will cease granting exceptions with regard to the authorisation and importing of medicinal products for the treatment or prevention of COVID-19
Prior notification of a new application with a new active substance enables Swissmedic to plan resources early on and supports efficient processing of applications
Medicinal products whose known chemical active pharmaceutical ingredient has a complex, heterogeneous structure may be deemed to be medicinal products with a known active pharmaceutical ingredient (known API, with or without innovation)
