Expansion of scope of temporary authorisations
2 dicembre 2022 – To make medicinal products for the treatment of life-threatening diseases available to patients as quickly as possible, it is possible for temporary authorisation to be granted under certain conditions defined by law. To date, only temporary new authorisations of human medicinal products with a new active substance have been possible. From 1 January 2023, temporary additional indications will also be possible. They can be submitted to Swissmedic either as a type II application for variation “Change to therapeutic indications(s)” or as an application for the new authorisation of a human medicinal product with known active substance (with innovation).
For more information, see here.