Expansion of scope of temporary authorisations

Temporary additional indications will also be possible from 1 January 2023


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 (Art. 9a TPA in conjunction with Art. 18 TPLO).

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).

The relevant specification documents, in particular the Guidance documents Temporary authorisation of human medicinal products HMV4 and Document protection HMV4, are being revised accordingly. Revised versions will come into effect from 1 January 2023. You can find the updated specification documents on the Swissmedic website from 1 January 2023, at ‘Documents and Forms’. You can already look at the German version of the revised Guidance document Temporary authorisation for human medicinal products HMV4 for advance information.

Related documents

Valid from 1 January 2023: