Changes to the Guidance document Temporary authorisation of human medicinal products

Swissmedic präzisiert den Geltungsbereich für die befristeten Zulassungen von Humanarzneimitteln


Medicinal products for identifying, preventing or treating a disease that is life-threatening or could result in disability can be authorised temporarily by Swissmedic. Application of the fast-track procedure for temporary authorisations enables medicinal products with a major therapeutic benefit to be made available to affected patients more quickly.

The present revision of the scope for temporary authorisations makes these possible for human medicinal products with a known active substance, provided that all criteria according to Art. 9a TPA[1] in conjunction with Art. 18 TPLO[2] are met. The restriction that the innovative aspect of the new authorisation with known active substance must be an indication extension has been removed from the scope.

The revised Guidance document Temporary authorisation for human medicinal products enters into force on 1 June 2024.

Related documents
Link: EN Version (gültig ab 01.07.2024) der WL Temporary authorisation for human medicinal products