Changes to the guidance document Temporary authorisation of human medicinal products

Clarification of the term "equivalent medicinal product" and timing of criteria assessment for temporary authorisation


All criteria according to Art. 9a TPA[1] in conjunction with Art. 18 TPLO[2] must be met cumulatively for a temporary authorisation. This applies both at the time the application for a temporary authorisation procedure is submitted and when the application for temporary authorisation is subsequently received and completed. The criteria must also be met in the event of an extension after the initial authorisation period.

One key criterion to be met is that there is no authorised, alternative and equivalent medicinal product available in Switzerland (Art. 9a para. 1 let. c TPA or Art. 18 let. b TPLRO). The criteria for assessing the equivalence of medicinal products include the indication, the target population to be treated, the mechanism of action, the ease of use, and the risk-benefit profile.

In addition, the process for applying for a temporary authorisation has been optimised. Differing processes will be employed in future, based on the result of the assessment of the documentation submitted with the application for a temporary authorisation procedure.

In particular, Swissmedic will now issue a preliminary decision to reject the application for a temporary authorisation procedure if the assessment reveals that the criteria specified in Art. 18 TPLO are not met. The applicant will be given the option of submitting a written statement to Swissmedic or participating in an Accelerated Application Hearing (AAA).

The guidance document Temporary authorisation for human medicinal products has been amended accordingly in sections 5 and 6 and Annexes 1 and 2, and is valid from 15 January 2024.