The temporary authorisation specified in the revised Therapeutic Products Act (valid since 1.1.2019) is designed to make medicinal products for the treatment of life-threatening diseases available to patients quickly despite the reduced data situation. Less stringent requirements apply to the completeness of the clinical documentation at the time of the initial evaluation and decision. As a condition of authorisation, the authorisation holder is required to complete the documentation subsequently. If all conditions are fulfilled, the temporary authorisation can be converted into an ordinary authorisation.
The content of the guidance document Temporary authorisation of human medicinal products HMV4, which has been valid since 1 January 2019, has been revised on the basis of acquired experience.
A new requirement is that the documentation on the fulfilment of conditions should be submitted to Swissmedic for review within two years of the official approval decision. At the same time, the authorisation holder submits an application for the granting of ordinary authorisation (conversion).
The guidance document also now states that applications for additional indications – as well as other variations and extensions – are possible for temporarily authorised human medicinal products, provided the clinical studies are concluded and the documentation is complete. Temporary additional indications for ordinarily authorised medicinal products are still not possible.
In addition, the revised guidance document describes the "ex officio" temporary authorisation (in Chapter 7) and the temporary authorisation in accordance with Art. 13 TPA (in Chapter 9).
The revised guidance document enters into force on 01.04.2020