Temporary authorisation to use medicinal products in accordance with Article 9b para. 1 TPA

13.03.2019

The total revision of the Ordinance on the Authorisation of Medicinal Products (AMBV) entered into force on 1st January 2019. Chapter 5 regulates the temporary authorisation for the use of medicinal products in accordance with Art. 9b Para. 1 TPA. The procedures formerly known as "compassionate use" (now temporary authorisation) refer to therapeutic products whose efficacy has already been proven in clinical trials. The therapeutic products show a benefit, but have not (yet) been approved.
For both ethical and other reasons, it is positive that these therapeutic products can be made available to patients early by the sponsor. The approval of the temporary authorisation is issued by Swissmedic (link to Swissmedic). The Ethics Committees give an advisory opinion to the attention of Swissmedic. Therefore, the sponsors must submit the necessary documents to the Ethics Committees first. swissethics provides a form for the application in BASEC (form: Application for a Temporary Authorisation), which also answers the most important questions. In the case of multicentric applications, all documents are submitted to the lead Ethics Committee.