The total revision of the Ordinance on the Authorisation of Medicinal Products (AMBV) entered into force on 1st January 2019.
AMBV 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. The approval of the temporary authorisation is issued by 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 through BASEC using the form ‘Application for a Temporary Authorisation’, before submitting the application to Swissmedic. In the case of multicentric applications, all documents are submitted to the lead Ethics Committee.