CASubmissionOfApplication object

Responsible for study submission

Sponsor
Legal representative domiciled in the EU/EEA

Guidance on submission of application

"Clinical Trial Application dossier Guideline"
(available on Swissmedic website in section: Home > Licensing > Clinical trials > Clinical trials on medicinal products > Clinical Trial Application

Additional Information

NB! Combined trials (medical device & IMP) must be reviewed by Swissmedic as IMP/transplant product trials and also as MD trials. The requirements for both trials must be met and two separate dossiers (full documentation as well as the complete application form, including electronic copy) must be submitted to the corresponding department of the CA.

The explicit submission procedure depends on the licensing status of both the IMP and MD and is specified in the "Information Sheet FAQ" (Q&A related to clinical trials with medicinal products), published on the Swissmedic website in section: Home > Licensing > Clinical trials > Clinical trials on medicinal products > Q&A and important links (Link: https://www.swissmedic.ch/bewilligungen/00155/00242/00327/00347/index.html?lang=en)

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395