On 4-May-2022 the Swissmedic shared information on the technical requirements for submitting applications for clinical trials for medicinal products.
For a valid submission, the applicants need to submit the following documents:
A) Electronic submission by postal mail
CD/DVD with the documents in the eDok folder structure
Submission form
B) Paper submission by postal mail
CD/DVD with the documents in the eDok folder structure
Complete paper dossier
The instructions for the submission can be found in this guidance and the Information sheet regarding the Clinical Trial Application (CTA) Questions and Answers will address most of the applicant's queries.
Click this LINK where you will find important information on the technical requirements for submitting applications for clinical trials for medicinal products.
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