In order to simplify the submission process of applications for clinical trials on medicinal products and to waive the submission of paper documents, The State Medicines Control Agency (SMCA) will now accept all documentation related to clinical trial applications in an electronic file format.
Sponsors and applicants of clinical trials are encouraged to submit applications and all related documentation through the Common European Submission Platform ("CESP"). CESP is a portal for submission of applications within the EU. Information regarding the submission of applications via the CESP portal, including ensuring access to the portal, is available on the HMA website.
The procedure for submitting applications via CESP is demonstrated in the presentation published in the section Training after registration. The documentation submitted via the CESP portal shall be provided in one compressed ZIP file. No other compressed files may be placed in this ZIP file.
Frequently asked questions and answers regarding the CESP portal are published on the HMA website.
In addition, in order to speed the process please make sure your ZIP file is readable and clearly named according to the submission type, for example:
- Clinical Trial Application - Protocol No. XXX - EudraCT No. XXX - Initial application
- Clinical Trial Application - Protocol No. XXX - EudraCT No. XXX - Substantial amendment
- Clinical Trial Application - Protocol No. XXX - EudraCT No. XXX - DSUR
- Clinical Trial Application - Protocol No. XXX - EudraCT No. XXX - End of trial declaration
- Clinical Trial Application - Protocol No. XXX - EudraCT No. XXX - Other trial related documents