ECSubmissionOfApplication object

Responsible for study submission

Sponsor

Guidance on study submission available

Yes

Guidance on study submission

"Note on Procedures for issuing CEIC s single opinion to carrying out Clinical Trials with medicinal products for human use" (also available in English on the CEIC website in section: Utilities/Information (Utilidades/Informação) > Notices (Notas Informativas).
The request for approval includes the application form, proof of payment of fees to INFARMED and the required documentation.

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
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