admin - CT dossier compilation, collection of site documents (CV, agreements, qualification forms, insurance, contracts, etc.) – up to 30 days
- CT dossier is submitted in parallel to Medicine and Medical Devices Agency (MMDA) and NCE (National Committee of Ethics) – examination period up to 60 days
- FO from NCE is submitted to MMDA
- MMDA is issuing the CT approval order
- For IMP import an application for MMDA import permission is requested. Approval time –up to 10 working days
Medicine and Medical Devices Agency (MMDA) fees for CT examination
Approval time ~ 60 days, depends on submission date and if are issued deficiency letters
National Committee of Ethics (NCE) fees for CT examination
Approval time ~ 60 days, depends on submission date and if are issued deficiency letters