CASubmissionOfApplication object

Responsible for study submission

Sponsor

Additional Information

(1) Clinical studies on MD with CE-marked used outside label or without label + MP: Submission to SGMUH (General Subdirection of Human Medicinal Products') in 2 copies. Evaluation by SGMUH and SGPS (General Subdirection of Medical Devices). Single unified opinion after evaluation process.

(2) Clinical studies on MP (not authorized in any EU country) integrated in a MD (e.g. insulin pre-filled pens): Submission to SGMUH (evaluation process like IMP trial)

(3) Comparing MP vs MD with CE mark used within label: Submission to SGMUH (evaluation process like IMP trial)

(4) Comparing MP vs MD without CE mark and/or with CE- mark used outside label: 2 applications (to SGMUH and SGPS). Sponsor notifies the Subdirections of application dates. Evaluation by both the Subdirections. Single unified opinion after evaluation process.

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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