CATimelineAuthorisation object

General timespan (max nr days)

60

Mode of approval (General)

Tacit (Silent)

ATMP/GMO trials (max nr days)

90

Mode of approval (ATMP/GMO trials)

Not specified

External expert advice required (max nr days)

180

Xenogeneic cell therapy (max nr days)

No time limit

Mode of approval (Xenogeneic cell therapy)

Explicit

Applicable national legal framework/ Reference

Art 9 of Legislative Decree 211/2003

Additional Information

If reasoned objections are expressed by local Competent Authority, the refusal applies only to the individual health facility concerned; if the competent authority is central, the trial cannot be conducted at any centre. The procedures to reach these decisions can be run in parallel or not, depending on the sponsor.

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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