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)

Explicit (written)

External expert advice required (max nr days)

+ 90

Xenogeneic cell therapy (max nr days)

No time limit

Clock-stop possible if complementary information requested

No

Timespan counted from

Date of submission of valid application

Applicable national legal framework/ Reference

Section 11 of Regulation 2/2012

Additional Information

In case of further clarification asked by the CA: Any requests for clarification must be made in writing within the respective time span.

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