CATimelineAuthorisation object

General timespan (max nr days)

75 (including EC approval process of max 42 days) - also applicable to Non-interventional trials with IMPs

ATMP/GMO trials (max nr days)

90 (including EC approval process of max 72 days)

Xenogeneic cell therapy (max nr days)

12 months form date of submission (including EC approval process of max 11 month)

Clock-stop possible if complementary information requested


Timespan counted from

Date of submission of valid application

Applicable national legal framework/ Reference

Section 3 of 95th Act of 2005

Additional Information

Approval process in detail:
The NIPN starts its assessment and, within 8 days, sends the copy of the relevant parts of the application to the competent EC for review. The EC sends back its reasonable within 42 calendar days starting from receiving the documentation from the NIP. Within another 10 days, the NIPN sends the applicant the authorisation/ rejection, the first Annex of that is the KFEB opinion.
In case when the KFEB is consulted first, its (positive) opinion is appended to the application to the NIPN. However, the NIPN’s approval time is still 60 calendar days in this case.