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 (authorisation in writing)
External expert advice required (max nr days)
180
Xenogeneic cell therapy (max nr days)
No time limit
Timespan counted from
Date of submission of valid application
National legal framework in place
Yes
Additional Information
Explicit approval is also applicable to MP developed by biotechnological methods wor where the active ingredient is a bilogical product.
NB! During summer holidays no clinical trial applications will be confirmed. The holidays are published on the IMA website in section Home > Licences > Clinical Trials > Application.
