CATimelineAuthorisation object

General timespan (max nr days)


Mode of approval (General)

Tacit (Silent)

ATMP/GMO trials (max nr days)


Mode of approval (ATMP/GMO trials)

Explicit (authorisation in writing)

External expert advice required (max nr days)


Xenogeneic cell therapy (max nr days)

No time limit

Timespan counted from

Date of submission of valid application

National legal framework in place


Applicable national legal framework/ Reference

Art 12-14 Regulation no 433/2004

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.