CATimelineAuthorisation object
General timespan (max nr days)
60
30 (for class I or IIa MD, other than MD of long term invasive IIa class + MD or IVD MD, having already been the subject of authorisation in France)
Mode of approval (General)
Tacit (Silent)
Explicit authorization only for research relating to MD incorporating products of human or animal origin
Timespan counted from
Date of submission of valid application
Additional Information
ANSM has to the option of notifying the applicant of its decision before the expiry of the 30 or 60 days deadline (e.g. in case of no objection and no request for additional information, the final decision of ANSM could be formulated within 15 resp. 30 days and would then be notified by letter to the applicant).
Related details are provided in the guidance "Avis au promoters/ Notice to sponsor" available on ANMS website.
