Is it mandatory to notify Fimea of the post-authorization safety studies (i.e. PASS studies)?
PASS study may be required by the authority or carried out of the marketing authorization holder’s own iniative. PASS may be interventional or non-interventional trial. Interventional trials are subject to notification process as detailed in the Reg. 8-2019 for clinical trials. Fimea is not required to notify of the non-interventional PASS study carried out of the marketing authorization holder’s own initiative. However if the PASS study was required by Fimea, it has to be notified to Fimea even in the case of a non-interventional study.