As we have been informed by the Authorities, the new Non-Intervention Studies Legislation has been in effect from 1 July 2019 and will apply to all applications submitted from 13 June 2019 onwards, as well as those before 13 June 2019 that have not yet been approved by the Hospitals Scientific Boards.
Therefore, according to the latest Government Gazette Issue B’2015 / 03.06.2019, the procedure for the approval and acceptance of non-interventional studies is changing. A Committee for Non-Interventional Studies is in place so that the Sponsor must first submit the study file to the Committee for approval.
The relevant procedures are currently under fine-tuning and specific instructions. The Authorities expect clarifications in due course. The Greek Medicines Authority (EOF) has already announced a related decision (No. A1b / GP45489) detailing the names as well as the roles of the members of the Committee for Non-Interventional Studies.
The new Non-Intervention Studies Legislation replaces the existing DY3 / 18910/2013 (Government Gazette 390 B’). For more information on this, please fill out the enquiry form attached to this page.