Spring Intro 2023
16/02/2023
Receipt of confirmation of EudraCT number Copy of EC opinion when available Copy/summary of any scientific advice If applicant not the sponsor, a letter authorising the applicant to act on behalf of the sponsor Application to CA in English accepted Informed consent form Subject information leaflet Examples of non-harmonised requirements: Arrangements for recruitment of subjects Protocol summary in national language Trial peer review when available Ethical assessment made by principal investigator Applicable authorisations to cover trials or products with special characteristics (e.g. GMOs, radiopharmaceuticals) Examples of labels in national languages Facilities for the trial CV of coordinating investigator in the MS concerned CVs of each participating investigator in the MS concerned Information about supporting staff Provisions for indemnity or compensation in the event of injury of death Any insurance or indemnity to cover liability Compensation to investigators Compensation to subjects Agreement between sponsor and trial site Agreement between the investigators and trial sites Certificate of agreement between sponsor and investigator when not in the protocol
25
National review and approval timelines: 30 – 60 days
Member State
Reg approval**
EC approval**
Austria
35 days
60 days
Belgium
28 days + 3 days validation (15 days for phase 1)
28 days (15 days for phase 1)
Bulgaria
60 days – MOH submission can be filed after approval of 60% of local EC approval has been collected
30 days
Cyprus
Up to 60 days if questions
30 days
Czech
60 days
60 days
Denmark
60 days (1 clock stop allowed)
30-60 days
Estonia
60 days (but average = 40)
60 days
Finland
60 days
60 days
France
60 days (Phase 1 quicker)
5 weeks + 30 days if questions
Germany
30-60 days
60 days
Greece
60 days
60 days
Hungary
60 days + 7 for validation
42 days
Ireland
30 days + 30 days if questions
60 days
Italy
Up to 60 days if questions
60 days
**In all cases submissions can run in parallel except Bulgaria. Unless otherwise stated timelines assume no questions
26
Made with FlippingBook Annual report maker