4.

For clinical trials involving more than one Member State the assessment process of substantial modification shall include three phases: an initial assessment phase performed by the reporting Member State within 19 days from the validation date; a coordinated review phase performed within 12 days from the end of the initial assessment phase involving all Member States concerned; and a consolidation phase performed by the reporting Member State within seven days from the end of coordinated review phase. During the initial assessment phase, the reporting Member State shall develop a draft assessment report and circulate it to all Member States concerned. During the coordinated review phase, all Member States concerned shall jointly review the application based on the draft assessment report and shall share any considerations relevant to the application. During the consolidation phase, the reporting Member State shall take due account of the considerations of the other Member States concerned when finalising the assessment report and shall record how all such considerations have been dealt with. The reporting Member State shall submit the final assessment report to the sponsor and all other Member States concerned by the reporting date.

← art_18__para_3__text_2 · All articles · art_18__para_4__text_1 →

Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.