3.

The assessment report shall contain one of the following conclusions concerning the aspects addressed in Part I of the assessment report: the conduct of the clinical trial is acceptable in view of the requirements set out in this Regulation; the conduct of the clinical trial is acceptable in view of the requirements set out in this Regulation, but subject to compliance with specific conditions which shall be specifically listed in that conclusion; or the conduct of the clinical trial is not acceptable in view of the requirements set out in this Regulation.

← art_6__para_2__text_1 · All articles · art_6__para_3__text_1 →

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