CHAPTER II

AUTHORISATION PROCEDURE FOR A CLINICAL TRIAL

Prior authorisation
Article 4
A clinical trial shall be subject to scientific and ethical review and shall be authorised in accordance with this Regulation.
The ethical review shall be performed by an ethics committee in accordance with the law of the Member State concerned. The review by the ethics committee may encompass aspects addressed in Part I of the assessment report for the authorisation of a clinical trial as referred to in Article 6 and in Part II of that assessment report as referred to in Article 7 as appropriate for each Member State concerned.
Member States shall ensure that the timelines and procedures for the review by the ethics committees are compatible with the timelines and procedures set out in this Regulation for the assessment of the application for authorisation of a clinical trial.