Common use of Validation Phase Clause in Contracts

Validation Phase. The validation of the dossier (Part I & Part II) is performed by the national contact point. Timelines of the CTR apply for the validation phase, while timelines of the law of 7 May 2004 (28 days or 15 days) apply once the T0 is given for the start of the procedure. However as far as possible, timelines for validation will be kept short. At the end of the validation phase which will last a maximum of 10 days (except for phases I mono- national trials for which the validation phase will last a maximum of 5 days), the sponsor will receive a notice of validation (beginning of assessment) from the national contact point. An operational calendar with a clear overview of the different timelines will be part of this notification to the sponsor. If the validation shows that deficiencies are present or that relevant documentation is missing, leading to the CTA itself not being valid, the sponsor is granted a 10-day period to remove the deficiencies. The corresponding response by the sponsor (Eudralink/CESP if possible) is to be sent to the national contact point. The national contact point evaluates the supplemented documentation within 5 days after receipt of the comments or the amended application dossier. If the national contact point comes to the conclusion that the documentation regarding Part I and/or Part II is still not valid despite the supplement or if the sponsor neglects timely submission of the supplement, the FAMHP informs the sponsor that the CTA can no longer be processed within the pilot. Upon successful validation, the national contact point sends the trial dossier to the College by means of an Eudralink. It is to be noted that the EC will have access to the entire submission dossier Part I with the exception of the quality documentation.