Annex I – Timetables for the CTR pilot process Sample Clauses

Annex I – Timetables for the CTR pilot process. 7.1. National initial dossier (other than phase I mono-national trial) Maximum duration of the process: 28 days (timeline as foreseen in the law of 7 May 2004) + 10 days for validation + max. 15 additional days if questions during validation + max. 12 days if list(s) of questions during assessment => max. 65 days Step DAY Confirmation of receipt to Sponsor/beginning of validation Date submission= T0 - 10 Notification of the validation status to the sponsor: T0 (+ max. 10 - Dossier complete => beginning of assessment - Dossier still not complete after max. 15 additional days (10 for the sponsor to answer the request for additional info + 5 for the national + max. 5 if validation questions) contact point to verify if the dossier is complete after answer from the sponsor) => dossier refused Compiled assessment report for Part I and assessment for Part II available :  Direct approval at T28 at the latest if no questions from FAMHP or EC  List(s) of questions provided by the national contact point to the sponsor T23 Response on questions by sponsor due by(maximum 12 days clock stop if list of questions) T23 (+ max. 12 days) Review of the answers by FAMHP and/or Ethics Committee and final coordinated decision sent by the national competent authority by T28 For an ATMP clinical trial, 30 days (as foreseen by the law of 7 May 2004) will be added to the 28 days legal delay. These 30 days will be added to the assessment period of 23 days.
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