Process Feasibility Study

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Harmonization conference phase

  • Feasibility Study is a special process that allows the Applicants to review and work on their timetable concept with the IMs before the path request is placed.
  • A precondition to start the feasibility study process by the leading Applicant is that the dossiers are in the Harmonization phase.
  • Time limitations
    • Inactive dossiers in Harmonization Conference are automatically switched back to Harmonization of the original process.
      • If there was no editing of a dossier 15 days after the starting of Harmonization Conference
      • If there was no editing of a dossier 8 days after the last change in Harmonization Conference
    • These checks are switched off during from approx. mid-December until approx. mid-January.
    • Exact dates are defined in the corresponding PCS Process Guidelines
  • Feasibility study process consists of the following phases:
    1. Harmonization Conference – Applicant/IM
    2. Feasibility Study Request – IM phase
    3. Feasibility Study Elaboration – IM phase
    4. Feasibility Elaboration Conference mode (optional during Path Study Elaboration) – Applicant/IM phase
    5. Feasibility Study Result – Applicant phase
  • Dossier does not have to run through all of the phases mentioned above.
  • Leading Applicant has always the right (except Feasibility Elaboration Conference mode) to end feasibility study in preparation or acknowledge the result and go back to Harmonization phase.
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