In this case Swissmedic will start the review of the responses as soon as possible (depending on the available resources), but at the latest after the 90 days, which is the maximum time for responding to the LoQ, for fast-track procedures for new MAA. Note: Even if a pre-arranged deadline cannot be met, the MAA is subsequently still reviewed according to the fast-track timelines (i.e., 50 days for Evaluation phase II, 20 days for review of answers to pre-approval).
The maximum response time to the pre-decision (PD) is. 60 days. To ensure that responses are processed promptly, the applicant must also inform Swissmedic, in advance, of the submission date of the responses to the preliminary decision. Communication of this date has to occur within 14 calendar days after the date of the PD.