Elvisfan schreef op 2 juli 2019 13:14:
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voor mij is het niet zo duidelijk wat de timeline is voor het SAG uiteindelijk een beslissing moet nemen (wetende dat Kiadis een versnelde procedure wil ...)
dit zeggen ze erover
In case a potential need for a SAG is identified at the pre-submission stage for very short procedure, the date for the SAG will be tentatively identified and CHMP will be asked to put forward tentative nominations for additional experts for formal appointment to participate in the meeting.
The timing of the meeting should be chosen so as to allow the maximum benefit from the SAG advice during the assessment procedure. This will vary depending on a number of factors, in particular, the type of input requested, urgency of the matter and procedural timing.
In general, the need for a SAG will be identified by the Rapporteurs following the Rapporteurs’ assessment of the data and circulation of assessment reports and before finalisation of the procedure. Typically, this will occur after assessment of the responses to the list of outstanding issues by the applicant/MAH and before an oral explanation/Opinion.
In certain cases, identification of the SAG could occur earlier in the process, for instance to assess complex technical aspects, rare disease, need for specialist clinical expertise, i.e., situations where the SAG could be asked to contribute to the primary assessment of the data or responses submitted in parallel to the Rapporteur’s assessment.