Medical professional at computer with communication graphics overlayedWe recently submitted a scientific advice (SA)/protocol assistance (PA) request via IRIS for a US based SME with an Orphan Product.  We had to use some workarounds for this version of the system, as there are some kinks to iron out particularly for ex-EU companies using an EU partner to submit the requests.  The EMA were incredibly helpful and are considering improvements as experience is gained.

This platform has only recently been extended to cover SA and PA, in addition to the existing use of IRIS for orphan designation applications, innovation task force consultations certain general requests and parallel distribution notifications.

Contact us at Agos Pharma for help if needed and

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