The following updates have been made to the IRIS platform:
1. It is now possible to request clarification on a Scientific Advice letter:
Users can request clarification on a closed Scientific Advice case related to an Initial Scientific Advice or Follow Up Scientific Advice by submitting a request "Clarification on scientific advice - simple process" in IRIS.
2. Add additional notes to a Scientific Advice submission:
A new section "Submission Notes" has been added in the Scientific Advice forms where users can add additional information related to the submission. This field can be used to specify why the procedure qualifies for not following standard deadlines (e.g., COVID rapid request).
3. Reassignment of notices for parallel distribution:
A new submission type, "Reassignment of notices for parallel distribution", has been added to IRIS. The procedure allows reassigning all notices for parallel distribution held by an applicant to a new owner, where as a result of a merger/acquisition the parallel distributor is dissolved, or it changed the legal form. For a step-by-step guide on how to do this please refer to the IRIS Guide for Parallel Distribution Applicants - https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/iris-guide-parallel-distribution-applicants_en.pdf
