This guide has been produced to show applicants how to use the IRISplatform to prepare and submit an #application and/or data for a #scientificprocedure (orphan designation application, scientific advice,ITF briefing meeting requests, PRIME, marketing status reports, inspections and veterinary signal management) and related activities, or applications for Parallel Distribution procedures.

Please note that for ParallelDistribution submissions separate user access roles are needed (it is possible to combine the roles; see the IRIS guide to registration and RPIs for more details).

Preliminary requirement

EMA Account and appropriate role:
for any type of submission in IRIS, you need an EMAaccount and an appropriate role in IRIS, to login into IRIS.
Registration needs to be done only once and will allow you to submit any type of scientific applications now and in the future.
For information on how to request an EMA account and an appropriate IRIS role (these are two separate actions), please consult the
separate IRIS guide to registration and the quick interactive guide to IRIS registration process on the IRIS home page.