The European Medicines Agency (EMA) Regulatory & Scientific Information Management Platform IRIS will be the compulsory submission method for scientific advice from October.
IRIS was initially used as the application system for orphan designation for a medicine, as well as post-designation administration. MAP understands that all routine scientific advice tasks will now be conducted through IRIS. The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) says this covers: Initial and Follow-up Scientific Advice, Initial and Follow-up Protocol Assistance, Initial and Follow-up Qualification Procedure.
The requirement to use IRIS will begin on 19th October 2020. A webinar has been scheduled to assist users in users navigating IRIS:
Read more about IRIS on the EMA website.