Starting with 19^th of October 2020, Marketing Authorization Holders of human and veterinary medicines should use EMA’s IRIS Regulatory & Scientific Information Management Platform in order to request scientific advice regarding the study design. 

The following type information may be requested via IRIS:

• human medicines:
  • Initial and Follow-up Scientific Advice;
  • Initial and Follow-up Protocol Assistance;
  • Initial and Follow-up Qualification Procedure;
• veterinary medicines:
  • Initial and Follow-up Scientific Advice.

Link to IRIS can be found here.

Guidance on how to register and use IRIS can be found here.

Online training: How to submit initial and follow-up scientific advice application (human) using IRIS (13/10/2020).

Online training: How to submit initial and follow-up scientific advice application (veterinary) using IRIS (14/10/2020).