IRIS Guide for Applicants: How to Create and Submit Scientific Applications, for Industry and Individual Applicants: Version 3.3

Updated Guide for Scientific Submissions on the IRIS Platform

This document provides a step-by-step procedure for preparing and submitting scientific procedures on the IRIS platform. It includes updates and consolidations to streamline the submission process.

Key Updates:

• Version Updates: Revised in versions 3.1 (28-Nov-2023) and 3.1 (03-Oct-2023), merging previously separate guides for scientific applications, inspections, and parallel distribution applicants.
• Structural Changes:
  • Updated format and structure while maintaining the original content.
  • Minor corrections in sections 2 and 12.
  • Additions to section 13 for pediatric medicine development and marketing status notification.
• Topics Covered:
  • Purpose and Context: Clarifies the guide’s objectives and scope.
  • General Operations: Applicable to all scientific submission types.
  • Specialized Submissions: Includes orphan submissions and pediatric medicine development.
• Submission Management:
  • Adding and managing submission contacts.
  • Assigning managers and contributors to submissions.

This comprehensive guide aims to simplify the scientific submission process, ensuring clarity and efficiency for applicants using the IRIS platform.

Region: EU Harmonized (27 Markets)

Source: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/iris-guide-applicants_en.pdf