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EMA Guidance: IRIS Guide for Applicants

On 03-June-2024 the European Medicines Agency released an updated "IRIS Guide for Applicants" that guides How to create, submit and manage IRIS applications, for industry and individual applicants. This comprehensive guide is aimed at industry professionals and individual applicants, ensuring a streamlined process for regulatory submissions.

IRIS (Integrated Regulatory Information System): IRIS is the EMA's online portal designed to facilitate the submission and management of regulatory and scientific procedures. It provides a user-friendly interface for applicants to interact with the EMA, ensuring efficient handling of applications and communications.

The purpose of this guide is to provide applicants with information on how to prepare, submit, and manage an application or data for a scientific procedure (orphan designation application, scientific advice, ITF briefing meeting requests, PRIME, marketing status reports, inspections, and veterinary signal management) as well as Parallel Distribution applications.

Key Topics Covered in the IRIS Guide

  • Creating an IRIS Account:

  • Registration Process: Applicants must first register on the EMA's IRIS portal. This involves providing necessary details and completing the verification process.

  • User Roles: The guide explains the different user roles available within IRIS, including administrators, editors, and viewers, and how to assign these roles based on organizational needs.

  • Submitting Applications:

  • Application Types: IRIS supports various application types, including scientific advice, orphan designation, pediatric investigation plans, and marketing authorizations.

  • Step-by-Step Submission: The guide provides a detailed, step-by-step process for submitting applications. This includes selecting the appropriate application type, filling in required fields, and uploading necessary documents.

  • Validation Checks: Before submission, IRIS performs validation checks to ensure all mandatory fields are completed and documents are correctly uploaded.

  • Managing Applications:

  • Tracking Progress: Applicants can track the progress of their submissions in real-time. The portal provides updates on the status of applications and any actions required by the applicant.

  • Communication: IRIS facilitates direct communication between applicants and the EMA. The guide explains how to use the portal to send and receive messages, ensuring clear and efficient communication.

  • Responding to Requests: The guide outlines the process for responding to requests for additional information or clarification from the EMA. This ensures that applicants can promptly address any issues that arise during the review process.

  • Common Issues and Troubleshooting:

  • Technical Support: The guide provides information on accessing technical support for any issues encountered while using IRIS. This includes contact details for the helpdesk and tips for resolving common problems.

  • FAQs: A comprehensive FAQ section addresses common questions and concerns, helping users navigate the system more effectively.

  • Best Practices for Applicants:

  • Preparation: The guide emphasizes the importance of preparing all necessary documents and information before starting an application. This includes understanding the specific requirements for each application type.

  • Attention to Detail: Applicants are advised to carefully review all information entered into IRIS to avoid errors and omissions that could delay the application process.

  • Timely Responses: Promptly responding to any requests from the EMA is crucial for maintaining the timeline of the application review.

By following the detailed instructions and best practices outlined in the guide, both industry professionals and individual applicants can ensure a smooth and efficient application process. For more detailed information, refer to the full guide available here.


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