13.02.2024

EMA: FAQs for the Use of IRIS

Recommendation

6/7 November 2024
Barcelona, Spain

In January, the question and answer catalogue "RPM for PLM (Regulatory Procedure Management for the Product Lifecycle Management) - Frequently Asked Questions and Answers" was published on the EMA website. In addition to the glossary, it contains 23 questions and their answers relating to the use of the IRIS system. These are divided into the following six categories:

Regulatory Procedures' transition to IRIS
IRIS and Other Portals
MAH contact point
Documents in IRIS
1st roll-out preparatory activities
General Information

Until now, the so-called "SIAMED" system was used to manage submissions and as a communication tool between the EMA and the applicant. IRIS is now to be the new "Submission Management System". The first step of the rollout was completed on 21 January, so that, for example, the change notifications and the "Marketing Authorisation transfer applications" for selected human and veterinary medicinal products can now be processed via this system.

It was also clearly emphasised that the PLM Portal and the eSubmission Gateway will continue to exist and be used alongside the IRIS system. The IRIS system will therefore not replace them.

Further information on how to use the IRIS platform can also be found in the "IRIS user guide for applicants". This guide was also revised in mid-January and has now been published in version 3.1. The new version now also describes the management of submissions and contains a new chapter "12. Product Lifecycle Management (PLM) procedures" with the following 10 sub-items:

12.1. Display and sort submissions
12.2. Search for submissions
12.3. Add contributors/managers to a PLM procedures
12.4. Communication model and change submission contact person to a PLM procedures
12.5. See section 2.4. Check the current status of PLM Submissions in the IRIS Portal
12.6. Withdrawal of a PLM procedure
12.7. Exchange of documentation and communication with EMA for PLM procedures (outside ECTD/VNeeS submissions)
12.8. Submission details and outcome information for PLM procedures
12.9. Steps after end of linguistic review
12.10. Re-examination

Both the updated "IRIS user guide for applicants" and the catalogue of questions and answers "RPM for PLM (Regulatory Procedure Management for the Product Lifecycle Management) - Frequently Asked Questions and Answers" can be viewed on the EMA website.