The European Medicines Agency (EMA) has answered frequently asked questions (FAQ) about managing regulatory product lifecycle procedures to inform the switch to the IRIS submission system.
EMA began using IRIS for certain product variations, notifications and applications to transfer marketing authorizations for human and veterinary medicinal products on 23 January. The agency is decommissioning its current submission management system, SIAMED, and making IRIS the portal for communication between EMA, the EU network and applicants.
Q&A Table of Contents
Regulatory Procedures’ transition to IRIS
1. What is the purpose of IRIS in the submission of regulatory procedure management?
2. Which procedures is IRIS covering after the 1st roll-out?
3. What remains unchanged for applicants with the roll out of IRIS for regulatory procedure management?
4. Is the transfer to IRIS only affecting CAPs, or will NAPs be integrated in the future as well?
5. Will mutual recognition procedures and decentralised procedures transition to IRIS? If yes, when?
6. When will the use of IRIS be mandatory for CAPs?
7. How are grouped variations and transfers selected for transition to IRIS?
8. Does the transition to IRIS affect the linguistic review process?
9. How are validation issues addressed in IRIS?
IRIS and Other Portals
10. Does the IRIS transition mean variations submissions are made through IRIS platform rather than through the current EMA submission gateway platform?
11. Is IRIS replacing the PLM portal for all procedure types?
12. Is the web-based electronic application form part of the transfer of regulatory procedures to IRIS or is it a separate project?
13. Why are there different portals for creation, submission, and submission management?
MAH contact point
14. How are notifications managed in IRIS?
15. Can more than one submission contact person be allocated for a submission in IRIS?
Documents in IRIS
16. How are document submissions managed in IRIS?
17. Can document be submitted after a closed submission via IRIS?
18. How long do documents stay available in IRIS?
1 st roll-out preparatory activities
19. Will there be a User Acceptance Testing (UAT) for IRIS?
20. Will there be training for IRIS?
General Information
21. How does the IRIS system handle data privacy and security concerns?
22. Is there an API available for IRIS?
23. Will the IRIS platform eventually replace the current repository?
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