NEW | Regulatory Procedure Management transition to IRIS platform

January 24, 2024

The EMA has announced that the 1st roll-out of Regulatory Procedure Management (RPM) for Product Lifecycle Management (PLM) has already started on the IRIS platform!

As the current submission management system used at EMA (SIAMED) is being decommissioned, IRIS will become the new submission management system and will become the communication portal between the EMA, EU Network and applicants.

This will include the transition of variations, article 61.3 notifications and Marketing Authorization Transfers procedures to IRIS for a subset of products authorized via CP.

The current eCTD/VNeeS submission process via the gateway for human and veterinary procedures remains unchanged, as well as letters of Intent via email, EudraLink or Service Desk. EMA communication will continue at the same milestones during a procedure, linguistic review process.

The IRIS user guide and the FAQ have been updated to include this new feature:

IRIS GUIDE FOR APPLICANTS

RPM FOR PLM – FAQ

Asphalion participated in the UAT performed in November, 2023 together with other Industry SMEs.

For further information, you can contact us at: info@asphalion.com

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