IRIS roll-out for life-cycle management

2024-02-11

Are you ready for the IRIS roll-out for Product Lifecycle Management Procedures?

IRIS will become the new submission management system and communication portal at EMA. The first roll-out is live since 23 January 2024, including submission management of variations, Art.61(3) notifications and MAH transfers for a subset of centrally authorised products.

EMA will no longer use EudraLink as communication portal for these products in the procedural steps covered by IRIS.

Later this year PSURs, PAMs, line extensions, renewals, annual assessments, PASS, and referrals will also be rolled out.

Need help? Contact us at info@regfile.se

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