Tag archive

European Medicines Agency

publicEuropean Medicines Agency · European Union · Updated Jun 15, 2026

IRIS Guide for Applicants - Updated Submission Requirements

MAHs and sponsors must register for an EMA account and appropriate role to submit via the IRIS platform, as this is a new requirement for all IRIS submissions.

Signal ManagementCountry ComplianceRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, Signal Management Lead, QPPV

verifiedRegulatory action: Procedural Guidance

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publicEuropean Medicines Agency · European Union · Updated Jun 15, 2026

IRIS guide to registration and RPIs

Urgency: High

Organizations must establish an active EMA user account, ensure they have a valid EMA customer account number, and complete the SPOR/OMS registration process within five to ten working days if not previously registered.

Country ComplianceSignal ManagementRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, Signal Management Lead, QPPV

verifiedRegulatory action: Procedural Guidance

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publicEuropean Medicines Agency · European Union · Updated Jul 3, 2026

Variations Requiring Assessment (Veterinary Medicines) - Q&A Update

Urgency: High

MAHs are advised to incorporate the updated FAQs into their compliance workflows and ensure that their submissions adhere to the updated guidance.

Country ComplianceRegulatory Intelligence Lead

SOP Impact1 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, QPPV

verifiedRegulatory action: Q&A

Read impact briefarrow_forward

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