Primary source: European Medicines Agency
The guide specifies that all submissions related to pharmacovigilance and safety in the EU must utilize the IRIS system for registration, with the requirement to request a new Research Product Identifier (RPI) if not already associated with an existing one.
Accurate registration and management of RPIs are essential for compliance with EU pharmacovigilance regulations, ensuring that organizations can effectively engage in safety monitoring and regulatory submissions.
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.
Regulatory Intelligence Lead
Review before 2026-06-15.
Detailed steps for industry stakeholders to register their organizations and products in the IRIS platform to enable regulatory interactions.
Registration in IRIS is a prerequisite for all pharmacovigilance and safety-related submissions in the EU. Correct RPI management is critical for data integrity across PV databases.
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.
Registration in the IRIS system is now a prerequisite for all pharmacovigilance and safety-related submissions in the EU, effective from June 15, 2026. Proper management of RPIs is critical for maintaining data integrity across pharmacovigilance databases.
What changed: The guide specifies that all submissions related to pharmacovigilance and safety in the EU must utilize the IRIS system for registration, with the requirement to request a new Research Product Identifier (RPI) if not already associated with an existing one.
Why it matters: Accurate registration and management of RPIs are essential for compliance with EU pharmacovigilance regulations, ensuring that organizations can effectively engage in safety monitoring and regulatory submissions.
Practical implication: 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.
Published from the Firecrawl policy change extraction pipeline.
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