IRIS guide to registration and RPIs

Key changes

Detailed steps for industry stakeholders to register their organizations and products in the IRIS platform to enable regulatory interactions.

PV impact

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.

Exact policy details

EMA user account requirement

Must have an active EMA user account.

Applies to: All applicants including sponsors of Orphan Designation or acting on their behalf.

Section 1.1.1 · p. 4 · High · Source

Organisation registration in OMS timelines

The SPOR/OMS registration process takes five to ten working days.

Applies to: For organizations not already included in OMS.

Section 1.1.2 · p. 5 · High · Source

EMA customer account number requirement

Applicants must have a valid EMA Customer Account Number.

Applies to: For submissions, including parallel distribution notifications.

Section 1.1.3 · p. 5 · High · Source

Research Product Identifier (RPI)

Each new application must be associated with an existing RPI, or a new RPI must be requested.

Applies to: For scientific procedures in IRIS.

Section 1.1.4 · p. 5 · High · Source

Extracted documents

• IRIS guide to registration and RPIspdfpdf_text · high · 32 pages