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EMA Guidance: IRIS guide to Registration and Research Product Identifiers

Last Week (20 April 2023) the European Medicines Agency updated and released the guidance on "IRIS guide to Registration and RPIs" which discusses in detail about the Preliminary requirements for all IRIS submissions, including substance and Research Product Identifier registration.

IRIS stands for "Integrated Review and Information System" and is a database used by the European Medicines Agency (EMA) to manage the assessment of applications for marketing authorization of medicinal products in the European Union.

The IRIS system provides a platform for collaboration and information exchange between the EMA and national regulatory agencies during the evaluation process. It is a secure, web-based system that is used to manage regulatory submissions, evaluate data, and generate reports.

Applicants must have a valid EMA Customer Account Number, this is a unique reference number for financial matters and is required to submit parallel distribution notifications.

Research Product Identifier (RPI) is a unique identifier assigned to a research product, such as a chemical compound or biological material, that has been synthesized or collected for research purposes. If an appropriate RPI does not exist yet, for a single medicinal product the RPI must be requested via IRIS.

To obtain a new RPI for a single medicinal product, the active “Substance(s)” in the product must be registered and appear as “authorised” on the official EMA list of all substances in Substance Management System (part of SPOR).

To access the IRIS platform and submit applications/notifications, you must ensure that the organisation on whose behalf you will be acting is listed in the EMA's Organisation Management Service (OMS).

Click this LINK to detail How to access IRIS and request RPI.


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