Quick Interactive Guide to IRIS Registration Process

On 25 August 2020 the EMA announced the availability of the quick interactive guidance.

IRIS is the EMA’s secure online platform to carry out certain regulatory procedures with EMA. It is a core part of EMA’s digital transformation process. EMA plans to extend the platform to cover other regulatory and scientific procedures. IRIS aims to make the handling of product-related regulatory procedures more efficient and user-friendly and to ensure better data quality through integration with other EMA systems such as the substance, product, organisation and referential (SPOR) portal.

Read the pdf 
Copyright Widler & Schiemann AG 2022. All Rights Reserved. /