Regulatory Procedure Management for Centrally Authorised Products transitions to IRIS platform

7 mrt. 2024
Regulatory Procedure Management for Centrally Authorised Products transitions to IRIS platform

The European Medicines Agency makes use of a different set of online tools/portals to communicate with the pharmaceutical industry. One of those online portals is the well-known IRIS-portal which was initially launched in 2018 for orphan designation procedures. Two years later the EMA added the submission of a scientific advice application to this portal as well. 

As years have gone by and EMA continuously seeks ways to improve online accessibility and user-friendliness of their online portals, a transition period has started to include regulatory procedures on the IRIS-portal. This transition covers the onboarding of the Regulatory Procedure Management (RPM) for Product Lifecycle Management (PLM) for medicinal products on IRIS. This means that the IRIS-platform will become the new system for submission management and the communication portal between the EMA, EU Network and applicants. On the other hand, the current submission management system used at EMA (SIAMED) is being decommissioned.

At first, IRIS is only set to handle Variations, article 61(3) notifications and Marketing Authorisation Transfers and the first roll-out already took place on the 23rd of January 2024. This roll-out is only applicable to a specific and by EMA selected number of 67 human generic products and 44 veterinary products for which the Marketing Authorisation Holders (MAHs) were informed well in advance.

As the IRIS portal is designed to handle procedures within the EMA, the transition will only affect Centrally Authorised Products (CAP)s and currently there are no intentions to extend this to Nationally Authorised Products (NAPs). However, it is important to mention that there are a few exceptions to the rule including Worksharings with NAPs, MRPs, DCPs and CAPs, single assessments of PSURs as well as some referrals and PASSes.

With transitioning the RPM to the IRIS-portal, it does not mean that the submission route will also go via the IRIS-portal. The current submission route for CAPs via the eSubmission Gateway will still continue to be used. 

According to EMA the transition of the submission management to the IRIS portal “will lead in the long term to process simplification and standardization for MAHs”. Its intention is to have all post-authorization processes managed on IRIS by Q4 of 2024, impacting all MAHs with Centrally Authorised Products (CAPs).

So, if you are a MAH with CAP(s) and you would like to prepare for what is coming this year, you should first request access as an IRIS industry user via the EMA Account Management System. 

If you have any questions or would like to have more information on how the transition of PRM to the IRIS platform will impact your company, please contact us via our Contact form.

Regulatory Procedure Management for Centrally Authorised Products transitions to IRIS platform