Paediatric submissions in IRIS

From 4 June 2024, paediatric submissions such as paediatric investigation plans, waivers or deferrals will have to be made via the IRIS platform (see webpage). More information and guidance on IRIS is available in a specific section in the IRIS website. Applicants can also refer to a video recording of the EMA Quarterly System Demo. 

Commercially confidential information and personal data

An EMA/HMA guidance document on how to identify and handle commercially confidential information and personal data in documents relating to human marketing authorisation applications and post-authorisation activities, that are subject to access to documents requests and publication in accordance with Regulation (EC) No. 1049/2001 or National legislations, has been released for public consultation until 28 June 2024.