Please note:

From January 2025, registration in IRIS will be mandatory for all lifecycle procedures managed by the EMA. It is important to note that nationally or decentrally authorised products may also be affected, e.g. for worksharings with NAPs/MRPs/DCPs and CAPs, single assessments of PSURs, referrals and post-authorisation safety studies. Therefore, please make sure that your company also applies for access to IRIS in good time, even if you do not have any centralised authorisations.