Revision of the Incident Management Plan for Medicines for Human Use (IMP‑H)
The EMA has updated its Incident Management Plan for Medicines for Human Use , strengthening how the European medicines regulatory network identifies, assesses, communicates, and escalates incidents across quality, safety, and efficacy.
The objectives of the IMP-H are:
1. To continuously and proactively identify and monitor incidents, and to take the necessary action(s) to remedy the situation with the main aim to prevent an incident from developing into an IMP-H major event and, where necessary, escalate a potential IMP-H major event to the MSSG.
2. In the case of an IMP-H major event confirmed by the MSSG, to ensure the urgent and coordinated action within the EMRN. This activity is referred to in this document as IMP-H major event management.
14 Nov 2025:
Added new scope section clarifying incident types, authorisation routes, and public‑domain triggers.
Updated exchange‑of‑information guidance: sharper criteria for PhV Rapid Alerts vs Non‑Urgent Information, mailbox for emerging safety issues, and integration with EU defect alert systems.
Updated exchange‑of‑information guidance: sharper criteria for PhV Rapid Alerts vs Non‑Urgent Information, mailbox for emerging safety issues, and integration with EU defect alert systems