EMA's risk-management-plan hub brings together the operational materials used to prepare and maintain EU RMPs.
Official resource
What the hub contains
The page provides current RMP templates and supporting documents, post-authorisation procedural questions and answers, publication material and links to related risk-management guidance.
Practical use
Use this resource when preparing or updating an EU RMP, confirming the current template, or determining how an RMP should be handled during a post-authorisation procedure.
The procedural material should not be read in isolation. The substantive pharmacovigilance framework comes from applicable EU legislation and GVP Module V, while EMA procedural advice explains how those requirements are implemented for relevant EMA procedures.