Draft guidance on format of the risk management plan (RMP) in the EU – in integrated format

  • Email
  • Help

Document details

Download document Draft guidance on format of the risk management plan (RMP) in the EU – in integrated format
Reference number EMA/PRAC/613102/2015 Rev.2 accompanying GVP Module
Status draft: consultation closed
First published 2016-02-29
Last updated 2016-02-29

Summary

The European Medicines Agency is consulting stakeholders on an amended risk management plan (RMP) template, to be used by medicine developers. The revision of the template is based on the principles described in the updated good pharmacovigilance practices (GVP) module V in the view of getting a focussed risk management system and simplifying the way information is submitted to the regulators.