Draft guidance on format of the risk management plan (RMP) in the EU – in integrated format

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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Download document Draft guidance on format of the risk management plan (RMP) in the EU – in integrated format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 open
First published 29/02/2016
Last updated 29/02/2016
Consultation start date 29/02/2016
Consultation end date 31/05/2016
Email address for submissions rmptemplate@ema.europa.eu

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.