Document details
| Download document | Guideline on good pharmacovigilance practices (GVP): Module XVI– Risk minimisation measures: selection of tools and effectiveness indicators |
|---|---|
| Reference number | EMA/204715/2012 |
| Status | draft: consultation open |
| First published | 07/06/2013 |
| Last updated | 07/06/2013 |
| Consultation start date | 07/06/2013 |
| Consultation end date | 05/08/2013 |
| Email address for submissions | gvp@ema.europa.eu |
Summary
Risk minimisation measures are public health interventions intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to reduce their severity or impact on the patient should adverse reactions occur. Planning and implementing risk minimisation measures and assessing their effectiveness are key elements of risk management.
This Module provides guidance on the principles for:
• the development and implementation of additional risk minimisation measures, including examples 89 of risk minimisation tools;
• the evaluation of the effectiveness of risk minimisation measures.