Guideline on good pharmacovigilance practices (GVP) 3 - Module V – Risk management systems (Rev 2)

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Download document Guideline on good pharmacovigilance practices (GVP) 3 - Module V – Risk management systems (Rev 2)
Reference number EMA/838713/2011 Rev. 2
Status draft: consultation closed
First published 2016-02-29
Last updated 2016-02-29

Summary

Good pharmacovigilance practices (GVP) module V, released in 2012, advises developers of medicines, marketing authorisation holders and regulators on the design of effective risk management systems and plans. This first major revision clarifies the activities a risk management plan should focus on during the life cycle of a product. This will help to ensure that a risk-proportionate planning of activities directs resources to areas where the need for additional information and risk minimisation is greatest.