BCI PRINCIPLES AND CRITERIA
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If you redistribute this textbook in a digital format (including but not limited to PDF and HTML) then you must retain on every page the following
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See websites for contact details
European Medicines Agency www.ema.europa.eu
Heads of Medicines Agencies www.hma.eu
The European Medicines Agency is
an agency of the European Union © European Medicines Agency and Heads of Medicines Agencies, 2017. Reproduction is authorised provided the source is acknowledged.28 March 2017
EMA/838713/2011 Rev 2*
Guideline on good pharmacovigilance practices (GVP)Module V ± Risk management systems (Rev 2)
Date for coming into effect of first version 2 July 2012 Date for coming into effect of Revision 1 28 April 2014 Draft Revision 2* finalised by the Agency in collaboration with MemberStates
16 February 2016
Draft Revision 2 agreed by the European Risk Management FacilitationGroup (ERMS FG)
23 February 2016
Draft Revision 2 adopted by Executive Director 24 February 2016Release for public consultation 29 February 2016
End of consultation (deadline for comments) 31 May 2016 Revised draft Revision 2 finalised by the Agency in collaboration withMember States
9 March 2017
Revised draft Revision 2 agreed by the EU Network PharmacovigilanceOversight Group (EU-POG)
23 March 2017
Revised draft Revision 2 adopted by Executive Director as final 28 March 2017 Date for coming into effect of Revision 2* 31 March 2017 Note: RMPs submitted for initial marketing authorisation applications and D121 responses applying GVP Module V Rev 1 will be accepted for a further 6 months, and all other RMP submissions (includingD91 responses for an initial application under accelerated assessment) will be accepted for one further
year until 31 March 2018. * Note: Revision 2 is a major revision with modifications throughout and contains the following: further clarification of what RMPs should focus on in relation to an important identified or important potential risk and missing information; removal of duplication within GVP Module V; removal of duplication of information in other guidance documents; Guideline on good pharmacovigilance practices (GVP) ± Module V (Rev 2)EMA/838713/2011 Rev 2
Page 2/36
further guidance on the expected changes in the RMP during the life cycle of the product; updated requirements for different types of initial marketing authorisation applications, with the aim to create risk-proportionate RMPs. The guidance is updated in parallel to an amended RMP template for initial marketing authorisation application. Guideline on good pharmacovigilance practices (GVP) ± Module V (Rev 2)EMA/838713/2011 Rev 2
Page 3/36
Table of contents
V.A. Introduction ......................................................................................... 5
V.A.1. Terminology ..................................................................................................... 6
V.B. Structures and processes ..................................................................... 7
V.B.1. Principles of risk management ............................................................................ 7
V.B.2. Responsibilities for risk management ................................................................... 8
V.B.3. Overview of the format and content of the risk management plan (RMP) .................. 89B%B4B 503 SMUP H ³3URGXŃPV RYHUYLHR´ ...................................................................... 11
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V.B.5.1. General considerations for generic products and advanced therapy medicinalproducts .................................................................................................................. 12
V.B.5.1.1. Generics ................................................................................................... 12
V.B.5.1.2. Advanced therapy medicinal products........................................................... 12
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