Guideline on good pharmacovigilance practices (GVP) – Module V (Rev 2)
EMA/838713/2011 Rev 2
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) .................. 8
V.B.4. RMP part I “Product(s) overview” ...................................................................... 11
V.B.5. RMP part II “Safety specification” ...................................................................... 12
V.B.5.1. General considerations for generic products and advanced therapy medicinal
products .................................................................................................................. 12
V.B.5.1.1. Generics ................................................................................................... 12
V.B.5.1.2. Advanced therapy medicinal products........................................................... 12
V.B.5.2. RMP part II, module SI “Epidemiology of the indication(s) and target population(s)”
.............................................................................................................................. 13
V.B.5.3. RMP part II, module SII “Non-clinical part of the safety specification” ................. 13
V.B.5.4. RMP part II, module SIII “Clinical trial exposure” .............................................. 14
V.B.5.5. RMP part II, module SIV “Populations not studied in clinical trials” ...................... 14
V.B.5.6. RMP part II, module SV “Post-authorisation experience” .................................... 15
V.B.5.7. RMP part II, module SVI “Additional EU requirements for the safety specification” 15
V.B.5.8. RMP part II, module SVII “Identified and potential risks” ................................... 15
V.B.5.8.1. RMP part II, module SVII section “Identification of safety concerns in the initial
RMP submission” ...................................................................................................... 17
V.B.5.8.1.a. RMP part II, module SVII sections “Risk considered important for inclusion in
the list of safety concerns” and “Risk not considered important for inclusion in the list of
safety concerns” ....................................................................................................... 17
V.B.5.8.2. RMP part II, module SVII section “New safety concerns and reclassification with a
submission of an updated RMP” .................................................................................. 17
V.B.5.8.3. RMP part II, module SVII section “Details of important identified risks, important
potential risks, and missing information” ..................................................................... 18
V.B.5.9. RMP part II, module SVIII “Summary of the safety concerns” ............................ 18
V.B.6. RMP part III “Pharmacovigilance plan (including post-authorisation safety studies)” 19
V.B.6.1. RMP part III section “Routine pharmacovigilance activities” ............................... 19
V.B.6.1.1. Specific adverse reaction follow-up questionnaires ......................................... 20
V.B.6.1.2. Other forms of routine pharmacovigilance activities ....................................... 20
V.B.6.2. RMP part III section “Additional pharmacovigilance activities” ............................ 20
V.B.6.3. RMP part III section “Summary table of additional pharmacovigilance activities” .. 21
V.B.7. RMP part IV “Plans for post-authorisation efficacy studies” ................................... 22
V.B.8. RMP part V “Risk minimisation measures (including evaluation of the effectiveness of
risk minimisation activities)” ...................................................................................... 22
V.B.8.1. RMP part V section “Risk minimisation plan” .................................................... 25
V.B.8.2. RMP part V section “Summary of risk minimisation measures” ........................... 25
V.B.9. RMP part VI “Summary of the risk management plan” ......................................... 25
V.B.10. RMP part VII “Annexes to the risk management plan” ........................................ 26
V.B.10.1. RMP annex 1 .............................................................................................. 26