Guideline on good pharmacovigilance practices (GVP) Module V – Risk management systems (Rev 2):
Introduction:
A medicinal product is authorised on the basis that in the specified indication(s), at the time of authorisation, the risk-benefit balance is judged to be positive for the target population. Generally, a medicinal product will be associated with adverse reactions and these will vary in terms of severity, likelihood of occurrence, effect on individual patients and public health impact. However, not all adverse reactions and risks will have been identified at the time when an initial marketing authorisation is granted and some will only be discovered and characterised in the post-authorisation phase. The aim of a risk management plan (RMP) is to document the risk management system considered necessary to identify, characterise and minimise a medicinal product’s important risks.
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Table of contents
V.B.1. Principles of risk
management
V.B.2. Responsibilities for
risk management
V.B.3. Overview of the format
and content of the risk management plan (RMP)
V.B.4. RMP part I “Product(s)
overview”
V.B.5. RMP part II “Safety
specification”
V.B.5.1. General considerations
for generic products and advanced therapy medicinal products
V.B.5.1.2. Advanced therapy
medicinal products
V.B.5.2. RMP part II, module SI
“Epidemiology of the indication(s) and target population(s)”
V.B.5.3. RMP part II, module
SII “Non-clinical part of the safety specification”
V.B.5.4. RMP part II, module
SIII “Clinical trial exposure”
V.B.5.5. RMP part II, module
SIV “Populations not studied in clinical trials”
V.B.5.6. RMP part II, module SV
“Post-authorisation experience”
V.B.5.7. RMP part II, module
SVI “Additional EU requirements for the safety specification”
V.B.5.8. RMP part II, module
SVII “Identified and potential risks”
V.B.5.9. RMP part II, module
SVIII “Summary of the safety concerns”
V.B.6. RMP part III
“Pharmacovigilance plan (including post-authorisation safety studies)”
V.B.6.1. RMP part III section
“Routine pharmacovigilance activities”
V.B.6.1.1. Specific adverse
reaction follow-up questionnaires
V.B.6.1.2. Other forms of
routine pharmacovigilance activities
V.B.6.2. RMP part III section
“Additional pharmacovigilance activities”
V.B.6.3. RMP part III section
“Summary table of additional pharmacovigilance activities”
V.B.7. RMP part IV “Plans for
post-authorisation efficacy studies”
V.B.8.1. RMP part V section
“Risk minimisation plan”
V.B.8.2. RMP part V section
“Summary of risk minimisation measures”
V.B.9. RMP part VI “Summary of
the risk management plan”
V.B.10. RMP part VII “Annexes
to the risk management plan”
V.B.10.4. RMP annex 4: Specific
adverse event follow-up forms
V.B.10.5. RMP annex 5:
Protocols for proposed and on-going studies in RMP part IV
V.B.10.6. RMP annex 6: Details
of proposed additional risk minimisation activities
V.B.10.7. RMP annex 7: Other
supporting data (including referenced material)
V.B.10.8. RMP annex 8: “Summary
of changes to the risk management plan over time”
V.B.11. The relationship
between the risk management plan and the periodic safety update report
V.B.12. Quality systems and
record management
V.C. Operation of the EU
network
V.C.1. Requirements for the
applicant/marketing authorisation holder in the EU
V.C.1.1. Risk management plans
with initial marketing authorisation applications
V.C.1.1.1. New applications
under Article 10(1), i.e. “generic”
V.C.1.1.2. New applications
under Article 10c, i.e. “informed consent”
V.C.1.1.3. New applications
under Article 10(3), i.e. “hybrid”
V.C.1.1.4. New applications
under Article 10b, i.e. involving “fixed combination” medicinal products
V.C.1.1.5. New applications
under Article 10a, i.e. “well established medicinal use”
V.C.1.1.6. New applications
under Article 10(4), i.e. “biosimilar products”
V.C.1.2. Risk management plans
first submitted post-authorisation
V.C.1.2.2. Unsolicited risk
management plan submission in post-authorisation phase
V.C.2. Submission of a risk
management plan to competent authorities in the EU
V.C.2.1. Risk management plans
updates
V.C.3. Assessment of the risk
management plan within the EU regulatory network
EMA GVP Module 5: