Annex I: Risk management plans

Location:
Annex
Source:
Eur-Lex

Format of the risk management plan

The risk management plan shall consist of the following modules:

Part I:

 Product(s) overview

Part II:

 Safety specification

Module SI:

 Epidemiology of the indication(s) and target population(s)

Module SII:

 Non-clinical part of the safety specification

Module SIII:

 Clinical trial exposure

Module SIV:

 Populations not studied in clinical trials

Module SV:

 Post-authorisation experience

Module SVI:

 Additional EU requirements for the safety specification

Module SVII:

 Identified and potential risks

Module SVIII:

 Summary of the safety concerns

Part III:

 Pharmacovigilance plan (including post-authorisation safety studies)

Part IV:

 Plans for post-authorisation efficacy studies

Part V:

 Risk minimisation measures (including evaluation of the effectiveness of risk minimisation activities)

Part VI:

 Summary of the risk management plan

Part VII:

 Annexes