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Long Description: Figure 2: Submission of 6-month and annual periodic benefit-risk evaluation reports (PBRERs)

This figure indicates that Region 1 requires 6-monthly PBRER and receives PBRER A, B, C and D (assuming agreement has been reached with pertinent regulatory authority[ies]). Region 2 requires annual PBRER and receives PBRER B and D. MAHs should discuss the acceptability of this approach with the relevant regulatory authority(ies). 6-month PBRER are for A and B, annual PBRER are for B and D.