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E2C (R2) Step 5 Periodic benefit-risk evaluation report ...

January 2013 EMA/CHMP/ICH/544553/1998 ICH guideline E2C (R2) on Periodic benefit-risk evaluation report (PBRER) Step 5 Transmission to CHMP April 2012 Adoption by CHMP for release for consultation April 2012 End of consultation (deadline for comments) May 2012 Final adoption by CHMP December 2012 Date for coming into effect January 2013 7 Westferry Circus Canary Wharf London E14 4HB United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail Website European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged. EC2 (R2) Periodic benefit-risk evaluation report (PBRER) Table of contents 1. Introduction .. 4 Background .. 4 Objectives .. 5 Scope of the PBRER .. 6 Relation of the PBRER to other ICH documents .. 7 2. General principles .. 7 Single PBRER for an active substance .. 7 PBRERs for fixed dose combination product.

determine if changes were needed to the reference safety informa tion* (RSI) in order to optimise the continued safe use of the product. The guideline was revised in 2003, to provide needed clarification, guidance and flexibility. Since that time, the pharmacovigilance environment has evolved, prompting reassessment of the role

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