Quantitative Benefit-Risk Assessment for the New PSUR 2014

The latest legislation waives the obligation to submit PSURs routinely for generic products, well-established use products, homoeopathic products, and traditional herbal products. The submission frequency will be variable and risk based. For these, PSURs shall be submitted where there is a condition in the MA or when requested by a Competent Authority on the basis of concerns relating to pharmacovigilance data or due to the absence of PSURs for an active substance after its authorisation.