Periodic Benefit Risk Evaluation Reports (PBRERs) are essential pharmacovigilance documents prepared and submitted by marketing authorization holders at specific time intervals following a product’s authorization. The primary purpose of these reports is to offer a comprehensive, concise, and critical assessment of the risk-benefit balance associated with a medicinal product. This evaluation takes into account both new or emerging information as well as cumulative data related to the product’s risks and benefits. PBRERs play a vital role in ensuring the ongoing safety and effectiveness of medicinal products in the post-authorization phase.
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