Safety Specification

A Safety Specification stands as a critical element within a Risk Management Plan (RMP), offering a concise overview of the safety profile of medicinal product(s). It encompasses both established knowledge and gaps in understanding concerning the product(s) in question.

This summary encapsulates significant identified risks, potential risks of importance, and areas where information is lacking.

Furthermore, it addresses the demographic groups that might be vulnerable (including labeled and off-label usage scenarios) and outlines unresolved safety queries that necessitate further investigation to refine comprehension of the risk-benefit equilibrium subsequent to product authorization.