Updating Product Information

Updating Product Information - Safety Variations

The safety profile of a medicine can change throughout its lifecycle as new safety information emerges. New safety information can arise from a number of different sources including the conclusions of a PSUR or as the outcome of a PRAC signal assessment. In certain cases a change to the product information may be warranted to reflect the updated safety information which involves updating the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL). The pharmaceutical company is responsible for submitting an update to their product information as a variation to its licence which must occur in a timely manner. This ensures that the product information for a medicine contains the most up to date safety information.