By: Vicki Schofield, Regulatory Affairs Specialist, email
Proactively self auditing labels, particularly with registered products issued with DIN or NPN numbers can save headaches down the road.
Why? Because every notification or administrative change that is put through Health Canada’s submission process is not only reviewed based on one change. The review process is rigorous, and takes into account any new requirements and new recommendations in Health Canada’s Guidances since the product was first approved.
What does this mean? It can mean that a product which was approved many years ago, although considered “grandfathered” in, could potentially have cautions added, areas of use removed, or even claims impacted on any new label alterations submitted to Health Canada.
Dell Tech monitors any changes to Health Canada’s labelling requirements and is aware of potential road blocks when it comes to simple submissions.