European Commission – DG SANCO Workshop “Economic Operators’ Obligation to Notify Dangerous Products” Practical Aspects of Dealing with the Notification Obligation Rod Freeman Partner, Product Liability Brussels 1 December 2006

The notification to authorities is not just a process Key Point:

Know your product Know the safety profile of your product –Are you in a position to put market reports in their context? –Do you take a worldwide approach to risk assessment? The challenge of conducting a meaningful risk assessment –Care when using methodology in Commission Guidelines

Know your product Know where the product has gone Know your market Traceability

Know what needs to be done Have your correction action plan ready Access to key information Access to decision-makers Ability to implement

A successful notification paves the way for a successful recall 5 tips for achieving it

Tips for a successful notification Tip 1 – Keep a global view –Don’t make the mistake of treating the EU as an afterthought to the US –Timing? –Content?

Tips for a successful notification Tip 2 – Don’t forget the importance of the personal touch –Give the enforcement authorities a point of contact –Use the opportunity to develop a constructive relationship, not destroy one

Tips for a successful notification Tip 3 – Know how to deal with confidential information

Tips for a successful notification Tip 4 – Keep control of a consistent message Set up systems to enable you to be responsive

Tips for a successful notification Tip 5 – Planning is everything