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Published byMarcus Whitehead Modified over 9 years ago
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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
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The notification to authorities is not just a process Key Point:
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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
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Know your product Know where the product has gone Know your market Traceability
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Know what needs to be done Have your correction action plan ready Access to key information Access to decision-makers Ability to implement
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A successful notification paves the way for a successful recall 5 tips for achieving it
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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?
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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
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Tips for a successful notification Tip 3 – Know how to deal with confidential information
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Tips for a successful notification Tip 4 – Keep control of a consistent message Set up systems to enable you to be responsive
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Tips for a successful notification Tip 5 – Planning is everything
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