1. Challenges in coordinating a pan-European recall John Blain, Andrew Austin To insert other ready-formatted pages: go to the insert menu/slides from files/ select ‘on-screen inserts.ppt’ Click the display button, then click the button on the right (marked with red below). Click on the slide(s) to insert then insert and close.

2. What is happening  Industry appreciation of new requirements is growing  But still a regime that is in transition

3. Challenges  Does the product fall within the GPS regime?  Sectoral regulation  Migration of commercial goods

4. Challenges  Notification  Massive frontloading of effort  Risk assessment  Methodology  Need for consistent approach across markets  Notify in one market or in all?  Confidentiality

5. Challenges  Dialogue with regulators  Recall as a last resort  Escalation via RAPEX RecallRetrofit Supply chain withdrawal On-pack warnings Public warningsChange supply route Notify intermediaries Product redesign Let the regulator dictate Let the insurers dictate

6. Challenges  Information/traceability  Internal and external communications  Resourcing  Regulatory liaison  And then there’s the world outside the EU…

7. Notification requirements in selected ex-EU markets BulgariaGhanaJordan CroatiaKenyaKuwait MacedoniaMadagascarLebanon RomaniaNigeriaSaudi Arabia TurkeySenegalSyria ArmeniaSouth AfricaIndia GeorgiaSudanPakistan TurkmenistanZimbabwe KEY Must notify Advisable to notify Needn’t notify UkraineZambia DjiboutiIran EgyptIsrael

8. © Freshfields Bruckhaus Deringer 2006 This material is for general information only and is not intended to provide legal advice.