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.

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

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

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

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

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

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

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