Challenges in coordinating a pan-European recall

John Blain, Andrew Austin

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

Recall

Retrofit

Supply chain withdrawal

On-pack warnings

Public warnings

Change supply route

Notify intermediarie

s

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

Bulgaria Ghana Jordan

Croatia Kenya Kuwait

Macedonia Madagascar Lebanon

Romania Nigeria Saudi Arabia

Turkey Senegal Syria

Armenia South Africa India

Georgia Sudan Pakistan

Turkmenistan Zimbabwe KEY

Must notify

Advisable to notify

Needn’t notify

Ukraine Zambia

Djibouti Iran

Egypt Israel

© Freshfields Bruckhaus Deringer 2006

This material is for general information only and is not intended to provide legal advice.