An agency of the European Union Presented by: David Mackay Head of Unit, Veterinary Medicines & Product Data Management Unit Incident Management Plan Veterinary Medicines Sector

IMP - Veterinary Sector 2 Background & Aim First adoption of a crisis management plan regarding safety issues for centrally authorised products (CAPs) for veterinary use – CVMP, April 1999, Revised plan, to account for environment and organisation changes within EMA - CVMP plenary meeting, February Veterinary crisis management plan has never been triggered or considered being triggered Significant re-organisation of the EMA Veterinary Sector in 2009 Considerable experience gained by EMA with human medicines in last few years

IMP - Veterinary Sector 3 Objectives of the new plan Create a two stage procedure where ‘incidents’ are continually monitored for their possibility to develop into a ‘crisis’ and then handled appropriately Scope covers –By default, all products and procedures where the EMA has a legal obligation to be involved (CAPs and products subject to referral) –Optionally on request from National Head(s) of Agency, products authorised by other routes where coordination of action and/or communication at the level of the network has added value

IMP - Veterinary Sector 4 Objectives of the new plan (cont’d) The plan is intended –To ensure that all incidents –that have the potential to develop into a crisis, and –where EMA involvement is (CAPs) or may become (products subject to referral) obligatory –are systemically reviewed with both a view to identifying potential crises and invoking appropriate action –Experience has shown that Member States may request the EMA also to assist with coordination when handling incidents involving both CAPs and NAPs or, occasionally, NAPs alone –To facilitate that the European Regulatory Network ‘speaks as one voice’ in crisis situations, irrespective of the types of products involved

IMP - Veterinary Sector 5 Objectives of the new plan (cont’d) The plan is NOT intended –To extend the role of the EMA beyond that established in Regulation 724/2004 –To interfere in any way with the established right of the national competent authorities (NCAs) to take pre-emptive action at national level, in accordance with the provisions of Community legislation –To take on an additional role in ‘incident surveillance’ for products not under EMA competence

IMP - Veterinary Sector 6 Incident Identification Continuous Monitoring by EMA and NCAs European Commission Policy direction Adoption of opinions EMA Incident Review Group (EMA IRG) Preliminary Risk Analysis EU Veterinary Crisis Group (EU VCG) Overall Strategy - Communication CVMP / CMDv / PhVWP-V Scientific Assessment EU VCG Closure & report on evaluation NCAs Implementation Commission decisions National measures Inciden t IMP Lifecycle