EMA Plots Out Priorities to Deal With Brexit Uncertainties

Regulatory News

The European Medicines Agency (EMA) on Monday released its Brexit Preparedness Business Continuity Plan, saying it will prioritize its core scientific activities, including urgent and significant public health threats relating to the safety and quality of medicinal products for human and veterinary use in the EU.

EMA said it's planning a phased implementation of the continuity plan, and in its first phase it will temporarily suspend or reduce lower priority activities to free up enough resources to prepare for Brexit.

“The second phase, whilst focusing on freeing-up additional resources for EMA preparedness for 2018 and 2019, also aims at ensuring that activities with the highest priority as described before can continue in a situation where staff loss can no longer be compensated through recruitment,” the plan said.

Among its most core scientific activities, EMA says it will prioritize urgent pharmacovigilance or quality defect issues, the suspension or withdrawal of a centrally authorized product (CAP) or non-CAP due to quality defects, urgent safety restrictions or variations, the detection of safety issues and what member states should track, the access and operations of the medicines supply, and sampling and testing inspections.

In terms of what has been postponed, EMA noted a number of activities. The public consultation of the draft EMA “Transparency Roadmap” is postponed until further notice and e-submission work will also be temporarily suspended  until further notice.

The continuity plan will be continuously reviewed and adapted as necessary, EMA added.

EMA’s Business Continuity Plan for Brexit