The European Medicines Agency EMA expects some uncertainty and higher workload because of the United Kingdom's withdrawal from the European Union (Brexit). To preserve the Agency's "ability to protect public and animal health", EMA has defined three categories to prioritise activities in a business continuity plan:
Category 1: Activities which need to be continued to avoid production and distribution risks and a "detrimental effect on the health and well-being of citizens".
Category 2: Activities which need to be maintained as long as possible to maintain the development of new medicines.
Category 3: Activities which can be put on hold.
Category 1 activities:
Assessment and safety monitoring of medicines
Maintaining the infrastructure of the European regulatory system for medicines
Coordination of actions to protect the safety of patients
Inspections/ maintenance of critical IT applications used by all Member States
Category 2 activities:
Proactive publication of clinical data
Initiatives aimed at promoting availability of medicines
Fight against antimicrobial resistance
Interactions with Health Technology Assessment (HTA) bodies
Category 3 activities:
Development of the European Medicines Web Portal (a new publicly-available online information source on all medicines marketed in the EU)
Contribution to the e-submission project
Development of a transparency roadmap
Participation in the benchmarking of medicines regulatory authorities in the EU
Participation in external meetings or conferences
Organisation of EMA meetings and workshops.
Despite the a business continuity plan, EMA is aware that "unexpected higher, faster or more permanent loss of staff as a consequence of the Agency's relocation may lead to a situation in which EMA's operations can no longer be maintained."