EMA Gives Update on Brexit Plans

The European Medicines Agency published a report on Nov. 13, 2018 of its Sept. 24, 2018 meeting with industry stakeholders to discuss Brexit plans and their impact on agency procedures. The agency stated in a press release that, besides some delays in processing EMA certificates, EMA procedures (such as marketing authorization applications, scientific advice, and orphan designation, etc.) will not be impacted by the agency’s relocation to Amsterdam and throughout 2019. EMA is advising companies to submit applications and requests “as normal”.

Phase three of EMA’s Brexit preparedness business continuity plan began on Oct. 1, 2018. Some activities were temporarily suspended or reduced such as guideline development and revision. “These steps have been taken to ensure that EMA can focus on its core business of protecting human and animal health and that freed-up resources can be redeployed to allow the Agency to safeguard its core activities related to the evaluation and supervision of medicines,” the agency stated in a press release. The agency anticipates additional temporary suspension or reductions starting Jan. 1, 2019 as part of phase four of its Brexit plan. 

Source: EMA