On Tuesday 19 June, the European Medicines Agency (EMA) released an updated Brexit guidance for pharmaceutical companies; cautioning them to be proactive in the wake of the UK’s withdrawal from the EU in March 2019. The EMA advises that proper planning and preparations are made to shield against consequences of a no-deal Brexit, which would see the UK treated as a third country outside the EU. This could result in supply chain disruptions of medicines both for human and veterinary use, a change in the status of inspection outcomes, of batch release processes and the marketing of multi-country packs of medicine.
A Different Approach?
The updated guidance is in line with previously published guidance but offers additional detail:
A practical guidance procedure outlining the steps companies must take to ensure they have the proper marketing authorization to continue to market their medicine in the EU after Brexit became available.
Other updates include a point of contact for companies at EMA for Brexit-related matters, a process update regarding transfer of orphan designations from a UK based sponsor to those in the EEA and how national scientific advice from UK authorities will be considered going forward.
For review of the latest press on the matter:
For more information please contact Julia Gillert of our London office, or Els Janssens of our Abu Dhabi office.