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:

The Pharma Letter

Regulatory Focus

For more information please contact Julia Gillert of our London office, or Els Janssens of our Abu Dhabi office.

Author

Julia Gillert is a Senior Associate in the Corporate Department of Baker & McKenzie's London office and is a key member of the Healthcare industry group within the London office and European and Global networks. Julia advises both domestic and international companies in the med-tech, pharma and healthcare sectors on a wide range of regulatory and general compliance matters. Julia has contributed to a variety of regulatory healthcare related publications and practice handbooks and co-edits the firm's European Healthcare Newsletter. Julia sits on the ABHI's Legal Issues Committee.

Author

Els Janssens is a senior associate in our Abu Dhabi office and provides knowledge management support to Baker & McKenzie’s global and MENA Pharmaceutical and Healthcare industry group. Els started her career in 2000 at Baker and McKenzie in Brussels focusing her practice on pharmaceutical law and commercial litigation. She has worked six years in London as a legal adviser with the European Medicines Agency (EMA). During this period she has supported the EMA’s activities in medicines oversight and regulation and interacted with the European Commission on legal matters relating to medicinal products. She also worked one year as senior legal counsel in Johnson & Johnson’s European legal department providing regulatory advice regarding various medicinal products and supporting the public affairs function on new legislation.

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