The European Commission has advised Marketing Authorisation Holders (MAHs) to abandon their ‘wait and see’ approaches to Brexit and act as if the United Kingdom (UK) will split decisively from the European Union (EU) in 12 months’ time, despite the proposed transitional period which will last from Brexit day on 29th March to 31st December 2020. Officials fear complacency will lead to supply disruptions if attempts to either soften or defer Brexit collapse.
The European Medicines Agency (EMA) has consistently advised MAHs to prepare for the UK to be treated as a third country from the end of March 2019 onward. This creates a relatively near-term deadline for MAHs to relocate their activities and regulatory records from the UK to other member states. However, amid uncertainty about the timing and nature of Brexit, it is thought that some MAHs have opted to delay committing time and money to preparations.
In the summary of a recent technical expert seminar, the Commission stated that “many MAHs have not yet taken the necessary regulatory actions, such as marketing authorisations transfers and relocation of Qualified Person Responsible for Pharmacovigilance (QPPV). While recognising the complexity of some of these procedures for companies to put in motion, there seems to be also a ‘wait and see’ approach by the MAHs”. The proposed transition period may encourage more companies to defer contingency planning in a belief that little will change for at least 20 months, however the UK could still crash out of the EU with no deal in March 2019.
Officials plan to step up communication with MAHs to encourage them to act now. The seminar summary highlighted the investments national regulators are making to equip themselves to handle work now performed by the Medicines and Healthcare products Regulatory Agency (MHRA), calling the commitments “valuable and essential.”
The Commission plans to hold another technical seminar in the second quarter.
To read more about the European Commission’s summary on the technical expert seminar on pharmaceuticals related matters, following the UK withdrawal, please click here.