Regulatory News

EMA to Pharma Companies: Prepare for UK to EU Shift

Setting the stage for a likely exodus from the UK for pharmaceutical manufacturers and staff, the European Medicines Agency (EMA) on Tuesday notified marketing authorization holders (MAHs) that for centrally authorized products, EU law requires them to be established in the EU or European Economic Area, which includes Iceland, Liechtenstein and Norway.

EMA also notified MAHs that some of their activities must be performed in the EU (or EEA), related for example to pharmacovigilance and batch release, among others.

“Preparing for the withdrawal is therefore not just a matter for European and national administrations, but also for private parties,” EMA said. “Marketing authorisation holders may be required to adapt processes and to consider changes to the terms of the marketing authorisation in order to ensure its continuous validity and exploitation, once the United Kingdom has left the Union.”

In addition, EMA and the European Commission said they expect MAHs to prepare and proactively screen authorized medicines for any necessary changes.

“The necessary transfer or variation requests will need to be submitted in due time considering the procedural timelines foreseen in the regulatory framework,” EMA said. “Marketing authorisation holders will need to act sufficiently in advance to avoid any impact on the continuous supply of medicines for human and veterinary use within the European Union.”

The medicines agency last week also noted that they are planning their own workload shift to fill gaps when UK experts no longer work with EMA.

EMA spokesperson Ester Arauzo Azofra told Focus via email on Tuesday that no date has been set yet for EMA’s departure from London, “but there is a shared understanding that this needs to be settled rapidly.”

Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use

EMA on United Kingdom’s withdrawal from the European Union