The Sweden-headquartered contract development and manufacturing organization (CDMO) has formed a “Brexit taskforce” to manage the transition, which is now less than a year away.
“The taskforce will assess all products and capabilities that have the potential to be impacted by Brexit,” explained Thomas Beck, senior vice president quality management, Recipharm.
“In case a Mutual Recognition Agreement is not met between the EU and the UK, the taskforce will support implementation of the analytical and quality requirements to enable a seamless Brexit for our customers,” he told us.
As part of the preparations, the company also plans to recruit more staff in laboratory and regulatory positions, as additional analytical, release testing, and administration requirements are expected post-Brexit.
Beck noted that the European Medicines Agency (EMA) has decided that the UK will be considered a "Third Country," in the same way India is, for example.
However, because Recipharm already operates "Third country" importation within the group, Beck said: “this is nothing new for us and we are well prepared to meet the challenges.”