Northern Ireland-based Almac Group has welcomed confirmation from the EU’s medicines regulator, the EMA, that, post-Brexit, Northern Ireland will remain in regulatory alignment with the EU, acknowledging that EU laws, in respect of medicinal products, shall continue to apply in Northern Ireland. The UK Government has now also confirmed that this will be the case.
As a result, manufacturing and associated QP (Qualified Person) certification, for both clinical supplies and commercial product performed at Almac’s global HQ site in Craigavon, will continue to be recognized both by the UK and European regulatory agencies and allow products processed at its facilities seamless regulatory movement into both the EU and UK.
“This latest confirmation, coming from both the EU and the UK, is a welcome step and ensures our current and future clients can continue to receive an unfettered solution with exclusive access to both the EU and UK marketplace. Crucially, our unique location in Northern Ireland ensures we can provide uninterrupted service provision now, and into the future, maintaining our position as a global leader in the life sciences sector," Alan Armstrong, CEO, Almac Group, said.
This news comes three years after the Group established a bespoke facility in Dundalk, Ireland, which enabled Almac to provide access to the EU, regardless of the final shape of Brexit.