Almac Group Welcomes Confirmation that Northern Ireland’s Pharmaceutical Industry will Maintain Regulatory Alignment with the EU Post-Brexit
June 4, 2020
Move offers Almac clients unique, unfettered and flexible access to both the UK and European markets
Craigavon, N.I., 04 Jun 2020 – 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 recognised both by the UK and European regulatory agencies and allow products processed at its facilities seamless regulatory movement into both the EU and UK.
Due to the geographical location of its global headquarters in Craigavon, Northern Ireland, Almac Group is now in a uniquely advantageous position to offer its global client base unique, unfettered and flexible access to both the UK and European markets. This move provides customers the clarity, confidence and reassurance they have been seeking regarding continuity of supply to their patients throughout the transition period and beyond.
Alan Armstrong, CEO, Almac Group, commented: “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.”
This news comes three years after the Group established a bespoke facility in Dundalk, Ireland, which enabled Almac to guarantee immediate and seamless access to the EU, regardless of the final shape of Brexit. This proactive move provided welcome reassurance to its global clients at a time of uncertainty throughout the Brexit negotiations. This new confirmation around the NI protocol will offer clients even further reassurance around another of Almac’s facilities.
About Almac Group
A unique culture delivering exceptional solutions
The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, analytical services, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.