Almac Brexit Solutions Hub
Almac's European Campus, Dundalk, Ireland
Following the EU referendum in 2016 Almac acted quickly to put in place its Brexit solution. We built our European Campus in Dundalk, Ireland to provide permanent access to the EU regardless of the specific details of any future UK exit.
Our new European campus places Almac in a unique position as Northern Ireland will be the only part of the UK to have a land border with the EU. In addition, it enables the continued use of Dublin airport as a European gateway.
The HPRA (Health Products Regulatory Authority (Ireland)) approved site enables Almac to conduct QP batch certification and release for both clinical trial material and commercial drug product directly from the EU. We offer a custom built QC laboratory and a processing facility for commercial drug product services including packaging, labeling, secondary pack out and kit assembly, walleting, blister overprinting and serialization. In addition, our dedicated 79,000 ft2 EU distribution center for clinical trial material offers GMP receipt & storage, QP certification, JIT labeling and global logistics.
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The “transition period” will last at least until 31 December 2020, subject to the UK and EU agreeing to extend the transition period further.
For the duration of the transition period, the UK will remain within the EU single market and customs union.
UK formally exits the EU and enters a transition period on 1 February 2020.
Almac Group announces the completion of the final phase of its £35 million custom-built European Campus in Dundalk, County Louth, Ireland on the 21st October 2019. This site provides uninterrupted service provision to its global clients regardless of the outcome of the Brexit negotiations.
Almac Group announces successful HPRA inspection of its QC laboratory on 02nd October 2018
Almac Group announces further expansion at its European Campus in Dundalk on the 18th January 2018 following the successful completion of HPRA inspections
Formal negotiations begin between the United Kingdom and the European Union
The UK served formal notice that it would exit the European Union
Almac Group announces further global expansion as it secures new premises in Dundalk, Republic of Ireland on the 26th January 2017
Almac Group initiates Brexit Steering Committee
The UK decided, by referendum, to leave the European Union
Brexit - a seamless solution
Timely assurance to you, our client, in relation to Brexit negotiations
Brexit Solutions Hub
What is Brexit?
Brexit is the withdrawal of the United Kingdom from the European Union voted for by the UK electorate in a referendum on 23 June 2016.
What is the time frame for Brexit?
The EU Withdrawal Agreement was ratified by UK Parliament in January 2020. The UK entered into a Transition Period on 01st February 2020 (until at least 31 Dec 2020), during which time the UK will retain the rights & obligations of EU membership as if it remained an EU Member State.
What is the 'transition' period?
The transition period is intended to smooth the path to a future permanent relationship.
The transition period enables the UK to exit the EU but remain within the single market and customs union (and retaining other rights and obligations of EU membership as if it remained an EU Member State). This period will allow businesses to prepare for the time when the new post-Brexit rules between the UK and the EU commence. It also allows more time for the details of the new relationship to be fully negotiated.
As Almac is a UK based company, how will Brexit affect me as a client?
There will be no impact on our clients as continuity of service is guaranteed – we have made a commitment to all our clients that there will be no period that Almac doesn’t have a presence within the EU.
How can Almac guarantee this?
During the transition period, it is business as usual for Almac clients. This is because during the transition period, the UK will remain within the EU single market and customs union (subject to all the rights and obligations that entails).
After the transition period, it will remain business as usual for Almac clients (regardless of the nature of the deal agreed between UK and the EU). This is because Northern Ireland remains aligned with the EU in relation to goods.
In any event, as part of our overall global expansion strategy, Almac has now firmly established an EU located operation as part of the Group based in Dundalk, Ireland. We are HPRA approved to conduct QP batch certification and release for both clinical trial material and commercial drug product directly from the EU. Further development of the European campus has expanded our presence within the EU by establishing a processing facility for commercial drug product services including packaging, labeling, secondary pack out and kit assembly, walleting, blister overprinting and serialization. In addition, our dedicated 79,000 ft 2 EU distribution center for clinical trial material offers GMP receipt & storage, QP certification, JIT labeling and global logistics and a custom-built QC laboratory.
What is the timeframe for this European campus?
Almac’s European campus was complete and fully operational well before the UK left the European Union.
The first phase was completed in January 2018, and Almac’s European campus in Dundalk has been regulatory-compliant in relation to batch certification and release of both clinical trial material and commercial drug product since then. Its dedicated QC laboratory was HPRA approved in October 2018 enabling analysis of commercial drug product on site. In early October 2019 the final phase was completed and approved, adding Just-In-Time Labeling and Just-In-Time Manufacturing capability, as well as additional capacity to the campus offering for GMP receipt & storage, QP certification, clinical trial supply distribution and global logistics, ensuring that a complete Brexit solution was in place before the Brexit deadline.
What other measures has Almac taken in preparation for Brexit?
Almac continues to engage with the UK Government and other key stakeholders to pose vital questions regarding the Brexit process and to help ensure that relevant key issues are addressed during the negotiations.
How can I find out more about Almac’s solution to Brexit?
Please contact your Almac representative for more information or alternately complete the form on this page and we will be in contact soon.
What is AEO and does Almac have it?
Yes, we have Authorized Economic Operator (“AEO”) status, an internationally recognized quality mark that covers international movement of goods, and which can provide the right to fast-track shipments through customs and safety and security procedures.