Brexit  – a seamless solution

Brexit – a seamless solution

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Almac Brexit Solutions Hub

Almac's European Campus, Dundalk, Ireland

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. In addition we can offer support analysis of commercial drug product and provide flexible secondary labeling and packaging solutions.

Frequently Asked Questions


Almac Brexit Timeline

Dec 2020

There is a proposed transition period from 29 March 2019 - 31 Dec 2020

March 2019

The UK is currently scheduled to exit the European Union on 29 March 2019

October 2018

Almac Group announces successful HPRA inspection at its European Campus

January 2018

January 2018

Almac Group announces further expansion at its European Campus in Dundalk on the 18th January 2018 following the successful completion of HPRA inspections

June 2017

Formal negotiations begin between the United Kingdom and the European Union

March 2017

The UK served formal notice that it would exit the European Union

January 2017

January 2017

Almac Group announces further global expansion as it secures new premises in Dundalk, Republic of Ireland on the 26th January 2017

July 2016

Almac Group initiates Brexit Steering Committee

June 2016

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 impending 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?

UK exit cannot happen before 29 March 2019 (the UK served formal notice on 29 March 2017, and applicable EU law requires a full 2-year notice period). Whilst the UK is currently scheduled to exit the EU on 29 March 2019, this date could be extended with agreement of the EU27 and UK.

What is the 'transition' period?

It refers to a period of time between 29 March 2019 and 31 December 2020 (which has been agreed in principle by the EU27 and UK, subject to both sides agreeing a final Withdrawal Treaty) to smooth the path to a future permanent relationship. The proposed 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 21-month 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?

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 currently 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 will expand 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. A dedicated 79,000 ft 2 EU distribution center for clinical trial material including GMP receipt & storage, QP certification, JIT labeling and global logistics and a custom built QC laboratory.

What is the timeframe for this European campus?

Our existing Dundalk facility is currently regulatory-compliant in relation to batch certification and release of product. We will continue to develop our European campus operations, in parallel to the negotiations on the UK’s exit from the EU, as required, thus providing an ongoing operational presence and ensuring uninterrupted service offerings within the EU well before the minimum timescale for UK’s exit which cannot happen before March 2019.

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.

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