PCI Brexit Communication, 12th April 2019
The European Council and the UK Prime Minister have agreed and announced an extension to Article 50 with a flexible Brexit delay until 31st October 2019, with a review at the end of June. However, the UK will be able to leave the EU before this October date should a deal be agreed by UK Parliament.
Once again we would like to reassure you that despite this delay to the Brexit process, PCI has a robust ‘Brexit plan’ to ensure the continuity of EU supply chains. This plan included the acquisition of an EU facility (Millmount Healthcare), located near Dublin, Ireland with the construction of a Clinical Storage & Distribution facility and a full analytical release testing laboratory allowing method transfer for release of commercial products.
We are delighted to advise that the Clinical Storage & Distribution facility in Ireland is fully operational and is shipping IMP to EU investigational sites. We will continue to conduct storage and distribution services from this European facility independent of the final Brexit outcome.
As we have previously communicated, a successful laboratory inspection was conducted by the Health Products Regulatory Authority (HPRA) and the site is awaiting the final documentation. A cohort of UK Qualified Persons (QPs) have also been added to the license as part of our ongoing strategy.
Irrespective of the final outcome of Brexit, PCI Pharma Services has always committed to ensuring that the security of your supply chain and management of your products will be maintained via our UK sites and our EU facility and we are working to ensure this process is managed effectively.
As the situation unfolds and if a deal is agreed by UK Parliament prior to 31st October 2019, we will communicate further advising of any implications to your supply chains. However In the meantime should you have any questions, please contact either your Project Manager, Commercial Account Manager, Business Development Manager or the PCI Brexit team brexit@pci.com
Salim Haffar, CEO & President
Please feel free to contact the PCI Brexit team brexit@pci.com
Please feel free to download and view our Brexit updates and factsheets
Update: 12th April 2019
We are writing to you today to advise that the European Council and the UK Prime Minister have agreed and announced an extension to Article 50 with a flexible Brexit delay until 31st October 2019, with a review at the end of June. However, the UK will be able to leave the EU before this October date should a deal be agreed by UK Parliament.
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Update: 3rd April 2019
On the 29th March 2019, a vote took place on the proposed first stage of the renegotiated Brexit deal by the United Kingdom (UK) Parliament. The plan was subsequently rejected and as a result, the extended deadline agreed during the EU Summit on the 21st March 2019 for the UK to leave the European Union (EU) remains as the 12th April 2019.
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Update: 15th March 2019
On 13th March, the United Kingdom (UK) Parliament voted in favour of leaving the European Union (EU) with a Brexit deal. A further vote took place on 14th March in favour of extending Article 50 (the UK/EU Withdrawal Agreement) beyond 29th March, however this will now require agreement from EU leaders at an EU Summit on 21st March.
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Update: 22nd January 2019
The UK Government Cabinet and European Leaders have formally agreed the plan for the departure of the UK from the European Union. However until the plan is agreed by members of the UK Parliament (scheduled around 12th December), there still remains uncertainty over the future of the relationship between the UK and Europe post 29th March 2019
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Update: CPhI October 2018
PCI is currently planning for a hard Brexit meaning that should the UK government trade negotiations not result in any agreement and the UK is entirely outside the European framework following the 29th March 2019 date, it is anticipated that materials QP released within the UK will not be recognized by the European Union
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Factsheet: Clinical Services
View the PCI Brexit Regulatory Risk Mitigation for EU Clinical Trial Applications
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Factsheet: Commercial Activities
View the PCI Brexit Regulatory Risk Mitigation for EU Commercial Activities
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Our dedicated team of specialists will be happy to discuss any of your Brexit concerns. Contact us on +1 779-208-1819 (US) or +44 1495 711 222 (UK/EU) or email talkfuture@pci.com
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