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 Pharma Services 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 firstname.lastname@example.org
Salim Haffar, CEO & President
See our Brexit factsheets below
Factsheet: Clinical Services
View the PCI Clinical Services Brexit Regulatory Risk Mitigation for EU Clinical Trial Applications
Factsheet: Commercial Activities
View the PCI Pharma Services Brexit Regulatory Risk Mitigation for EU Commercial Activities