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. Further to this, on the 1st April 2019, UK Parliament voted on four potential amendments to the proposed deal, with all four being rejected resulting in further Cabinet debate planned for the 2nd April 2019.
On the 19th March 2019, The Department for Transport issued a statement confirming that EU Ministers had formally adopted laws meaning UK airlines and hauliers will continue to be able to provide services to and from the EU in the event of a ‘no deal’ scenario. For UK hauliers, this means permits will not be required for the vast majority of journeys to the EU until the end of 2019. PCI Pharma Services is working closely with all contracted hauliers to manage customer requirements.
We are writing today to reassure you that despite the ongoing uncertainty, 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. A successful laboratory inspection was conducted by the Health Products Regulatory Authority (HPRA) and the site is awaiting final documentation. We are also pleased to communicate that a cohort of UK Qualified Persons (QPs) have been added to the license as part of our ongoing strategy.
Irrespective of the final outcome, 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.
An emergency EU Summit has been called for the 10th April 2019 ahead of the 12th April 2019 deadline. As the situation continues to unfold and we gain additional clarity, 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@pciservices.com).
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