In the days immediately before and after a no-deal Brexit, ACM Global will route all shipments via a specialist courier operator, which will ensure that all shipments are managed on an individual basis rather than a bulk courier entry. The process will allow for intervention at either pick up from the investigator site, or at the UK border if required.

Shipments will be pre-cleared where possible and allowed by the country via direct connection with the local customs systems in the UK and the EU.

Shipments will be routed via the most efficient route, with the option of choosing from a number of major commercial airlines, or via the specialist courier’s vast network to guarantee flight space. This will include a decision on which UK entry point is chosen, ensuring that all shipments are not centralized via the main UK gateways. 

Temperature-sensitive shipments will be maintained as specified. Even in the event of delays, our dry ice supply chain is sourced locally in each country to always ensure availability at all times. Additional packaging stock has been secured for all temperature ranges.

• With the Withdrawal Agreement successfully passed through the UK and EU parliaments, the UK is currently in a transition period, and as such, temporarily remains part of the Customs Union and Single Market. While a number of outcomes are still to be determined by the end of 2020 with regard to Brexit and its impact on commerce, ACM is still planning for all eventualities. To ensure ongoing trials can continue, ACM is recommending all investigator sites within the EU acquire an EORI (Economic Operator Registration and Identification) number, which can be obtained via https://rebrand.ly/dn5. This measure will ensure safe passage of trial samples within the EU.

• Currently, air freight transportation is used to ship kits from the ACM UK facility and also return clinical trial test samples to the UK facility. Therefore, we would not anticipate the kinds of problems that may occur with ground transport routes. All return shipments will continue to be managed using a medical courier service, thereby safeguarding shipments and ensuring the highest priority possible.  

• Couriers would be required to change the type of airway bills that are currently in use. We have collaborated with our logistics partners and defined a plan for how to implement potential changes. Sites would receive clear instructions regarding booking and shipping processes well in advance of any shipments being sent from the collection site. As your central lab partner, the ACM-Brexit Response Team (ACM-BRT) would provide you with training for this process and any new logistical processes that may evolve as a result of Brexit.

• In the days immediately before and after a no-deal Brexit, ACM would employ a specialist courier operator to deliver sample shipments, ensuring individual tracking of each shipment. This change would enable interventions at pick up from the investigator site, or the UK border if needed. Additionally included, would be a provision for on-demand, bespoke regulatory documentation, as required.

• Currently, export licenses are not required to ship kits from the UK to EU or non-EU countries. Similarly, import licenses are also not required. ACM Global is a registered importer with the HM Revenue & Customs (HMRC), and presently, we have no indication that import and export rules will change post-Brexit. The ACM-BRT will continue to monitor the situation and will communicate any potential changes as they may arise.

• Currently, customs clearance is not required for items traveling within the EU zone. Presently, we follow a simplified customs clearance process for sample shipments into the UK that originate from outside of the EU.

• At this time, samples returned to the UK are allocated a nominal monetary value and are not subject to physical checks. We currently receive a high volume of sample shipments from non-EU countries, and these are normally received within 48 hours.

• We do not anticipate changes that will significantly impact the processing and transit times for samples returned to the UK facility. Any news to the contrary would be reported promptly.

• Yes. All shipments may require customs invoices to enable customs clearances. To facilitate the new process, ACM would supply all test sites with the required documentation and instructions one week before Brexit. Investigators would need to include the completed documentation with their shipment to ACM UK and the ACM-BRT provides bespoke, gratis consulting to investigator sites to ensure that this process is a seamless one.

• An increase in shipping costs is possible, based on the need to generate additional documentation for EU to UK customs clearances. We invite you to submit an RFP so that we may provide you a competitive proposal.