The countdown has begun to the end of the Brexit transition period on 31st December 2020. Sponsors face increasing uncertainties that will affect clinical supplies across Europe and the UK, post-transition period.
Provisions within the Withdrawal Agreement, in the form of the Ireland/Northern Ireland Protocol (“the NI Protocol”), offers a clear opportunity and commercial advantage for Sponsors working with a CMO in Northern Ireland. The NI Protocol will come into force on 1st January 2021 and will apply even if the EU/UK fail to conclude a trade agreement.
Under the NI Protocol, Northern Ireland will continue to enjoy ongoing regulatory alignment and free movement of goods with EU27, i.e. business as usual and QP release in NI will continue to be mutually recognized in both EU27 and the UK. The NI Protocol delivers a unique advantage for Northern Ireland.
Find out what this means for you and your clinical trial by downloading our White Paper.
This White Paper will:
- Explore the impacts of Brexit for Sponsors from the origin and transfer of clinical trial material through to QP release, logistics and distribution to clinical sites.
- Offer guidance on reviewing risk mitigation plans surrounding Brexit and the core strategies available to Sponsors seeking continuity for ongoing and planned studies while maintaining compliant, cost-effective and patient-centric operations through the transition period and beyond.
- Explain the nuances of the NI Protocol and how it offers a ‘business as usual’ approach to clinical supply chain management from 1st January 2021.
- Provide clarity, confidence and the reassurance you have been seeking in relation to the post-transition period.